[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

Hearings on HIPAA Code Set Issues

April 9, 2002

Hubert Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20020

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
(703) 352-0091

PARTICIPANTS:

Committee Members:

Staff:


TABLE OF CONTENTS


P R O C E E D I N G S [8:30 a.m.

Agenda Item: Call to Order and Introductions

DR. COHN: Good morning. I want to call this meeting to order. This is the first day of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy.

I am Simon Cohn, chairman of the subcommittee and I am the national director for health information policy for Kaiser Permanente.

I want to welcome fellow subcommittee members, HHS staff and others here in person. I also want to welcome those listening on the Internet, especially those from home state of California, where it is not quite 6:00 a.m. now, but hopefully we have some of them in listening.

I also want to remind everyone to speak clearly and into the microphone.

Today is the second of several hearings planned for 2002 on code set issues. The focus today and tomorrow is on the HIPAA medical data code sets and whether there is a need for possible expansion to the list of codes or need for replacement of some of the code sets.

I want to thank Betsy Humphreys, Vivian Auld, Pat Brooks, Donna Pickett and, of course, Karen Trudel for their help at putting this set of hearings together.

With that, let's now have introductions around the table and then around the room. For those on the National Committee, I would once again remind you that as part of your introduction if you would note if there any issues coming before the subcommittee today for which you need to recuse yourselves.

I also want to explain to the subcommittee and also to the audience that we don't have very many microphones. I know Jeff was looking for one himself and couldn't find. We are going to have to sort of move the microphones around the table, I think, as we are doing introductions.

I believe those in the audience have to come to the microphone here and please state your name and affiliation.

With that, Karen, would you like to start out?

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services and staff to the subcommittee.

DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the committee and the subcommittee. I am also a member of X12 and JOFACT(?).

MS. GREENBERG: Marjorie Greenberg, the National Center for Health Statistics, CDC and executive secretary to the committee.

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

DR. YASNOFF: Bill Yasnoff, CDC, staff to the subcommittee.

MR. AUGUSTINE: Brady Augustine, Gambro Healthcare, member of the subcommittee.

MS. AULD: Vivian Auld, National Library of Medicine.

MR. AVERILL: Richard Averill, 3M Health Information Systems.

MR. GUSTAFSON: Tom Gustafson, Center for Medicare and Medicaid Services.

MS. HUMPHREYS: Betsy Humphreys, National Library of Medicine and having little or no credit for this particular hearing.

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

MR. BLAIR: Jeff Blair, vice president of the Medical Records Institute and member of the subcommittee.

DR. COHN: Could we have those in the audience please come and introduce yourselves.

MS. WHALEN: Lenore Whalen, representing the Federation of American Hospitals.

MS. LEON-CHISEN: Nelly Leon-Chisen, American Hospital Association.

MS. FREYBURG: Elizabeth Freyburg(?), independent contractor.

MS. PROPHET: Sue Prophet, American Health Information Management Association.

MR. ROONEY: Dan Rooney(?), American Health Information Management Association.

MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.

DR. BRAITHWAITE: Bill Braithwaite(?), a consultant with Price Waterhouse Coopers.

MS. GEINENI: Belina(?) Geineni(?), president, Alternative Link.

MS. BARTLETT: Melissa Bartlett, the American Association of Health Plans.

MS. PEYTON: Patricia Peyton, Centers for Medicare and Medicaid Services.

MS. GILFOY: Helene Gilfoy with Gilfoy Consulting.

MS. STEINBECK: Barbara Steinbeck, 3M Health Information Systems.

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

MS. PICKETT: Donna Pickett, National Center for Health Statistics.

DR. MULLEN: Dr. Mullen, a consultant for 3M and a former member of the National Committee on Vital and Health Statistics.

MS. GRANT: Thelma Grant, 3M Health Information Systems.

MR. LETHGO: Tom Lethgo(?) with the Health Insurance Association of America.

MR. GOLDFIELD: Norbert Goldfield(?), medical director of 3M Health Information Systems.

MR. MILLER: Bob Miller, Christian Science Legislative Office.

MS. BROOKS: Pat Brooks, CMS.

MS. TAYLOR: Ann Taylor, CMS.

DR. COHN: Is that everyone? Okay. Good.

Let me just make a comment or two and then I will be turning the microphone over to Dr. Zubeldia.

Today the focus is on ICD-10-PCS and we are going to be talking about it a little to get updated on what has happened over the last several years since it was actually developed, as well as understand a little better about its current abilities, appropriateness as a replacement for Volume 3 of ICD-9-CM.

That will be the primary focus of the agenda today. At the end of this day, we will be talking a little bit about what we have learned and next steps, as well as open items that need to be addressed from our last set of hearings.

I doubt that we will be making any decisions today. Indeed, we will have another set of hearings coming up in late May, talking once again about other issues related to code sets, but I want, obviously, the subcommittee to -- as they listen to the testimony, think about really the next step issues, what else we need to identify and how we are going to begin to try to put all this together and to hopefully have a set of recommendations for the Secretary later this year.

Now, with those comments, I actually need at this point to announce, as I asked all the other subcommittee members to announce if they have any conflicts of interests or need to recuse themselves. I need to indicate to the subcommittee and those on the Internet that I am actually a member of the CPT Editorial Panel.

I think as most of you know, CPT is a HIPAA medical code set and because of this, I am obviously going to recuse myself from voting on matters coming before the committee today and, indeed, have actually asked Dr. Zubeldia to chair this session.

With that, I turn the microphone over to you.

DR. ZUBELDIA: Thank you, Simon.

Agenda Item: Review Agenda

I think that in the interest of time, that probably we should start with the testimony that has been prepared. We have a pretty packed agenda. So, we are going to try to stick to the time, even though we are starting about half an hour late. So, I would just turn it over to Tom Gustafson for your testimony.

Agenda Item: Possible Replacement of ICD-9-CM Volume 3 (Procedures) with ICD-10-PCS

MR. GUSTAFSON: Thank you very much. I am Tom Gustafson, as has already been made evident, and I am the director of something called the Purchasing Policy Group within the Center for Medicare Management at the Centers for Medicare and Medicaid Services. The title is not terrifically important. The functional importance here is that my group handles payment policy for the acute care portion of the Medicare program and the ICD-9 coding efforts of HCFA and the CPT coding efforts of HCFA are both under my direction.

The role I am going to perform today is to provide a general and I hope mercifully brief introduction to the subject. Others who will follow me will go into various aspects of it in more detail. But for the record and the benefit of those of you who may not have been following the intricate developments here hour by hour, let me try to lay some of this out.

So, I am going to attempt to give some history and context to the decision that will ultimately face the Secretary of whether to recommend changing the standard code set for inpatient procedures from the current international classification of diseases, 9th revision, clinical modification, otherwise known as ICD-9-CM, to the ICD-10 procedure coding system.

Now, the World Health Organization created the ICD-9 and the U.S. subsequently modified it, creating what is referred to as the clinical modification, by adding more specificity to the diagnosis codes and this country also added a procedure coding section. This was implemented in the United States in 1979.

As a general proposition, I think it would be fair to say that this coding set has served research purposes quite well, but we must also consider another major use of the system, which is payment for health services, which is, of course, a major concern of my agency.

When Medicare introduced the inpatient prospective payment system in 1983, now the granddaddy of our payment systems, it used the ICD-9 codes as the basis for assigning cases to diagnosis related groups or DRGs. These groups in turn are the way we decide how much to pay for things.

Lots of changes have happened since then and the code set has been revised in various ways to keep pace, but, however, it may now be reaching the end of its useful life and, hence, the need for the meeting we are having today. To maintain the currency of the code set as the health care environment changes, the Department of Health and Human Services created the ICD-9-CM coordination and maintenance committee in 1985. This committee discusses proposed revisions to the codes.

It meets twice yearly in a process that is open and accessible to the public. I think the process, in fact, is generally a success story and is viewed by others as a model of how to go about this kind of activity.

The Health Insurance Portability and Accountability Act of 1996 had an administrative simplification title -- this is the act familiarly known as HIPAA -- which created a national process for establishing standards for coding systems and designating standard code sets.

The point was to improve the efficiency of the entire system by enabling electronic exchange of information in standard formats that everyone could count on being able to use. A final rule published on August 17th, 2000, designated ICD-9-CM as the national standard for inpatient hospital reporting of diagnosis and procedures.

It was chosen largely because it was system then in use in the United States, not because people regarded it as a paragon. At that time, the ICD-10, which we are discussing today, was still on the drawing boards. Now, as I said earlier, the ICD-9-CM has been useful for both research and for payment, but structural limitations have challenged its ability to keep up with the rapidly changing clinical environment.

Codes basically work with four numeric digits, at least on the procedure side, and the first of these established the categories in a hierarchical structure, based largely on organ systems, which allow for automatic grouping. This is highly useful for research and for analysis for payment purposes.

The trailing digits specify the particular procedure. The result of this is that as a general matter only ten codes are available within each category. When more codes are necessary, we must jump elsewhere in the numeric sequence, which disrupts the groupings and can lead to confusion among coders and analysts.

Earlier in my life, I had the challenge of helping to move a large college library from one building to another and when we did that, we took a shelf of books from the old library and put it into a half a shelf of books in the new library. The reason was so there would be space for the collection to grow in the future. This is the challenge that the ICD-9 has. The shelves are full. When you come to push another volume into the shelf, you find it won't go there and you have to stick it down at the end of the aisle and you can see how people would be confused about trying to locate things under those circumstances.

The basic categorization here is 23 years old and the number of procedures that were not contemplated when the categories were set up have been invented since then and have risen now to be matters of substantial use in the health care community. So, updating this inelastic system has been quite difficult and has required compromises that degrade its efficiency for both research and payment purposes.

The ICD-10-PCS, a possible long term solution to this kind of problem, was initiated as a possible successor to ICD-9-CM. The National Committee on Vital and Health Statistics established criteria for the development of this system. These criteria included that the system should be complete; second, that it should be expandable so that it can readily accommodate new procedures and technologies; third, that the system should employ a standardized terminology, so the same thing means the same thing -- the same words mean the same thing everywhere in the system.

The system should be what is referred to as multi-axial so that each code character has a common meaning -- and Mr. Averill will explain this further in his presentation -- and that the procedure description should be limited in such a way that they do not rely on diagnostic information.

Now, the ICD-10-PCS has been developed by 3M Health Information Systems under contract with CMS. We are the agency previously known as HCFA. So, of course, HCFA started this but we now call ourselves CMS. The development process was open and included a technical advisory panel that provided advice throughout the process.

The ICD-9-CM coordination and maintenance committee was provided frequent updates with what was going on here. The ICD-10-PCS meets the criteria that were outlined for it at the start. It uses seven alpha numeric characters, as opposed to four decimal characters, which provides much greater capacity to give an order of magnitude on this.

At present, the ICD-9-CM designates fewer than 4,000 procedures, while the current draft of ICD-10-PCS has almost 200,000 and there is plenty of room for more. We have embarked with 3M on an elaborate set of tests. Our multiple field tests were performed during 1998, 1999 and 2000. I think Mr. Averill will describe some of that as well.

The final draft was released in 2000 that incorporates results based on this testing. We also developed a training manual that was tested and refined and various other ancillary products have been made available. As part of the activity of the coordination and maintenance committee, a public hearing was held on May 17th, 2001, on the question of the possibility of having the ICD-10-PCS succeed the ICD-9-CM. You will hear a summary of that meeting later today.

So, the current status is that we have developed, tested and posted for everybody to see the ICD-10-PCS system in its many ramifications. Under HIPAA, the next step in consideration of this new system is today's hearing. The committee is to make a recommendation to the Secretary of Health and Human Services. Once Secretary Thompson receives that recommendation, he will decide whether to propose adopting ICD-10-PCS as the national standard.

This proposal would have to appear in a proposed rule and if successful, subsequently a final rule published in the Federal Register. So, how should we proceed? Well, I think this is a hard question. We need to consider the costs and benefits of staying with the current system versus those of moving to another system, moving to a new system and this one in particular.

That is something which certainly bears the careful deliberation of this committee.

I will stop my remarks there and I believe there may be some time, Mr. Chairman, for questions if members of the committee or others have some.

DR. FITZMAURICE: Tom, you had mentioned that there were desirable criteria that you found in a procedure coding system, that it be a complete, expandable use of standardized terminology, multi-axial and that the procedures description does not rely on the diagnostic information. Is this generalizable not only to a coding system used for institution procedures, but also for ambulatory procedures, these are the same desirable characteristics?

MR. GUSTAFSON: I honestly have not contemplated that question myself. I think that would be one the committee might wish to consider. So, those in the abstract are certainly desirable features of any coding system, I would suggest to you.

DR. FITZMAURICE: I guess a follow-up question to that would be is there any other procedure coding system out there that might be close to PCS that could be used for institutional medical procedures?

MR. GUSTAFSON: I don't know.

DR. FITZMAURICE: Thank you.

MS. GREENBERG: As the committee's sort of institutional memory, I am pretty sure that those criteria were laid out in a report on a single procedure classification system report that was developed by the committee. So, it wasn't specific to institutional. Am I correct about that, Donna? Yes.

MR. AVERILL: If I could just mention, I have a copy of your report if you would like it. I will just give it to the chair later.

MR. BLAIR: I have two questions. I thought I remember that in addition to the criteria that you mentioned, that in the document that was given to us to read, you know, prior to our session, that it also indicated we would have consistent definitions and that it would focus on the concept or meaning, not just the linguistics. Is that correct?

MR. GUSTAFSON: I believe that to be correct.

MR. BLAIR: And by the way, I am just going to ask for your help on this one thing here. Are you in front of me?

MR. GUSTAFSON: Yes. You are looking approximately at me and at Mr. Averill as well. He may be able to elaborate more on your question.

I was simply highlighting certain of the characteristics, certain of the criteria, which had been identified. I believe there were a set that went beyond that as well.

MR. BLAIR: Given that that is the case, I would infer that if in the future we go to other terminologies to capture information, clinically specific information at the point of care, for problem lists, for example, ala like, you know, possibly SNOMED or MedCin(?), LOINC(?), those, it sounds as if ICD-10-PCS is much better positioned -- maybe Betsy Humphreys could help us with this -- is much better positioned for a mapping between the possibility of SNOMED in the future linking to ICD-10-PCS? Is that correct, that this helps facilitator enabling mapping?

MR. AVERILL: Maybe we should just hold that question until I do my presentation and then we can come back to that question with a little bit more background. I think the answer might be clearer.

MR. BLAIR: Thank you.

DR. ZUBELDIA: Before we move on, let me ask a question. The ICD-9-PCS has about 4,000 codes -- yes, Volume 3 -- CPT has under 10,000. There is about 500 dental codes for dental procedures. You are talking about 200,000 ICD-10-PCS codes. Could you help me understand a little bit the difference in magnitude?

MR. AVERILL: Again, it probably would be easier for me to go through my presentation before we get to some of these more detailed questions because then I could refer to certain things that I talked about.

Tom gave a broad overview. I will get into a little more specificity.

PARTICIPANT: Let's move on.

MR. AVERILL: Okay. Should we just move forward?

MR. GUSTAFSON: I may have to leave at a certain point here. Let me just observe here as a matter of payment policy that desirability of having a larger number of codes available appears to the folks in my office on a daily basis. The agency is under some very substantial pressure from those who are paid and perhaps even more importantly, those who supply those who are paid, by which I am meaning the drug and device industries, to have a differentiated payment system that allows us to identify when, for instance, a particular pacemaker is used or a particular drug is used and has enough room to accommodate that so that we can possibly make differentiated payments based on use of particular items in the inpatient setting.

So, we regard that as a matter of some importance, not to say that we want to necessarily agree to all such requests, but we believe that the system ought to be able to accommodate this kind of concern.

DR. COHN: Tom, actually I have a question or two for you, since it sounds like you are going to be leaving momentarily.

This has to do with I think your sort of broader view and your role within CMS. We have obviously been looking for some time to identify an authority or someone with a sort of a broad view within CMS, who could help us with sort of the broader issues related to gaps in all of the procedure code sets.

Indeed, tomorrow we will be hearing about other proposed code sets, related to, for example, alternative services and other areas. One of the things we have been seeking is some guidance from CMS about whether there are issues related to needs for those sorts of codes for identification.

Obviously, you have just now been identifying issues around supply codes and product codes. Are you the person that we should be following up with about these issues?

MR. GUSTAFSON: I think I may be as good a person to start with as any. Karen Trudel, of course, is a lead for us in many areas. But insofar as the agency addresses acute care payment policy, I am your guy. My colleague, Tom Hoyer(?), deals with chronic care policy. Insofar as there are issues that may relate to home health, skilled nursing facilities, ESRD and some of their services in that branch of care, he may also be someone who can be a resource to you.

We would be very happy to arrange whatever would be suitable in terms of interacting with you on those problems.

DR. COHN: Okay. So, potentially, having a session with just the two of you with a discussion might be helpful. I know, Kepa, you had identified that previously as a desire for us to understand better the payment policy issues around all of this.

Thank you.

DR. FITZMAURICE: Simon just raised an interesting point. I want to expand a little bit. Are you responsible for coding systems under the Medicare program and the Medicaid program or is there a counterpart in the Medicaid program that we should also consult with on codes used for the Medicaid programs.

MR. GUSTAFSON: I am not aware, although I will look at Pat Brooks to see if she knows something I don't, that there is a specific source within Medicaid?

MS. BROOKS: [Comment off microphone.]

MR. GUSTAFSON: There is a third portion of the coding world actually reports to Tom Hoyer, relates to the is it Level 3 codes in HCPCS. Most of the action there is on durable medical equipment, which is part of why it is in his group.

But just to give you an example of how that works, that is a code set or a portion of the code set, which is maintained jointly by several major payor organizations of which we are one. We, in turn, have a committee that helps advise us on the subject, which includes representatives of state Medicaid agencies. So, there is not a separate Medicaid presence, but CMS, which actually is CMMS, includes both the Medicare and Medicaid interest.

I guess I would suggest that insofar as we are dealing with CPT or ICD-9, I believe we are primarily serving as a voice for Medicaid, mostly that is a derivative process.

DR. FITZMAURICE: There is one thing that has been happening that I frankly think it is a good thing and that is there may be 30,000 local codes that have been out among the states and the states themselves are working together to winnow that down to fewer than 1,000 codes, reducing duplication, linking them up with existing CPT codes and other codes so that the codes mean the same thing across states.

We have heard from testimony that HCFA, CMS has been active in this and I think it is a grand result for the medical informatics community to see the actual application of this consolidation. To the extent that you and your staff can take credit for it, I wish you plenty of credit.

DR. ZUBELDIA: Thank you.

Let's go with Dr. Averill's testimony here and then we will have some more questions, I am sure.

Agenda Item: Overview of ICD-10-PCS

MR. AVERILL: Thank you and good morning.

I am Richard Averill. I am research director for 3M Health Information Systems. I was the principal investigator on the CMS contract to develop ICD-10-PCS. As Tom said in his opening remarks, ICD-10-PCS was developed as a replacement for ICD-9-CM procedure codes, which are used for inpatient reporting.

In terms of their chronology of the development in 1991, there was a contract for the preliminary design of the system. Based on the results of that, CMS let a contract in 1995 for the complete system. The first draft of the complete system was completed in 1998. During the period 1998 to 2000 there were multiple field tests of the system. Then in November of 2000, the updated version was released, incorporating all the results of the field tests.

Also, this past November 2001, we did a minor update of this system based on some comments that had been received from the field. As Tom also alluded to, it was a very open development process. The development process was overseen by a technical advisory panel, who provided review and comments throughout the development and, indeed, several of the members on the this committee were members of the technical advisory panel. It included AHIMA, the American Hospital Association, the American Medical Association, representatives of managed care organizations, medical informatics community and other federal agencies.

So, this particular technical advisory panel had extensive input in the overall architecture and design of the system. We also did frequent updates to the ICD-9-CM coordination and maintenance committee, sought suggestions from both that committee and the audience, who routinely attend those committee meetings, try to incorporate those comments in during the development process. The entire system is available on the CMS web page. I missed that HCFA there. Old habits --

PARTICIPANT: [Comment off microphone.]

MR. AVERILL: So, many people have downloaded the entire system. Indeed, a number of foreign governments have downloaded it, are actively evaluating it. The country of Germany has made a complete German version, German language version of the system and is currently evaluating whether that country might move to a German version of ICD-10-PCS. So, we actually get quite a few inquiries from foreign governments because many of the individual countries around the world are faced with the problem of coming up with a new, more robust procedure coding system.

As Tom also alluded to, this committee in 1993 proposed the adoption of a single procedure classification system. Now included in that proposal was the specification of recommended characteristics of a procedure coding system. We looked at that very closely when the system was being designed and found the criteria that this committee put out to be very thoughtful, very insightful and we tried to, as closely as possible in the development of ICD-10-PCS follow those criteria.

What I will do is briefly review those criteria. First was comprehensive. All procedures would be classified within the system. Your criteria were that it would be non-overlapping, that all substantially different procedures have a unique code. That is one of the major frustrations with ICD-9-CM right now is that very disperse or very different types of codes or procedures will be mapped to the same code.

So, when one is doing a system say like DRGs in which you are dependent on the detail and the accuracy of the code, it is very difficult to make decisions sometimes in terms of where to place certain procedures in what DRG because so many very different procedures get assigned the same code. So, the non-overlapping criteria we thought was particularly important.

Expandability, as new procedures and technologies become available, that they can easily be incorporated as unique codes. A hierarchical structure that allows individual codes to be aggregated into larger categories greatly expedites research, greatly expedites an understanding of the coding system. Multi-axial, each code character to the extent possible has a consistent meaning so that if, for example, one wanted to look at all percutaneous procedures, it would be very desirable to go to a single character in the coding system and be able to look at a particular value of that character and find that out percutaneous procedures.

ICD-9-CM right now, that can be a very laborious task. You basically have to go through the whole book to try and find those codes and from the tabular, often you can't tell. You have to go to the index to find out what is actually routed to the code. That could be a major effort, something as simple as that in the current system. So, we felt that it was very important to the extent possible that each character within the code system have such a consistent meaning.

Standardized terminology, we wanted all terminology to be precisely defined. An enormous amount of effort was put into that criteria. Every word that is used in ICD-10-PCS has an explicit written definition. It is an incredible frustration in using ICD-9-CM in terms of what particular words mean, in particular chapters, can be different. There is no definition written down. It makes training with coders very difficult.

So, an enormous amount of effort was put into the issue of terminology. Finally, that diagnostic information not be included in the procedure description. So, we are very careful not to do that, that if someone wants to have diagnostic information about a patient, they should go to the diagnosis system and not the procedure system.

So, these were the main criteria. You had a few other criteria, but these were the main criteria that were issued by this committee and we attempted to follow those criteria throughout the development of the system.

Now, in terms of the structure of ICD-10-PCS, it is based on a seven character alpha numeric code. So, we used the digits 0 through 9 and the letters A through H, J through N and P through Z. We don't use I and O because we are trying to avoid any confusion with 1 and 0 in the actual physical presentation of the code number.

ICD-10-PCS is divided into 16 sections. The largest and the one most people would be familiar with would be the medical and surgical section, which contains all of traditional, what we think of as surgical procedures, but then there are separate sessions for obstetrics, placement, administration, measurement and monitoring, imaging, nuclear medicine, radiation, oncology, osteopathic services, rehabilitation, diagnostic audiology, extracorporeal assistance in performance, other extracorporeal therapies, laboratory, mental health, chiropractic and then as always there are a few miscellaneous things that kind of defy neat classification that we put in the miscellaneous chapter.

So, in your handouts this morning, there is a complete description of each of these sections and how each of those sections are structured. I am just going to spend a few minutes on the medical and surgical section, just to give you a feel for how the system is constructed.

As I said, it was a seven character alpha numeric code. This diagram shows you the seven characters. The first character tells you the section. So, that would be medical/surgical in this particular example. Then the body system, for example, heart and great vessels would be a broad body system. Then the root operation, the root operation basically tells you the underlying objective of the procedure.

Character 4 is a more detailed specification of the body part involved in the procedure. Character 5 is the approach. How is the site of the procedure reached? Was it done percutaneously? Was it done with an open procedure? Was it done endoscopically, et cetera?

Character 6 tells you whether there was any device involved in the procedure. So, for example, was a pacemaker put in? One could go into detail if one wanted to in terms of what kind of pacemaker, for example.

Character 7 is a qualifier that can be used for various purposes to add additional specificity to any code when such specificity is desired.

-- for new procedures in the system, excision and resection. Now in ICD-10-PCS, the word "excision" is used to mean cutting out or off without replacement a portion of a body part, in contrast to resection, cutting out or off without replacement all of a body part. So, very specific definitions of what the objective of the procedure was is written down for each term used in ICD-10-PCS.

These are just two examples in the medical/surgical section. On this slide are all the root procedures in the medical/surgical section. What there are are a total of 30. So, in all of what we traditionally think of surgery, there are only 30 different things that are done. So, if one steps back and starts writing down all the different terms that one thinks of when one thinks of a surgical procedure and asks, well, what is really going on here, what is really the objective of the procedure and you start asking yourself, well, what is different about this procedure versus that procedure.

What you find out when you go through that exercise, even though, frankly, we would never have predicted this day one going into this, that really there are only 30 unique things that are done in all of surgery. And here are the 30 terms that we selected to describe those 30 unique things, each of which have a specific definition written down.

So, these are the 30 types of procedures that are done in what we traditionally think of as surgery. Now, the tabular in ICD-10-PCS is set up quite differently than what we are used to in ICD-9-CM. ICD-9 tends to be a list of code numbers. Here it is basically set up in a true tabular form and at the top of each page is the first three characters of the code. In this particular case, the first character of 0 means it is from the medical and surgical section. The second character of 2 means that it is a procedure on the heart and great vessels.

The third character gives us the root operation, in this case, dilation. The definition of that is expanding the orifice or lumen of the tubular body part and then the next four characters are specified in a tabular type of form. So, here in character 4, we have the various combinations of coronary arteries listed for which dilation can be done on the heart and great vessels.

Character 5 gives you the different combinations of approaches. Character 6 basically gives you the option of saying an intraluminal device, basically a stent, was used or we always put a device, NEC(?), in the device column in case in between updates, some new type of device is created. In this case, we don't use any qualifier of character.

So, as an example of coding in ICD-9-CM versus ICD-10-PCS, if someone had three coronary vessels, what we would normally call a PPCA, if one had a PPCA on three coronary vessels and had a stent put in, then in ICD-9-CM, we would write down two code numbers, 3605 for multiple vessel PPCA and 3606 for insertion of a coronary stent or stents. In ICD-10-PCS, this would be 02725DZ, which is dilation, three coronary arteries, percutaneous, intraluminal approach with an intraluminal device.

So, you build your code up from tabular representation. Now, in terms of documentation, complete definitions manual is available with a tabular and an index. Now, one of the interesting things that we did hear, the tabular and the index are completely computer generated. So, it is not someone sitting at a monitor, typing in new codes and so on. This is a complete table-driven system, where if we add a new code, we just basically turn on a new cell. The English description of that gets automatically built by the computer. The tabular gets regenerated and the index gets updated all automatically. So, we did not want -- that insures a comprehensive and consistent index because it is all being generated by the same computer program.

User's manual that has been developed, presentation material. Summary articles are all available. A complete mapping from back to ICD-9-CM is available. All of this is on the CMS web page. I will emphasize that this was all developed under CMS funding. So, everything is in the public domain. There is no copyright issues. As I said, numerous foreign governments have downloaded it and have been testing ICD-10-PCS. So, it is a totally open and free system to the public.

In terms of ICD-10-PCS testing, there was an independent testing evaluation performed. CMS contracted with the clinical data abstraction centers or the CDACs. These are CMS contractors for reabstracting type of work. There are two of those. Each of those sites abstracted 5,000 records and coded them in ICD-10-PCS. A three day training session was provided and the documentation was provided to the CDACs to get them ready to do the ICD-10-PCS coding.

In addition, a subset of those 5,000 records were coded both in ICD-9-CM and ICD-10-PCS. The results of the testing were that the CDACs felt that ICD-10-PCS achieved its stated objectives. So, if one goes through the criteria from this committee, we ask the CDACs did they feel that those criterion were met and the answer was yes.

We found that the code was either roughly the same or in some cases shorter. In particular they said that non-specific codes in ICD-9-CM were much easier to code in ICD-10-PCS. It can often be frustrating in ICD-9-CM when there is a code that really doesn't describe the procedure and that procedure is routed to a very generic type of code. It often takes longer for the coder to feel confident that they have gotten it to the right place.

The precise specificity of ICD-10-PCS actually made the coding in those situations faster. They certainly felt that at the end of the day there was a much better, more accurate, more complete description of what was done to the patient, based on ICD-10-PCS, that if one looked at the description of the procedures that were done, that one had a much better clinical picture of what was done to the patient than one was able to achieve with ICD-9-CM.

They felt that no loss of accuracy, that there was -- that the ICD-10-PCS with its definitions and its straight forward nature would be at a minimum as accurate as current coding in ICD-9-CM and in all probability more accurate.

We found in the training that while the first couple days could be a challenge because it is so different, that very quickly, coders became very proficient in ICD-10-PCS, in relatively short order of the order of within probably by the second week, they were fairly comfortable coding in ICD-10-PCS, mainly due to the clear definitions, clear rules. They didn't have to go back and learn volumes of coding clinic rules, learn the mysteries of the index in ICD-9-CM, those sorts of things.

So, in general, the people, once they have learned -- gotten through the first week, they felt very positive. So, in summary, based on the testing and based on comments that we have received to date that ICD-10-PCS has achieved its objectives of comprehensiveness, expandability and standardization of terminology, that its multi-axial structure allows new procedures and technologies to be readily incorporated into the system without overlap.

With that, I will be glad to answer any questions.

DR. ZUBELDIA: Thank you very much. That explains a lot of the questions at least I had from the previous testimony.

I have a question now. In this final project that you did to test the feasibility, have you looked at grouping the ICD-10-PCS codes in groups similar to what is useful DRGs?

MR. AVERILL: Well, clearly, since we were also the contractor that for CMS updates the DRGs each year, we were critically aware that that would be a task and, indeed, in our current contract, that is a task, once CMS actually asked us to perform that task. So, much of the initial motivation for the development of ICD-10-PCS was the frustration with assigning codes to DRGs. A clear, constant example is that many things today can be done by non-surgical means. So, the same procedure could be accomplished percutaneously, can be accomplished endoscopically, can be accomplished surgically.

Well, right now, many of those codes, because there is only one code, we are assigning it to a surgical DRG, where we really should assign it to a DRG dealing with an endoscopic procedure or maybe even if it is just percutaneous and medical DRG. So, we were very much aware that we would -- the task would be there to map it to DRGs. So, we feel that would be a very straightforward endeavor. Indeed, it would be a pleasure because many of the current problems that we see with DRGs that originate from lack of specificity in the codes could be corrected at that time.

So, that would be actually a very enjoyable project to do and we feel it would be very straightforward. The only challenge that we see is because there are so many more codes, exactly how we would present the definitions book. The definitions book, unless we were very clever, would probably become somewhat larger than it currently is. So, other than that challenge, the actual recreation of the DRGs and ICD-10-PCS would be a very straight forward process.

DR. COHN: Jeff, I was going to go and then I think you are next.

I actually have a couple of questions and I guess, first, a very basic question. I was just sort of looking at the areas and was being reminded about ICD-10-PCS and I guess for the interest of full disclosure I should mention that there are a number of people around the table that actually sat on the technical advisory committee. I sat on it. Marjorie Greenberg, our -- weren't you on it? Oh, I am sorry. Donna Pickett. I am sorry. I know Betsy Humphreys was. I believe Clem McDonald -- once again, I don't think it matters one way or another. I don't think I have to restrict my questions, but I did want to sort of comment.

Having said that, I did notice, for example, that the areas that you cover in ICD-10-PCS are sort of an interesting -- I won't say hodge-podge, but beyond the medical/surgical -- for example, you have lab and I was just sort of curious about how that relates to LOINC, which appears to be a developing national standard lab terminology.

Does that connect in or is that something that should be segmented out and not thought about? That is question No. 1.

MR. AVERILL: Well, Dr. Norbert Goldfield, who headed up the laboratory portion is here. I am going to let him answer that. So, why don't we let him take that question and then we will --

DR. COHN: Could you quickly answer that? Because, obviously, that was done before, I think, LOINC came into prominence.

DR. GOLDFIELD: I am not sure if Clem is listening via the Internet. I assume he is. He wouldn't come in person. There would be no reason for him to come since that would be his style.

But clearly we worked very collaboratively with the LOINC people throughout. In fact, we have established

-- and this, obviously, would have to be completely reupdated -- we did a mapping to LOINC. So, there is a map that is old at this point, but there was a mapping to LOINC and we had numerous, numerous conversations between ourselves and the LOINC people. I made a presentation to the LOINC group at one point. So, clearly there was the understanding and realization and appreciation that LOINC is a standard, but at the same time we felt that under the contract specifications, we needed to have the complete set of testing done, but to move the process forward, we did do this mapping and then, obviously, the decisions will be beyond us as to what would have to be -- what would be used and what would not be used.

DR. COHN: Okay. I have actually got three questions here for you. Are you okay with that?

Okay. Second question just has to do with the issue of DRG and revenue impact. I think we all observed that revenue policy does sort of drive a lot of decision-making. Maybe this is a question for you, Tom. I think there was some hope by at least some parts of the industry that there will -- as a result of any change, that there will be additional revenues to hospitals from other groups. Is there any intent in this if one develops a new set of DRGs, that there would be additional revenues available or is this intended to be revenue neutral?

MR. GUSTAFSON: I think that any change we would make of this sort would have to be revenue neutral. Basically, we are constrained by Congress in terms of how we set the updates for the system. We have conferred a bit internally about how to proceed on this. Steve Phillips is the division director in charge of that area has -- and I have had several conversations and I believe he has been working with staff on this as well.

But as a general proposition, I think what we could look for is a -- if we move to this new coding system is one that would have the potential of paying in a more differentiated fashion under some circumstances, perhaps allow an expansion of the DRGs and the number of DRGs, allow more accurate payment in short. But I think there would be no intent on our part to see that accompanied by any substantial increase in the amount of payments that the Medicare program would make in the aggregate.

DR. COHN: Okay. Let me ask one final question and then I will probably stop for the rest of the session here.

It just has to do with -- I have woken up a little more and reviewed your testimony. You mention actually in your testimony that it would be desirable to have an -- these are the cost benefit analysis performed on moving to a new coding system. Has that been attempted or completed by CMS or is that just a recommendation of something that ought to be done?

MR. GUSTAFSON: I would characterize that as a general point of deliberations that all parties involved in making this decision need to be aware of, which is to say there are costs and benefits, as I mentioned very briefly, to retaining the current system. What you got is what you got. It is like the car in your driveway. It is paid for. It may not go as fast as you like or have as good gas mileage, but we have got it and that there is a substantial advantage to sticking with what you have.

On the other hand, you have heard already from Mr. Averill and myself about the rather substantial or what we view as the rather substantial limitations to the current system and we have to acknowledge that moving to a new system would require some costs on somebody's part. Rich pointed out the training that was used in the testing exercise. Well, if you have to train every coder in the country for a week or every inpatient coder for a week, I mean, there is a cost associated with that and folks need to be aware of that.

I don't think we had contemplated or would necessarily recommend a short of sharp pencil economist exercise on this point, although one could embark on such an analysis if the matter seemed to be substantially in doubt.

MR. AVERILL: One thing I might add on that is that we focused on the reimbursement side, but the whole efficacy of what procedures are being done in the U.S., what kind of outcomes we are getting, you can take something as luminous as radiation oncology. You look at the current system and you basically have for all practical purposes no information in terms of what is being done in that arena, what are the different therapies being applied and so on.

We had a great deal of trouble constraining radiation oncology to roughly 1,200 codes. There we could get some very precise information about what is being done, track it over time. Right now we have absolutely for all practical purposes no information in terms of the national coded database. So, even ignoring the payment issues, just understanding what is being done, what trends are there and then ultimately asking some efficacy types of questions, I think that is crucial for moving forward.

MR. BLAIR: Simon touched on one of the areas where I did have a question but before I go on, in the interest of full disclosure, back five years ago when I was with IBM, I was involved with a six month consulting engagement with the College of American Pathologists that was developing SNOMED-RT at the time. I don't consider that a conflict of interest in any way, but it is there for full disclosure.

With respect to the cost benefit area, I am not sure that I interpreted this correctly, but I thought that in your response to Dr. Cohn's question on cost benefit, it appeared to me as if a good deal of your focus was with respect to the cost to Health and Human Services for educating, maintaining, updating ICD-10-PCS compared to ICD-9-CM. My perception would be that a good deal of the cost saving is going to be for the users within the provider committee, the users within other parts of the payer community and for users within clinical research.

So, I would hope that when you do look at cost benefit that you include those and make sure that we are representing the savings to all of those groups.

MR. GUSTAFSON: If I can just comment on that, I would heartily endorse what you say. I think that the committee and ultimately the Secretary and whoever may comment on the rule should we proceed in that direction is making what we must acknowledge is a national decision and we need to take account of the costs and benefits and the other virtues and whatever the opposite of a virtue is for all members of the community that are being affected by this.

If it is more of a problem for CMS to administer a system or costs us more money to pay 3M to do it -- you know, help us with it or what have you. That is a comparatively minor element and certainly my agency's thinking is not dominated by the sort of internal costs that we have, but with a keen eye toward attempting to make ultimately a payment system, but even more generally a coding system that works best, is most efficient, so forth and so on. I think we have to acknowledge as we do that that whatever forward future course there is on this, there are going to be costs associated with that.

If we stick with the current system, there will be the foregone opportunities to learn more about what is going on, to have a more differentiated payment system. If we move to the new payment system, you have heard Rich explain its many virtues. Personally I find those fairly impressive, but as an economist, I have to tell you you also have to look at the fact that it costs you something to get there. You just need to -- we all need to look at all of that and not just be blinded by any part of it.

DR. ZUBELDIA: I have a question. Maybe you can clarify for me to what extent this code set overlaps with other code sets. I am looking at page 20 of this 3M HIS report, where it describes the laboratory procedures and miscellaneous procedure codes. It seems to me like with this very flexible and comprehensive code system there would be a complete overlap of the laboratory section of the CPT book.

On the miscellaneous procedure codes where you cover acupuncture and yoga therapy and all of that, have you looked at the overlap of those codes with other alternative codes for alternative medicine?

MR. AVERILL: Well, we certainly were aware of the existing coding systems throughout the world. We do a fair amount of international work. So, in the process of doing this, we scoured all the different procedure coding systems out there to make sure that if there were procedures being coded somewhere, that someone thought was important to code, as well as obviously, all the input we got throughout the development process, we included those.

So, we tried to throughout the development make that as comprehensive as possible, such that -- I am not sure what you mean by overlap, but I think Norbert wanted to make a --

DR. GOLDFIELD: I think, again, to the extent that there is overlap, there always has to be overlap, but just to give a clear example of the development process on a laboratory, for example, we work very closely with LOINC, which, obviously, is extremely comprehensive, but just as importantly we work with all the colleges, American College of Pathology, American Society of Microbiology. So, all these different groups had input and then there are some very rarified groups of laboratory professionals.

So, within the context, that was sort of a development process. As a consequence, that will create de facto overlap with the other different systems that are out there. But just I wanted people to understand a little bit as to how the process was developed. It was executed with respect to laboratories, (a) with the realization that LOINC was there. So, we had a very close relationship with LOINC. And then (b), there was always an effort to the extent that people were willing and pretty much in most situations, institutions were willing to work collaboratively with organizations that represented that specific discipline for them to in essence provide much of the input on the codes that were there.

MR. AVERILL: It is ultimately, for example, with LOINC, it would be up to CMS and yourselves whether LOINC should be used or whether the laboratory portion of ICD-10-PCS would be used at all. Contractually, we were required to develop all these sections. So, in coordination with LOINC, we tried to develop a section that was consistent with that.

DR. ZUBELDIA: The question was more on CPT codes. Have you looked at the overlap between ICD-10-PCS and CPT?

MR. AVERILL: Well, when you say overlap, you mean that the -- are all procedures in CPT codable in ICD-10-PCS?

DR. ZUBELDIA: Yes.

MR. AVERILL: To the best of our knowledge, that should be true.

DR. FITZMAURICE: As we look through the vocabularies and coding systems, we are sensitive to principles --

MR. AVERILL: Let me do just one clarification. Clearly, this is inpatient. So, things like E&M codes and things that are specific for office visits would not be. So, with that caveat, those things that specifically relate to office visits, those types of services, which are not applicable to an inpatient setting, with that one exception, everything that is codable in ICD-9-CM, CPT and most of the other developed procedure coding systems in the world should be codable in ICD-10-PCS.

MR. BLAIR: Could somebody help me at this juncture get a feeling for the degree of overlap that that causes then? I don't know whether Simon can help or -- does that create a very large overlap or just a small one?

DR. COHN: Well, I think, I mean, basically historically there has been a large overlap. So, this is really nothing new. With ICD-10 Volume 3, there was always the ability for an in-hospital procedure to be coded by the hospital at their level of specificity and then the physician would also use CPT to code the procedure, but usually at a slightly more specific level heretofore using CPT. Richard, do you agree with my characterization?

MR. AVERILL: Well, basically, the objective of any procedure coding system is to allow the coding of any procedure that is done. So, in this case we were trying to create a procedure coding system that would allow any procedure done in a hospital to have a unique code. So, to the extent that any of the other coding systems out there have the same objective, there will be overlap.

DR. COHN: Jeff, also, I think this afternoon we actually have Tracy Gordy from the AMA, who will be, I think, probably talking about probably at least their view of the overlap between these.

MR. GUSTAFSON: Perhaps I could jump in here for just a moment, at some risk to my personal health, to just comment very briefly on what we understand the decision before the committee to be and that relates to the use of ICD-10 as a possible successor to ICD-9 for inpatient services. Laboratories and outpatient services are paid, using the CPT code at present. Whether that is the appropriate standard for all time is a different question, a separable question.

Just to give some perspective on this, in very rough orders of magnitude, laboratory payments in the U.S. go about a third to hospital-based laboratories, about a third to independent laboratories and about a third to physician office labs. Those figures are not exactly right, but I don't remember exactly what they are. But they are roughly in those groupings so that were we ever to contemplate the question of appropriate code sets for laboratories or if possible a different code for laboratories, one would need to consider the various parties that are making use of them and ICD-9 may be a simple and obvious answer in a hospital context, may be a very different perspective from the standpoint of a practicing physician's office. So, one would need to consider that as well.

DR. ZUBELDIA: We have time for one more question and then we will move on.

DR. FITZMAURICE: Rich, I wanted to get to the characteristics and the hierarchical structure. As we look for principles, guiding principles, and looking at coding systems and vocabulary systems, I want to make sure that I understand the hierarchical structure. You say that individual codes can be aggregated into larger categories. To me that breaks it down into two things.

One, you have to enumerate fine enough entities for the aggregation and then, secondly, you have to classify them in some meaningful sense. I think of grabbing a handful of sand and if it is aggregated too finely, enumerated too finely, then you might have yellow sand, red sand, brown sand in there and that couldn't be classified well for, say, its light reflecting capabilities. You would want to enumerate individual grains of sand and one of the characteristics might be their color.

On the other hand, somebody may not care about how well it reflects light. They are not going to use it for the roof of a house, but they want to know -- I want to keep my beach from washing away. How well does it clump? Is it rough or is it smooth?

Does hierarchical structure mean that you have to be sure to enumerate finely enough for the purposes for which you want it, whether it is quality of care, whether it is payment purposes. They might lead to different kinds of enumeration and you would have to classify them well, but a classification that is useful for payment might be different than a classification that is useful for clinical care or looking at the quality of care.

As a tradeoff, how to try to make your enumeration of the individual elements, like the individual procedures, and your classification serve multiple purposes. Or do you have to fall back on different classifications for different purposes?

MR. AVERILL: Well, you go back to one of the other criteria, which was not overlapping. So, I think that really drove us to make each unique procedure a unique code. Then the big question becomes structurally how do you put that together to meet the hierarchical purposes and the aggregation purposes to which various entities might want to put the coding system.

So, hierarchically one could say, well, you could look at the second character and get all the procedures done on the heart and great vessels. You go to the fourth character and get those procedures done in the coronary arteries. So, you could aggregate up that way or aggregate down that way or you could go to the fifth character and say I want all the procedures on the heart and great vessels, on the coronary arteries that are done endoscopically and be able to get that.

So, depending on your purpose and what you wanted to look at and how fine you wanted to get, you can basically aggregate different code characters together in a hierarchical way to get the subset of procedures that you would be interested at the level of specificity that you are interested in.

DR. FITZMAURICE: So, it is not only making the enumeration fine enough, but capturing enough of the characteristics of that individual element that is useful later on.

MR. AVERILL: Right.

DR. FITZMAURICE: Thank you.

MR. BLAIR: Could I kind of build on Michael's question, which I thought was very much on target, and your answer seemed to be in terms of the structure and in terms of the fact that you have precise definitions, which all does assist in driving things down to the level of clinical specificity that would be needed for patient care, but the piece that wasn't clear to me was when you were pulling this together and you were consulting with other groups, did the use of it, was it focused specifically on purposes for reimbursement and for statistical purposes or did you wind up having individuals say we need to go down to this level of granularity to improve patient care or clinical research?

MR. AVERILL: Well, it was the latter and that was -- so, we were not driven by payment purposes. Obviously, we had that clearly as one of the objectives, but it was by no means the only objective. So, there are many distinctions that are made in the system that for the purposes of payment, one would in all likelihood be unlikely to make different payments based on that level of distinction.

But for purposes of monitoring clinical care for quality evaluation and so on, we had -- there was a great deal of input saying that that level of specificity was desired. So, we constantly went back to the notion of non-overlapping for whatever purpose, be it quality assessment, be it health services research, be it payment.

So, clearly for the exclusive purpose of payment, we could probably have much fewer codes in this system.

DR. ZUBELDIA: Thank you.

Next is Vivian Auld, National Library of Medicine

Agenda Item: Summary of May 17-18, 2001 Meeting of the ICD-9-CM Coordination and Maintenance Committee Regarding ICD-10-PCS

MS. AULD: Okay. As Kepa just said, my name is Vivian Auld. I am from the National Library of Medicine and my task today is to provide a summary of the May 17 through 18th, 2001 meeting of the ICD-9-CM coordination and maintenance committee and their discussion of ICD-10-PCS.

What I am going to try and do is give you a birds eye view of what was discussed at that meeting. The entire minutes and all of the testimony is available on the HCFA or CMS web site. So, I would strongly recommend that if you want the full flavor of what was discussed, that you take a look at the actual minutes.

The purpose of the meeting, as I said, was to discuss whether or not HCFA, now CMS, should have ICD-10-PCS named as a national standard replacing the current ICD-9-CM Volume 3 procedure codes for inpatient hospital use. As both Tom and Richard have already said, there has been significant thought, planning and testing that have gone into the development of PCS and this meeting took place after a lot of the testing took place. It was a chance for industry to react to all the work that had gone in by 3M and CMS.

There were 11 organizations that testified at the May 2001 meeting. Five of those are going to be testifying again today. The organizations that testified were AdvaMed, who will be testifying today, AHIMA, who will be testifying today, American Hospital Association, who will be testifying today, the AMA, who will be testifying today, the American Speech Language Hearing Association, DRG Review, Federation of American Hospitals, who will be testifying today, Ingenics(?) Syndicated Content Group, Medical Technology Partners, McKesson HBOC and Princeton Reimbursement Group.

So, what were the overall conclusions of the meeting? Essentially all of the organizations with the exception of the AMA supported the adoption of ICD-10-PCS. Of those ten, three strongly recommended further testing, evaluation and planning prior to adoption. The three were AHIMA, AHA and FAH. All of the organizations agreed that any implementation would require significant resources before it went forward.

As both Tom and Rich have already indicated, there were significant limitations in ICD-9-CM Volume 3 and since they have done a really good job of explaining what those are and these have been simply repeated by these various organizations, I am not going to cover this slide. All of the organizations also talked about how ICD-10-PCS addresses those limitations and, again, Tom and Rich have covered those -- since, again, they are covering the same information, I am not going to reiterate those again.

One thing that people did come forward with is the fact that ICD-10-PCS is not perfect. One of the things that they stated was that granularity falls short in some areas. In some cases, it is actually taking a step back from where they were with ICD-9-CM.

There are also substantial departures from all the existing health care code sets and, again, the fact that it is going to require significant resources some felt made it not perfect.

So, what was the time frame that people were suggesting if you did implement PCS? This was actually one of the most contentious points that was discussed. There wee essentially two opinions if they were expressed at all. One was to implement immediately, which was expressed by AdvaMed and Princeton Reimbursement Group. The second option was to implement three years after HCFA implementation in conjunction with migration to ICD-10-CM. There were some indications that if you moved forward with ICD-10-CM or PCS without the other, you were going to cause problems in overlaps and having to maintain too many code sets.

Some of the issues that would affect the time frame were coordination between parties. This is something that they consider was imperative and the fact that more testing is needed prior to implementation.

Now we keep saying that significant resources will be needed for implementation. Some of the areas where those resources will be required is in the changes that will be needed for the software, such as redevelopment of related systems, including groupers, payment policy and performance measurement systems.

Another area where you will need resources will be cross walking among the different coding systems. As has already been mentioned this morning, extensive training is going to be required due to the different -- due to the fact that this is such a significant difference from all previous code sets that have been -- exist at this point. Obviously, as Tom has already mentioned, cost is a very significant factor.

I would also add that the cost is one of the reasons that the AMA didn't support it. They felt that it was -- the benefits received did not justify the cost.

Some of the other issues that were raised were the maintenance of ICD-10-PCS. You are going to need a very well-defined maintenance and implementation process. AHA felt that the current ICD-9-CM C&M process works quite well and should be adopted for PCS.

There were suggestions that -- suggestion frequencies for the update varied from organization to organization. The Federation of American Hospitals suggested that it be once a year in conjunction with the Federal Government's fiscal year.

AdvaMed suggested that it be quarterly and some just said more than once a year. They weren't very specific.

There was also a request to have a minimum time between the time that a new code is proposed and when it is implemented. I find it interesting that a lot of these issues are touching on some of the other issues that we are hearing in the various code set hearings that we have been having over the last few weeks, months.

Other issues that deal with guidelines and coding rules, they want -- AHA wants to make sure that there is clear, unambiguous instructions and consistent official coding and reporting guidelines. AHIMA wants -- they requested that the process be established for developing rules and guidelines. They also asked that we implement rules and guidelines on the same schedule as the code set. It doesn't help if they come out at different times of the year.

Also, the cooperating parties, AHA, AHIMA, CMS and NCHS should continue their role in developing guidelines and clarifications.

Some additional suggestions that came up were that we identify a body within CMS that can and will promptly respond to questions regarding implementation. This was specifically geared towards software developers, that they need some place that they can go and get answers when they need them.

They asked that all materials associated with code sets should be easily accessible and some were suggesting that they should be available on the web. Some of them were requesting them also in print. Either way, they wanted one place that they could go for everything.

They also requested that CMS should develop a web site that can act as a clinical coding resource. What they were really getting at was someplace where people could go and pose questions and get responses from other users or CMS and that all this information, the questions and the answers could be resourced -- could be archived so that all this information can build and be available over time.

The last point is AHIMA and Ingenics both argued in favor of a single procedure classification system. They stated -- one of the reasons for this was the fact that you would have an overlap in services, forcing facilities to use and maintain two procedural coding systems. In response to these comments in the minutes, CMS stated that there are no plans to implement ICD-10-PCS as a single procedure coding system.

So, with that, any questions?

DR. ZUBELDIA: Thank you.

Let me start the questions by asking for a little bit of a clarification. You said that one of the issues discussed was the implementing both the ICD-10-CM and PCS simultaneously. What is the linkage between the two? Is there a correlationship between the two of them and they are both ICD-10?

MS. AULD: I don't know that I am the best person to answer that. So, I will look at Donna or Pat, who were at the meeting.

MR. AVERILL: There is no intrinsic relationship between the two. I think it is an implementation issue that if one is going to revamp how diagnoses are coded and procedures are coded, that if that is going to happen -- if both are going to happen in the near future, I think the industry would like to undergo both changes simultaneously as opposed to have sort of the disruption, if you will, one year and then two years later have a second endeavor on, say, the diagnosis side.

So, I think it is more of implementation convenience than anything else.

MR. BLAIR: Vivian, you mentioned that there were a few members that felt that there needed to be more testing. Are you able to expand upon that and -- I am sorry.

MS. HUMPHREYS: I was just commenting that the people who made those comments, I think, are going to be testifying later. So, perhaps it would be better to ask them.

MS. AULD: Yes, definitely.

DR. FITZMAURICE: A clarification and then a follow-up question.

I notice on two consecutive slides, ICD-10-PCS addresses these limitations and then it is not perfect. You have the same bullet. Is that a typo? It says substantial departure from existing code sets. I don't know if that is a limitation that is being addressed or if it is a not perfect bullet.

MS. AULD: I did that intentionally simply because it depends on your perspective as to how you are going to interpret that.

DR. FITZMAURICE: Okay, but I see the same organization might say it is a limitation that is being addressed, but they also might say that it is not perfectly addressed that way.

MS. AULD: AMA is the one who brought it up. Others alluded to it and that is why I put it on both slides.

DR. FITZMAURICE: The follow-up question is --

MR. GUSTAFSON: Do you recall that economists can hold two things in mind at the same time, on the one hand and on the other hand.

DR. FITZMAURICE: I do remember that, Tom. Thank you.

I am told that there is a national shortage not only of nurses but also of qualified coders. So, it appears that if we are going to have this coding continue, we are going to have to be training new coders, who are sensitive to the costs and the benefits of coding systems.

Is there any research, any study, any pilots that show which systems are easier to train a new coder in a particular system? Or is that something that is needed?

DR. COHN: AHIMA may want to testify on that issue.

MS. BROOKS: I am Pat Brooks, CMS. I think AHIMA and AHA will probably go into greater detail, abut I know when we teach kids at school -- when we teach people how to use ICD-9-CM at schools, it takes weeks to learn the procedure things and then people like myself, who have been doing this over 20 years have to memorize what award means in a particular section and share that. We were surprised pleasantly that our CDACs, both sets, could both use the system in 2 1/2 days. That was rather astonishing to us.

DR. FITZMAURICE: So, that is a cost differential to be taken into account when you are looking across all the coding systems.

DR. COHN: Though probably we should be aware that I think the CDACs were trained coders. Is that correct? These were trained coders that were learning a new coding system as opposed to people who didn't know how to code at all.

DR. FITZMAURICE: Thank you, Simon.

DR. COHN: Just a little level setting.

Can I make a comment? Vivian, I just want to thank you very much for distilling the whole day's worth of testimony into 15 minutes. I asked her to sort of help us with that, knowing that it was going to be sort of tough for people to go through -- I think it was about 150 pages of testimony.

MS. BROOKS: It is about 57 pages.

DR. COHN: Oh, is that all? I am overstating it then. I really want to thank you. I think we are all very much appreciative of that.

DR. ZUBELDIA: Let's take a -- we have scheduled a 15 minute break. Let's take a 15 minute break and continue at 10:30.

[Brief recess.]

DR. ZUBELDIA: Let's begin again. We now have a panel that is going to talk about the possible replacement of ICD-9 with ICD-10-PCS. I would like to start from our left to the right and go through the panel members and then we will have questions for the entire panel.

Agenda Item: Panel 1 -- Possible Replacement of ICD-9-CM Volume 3 (Procedures) with ICD-10-PCs

MS. LEON-CHISEN: Good morning. My name is Nelly Leon-Chisen. I am the director of coding and classification at the American Hospital Association or AHA. On behalf of our nearly 5,000 member hospitals, health systems, networks and other providers of care, I would like to thank you for the opportunity to provide comments on the possible future implementation of ICD-10-PCS.

The AHA's central office on ICD-9-CM serves as the United States clearinghouse for issues related to the use of ICD-9-CM. The ICD-9-CM central office was created as a result of the memorandum of understanding between the AHA and the Department of Health and Human Services back in 1963. We are also the publisher of Coding Clinic for ICD-9-CM. Coding Clinic is the official publication for ICD-9-CM coding guidelines and advice, as designated by the cooperating parties.

Collectively, CMS, the National Center for Health Statistics, NCHS, the AHA and the American Health Information Management Association, AHIMA, are known as the cooperating parties. Accurate and precise reporting of clinical codes is extremely important because clinical codes are key to benchmarking, quality assessment, research, public health reporting and strategic planning, in addition to accurate reimbursement.

For instance, ICD-9-CM codes allow hospitals to develop critical pathways for those diagnoses and procedures that are high volume, high risk or high cost and those in which the course of treatment is similar between patients. The hospital can determine which procedures are high volume by examining their clinical abstracted data and selecting the ICD-9-CM codes that appear with highest frequency.

Let me talk about why change at this point. ICD-9-CM has been in use for more than 20 years and it is long overdue for an overhaul. Many of the new procedures and innovations in medical practice are not adequately captured in the ICD-9-CM. The ability to expand enumeration for a particular procedure category is limited because of the physical numbering constraints contained in the current system.

Consequently, some categories provide vague and imprecise procedure codes and recently we have seen that chapters 00 and 17 were open for the creation of new codes. However, at the current rate, for example, 24 new codes were created this year. These new chapters will be insufficient to keep up with the need for new codes.

Because of numbering constraints, ICD-9-CM groups several distinct procedures perform on different parts of the body and with widely different resource utilization together under the same procedure code. For example, code 99.29, injection or infusion of other therapeutic or prophylactic substance has been used to report a variety of procedures, such as an injection of epinephrine to cauterize a rectal ulcer, infusion of a narcotic into a pump for pain relief, insertion of an implant in the eye for slow release of an antiviral drug and injection into the uterine artery to treat a fibroid.

This vagueness in coding does little to help hospitals, payers or researchers. To identify patterns or treatment procedures, medical records must be pulled and examined. For example, a researcher studying outcomes of antiviral drugs released via implantation in the eye would first need to examine all the medical records with 99.29 to identify the subset of patients that received the antiviral drug, a very labor intensive task.

More detailed code assignments made possible by ICD-10-PCS are needed. That would greatly reduce the administrative burden for hospitals. More detailed codes would reduce the requirements for submission of additional documentation to support claims, allow the capture of accurate data on new medical advances and provide data to support performance measurement, outcome analysis, cost analysis and monitoring resource utilization.

The time line for implementing the new system should be carefully orchestrated to minimize the administrative burden to providers. Hospitals are already facing numerous regulatory changes over the next several years, including the HIPAA privacy, security and electronic transaction standards, as well as implementation of new prospective payment systems, all of which will add significantly to the hospitals burden and costs.

Therefore, the ability of hospitals to absorb all of these regulatory changes must be carefully taken into consideration. The vast majority of hospitals are dependent under hospital information system vendors for programming changes. Therefore, the AHA supports the HIS industry in requesting the ICD-10-PCS implementation for procedure coding be carried out in tandem with the migration through the ICD-10-CM diagnosis codes. The AHA also supports their recommendation to implement ICD-10 three years after HIPAA implementation.

One of the reasons that we heard about wanting to have both diagnosis and procedure coding changes being implemented at the same time, because of the changes involved in the software changes, that they would wind up going into some of the same tables, some of the same systems and to change both diagnosis and procedure codes would require going into the same programs twice if these systems were not implemented at the same time.

With regards to the costs, implementation of ICD-10 will be a complex and costly process. Therefore, Medicare along with other health plans should be sensitive to these to these increased regulatory costs and adjust payments accordingly.

The AHA believes that the costs of implementing significant new regulations should be worked into the Medicare prospective payment rate updates. Further, we believe that Congress should establish grants to help hospitals with the enormous costs of complying with the HIPAA rules, including conversion to an entirely new coding system, such as ICD-10.

For hospitals the bulk of the costs associated with the adoption of a new procedure classification system will be the costs associated with training personnel. Hospital support staff, such as coders and billers, will have to attend training seminars to familiarize themselves with the new coding guidelines, rules and definitions.

Hospitals will have to work with their medical staff to ensure that the appropriate documentation is available to support the new coding system. ICD-10-PCS code selection requires that more specific and detailed physician documentation be available in the medical record. This greater level of specificity may also require that coders and billers, expand their knowledge of medical terminology, anatomy and physiology and disease process.

Changes to the coding system also require extensive and costly modifications to information systems. Hospitals use a combination of purchased software and in-house developed applications. The software applications that will require modification encompass functions, such as code assignment, medical records abstraction, aggregate data reporting, utilization management and clinical systems billing, claim submission and other financial functions.

In essence, every electronic transaction requiring an ICD-9-CM procedure code would need to be changed. These changes would include software interface, field length formats on screens, report formats and layouts, table structures holding codes, expansion of flat files, coding edits and significant logic changes.

Hospitals will have to bear the financial burden associated with software changes, as well as possible hardware upgrades. I would like to emphasize that these changes would take place whether you move from ICD-9-CM to ICD-10-PCS or any other procedure classification system. During the transition period, information systems will have to support both ICD-9-CM and ICD-10, both PCS and CM coding systems, requiring additional data storage space.

Small and rural health care providers in particular, many of whom are already facing serious financial challenges and have less sophisticated information systems are further handicapped in their ability to accommodate such changes and may require additional resources and support to help them require information and coding system support programs.

Let's talk about testing. A little bit was mentioned earlier today. The AHA has worked closely with institutional members in the initial informal field testing of ICD-10-PCS. Based on this testing, ICD-10-PCS holds a great deal of promise and should be considered for future use. The AHA believes that before implementation takes place, however, the new system should be tested for all services in all settings.

Thus far, the testing has been limited to primarily the medicine and surgery section in the in-patient hospital setting. Other sections to be thoroughly tested are obstetrics, measurement and monitoring, imaging, nuclear medicine, radiation oncology, osteopathic, rehabilitation, audiology, therapies and mental health.

Also, further formal testing should be undertaken with coders using real records. Additionally, the testing should also consider the compatibility of the new system with existing payment systems, such as DRGs, APCs or simple fee schedules. The AHA expects that the use of ICD-10-PCS will not result in lower reimbursement to providers, compared to levels they would receive by using ICD-9-CM.

I would like to stress that no decisions should be made or discussions entertained regarding a potential single procedure classification system until all contending systems have been thoroughly tested for compatibility with existing payment systems. This testing should be undertaken by an objective organization, preferably under the direction of NCVHS.

We ask that you consider the following implementation issues. We would support migration to ICD-10-PCS after testing has taken place and funding is established. Medicare, as well as other payers, should be sensitive to the increased regulatory cost resulting from this migration and should adjust payment accordingly. The AHA would be pleased to assist NCVHS and CMS in identifying the nature and magnitude of these costs.

We support a well-defined implementation and maintenance process. This process should be broad-based and take into consideration the needs of all users. It should also be predictable and take into account the capabilities of the users to adapt the coding changes when they occur. This includes the establishment of routinely scheduled meetings to review coding changes and a date certain for using approved coding changes.

The AHA supports the current ICD-9-CM coordination and maintenance process and would support the same process for ICD-10-PCS. This process is well positioned to reach the broadest audience possible.

We believe there should be clear, unambiguous instructions and consistent official coding and reporting guidelines. These should be readily available and accepted by all payers, preferably as part of the HIPAA standard code set, just like the current ICD-9-CM official coding guidelines are part of the standard code sets. We would like to continue the role of the cooperating parties; namely, AHA, AHIMA, CMS and NCHS, in the development of guidelines and clarification on the application of ICD-10-CM and ICD-10-PCS, as we currently do for ICD-9-CM.

The AHA has a long-standing memorandum of understanding with HHS to provide ICD coding advice and training. We intend to continue in this capacity under ICD-10. The AHA is uniquely positioned and ready to take a leadership role in the training of our members. Our members include hospitals and health systems, providing services across a continuum of care. We have skilled nursing, home health and outpatient services, in addition to acute, subacute and long-term inpatient hospital care.

Our members look to the AHA for guidance and support and coding training and education. The AHA's Coding Clinic for ICD-9-CM and the Editorial Advisory Board serve as the nationally recognized source for coding advice. As such, we have an established process that reduces confusion and provides clarification and consistent interpretation of coding rules. The same process would be beneficial under ICD-10.

A detailed implementation time line along with milestones should be developed. That AHA would be happy to work with NCVHS and CMS to assist in developing a reasonable implementation time frame.

Lessons learned from other international implementations of ICD-10-CM should be applied. Backwards and forwards, electronic cross walks between ICD-10-PCS and ICD-9-CM Volume 3 codes should be made available free of charge or at a reasonable cost.

Again, thank you for the opportunity to provide comments to you today. I will be happy to answer any questions you may have.

DR. ZUBELDIA: Thank you.

Mr. Hull.

MR. HULL: Good morning. My name is Stephen Hull. I am an associate vice president in the AdvaMed payment and health care delivery department. I am pleased to be here today to present a statement on behalf of our members.

I will abbreviate the written statement in my verbal remarks, but I understand a copy has been shared with this committee.

AdvaMed supports the rapid adoption of ICD-10-PCS. We believe it is a change that is long overdue and we are very concerned about difficulties experienced currently under the ICD-9 procedure coding system. We are concerned that the ICD-9 system lacks the capacity for additional codes to keep pace with advances in modern medicine.

Codes must be assigned according to the rational construction of ICD-9 and there is often not room for the placement of a new procedure code in the appropriate section for new services in technologies. It is important to recognize that an optimal inpatient billing system must be capable of describing multiple aspects of medical procedure, including the body system organs, surgical approach, specific procedure and the specific technology used during the procedure in some cases.

In short, accurate codes would allow for accurate billing, proper calibration of DRGs over time and adequate payment for needed hospital services. We believe that the ICD-10-PCS system offers much advantage in those areas, as compared to the ICD-9 system.

AdvaMed supports rapid implementation of the ICD-10 system, but we also urge CMS to implement important changes to the process for assigning new codes. The support of this committee on this issue also would be appreciated. We believe that the present approach to assigning ICD-9 procedure codes is not timely and does not result in a sufficient number of new codes to describe procedures relating to technologies.

AdvaMed has long been concerned about the availability and timing of code assignment for inpatient services that involve new technologies. Essentially, the current ICD-9 system rarely provides for codes until after regulatory approval. Because of the annual coding cycle, new services may wait up to 18 months before a new code is even assigned. After code assignment, Medicare's inpatient prospective payment system may lead to additional delays of two years or more before an item is assigned to an appropriate payment group.

AdvaMed also urges CMS to consider the assignment of new codes for procedures related to technologies that are still undergoing clinical trials. Earlier assignment of codes would allow for tracking and analysis of clinical and economic benefits and better outcomes research for new types of medical therapy.

We note that CMS recently has posted on its web site a cross walk table for ICD-9 and the proposed ICD-10-PCS codes. We are very grateful for their having posted this. We do understand that this cross walk was created several years ago and it does not reflect all of the current ICD-9 codes. We urge CMS to create a more current version of this table so that interested parties can better understand how the new ICD-10-PCS system would change or affect billing procedures.

If this committee renders a favorable recommendation regarding the adoption of ICD-10-PCS, we would urge CMS also to publish in similar format any revisions to the DRG grouper that may be driven by the adoption of the ICD-10-PCS system and to provide an opportunity for comments on these revisions.

That is the bulk of my remarks. I would actually like to conclude with an observation and perhaps a question to the other panelists that it was mentioned earlier that ICD-10-PCS ought to be considered for roll out in conjunction with the introduction of the ICD-10 diagnosis system. I am curious about whether that would pose training hurdles in terms of obliging hospital billing staff to learn two systems simultaneously and that there may, in fact, be a down side in that regard leading to perhaps a better situation in rolling them out sequentially.

Those are all the remarks I have. If there are questions, I would be happy to answer them. Thank you.

DR. ZUBELDIA: Alissa.

MS. FOX: Good morning. My name is Alissa Fox and I am executive director for policy for the Blue Cross and Blue Shield Association. As most of you know, the association represents 43 Blue Cross and Blue Shield plans across the country that provide health care coverage to 83 million Americans, one in every four Americans.

On behalf of the association I want to thank you for the opportunity to be here today to talk about the possible replacement of ICD-9-CM with ICD-10-PCS codes. Blue Cross and Blue Shield Association strongly supports simplifying our health care system for our consumers, hospitals, physicians and others. We believe that standardizing clinical codes is an essential element of administrative simplification.

Our plans are now aggressively reworking their systems to implement standard codes that are required to be used by the entire health care industry by next year. We recognize what you have heard earlier today, that the current ICD-9 standard has limitations and we agree that accurate and precise reporting of clinical codes is just extremely important.

However, we ask the committee to postpone making recommendations to require the health care industry to overhaul its systems and processes once again in order to convert to ICD-10 until two things occur. First, and most importantly, the committee should postpone consideration of any changes of this magnitude until after the health care industry has successfully completed implementation of the initial HIPAA standards specified in the law.

As I understand it, I think we are in agreement with AHA on this point. Let's get that done. Let's make sure it works right, let the dust settle before we start contemplating another wholesale change in our systems. Simply put, the health care industry has a massive job in front of them. Providers and health plans are now facing very significant costs and complexity of complying with multiple federal rules simultaneously.

Privacy, the standard transactions and codes and there are more rules expected in 2002. These are in addition to the myriad other regs that govern the industry. AHA mentioned the prospective payment systems and there are others affecting other providers for health plans. The Department of Labor claims regulation is a huge regulation that is now requiring health plans to revamp their systems to comply with that regulation.

These rules all require a significant and costly reengineering of systems, business process changes and constant retraining of staff and also diversion of patient care for providers and for health plans, diversion from product innovation. It is important to recognize that these federal changes are an addition over and above the changes that are otherwise being required at the state level and by private accreditors. So, there are a lot of changes going on all at the same time.

The industry needs time to focus on making these changes properly and to make sure that we don't make mistakes and disrupt payments and other services. We caution against overwhelming the system at this critical junction with yet another massive change.

Second, we urge the committee to assemble a multidisciplinary team to identify all the issues involved in converting to a new system. Over the past two years, as our plans have been working to reach compliance with the initial HIPAA standards, we have learned a great deal about the impact of system changes on our business.

Unfortunately when we first began on the transaction and code sets, we treated it as an information technology issue. We just thought it was an IT issue. That is it. We soon realized that it was much bigger than we had initially imagined and it virtually affected every aspect of our operation, as well as all of our business associates and partners and providers.

In order to identify all the changes required, our health plans assembled multidisciplinary teams, comprised of staff throughout the company; claims and adjudication staff, medical management, actuarial, legal and provider contracting, just to name a few, to determine how these new rules impact all operating areas and to develop effective solutions.

Through this process we were able to identify the ripple effects of administrative simplification on just the transactions of code sets was than an IT issue. We know that ICD-10 is far more than just a coding issue. Without a doubt, converting to ICD-10 is a monumental undertaking. The Work Group on Electronic Data Interchange has drafted a white paper that begins to inventory the extensive issues involved. You have heard some of those issues this morning.

These changes range from system overall, staff training, recontracting and other business process changes. Since clinical codes are the underpinning of virtually everything in the health care system, these changes impact not only payment, medical policies, quality improvement programs, benefit design, as well as fraud and abuse prevention.

We believe that by assembling a multidisciplinary team, this committee could build on WEDI's work on the white paper, to assure all these issues are properly identified.

Thank you for this opportunity to appear before you today and we stand ready to answer your questions, but also to assist you in this task because we think there is a lot of thinking that needs to get done before we implement another major change.

DR. ZUBELDIA: Now, let's open the floor to questions from the panel.

Simon.

DR. COHN: Nelly, I just wanted a clarification from your testimony. You indicate in your testimony that you believe that ICD-10-PCS should be implemented three years after the implementation of the HIPAA administrative simplification regulations.

You also follow that on in the next paragraph by basically asking that the cost be paid for by -- it sounds to me like the Federal Government, by CMS, in relationship to -- by increasing payments or adjusting payments accordingly to help fund that transition, at least as I understand this.

Now, I would observe -- I may be misunderstanding this, but as I read it, I was trying to figure out whether one is contingent upon the other or whether these are two completely separate thoughts. So, let me just sort of ask you is the AHA in favor of moving to ICD-10-PCS if there is no additional funding from the Federal Government? Or is additional funding required for you to consider that?

MS. LEON-CHISEN: At this point, I don't think we have a choice. Additional funding would be helpful to make the transition, but we simply think that ICD-9-CM Volume 3 is not fixable. You can't keep dragging that along indefinitely. So, we do support moving to ICD-10-PCS. The additional funding would just help us make that transition a little less painful.

DR. COHN: Okay. So, to just make sure I understand. The position of the American Hospital Association is that even if funding is not available from CMS and the payments continued to be revenue neutral, as was described, you would still support the three year transition. That is yes.

MS. LEON-CHISEN: That is yes. I am sorry.

MR. BLAIR: Two areas of clarification, please.

Stephen, am I pronouncing your name correctly?

MR. HULL: Yes, you are.

MR. BLAIR: Stephen, you encouraged us to consider moving more rapidly than the recommendations -- well, moving more rapidly. When you said moving more rapidly, are you saying more rapidly than the proposal that the AHA -- that Nelly has offered us, which is that the compliance -- I am assuming when you said three years after the financial administrative transactions compliance date is done, is, you know, in place, that there would be a compliance deadline for ICD-10-PCS. Is that correct, Nelly?

MS. LEON-CHISEN: Yes, that is correct.

MR. BLAIR: Okay. Then, Stephen, are you saying that you believe we could move more rapidly than that?

MR. HULL: Yes, we do. Although our members do not operate hospital billing systems, our belief is that something more expedited ought to be considered.

MR. BLAIR: Maybe if that is the case, then maybe when a more detailed proposal or elaboration of the AHA proposal is set forth, it might be helpful, Stephen, if you could identify those areas, which can be accelerated.

MR. HULL: Absolutely and I would be delighted to follow up and send a letter to this committee identifying such areas.

MR. BLAIR: Okay. Then the other area that I needed a little bit of clarification on, Alissa, I believe that you indicated -- pardon me -- you asked the NCVHS to postpone our recommendations with respect to ICD-10-PCS and my thought was when you were saying that, I wasn't sure whether you were thinking that our recommendations -- well, let me put it this way.

The AHA made a proposal, which I think we sort of understand now and my thought is that given the history of how long it takes for our recommendations to go through the appropriate processes within Health and Human Services with a notice of proposed rulemaking and then a final rule or an adjustment to those rules, that even if we made our recommendations very expeditiously within the next several months, that it might be all that HHS could do to comply with the guidelines that the AHA has recommended.

So, are you saying that when you ask us to postpone our recommendations, are you saying you feel that the AHA's proposal is too aggressive?

MS. FOX: I am not really sure the AHA's proposal -- they say everything is done and it is unclear when everything is done is. I am not sure what -- Bill Braithwaite actually explained that to me a couple of years ago when I didn't understand all the -- was done. I thought, you know, I had an idea and he explained to me that that date is not that clear.

But I would say that I think we should take this opportunity -- I don't think we know enough of what it really means. How much is it going to cost to do ICD-9 -- go from ICD-10 to PCS? What are the issues for going to doing just the PCS and not the CM? What are the cost differentials of it?

What are all the implications to everybody? What are the implications to the Medicare system? Are there issues -- I was just asking Nelly because it has been raised to me that there could be some payment implications for -- benefit payment implications for hospitals. For example, if you are changing all -- now you have a lot more codes and to the extent that it does change the DRGs and I guess that is an issue. Does that mean that some hospitals might -- there might be winners and losers? I know that any time you change the RBRBS system, that is the exact implication that you have. I think that we really need to clearly understand what the implications from these changes are before making these recommendations.

By assembling a multidisciplinary team and trying to as an industry, the entire industry working together because I think we really need to do this together, come up and really look at what all the implications are and then let's cost it out. Let's make sure we know what we are doing. You know, should it be done separately? Should it be done together? Let's raise all these questions and really very thoughtfully think through, you know, when -- when is the right way to phase this in. How to do it. It is just really -- I think we need a lot more information than we have today.

MR. BLAIR: Okay. My memory isn't perfect and you just listed a number of areas that you feel we need to consider. Is that in the hard copy document that you gave us?

MS. FOX: Yes.

DR. ZUBELDIA: I have a question for both Nelly and Alissa.

Nelly, you mentioned that the ICD-9-CM diagnosis code should be migrated to the ICD-10-CM diagnosis codes and I haven't heard yet what is broken with them that would require such migration. At least I would like to hear from you what is the position on the ICD-9 diagnosis code migration.

DR. COHN: Kepa, we are going to talk about that next in the hearings also.

DR. ZUBELDIA: Okay. Then we will talk about that later, but could you tell us why the AHA is recommending migration of the diagnosis codes?

MS. LEON-CHISEN: Actually, I will try to be brief because I realize the next hearings are going to be devoted primarily to that, but ICD-9-CM diagnosis is also an old system. It is also 20 years old and there is a lot of changes that have taken place in the last 20 years. We have been kind of trying to patch up the diagnosis portion. It is not as bad as the procedure side because you have a little more room, but there are improvements with ICD-10 that, you know, we keep -- every time we meet with the Coordination and Maintenance Committee, a lot of times some of the changes that are being proposed, you know, it comes out that it is things that if we would have implemented ICD-10-CM, that would have been fixed with 10-CM diagnosis, but since it has been delayed, we are making little tweaks and tugs and little minor changes to ICD-9-CM to try to address the needs of the people that are not currently addressed under ICD-9.

DR. COHN: Nelly, I actually wanted just a little more -- once, again, I keep asking for clarification, but I just want to make sure that I understand. I have a general question for both you and I think and Alissa.

Jeff, when he was asking you about your recommendations about three years after implementation, sort of stuck in, well, after the implementation of the administrative transaction final rule, thought you didn't say that in your recommendation. I wanted to sort of understand from you, are you talking about three years after the compliance with the administrative transaction final rule, which would be either 2005 or with a year of extension, 2006, or are you talking about after, for example, security and claims attachments are implemented, which might knock it out -- I mean, Jeff could comment on how long that might take.

What exactly a time frame are you talking about and after which implementation are you referring to?

MS. LEON-CHISEN: Yes, basically after all of them and primarily because we are at the mercy of the information system vendors. They have got the programmers working on the transaction standards and on claims attachments. Some of them wind up being the same exact people working on the same system.

So, if the information systems people would be able to tell us that they could be quicker about it, we would probably reconsider their time line.

DR. COHN: Okay. So, you are talking not really about 2005, 2006, but more likely 2008, 2009 at this point, recognizing we haven't gotten security out yet and that would be two year implementation and claims attachments are still -- haven't even been released as a notice of proposed rule yet. Is that correct?

I mean, so you are leaning until after claims attachments are finalized.

MS. LEON-CHISEN: Right.

DR. COHN: Now, having said that -- and I would ask both you and Alissa the question of is there a value for the industry to have a long term direction that they know they need to get to by x length of time and would that be helpful to either the Blue Cross Association or to the American Hospital Association or should one defer even pointing the direction until all these things are implemented and then give a three year implementation time line.

What is your advice and guidance to the committee on this?

MS. FOX: My advice is that -- I think there is several years that I think we both agree at a minimum before people are contemplating movement here. That gives us the time we think is critically needed to really look at this, work together, inventory all the issues, what are all the costs, answer all these questions so that we can make a decision and make a recommendation to you knowing all of that information. I think we have the time to do that and I think that would really be helpful for us all to work together to really try to flesh out all these issues before making -- just saying three years after x days, if we have all that information, I just think we could make a much more knowledgeable recommendation.

DR. COHN: Okay. Nelly.

MS. LEON-CHISEN: I think it would be helpful if we would know up front what direction you intend to take. As I mentioned earlier, the hospitals are working with primarily two types of systems, vendor systems that they purchase, as well as in-house. It is the in-house systems that probably are going to be a little more difficult and more burdensome to deal with because as you know some of them may be just managed by the individual hospital's IT department and they are already severely limited.

So, if in some way hospitals would know we were going to ICD-10-PCS, people could start working under that assumption even now as they consider purchasing upgrades to their information systems, as they are making decisions as to whether they should continue with their home grown systems or look to an outside vendor for these things. They could start budgeting for the future so they can be ready.

I think that the longer time that you allow for people to plan, the better off they are going to be.

MS. TRUDEL: I would like to get a sense of the flip side of that. What is the risk involved in continuing to operate 9-PCS over time when -- CM, I am sorry -- when it appears to be losing its ability to be responsive? And is there some point in time where there is an expectation that it may actually break.

MS. LEON-CHISEN: Yes, I think there will be a time when it will actually break because at this point we are a little more optimistic that it can have a few more years because we found -- I shouldn't say "we" -- Pat Brooks and her staff were able to find two chapters that had not been used. So, that gives us a little more leeway. I think it is important to understand that it is not that you are going to get to the point where you are not going to be able to report a code for a procedure. You just won't be able to report it with something specific or with something very meaningful, but you can limp along by saying, okay, you know, anything where you inject or put a substance into someone, into a person, we can use 99.29.

Frankly, that is how those examples that I gave you would up in there because there was no room. This was prior to those two chapters being identified. So, you could limp along, you know, with the reimbursement and the data won't be accurate but you will still be able to assign a code to every procedure.

MR. HULL: Could I also respond to the question?

We don't think there is a point in time when one can specifically identify when the system will be broken. We are very concerned that over time, though, there has been an erosion of the system and its specificity of payment. We note that the other countries that have adopted DRG systems have been able to do so with 50 percent more DRGs than the United States has in the Medicare program, essentially providing more specific payment for the different cases, the different DRGs.

We think, in part, this is a reflection in this country of the ICD-9 system, a lack of diversity and codes leads to a lack of diversity in DRGs. So, it is difficult to predict the exact year when it would be broken, but we are very concerned that over time there just hasn't been a currency in our payment system in terms of the practice of medicine.

DR. YASNOFF: I wanted to ask Alissa for a clarification. It is not clear to me whether you are saying that the association takes no position on the conversion to ICD-10 or alternatively that you recognize the problems with ICD-9-CM and you see the advantages to ICD-10-PCS, but want to be sure that it is well understood and the transition is managed properly.

So, is it that you are neutral or that you see value in the conversion, but want to be sure it is managed properly or -- and I don't want to put words in your mouth

-- is it something else?

MS. FOX: I would say it is a combination of both. I think ore information is really needed for us to really say, yes, we should go forward as this type of phase-in because we really don't have the information we think to answer some of the questions that you are asking. We really don't understand it. We don't want a system where we can't add new technology to the system. I mean, that doesn't make sense. It clearly doesn't make sense.

We need to make sure our coding systems are as precise and accurate as, you know, is appropriate, but at the same time, we should be able to clearly state what are the advantages to the health care system, what clearly are the advantages of moving -- changing our coding system, what are the costs associated with it, what are all the implications. Let's clearly lay all of that out and then let's develop a game plan going from there.

But we don't have all of those issues laid out and we just feel strongly that you really need -- you know, we are here, I think, all of us, I mean, the hospitals are feeling they need a lot more money to make sure that they can provide the level of services that they feel are appropriate to guarantee patients getting the best care they can. We need to make sure that we are providing valuable services to our customers and, you know, health care inflation is going up at 14, 15 percent this year and you see what is happening at the states.

The states are cutting back on their children's health programs. I mean, it is terrible. We need to make sure that as a society that we are more going to be investing in a costly revamping of our systems, that we go into that with our eyes wide open. Let's make sure we clearly have what are all the advantages, all the good things that we are going to get from new changes, but also what are the costs and make sure we have examined all the alternatives so that we make sure that we are going forward, changing our systems in a way that is adding value to Americans really.

I mean, that sounds a little corny, but --

DR. YASNOFF: So, it sounds like you are not -- I am, again, trying to clarify -- it sounds like that your members are not of the opinion that the current coding system presents immediate difficult problems that need to be addressed.

MS. FOX: I am not saying they shouldn't be addressed, but we are not sure that going to ICD-10 right away is the best solution. So, we want to look at all the solutions.

DR. YASNOFF: So, it is --

MS. FOX: And we are starting to think of are there -- and I don't know if others have explored this, but we have started to want to look, are there other short term solutions that could be examined to make sure that, you know, things are being coded appropriately. So, we want to examine that. We don't know the answer to that.

DR. YASNOFF: Let me try to say it back to make sure I have understood this.

The association does see that there are problems with ICD-9-CM that need to be addressed, but what is not clear from your perspective is whether ICD-10-PCS is the solution and whether there might be other solutions and what the timetable should be. Is that a fair statement?

MS. FOX: I would just say that we would like more information. I don't want to say that we don't think we should go to ICD-10 because I think there is a lot of appealing -- a lot of people, you know, are there and we think there is definitely the sort of definite consideration, but we just want to make sure we have the complete picture. We don't have the complete picture right now. What are all the costs and implications of going there and then let's make the decision.

DR. YASNOFF: Thank you.

MS. GREENBERG: I think I raised my hand before Karen asked her question and this may be more rhetorical than anything, although I would like a response probably from AHA, but I was struck in Ms. Fox's testimony by a statement that clinical codes are the underpinning of virtually everything in the health care system. I thought that was well put.

I assume that others on the panel probably agree with that. I have also heard -- I mean, there is just a real disconnect, I guess, and that is why perhaps your proposal is a good one about really convening and I would say not in a leisurely fashion but in a rather expedited fashion some type of multidisciplinary group to really to address these issues and, you know, to find one that is objective would probably be quite a challenge.

But, nonetheless, I have heard that clinical codes are the underpinning of virtually everything in the health care system, that the current code sets are 20 plus years old and have serious deficiencies and, yet, a recommendation from AHA, at least, that we maybe go this entire decade with the current systems because that is essentially if you really want to wait until three years after all of the HIPAA regs are implemented, I think you have basically got us through the decade.

Is that really going to work for American hospitals or do we need to start thinking outside of the box or of some way to address this because -- maybe I have heard you wrong, but I mean that is -- those three things just don't seem to work in my mind if we have any interest in, you know, running an efficient health care system. Effective as well as efficient.

MS. LEON-CHISEN: May I answer that? Yes, I understand, Marjorie, you know, we are sort of saying that, yes, the ICD-9-CM is broken and needs to be fixed. Part of the reason why we said wait three years after implementation of the other HIPAA standards is that we are really relying on the information system vendors to make these changes for us. So, if there was a way to sort of work with them and have them expedite the time line, that is something that we are willing to consider.

So, it is a little unfortunate that at this panel today you don't really have an information system vendor that can kind of address that issue. That may be something that needs to be looked at in the future in terms of truly have they inventoried their systems and have they truly calculated how long it would take them to make the changes.

MS. GREENBERG: Now, you had actually -- if I could just say one other thing -- you had said, I think, in your testimony that the main cost would be retraining or training coders but actually maybe that was an understatement is it really the -- is this issue with your vendors equally large or equally large or larger because those are really two different areas. I am sure they are both impacted but --

MS. LEON-CHISEN: Right. I think the vendor issue may be larger but the cost associated with training the coders, I think -- and AHIMA will probably be addressing this because the coders are their members. I think coders in the U.S. would stand ready to learn a new coding system. It would take time and it would take development of training materials and so forth. But I think that it is doable. It is probably the information systems that we don't have as much influence over as opposed to the training of the coders. We are willing to step up to the plate and be a leader in that area.

MS. GREENBERG: Thanks.

MS. TRUDEL: I am just trying to get a sense of what the outside parameter was, which is why I asked my first question. I guess my question is for Nelly and for Alissa. How long do you think we can wait before we do something? What is the outside limit?

MS. FOX: I don't know the answer. That is why I think we just need a lot more information, you know, to get that kind of information. I agree, that is an excellent question.

MS. LEON-CHISEN: That is a tough question. As you can tell, I mean, we were silent. It is a tough question and I don't really know how long, but I think we would be willing to reconsider the time line if we could find the vendors that would be able to help us.

MR. BLAIR: Nelly, you encouraged us to postpone a decision until more information is available and you have indicated -- I am sorry -- Alissa, yes. Sorry And, you know, clearly with the history with the financial administrative transactions, these are complex areas. I really respect the fact that you are saying we really need to understand the impacts of a change in the procedure coding systems.

But I want to try to pin you down when you say postpone it. Okay?

MS. FOX: Sure.

MR. BLAIR: If there is an additional study to get us better information so we could make a wiser set of recommendations, it means that somebody needs to pay for the study. So, let's assume that the funding is available. It means that groups of individuals need to be available to go ahead and participate in that study and let's say we have commitment from all of the appropriate organizations. Given that the resources and the funding are available, how long would it take to get the kind of information you are suggesting back to the NCVHS are you talking about? Three months? Six months? A year? Two years?

Give me your feeling, your impression of how much time it would take for that information to be available to us.

MS. FOX: I would say about six months to try to convene a multidisciplinary group, work with a consultant to come up with cost estimates and mentor these issues. We have looked at that. When we looked at standard transaction in code sets and did that sort of analysis on our own, it took us I would say three to five months to try to do that.

MR. BLAIR: Okay. Given that -- then let me take the next step, that if everything is in place, it would take about six months to have that additional information available to us. Who are you envisioning would be funding the study?

MS. FOX: I think the industry should fund the study and we would contribute -- we would contribute to the study.

MR. BLAIR: Okay. Then when you say the industry, are you saying, for example, a lot of the folks that are here testifying today, the AHA, Blue Cross-Blue Shield, the AMA?

MS. FOX: I think you need representation from the states. I think you need all the stakeholders to be at the table.

MR. BLAIR: And you feel like you could get those recommendations to us within a six month time frame.

MS. FOX: I think that is a reasonable -- I mean I think it was just not us. I think it is not up to us, obviously. I think it is really the industry that really needs to think that this is something important to do and really would want to commit to doing something like that.

MR. BLAIR: Are you in a position -- you may not be, so this is just a question -- are you in a position where you could step forward and say Blue Cross-Blue Shield could take the lead in pulling together --

MS. FOX: I don't know if we could take the lead, but we definitely want to be a participant in such an effort.

MR. BLAIR: Thank you.

MS. HUMPHREYS: I just wanted to comment that in order for the vendor community to potentially speed up activities or focus toward this so that this wouldn't -- any change, whatever that change may be, to address these serious deficiencies in the ICD-9-CM code sets could be done within inside a decade. I think that they would need an earlier recommendation about where we are going. They are going to hang around -- I mean, there isn't going to be any forward motion, I would think, until it is clear what it is that we have the goal at -- I mean, what we are headed toward.

DR. ZUBELDIA: I would like to follow-up on that because it is hard enough with a hard mandate, such as HIPAA, to get things done on time with the mandated deadline and now we are going into an extension. Would it be reasonable to think that if there is a recommendation from NCVHS to move to ICD-10-PCS by a certain date, would it be reasonable to think that the vendors would start migrating before the deadline or is it purely utopic and will have to have a hard mandate as to when this has to happen?

What is your impression? I mean, you say that you don't have a lot of control over the vendors. The fact is that the hospitals hold the purse strings that drive the vendors.

MS. HUMPHREYS: Yes, but, Kepa, until the day you declare that we are using the new system, they have got to run the old one. Otherwise, how are they going to be paid?

DR. ZUBELDIA: But I think that there is a relatively easy transition between the two systems from what I have heard today. There is already a mapping done by CMS between ICD-10 to ICD-9. And it is many to one and it is relatively easy to transition with that sort of mapping. It could be that the vendors can implement ICD-10 ahead of the schedule and still produce ICD-9 in the administrative transactions going out by just doing a simple mapping. That seems to be relatively easy.

So, is that feasible? Or this should be a one-time jump?

MR. AVERILL: Since I am probably the closest thing to a hospital system vendor here and probably the hospital system vendor that would be most affected, since we do the bulk of hospital medical records.

MR. BLAIR: Could you identify yourself?

MR. AVERILL: Richard Averill.

MR. BLAIR: And you are with?

MR. AVERILL: 3M Health Information Systems.

First, I would make the observation that the conversion to OPPS was probably a bigger impact on the vendor community than this would be in terms of creating new processes, totally new software that had never existed before and that was done in roughly -- well, less than a year turnaround time from notice of exactly what we had to have in place to full operation.

So, I would consider what we just went through with OPPS more of a major change than this would be. Here we are taking existing systems and modifying them for a new coding system as opposed to creating totally new systems that we never needed to have before.

So, in answer to the question, clearly if this committee set a direction, the vendor community -- and I would speak for 3M HIS -- would clearly be working on it well in advance to try and be prepared for whatever date -- what was ultimately chosen. So, I think it is fair to say that the vendor community would be rapid or be well in advance making preparations once a date was set. So, if a date was chosen, that would be very helpful.

MR. AUGUSTINE: I would just like to add having some information systems experience in my background, this would be a major change. Not only are you changing the type of -- the AHA report kind of sums it up here where they talk about your changing the software interfaces, the file formats, the report formats. These codes are ubiquitous in everything that a hospital does. So, basically every screen -- everything you do with it, it is going to have to change. As well, a lot of systems are proprietary. They are not all vendor-based and finding programmers to program some of these archaic languages the hospital has used are very difficult and very costly. So, I would envision that this would not be an easy transition to make.

DR. COHN: Kepa, I have a question for Pat Brooks, who is, you know, basically the developer and maintainer of Volume 3. We have obviously been talking about either Volume 3 being broken or will be broken at some point in the future. And I am curious, obviously, Stephen Hull has made some comments that it is already broken from his view because he is not getting the reimbursement he would like or there aren't enough DRGs.

But we have also heard about you having to open up a new chapter. So, I guess the first question is is are the concerns that Stephen Hull has about the fact that there aren't enough DRGs around to assure appropriate payment for, I guess, new technologies? How much validity is there to that concern?

No. 2 is given the fact that you are currently opening up new chapters and even though things aren't contiguous, how long do we have for a transition until things get broken to the point you can't fix them anymore?

MS. BROOKS: If you want my opinion, if you decide now and give us a date, we wouldn't have enough code space to make it to whatever date you have picked. When we opened up those two new chapters, we opened up -- all we opened up was 200 codes. Some of the proposals that we are discussing in May, if we went with what some of the people want, I could use up 20 in one proposal I am talking about. That is one proposed item.

So, we are getting very stingy when people ask us to capture new technology. They may have a good proposal that needs five codes to capture a facet and we say your idea is brilliant. We love it, but we are only going to give you one. It is going to be pathetic. So, if we had a date, we will limp along and we will stick things in very odd places, in addition to these 200.

People are going to think it is a very odd thing, looking for heart and liver and stomach all in one section of the code book when everything else is over in the other area. So, I think we are closer to being broken. It is getting embarrassing to me to do these proposals and sometimes at the meetings where we propose them, people laugh in the audience about how we are trying to cope with this. We don't have ten years.

We are going to have to -- I don't know what we will do.

DR. COHN: Let me just ask one question then, Jeff, I think you have a follow-up.

How many cubbyholes -- I mean, I realize that a coder, especially a developer of a coding system likes to have perfection in their coding system and I do know that ICD-10-PCS is, quote, unquote, perfect because it hasn't been used yet and the minute it gets used they are going to find they are going to have to stick things in places they hadn't intended.

I mean, it is true about all coding systems that I know of. So, how many -- recognizing that we are dealing with a world that lacks perfection, how many other cubbyholes do you have to get us through?

MS. BROOKS: Well, if we to use the "I," if we want to stick all the body parts in the "I," we have some codes there. For cardiovascular, there are hardly any spots left. So, nobody better do anything in the cardiovascular area in the foreseeable future.

A few other areas are like that and what we do is we go and we bring up the audience and we are going to stick the third of whatever this is, like some spinal procedures we are working on. Some of them were put on the spinal area. When we run out, then we stick them over in another body system. That may not be such a problem for coders, who can look up at the index and get there. What is a real problem for is people like Mike's agency that do research and they think they got looking at the outcomes for all the spinal procedures and they think they have found them all, they aren't aware that we have scattered them throughout the book.

So, people are doing data analysis is the more complex. You wouldn't believe the hours we spend trying to help coders get someplace and the exclude notes, the gyrations we go through. It is becoming more and more difficult and it is going to be hard for coders to code accurately when they go through this very bizarre looking approach that we are getting ready to start.

MR. BLAIR: Given what Pat Brooks has just told us, it leads me to feel as if we may not really have the luxury of continuing on for six, seven, eight or nine years because ICD-9-CM is deteriorating in terms of its ability to be able to be able to support what is considered to be, what, the central portion of health care, according to what Nelly said.

So, could I take -- could I ask Alissa, given that you also heard what Pat has told us, would you consider then when you are saying that there is a lot of other issues that need to be considered, modifying slightly that recommendation to us where it is not a matter of the study being done for us to determine whether or not to move forward and the time frame to move forward, but instead all of the issues that need to be considered to enable a successful industry migration to ICD-10-PCS?

MS. FOX: I am not sure I understand your question.

MR. BLAIR: Let me rephrase it again. I think that what you were saying is we should postpone any recommendation NCVHS makes to move forward to ICD-10-PCS and I think that hearing Pat Brooks, we may not really have the luxury of postponing it very far, but I do feel as if a lot of the issues that you raised are very valid concerns, but maybe we need to put them in the context of what needs to be done to enable a successful transition to ICD-10-PCS, as opposed to whether or not to go to ICD-10-PCS.

MS. FOX: I just firmly believe that before you can make a recommendation, you really need to have a lot more information. Not knowing the costs, not knowing, you know, what the exact limitations are, you know, what are other alternatives, if there are any. I think that is the kind of discussion we would like to see happen so we have a lot more information. But, yes, I mean, if there is no other alternatives, yes, then I would agree that we should be looking at how to do it, but when you look at making a recommendation on it, I think it is just critical that we need to understand all the implications, all the costs, both the government costs, state costs, private sector costs, other implications.

I think there are many other implications before making a recommendation on this issue.

DR. COHN: Maybe this is sort of a follow-up. Jeff, I think what Alissa was saying -- and I just want to be sure I understand -- you are sort of suggesting as a first step we look at all the options and make sure that we are picking the right thing to do before we start mobilizing to do it. You are asking for a little more certainty on that.

MS. FOX: Yes.

DR. COHN: And once we know what that is and you have talked about six months or whatever -- I mean, I am not sure that I think that -- I am trying to think of the last approach -- process I have been involved with that only took six months, but -- I think we are being reminded that there are actually successful evidence of that. But I believe that is really what you are talking about as a first step to really understand and be convinced that we really need to do X before we do X.

MS. FOX: That is exactly our feeling. Thank you. Thank you for stating it so great.

MS. GILFOY: Some of the points that were raised were the issue of the vendor involvement, specifically the HIS vendor involvement.

DR. ZUBELDIA: Helene, would you introduce yourself?

MS. GILFOY: I am sorry. Helene Gilfoy.

-- specifically the HIS vendor involvement. I went back while we were discussing this and this is not meant to eliminate the process that Alissa was talking about with looking at all of the implications because I think there certainly are more implications as we are finding more and more with the transactions and code sets. We certainly need to look at that but I went back and looked at some recent gap analysis that I have done and these are all with HIS vendor supplied packages. They are not with self-developed packages. Ten out of 16 vendors that I looked at could support a seven digit procedure code or a seven character positions code, which is what my understanding that ICD-10-PCS is going to go to.

I think Brady's comment about the IT implications is certainly well said, but if they are already supporting seven positions, we have to assume that they are supporting that seven position in all of their database, in all of their screens, in all of their reports. So, if you have got 10 out of 16 vendors -- and that is just a quick look that I did -- then the vendors are probably pretty encouraged and pretty able to -- at least 10 out of 16 are pretty able to move forward to supporting the PCS structure.

That does not take away the issue that everybody has been talking about of the business implications.

DR. ZUBELDIA: Well, if there are no more questions, I want to thank the panel for your testimony. It has been very, very interesting, very important.

We will stand recessed for lunch until an hour from now. Let's see if we can start at 1:00 sharp.

[Whereupon at 12:00 noon, the meeting was recessed, to reconvene at 1:00 p.m., the same day, Tuesday, April 9, 2002.]


AFTERNOON SESSION

Agenda Item: Panel 1 (continued) - Possible replacements of ICD-9-CM vol. 3 (procedures with ICD-10-PCS

DR. ZUBELDIA: Good afternoon. This afternoon we have a panel composed of Tracy Gordy of the American Medical Association, Sue Prophet of AHIMA and Lenore Whalen from Providence Health Care, and so, we will have enough time for questions and for the testimony.

Let us start from our left to our right. So, Tracy, go ahead.

DR. GORDY: Thank you, Mr. Chairman. My name is Tracy Gordy. I am the Chair of the AMA CPT Editorial Panel. It is our pleasure this afternoon to speak to you on behalf of the AMA and the CPT Editorial Panel.

I want to add that the CPT Editorial Panel appreciates the selection of CPT as one of the HIPAA transaction standards national code sets and accepts that responsibility for the designation it entails, and it is just that sort of work and responsibility involved in maintaining the code set that I want to address you in regard to this afternoon.

Our statement will summarize the views of the AMA on ICD-10-PCS as a replacement inpatient coding system for ICD-9-CM, Volume 3. I am going to address what the AMA believes is necessary to implement ICD-10-PCS should it be selected.

As the Chair of the CPT Editorial Panel I believe that I have a unique perspective on the necessary leadership and technical requirements for the successful implementation of any new code set, particularly those codes that are related to health care procedures and services.

The AMA has followed the development of the ICD-10-PCS closely and has appreciated the opportunity to participate in the Technical Advisory Panel established a few years ago by the Centers for Medicare and Medicaid Services. We think that the ICD-10-PCS project has made valuable contributions to many of the issues related to coding and terminology and those contributions may and ought to find numerous applications.

At the same time our preliminary review of the code set along with many of our medical specialties has identified a number of problems with the code set that in our view would pose great limits on its acceptability by practicing physicians, not the least of which is the introduction of an overwhelming number of new codes, perhaps up to 197,000.

As discussed in May at the ICD-9 Coordination and Maintenance Committee meeting the AMA believes the implementation of ICD-10-PCS will only add to the regulatory burden faced by hospitals, physicians and other health care providers.

The complexity of ICD-10-PCS coding structure merely adds to the extraordinary burden CMS/HHS rules and regulations already imposes on a regulated community. It is ironic that the imposition of a more complex coding system is being contemplated as Secretary Thompson's Advisory Committee on Regulatory Reform is urgently seeking solutions to remove or eliminate as much of the regulatory burden already existing in federal programs.

In addition, the structure of ICD-10-PCS will require the investment of significant resources to implement in terms of education of users, computer systems changes, testing of reporting functions and ongoing maintenance and update process. The AMA is concerned that inherent structure problems associated with ICD-10-PCS makes such a commitment imprudent and questionable.

ICD-10-PCS is a substantial departure from ICD-9, and from all existing health care codes sets. Unlike ICD-9 or CPT, ICD-10-PCS does not have pre-composed descriptors. Rather, codes and descriptors are built from tables that assign values and terms by the placement of characters in the code string.

For example, the first character of the string defines the chapter/section, and the second character usually although not exclusively defines the body system. The need to construct codes and descriptors could cause significant problems for some specialties. For example, in trauma care, the requirement to code every subset of a multi-system problem with a separate seven-character code string would be complex and time consuming. These complexities would be exacerbated for procedures that involve six or more types of body systems. Using the example of a Whipple procedure, for example, and a Whipple procedure is a proximal subtotal pancreatectomy associated with a total duodenectomy, partial gastrectomy, a choledochoenterostomy and a gastrojejunostomy. All six of those would have to be coded with a separate seven-code string rather than one. This problem would be compounded for the coder because all the eponyms have been removed from ICD-10-PCS.

The AMA believes that this complexity and excessive formalism may cause problems for users and will certainly require significant education of physicians, coders and others billing or paying for the services. In order to create the descriptors ICD-10-PCS relies on character positions with embedded meaning. In some instances the descriptors are not based on the natural language of physicians and other health care professionals but rather on a reconfiguration of the standard anatomic organization. The 31 body system characters in ICD-10-PCS do not conform to traditionally named body systems. For example, we do not differentiate as physicians between upper and lower body arteries and veins and this will cause all kinds of problems such as if you try to code for an umbilical artery transfusion where would you put that? In order for anyone to use ICD-10-PCS they need significant education. We heard some of that this morning and an informed individual cannot begin coding by using an index, intuitive reasoning or clinical knowledge with ICD-10-PCS, and as a result physicians, other practitioners and coders will need to learn a vocabulary that is generally not compatible with the language they now use to document services and procedures.

A new cadre of ICD-10-PCS coders is going to have to be developed at great expense. The AMA believes the seven-character alphanumeric structure limits expansion by assigning meaning for each character slot. For example, 34 characters are available for each chapter/section and in character position 3, 30 root operations have been defined leaving little room for expansion to include new root operations. Other code sets are moving away from this type of intelligent numbering just for this particular reason.

In addition to the structural and technical deficits of ICD-10-PCS the AMA views implementation issues as another reason ICD-10-PCS should not be named as a replacement for ICD-9-CM, Volume 3. The discussion of implementation issues I am going to divide up into systems issues, reporting issues and maintenance issues and I have already addressed the need for the education requirements.

Significant investments would be required to change computer systems to accommodate ICD-10-PCS. ICD-9-CM, Volume 3 is a 4-character numeric code set. This means that all computer systems would need to be modified to accept the increased number and type of codes. We are talking about user computer systems now. Existing software would need to be changed and/or new software acquired. If you do that there is a high possibility that you are going to have to acquire new hardware to adapt to this new software.

Additionally it is important to consider the context of system changes. Currently many providers and payers are undergoing the changes to comply with the requirements for electronic transactions and the privacy standards in the Health Insurance Portability and Accountability Act. Systems changes necessitated by ICD-10-PCS are in addition to the extensive changes already taking place making the overall bill even larger and the project more complex. Certainly any system changes to accommodate the replacement of ICD-9-CM, Volume 3 should wait until the HIPAA changes are accomplished.

A major requirement for the implementation of any replacement for ICD-9-CM, Volume 3 is the ability to map back to ICD-9 in order to accomplish the DRG assignments of surgical patients. In order for ICD-10-PCS to be implemented successfully DRG assignment must not only be accomplished but the assignment should not differ from that achieved under ICD-9-CM.

To date we don't know of any testing that has been done to ensure that consistent and reproducible payments based on a sample of past years has actually occurred. We heard this morning that there is a fact to that, but has that actually been tested? Inconsistent DRG assignments could result in incorrect payments which would cause problems for the administration of the Medicare Prospective Pay System. A flawed mapping may result in delayed payments as efforts are made to correct the errors. These factors combined with system changes create the possible scenario of widespread financial problems for inpatient reimbursement that would impact both physicians and hospitals.

In addition to the financial issues surrounding reporting problems, problems associated with longitudinal data quality and comparability are also an issue. As coders become experienced using this new system, coding interpretations may change and mappings may change thus affecting the coding comparability and any retrospective analysis.

The future maintenance and updating of ICD-10-PCS is a critical factor to consider in its selection to replace ICD-9-CM,Volume 3. The AMA believes that serious consideration needs to be given to the establishment of an editorial board with sufficient resources and independence from CMS and HHS to adequately maintain and update a code set with the complexity and built-in rigidity of ICD-10-PCS. To date we don't know of any maintenance process that has been specified.

The AMA believes it is important for clinical leadership in updating and maintenance of any procedure code set. The input of physicians who perform the services and procedures under consideration is an essential component of an accurate code descriptor. Similarly the input of physicians and other health care professionals in the decision-making process is critical for coherence with generally accepted medical practice and clinical terminology.

While we recognize the functional limitations on the size of a rigorous editorial board the CPT Editorial Panel has found that broad clinical input on editorial decisions is essential for the development of a quality end product.

The current ICD-9 Coordination and Maintenance Committee is adequate, but the structure and the breadth of ICD-10-PCS will involve a greater degree of complexity and clinical decision making. The use of character position with embedded meaning suggests that substantial clinical input will be needed to ensure the character placement is medically and anatomically accurate so that meaningless codes and series of codes are not developed. Also, since ICD-10-PCS is limited by the possibility of 34 characters in each of the seven positions considerable thought would need to be given to how the code set should grow. Factors for future growth include changes in therapeutic and diagnostic medical devices, clinical specialties and subspecialties that have experienced a proliferation of new services and clinical services on the horizon such as gene therapy.

In addition to an independent editorial board the detailed specificity and very large number of codes requires that ICD-10-PCS be maintained as a relational database. This would allow the editorial board to build and maintain relationships between the codes, preserve consistent terminology and eliminate duplicate codes or different ways of coding for the same service. The development and support for such a tool is expensive, but is needed for the timely and accurate maintenance of an ICD-10-PCS.

So, let me summarize briefly for you here. The combination of educational needs and expenses, system changes and expenses and the possibility of reporting errors all result in plausible and serious system-wide disruptions and financial disorder. The AMA believes that considerable further study is necessary regarding the cost/benefit of implementing ICD-10-PCS, as well as to determine if administrative simplification will be achieved by its use.

Ideally there should be one procedure code set that is used uniformly by health professionals in all sites of service. Such a code set would allow for true administrative efficiencies, would reduce burdens on those who are currently mandated to use multiple code sets and would help facilitate the creation of databases to effectively analyze differences in treatment patterns and outcomes. If the ICD-9-CM, Volume 3 is considered hopelessly flawed and out of date, then it seems we face a historic opportunity to replace that volume with a code set that will provide a true uniformity across care settings.

We see no particular merit in spending considerable sums of money to implement a new code set that even if it is successful will only perpetuate a dual reporting coding compilation that medical professionals find awkward and wasteful. The AMA believes that the CPT code set is the code set that already enjoys universal acceptance and should be used in all sites for reporting procedures.

In 1986, CMS had a grant that allowed for the tracking of CPT with the DRGs and it was thought to be feasible at that time but there was never any follow-up to that. So, as you know CPT is used in the outpatient services for physicians and other health care providers that we have the ability to use that under CMS and for the 60 percent of the population out there that is not governed by CMS. It, also, handles the outpatient surgical procedures. So, the only place that ICD-10-PCS is to replace is the inpatient services which as many of you are aware is dwindling in its importance as we develop more and more services that are normally done in the hospital setting not an outpatient setting.

We appreciate the opportunity of appearing before you. I would be happy to answer any questions. I have some backup in case I can't answer them.

Thank you.

DR. PROPHET: Chairman Cohen, members of the National Committee on Vital Health and Health Statistics, Standards and Security Subcommittee, ladies and gentlemen, good afternoon.

I am Sue Prophet of the American Health Information Management Association. On behalf of our association thank you for allowing us this opportunity to provide input on replacing the ICD-9 procedure code and system with ICD-10-PCS.

As you know from our previous testimony AHIMA is a professional association representing more than 41,000 members. We manage patient information in the form of health records and databases and provider health plan, government and private organizations.

In our testimony today I will be covering AHIMA's perspective on the ICD-9-CM procedure codes and whether they should be replaced and the short answer to that question is yes, we believe that they should be, our perspective on the proposed ICD-10-PCS and why we think that this still meets the requirements for a replacement system, implementation issues that will arise if ICD-10-PCS is selected and specifically training of health care professionals and coding systems whether they need professional coders or others who test or use this system and why the Secretary's decision concerning ICD-10-PCS should not be made in a void.

I would like to refer you to our written testimony for full details. I am only going to cover the high points in oral testimony.

Our position regarding replacement of the ICD-9 procedural coding system with ICD-10-PCS is as follows: First, replacement with a new procedural coding system for inpatient services is absolutely necessary, and we believe ICD-10-PCS meets the criteria for such a replacement system.

As you have heard many of the other presenters discuss the ICD-9-CM procedural coding system is obsolete and must be replaced. It was designed and implemented more than 20 years ago and since that time many dramatic advances in medicine and medical technology have occurred that were not anticipated and have not been adequately accommodated such as new approaches for doing procedures like laser and laparoscopic procedures. There are many day-to-day problems health care entities are facing due to this obsolete system, a number of which I have outlined in your written testimony.

The vagueness of this system leads to numerous examples of inadequate specificity for many of the uses of coded data today, reimbursement, outcomes analysis and many others that are, also, outlined in our written testimony.

Just a couple of examples, there are a variety of totally different new surgeries including both open and arthroscopic repairs which are classified code 81.47, other repair of the knee. Numerous types of aneurysm repairs are classified in code 39.52, other repair of aneurysm. So, as Pat and some others alluded to this morning yes, we will always have a code in ICD-9-CM where we can place the procedure. The issue becomes how many different procedures can we classify to the same code before we say that the system is broken.

Excision of skin lesions and all types of destruction of skin lesions including that by laser, cryosurgery, cauterization and fulguration are all classified to code 86.3, other local excision or destruction of lesion or tissue of skin and subcutaneous tissue.

One question that came up during lunch is how do you tell when the ICD-9-CM procedural coding system is broken and AHIMA would like to propose that it is already broken. We are already assigning very disparate procedures to the same code today.

We are already using a procedure coding system on the brink of collapse, and unless the situation is addressed quickly and in concert with other coding system decisions that must be made there will be serious consequences to the health care industry.

Attachment 1 of the written testimony provides a brief description of some of the mechanical problems that face the industry. CMS is the Coordination and Maintenance Committee trying to keep the ICD-9 procedures coding system going. Based on our involvement and testing with ICD-10-PCS to date AHIMA believes that 10-PCS represents a significant improvement over the ICD-9-CM procedural coding system and substantially meets the characteristics of the procedural coding system outlined by the MCDH as well as by requirements and characteristics included in Attachment 2 of our written testimony.

ICD-10-PCS provides much more complete and accurate descriptions of the procedures performed than the ICD-9-CM procedural coding system. Specificity not only to reimbursement but also is integral to internal management systems, external performance comparison, assessment of quality of care and many of the other uses of coded data that are outlined in our written testimony.

The detail and completeness of ICD-10-PCS are essential in today's health care environment. AHIMA does not believe that reimbursement considerations should drive code set revisions. However, good, specific coded data should be used and can determine and support appropriate reimbursement.

The payment computation system and not the coding system should define the reimbursement. The level of specificity and ICD-10-PCS will provide payers, policy makers and providers with much more detailed information for establishing appropriate reimbursement rates, evaluating and improving the quality of patient care, improving efficiency of the health care delivery, reducing health care costs and effectively monitoring resource and service utilization.

Based on our involvement with the existing ICD-9 standard procedure coding system the Coordination and Maintenance Committee has struggled to maintain the existing system and our testing of ICD-10-PCS AHIMA believes that this system is an acceptable replacement for the current coding system within the current use currently designated under HIPAA.

Regarding training we believe that interactive Internet based training would be an excellent methodology for training both coding professionals and users of coded data on ICD-10-PCS relatively quickly and cheaply.

It has been over 10 years since the US converted to a new procedural classification system. Because today's payment systems are based on coded data and as someone mentioned earlier our entire health care infrastructure is based on clinical coded data, the size of the work force directly engaged in coding and hence the range of coding skills. Today there are thousands of mastery level coders signified by our CPS and CPSP credentialing.

While the transition poses significant challenges there are fortunately many new training vehicles available and appropriate for this effort. First, a number of publications dedicated to coding training has grown significantly over the past 20 years.

Face-to-face seminars that were widely used to train for ICD-9-CM remain an effective training vehicle but new technologies offer alternatives, possibly superior to traditional face-to-face training. For example, audio seminars can be delivered at low cost to a large audience using telephone, Internet or audiotapes and web-based training offers new acceptable and flexible training opportunities. This is an exciting methodology for training masses of people which can be highly effective in terms of quality of the education results, such as how well participants learn to use the system and are able to apply it in their work place as well as in the area of cost.

From our experience with training individuals and observing as an educator in the public arena AHIMA anticipates that experienced coding professionals will require approximately 15 content hours of instruction in ICD-10-PCS, assuming that this system is only used in those settings, in those services that the ICD-9-CM procedure codes are currently used. In the hospital inpatient setting the medical-surgical section if the portion of ICD-10-PCS that will primarily be used with limited use of a few of the other sections. Such instruction would include both education of he structure, principles, rules and guidelines of ICD-10-PCS as well as hands-on practical application using clinical data.

For categories of users other than coding professionals you just need to have some level of understanding of the system in order to use the coded data. We believe based on the level of knowledge needed that 4 to 8 content hours of training would be needed for those types of users who do not need hands-on coding skills.

AHIMA remains committed to continuing our history of training the health information industry. We can reach out to make education accessible as we did for ICD-9-CM not only through the Internet but also through our network of 52 component state associations and our network of coding professionals who have significantly expanded the implementation of ICD-9-CM. Because the scope of health information management includes coding we are prepared to address appropriate coding documentation management and data analysis issues related to the system change.

Coding leadership professional development and coding consistency are essential to teaching issues for AHIMA. So, you can certainly count on our support, and I would, also, like to add that our commitment to being involved in training is not limited to our members but also to many of the non-members who would require education on aspects of ICD-10-PCS.

Rules and guidelines for the proper use of ICD-10-PCS should be developed and the definition of the ICD-10-PCS standards should include system rules and guidelines.

In our previous testimony of the February 5, hearing regarding medical codes and standards in HIPAA we indicated the need for such codes and standards to include the rules and guidelines for proper use to ensure consistent application of reliable data.

At present there are no rules and guidelines for proper application of ICD-10-PCS. So, these rules would need to be developed well in advance of system implementation.

The ICD-10-PCS standard must, also, address the section of 10-PCS that needs to be included as a required data element of electronic transactions. These must be clearly identified in order to prevent confusion and inconsistent coding and reporting practices. There are many procedures, many sections of ICD-10-PCS for which currently we do not typically report ICD-9-CM procedure codes such as the laboratory codes that were mentioned earlier. Unless it is clear which sections of ICD-10-PCS are really part of the standard it will be difficult to develop appropriate educational programs and coding practice consistency will be impacted.

Also, if all sections within ICD-10-PCS will be recorded then our afternoons of training time will need to be expanded as our training time estimates were based only on using 10-PCS for the 9-CM purposes that we are currently using the codes for.

A modified maintenance process is needed to ensure representation among stakeholders and public process in streamlined system revision. In February we indicated that maintenance is a key issue for any complete and flexible medical coding system.

Attachment 3 of our written testimony describes specific principles AHIMA has espoused for medical codes in that maintenance process. These six principles indicate that sound maintenance processes are as important as sound systems and ICD-10-PCS already has this latter requirement.

The responsibility for maintaining this coding system and development of the associated rules and guidelines should be the domain of a single agency so that the decisions analysis of the needs of users, payers and providers to ensure that data integrity is not compromised.

As we recommended in February AHIMA continues to believe that the logical choice for this central authority is the National Center for Health Statistics. An advisory group comprised of representatives of stakeholders should be established to provide input into the maintenance and guideline development processes.

We, also, recommend that the current cooperating structure be continued as it has served as a successful process for the development of guidelines that best meet the needs of the major constituent groups.

We, also, believe that a standard effective date for ICD-10-PCS implementation should be established by which all affected payers and providers would be required to abide. AHIMA has noted that a decision related to ICD-10-PCS cannot be made in a void. While we believe the problems associated with the current ICD-9-CM procedure coding system warrants immediate attention and leadership such decision making must take into account the current and future health care environment in the US.

Ideally while ICD-10-CM and ICD-10-CPS should be implemented at the same time in order to limit the transmission period by disruption of data quality, coding accuracy, coding productivity and proper emergence of claims will occur, we acknowledge that the systems are so distinctly different that it would be possible to implement them at separate times.

If it is decided to implement one earlier than the other and CPS earlier than 10-CM it would allow for easier and quicker implementation and training than if institutions were to face conversion of both systems at the same time. In discussion with our members since the two systems are not related and are entirely separate they felt that having to learn both at once might not necessarily be an advantage but might be overwhelming. However, this question of simultaneous or separate implementation must be addressed in the context of the health care environment in order to assure that there are appropriate time tables of contingent planning developed to accommodate the needs of the entire industry and not just 10-PCS.

Concerns were raised in the past about two separate implementations in the area of information systems and databases. AHIMA believes that this question should be explored and further suggests that perhaps there might be a way for IS professionals to make a long-time change in their information systems and databases provided they were confident that conversion from ICD-10-CM and CPS was a certainty, specific details as to the system and database needs were common throughout the project and they had agreed it was more economical than two conversions. Such an approach would limit the flexibility as called for in the actual coding conversion and implementation, and it is consistent with some of the comments that were made this morning about a date certain for implementation in which people could start preparing as soon as possible.

After looking at all of these considerations AHIMA believes that it would be possible to replace the ICD-9-CM procedure coding system before full implementation of ICD-10-CM as long as this decision is made and plans for the ultimate conversion to both systems are managed.

The issue of replacing ICD-9-CM feature codes with ICD-10-PCS, also, cannot be entirely separated from the issue of adoption of a single procedural coding system. Thus, we continue to call for the evaluation of a single system so that informed actual decisions can be made as to long-term solutions for all health care settings, services and payers.

AHIMA along with the MCDHS has been calling for the adoption of a single procedural coding system to be used across all sites serviced in the US. Our February testimony to this Subcommittee and to the Coordination and Maintenance Committee last May called for a federal study of this proposal.

AHIMA believes it is time for the US to have a means of collecting and analyzing featured data across the sites of service. I will not repeat our testimony in that area since it was given to the Subcommittee previously.

With regard to today's discussion, however, AHIMA does not believe that consideration for more implementation of ICD-10-PCS should be held up while waiting for the leadership and the funding of a study for a single coding system. Clearly the crisis surrounding the limitations of the current inpatient procedure coding system has need for replacement and regularity cannot wait.

AHIMA believes that implementation of ICD-10-PCS will inpatient acute care setting would not only relieve the problems currently inherent in ICD-9-CM but also provide better experience for such a study in the future for a uniform procedure coding system.

AHIMA is aware that other procedure coding systems currently exist. However, we do not see any other coding system capable of replacing the ICD-9-CM procedure coding system at the present time.

This situation could change in the future, but the need is today. ICD-10-PCS was specifically designed to replace the ICD-9 standard procedure coding system and appears ready and able to do so.

Therefore, as of today in light of all of the other variables we see ICD-10-PCS as the only viable option for meeting our critical need for a replacement system as soon as possible.

While there are significant cost implications associated with adoption of ICD-10-PCS as a standard code set, many of which such as computer systems and locations are described more fully in our written testimony, we also must note that there are significant costs associated with maintaining the status quo.

We are paying a very high price for having delayed this long and the cost increases. We are already a decade behind in implementing new ICD modifications and like any system maintenance experience catching up can be more costly than staying current.

Further delay will not reduce the direct costs but we cannot ignore the indirect costs any longer. It has been suggested that ICD-9-CM procedural coding system could somehow be fixed rather than adopting an entirely new system. We believe that we have been attempting to fix the ICD-9 procedural coding system for several years now and have reached the point where no more fixes are possible without severely disrupting the system structure as explained earlier.

ICD-10-PCS has the capacity to grow as medical science grows and it could serve our health care procedural data needs for many, many years to come. We believe that the benefits of the improved data resulting from ICD-10-PCS are well worth the cost and difficulty encountered during the transition period.

We, also, believe that we are incurring significant costs by utilizing a hopelessly outdated and limited system and that ultimately reduction of costs will be realized as a result of the availability of better data.

For example, greater specificity in clinical detail will help to reduce the number of cases where copies of medical records need to be submitted for clarification for claim adjudication. Also, better data will result in improved patient outcomes due to a better understanding of the effectiveness of various treatment options as well as reduced patient errors.

AHIMA and its national network of coding professionals is uniquely capable of assisting in the research on the right system, the best implementation strategy and the design of a new maintenance process. Our coding professionals have training and experience and could learn and utilize a new professional coding system and limit the learning curve. We are uniquely capable of taking the lead in a national work force in retraining and user education for both new procedural and diagnosis coding systems.

Thank you for the opportunity to present our views regarding replacement of ICD-9 procedural codes with ICD-10-PCS and the environment that must be considered in this decision. AHIMA is deeply committed to working with the Department of Health and Human Services, and CHS and other health care industry groups to advance coding practice and improve our nation's health care data through adoption of standards.

Thank you.

MS. WHALEN; Good afternoon. I am Lenore Whalen with Providence Health Care and I am representing the Federation of American Hospitals. On behalf of the Federation I thank you for this opportunity to address the topic of replacing ICD-9-CM, Volume 3, and ICD-10-PCS as the standard code set for hospital inpatient services.

The Federation of American Hospitals is a national representative of over 1600 privately owned or managed community hospitals and health systems throughout the United States.

Members range from small rural hospitals to large urban medical centers and offer a variety of services including acute hospital care, outpatient services, skilled nursing care, rehab and psychiatric care.

The Federation of American Hospitals understands the importance of quality health care data. The Federation believes that complete, accurate and consistent information is the cornerstone and one of the most essential resources of a health care organization. Meaningful health care information is important for a number of reasons including the ability to improve the effectiveness and assess the quality of patient care to reimburse providers for services rendered and to aid in research as well as strategically plan for the future of health care

Our testimony will address the following topics: Does ICD-9, Volume 3 need to be replaced? Is ICD-10-PCS an appropriate replacement system and what are the implementation considerations?

As medical technology continues to advance it is necessary to consider whether or not the current code set used for capturing inpatient procedures is currently adequate and whether or not it will be adequate for the long term.

Our position is that ICD-9-CM, Volume 3 is not adequate for current and long-term use and that providers, payers and Medicare beneficiaries would be well served by conversion to ICD-10-PCS with appropriate consideration of the issues noted below.

ICD-9, Volume 3 needs to be replaced because it does not have space within the current classification system for new procedures. As a result, ICD-9-CM often cannot capture new procedures or establish procedures performed via a different approach. Thus, the old classification numbers are continually capturing a wider variety of procedures and approaches under the same number. This inhibits research about new procedures and the associated impact on public health care quality and resource use.

The Federation is of the opinion that ICD-10-PCS is an appropriate replacement procedural classification system for ICD-9, Volume 3. ICD-9-10-PCS offers many advantages when compared to the current ICD-9-CM, Volume 3. Based upon our comparison of ICD-10-PCS to essential criterion elements for success we are of the opinion it is the system of choice.

The first of our criteria is that the system be in the public domain. It is critical that information required for billing be in the public domain to facilitate training and the use of codes and official communications.

The ICD-10-PCS set and training manual are available for use within the public domain including availability on the Internet.

The system is familiar to the hospital inpatient coders. Information about ICD-10-PCS is on the AHIMA web site. Articles have been published in professional publications, read by hospital coders. National seminars have been conducted. Information has been presented at the Society for Clinical Coding annual meeting and a recent audio conference was, also, provided.

Terms used in the code set should be well defined to minimize the need for guideline development and the variability of code assignment. The classification system should allow for consistency of terms throughout the system, accumulation of statistics for financial, quality and outcomes measurement, payment and facilitation of information retrieval.

Based upon our research ICD-10-PCS contains terms that are clearly defined and are standardized throughout the code set.

Due to the use in payment methodology, the code set should be updated. We believe it should be updated with the federal fiscal year.

The code set selected should be usable on the current UB-92 form locators 80 and 81 and form locators of the UB-92 will accommodate seven alphanumeric characters of ICD-9-PCS, and there isn't a whole lot of change that needs to happen there.

The uniform hospital discharge data set is the basic set of data collected on all hospital inpatients. This data set requires the reporting of all significant procedures. ICD-10-PCS has a unique defined code for each procedure which would not change with updates.

Each substantially different procedure should have one unique code assignment, that is it should not be possible to correctly assign the same procedure to more than one code. The code set should not reuse a code for a different meaning.

ICD-10-PCS has a unique defined code for each procedure which would not change with the updates. Expandability is one of the primary reasons for replacement of ICD-9-CM. The main code structure should be expandable rather than an add-on section. Space has been included within the ICD-9-10-PCS code set for expansion. There is no temporary place for new codes.

The lack of ambiguity in the system should eliminate confusion about distinction between codes and what a given code includes. The system should allow the reporting of all procedures that might be performed rather than those that are only considered consistent with contemporary practice and performed in multiple locations by multiple physicians.

The system should capture unusual and/or experimental procedures performed in advanced or alternative treatment settings. This, in fact, is the legislative goal.

The payer independent of the reporting requirement can determine payment. ICD-9-10-PCS allows for the detailed reporting of procedures regardless of payment considerations. It, also, allows for the reporting of new technology in the main code structure and was designed to allow reporting of all procedures.

There should be minimum need to change, update the system and changes should occur in the main code system rather than an add-on system. Based on the architecture of the system it appears that ICD-10-PCS will have only minimal changes.

The structure and terms in the code set should allow for systemized, clinically cohesive data retrieval for one main code set.

Data retrieved should be understandable by non-clinicians with minimal explanation. Code numbers should remain the same for the same procedure. In ICD-10-PCS information retrieval can be done based on the position in the data field or by range of codes. Thus, all procedures on a particular body part by a specific approach, etc., can be easily retrieved.

ICD-10-PCS can be coded manually from paper records, and it lends itself to the logic of an encoder. The procedure classification system should not include diagnoses within the procedure description.

ICD-10-PCS does not contain diagnostic information in the procedure code. Throughout the system the same definitions and guidelines should be used. ICD-10-PCS as presented in the training manual is consistent throughout the classification.

Even though there may be other considerations for a new procedural system the Federation is of the opinion that the ones provided during this discussion are the most critical.

We, also, want to respond to the question regarding implementation considerations for ICD-10-PCS. This portion of the testimony will be divided accordingly.

Education. Detailed education and training must be provided to the HIM professionals and coding staff. Additionally education must be provided to other users including but not limited to administrative personnel, billing personnel, researcher and to the physician community. Training must be provided to the FIs, fiscal intermediaries and should be made available to private payers.

While there has been some public domain development of an educational tool this tool needs more testing before widespread use. This time must be allocated to finalize training tool development and to train the trainers.

CMS must continue to provide assistance with training development. CMS should, also, assist in getting information to medical publications, including physician journals to spread the word about the program, about the new system. Web-based training should be made available. The payment error prevention payment program should assist in the training process.

There needs to be a hot line capability for trainers and coders to bring questions and problems for immediate assistance. CMS must assume primary responsibility for educating and ensuring consistent application and understanding by the fiscal intermediaries. Private payers should, also, receive training and education.

CMS must, also, assume responsibility for educating physicians although others will have a role in this education process.

Multi-hospital systems will need to provide in-house training for coding personnel and administrative personnel and physicians. Smaller facilities may have to rely on professional organizations and private consultants for training assistance.

CMS must ensure that every facility regardless of size, location and/or ownership has fair and equal accessibility to quality training at a reasonable price.

Professional organizations will need time to plan for their educational activities. We are of the opinion that professional organizations will be instrumental in the successful delivery of education.

Payer synchronization. It is critical that all payers convert at the same time using the exact same reporting requirements. A high priority should be placed on national standards for all payers with the same reporting requirements. This approach is consistent with the intent of HIPAA and is the only way to ensure data integrity in the country and efficient and effective provider implementation.

Lack of a national standard would result in increased costs for the provider community. All discussions regarding the development and maintenance of the system needs to continue to be in a public forum with the opportunity for the users to provide comments and have questions or concerns addressed.

It is our recommendation that the maintenance process be conducted in the public domain and allow for comments and questions in a cost-free public forum such as the Federal Register.

Since coding guidelines, rules and interpretations can impact the system as much as maintenance of the system, the process for development and implementation of guidelines, rules and interpretations should be conducted using the same open process as the maintenance update process outlined earlier.

The publication of all guidelines and rules should be available to the public domain. Providers should not have to purchase software, a printed code set and, also, numerous sufficient publications explaining the official use of the code set. Copies of software, the code set and guidelines and rules should be available at cost through the National Technical Information Service, the Federal Register and/or other public documents.

All publications should be in the public domain, for example, you could not copyright it to allow reproduction.

The committees responsible for the maintenance and guideline development should meet publicly. If possible a listen only capability for these meetings, real time and post meeting should be provided through the Internet. If their concern is about the arm of the HHS that administers Medicare payment being in charge of the procedural coding system the responsibility can be assumed by other administrative areas of the department such as the National Center for Health Statistics.

Time must be allocated for the DRG conversion methodology to be developed and tested for fairness. There must be adequate hardware and software that has been tested and certified prior to training and implementation. The costs for necessary hardware enhancement should be reasonable, not contribute to the increased health care costs and be affordable for small hospitals.

Implementation is urgent. The implementation of ICD-10-PCS as the replacement system for ICD-9-CM could not occur any earlier than October 2003.

In our opinion the implementation of ICD-10-PCS should occur quickly. The provider community could respond to the challenge of a new procedural coding system if adequate attention was provided to a concise, reasonable and timely implementation plan.

Additionally the Federation would be remiss if we did not take this opportunity to encourage the reviewer of a future single classification system for procedural reporting regardless of the treatment setting.

It is the opinion of the Federation that it is in the best interests of patients, providers and regulators that a nationally recognized standard for reporting procedures be adopted. If there continue to be multiple standards it will be extremely difficult for health care providers to be sure that they are complying with varying standards, rules and regulations.

Trying to provide consistent education and training as well as the development and implementation of policies and procedures with the current approach is operationally inefficient and can complicate efforts to promote, ensure and validate compliance activities.

We recognize that the development of a national standard will take time. Although no system is ready to fulfill this need today, it is our opinion that ICD-10-PCS could be used as the foundation for such a system.

Therefore, implementing the new inpatient procedural classification sooner rather than later will only position us for the future of a single procedural classification system.

Lastly, the provider community recognizes the need to become more knowledgeable of the modification of ICD-10 as a replacement for the diagnosis section of ICD-9-CM. We look forward to participating in the upcoming hearing on this topic.

In closing, we would make the following summation points: There is a need for a replacement classification of ICD-9-CM, Volume 3 based on the current system limitations. ICD-10-PCS is the recommended replacement as this system meets the critical criteria necessary for success.

Consideration must be given for implementation issues such as open maintenance and guideline development and the provider community can respond to the challenge of new procedural classification system if adequate attention is provided to a concise, reasonable and timely implementation plan, and this morning there were some issues about coders and whether they would be able to use the ICD-10-PCS system better than the current Volume 3.

I have been in the coding field for about 30 years, and I have been a director of medical records but besides that I, also, teach coding, and I have had the opportunity to present this coding system around the country and a number of the audiences that I have dealt with a good majority of them have been directors of medical records who don't do the coding in medical records. They allow their staff to do that, and just for a testing site we used a couple of examples that 3M has provided in their training manual and they found they liked the system because they hadn't been coding in years, and they found it to be very usable, very friendly to the user and easy to accommodate for the code assignment.

As an experienced coder I am going to be honest with you. As Sue reiterated before it may take a little longer for me because I have been in the field for so long. I have the ICD-9 mind set, and it doesn't quite cross over to ICD-10-PCS. So, it may be a little difficult for me and maybe more experienced coders will find the same thing to be the case.

For a new coder, somebody who is coming out, if we were going to implement this in, say, 2006, we could start training coders now to be able to use the system and still be training them for ICD-9 but be able to give them something to look forward to.

I think this is a challenge. I am looking forward to that challenge. I may retire after that, however, but I am looking forward to that challenge, and I certainly thank you for the opportunity to present to you for myself and, also, for the Federation of American Hospitals

Thank you.

DR. ZUBELDIA: Thank you. Those were great presentations. I would like to start the questions of clarification.

Ms. Whalen, I am pretty certain when you said in your final statement that there has to be one procedural coding system you are referring to inpatient coding, right?

MS. WHALEN: Yes. Well, actually no. We are referring to all of the areas. I think ICD-10 from the perspective of looking at the other systems, I think ICD-10 can easily become the one procedural coding system. I think it lends itself very easily to the outpatient setting as well.

DR. ZUBELDIA: Okay, thank you.

MS. WHALEN: And that is talking from a coding perspective.

DR. ZUBELDIA: Sue Prophet, on Page 13 of your testimony towards the middle it says, "However, we do not see any other procedural coding system capable of replacing the ICD-9-CM coding system at the present time. Does that exclude the ICD-10 in that statement?

DR. PROPHET: We were talking about it because ICD-10-PCS was specifically developed to replace 9-CM, Volume 3, and we believe that of all the systems that we are aware of that are out there today any of the others there are going to be some significant radical changes in processes, perhaps even structure and that might be more of a massive undertaking in implementing 10-PCS since that was specifically designed for this.

DR. ZUBELDIA: Thank you.

Anybody else?

Mike?

DR. FITZMAURICE: I guess what is running through my mind is what about CPT-4 versus ICD-10-PCS? There are parameters of training. There are parameters of existing use, and I am not knowledgeable enough to know that if there are separate domains, that is on inpatient it is medical and surgical; on outpatient it is not, but as we were reminded more procedures are being moved out of the hospital and into ambulatory surgery centers. What about CPT versus ICD-10-PCS? There is granularity. There are all kinds of these characteristics. Do we know enough about whether one can replace the other or either one could replace ICD-9-CM in the hospital for an ambulatory setting?

I don't want to open up a whole raft of studies that could be done, but I have heard an awful lot of testimony that says that we need one coding procedure, one system for coding procedures. It could be CPT-4. It could be ICD-9. It could be ICD-10-PCS, and I am confused about where things stand on the criterion that we would use to judge a good coding system.

I have not heard addressed any overlaps between the two systems or their suitability for the different domains that they now don't employ. So, if we focus just on what is happening inside of hospitals and the coding system one argument that was made is that CPT-4 could do the job for hospitals.

Other people prefer ICD-10-PCS. Is there a basis at this time for making a judgment?

DR. PROPHET: I would say, "No." As we said in our February testimony we really feel like there does need to be a feasibility study of what would be the best system for all settings or even if given our disparate reimbursement systems that we have today, whether a study might show that it is not possible to go to a single system, but we don't know any more about whether 10-PCS would work well in a physician's office setting than we really know whether CPT would work well in the DRG system with all of the ways that inpatient codes occur. So, that is where we think that there really needs to be a feasibility study where that is looked at if a system, any of the systems could work across all of the settings.

DR. FITZMAURICE: I would be interested in other opinions from the panel if you have any to share.

DR. GORDY: I think that there is a possibility that CPT in the hospital, as was indicated to you a while ago, there was a study. That study was never fully developed and would certainly have to be repeated to see if it could be crosswalked appropriately to the DRG system, but it presently is being used on a prospective basis in the outpatient surgical centers as was pointed out.

So, if CMS goes to a prospective paying system it may be unlike the DRG but more like the outpatient setting in the hospitals who already have that system.

CPT currently covers everything but the inpatient.

MS. WHALEN: Okay, from a coder's perspective it is very difficult right now. You have to kind of switch your hat when you are doing inpatient coding versus outpatient coding, and the ideal situation would be to have one procedural coding system so that you don't have to switch hats. It is very difficult as a coder to go from ICD-9 to CPT or from CPT to ICD-9. They don't talk the same or look the same, and I don't believe that ICD-10 will look the same as CPT nor vice versa.

In my opinion I would love to see, but that is my opinion, okay, not the Federation's, my opinion, I would like to see one system, whether that is CPT or ICD-10-PCS to me doesn't matter. It is going to be something I am going to have to learn. CPT is familiar to a lot of the coders. However, it is not in the public domain which makes it difficult to provide the training materials. We would have to go through the American Medical Association to get permission to do that, and that is one of the issues, I think that the Federation is looking at from the standpoint of the CPT versus ICD-9. Whatever system we use for procedure system or for the code set, it needs to be in the public domain and that is what I want to stress. Whether we go to one system or whether we go to two, we are used to change in HIM. We have been doing it for years, and we will work around it whatever you all decide to do.

DR. FITZMAURICE: So, when you say that you don't want to see a system copyrighted, you don't object to the copyright to make sure that it is a consistent system throughout. You object to its not being in the public domain?

MS. WHALEN: Right.

DR. ZUBELDIA: What about the non-procedures; what about things like evaluation of management services or supplies or other services that are coded with HCPCS; where do those fit?

MS. WHALEN: They would not fit unless ICD-10-PCS is going to accommodate that. I didn't see that that was a functionality of that system. They would have to develop something on the evaluation and management side to make that happen, but that could be done fairly easily I think, but then I am not a 3M person. So, I really don't know.

DR. PROPHET: One of the issues that AHIMA has testified on previously is about that we would prefer to see the issue about supplies and names of devices separated from the performance of a procedure type system and we don't see HCPCS as really being a duplicative coding system because we think the naming of supplies, the naming of devices as a different sort of identification and looking at the type of procedure that was performed.

MS. WHALEN: And typically those are not coded by the HIM staff or coders. They are coded through a charge master.

MR. BLAIR: Tracy, could you help me understand a little bit on time frames? I have been learning a lot through these testimonies. I am not an individual who has worked with either ICD or CPT codes directly, and we have heard this discussion of the development of ICD-10-PCS codes and how it took a year or two to do the first draft and then additional drafts were done and then different groups tested it, and it was modified, and we are looking at 5, 6 years so far in development, and people have testified to us that there are still aspects of ICD-10-PCS that have yet to be tested.

You have indicated to us that we ought to consider CPT codes and that the only areas that CPT codes don't cover at the moment are the inpatient med surg areas. How long will it take for the AMA to develop, test CPT codes to cover that area?

DR. GORDY: That is a good question. I am not sure I am prepared to answer how long, but let me say that in another way. If you alluded to the Whipple procedure that is not a procedure that you are going to do in an outpatient setting but not because you couldn't do the procedure because of the morbidity involved of the patient that is going to require inpatient stay.

So, when you look at that then you already have the procedures. The physician is already coding the procedure that the hospital is doing under Part B for CMS. So, the Whipple, whether it is done in the inpatient or the outpatient, it doesn't really make any difference to the physician as such. It does make a big difference to the hospital.

So, cross walking a Whipple, for example to the hospital setting would be basically understanding the morbidity of the particular issue.

We had a trauma case. The procedure could be done perhaps on an outpatient basis, but again the morbidity of the patient is going to dictate how long the patient stays in the hospital or the complications that may be concerned. So, cross walking to the DRGs in my simpleton mind will not take that long since it was done before. It needs to be repeated and I don't know what the length of that would be, and I don't think it could be in the 6-month time frame that you heard this morning, but it seems to me that that is probably not unlikely that that could be done within perhaps a year or so.

MR. BLAIR: Apparently for those procedures that are already within CPT codes to accommodate them from an inpatient setting would not take that long. What are we looking at in terms of the body of codes that are not in CPT now? Are we looking at 15, 100 thousand, 50 thousand, 100 thousand? How many codes are we talking about that would need to be developed and tested?

DR. GORDY: Right now CPT has a little less than 10,000 codes. We have the capability of going to almost 100,000, nine, nine, nine, nine. So, would you have to add codes? From the standpoint of procedures, from the standpoint of care if you had a non-procedural thing like the care of a pneumonia I don't think that we are talking about anything with major implications for coding, but I would yield to my two colleagues here because both of them, Sue, especially knows CPT very well. So, maybe her comment would be more cogent than mine.

DR. PROPHET: I don't think any of us would say that there are not, I mean medical, inpatient medical surgical procedures in CPT. Certainly they are but right now since CPT is designed primarily for physician reporting and I don't have a number in mind but there are lots of situations not right or wrong, just because of the primary purpose of CPT where distinct codes may be created or not created based on the premise of difference in physician work, say, which is not the same thing as granular reporting of the procedure.

So, I don't know if we have a number of how many additional procedures or procedures that might need to be split apart because different data would be needed from the facility perspective, but I think that that would have to be looked at at the feasibility study.

Are the codes designed to also accommodate those types of uses or would some different structural changes have to be changed, and I, also, think one of the concerns of AHIMA beyond just the structure of the codes themselves is the six principles of code set maintenance that you will find at the last page of the written testimony that our members and leadership feel would be ideal for any single procedural coding system, whether that be 10-PCS, CPT or something else.

DR. ZUBELDIA: This hasn't come up yet but bundling and unbundling of procedures, is that feasible under ICD-10-PCS? It seems to me like today if you were to deal with Whipple as independent procedures they would all get bundled under one procedure code. That is not even possible with PCS. Maybe that couldn't work for reimbursement.

DR. PROPHET: PCS is very granular and richer. Pat might be able to address this better than I can, but my understanding from looking at it and being involved in the testing is that it is very granular and one of the things that AHIMA has proposed as a single procedural system is a system that is granular enough that you would not have to change all of the reimbursement system to match the coding system. You could pay whatever you want to pay on those codes.

So, if you had reported six codes and that particular payer decided that they were going to bundle it into one payment or only pay for it based on three of those six codes or whatever they want to do, that would be fine, but it wouldn't change the code reporting structure.

So, the codes would be granular enough that they could bundle them up, unbundle them, do whatever they wanted to design the payment system around them, and we believe that 10-PCS is probably granular enough to do that, and, Rich, I don't want to jump on 3M's thing here, but one of the reasons actually that AHIMA was glad not to see eponyms in 10-PCS is because those terms are not necessarily used consistently across the country, and for example, in the Whipple procedure that he gave as an example, that particular differentiation of what is included in that procedure, that is not always what some physicians are referring to when they call it a Whipple procedure which is why 10-PCS is sort of boiled down to these are actually what you did, call it what you will or name it after whoever you want to, but these are actually the components of what you did.

MS. WHALEN: Again, remember that you want to use these procedures in research, too. So, we are not just talking reimbursement, and it needs to be granular if you want to use it in the research field or any other statistical data set.

DR. ZUBELDIA: I am a little concerned because a few years ago we looked at the HCPCS J codes and decided that they were not granular enough, and decided to go to NDC codes. Are we going to run into a similar situation?

DR. PROPHET: At least from our perspective in the testing that our members have done on the system, yes, to a certain extent it does require more detailed medical record documentation which a lot of our members were at first concerned about, but when they actually tried to apply the system, they found that most of the time the level of documentation was there to support that level of detail.

DR. COHN: I am concerned how all of this is going to work in the future. I just want to get your thoughts on this in terms of the hospital inpatient. Now, say a patient is admitted to the hospital. A physician performs a local procedure on the patient. So, he describes it as a Whipple procedure. Presumably he or she may know the CPT code and affixes it on there. Can then the professional reverse engineer that report to produce those six codes?

DR. PROPHET: On the UB92? Yes, that is the way it works now is that when the coder in the HIM department is coding the procedure they don't just code the name of the operation based on what the physician says it is because sometimes it doesn't include all of the pieces that the physician has performed. So, they are instructed to read the entire operative report now and pick up all of the appropriate ICD-9-CM, Volume 3 codes to describe what is in the operative report.

DR. COHN: I am not an expert on Volume 3. Let me start by saying that, but generally Volume 3 is a relatively non-granular procedural code set. Am I correct?

DR. PROPHET: True, but there are times when you will have more than one ICD-9, Volume 3 procedure code in one operative episode.

DR. COHN: Okay, so picking up additional things.

DR. PROPHET; Right.

DR.COHN: Sort of reverse engineering; it sounds like we are bordering on that, okay.

DR. FITZMAURICE: Is that good or bad, reverse engineering?

DR. COHN: I don't know.

MS. HUMPHRIES: The issue I guess is they have done the testing and I guess I think it ended up with saying AJ, saying it has to be tested. They have done testing and I am sorry, I have forgotten whether it is the HIM or AHA specific, but presumably it meets the medical-surgical part that was tested. They have the comparative data and what it was originally coded from. So, I guess you could retest for it.

MS. WHALEN: From the standpoint of inpatient coding we are not used to the CPT at all. So, we are using ICD-9. So, in order to code it she or he has to read the operative report to be able to code all components of that operative procedure. So, Whipple may not be just one code. It may be three or four codes in ICD-9.

DR. COHN: Is that correct?

MS. WHALEN: Could be.

DR. COHN: So, is that the effect?

MS. WHALEN: Off the top of my head I don't know, but it could be three. It could be two. It could be one. So, it depends upon what we have done. I am sorry to say this, but we never by what the doctor says in his title of operative procedure. We actually read the operative report. You can throw darts. It is fine.

DR. COHN: I guess physicians understand where we stand.

(Laughter.)

MS. HUMPHRIES: This is very analogous to not taking the author's key words from Medline.

DR. AVERILL: In our technical advisory panel this is a particular issue of using evidence that was debated and discussed quite a bit. There was a strong consensus in the technical advisory panel not to allow evidence in the system. There was a great deal of dialogue on that and that was a strong suggestion from the technical advisory panel.

DR. ZUBELDIA: But it sounds like we need macros.

DR. AVERILL: Where we put those types of things for guidance is to put those in the index as opposed to the coding system itself. So, in the index there will be references, you know, just take a simple term like appendectomy, well, that will route you to exactly the right place in the tabular. So, if you want to look up a word like appendectomy or words like that, they are all in the index, and so those types of things are there but things like Whipple there is a lot of, I don't want to use the word "controversy," but not a clear consensus of exactly what that word means and what it entails and exactly what the constituent parts are of that procedure and because of that there was strong direction from the technical advisory group not to include those kinds of terms in any way.

DR. ZUBELDIA: Since you have the microphone, would you comment on the feasibility of using the ICD-10-PCS for non-procedures like services, like an ambulance run or supplies or other things that are not procedures?

DR. AVERILL: Clearly the system was not designed for that. So, you just talk about the structure itself. So, one could create a task which in the context of a seven-digit alphanumeric code one could create codes for those sorts of things. It is no different than taking any of the other sections for which codes were developed. It certainly wasn't intended for that purpose but I think structurally the structure could accommodate such a thing if one decided to take that on as a separate task.

DR. COHN: Let me ask you one other question. I think we have all talked about principles of coding and I know that we have heard a lot about them today as well as been reminded of previous NCVHS principles. I do know with the technical advisory group one of the early principles we talked about had to do with meaningless identifiers which was not accepted by ICD-10-PCS and I think there have been some of us who have observed that it has caused some interesting structural issues in ICD-10-PCS such as the differentiation between upper and lower veins and arteries and things like this. Is this something in retrospect that you would do differently or do you feel it makes the most sense?

DR. AVERILL: I think the advantages in terms of using the data for research purposes and being able to in a hierarchical sense clearly identify different classes of procedures on so on far outweigh any of the disadvantages with clearly identifying what the character does in setting standard values for each of those characters. So, no, in retrospect I would not argue that we made in any way, shape or form a mistake with that.

DR. COHN: Let me follow up on that question since obviously that is the path that has been taken, what is going to happen with ICD-10-PCS in terms of the architecture when you run out of the various character pieces?

DR. AVERILL: What we have found is certainly unless we are going to change Gray's Anatomy that the anatomical sites are I think quite stable. Certainly from the group procedure perspective we struggled to find more group procedures and indeed we originally had two characters for that and through any of the sections that we went through medical-surgical we wound up with 30 and no one can even think of possible additions.

So, we feel quite confident that the structure that we now have for root procedures and body sites in terms of probably the biggest dimension that would be a candidate would be the device column in which new devices would come into being.

There you really have almost unlimited amount of space because you can start making the device column specific to the procedure or specific to the body site if you ever needed to do that, and that gives you almost a limitless amount of space if one chose to do that.

Currently we have done it in a bit more standardized way where the device is pretty much standard within an organ system, but we could increase the number of codes there almost exponentially if we needed to, and so body sites being stable our experience with root procedures because we are coding fundamental objective of the procedure we think there is more than ample room for as long as we can foresee.

DR. FITZMAURICE: Simon raises the concept of codes assigned to elements of something that could lead the coding system into a classification system, but I buy into that and so, I am puzzled. It would seem to me that if each procedure were classified the way you classified it and assigned a number where you have assigned it there would still be an advantage to have a meaningless code in case something had to be shoehorned in.

I can imagine genomic procedures coming up and expanding like crazy in my imagination and maybe the classification system would be changed in some way, but these meaningless numbers would allow a computer to read through them and perhaps map more quickly into a CPT-4 or perhaps an ICD-9 and other coding systems. So, are you saying that there are no meaningless, unique numbers attached to each procedure?

DR. AVERILL: We discussed this at the technical advisory panel at some length and while we decided to go with the seven-character meaningful representation we always made the observation that CMS or any collective body who decided how to implement the system could take our seven-character alphanumeric and make that part of the English description if you will and just sequentially number all the codes for the purposes of reporting.

So, you could serve both ends if one chose to implement it in that way. That is certainly an issue that could be debated whether or not we want to take all the ICD-10-PCS codes and number them 1 through 193,000 or whatever the number is and that is what gets reported and the seven-character alphanumeric is just technically part of the English description of the code.

DR. FITZMAURICE: I think I agree with you because your argument is that the seven characters are unique themselves and so you don't need another unique number.

DR. AVERILL: Right.

DR. FITZMAURICE: One could assign another unique number and then we would have two standards for that. I would like one person doing it or one company doing it.

DR. ZUBELDIA: Have you identified impossible codes in ICD-10-PCS?

DR. AVERILL: No. In other words you have the tabular, and I showed you a brief example of the tabular. the only entries in the tabular are what is considered possible. So, if you did all the combinations and I don't know how many, probably billions of possible combinations there are given the seven, whatever, seven to the 33, that is a big number. I haven't figured that number out, and so the 193,000 cells are only cells which we consider possible. One could fabricate a series of digits that wouldn't be allowed in the system easily and that would be considered an impossible procedure.

DR. COHN: Actually I wanted to change the topic a little bit if that is okay. Richard, thank you very much.

Sue, I just wanted to follow up with you on some of your comments, not so much what was written today but your comments about a feasibility study, and obviously this morning we heard from Alissa Fox about another sort of study but I am wondering from your view have you listened to her discussion? How consistent is what she is suggesting with what you were proposing in the previous testimony?

DR. PROPHET: I think she was referring to a study of the implications of cost resource, otherwise of 10 PCS adopting it and I assume versus maintaining 9-CM, and I guess what we would add to that is looking at, but then I think she was, also, just thinking of it from the concept of where we are here, implementing 10-PCS for acute care inpatient services.

In our feasibility study we were saying, "Okay, we agree that something needs to change, that 9-CM cannot last much longer," and we would like to have a single system across all sites of service, and therefore let us look at the different systems out there and how they would work as a single system in all of these settings since that system is currently not used in or I presume she was focused on looking at implementing 10-PCS as it was outlined here today in the inpatient setting.

DR. COHN: Let me just correct, I think that maybe what you are talking about, at least my understanding of what she was talking about was really trying to identify what ought to happen when I said, "There is a problem here," what ought to happen and what it would take and all of this, and I think what you are doing is adding the piece of well, gee, while one is doing that one ought to look if there are some exclusions that might move us towards a single procedure coding system.

DR. PROPHET: Right, and you can look at it as two problems or a very variable of the same problem. I mean one problem is 9-CM right now is used in the inpatient hospital setting, and it needs to be replaced, and we can focus solely on that element of the problem or we can say, since we have to do something there anyway, can we look at the full context of the duplicative code set issue and is there a way to resolve that larger problem at the same time or within a reasonable period of time.

DR. ZUBELDIA: So, do you have a feeling for how long it would take for the system in general to transition from 9 to 10-PCS if we were to start tomorrow and we have no other interferences or HIPAA transactions on security?

DR. PROPHET: Our expertise is more from the training and education component than it is from all of the systems development issues, and quite frankly we feel that from the training perspective we could easily do it within the length of time that it would take if we decided tomorrow we were going to go in this direction because my understanding under HIPAA is that even once we have a final rule out which we are not even close to a proposed rule it would still be a 2-year implementation time line probably.

So, you know, we are talking it is going to be close to 2005 even if we got going tomorrow by the time it was actually completed and ready to go.

DR. ZUBELDIA: This is not an IT program. This is a global systems program, reimbursement, coding, medical bar codes. The IT component I think is very small even though it may seem big. I am in the IT world and I see this IT problem as very small compared to the system business problem.

How long do you think that the system, the health care system not the computer system would take to transition?

DR. PROPHET: I am not sure we can address the full, what the health care industry, how long it would take. I would say 2 years would be reasonable.

From a training perspective which is where we are really the experts in education and training perspective a year would be very reasonable to both develop products and to conduct the training, particularly using the various electronic media that we have available for training which expedites it.

DR. GORDY: I don't have a clue either. I think Sue's comment probably a couple of years to get it implemented is a reasonable figure. I doubt seriously that you could do it much quicker than that.

The comment was made this morning that you are probably going to have to run 9 and 10 concurrently for a while.

We have experience at CPT that people are still using codes that we no longer have in the book. That is why we don't do away with the number. We don't put the number in the book, but we don't use that number again because people continue to use those. So, you are going to find systems out there that are going to be very slow to develop. So, I think 2 years is an optimistic number.

MS. WHALEN: I think that would depend upon whether we are talking about the whole industry. That includes physician component because that is going to be a whole big learning curve for physicians and their group. It is totally different.

DR. ZUBELDIA: You are advocating this system including for physicians?

MS. WHALEN: I am saying that if that is what you are asking, that is what I am saying. When you said, "The whole industry," are we talking about including the physicians? My experience with physicians it is not easy to teach them something new especially when it comes to coding.

(Laughter.)

MS. WHALEN; Documentation is still a big issue in the coding field. So, I am sorry. I realize there are lots of physicians in the room. But in all truthfulness I was around when we went from, and unfortunately that kind of ages me, I was around when we went from 8 to 9, and that was a pretty big change for us. That is 30 years ago, oh my God, 30 years ago, and that was a big change for us.

As far as the coders and the health care industry I think we are used to change. All I can say is it is ongoing thing in the health care industry. There is change going on all the time. So, in order for us to get ready I think probably at the most 3 years, I mean at the most I think 3 years would be it. From a training perspective I think a year. The AHIMA is very good at training and especially with the media that we have available today. It is so much easier to get training.

MR. BLAIR: Just one observation here because I am struggling as a non-clinician, you know, trying to pull this stuff together and one of the observations that I have is that clearly we are going to have to change because ICD-9-CM, Volume 3 is not going to last much longer. We are going to have to change to something, and it might be ICD-10-PCS. It might be CPT. No matter what we change it is going to involve the costs of change. So, in my mind since the question has been raised whether ICD-10-PCS is a better answer than CPT I think that we need to address that based on the functional value of each coding system, not winding up saying, "Well, it is going to cost a lot, and it is going to be disruptive to change to ICD-10-PCS."

It is going to be disruptive to change to CPT as well. So, the cost of change is something we have to understand and carefully work no matter what the change is, but I think if we are going to try to discern whether it is CPT or ICD-10-PCS somehow we need to get information comparing the functional value and openness and growth opportunities for each and compare those against each other.

DR. ZUBELDIA: I think that is a segue to my change of topic onto something that I would explore a little bit to see if it needs further exploration. What about CPT-5? Where does that fit in the picture?

DR. GORDY: CPT-5 is actually being incorporated into CPT at the present time. The material that came out of CPT-5 you already find in the book at the moment. So, rather than having a sudden date change and going to another volume called CPT-5 what you are going to see is an integration of the process, and we are doing that at the present time, taking out, for example, we have diagnoses in some of the codes. We are making an effort to remove all of those from the codes. Those kinds of things that came out of CPT-5 are presently being implemented in CPT-4.

So, it is a seamless kind of thing. You are not going to see a sudden transition from 4 to 5 as such.

DR. ZUBELDIA: Does that include the codes that would be necessary for inpatient procedures?

DR. GORDY: In the sense that we have an increased granularity development in the CPT process I would think the answer at least my, again, maybe somewhat simpleton approach to it is the answer would be yes because what I said a while ago is that what you are doing, you are basing at least the way medicine is being priced at the present time, Medicare gives you a DRG. A benefit company gives you a fixed rate in the hospital for days of non-procedural kinds of care and for something like pneumonia or like depression in the psychiatric industry you get a fixed rate for so many days, and in the care for where you have a procedure done then those are really already there.

What you don't have is what happens as I said a while ago the morbidity portion which can be adopted from the DRG standards at the present time. So, granularity has increased in CPT. It should carry over into the hospital. I am speaking off the top of my head obviously because we don't have a current study to say that yes, we can map what we currently have in CPT to the DRG system. We only have a study that is now 18 years old.

DR. ZUBELDIA: So, how are the hospitals billing for non-procedural stays like depression? Does that fit into the ICD-9, Volume 3?

DR. PROPHET; Volume 3 is only procedures. So, right now if you have a hospitalization for an appendectomy that gets billed with an ICD-9-CM procedure code. If your hospitalization was for depression it would be billed with ICD-9-CM diagnosis code, and that is how it would be.

DR. COHN: And no procedure code.

DR. PROPHET: And no procedure code, right.

DR. GORDY: The most important thing to understand here though is that while if you went back to the eighties when you could bill per day kinds of things that is a whole lot different than the payment systems that currently are going on. They may have per diems and some contracts. I am talking about non-Medicare now and they may have fixed rate for certain like a DRG. It depends on how you write the contract or what you sign. It is not driven by any one particular thing.

DR. ZUBELDIA: How about non-medical procedures, wisdom teeth extraction in the hospital setting? Are there some dental procedures?

DR. PROPHET: Yes.

DR. ZUBELDIA: That are being billed under ICD-9, Volume 3?

DR. PROPHET: Yes, certain types of things.

MR. BLAIR: Just maybe before the group closes here there were two areas that were alluded to in the past. I would just sort of like to get a good understanding of this. For ICD-10-PCS and for CPT-5 could the panel help me understand how they are both prepared to accommodate the growing area of procedures for complementary and alternative medicine and areas that might involve human genomics?

DR. GORDY: I can only speak to the CPT portion because I don't know about the ICD-10. In the process for alternative medicine currently it is that they have the ability to submit requests for codes to CPT just like anybody else, and we have some codes already present, for example, acupuncture. There are only two, but you must understand that CPT is based on peer-reviewed literature and before a code can be accepted into CPT we must have some kind of peer-reviewed literature to establish its efficacy.

So, when the codes for the acupuncture were presented they could only come up with two at that time. Now understand this was probably 5 or 6 years ago and at that time we could only come up with two codes.

So, there is a process that anybody who wanted to put alternative medicines with any kind of evidence based peer-reviewed material could bring that forward and would be reviewed by the panel and likely accepted.

Then it would go to the Relative Value Update Committee for a value to be attached to it relative to the system that it was involved.

MR. BLAIR: Is anybody else able to describe how the ICD-10-PCS codes --

DR. GORDY: There are two things. Oh, I am sorry, I apologize.

DR. GOLDFIELD: My name is Delbert Goldfield. I am Medical Director of CMHAS. I just want people to know that there are a variety of different coding systems that look specifically at alternative and complementary medicine.

Within that framework what we have done, there are two things. No. 1 under miscellaneous there is acupuncture already present.

No. 2, I want to restate the process by which we went about the development, for example, most recently on the substance abuse side which is the most recently added section. We worked collaboratively with the various different societies and after approximately a 6-month period came up with a set of codes which I should say, I should make sort of a comment on Tracy's comment that our philosophy is looking at the codes and the procedures that are currently being practiced not just whether or not there is efficacy because we are also looking at it for outcomes purposes so that institutions, there is a lot that is out there that is actually being done for which it builds on either CPT or I9 for which we really don't have as good an understanding as we would like there to be.

So, what we did with respect to substance abuse and the same thing on the acupuncture just as an example, we tried to apply the current state of what is in practice. So, the process we would go with the other complementary medicine and alternative medicine procedures is to work collaboratively with those institutions and organizations to come up with a set of codes to reflect what is in practice because we believe that the best coding system is one that is not just used for reimbursement purposes but has clinical meaningfulness and therefore could be examined for purposes of research on outcomes.

DR. GORDY: I might, also, add that in the CPT process as he pointed out we have a set of category 3 codes. Category 3 codes are codes where it is for new technology that hasn't been, the efficacy hasn't been established and also for clinical areas that haven't been established.

Those codes, category 3 codes are not valued by the relative value update committee. So, it would be carrier priced based on the individual submitting it to a carrier.

MS. HUMPHRIES: Are these answers that you have given to respond also to Jeff's questions on the genetics side or is there a different answer?

DR. GORDY: CPT has some genetic codes, and I will tell you we almost have to have an interpreter when they come to the panel because it is very difficult for us to understand but we are putting genetic codes into CPT now.

DR. ZUBELDIA: But the codes under ICD-9-CM, ICD-10-PCS, the codes that you are talking about for alternative medicine are institutional codes. Do they contemplate alternative medicine services for an outpatient setting?

DR. GOLDFIELD: My wife always tells me to use my words carefully and I have known Simon long enough that he is smiling at me. I would just say that clearly there is obviously within institutions there are individuals who work with institutions. So, within a hospital you know to answer it this way that speech and language therapy, that speech and language therapy for example, where we work with people with ASHA(?) or the American Physical Therapy Association, those same kinds of services can be provided on an inpatient basis and an outpatient basis. So, we are trying to really cover the services that are provided by individual on an inpatient setting, and understandably when people contribute to that discussion they may not immediately switch their hats especially since there is partial hospitalization these days. I mean the term "hospital" is rapidly losing its meaning. So, I would answer it that way.

DR. YASNOFF: I have two questions. First, I wanted to rephrase Kepa's earlier question about the time for transition to some new --

DR. ZUBELDIA: Could you identify yourself?

DR. YASNOFF: Bill Yasnoff from CDC. I wanted to rephrase Kepa's earlier question about the time for transition to some new coding system and I want to ask it kind of the other way which is in your opinion what is the absolute minimum time under any circumstances that you could imagine that such a transition should occur? In other words, shorter than that time you would just shake your head and say, "That is just totally impossible." I am not being specific to a transition from 9-CM to ICD-10-PCS or to CPT or to some other system, just any kind of a change like that, what is the absolute minimum time that in your mind would be needed?

DR. PROPHET: From AHIMA's perspective I would have to say 1 year would be the absolute minimum.

MS.WHALEN: I would have to agree. I think you could do it in 1 year.

DR. YASNOFF: But less than 1 year you would just throw up your hands and say that it was impossible?

DR. PROPHET: Right. When you are looking at the number of AHIMA members and coders out there, that is a big group.

DR. YASNOFF: Okay, that is helpful.

The other question is I am assuming but I wanted to ask specifically that there has not been a formal study looking at potential mapping of CPT terms to ICD-10-PCS. No one has done such an attempted mapping. It has been done for ICD-9-CM but it has not been done for CPT. So, therefore, if I asked the question can all CPT codes, either CPT-4 or proposed CPT-5 codes, can all of those be represented in ICD-10-PCS, can that question be answered?

DR. AVERILL: We haven't done the formal study. The objective was to create a coding system that represented all inpatient procedures. Now, certainly from a physician work perspective there may be some dimensions for example that CPT feels is important, such as how many centimeters a laceration may be and they may have separate codes for that which for the purposes of an inpatient procedure weren't viewed to be particularly relevant, and so in all probability even though we have not done that mapping short of those dimensions that deal more with physician work than necessarily the actual performance of the procedure the expectation would be that there would be overlap.

DR. YASNOFF: I understand, but it sounds like there are some CPT codes even though we don't know exactly what the overlap may be but there are some CPT codes that you do not believe could be represented in ICD-10-PCS.

DR. AVERILL: There is a difference between are or could be, and so --

DR. YASNOFF: That is what I am asking.

DR. AVERILL: Right. So, if one wanted to, for example, we discussed the length of the repair of the laceration and put that in the qualifier column one could easily do that. We chose in the development of I-10-PCS not to make those types of distinctions for purposes of inpatient reporting. Structurally it would be simple to add those distinctions if we decided it was relevant to the purposes of inpatient reporting.

DR. YASNOFF: So, it may be possible but it has not been studied in the sense that it may be possible to represent all current CPT codes in the structure of ICD-10-PCS, but we don't really know for sure. Is that essentially what you are saying?

DR. AVERILL: Essentially but with probably a probability that we would be successful in that representation for 99.999 percent kind of thing. I can't think of anything which we couldn't represent if we so chose with the exception of those things which are purely visit based. The ENM codes we have not chosen to create a section of I-10-PCS that dealt with that. Structurally a structure is there. So, one could in a very straightforward manner do such a thing, but the decision was made not to do it.

DR. YASNOFF: Dr. Gordy, did you want to comment on that?

DR. GORDY: No, we have not tried to map back to ICD-9 or ICD-10.

I think his comments are correct in the sense that my understanding of both CM, Volume, ICD-9 and ICD-10-PCS is that they are addressing procedures. So, when you have cognitive care ICD-10 is not designed at the present time to address that.

DR. PROPHET: I would just like to add when you talk about representing procedures one of the issues that we have between 9-CM and CPT that I presume based on the different premises on which they are sometimes structured we would, also, have between CPT and 10-PCS which would come out in our recommended feasibility study is that you might be able to represent the procedure or service per se but how it is represented and the pieces of information that are considered important that Rich alluded to may be different in both systems because of the focus on physician work on one side and the look at it from the inpatient facility look on the other side.

So, the procedure might be there in both systems, but how it is described could be quite different. So, it is really not a one-to-one map.

DR. YASNOFF: So, what you are saying is even if there are codes in both systems they may not be a one-to-one match.

DR. PROPHET: Right. They may not mean exactly the same thing.

DR. YASNOFF: Which is not surprising because the coding systems are designed for different purposes.

DR. PROPHET: Exactly.

DR. YASNOFF: Thank you.

DR. ZUBELDIA: I would like to ask a follow up to Dr. Yasnoff's question on timing. Let us say that it is October 16, 2003, and everybody has successfully implemented the HIPAA transactions, and we are all celebrating and so we are going to start transitioning to ICD-10-PCS and that transition could be done in 1 year or in longer time. What would be the longest that you would like for that transition to happen considering that ICD-9 is broken? For how long do you want to drag that brokenness along?

DR. PROPHET: As little as possible, but I guess I would have to say at the outside we would prefer not to go past 2005 with ICD-9 because by then we probably won't need to have coordination and maintenance committee meetings or anything else because there won't be any more codes. We will just have one code that says, "Other," and if something comes up that is where you send it to.

MS. WHALEN: I would have to agree with the time line that she was saying. I think 2005. That is 2 years after HIPAA.

DR. FITZMAURICE: I did want to raise the issue that we have diagnosis codes for telling what is wrong with the patient. We have procedure codes for saying this is what the medical professional did, but a payment rate schedule might even require more information than you find in a diagnosis code or procedure code. They might base it on the qualifications of the medical professional, or whether it is done in your own office or in an emergency room, an ambulatory clinic or in a tool shed and so coding systems may not be able to handle all the needs for a payment schedule or for research purposes but I think describing accurately what a medical professional has done, describing actually what is wrong with the patient is a really good start.

DR. ZUBELDIA: I think that is an excellent comment to end the panel. I want to thank everybody for participating. We would like for you to stay. We will now have a 15-minute break and then after the break we are going to have the Subcommittee discussion but in the discussion sometimes we may want to get your feedback. So, don't go away yet, and we will reconvene in 15 minutes.

(Brief recess.)

DR. ZUBELDIA: We have an hour to discuss what we have heard today. I would like to ask Karen Trudel to start by making a summary of what we have heard and the different facets of these coding systems that have been discussed today.

Karen?

Agenda Item: Subcommittee Discussion of ICD-10-PCS Testimony

MS. TRUDEL: Okay. Actually this is a picture but I am not going to share it. We started out this morning talking about a very specific, what I would call a primary issue about ICD-9, Volume 3 for inpatient procedures and the issue was this appears to be breaking; what do we do about it?

As the discussion when on throughout the day we began to talk about how that particular code set and those particular procedures related diagnosis codes and to other codes for services and procedures, outpatient services and procedures, physicians, non-institutional services and procedures, devices and supplies and the notion of needing one big code set that would handle all of this or parts of it, and so I want to put on the table that there is a primary issue and then there are lots of downstream issues. One of the things I think the subcommittee needs to think about is which of those dimensions are they going to use to look at this problem; are we just looking at the issue of inpatient procedure codes and the need to do something about Volume 3 or do we need to look at this immediately in a broader sense?

I think some of the people said that we need to look at ICD-9 now. There is a need to look at a comprehensive procedure coding system in the future and then I think I heard some people say the opposite.

So, I guess that would be the first point of discussion.

DR. COHN: As I am sitting here looking at your picture, and I am not sure that as I look at your picture I am trying to figure out are you putting devices and supplies on the table or are is that yet an added code, and I guess what I heard is somewhat what you heard and I guess in my own mind I think there is a continuum of procedures that sort of span, it is sort of a questionable focus and perspective but there are inpatient procedures; there are hospital outpatient procedures and then there are ambulatory procedures and maybe I am saying the same thing that you are and the big focus right now because the big thing that needs to be fixed is to make sure we have a fix in the future for hospital inpatient, but I was, also, I guess, hearing almost sort of general sort of agreement that whatever work is done on that that we ought to make sure that people are taking the wider view to sort of make sure that they are not missing an opportunity to move towards a singular procedure coding system that might be able to handle those three sites of service, and I guess to my view it is really more the main focus on hospital inpatient but as part of that we need to be looking at feasibility that included whether there was an opportunity here to move towards fewer rather than more procedure coding systems.

Kepa, what do you think?

DR. ZUBELDIA: Theoretically I like the goal of fewer procedure systems. It simplifies things when everybody has to code the same thing the same way. In reality I still have a bitter taste of the NDC and J codes in my mouth, and I am concerned that the view of an institution for the services rendered inside the institution is not the same view as the physician rendering the services, and I am not sure that we can cast one into the other. I am not sure that there is a way to do this encoding system if the physician is counting how many stitches he is putting in an incision and the hospital couldn't care less, and that is just an example. There are very different views and I got a little bit of maybe a bad start in the morning when there was this movement towards well, as we are replacing the CPT, I am sorry, the ICD-9 procedure codes we might as well replace the diagnosis codes just because they are in the same book or maybe not even the same book, a different volume but called ICD-9. I am not sure that that has been justified at least not today, and we have to talk about that. That has been justified and I am afraid of change unless it is very well defined and justified why.

So, I am concerned with a coding system that would be applied for all health care services whether rendered in an institution or by a physician. I am not sure that fits yet.

DR. COHN: So, I think you also agree that the main focus is on hospital inpatient?

DR. ZUBELDIA: Yes, and if ICD-9, Volume 3 is broken, let us fix Volume 3. I am not sure that anything else needs to get fixed.

MR. BLAIR: I thought that we had heard discussion that people felt that the ability to fix Volume 3 was leading to diminishing returns and that we can't really do that.

DR. ZUBELDIA: When I am saying, "Fix Volume 3," I don't mean fix Volume 3. I am saying, "Replace Volume 3." If Volume 3 is broken let us get something to replace it with.

MS. HUMPHRIES: I do feel that since neither ICD-10-PCS has been fully developed to handle everything that would take place in an ambulatory care setting although I think that is theoretically possible and neither CPT has been examined or fully developed to handle the other side in inpatient although that may also be theoretically possible that obviously the development of either one for those, you know, expansion of either one for that other purpose for which they are not yet intended and the full testing of whether that works or not and what needs to be done we are clearly adding into the equation an enormous addition called time frame beyond that which may already seem too enormous to many of us about the quote, replacement of Volume 3 by the system which was developed in fact to replace it. So, I think that irrespective of theoretical desirability you would, if you decided that you were going to bite that off and handle it all, doing it, it seems to me would clearly, it is hard to imagine how you could do it without adding to the time frame before you would have some sort of a replacement or CM Volume 3, you know, unless we decided that we can't possibly do anything until 2010 anyway which I guess we started out with some people sort of indicating that which doesn't seem to me to be very workable in which case of course we would have 10 years to develop whatever, but I don't, you know, that seems like the situation.

MR. AUGUSTINE: I disagree with Betsy. I think there is like a short-term solution and a long-term solution. We have an idea situation with really one code set for procedures but right now we are doing all we have to do with just ICD-10-PCS and that is really the most important thing.

MS. HUMPHRIES: I, also, sort of feel that even while not necessarily disagreeing that we may not fully understand the full impact of putting, I mean the health care system impact of putting ICD-10-PCS as Alissa was commenting, I mean I think even perhaps less do we understand the full system in practice.

Kepa was alluding to moving to one and even though I am theoretically very in favor of this, I don't know that is where we eventually will go.

DR. ZUBELDIA: Let me make a comment on that system impact. We have heard that it would take the recorders and the hospitals somewhere between 1 and 3 years to transition. With a procedure coding system that has to be fit into groups of about 15 to 17 hundred payers and those payers have to identify how much they are going to pay to each one of those almost 200,000 procedures in a hopefully somewhat neutral fashion, I think that the load on the payers to transition is much heavier than the load on the hospitals to transition, and I am not sure the payers can do that in 1 to 3 years.

MS. HUMPHRIES: My understanding of the system is perceivably much less. When we refer to this number of 197,000 procedures we are referring as Rich said to those which are manageable as being not totally off the wall but not necessarily the number of procedures that are actually done. Those are all possible, that is they are not impossible, but the question is are they conforming, and if they are not conforming then they are not in what conceivably has to be dealt with by the payers.

DR. ZUBELDIA: The problem is if the payer gets one of those procedure codes and they have never seen it before now they need to do the research for that procedure.

So, there may be some factor that is affecting the payment.

MR. AUGUSTINE: Just to flip it and to look at not on the reimbursement side but on the patient quality side PCS adds rather than just each character, I guess in the index or in the number just being in ordering every character adds value and that gives you the ability to track and trend and monitor patient quality care, determine trends a lot more quickly and research in the econometric area, and it adds a lot of possibility that we don't have with existing systems. So, that is pretty exciting from the patient care perspective.

DR. YASNOFF: I wanted to capsulize what I think the issues are, and basically I think there are three issues. The first issue is do we need to change from ICD-9-CM to something else, and I think pretty much all the testimony we heard was that we do. So, I am going to take that as a given that the change is needed, and then the second issue is what should we change to, and basically we heard, I will say three options. We can change to ICD-10-PCS. We can change to CPT or we can postpone that decision until we get more information, that we don't have enough information to make a decision or there may be another option. So, I see that there are basically those three options.

MR. BLAIR: Could I question the last observation that you made where you said that we have three options, and I guess I didn't quite hear it that way? What I heard was we do have the option of going forward with ICD-10-PCS , and we have the option of examining whether CPT could be an option. It isn't even developed yet for the inpatient area, but it is an examination, a study to see whether it is feasible to create a portion of PCT to become an option, but it is not an option today. It doesn't exist today for us to look at. Is that correct?

DR. YASNOFF: Yes, I accept that as a modification of the choices. So,CPT as it would need to be developed.

DR. COHN: I guess for historical accuracy I think we, also, heard that both systems would need further evaluation, since we heard ICD-10-PCS needed to be evaluated out of Medsearch(?) and it will be in all of this stuff. Similarly CPT would be considered it would need evaluation to see if it indeed handled the domain appropriately, though given that it currently codes all of the physician procedures that are done by physicians in hospitals one might argue that there is probably not much evidence on that side.

DR. YASNOFF: Anyway the third issue is if we are going to make this change, what should be the time line for the change, and I think what we heard is that for practical purposes we wouldn't want to start the change period until October 2003, at the earliest. That is essentially, I am a inferring a little bit too much into the testimony, but it seemed to be that folks are saying, "We can't start this change while we are, also, working on the existing set of changes, and that a reasonable period of time to make the change would be about 2 years." So, we are looking at 2003 to 2005.

So, in a nutshell it seems to me that as of this moment at least I will speak for myself I don't feel that I have enough information to make a decision and a recommendation, but I think that the next step or one next step that makes sense to me is to gather some of this additional information from the various folks who would be involved in this change and ask them to ask people to come forward and tell us what would the implications be if you were to find yourself in the position where you had to change to ICD-10-PCS starting in October 2003 by October 2005, and what are the implications for your organization and go through either hire someone to do this work or bring in testifiers to tell us what the impact would be on their organization. Similarly we could ask a similar set of questions about CPT.

DR. ZUBELDIA: There is a fourth issue that I think goes along with your issue No. 2, and that is if the change is going to happen and it is either CPT or ICD-10-PCS does that change extend to non-inpatient procedures; does that change extend to other procedure codes, and I think we need to keep that a separate issue.

Simon?

DR. COHN: I think Dr. Yasnoff put it together very nicely, and I think the issue No. 1 as you described, I think we all come away convinced that we are not going to be able to stay with Volume 3 forever, and there has been nothing today that has probably been embedded in my psyche since that belief that it is not going to make it forever. I think similarly I sort of don't feel like I have the data needed at this point to make a recommendation around either PCS or CPT or whatever, not that I necessarily would, but I was certainly taken because I would recuse myself on that issue, but I was certainly reminded this morning listening to the Blue Cross and others that I think there is a feeling at least I had from the industry that they feel that they need to really sit down and think hard about what makes the most sense, what they would like to be going forward with. I don't think that they have even gotten to the point of conceptualizing it to this level, and I think that they will, at least what I presume from Blue Cross Blue Shield that they would like to come back and sort of after having thought about it for a while and sort of beginning to lay out some of the options and maybe there are some others that we just haven't perceived, and indeed, maybe we need to spend some time with them and others asking that direct question along with once we begin to understand from them what they want, also, the issue of time lines since it is hard to know what time line you would need until you know what you are transitioning to.

MS. HUMPHRIES: There was another piece of this that I think I heard which is that the question is when you are asking people to react to something maybe to make it a little clearer to them what they are reacting to. As I understand and again, you know, Pat can correct me but based on the testimony that Sue and others made there is the piece of PCS which is very comparable to what they are currently using ICD-9-CM, Volume 3 for, and since ICD-9-CM, Volume 3 is what is broken then the issue is okay what is your level of difficulty, resources, whatever to use the piece of PCS which handles and corresponds, those sections of it which handles and corresponds to what you currently use ICD-9-CM for, and is that a level of difficulty because some of this business of needing extra data, you know, tested in other settings, whatever, I wasn't quite sure whether some of that testing in other settings related to using ICD-10-PCS for activities for which maybe we are not using 9-CM now and it is not that I am not favor of all of this, but you know maybe if we focus the question about what are your costs and issues around implementing 10-PCS for that which would mean that you throw away Volume 3 and now you are using this thing instead rather than the full complement of what you might conceivably use it for given the system as related, but this would be a better question to ask because I don't, I mean our immediate goal here is to I think have a, you know, the most cost-effective replacement for this thing which is broken and then the fact that the same system might be extended into other areas and replace other things or not could be a follow-on question and not the tail that should wag the dog since I believe that it is Volume 3 which is the broken piece here.

MR. BLAIR: I don't know if I can pull this together like I had it in my mind just a moment ago. It seemed like it was all logically flowing together into like four key questions where we need research to be able to pull it together where we could make a decision, and one of the things that is, one of the concepts that is behind this is that we are not, I think we should be careful to not put ourselves in a position where the perfect is the enemy of the good.

No matter what solution we come to, it will be imperfect, and if we keep pressing this and delaying it, then we have a growing problem with a system that is crumbling at our feet. So, here are my thoughts, and I think I could break them down into four key questions we have to go after.

One is the issues that Alissa brought forward to us, is that if we do go forward with ICD-10-PCS what are the show stoppers; what are the areas of perfection; what imperfections; what are all of the related issues that she was bringing up which might say, "Oops, it is not going to be a viable solution for us"? So, I think that that is kind of question No. 1 is the study that Alissa suggested.

Then question No. 2 is do we have alternatives, and one of the possible alternatives is CPT 4 or 5, and I think we need to go to Tracy or an outside entity to answer a couple of questions with respect to CPT 5.

No. 1, does it give a better answer? Does it have the potential to give a better solution than ICD-10-PCS? If it does, how long will it take to bring it to a point where it is implementable, and then No. 3, if there are satisfactory answers for that, and this is No. 3 within item No. 2, is to then compare the maintenance costs for both because we could wind up picking a perfect solution that is so costly to maintain and time consuming to maintain that that becomes a consideration in terms of updating in the future.

The third major question I think is in terms of let us say that we have two viable alternatives. Then if we do have two viable alternatives what are the tie breakers? Maintenance is one area; the ability to accommodate future growth into new areas is another area. Flexibility to grow beyond the scope that we have defined it into either ambulatory or acute care or whatever is a third area. There is a whole bunch of areas that would then be tie breakers if we get to question 3, and then I think question, I don't know if I would say question 4, but maybe it is a boundary on this little process, and the boundary is that I think we need to set ourselves or agree to a realistic time frame for the study to be done for us to get the best answer we can within that time frame and to be honest with you my inclination is to say 6 months from now that we get the best answers we can within the next 6 months to these types of questions and make the best decision we can at that point because we are dealing with a system that is crumbling under our feet.

DR. COHN: Jeff, are you suggesting a hearing sometime in the fall?

MR. BLAIR: Yes, and I am saying that reluctantly because to be honest with you, you know, I was really hoping that we could sort of wrap this up in June, but I think that these issues are really important, and we have to have a certain level of confidence as we go forward. I think that Kepa mentioned the fact that we were blindsided. Is that a phrase that I could politically correctly use, with respect to NDC and J codes? And we want to be careful to not be blindsided again.

On the other hand, we can't get to the point where we are studying things to an infinite degree. I guess I would ask the rest of the group, do you feel as if a 6-month window for us to get answers to these questions that you would feel comfortable with that?

DR. ZUBELDIA: Jeff, my reaction to that question would be it depends on the scope. If the scope is to replace the brokenness of ICD-9, Volume 3 with something that will fix that problem, then I think that 6 months is plenty. If the scope is to extend the coding system to a common procedural coding system for both inpatient, outpatient and everything else then we probably don't have enough time in 6 months.

MR. BLAIR: My inclination is to keep our scope limited. I would go with the former. It doesn't preclude the broader scope in the future, but I think that time is of the essence.

DR. YASNOFF: I wanted to remind the group that our representative from Blue Cross Blue Shield Association volunteered to put resources into such a study.

MR. AUGUSTINE: One other comment I want to make is since we won't really be able to work on this for a few years anyway why don't we go ahead and be thorough and look at it from all angles as opposed to just trying to fix the short-term solution.

MS. HUMPHRIES: I think the issue is if we, despite the fact that it seemed like a long time away at one point, October 2003, is not that far away, and if we are going to give people 2 years to implement so that at least by 2005 they are using something or 1 year, I mean given all of our not really a track record here with the timing of these things, I mean 6 months is the only way that you would ever get something published by October, I mean a recommendation all the way through and published as an NPRM by October so it could be implemented 2 years later.

DR. FITZMAURICE: I was counting up. Six months from now is October. One could set up a hearing date in October and say that if people have information on the costs and the benefits and models for analyzing this we would like to hear from you at those hearings, synthesize and try to make a decision and recommendation by February. Do you think we can do it in that time?

PARTICIPANT: I don't think we need models.

PARTICIPANT: We want a final study.

MR. BLAIR: It would be information so we could make a decision.

DR. ZUBELDIA: And maybe we can get some more of that now. Maybe we can get the AMA, the AHA and Blue Cross Blue Shield, if they could answer a couple of question. Maybe we can help with that information right now.

DR. COHN: Since we are likely to be asking the AMA to do something, we probably ought to let the AMA representative respond whether they can do it or not.

DR. BEEBE: Sure, Michael Beebe with the American Medical Association. In 1989, we hired a Cooper's(?) librarian to do a study on the costs of going to a single procedural coding system, and things have obviously changed since 1989.

In the past 2 or 3 months I have been working with Price Waterhouse Cooper's to do a study on the costs of using CPT for inpatient coding, the costs of using ICD-10-PCS for inpatient coding and then, also, the costs of a single procedural code set, and we have been back and forth in trying to frame the questions and come up with an appropriate study and I have gotten some pricing figures recently from Cooper's librarian, and we are considering whether or not now we want to move forward with that kind of study.

So, just to let you know that this is something that we are thinking about that we have invested some time in already, and I think probably hearing what the Committee said we might invest in that.

MS. GREENBERG: I was just going to point out that the Committee does have some resources available to it if a study could be designed that you felt would be helpful to address some of these issues. I mean I think I heard that the stakeholders would put some resources, certainly their own resources probably into whatever they needed to do, but there is some advantage of not relying on one of the stakeholders for the study.

MS. TRUDEL: It seems to me one of the biggest stakeholders in this whole thing is the American Hospital Association, and I am wondering what their response to all the discussion is.

DR. LEON-CHISEN: Nelly Leon-Chisen, with the American Hospital Association. Yes, we would be very much interested in having a study, and I agree with Marjorie's comment that we would prefer that the study be conducted by an independent objective organization. We would be willing to help out and help develop a model and all that, but I think the study would have more credibility if it was conducted by the Committee.

Obviously we would be doing some research of our own with our own members in terms of trying to find out what the implications are and the costs are, but no matter how we do it, whether we do it or the AMA I think there is always going to be a question whether it is a biased study based on who is conducting the model.

DR. ZUBELDIA: I would like to ask a question, and maybe we can simplify this a little bit. Betsy mentioned that it may be possible to replace the ICD-9, Volume 3 with a piece or maybe a chunk or some of these sections of the ICD-10. Is that possible?

MS. HUMPHRIES: I think we probably should get Pat up here to comment on this. This was just my understanding listening to Sue, but I might have missed it.

PARTICIPANT: I have to tell you that most of what hospitals code today they code and report because it affects t he DRG and most of those codes are the medical-surgical kind of codes that are in ICD-10-PCS , but as long as we were doing all this work we said, "Wouldn't it be nice if we developed additional types of codes that people code internally; if they want to do studies there are things they could sue, and so a lot of these codes are being developed for different purposes that people may have a need to do. They may never use any of those codes and send them in to us or another payer if they don't think they are going to get paid but they are there.

I think if you want to know what they are using, how they will use it, if you take that medical-surgical chapter you have got in essence most of the things that are coming in right now. All the other stuff is just nice stuff that they may use internally or for tracking purposes or whatever. Betsy stated it beautifully.

DR. COHN: I understand the AHA recommendations talked about obstetrics measurement, monitoring, imaging, nuclear medicine, radiation, oncology, osteopathic, rehab, audiology therapies and mental health that needed additional testing and evaluation. Are those things that we should not consider and take out because --

PARTICIPANT: No, if you want to use them for tracking purposes or for monitoring then you probably want to check them. If you are asking me do most of those affect the DRG assignment no, they don't. So, as far as payment system impact for many of those chapters they are not there.

DR. COHN: Okay, now, let me just ask because I know that there are people who use DRGs and other things like that that aren't CMS. Are some of these chapters used by non-CMS payers as part of the DRG or some other sort of payment.

PARTICIPANT: No, I am overstating a little bit, like for the obstetric and newborns, yes, the New York people do a lot of work, and we are probably going to propose some modifications now, a small little subset, but as far as the imaging things I don't know of anybody that has a DRG that is based on a lot of these kinds of codes. They kind of follow our lead and we for the most part look at surgical kind of procedures or things that are pretty resource intensive where there is a lot of debate.

MS. HUMPHRIES: What I was coming at is obviously the value of the system is that it can do more, but the issue of replacing something that is broken by something that isn't, I just feel that when we are computing costs of doing this we don't want to say, "Let us talk about the cost of moving from this which is used for this subset to using every bell and whistle of this new system," because if obviously doesn't have to be phased in or used that way in order to solve some of the problems. That is my point and I think that we need to be clear when you are asking people to cost what it is you are asking them to cost because you would get very different answers I believe.

DR. LEON-CHISEN: Nelly Leon-Chisen, AHA, again. If I could just clarify what our testimony was addressing, if we are only talking about replacing ICD-9-CM, Volume 3 procedures for inpatient the only chapter that I would say would need further study before we implement it would be the obstetrics section as Pat mentioned. The other chapters would be useful to have if we were looking at a single procedure system. Obviously they would be wonderful to have for tracking because a lot of our hospitals may do internal tracking internally.

Some physician researchers within the larger institutions may have their own systems, but if we are talking primarily Volume 3 inpatient then the only chapter that I would say would need further testing would be obstetrics, and as part of this whole thing that I would, also, want to remind you that we wanted it studied for how would it fit under DRGs. I know that Rich Averill mentioned earlier that 3M would be positioned to do that kind of mapping and study and apparently it hasn't been done yet.

So, I would encourage that the study that is done take a look at how will it play into the current payment systems that we have.

DR. ZUBELDIA: The recommendation from the Subcommittee would be to adopt all of the chapters because there codes sprinkled that have to be used. We couldn't carve out and say that the Secretary should adopt only chapter zero. The Secretary would have to adopt the whole thing.

PARTICIPANT: If I could clarify a little bit, the way I think that CMS would approach this is if we had a proposal we started working toward implementing ICD-10-PCS we would have to do a notice to implement ICD-10-PCS and get comments in. We would have to have a separate, and the ones we do every single year, a proposed notice on how the DRGs were changed this year, and the year we implemented it we would go out for public notice and say, "Okay, this year we are going to implement the DRGs used in ICD-10-PCS and here is our mapping."

People would comment on that separately. Those are two different issues. We wouldn't develop and get comments on, I can't imagine on one notice to use an entity or to use it in the same time. It just doesn't make sense.

DR. ZUBELDIA: Two different things, but in order for your DRG grouper notice to say that this is how we are going to do the grouping this year, you need to have the flexibility to pick and choose codes from all sections.

PARTICIPANT: But we do now, and we do the same with that. Many codes in ICD-9 now don't affect the DRG assignment. So, people reportedly think that is wonderful, but there are certain ones that are flagged as affecting DRGs. The same thing would happen with ICD-10-PCS and if they chose to send them in we would be happy, if they didn't, they would probably mainly send in the ones that affect the DRG.

MS. GREENBERG: I think you have clarified it but I just wanted to make sure that we weren't talking about recommendation to implement part of a system. I think that would be a mistake, and I assume that there are codes in these other chapters that currently can be coded in ICD-9-CM and you wouldn't want to implement a system that had less in it than 9-CM, Volume 3.

MS. HUMPHRIES: Yes, I didn't mean that. I just meant that I could imagine somebody saying, "Well, if I had to implement the system and I had to report all of these data which I am not collecting now and have no impact on the DRGs, it is going to cost me." That is not required to implement this for any purpose, I mean even though some people may elect to do it. I just don't think we would want cost estimates that include that expansion of activity just because we happen to designate a code set that could cover it but there really isn't a need. I mean nobody is going to be mandated to do it.

DR. ZUBELDIA: And that was in line with the induction of the code set only for inpatient procedures because it would be that the code set can perhaps do other things, but the adoption of the code set is for inpatient procedures. I think it would be perfectly in line with that concept.

DR. COHN: I felt like we were getting to something concrete and then people began to sort of fade away, and so I wanted to sort of come back to exactly what we were doing and what we were asking others to do, and it sounded like we are reflecting on the early morning testimony by Tom Gustafson where he recommended a number of implementation activities that needed to occur, and obviously one of them had to do with crosswalk and it sounds like the crosswalk needs to be updated, and that needs to be open for people to look at and comment about, and it is probably one of the show stoppers that Jeff might comment on if this is adequate, how we see this issue of mapping the ICD-PCS into the DRG system which is I think what we are asking to do, have them do, and that is not us doing, at that phase it would be the responsibility of CMS to do that, and I think that was something that the AHA was asking perhaps so that they could evaluate it and make sure that was sufficient to their needs. Is that not something that we are even talking about doing, but then we were talking ourselves and we are going to obviously have this other DMA that is going to come hopefully in 6 months with whatever DRG mappings they have as well as a view of how well it would work if CPT were being used, and then the question gets to be what are we exactly doing if we are going to be doing a study ourselves or an evaluation.

MR. BLAIR: One other thing, can I get back on what you are saying? Since it appears as if we are driving towards trying to get all the information together where we could make a decision 6 months from now one of the pieces that might interim to that that might be available in 3 months like when we meet together in June or the end of May or something and the AMA may be able to help us with this somewhat is would it be possible for the AMA to give us a presentation maybe in the June time frame of what their proposed code system would look like for inpatient and how it would compare in terms of function and value with ICD-10-PCS and how long it would take to develop, if that could be an interim to --

DR. ZUBELDIA: Jeff, let me backtrack for a second into a different train of thought before we get into that? I think that we can divide this problem into what we must have and what would be nice to have, and it sounds to me like what we must have is something that replaces the ICD-9, Volume 3. It is broken, and we must have that before 2005. What would be nice to have is a single procedure coding system for all health care, and it would be nice to have some other additional studies, other things, but I think that maybe we can get to what would be nice to have by taking a step on what we must have first and I agree that it would be nice to have all these other studies, but we are going to run out of time, and it seems pretty clear that ICD-9 is to be replaced.

It is, also, pretty clear that CPT doesn't have anything to replace ICD-9 with today, and that if we were to converge into a single coding system we could converge into one or the other into either CPT or ICD-9, but that is going into the realm of what is nice to have. I don't think that we must have the convergence. It would be nice, but it is not necessary whereas the replacement for ICD-9 is something that we must have.

MS. HUMPHRIES: Yes, but I think, Kepa, there are some people who still feel or who feel that one of the options is actually to get CPT expanded to do that within the time frame that we have available to us.

I don't know whether it is true or false, but I think that is what Jeff was getting at, that the AMA could come in and tell us whether that was even feasible or not.

DR. ZUBELDIA: I would like to hear some comments from the AMA and since we have a payer representative in the room maybe we can hear from payers as to what they think of all this.

DR. BEEBE: I think our view at AMA is that there was a study done in 1986 that did show that CPT could be used for DRG determinations. We were of the mind that we would like to see that study redone . We very strongly believe that it would not take too much of an effort to use CPT for inpatient coding to help determine DRGs.

We don't think that we need 200,000 codes to do this. We think that the 9 thousand some codes that are in CPT would be more than sufficient.

MS. HUMPHRIES: That makes me understand that your view of the matter if that the only reason why ICD-9-CM is being used in inpatient settings, the only reason is to drive the DRG, and I am not --

DR. BEEBE: I don't think --

MS. HUMPHRIES: Therefore in order to replace ICD-9-CM you have to take care of the rest of the things that it is being used for, too.

DR. BEEBE: I think that I may have overstated my case, but I don't believe that that is the only thing it is being used for. I think that in the view of many people that is a very important thing that it is being used for, and now, as to whether payment is more important than research or research is more important than payment, I mean that is the chicken and the egg.

MS. HUMPHRIES: I guess my view is that we thought we needed to at the minimum give whoever is using ICD-9-CM something that fulfills the functions that it currently fulfills in the inpatient setting, I would think.

So, it seems to me that when we are looking at CPT or any of these systems as a replacement for it we can't say, I mean be totally focused on the fact that the systems can drive the DRG. If 9-CM is being used for something else, it will have to be used, whatever this replacement is will have to fill that need, too.

PARTICIPANT: I have to say first of all that I am not familiar with the study that you talk about that someone did that CPT goes into DRGs. I have to state that up front, but I have to say one thing about DRG structure in general. When we do ICD-9 codes, and we are very careful with it, we can't have anything overlapping and one thing, and I am not an expert in CPT but one thing that happens because physicians bundle the things they do, their effort together, there are concepts of one CPT that overlap with another CPT code.

That makes DRG kind of structures kind of difficult. A code can't go two places. So, you have to make decisions. If there were analysis you would have to do analysis of all CPT codes where there is overlap and pull all that overlap apart. That I can tell you is not a very simple task and the hospital effort is looking at what is done to the patient and the general patients are alike. CPT is the work of a physician, how big and how small; they are such different concepts that it is hard to think about the bundles that would work well.

You were talking about a major project to do this analysis and see how this works. You won't get it done in 6 months.

DR. AZWARGA(?): I am Pat Azwarga. I am with the Blue Cross and Blue Shield Association. I have to say that we haven't begun to do the work yet that Alissa alluded to this morning in terms of studying what it would take to migrate to ICD-10 or what all the possible impacts would be on our business systems. It is something that we have preliminarily begun to talk to Price Waterhouse Cooper's to see if it is something they would like to see.

It would be helpful to us, I think to do for us, that is, it would be helpful to us, I think for you to narrow because it sounds like there are a number of different considerations that many of you have or there have been differing ways and if you could just tell us what it is that you would like to hear, we would be happy to continue that discussion with PWC and deliver something in that 6 or so month time frame that Alissa alluded to this morning. Would that be helpful to you? I can bring that back, and we will discuss it.

DR. COHN: Yes, I think it is going to be very important to have peer reviews as well as the developers of the code systems, myself, in terms of perspectives on this one, and I think probably what we need to do is to come up with a specific set of questions, really hearing some of them that I think we are asking, but I would hope that we would be able to get to a relatively crisp set of questions that we could ask you to answer.

DR. ASWARGA: That would be helpful, and then we could proceed.

DR. ZUBELDIA: Let us hear from other health plans.

MR. MUSCO(?): Thank you. I am Tom Musco with the HIAA. I would just like to make a couple of points. One is to say that though I don't know the prevalence of the various reimbursement systems that are out there. There are reimbursement systems that are not solely based on DRGs, that there may be payments made on a per diem basis or perhaps even through contractual arrangements on discounted charges, so that the codes that exist currently in ICD and that would be replaced with something new I think would have to address more than just that grouping, that DRG bundled payment.

Secondly, I would agree with what Alissa and Pat have said for the Blues that in substituting something for the current Volume 3 that it is not as simple as just that substitution and that we would, also, agree with a study and perhaps participate, help with that study.

Because of the various systems that are involved, patient history systems, utilization review, disease management systems, all make use of these codes, and so it is not just one set or one group of codes that need to be replaced but as Alissa mentioned it does have this ripple effect throughout these systems, not just for reimbursement that payers must use and update periodically.

DR. YASNOFF: If I remember correctly in our report in 2000 we elucidated some guiding principles in terms of selecting standards in terms of their desirable characteristics, and we talked about those quite a bit, and it seems to me that the study that the Committee would want to commission would be what choice would reflect those best, those guiding principles given this set of circumstances and a coding system that is broken.

DR. ZUBELDIA: That is an excellent recommendation. We will have to weed out all the stuff, huh?

MS. GREENBERG: I was going to suggest, too, although I certainly can see value in narrowing the scope for practical reasons as you discussed, but that we will be happy to make available to everyone on the Subcommittee the reports that were done in the nineties on a single procedure classification system and the criteria for. desirable criteria for a procedure classification system and so you can at least see the rationale that came out, why the Subcommittee or the Committee at that time recommended a single classification system.

I mean I don't think anyone is on the Committee now who was on it then. So, we will definitely make that available to everyone on the Subcommittee.

DR. COHN: I have a sense that Barbara Starfield might have been on at that point.

MS. GREENBERG: Yes, she may have been, she and Lisa Iazoni, but Lisa isn't on the Committee anymore.

DR. COHN: I was just going to comment, and I want to thank you for being willing to distribute all of that to us. I think we are, also, very thankful that you are willing to offer up some resources to assist with our part of the evaluation. Obviously my view on all of this stuff is that we delegate as much as possible, recognizing that even though there is a certain part of whatever we do that needs to be under our control and may be described as objective, if we are lucky, but there certainly is much value to having many others in the industry participating and thinking and working on their views, recognizing that it help them understand the questions we are trying to address so that we understand their perspectives on it because there is a value to being unbiased, but there is, also, certainly a major value to having widespread input from the industry recognizing a lot of them are going to have to foot the bill for it.

MS. GREENBERG: I agree, but I wanted you to realize that there were some funds, and if only, you know, I think you need to think about how you would want to use them, what you would want. Would you somebody to kind of pull all this together? When people say 6 months I don't think they mean people working on this month to month when they get a chance. I mean I think they are talking about 6 months of a fairly concerted effort which even, I mean the staffing that we provide to the Subcommittee is not full-time staff. I am told they have other responsibilities as well.

DR. COHN: Their day jobs, you mean?

MS. GREENBERG: I consider this part of their day jobs. I don't use that term. I definitely consider their staffing the National Committee part of their day jobs. I know sometimes their bosses don't, but nonetheless they are part of a broader job responsibility.

DR. COHN: Do you think we need to go back and revisit because we keep seeming to be jumping from are we focused on the near-term, coming up with a fix to ICD-9, Volume 3 and anything else beyond that is valuable which I think is what Jeff had proposed in his sort of structure or are we sort of taking this longer look where I mean maybe we could describe this as a little longer, and I sense Marjorie is trying to inform us in that direction, also, and I think we had better decide which will we be focused on.

MS. GREENBERG: On that theme and I mean I don't vote anyway; so, I won't have to recuse myself from anything. I mean it is not a secret that the development of ICD-10 and 9-CM, Volumes 1 and 2 and 10-CM is under my jurisdiction. So, I mean I have to be honest about that in case there is anyone who didn't know that, but I do think, I mean I don't think you want to lose 2 months, but you really don't want to look at this completely isolated from replacement to ICD-9-CM, Volumes 1 and 2.

I mean there are, I think, pros and cons as we heard. You know, even when you hear in a month and one-half that much of ICD-9-CM, Volume 1 and 2 is somewhat broken, also, maybe not as badly broken but certainly is also a 20-some-year-old system, etc.

So, I think you are going to want people to think in terms of the pros and cons of replacing them both, you know, the whole ICD-9 suite at the same time or separately, at different times, and otherwise you risk asking people to go look at certain things and then coming back and asking them to look at it again.

I mean it would be nice if we had those, you know, had it finalized. We could get certain things going, but finalize really what you want people to be telling you after the May hearing as well, but I mean I think it is difficult to look at these totally separately.

DR. ZUBELDIA: Yes, and Karen is going to make a proposal on this discussion.

MS. TRUDEL: As I look back on my notes it appears that the first thing that needs to be looked into is the relative viability of 10-PCS versus CPT. That appears to be something that perhaps the Subcommittee could get, the staff could get together with you on, Marjorie.

MS. GREENBERG: I didn't hear what you said.

MS. TRUDEL: Ten-PCS versus CPT and perhaps staff could get together with you and talk about whether we could identify some resources to begin taking an independent look at that based on the guiding principles that Phil mentioned before.

If that is narrowed down, then I think we are in a position where we could begin to look at some of the implementation problems that Alissa brought up. I don't think that we necessarily want to consider implementation problems when we decide what is the best code set. I mean aren't those sequential decisions?

MS. GREENBERG: That is correct.

MS. TRUDEL: Don't you decide the best codes and then how to implement.

MS. GREENBERG: Right, yes. When you go to the implementation questions then you probably want to see it in the perspective of diagnosis as well, but looking at that coding system I don't think you need that perspective.

MS. TRUDEL: Right. So, I guess the first thing that I would suggest would be that the Subcommittee staff meet with Marjorie and talk about possible resources and a design for getting that work done.

DR. ZUBELDIA: Could some of that be brought back to the Subcommittee for the May 29-30, meeting and allocate some time to that discussion and maybe we can at that point consider both the diagnosis and the procedure codes together or separate, at least make that decision whether we want to take them together or separately? Is that a realistic time frame?

MS. GREENBERG: If you are going to get some type of contract, even a professional services contract you know something done under a task order that is pretty quick to have results by, I mean this is already April 9, today, and that is like May 29. It could certainly be under way, yes, but I don't think you would have your --

DR. ZUBELDIA: But something preliminary that would be useful.

MS. GREENBERG: Oh, yes, I mean I think that is doable, provided, you know, really the key is to identify a group or a person who you feel could do this in a scientific and objective way.

DR. COHN: I think we need to have a sort of a project plan and an overall scope, recognizing some of it is going to be under our control, and some of which we are going to be asking other groups to do, I think.

MS. GREENBERG: Yes, sure.

DR. ZUBELDIA: And the scope decision that needs to be made needs to be made relatively quickly, but it may be that we can get the project somewhat started before we make the scope decision.

MS. GREENBERG: You have to decide the scope of the project before we start.

DR. ZUBELDIA: The scope would have to go through a single code set.

MS. GREENBERG: Oh, with that, yes.

DR. ZUBELDIA: It will continue with the ICD-9.

MS. GREENBERG: I think the question that Karen posed was the ICD-10-PCS versus the CPT for a replacement for ICD-9-CM, Volume 3.

DR. ZUBELDIA: Correct.

DR. AVERILL: If I could make one comment, this is Rich Averill, the 1993, report was I thought a very comprehensive and objective report, the report of this Committee in that it laid out criteria, not making a decision but laid out the criteria in terms of how to make a decision, and so, I think one thing that would be very helpful if you could start with criteria in terms of how to make the decision before someone just launches and tries to do in sort of an unstructured way, make a recommendation but debate the criteria and maybe look at that 1993 report and see if that criteria in the 1993 report you still feel is applicable. If it is no longer relevant, what are the new criteria, and I think it would help the whole industry understand any recommendation you ultimately make, if you start off first, independent of looking at either system what are the criteria or the properties that you think a system should have.

if we are going to go through all this time and effort and expense to go to a new system, you should be wanting to achieve certain benefits as a result of all that time and effort, and you could articulate those properties that you want to see the system have and then make a decision once you have articulated those properties.

MS. GREENBERG: Bill's recommendation was very good because I think looking at those two sets of criteria which are addressing somewhat, I mean the 2000 criteria are really for standards more broadly under HIPAA. The 1993 report was primarily related to procedure classification, but I think looking at the two of them together and then you know there is some overlap I think, but they are kind of different views. I think it will be very helpful to the Subcommittee in kind of focusing on that.

DR. COHN: I was just going to comment because actually I was doing a considerable amount of work with others looking at characteristics of systems that should be adopted. So, we probably shouldn't forget things since 1993. There has been work since 1993.

MS. HUMPHRIES: It seems to me that you are selecting the HIPAA code set so that the criteria for selection and HIPAA standards have to trump anything else, don't they?

MR. BLAIR: Yes, and we included kind of the thread starting with what Simon and Chris did in their CPRI study and the ANSI-HISP(?) study on criteria for selecting good clinical terminologies and that flowed into an ASTM standard and we quoted it in the PMRI report as well as part of our guiding principles for selecting standards. So, you might fold that in as well.

Agenda Item: Future Agendas - Issues Carried Over from February 6-7, 2002 NCVHS Meeting

DR. ZUBELDIA: So, I think we have kind of a plan of action with some deliverables, at least in Committee deliverables to be brought to the next meeting, and we can take it from there.

We have to allocate some time in the next meeting. I would say is a good time to take a look at our future agendas. If Vivian Ault is in the room she can walk us through this.

DR. YASNOFF: Kepa, I have a question. We have a meeting of the Subcommittee scheduled in May. Do we have any definitive meeting dates of the Subcommittee beyond that? I don't have any in my calendar, but I may not have --

DR. COHN: This is actually a discuss that Karen Trudel and I had. We had actually asked staff to poll for dates, and there must have been something lost in the communication here in the sense that polling has not occurred. Therefore we actually have three 2-week periods starting I think in the end of August, early September and then leaving off through the fall that we were going to be asking people to hold for.

MS. GREENBERG: Quite recently there was an e-mail from you, I thought, asking to poll for these dates but we will check into that if it hasn't been initiated yet.

DR. COHN: Maybe there is a way that I can actually bring the dates, pull them out of my computer and have people fill out their availability tomorrow which might give people a little jump on dates because I agree with you. I think we would like to have the hearing scheduled for the fall.

DR. PICKETT: Not including the topics that were discussed today we had developed from the February hearings suggested topics for the May 29-30, hearing. The first one on the list is the ICD-9-CM, Volume 1, Volume 2 replacement with ICD-10-CM. There were, also, issues related to the process for updating the alphanumeric HCPCS codes and a presentation from CMS staff to address some of the issues that were raised in previous testimonies.

What you have in front of you is basically a brief outline of some of the issues that were identified at the February Subcommittee hearings, but also, there were similar issues raised about the AMA's process for updating the CPT 4 which are somewhat related so that we have added that to the list as a suggested topic.

Of the topics that you see here let me say that in going back through the testimonies and synthesizing it into this one page we basically looked at comments that were made by two or more of the testifiers, and so this was representing a slightly broader-based look. It just wasn't one particular group mentioning some of these items, and, Betsy I will turn to you for the discussion of the nursing issues because I know you and Vivian have had the discussions with them.

MS. HUMPHRIES: Yes, just to say that these process issues include the issues that we heard a lot about in February about well, if everybody is moving to more frequent updates of these HCPCS and CPT then are the payers and everybody, the hospitals going to be getting an update every month because these are uncoordinated updates and so forth. So, we did raise questions like that with CMS and we will be sending a set of similar questions to the AMA as to those issues and some others related to CPT.

The nursing issues as such, basically we were concerned about the notion of whether we had gaps in HIPAA code sets with nursing, and we contacted Carol Bickford from the ANA to discuss the issue about whether there were, in fact, avenues in which nursing procedures were being reimbursed today and you know whether these were covered in the code sets and so forth, and while we were discussing this with her, she said, "Yes," that she thought that there were such procedures but they were being handled with local codes which got back to the issue that came up in the February hearing that although the states and CMS seem to be on the case of elimination of local codes that are used in that context, Simon and others said, "You know, we expected to receive a lot of requests from other people for local, you know, to eliminate their local codes, but we haven't heard from these people."

So, our discussion with Carol led us to believe that we might be able to, through her and others identify some people who are actually paying for home procedures being done in the home and they are not covered, and they were local codes, but these people haven't come forward to get the situation resolved, you know, which was an issue that we thought could be a problem. So, maybe we can follow that thread a little further based on what we hear in tomorrow's testimony about whether there are, also, private insurers who are currently reimbursing for alternative procedures and so forth, and they may be handling them in some local code way and you know we have the specter that we will suddenly announce we are implementing and there are no local codes and then everyone will leap out of the woodwork saying, "But wait a minute, we have local codes."

Then there is a summary of the carryover issues that were specifically identified by the groups that provided testimony at the February Subcommittee hearings but many of these issues I should say are actually carryovers of comments that were made as part of the NPRM and final rule for the initial code sets adopted under HIPAA, and so these are ongoing issues that have been raised and probably need some attention to.

The first one, and these are not listed in any particular order, but the issue of guidelines. Currently among the HIPAA code sets only the coding and reporting guidelines for ICD-9-CM were adopted as part of the code set, but many in the health care industry are concerned that the guidelines were not adopted for the other code sets that were named as part of HIPAA, and historically that has created many problems because you have payers that have created their own rules and are using these code sets differently, and I am sure that between the AHA, AHIMA and FAH and others could speak much more eloquently about the problems that this creates but it is an ongoing issue.

We are aware that there are still some payers who really do not wish to accept the guidelines even for ICD-9-CM and don't quite understand that that is part of the HIPAA standard, but the other code sets that were named, also, there are ongoing issues about those and how those code sets are used.

DR. PICKETT: And the issue of guidelines for HCPCS is one of the issues that I think CMS will be addressing.

MS. HUMPHRIES: On the code set update frequency, that is an interesting one because the stakeholders are going in different directions on this. Some are saying, "Please don't update any more frequently than once a year," but you have others who are saying, "You absolutely must update more frequently than once a year."

Particularly on the technology side where advances are occurring at a rapid rate they think it is not sufficient to update just on an annual basis. However, I think having additional information from AHA and AHIMA and other groups about the impact of how the frequency of the updates actually may provide an additional administrative burden is something that is probably noteworthy for discussion, and then specifically as it related to the AMA's creation of new category 3 codes within the CPT there were comments made at the last hearing that there were problems with how those category 3 codes were implemented and that actually some payers and others were not able to accept the codes because the structure of the codes was very different from what normally goes into the system, and that there were some disruptions in process, etc. So, there were some concerns about that, and lastly, as we heard today earlier mentioned the need for an open and public process for these code sets; there is concern that the users of these code sets may not have the ability to actually submit code requests or actually be involved in the discussions related to the update of that particular code set or actually be able to provide comment as it relates to those code sets, and then there was the information provided by the NCPDP regarding the fact that there were gaps created with the initial standards because not all of the code sets that were applicable to billing for supplies was actually adopted as part of the initial code set.

NCPDP actually cited NDC, UPC and HRI as other codes that should be considered under the HIPAA code sets and then lastly the issue that NCPDP also, identified was the need to recognize the NCPDP standard for billing professional pharmacy services in addition to the X12N837.

DR. COHN: I have a question. In terms of the brief summary of carryover issues now there was a letter sent to CMS asking them a question; how many of these things are we waiting for responses from CMS on? There are other issues about changes to HCPCS and --

MS. HUMPHRIES: They have all the issues and my understanding, Karen, is that they are expecting to talk about all of them when they come.

DR. PICKETT: But again, some of the issues are very specific to CMS and the alphanumeric HCPCS process but some of the issues on the updates are generic across all code sets. So, it is not specifically a CMS issue. It is for any of the code sets that are currently updated more frequently than once a year and the timing of that and whether it should be with the federal fiscal year or January. I mean there are lots of issues there that I think many of the stakeholders could provide additional information on.

MS. HUMPHRIES: I think the thought was in discussion that since we were dealing with procedure coding at this meeting that we would hold our questions for the AMA related to the update frequency into whatever other questions we might have wanted to ask them rather than using the incremental torture method.

DR. ZUBELDIA: I noticed that Michael raised his hand when we were talking about the Category 3 codes. He has an update.

DR. BEEBE: Right. It is Category 3 codes, and I would be more than happy to come back to talk to the Committee about anything they like. With respect to the update of the Category 3 codes which became somewhat of an issue last time we had a CPT panel meeting in the February following NCPHS meeting. We sat down with Blue Cross Blue Shield Association, HIAA and CMS, and we all agreed upon, and Sue can talk about this, we all agreed upon an update system whereby we would release Category 3 codes in January for July implementation, and we would release them again in July for January implementation, and Blue Cross Blue Shield, HIAA and CMS all agreed that their computer systems could accommodate a 6-month phase in to allow them to adopt the Category 3 codes.

DR. ZUBELDIA: The problem I think was the structure of these codes and that is something that some payers just can't handle.

DR. COHN: I don't think we need to solve that today. I think we just need to be aware that many of them exist. I think of these issues I would say No. 1, I don't know when or how we deal with this one is the issue about open and public processes, and I was reminded as I was listening to the discussions at our last meeting that sort of opened this relating to code sets, it seems to be a definition that nobody knows what it means exactly, and I guess I am not suggesting in May but sometime later in the year we need to talk to people to get a better idea of what really is considered to be an open process, and I, for myself, would reflect that there is some processes that I hear described as open that I, myself feel are very closed and then vice versa. So, if I feel that way, I would not be surprised if there is not a fair amount of confusion, and certainly I would expect that there might be code set developers that might be willing to move towards something open if we could tell them exactly what it was.

MS. HUMPHRIES: I think we heard testimony to that effect at the last meeting.

DR. COHN: So, I guess the question would be is that something that we want to spend a little bit of time on the last half of the year in terms of seeing if we can tease this apart a little more, and Marjorie is looking at me like she needs to say something.

MS. GREENBERG: Was it in the NPRM or was it, there was something I thought developed by the coding and classification team on what they felt was an open process.

MS. HUMPHRIES: I think there is language in the preamble in answering questions as to what is generally considered, but we can pull that out. I think that there was a lot of discussion around this issue, and the Committee has to do what they think is right based on what has actually eventuated.

At the time that we were doing it we felt that there really was not one single process that met the definition of open, and we are not going to give people the 12 steps you have to do it this way; there is no other way to do it, but I think what we need to figure out is whether there now is considered to be too much leeway because we have stakeholders who really feel that they are being excluded or that it doesn't meet the minimum definition of what is open, but we will go dig that out.

There were some guidelines, I think in the preamble.

DR. PICKETT: It is in the preamble and again, this is a recurring theme. It came up during the comments to the NPRM and it has come up at every hearing that we have had thus far on code sets. So, that is the reason it made it to this list because it is an issue that clearly the stakeholders are saying is an issue but we have not further defined it or received additional input to hear what they think might happen to some of the code sets that are considered somewhat more closed and how we might recommend making changes to those.

DR. COHN: I guess from my own view on it I am trying to in my own mind decide whether the issue of openness has to do with everybody being heard or whether it has to do with access to decision making which are two very different sorts of openness.

MS. HUMPHRIES: And the third piece of it is that anyone can listen to what is going on.

DR. ZUBELDIA: And there is another piece which is the cost of those codes, and that is kind of coming up at every meeting and it is associated with openness, and some people perceive that an open process leads to free, available at no cost.

DR. PICKETT: Our guiding principle, however, said, "Reasonable cost." We didn't say, "Free." So, we were careful in our guiding principles to clarify that.

MR. BLAIR: Could I ask a question here? Simon, when you started talking about an open process I began to think of whether new codes like, for example, complementary and alternative medicine, whether it had a chance to become part of the system if the criteria was peer review, for example; then it tended to make it extremely difficult if not impossible for complementary and alternative medicine to be accepted into the billing code systems. Is that not within your definition of open? I thought that was what you were referring to.

DR. COHN: Oh, no, actually I wasn't referring to that at all. I think your conduct of standards for acceptance of codes, I was just referencing the process by which codes are considered and decided upon in terms of whether it is considered to be open, and I think you are bringing up a whole other issue which is what are the standards used upon which a code has landed. I don't know where to put that one.

DR. ZUBELDIA: I think the open process is for obtaining existing code sets or in the future for obtaining code sets in general.

MS. HUMPHRIES: We are going to have more testimony around that tomorrow about whether the current systems deal with gaps, perceived gaps well or not, but clearly you could define open in any way. I mean obviously from the point of view of the Committee if a need is legitimate in the industry then it either has to go into one of the existing code sets or you have to approve another code set for it; I mean I would think that one or the other has to happen.

DR. COHN: So, that is something obviously to reflect on tomorrow. I think the open issue we will take a look at probably and somehow related to the cost issue and it will be sometime during the last half of the year just knowing that we don't have any time before that i don't think.

Now, the other issue that I thought deserved some discussion or at least how to deal with it had to do with this issue of billing supplies for NCPDP. The Subcommittee actually has received a letter asking for time and consideration on how to deal with that.

If you remember there was a previous testimony on that issue and I just wanted to bring it up as something we received subsequent communication about.

DR. ZUBELDIA: Whether the cognitive services, the pharmacy should be billed in the A37 professional.

DR. COHN: Well, no, actually I am referring to the first issue which is --

DR. ZUBELDIA: There are two parts to it.

DR. COHN: Two pieces, right.

DR. ZUBELDIA: One is what transaction set to use whether it should be A37 professional or BSEPT transactions and the other is what Colt(?) said should be used, and they are two related issues because you can only use certain code sets in certain transactions.

DR. COHN: We are talking about the billing supplies.

DR. ZUBELDIA: But there are two parts, coding the services and supplies and to those two parts there are two parts to it. One is the transaction set and the other is the code set to be used, and NCPDP needs to have as soon as possible clarification as to what to do in those two areas.

MS. HUMPHRIES: We are running out of time. What we need to do is bring that up again tomorrow with Herb because I think he is the one that has been following that.

DR. COHN: I guess we need to think hard recognizing that we don't get together every day of the week and obviously we need to try to defer to those who are very capable of handling some of these issues. Now, with the open, we may have hope with the responses already. We will have to find out tomorrow.

Now, are there any additional issues? Obviously we have got a fairly active code, set of code issues and we actually are supposed to be probably doing other things other than just code sets even though it may not feel that way, but were there any other issues that needed to be dealt with in terms of these current code set issues?

Okay, now, obviously keep the list of ongoing activities here, and I didn't pass them around this time but I could certainly provide it, but certainly of these things that are going on, I mean the first one, the compliance will become an issue at some point. Luckily it doesn't seem to be an issue next week. We would like some time later on this year to deal with PMI next steps and probably as we begin to think about the issue of procedure codes, certainly there was an interesting issue of what are administrative procedure code sets versus what are clinical procedure code sets, and I am trying to avoid obviously making this a gigantic question or issue but we probably need to be thinking about that a little bit and obviously we will be talking in just a minute about the drug project that Betsy has been working on, and other than that I think we are moving along pretty well.

DR. ZUBELDIA: I think that the only thing we have on the agenda for today is Betsy's presentation on clinical drugs and where we are on those.

Agenda Item: Clinical Drugs - Project Overview

MS. HUMPHRIES: You should all have a little handout. Up in the corner it says, "Clinical Drugs" on the left, and you read from left to right across.

I am reporting on this for Dr. Stuart Nelson who is the person at the National Library of Medicine who is knowledgeable about this project, and I have given you his contact information so that if you wish greater amounts of detail you can contact him for it.

We don't need to be reminded of the NDC issue because Kepa keeps bringing it up, but in a previous Subcommittee meeting in discussion regarding NDC it became clear to anyone for whom it was not already clear that there was a missing code set or control vocabulary that is a code set of control vocabulary that was specifically corresponded to the level of information that is generally known at the time a drug is prescribed.

We had an NDC code which is the product level and that is to remind everybody this is where you have one NDC code for the same drug in a 100-count bottle and another NDC code for the identical drug in the identical dosage but in a 50-count bottle. So, this is information which normally speaking the person who is writing the prescription does not have because they are not quite clear what the pharmacy is going to hand to the patient when they get there, and that level is, also, difficult in clinical information systems because of the fact that it grossly complicates the notion of having automated decision support reminders on drug-drug interaction checking because there could be literally hundreds of NDC codes that actually represent aspirin of a comparable dose.

So, at any rate everyone agrees this was a problem, and it was not a new problem because in fact it was one that HL7 had identified several years previously and had been grappling with how they could come up with sort of a standard form for representing what is known when the drug is prescribed, and it happened that the National Library of Medicine and the Veterans Administration and the Food and Drug Administration coalesced around whether we could move this ahead because HL7 had done a lot of good work in sort of almost defining what this was, but then they were having difficulty keeping all the players enthused about really forcing through to doing it, and it is an issue that matters to us in the National Library of Medicine's UMLS system because we have all these things that we represent in the UMLS drugs, clinical drugs, things that have been ordered or prescribed theoretically from multiple systems, Multem(?) Micromatics(?) First Data Bank, you name it, all these systems, and they all have a slightly different way of representing these things which is not generally amenable to the same type of machine matching that we use to get a real concept level in other concepts, in other types of terminology.

So, just to say this, I mean there are about 10,000 drugs that have been approved by the FDA and yet we seem to have 81,000 things in the UMLS that were listed as clinical drugs.

Now, some of this makes sense because we would have the components of drugs separated out and so forth, but we clearly had a lot of what we called missed synonymy. So, we decided that one thing that would help us solve our problem was exactly what everybody else wanted which was sort of a standard representation which the name today is RX norm, the RX normal form, right, that we would map all of this stuff to, and the idea was that if we could do work with VA and others and fix this problem from what already existed in the UMLS and if we could engage the FDA in making sure that this normalized RX norm form was created in the future every time they approved a drug that maybe we would have solved this problem.

So, the approach that is being taken is that we have developed a standard limitation. This has been developed in consultation with HL7 in the meetings around there to hash out the form it would take and place at HL funding meetings, and this form includes each ingredient, the strength and the dose form.

So, we are using a standard list of dose forms which is something that has been developed by HL7 and we have the standard method that we have drafted out for representing strength.

So, the whole plan is okay we are going to create this normalized form for all of the approved drugs and in the UMLS system we will have separate concepts for the ingredients, the drug components which include and that is defined as the ingredient with strength attached to it the does forms which are things like tablets or whatever, the drug and then the full drug formulation which includes all the drug components of that particular drug and the dose form, and then we are going to have a whole bunch of labeled relationships between all these concepts because obviously once you have a complete drug formulation in the standard form you have all these things you want to link to it like every brand name that you know for it and all of the separate little ways of representing the same thing that comes from Multim and Micromatics and wherever they come from and then of course you, also, want a connection between these and the separate drug ingredients and components and it goes on and on.

There is an example here which I won't go through and so, our goal is to create these things and then map everything that we currently think is some sort of a form of a clinical drug from the VA's national drug formulary which is from Multim, from Micromatics, from First Data Bank and from Metaspan(?). We want to connect them all to this RX normal form.

Yes, Jeff?

MR. BLAIR: In some respects people refer to this initiative as a drug reference terminology.

MS. HUMPHRIES: Yes.

MR. BLAIR: And it is changed to RX norm and could you help me understand what was the thinking behind using normalization? Is there a functional difference?

MS. HUMPHRIES: I might be about out of my depth but allow me to say that the VA is interested in a full drug reference terminology which would have additional properties. The piece that we are dealing with is standard nomenclature for the representation of the drug, what is known about the drug at the time it is prescribed. So, the drug reference terminology would have this plus additional relationships and attributes, and what ours would do right off the bat would be to give everyone a standard way of representing this thing and if everyone mapped to this then they would be able to do their various things they wanted to do and they would, also be able to which is obvious an issue for large providers that just got merged yesterday or even those that didn't just get merged yesterday where in different parts of the system some of them use one of these drug systems and some of them use another, and they are not readily able to exchange information or to coalesce.

When we get through what we are doing theoretically you could take any of these commercial systems and you could map to this normal form which means that you would be able to inter-operate in ways that you cannot do it today.

So, we have some more examples here which I won't go through that the timetable for completion of this effort is generally we think as follows. Our first experiment was to create this RX normal form for all of the drugs that we or a big chunk of drugs in the VA's national drug formulary. This was done and these were released in the first 2002 version of the medical source which was put out in January 2002.

So, this gives people right now if they care to look at it, they can look at these forms, what they look like for these VA drugs.

So, the second experiment is to look at the scaleability of this approach and to attempt to create the normal forms and then map them for the other drug services, and we are sort of refining the dose forms and the model as we go into more drugs.

So, what we expect to do is to complete this phase or a big chunk of this work for the second 2002 release of the medical source which will be available in May and in this we will have many more of these and we will have a great deal of mapping already completed between the different forms from the different drugs although not perfect yet and what we will also do is take maybe the one or two hundred most commonly prescribed drugs and make sure that fully instantiated for them are all of these relationships that I mentioned from the ingredients and the brand names and everything for that smaller subset. So, we will still not be finished.

We hope we will complete the mapping of all of the things for the January 2003 release and we will have more enhancements to this available in July 2003, and one of the issues here is these data are being, you know this normal form is being created by the National Library of Medicine in conjunction with these other organizations. So, it is freely available to anyone who wants to use it, and we are inviting in each of these releases, we are really trying to get as many people as possible to get at it whether it is a correct model or what. So, we expect continuing feedback and improvement you know our sort of goal is that maybe in 2004 new ones would be available at the time that FDA approves the drugs.

I don't have control over that last one, but that is the goal that we have in mind.

Yes, Jeff?

MR. BLAIR: What kind of reaction are we getting from First Data Bank and the other drug information system vendors in terms of, you know, they have their proprietary systems. They share that with us to some degree. Do they feel as if this has potential for them to adopt it rather than retain the proprietary systems?

MS. HUMPHRIES: I think they are all relatively enthused about this.

MR. BLAIR: Wonderful.

MS. HUMPHRIES: I think that they feel that this takes a degree of work from them and allows them to spend their resources more on their value added drug-drug interaction and other information that they are providing which of course is not in this. So, I think they sort of are not opposed to this at all. At least, Vivian you have had more of this but that is my sense that we haven't found anyone who has been other than relatively enthused about this whole effort, and our desire of course is to have people who really want to make use of this look at these iterations as they come out and give us feedback so we can get this to the point that we all love it, and then we can get FDA to assign them new coming out and then hey, one problem perhaps slightly solved.

MR. BLAIR: Going down that path in terms of FDA reaction to this is it possible that RX normal form might be adopted by the FDA to where there might be consistency for example that Medra(?) codes or --

MS. HUMPHRIES: Medra is dealing with a different issue. Medra is dealing with the adverse reactions that come in testing a drug or are identified post market release of a drug, but I do think that the FDA is very interested in this, and I think that the Committee may very well at a future time, I don't think we maybe have too much time in the near term with your Subcommittee, but I think that the FDA is interested in more, is really ratcheting up its participation in standards-related activities and attending meetings and is trying to coordinate across the agency in what I consider to be very valuable ways and you may want to have the, Janet, I think, Showalter who is coordinating this out of the Administrator's Office now, you may want to hear from her in the future but I think the FDA is really doing some good things in this area.

MR. BLAIR: Betsy, thank you very much for the work that you have done in pulling this together.

MS. HUMPHRIES: I will pass those thanks on to my colleague, Stuart Nelson who truly deserves every last one of them, not that Steve Brown of the VA and Randy Loven of the FDA don't deserve, some of the people at HL7 but in terms of NLM Stuart gets all the credit and deserves it all.

DR. ZUBELDIA: Betsy, has the institute been involved in this for their electronic prescription transaction?

MS. HUMPHRIES: My assumption is that if -- I don't know the answer to that unless they routinely also audit such matters at HL7 meetings in which case they would have been. You see the understanding here is that in fact the NDC code as we heard is entirely applicable in the arena in which the NCPDP operates their standards because they are selling a product.

DR. ZUBELDIA: Except for script. The prescription transaction has the problem that they don't have an NDC code to use at the time of a prescription, and that is --

MS. HUMPHRIES: Okay, then I will follow up with Stuart on this, and we obviously would be very interested in any reactions they may have about how this is going to be workable for them or not.

DR. ZUBELDIA: Thank you.

With that, are there any other questions?

DR. COHN: I guess I should let everybody know that if you look at your agenda tomorrow we are actually starting at 8 a.m., which is 5 a.m., California time and we will be adjourning by 1 o'clock and hopefully a little bit before, and we are recessed until tomorrow at eight.

Thanks very much.

(Thereupon at 5:07 p.m., a recess was taken until 8 a.m, the following day, April 10, 2002.)