[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

September 24, 2003

Hubert H. Humphrey Bldg.
200 Independence Avenue, SW
Washington, D.C.

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
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List of Participants:


TABLE OF CONTENTS

Call To Order

CHI Issues

ICD-10: Next Steps


P R O C E E D I N G S (10:00 a.m.)

DR. COHN: Good morning. I want to call this meeting to order. This is a two-hour breakout session of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. I am Simon Cohn, Chairman of the Subcommittee and the National Director for Health Information Policy for Kaiser Permanente.

I want to welcome subcommittee members, our HHS staff and others here in person. I believe that we are on the Internet, as I understand, so I want to make sure that everyone speaks clearly and into the microphone, and introduce themselves if at all possible when they are speaking.

We have a pretty full agenda today. We are going to start out with an update from Cynthia Wark and Steve Steindel on CHI. As you all know, we have a letter that we discussed yesterday and edited, and based on what we hear today, we will potentially be making further revisions to that letter in terms of specific domain comments. So you all need to keep that in mind. That will be about the first hour of our session.

From there, we will be having a discussion for about 30 minutes about ICD-10, what we heard yesterday and the next steps, in preparation for our hearings later on in October. As you know, the intent here is to take the cost impact, begin to think about what we have heard, identify what questions we have for additional testifiers and reactors, and begin to think about what sort of point of view we may want to be expressing to the Secretary.

Finally, we will be talking about other aspects of those hearings in October. Just remember, we have three days in October, the 28th, 29th and 30th.

I do want to announce that we have polled the subcommittee for dates in 2004 for hearings. While I am not going to discuss topics, I do want to identify that we have identified dates that most everyone seems to be available for. The dates for upcoming hearings for the first half of 2004 -- and this will be e-mailed to you after -- are for January hearings, January 27 and 28, the March hearing will be March 30 and 31, and then we will be having a May 25 and 26 hearing.

MR. BLAIR: Simon, could you repeat those? I couldn't get the Dictaphone out quite fast enough.

DR. COHN: Sure. January 27 and 28, 2004, March 30 and 31, 2004 and then May 25 and 26. I think the hope will be that in 2004 we can move back to two-day sessions, as opposed to what have recently been three.

As always, I want to emphasize that this is an open session. Those in attendance are welcome to make brief remarks, if you have information pertinent to the subject being discussed. We will try to make time at the end of the session, if there are any open mike issues that anyone wants to bring forward. For those of you on the Internet, we welcome e-mail and letter comments on issues brought before the subcommittee.

With that, let's have introductions around the table and around the room. If there are any issues coming before us today for which you need to recuse yourself and you are a member of the subcommittee, we ask that you do that at this point.

Maria, would you like to introduce yourself?

DR. FRIEDMAN: Maria Friedman, Center for Medicaid and Medicare Services and staff to the subcommittee.

MR. BURKE: John Burke, Office of the Secretary, staff to the subcommittee.

MS. PICKETT: Donna Pickett, NCHS, CDC, staff to the subcommittee.

MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.

DR. HOUSTON: John Houston with the University of Pittsburgh Medical Center, and I guess I am actually on the committee.

MS. BEBEE: Suzie Bebee, ASPE, staff to the subcommittee.

MS. WARK: Cynthia Wark, CHI, project management team.

DR. STEINDEL: Steve Steindel, CDC, staff to the subcommittee and liaison to the full committee.

MR. BLAIR: Jeff Blair, Medical Records Institute, Vice Chair of the subcommittee. Simon, do you want us to list relationships and conflict of interest stuff?

DR. COHN: Sure.

MR. BLAIR: Member of AMEA, ASTM, HL-7 and HEMS, and to the best of my knowledge I have no conflicts of interest.

DR. ZUBELDIA: Kepa Zubeldia, Claredi Corporation, member of the committee and subcommittee. I don't think there is anything that would impact this.

DR. COHN: I think there are several others who have just arrived. Would you like to introduce yourself?

DR. GREENBERG: Skating in from the other subcommittee.

DR. COHN: That was Marjorie Greenberg.

DR. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC.

DR. COHN: Power?

DR. GREENBERG: Yes, I now have power, I am happy to report, at home. I am the Executive Secretary for the committee.

DR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member of the committee.

(Introductions from the audience.)

DR. COHN: Thank you all. Given that we will be talking about ICD-10 today, I do need to announce this publicly. As all of you know, I am a member of the CPT editorial panel, and therefore I will be recusing myself on discussions related to CPT.

With that, Cynthia, do you want to lead off with discussions about CHI, please?

MS. WARK: it is a pleasure to be here this morning to share information about the Consolidated Health Informatics initiative, and in particular this time slot was set aside to bring to the subcommittee preliminary results from six domain work groups and one final work group.

Based on our experience last May when we had several team leads come make presentations about their work group results, we have modified our approach a bit, and I did want to share that with the committee as well as the observers. It was decided that we would have one presenter from the CHI project management team to go over all of the reports. I also want to let everyone know that there are approximately five of the 17 leads here in the room, and I will invite them to make any comments that they have or answer any questions that I am unable to pertaining to their specific work groups.

Because we had two days of power outage last week, our schedule was a bit interrupted. We intended to get the reports to the subcommittee late last week, and did not do that until early this week.

I wanted to therefore go over the handouts that are available. There are six preliminary reports for the diagnosis problem west work group, the medical devices and supplies work group, anatomy and physiology, nursing, disability, laboratory interventions and procedures, and there is also one final report on the demographics work group. That includes both the final information sheet as well as a spreadsheet attachment.

Before I go into each of the preliminary report presentations, I wanted to review the schedule and the progress on the CHI initiative, and to give some perspective for the subcommittee as well as others listening to how these reports fit into our overall time line.

This is our team schedule for the calendar year 2003. s you can see, the teams six to 11 were performing their analysis during February to May time frame. A new round of teams were launched in the June time period, and we will have the remaining teams launched if not this month, next month.

Briefly, the domains with final recommendations are lab result content, demographics and units. The subcommittee heard presentations on lab result contents and units last month, and today you will hear the final presentation on demographics. We also have three domains with recommendations nearing readiness: immunizations, medications and interventions and procedures. We hope to bring these to the subcommittee late in October.

The teams that are currently deployed, many of whom you will hear from today, are listed here on the screen. You will note that interventions and procedures was listed twice. That is because we broke it up into non-laboratory interventions and procedures and laboratory interventions and procedures. The non-lab was presented in May, and we are now bringing the second part to you today.

The last round of teams to be deployed, some of which are actually launching now, teams and pro teams, was launched approximately two weeks ago, and the remainder are being formed now.

This is a graphic of the standards adoption process, and to enhance everyone's understanding of where the reports fit into the standards adoption process, the teams deploy, and after completing some of their initial analysis, the preliminary reports are brought to the subcommittee for sharing and to gain feedback, particularly from the members of the subcommittee and the work that you all have done with respect to some of the PMRI standards.

Following the complete analysis, there is a technical presentation to the CHI council, department agency review and feedback. The council establishes a consensus and then comes to the subcommittee with the final report to see if there is anything that we have missed prior to the actual adoption.

Just a reminder. There is a range of possible recommendations. The work group may conclude that there is a perfect terminology that needs only evergreening to maintain. They could conclude that there is an imperfect terminology with weaknesses and gaps that need to be fixed, or they could come forward with a recommendation that there is no solution for a domain at this time.

With that, I will go to the preliminary reports, starting first with diagnosis and problem list. As indicated here on the information sheet, the two co-chairs are Carla Porter and Beth Acker from the VA. This domain is defined as a terminology that is used to identify and describe clinical diagnoses and problems.

The CHI work group adopted a broad definition of diagnoses and problems that reflects and is consistent with work previously done as part of the government computerized patient record initiative. Therefore, the broad definition is that it is a series of brief statements that catalog a patient's medical, nursing, dental, social, preventative and psychiatric events and issues that are relevant to the patient's health care. So the work group did take a very broad definition and approach to this domain.

A broad range of diagnoses in various stages will be reviewed and considered. The reason for this statement is that in particular, the issue of modifiers for diagnoses and stages of diagnoses such as preliminary or final. These terms are not thought yet by the work group to be well defined enough, or addressed enough, in terminologies of information models that they would be able to explicitly include that in the scope of this domain.

So they are considering the various stages of diagnoses and they will explicitly address those and gather information, but it is not their intent to come forward with a recommendation for a standard to be adopted for all of the modifiers. That is why in the scope table, modifiers and descriptions are stated to be out of scope.

The nursing diagnoses are specifically listed here as being out of scope. They are not necessarily defined to the nursing work group to address nursing diagnoses. They will wait for the nursing work group to address nursing diagnoses by their work group, and then upon their coming forward with that report to the CHI council, they will then deliberate on whether the nursing domain has adequately addressed all of the issues having to do with nursing diagnoses.

The alternatives identified by the work group are listed here on the information sheet. For those listening, they are SNOMED-CT, ICD-9-CM, ICD-10-CM, DSM-IV, which is the diagnostic and statistical manual of mental disorders, fourth edition, MEDSEN and ICPC.

Initial thoughts, issues and comments for feedback. This work group felt that an enormous amount of information gathering and analysis of PMRI terminologies had already been done by the subcommittee, and that the CHI work group should not repeat this work. Therefore, they will review the documents provided by the terminology owners and identify any additional information requirements that need to be conduced for CHI. The work group is limiting the scope of the project to terminology only, and not including messaging standards.

Before I go on to the next one, I'll stop there and ask if there are any particular comments that the subcommittee has for the CHI work group, or any questions.

DR. STEINDEL: Cynthia, Stan sent me a response to this question. I raise it to you because I couldn't be at the meeting. The one thing that I am concerned about with the scope of this problem is, it leaves open the situation that we could have one coding scheme for admitting diagnosis, one coding scheme for problem list diagnosis and the working diagnosis during this day, and a final coding scheme for discharge diagnosis. I would like to make sure that the work group does address that situation in some fashion.

MS. WARK: Okay, I will certainly take that back to them. It is the intent of the work group to explore the area of modifiers in the various stages of diagnoses. They will address reference terminologies that are available and are on the alternative list to see the extent to which they address those various stages.

I don't think -- they will certainly deliberate on it, but I think that the work group feels they cannot fully address this and identify a solution within the time frame that they have.

DR. COHN: Jeff.

MR. BLAIR: Just an administrative question. You are trying to get copies of the filled-in questionnaires, and when I was trying to send them to you a week ago, I was having a problem getting some of them through the firewall. Were you able to get them?

MS. WARK: We have not yet been able to get those. I don't know if it is a firewall issue or other technical issues. Our e-mail system has certainly been plagued for the last month with problems. So we will continue our efforts to try to work with members who may already have those available, where we can get it without having to go through the --

MR. BLAIR: There are a lot of other folks in your staff that have already had them since last May. So maybe they can forward them to you, because they are already inside the firewall.

MS. WARK: Okay, thank you. I appreciate that.

I will move on then to the next preliminary report from medical devices and supplies. This work group is being led by Brock Heflin from the FDA.

The domain is defined as a terminology used to inventory or exchange information on medical devices and medical supplies within and between agencies and between agencies and the public. The work group excluded staff resources from the domain scope, as its members were unfamiliar with terminology that covered the subject, and believed that it was relatively unrelated to medical devices and supplies.

The group believes that the terminology should be highly comprehensive and sufficiently specific to the generic device and supply group level to accommodate regulatory and inventory activities. The terminology should be organized in a simple hierarchy to enhance structure and facilitate navigation.

The work group has identified seven alternatives that they are assessing, including SNOMED-CT, UNSPC, the United Nations System for Product Classification, ICD-9, HCPCS, GNDN, the Global Medical Device Nomenclature, UMDNS, the Universal Medical Device Nomenclature System, and FDA's classification.

This work group is fairly early on in their analysis. They appreciate the testimony that was provided in the August subcommittee meeting on behalf of medical devices and supply terminology experts, and that has been very helpful to them. At his point however, they have not done extensive analysis. They are hearing and operating from some initial assumptions that there are several candidate terminologies. However, most are thought to be lacking in the breadth or level of detail required for all activities in the medical devices supply realm in the federal enterprise. Those that seem to be sufficiently developed are highly similar in scope and organization. The government is aware of attempts being made by the terminology owners to harmonize.

At this point, this is a preliminary report, and these are some of the thoughts on their discussion. We would certainly appreciate hearing from the subcommittee any additional points or information that could be made available to the CHI work group.

I'll stop there.

DR. COHN: Comments from the subcommittee? I guess I would have one comment. I know this is preliminary, but I think it is going to be critical to identify the level of detail that is required here. I think in our testimony that we received, we heard that there seem to be at least two levels, and probably three or four in all of this.

The question is, what is the business case that you are trying to solve here. At the end of the day, I keep going back to patient safety issues. You would really want to know the device that went into somebody if there was a malfunction or failure, and be able to identify it very specifically, as well a have a hierarchy to understand similar types of devices and all of this.

I'm not sure that I have quite seen that construct yet. It may require more than one terminology. It might require things being fit together. Certainly anything that you can do to shed some light on this would be very helpful. I think this is a very important area, akin to drugs in the sense of its complexity, but we do need to figure out how to deal with this in a way where there is comparability.

I don't know if others have opinions or comments on this one, but we thank you for moving into this area. But it is not simple.

MS. WARK: That is very helpful. In the early discussion we have had with the council, those specific issues were raised, that we needed to figure out what the business case is in the federal enterprise for this type of information, and in particular taking into consideration the safety issues.

The analogy that I can think of is in the demographics domain, where they develop a checklist of elements that were needed for the business purposes in the federal enterprise, and then they use that to evaluate and compare the various alternatives. So that was a model approach for that sort of issue, to try to get down to the variable level that is needed for the various business purposes, and to use that to evaluate the terminologies.

DR. COHN: Other comments? Once this group has a checklist together, they may want to share it before we see a final report.

MS. WARK: The next area is anatomy and physiology. The work group lead is Steve Steindel from the CDC.

The scope of this domain is really twofold. First is anatomy. The definition that they used is, anatomy is used to describe anatomical locations for the following purposes. Without reading through the whole report, they describe the various business functions in the federal enterprise, including clinical care, where the site of a procedure would need to be known for source of culture specimens, surgical site location, blood pressure, et cetera, location of an observation such as a site fracture or site injury, also for surgical uses, precise anatomical structure involved in a procedure, pathology for describing items observed, research purposes.

They also went on to define in their scope that anatomy would have the following requirements. There is the part of hierarchy, laterality, synonyms and virtual locators.

Also, under the scope of anatomy, modifiers would be included, basic terms such as necrotic and also that it would be compatible with animal models.

The physiology scope was described as, used to describe or infer human physiology, at least at the organ systems, cellular and biochemical levels. Physiology terminology includes tests that are used to infer the physiological state at any of the levels noted.

The terminology that infers cellular physiology by direct inspection of cells is also included. The terminology must include concepts for both normal and abnormal physiology. As you can see from the scope table, it includes all of those areas in the scope. However, the physiology of the patient was out of scope.

The alternatives identified are seven, including MESH, NCI anatomical terminology, SNOMED-CT, clinical LOINC, foundational model of anatomy at the University of Washington, the HL-7 site table and the Veterans Administration NBFRT physiology effects hierarchy.

This work group is a little further along than the previous two. Therefore, they have had substantial discussion that is included here under initial thoughts. In the area of anatomy, they have evaluated SNOMED-CT and found that it has the benefit of relative completeness for anatomy terms and concepts. They have also evaluated the HL-7 site table that they felt could be used as a complement to the SNOMED-CT concepts. However, the current HL-7 site table is noted to be incomplete, and requires addition of more general anatomy terms.

HL-7 has a mechanism to facilitate the addition of these terms through their vocabulary technical committee, and it was felt that if these two were to be used in conjunction, that there would need to be a closely coordinated effort between the maintainers of HL-7 and SNOMED-CT to insure synchronization of the terms.

They have found that the NCI thesaurus provides an extension into sub-cellular structures for research that goes beyond what is available in HL-7 or SNOMED-CT. This could also serve in a complementary fashion to other terminologies. The NCI thesaurus anatomy work is early in development, has not been released, is a work in progress. A developmental version was shared with the CHI work group. It is anticipated that it will be included in the NCI thesaurus by fall 2003. However, the work group was reluctant to charge ahead enthusiastically in this area, since it is so early in its development, and any recommendation they felt should be accompanied by a condition that the work should be completed and reviewed and take place within six to 12 months.

They also looked at the foundational model of anatomy, which is a work in progress at the University of Washington. It was felt to be complete, have a well structured anatomy terminology. It is optimized for the spatial representation of anatomical structures and not clinical concepts, and for this reason, they felt it would be unlikely to be recommended as a standard, although mapping to the terminology would be useful.

In the area of physiology, the work group could not identify an acceptable terminology that covered cellular physiology. Therefore, under general comments, you will find specific areas that the work group would like to get some feedback on, in particular that the definition of clinical physiology be validated as it formed the basis of looking at SNOMED-CT and clinical LOINC.

There was some work done in the area of physiology to assess the VA NDFRT medication physiologic effect access, and it was felt to be too narrowly focused for drug physiology to be of general applicability. However, it was the closest terminology they found that addresses the subject.

Under the broader definition of clinical physiology, the work group has looked at clinical LOINC and the appropriate hierarchies with SNOMED-CT. However, they did find that the terminologies had significant weaknesses. It is recommended that CHI revisit the area in 12 to 18 months for progress.

General comments. The work group would like to note that while a high degree of synonymy allowed us to interchange anatomy concepts freely, we did observe difficulty in navigating with SNOMED-CT hierarchies to find anatomically related terms. In part, this is due to the mixed use of ISEA and part of relationships. The SNOMED clue browser is designed to navigate, and is a hierarchy and hides the part of relationships.

We also note above that diverse locations we found in that hierarchy for physiology function concepts, both test and findings. Furthermore, we note that the organization issue noted in the CHI recommendation to use laboratory LOINC applies also to clinical LOINC.

Finally, we note that successful organization is use dependent, and interpretation guidelines might be in order.

I mentioned the request for validation of the definition of clinical physiology. The work group also noted that a critical look needs to be taken regarding clinical LOINC with regard to utility content extension and overlap with SNOMED-CT. The work group is asking the NCVHS subcommittee to investigate these areas through the hearing process.

I will stop there. Steve Steindel, the team lead, is here with us, so I would invite him to make any additional comments for anything I did not cover.

DR. COHN: Steve, did you want to make further comments about what your thought was here, since you are the team lead?

DR. STEINDEL: I think Cynthia did a very good job of covering the summation of what the work group observed. I'd be happy to answer any questions.

DR. COHN: Questions, comments? John.

DR. HOUSTON: I just have one question. Where is implants?

MS. WARK: Where is implants?

DR. HOUSTON: Where would implants be handled through the CHI? Is it this or the medical devices?

DR. STEINDEL: The actual implant itself would probably be handled in medical devices. Where the implant was put in would come under anatomy.

Simon, if I may comment very quickly on what Cynthia talked about, basically what we outlined was some work that we are asking the subcommittee to undertake next year.

DR. COHN: Oh, okay.

DR. STEINDEL: This is not to be resolved in this session or an immediate session.

DR. COHN: I was trying to think of our ability to resolve this issue in 2003. I thought it was not likely.

DR. STEINDEL: I don't think the work group is asking for that.

DR. COHN: I guess I am also assuming here, looking at this, it appears that you will likely come forward with some final recommendations about anatomy, but physiology is the area that needs further investigation?

DR. STEINDEL: That is a correct assumption. The physiology recommendations will be very conditional, if at all.

DR. COHN: Okay, great.

MS. WARK: The next preliminary report is from the nursing work group. Alicia Bradford is the team leader.

This domain is defined as a terminology that is used to identify, classify and name the delivery of nursing care. Sub-domains are derived from the nursing process and the ANA approved nursing minimum data set, emphasizing nursing assessing, diagnosis, interventions and outcomes of nursing care.

There were a long list of alternatives identified, 11 to be exact, starting with SNOMED-CT, the ABC codes, NANDA, NIC, --

MR. BLAIR: Do you want to spell that a little slower?

MS. WARK: Sorry.

MR. BLAIR: That's okay.

MS. WARK: NANDA, NIC and NOC are three complementary terminologies. The first is the North American Nursing Diagnosis Association, specifically addressing nursing diagnoses. The second being the nursing interventions classification, dealing with interventions, and nursing outcomes classification. It is noted in the report that -- and perhaps that was a little slip there, running all three of those together, because it has almost become a habit in the nursing community to refer to them in a bundle. There has been some recent work done on harmonizing those three terminologies. They are intended to be used together to complete the nursing process.

The next one was the Omaha system. Next is home health care classification, the patient care data set, the peri-operative nursing data set, international classification for nursing practice, and clinical LOINC.

This work group was recently launched, within the last month. They have done quite a bit of work over the last few weeks to begin to compile the list of alternatives, and to evaluate those alternatives. The discussion of this work group seems to be focusing on the large number of terminologies that are available, and the extent to which the terminology owners have been working together to harmonize these, and working with for example SNOMED to incorporate many of these terminologies into the comprehensive terminology.

The other issue with the nursing work group that has been articulated by the diagnosis and problems work group is the desire to not have silos or terminology islands that did not effectively interface among the domains.

So for example, in the area of diagnoses, where the diagnosis work group has indicated that they will leave that out of their scope and wait for the nursing work group to come forward with their recommendation, they also sent the message that what comes forward would be viewed favorably if it was integrated with other terminologies in that same domain.

So that seems to be the central focus of the nursing work group. There is no dearth of terminologies out here, and the nursing community has demonstrated some harmonization efforts recently, and the work group is assessing those.

So I'll stop there for comments.

DR. COHN: Comments? Okay.

MS. WARK: The next area is disability. The co-chairs from ASPE are Jenny Harvelle and Sam Shipley. I will remind the subcommittee members that originally we had disability as a validation effort, and we modified that to be a full evaluation effort. Originally it was not thought that we had more than one terminology to look at, and as time went on -- and this one was toward the bottom of the list -- it was clear that we had more than one choice.

So we did have a full team launched in this area, and they have defined disability terms as being used in the federal health care sector for payment, policy development, surveys, public quality reports, external quality monitoring, internal quality monitoring and eligibility determinations.

There are three areas that were identified, SNOMED-CT, ICF and also UNLS. I'd like to point out that in the initial section, the further elaboration of UMLS is referred to as other sources available in the UMLS. It is not the UMLS per se, but the presence of the terms in sources within UMLS.

The disability work group has taken a rather interesting approach. They are compiling concepts and phrases that are used throughout the federal health enterprise having to do with disability. They are using this inventory of concepts and phrases to analyze the degree of content coverage provided by SNOMED-CT, ICF and other sources available in the UMLS. Vivian Auld, for those of you listening, a member of the subcommittee, has been an enormous help in this area, and is performing a great deal of work to conduct that analysis through the National Library of Medicine and the work group is proceeding now, and it should be rather interesting to see what the results look like.

At this point, that is where the work group is.

DR. COHN: Comments? I'd say I will be very interested to see what you come up with, only because this is such a multidimensional areas. In some ways it is the same as your diagnosis domain. There is administrative, there are functional axes. I am appreciative of the fact that you have at least identified a scope on this one, that should make the answers somewhat interesting as you come up with them.

When will we be hearing?

MS. WARK: I will defer to Vivian on that, since she is doing the work.

MS. AULD: Isabel has put a little wrench in this. I am hoping to have the analysis done by the end of this week, more likely the end of next week. Then the committee can review the results. We are intending that -- this is my first analysis that they will get a chance to review and give me comments about what areas they want me to look at a little bit more closely, and then I can refine that.

DR. COHN: Okay, great. Thank you. Other comments, questions?

MS. WARK: Moving on to the interventions and procedures laboratory test order names, we did break this work group into two parts, and this is the second part. Laboratory test order names are the focus of this report, and more specifically the representation of the names of laboratory tests associated with an order within a computer system. Laboratory results, naming, laboratory test result values, demographics, anatomy and disability and genes or proteins are not included in this domain. The coding system will be hidden from the user.

Finally, the team recognizes that orders may undergo a series of additional events and modifications prior to the actual test being run and entered.

The alternatives identified are LOINC, CPT codes and SNOMED-CT.

The main focus of this work group has been to distinguish between an underlying reference terminology and the extent to which any of those work with interface terminologies, because of the fact that the underlying reference terminology for laboratory purposes needs to be rather detailed, specific and extensive. As indicated in the report, the work group recognizes that it is impossible for clinicians to be navigating and wading through the underlying terms in a reference terminology.

So keeping that in mind, the work group did look at the terminologies from the standpoint of, are they sufficient to represent the breadth of content required in this area. They have also discussed the degree to which these reference terminologies incorporate any interface terminology representations.

In particular, they are saying that the adoption of hierarchical features will make a terminology more comprehensive and flexible, and this would allow for standard aggregation of terms across the health care system. use an identifying needed term for example when a physician is ordering a laboratory test, and identification of terms to assign within an institution.

The work group has determined that most individual analyte tests are ordered as parts of panels. Therefore, the development of standard panel names within a solution would significantly increase the speed of adoption.

Also indicated here is the fact that this would be used within a messaging standard, HL-7, which has already been adopted by CHI for order entry, and LOINC has previously been adopted as the standard for laboratory test results names.

So that is the thinking of the work group. Really, the crux of the issue for them has been how that underlying reference terminology works with interface terminologies.

Any comments?

DR. ZUBELDIA: Cynthia, do you have a process in place to feed those panels back to a CPT editorial panel, for instance, for inclusion in new CPT codes?

MS. WARK: Do we have a process in place within CHI to feed those back to the CPT board? Is that what you are asking?

DR. ZUBELDIA: Yes, to CPT or to LOINC, to cross pollinate those terminologies.

MS. WARK: The CHI work groups are short term work groups, and not operational work groups. They represent -- individuals represent the operational component of the various federal agencies, for example, the Veterans Administration. However, it is not their scope and their charge to produce the terms that need to be added or modified.

To the extent that they uncover those during their work, they will certainly include that information in the final report and said that it can be made available to the terminology owners. The work of -- once the standard is adopted, and the work of resolving the gaps, however, is not the job of the teams.

DR. COHN: Steve.

DR. STEINDEL: Kepa, you did raise an interesting point, that perhaps the CHI councils should consider as part of these reports. These reports right now, while they have identified overlapping terminologies, have made the recommendation that mapping occur. Maybe that recommendation -- and I read this in what you were just saying -- maybe that recommendation in cases where it is really critical with respect to the HIPAA process, should include a recommendation for a formal agreement between the two respective terminologies to agree on establishing convergence or terms.

MS. WARK: Any other comments on lab INP?

DR. COHN: I think the only comment I would make is, this issue of panels which Kepa has already identified has been an historically vexing issue for the entire health care industry.

You haven't identified the solution, but you have identified that that is a criteria in what you are doing. So I will be curious to see as you drill down what you will discover about that.

Steve.

DR. STEINDEL: Just as a comment on that, putting on several of my other hats, there is a laboratory LOINC meeting October 7. The idea of ordering panels is going to be part of that discussion, and how to make them more generalizable, so they transfer. It was discussed at their May meeting as well, so they are already thinking in this area.

DR. COHN: I think we will be hearing more about this one, and seeing what happens.

MS. WARK: Next on the agenda is the final demographics report. We came to the subcommittee back in May for the preliminary report in this area, and we now have the final report. The work group lead is Bess Franchie at the VA. Beth could not be here today, however Marjorie Greenberg, who was an active work group member, has offered to help me out with any questions that I can't answer or that aren't included in the information sheet.

The standard for demographics will be used to set the requirements for selecting and storing specific patient demographic data, be used for various purposes, primarily that of correcting identifying patients.

Through later research, demographic information can serve as an important component in the identification of health trends within various segments of the population, and can focus on these demographic groups to recognize reactions to specific health care regimens and clinical trials. The collected information can be used to track the elimination of health disparities, a high priority initiative for many government departments and agencies such as the Department of Health and Human Services.

The scope of demographics included patient care, financial billing, legal and regulatory concerns, research and communication. The alternatives considered for demographics were HL-7, SNOMED-CT, ASTM-E 1384, X-12 and MEDRA.

The final recommendation is for Health Level 7, Version 2.4 and higher, with areas of weakness to be addressed. One of the key points of HL-7 is that it complies with the OMB's race and ethnicity standards for reporting.

Referring back to my earlier comment of how the work group went about their analysis, they performed a comprehensive review of the standards and early elimination of any that did not properly meet the immediate demographic requirements for the data elements or concepts identified as patient demographics. The work group developed a check list of data elements needed for proper demographics selection and unique patient identification. The spreadsheet attachment should be with the report.

They used this spreadsheet to evaluate the alternatives, and in the end selected the standard that best meets the overall requirements along with the recommendations for filling the gaps. There are few areas identified in the report where there are conditions and gaps.

We will work with HL-7 to address weaknesses in the following areas. There are four areas noted. One is marital status to address the overlaps, gender to refine the values, insurance status to add that, and living status to refine the values.

It was also recommended by the work group that a separate group maintain a mapping to X-12.

DR. GREENBERG: I think maybe the document that many received might be missing a page here.

DR. STEINDEL: Marjorie, I think it is the way they just copied the spreadsheet.

DR. GREENBERG: No, I realize that. I noticed here that under final recommendations, you go to the next page and there is nothing there about marital status.

MS. WARK: It starts with final recommendation, HL-7, and the compliance with OMB's standards. The next page starts off, the work group performed comprehensive review. You don't have that?

DR. COHN: No, it goes to insurance status.

MS. WARK: There is a page missing.

DR. GREENBERG: There is a page missing?

MS. WARK: There must be a page missing in your packet. What is on that page is what I just indicated about the review of the standards, how the work group went about its analysis. There is also content coverage, which says, see attachment. There is an area on acquisition, that the standards are available from HL-7. HL-7 asserts and retains copyright in all works contributed by members and non-members. Then the conditions; it begins with the conditions, marital status. So I think you must be missing that page.

DR. COHN: Let me just start asking a question here. First of all, I will publicly disclose that I am actually neither a member of X-12 or HL-7, so I hope I can ask this question.

DR. GREENBERG: Even if you were --

DR. COHN: Even if I were, I probably could. I guess I was surprised at the demographic issue. Demographics are one of those fundamental things that ought to be the same most places. Maybe I am being naive on this one.

DR. GREENBERG: I would hope.

DR. COHN: But I guess I'm wondering, since right now X-12 is the standard for administrative and financial transactions for characteristic applications, what is the issue with X-12 versus HL-7 that made it unsuitable for being named as the standard?

That is the question. I am also wondering why the X-12 and HL-7 standard isn't the same, as opposed to having to be mapping.

DR. GREENBERG: I'm shocked to learn they aren't the same.

MS. WARK: Do you want me to respond?

DR. COHN: Yes, please.

MS. WARK: I'll just share a little bit more detail from the report. By the way, the final reports for the standards, once they are adopted, is placed on the E-gov dot gov website. So the full extent of information rationale in work that was performed and information gathered by the work group is made available to the public.

I have personally done an analysis of the demographic variables between the X-12, because of the HIPAA code sets, and HL-7 to determine the extent to which they were different, and the extent to which the mapping issue was critical.

There are many differences between X-12 and HL-7. In X-12, for example, the patient's place of birth and mother's maiden name are not represented nor supported in the standard. The OMB race and ethnicity standards in X-12 are not --

DR. ZUBELDIA: May I interrupt you for a second?

MS. WARK: Sure.

DR. ZUBELDIA: You are looking at the portion 4010 of the HIPAA implementation guides? Or you are looking at the X-12 current standards? I believe you are referring to the implementation guides.

MS. WARK: Yes, I was looking at the HIPAA implementation guides. It is possible, as I understand the way the X-12 standards work, it is possible that they could make some changes.

DR. ZUBELDIA: Because the X-12 standards address the race and ethnicity according to the OMB guidelines, and the X-12 standard also addresses all of these demographics that you are discussing. That is not in the HIPAA implementation guides, but it is in the X-12 standard.

DR. GREENBERG: It is true that the OMB standard is available through the X-12 as an externally maintained code set which is maintained by CDC. I think that is the agreement. It is the same as in HL-7, so it isn't currently available for use in the HIPAA transaction.

Some of the other elements though, it was our understanding, were not available from the others that are actually missing, that were in HL-7.

MS. WARK: A couple of the others were data elements representing educational status or living status. So there were demographic elements that the work group had on their list as requirements by the federal enterprise that at the time they assessed X-12 were not available.

DR. GREENBERG: Another consideration was that the HL-7 messaging standard has already been adopted by CHI. That is, using this basic vocabulary for a demographic in HL-7 seemed to be consistent with that.

So I certainly agree that there needs to be a mapping, and to the extent possible harmonization between the two.

DR. ZUBELDIA: But I think it is comparing apples with oranges, because you are comparing the HL-7 messaging standard with a specific implementation guide of X-12, which is at best about seven years old. So I don't think it is a very good comparison.

DR. GREENBERG: I'm not sure if the person who gathered the information on X-12, I'm not sure if they limited themselves to the implementation guides. But to the extent that some of the elements that were not found in X-12 such as the ones that were mentioned actually are available in the X-12 standard, we need that information. If nothing else, this would certainly facilitate the harmonization process.

I still think a good argument can be made for selecting the HL-7, in light of the fact that for the CHI purposes, HL-7 is the messaging standard that was adopted.

DR. COHN: Steve.

DR. STEINDEL: Perhaps Michelle Williamson who is in the audience can address this question. I think some of the missing elements are addressed in the public health implementation guide for X-12, that adds some of these elements to it.

DR. GREENBERG: That may be correct, the appropriate OMB consistent --

DR. STEINDEL: I think some of the others are as well.

DR. GREENBERG: And the mother's medical record number is available is now available in the standard, and is available in the public health guide. But then again, if our concern is harmonization with HIPAA, we are talking about elements that are not in the HIPAA guide, but they are in the standard.

I could ont agree more with Simon. If you recall, several years ago, maybe it was before HIPAA, but it was certainly before CHI, when I believe you and Chris Schute were looking at just the issue of gender, and found differences in the way they were being collected. So demographics is so basic, that it is essential that these be harmonized across certainly X-12 and HL-7, and probably any other standard that captures demographics.

DR. STEINDEL: Marjorie, my point was that they exist in the public health standard implementation guide. That means we have already identified the elements as they exist in X-12, and it would make the harmonization easier.

DR. GREENBERG: Absolutely.

DR. STEINDEL: I think the primary point of the demographics domain is that the set we should center on right now is HL-7, because we found that that described the clinically needed information the best.

DR. GREENBERG: Right.

DR. STEINDEL: And that others should strive to harmonize with that set, and the harmonization should be easy with X-12, because most of the elements already exist. If we have identified one or two that do not, Michelle who is now sitting at the end of the table is very familiar with adding elements into X-12. So it is not going to be a big problem.

DR. GREENBERG: No, I agree. It may be that a few of these elements which are considered important for clinical purposes, X-12 doesn't have a need for, though I would think that the education status certainly -- because X-12 is a lot more than health.

DR. STEINDEL: X-12 may not define it in the 837, but it does define educational status for other transactions.

DR. GREENBERG: In a different part of the standard.

DR. WILLIAMSON: And it does describe a lot of it in the standard itself, so as Kepa brought up, I think the comparison is something that we really need to look at if we are looking at the specifics of the guide as opposed to the specifics of the standard, in terms of the applications.

DR. ZUBELDIA: It would be trying to compare all of HL-7 with the HL-7 booklet that addresses a specific HIPAA attachment. There is a lot more to HL-7 than that one HIPAA attachment. So you are doing that in the other direction.

I'm not saying that X-12 should be the standard that should be adopted, I'm not saying that by any means. But the comparison of the reasoning why HL-7 versus X-12 is faulty. I think that what Steve is saying is a lot more effective reasoning, since HL-7 is the messaging standard, why not go wit the demographics that are built into HL-7, which makes perfect sense.

MS. WARK: And the work group did state that they selected the standard that best met the needs of the overall requirements, recognizing that the harmonization work between HL-7 and X-12 was an important followup.

I am aware that there have been proposals in both HL-7 and X-12, and there is an effort under way to harmonize between the two.

DR. COHN: Suzie and then Steve.

MS. BEBEE: Just to further what Kepa was saying about the scope of HL-7, it is the same way with X-12. I think the demographic group looked at the 837, but there is more to race and ethnicity than being in the 837. Whether it is a standard, it is also something that Michelle Williamson and Bob Davis of New York and I did to harmonize with eligibility enrollment. There are other transactions where there are demographics, and they don't necessarily harmonized with X-12 as well. So that is something that is ongoing all the time.

DR. COHN: Steve.

DR. STEINDEL: I'm changing hats and putting on my subcommittee hat now.

DR. COHN: Thank you, welcome back.

DR. STEINDEL: I need to ask Kepa if -- the CHI recommendation that has been handed out to the group has a bullet: It is also recommended that a separate group maintain a mapping to X-12. Do you see a need to change that wording any?

DR. ZUBELDIA: I think there is a need to have a mapping to X-12. I think there is also a need to cross pollinate and harmonize the demographics in X-12 with the demographics in HL-7, because otherwise you would end up transferring some clinical information with the set of demographics that cannot be mapped to get administrative information, and cannot then be conveyed in the administrative HIPAA transactions.

DR. STEINDEL: The next bullet of the recommendations: Any other required federal standard that should emerge will require a harmonization between HL-7 and the new required standard.

So I think between those two bullets, they cover what you would like. If you have any suggestions in wording changes, I need to capture them.

DR. ZUBELDIA: I would add this harmonization concept, not just the mapping concept, because there are some unmappable concepts. I was looking at the patient gender, patient six, which shows male-female, other, U for unknown, A for ambiguous, N for not applicable.

Some of these concepts are not mappable to X-12, so when there is not a map, there should be an effort to harmonize between X-12 and HL-7, so the transactions that are sent in the administrative side can reflect the demographics captured in the clinical side.

So I would recommend a separate group maintain a mapping to X-12, and if no mapping is possible, to initiate a harmonization effort.

DR. COHN: Sounds good. Stan.

DR. GRIFFITH: I agree with that. I think in fact this committee or CIAD, one or the other, could actually facilitate that In other words, the two committees are likely to just keep doing the work that is on their plate, unless somebody asks them to harmonize.

So I think this committee could actually make it happen if NCVHS sent a note. I don't know if that should go through the DSMO or how that should happen, but if we could send a note and say, would you please harmonize -- if we could actually give them a list of fields and say, we think you should harmonize this set of data elements so that they have consistent values and consistent representation, then I think it would happen. I think HL-7 and X-12 would get a subcommittee and they would do that.

If we don't say that, then I think they are likely to just keep doing the work. You can have input to one or the other, but as long as the committees aren't meeting together in some way, you always have the potential for them to end up different.

DR. COHN: Steve.

DR. STEINDEL: Effectively, Stan, since this will be a modification that we will make to the recommendation that goes forward to the Secretary to pass on to CHI, and it will contain the wording that Kepa just had about harmonization, we are effectively transmitting that information.

DR. COHN: Marjorie.

DR. GREENBERG: I was just going to say, to the extent that our report here on demographics, I don't think it would change the bottom line of recommending HL-7. But if it is incomplete in our identification of what can be found in X-12, because we didn't peruse the entire standard, and since these reports are going to be posted for public information, right, we should correct that.

I don't know if maybe Kepa can be helpful to us in identifying the elements that we didn't think were in X-12 that are actually X-12 elements.

DR. COHN: I would actually go in a slightly different direction here. I want to try to get to where our recommendations are. I personally don't see any issues with the HL-7 recommendation, but I think what we are doing is, we are actually changing the recommendations in the CHI report or creating some sort of an addendum in our notation.

I am trying to get the recommendations where we are concurring with the demographics, with the following modifications, as modified. Essentially what we are doing is trying to deliver a message to CHI that they need to work with X-12 as well as HL-7 around this harmonization.

It is probably something we need to put on our own list, since we are going to be talking with the DSMOs, either at the end of this year or at the beginning of next year. It is really a question we should ask them about, how are they going to harmonize these demographics. I don't think everything in the world needs to be harmonized between these standards, but there are certain things that ought to be arguably harmonized or mapped, or if not, they ought to be on a case by case basis.

DR. ZUBELDIA: Simon, this brings up another topic, or maybe the same topic. The place where this harmonization among standards is supposed to happen is HISB. I am wondering if CHI should be a member of HISB, and bring these issues to HISB for harmonization.

DR. COHN: I think there is actually -- are there two members already on the HISB?

DR. STEINDEL: There are at least three members in the room.

DR. GREENBERG: NCHS is a member of HISB.

DR. ZUBELDIA: But CHI as CHI.

MS. WARK: CHI has had some discussion about coordination with standard organizations. We haven't completed those discussions, but certainly ANSE HISB has been identified as one of the bodies that we might communicate with to follow up on these recommendations.

DR. STEINDEL: Kepa, specifically the recommendation that we are noting right now, it is also recommended that a separate group -- and we haven't defined what the separate group is, so this would go into CHI. If CHI chooses to approach ANSE HISB, which would probably be a recommendation to go to that group for harmonization.

DR. COHN: Am I hearing a motion for acceptance of this with these modifications? Is somebody moving that? Jeff, did you move that?

MR. BLAIR: Actually, could I propose that Kepa actually make the motion?

DR. ZUBELDIA: I move that we approve these recommendations with the change that Steve noted.

DR. COHN: Jeff, were you going to second that then?

MR. BLAIR: Sure, I'll second it.

DR. COHN: Steve, could you read exactly the modification?

DR. STEINDEL: The modification is to the next to last bullet on page three of the recommendations and now reads, it is also recommended that a separate group maintain a mapping to X-12, and if no mapping is possible, initialize a harmonization effort.

DR. GREENBERG: Initiate harmonization?

DR. STEINDEL: Initiate.

DR. GREENBERG: Let's say a mapping is possible, but when you map, they are not identical. So do you really want to start the harmonization even if you could map?

DR. ZUBELDIA: Even if you could map.

DR. GREENBERG: So I think if no mapping is possible --

DR. ZUBELDIA: And where appropriate, initiate harmonization.

DR. GREENBERG: When appropriate. Sometimes the mapping may be good enough, but other times you might want to try to harmonize, even if you could map.

DR. STEINDEL: So is this the wording that the subcommittee would like? It is also recommended that a separate group maintain a mapping to X-12, and when appropriate initialize a harmonization effort.

DR. GREENBERG: Where appropriate.

DR. COHN: Is it when or where?

DR. STEINDEL: Where.

DR. COHN: And HISB has potentially been described as a separate body or a number of other separate bodies. But I think we will put this on our own list to talk to the DSMOs about when we get together with them.

Any other discussion on this motion?

DR. GREENBERG: I just wanted to share one thing with the committee, just to get some perspective of this committee's long term involvement in these issues, and impact. That is, the work that the committee previously did in identifying core health data elements that they encounter in enrollment did inform the group's checklist of elements that they thought should be captured.

DR. COHN: Great. Shall we vote on this recommendation? All in favor.

(Chorus of Ayes.)

DR. COHN: Any abstentions? Any negatives?

DR. GRIFFITH: I think I have to recuse myself.

DR. COHN: You abstain.

DR. ZUBELDIA: Since I am a member of X-12, I may have to recuse myself, too.

DR. STEINDEL: Do we have a quorum?

DR. GREENBERG: We've got four members.

MR. BLAIR: The quorum is still established. Is this the kind of motion where there is a conflict of interest? I don't really see that this is really injecting a conflict of interest, where either Stan or Kepa would need to recuse themselves from this.

DR. GREENBERG: The recommendation is to adopt HL-7 as a standard. I think Stan has an official -- is a member of HL-7.

MR. BLAIR: I think it is a little different, because I think what it is, as to whether we concur with the CHI recommendations. Is that not correct?

DR. COHN: I think maybe we can handle this one offline.

DR. GREENBERG: I agree that Stan should --

DR. COHN: But I can't see any reason for Kepa to not -- I think we are okay. Motion passed. This is the problem with all of the groups; we are all such experts and involved with things.

DR. GREENBERG: I think you're right, but we have a quorum, even if people have to recuse themselves. We have a majority of those voting.

DR. HOUSTON: The people that recuse themselves would still -- the vote would be of the remaining numbers.

DR. COHN: Thank you very much. We will be spending much of a day with you in October, going through all of this stuff. I would ask if at all possible if we could have enough time where we could actually read through it before, and I know that was the intent this time. Hopefully we are out of hurricane season after this.

MR. BLAIR: Do we have a minute or two for a bio break?

DR. COHN: Should we give everybody a five-minute break for a bio break before we move into our discussions on ICD-10? We will take a break for five minutes.

(Brief recess.)

DR. COHN: Would everyone now please be seated? We are going to get started with our second session. We have on the agenda the discussion about ICD-10, next steps. I think that co-mingles with the discussion about planning for the October hearings.

Let me say generally that we actually have an overall frame of what we think is going to happen in October. It starts on the 28th, with a discussion on CHI which we think is going to take probably somewhere between half and three-quarters of the day.

At the end of the day on the 28th, I think we will be reserving some time at least at this moment for any HIPAA related issues. Now, this is October 28, so HIPAA will have been implemented on October 16, but I think it makes sense to leave a little time for any issues that may need to be coming forward.

On the 29th, we are going to be spending the entire day on ICD-10. Then on the 30th, we will be talking about the PMRI letter and trying to complete that as the main focus of that day. Hopefully everybody is in agreement generally with that way of doing things.

Now, I do have to say that up until this meeting yesterday, I was somewhat optimistic that we would in that day have testimony, and also come to agreement on the letter that we take to the committee in November. I still think it is possible, but I was reminded listening to the reactor panel yesterday that this is something by the end of the day that we need to make sure that we have an open process, and that we do hear from everyone that we need to hear from about these issues. So I think the hope though is that we can do both on the 29th of October, both to hear additional testimony from those who feel that they need to come forward with additional testimony, as well as hopefully come to consensus about what we may want to recommend to the full committee.

I guess I thought that there needed to be a number of things that we need to think about simultaneously. I made some notes from yesterday, but I'm sure there are lots of gaps, and all of us need to think about what will get us completed at a reasonable time.

Certainly one piece is going to be -- I sensed listening to CMS yesterday that we will need to be hearing more from them, and hopefully we will have the cost impact study from their perspective by that time. We may also see a final report from Blue Cross Blue Shield in that framework also. We will have the opportunity I hope to hear from other groups who may either have additional comments on the cost impact study, or have developed their own information.

DR. GREENBERG: I know that Donna has spoken with several groups with whom it was discussed, whether they wanted to be on the reactor panels yesterday. They elected not to be, but they were interested in October. I don't know if you want to identify who those were.

MS. PICKETT: At this point I'd rather wait, because I would want to see if they are still interested or have a different approach.

DR. GREENBERG: Okay. But if there are additional people beyond those we have already been in touch with, who need to be contacted, then we need to know that.

DR. HANDRICH: One thought that occurred to me after hearing some of the speakers on the reactor panel speak to the issue that, out there in the hinterland, people aren't thinking about this at all, or are even particularly aware that this change could happen, and then thinking about the comments that several made regarding the cost impact, and just general need for good planning and resource allocation on the part of states and on the part of state Medicaid programs, made me wonder whether there ought to be some kind of outreach to states and Medicaid programs in general to offer to give them an opportunity to react at that time.

Also, it seemed like it might be a good way to set it up in terms of talking about the rationale for thinking about going forward with a change like this in some kind of a planful manner, so as to avoid unnecessary panic about it.

DR. COHN: Peggy, thank you. I wanted you to articulate that issue. Do you have thoughts about what groups would best be able to do what you describe?

DR. HANDRICH: There is a National Association of State Medicaid Directors, and they would speak to the issue from states' perspective. I think CMS will have a perspective on the federal side. It is my understanding that they have now sent out letters to the state Medicaid programs, asking them to react to this.

The concern I have is that the letters have just recently been sent out, and I am confident that most Medicaid programs systems people do not at this time feel a lot of capacity to give this issue a lot of attention until after October 16.

In terms of reaching out to states in general, in terms of the other responsibilities that they have, and that state legislators must consider whether or not to fund, public health, just the operation of data repositories, corrections, the funding of state employee health plans, would suggest that some other kind of more general outreach to states might be appropriate, too.

I think the committee could talk about what might be the best vehicle for doing that. There is the National Governors Association, as one way to go, and CSL.

DR. GREENBERG: I just wanted to mention that as you know, Donna and I are both going to be out of the country for about ten days prior to this hearing; we appreciate that it has been rescheduled. But we will of course be at the hearing.

But beyond those that have already been contacted, I know that Donna could use some assistance in contacting others, and then staying in touch with them and following up with them, since we will be gone.

DR. COHN: Jeff.

MR. BLAIR: I say this with a little bit of trepidation that I am opening a Pandora's box, but maybe we ought to give some thought to this, anyway. It reflects some preliminary observations of where we are.

If you agree with these thoughts, then maybe we ought to pursue the ICD-9 to ICD-10 migration a little differently. I don't know if we are going to get a whole lot more benefit by hearing testimony from other payors or providers. We may have already pretty much gotten the gist of the message. But I think the gist of the message is that providers generally -- generally, not in all cases, but generally look upon this as something which is going to be a burden on them, an additional transition, and they don't see a great deal of benefit. They may see some, and there may be some entities that may support it, but in general they see --

DR. GREENBERG: To which providers are you referring?

MR. BLAIR: Let me remain ambiguous for right now. I mean hospitals and ambulatory facilities and physicians, okay? Whereas, there is a clear benefit -- I guess the payors in particular are also ambivalent, except that public health sees a real clear benefit, and clinical research might.

So the users of the data see the benefit, but the folks that have to do the coding look upon it as a burden. If that generalization is just going to be reinforced by additional testimony, then I almost wonder whether we might try to see if there is a way to change the paradigm, if we are going to try to see we can move forward. The change in the paradigm means, is there some way for those to see that there is a benefit to help or compensate or facilitate or relieve the burden for those that will be having the burden. Because if we can do that, then maybe we can facilitate the change, rather than just have us go on endlessly with a lack of consensus.

DR. COHN: I know Nellie has a comment, and I think it probably has to do with the fact that her testimony yesterday from the AHA was supportive of this transition.

MR. BLAIR: I understand. That is why I said generally.

PARTICIPANT: That is why I was concerned when you said hospitals. We are part of the group not supporting it, because the AHA has consistently supported ICD-10-CM and PCS, as well as the Federation of American Hospitals.

MR. BLAIR: That's true.

PARTICIPANT: If you are talking about the organizations that would be supplying the data, that includes us, and also AHIMA, who includes the coders who are at our facilities reporting these codes.

MR. BLAIR: No, I do recognize that.

DR. GREENBERG: Nor did we hear that AMA did not support this for the ICD-10-CM or ICD-10-PCS in the inpatient environment. So your comment about providers to me is -- I'm not sure --

DR. GRIFFITH: I would have characterized it quite differently. I would have said that we were reaching consensus on ICD-10-CM. Id isn't hear anybody speak against that.

People talked about the cost, and wanting plenty of time to transition and that sort of thing. But I felt like we were much closer to a consensus there. On the change to ICD-10-PCS, it seemed to me that there were still very divergent views on the value of that.

So one of the things that I found very useful in fact was, in all of the estimating that is going on of costs and benefits and other things, to me it was the most useful to hear from some actual data from the AHA-AHIMA coding study. That was wonderful.

I was wondering, is there any sort of information like that for instance in looking at -- has anybody done any studies to say how fast or how efficient or how reproducible ICD-10-PCS is compared to using CPT or just continuing to use Chapter 3 of ICD-9?

DR. COHN: I think really, we are going to try to keep our focus here. We were really trying to compare it against Volume 3. I believe that there were some small studies done by CMS that they referenced yesterday, that showed for skilled coders, there was not -- that basically the timing was about the same. I may be completely killing the results of that work.

DR. GRIFFITH: This is for PCS?

DR. COHN: You were asking about PCS.

DR. GRIFFITH: Right.

DR. COHN: But I think it was observed by Tom Gustafson yesterday that that was a small study. Obviously there hasn't been anything quite on the level of what the AHA and AHIMA did in terms of real world, looking at procedures I am familiar with. Steve.

DR. STEINDEL: It is actually referred to in the RAND study. There were two studies that were done about five years ago by CMS, that were limited in the number of charts and the number of people. One study showed roughly that it was a wash, and the other study showed that it was a little bit lengthier.

DR. COHN: But that is just one piece of the whole puzzle here.

MR. BLAIR: Maybe what I was really referring to was Clem's concerns, which drove us to the cost-benefit study in the first place. I tend to feel as if I have a high degree of respect for Clem as picking up on a lot of concerns around providers.

DR. COHN: And Jeff, just be aware that I was reviewing our history a little bit, and realized that there was actually a letter from the joint commission, from the state Medicaid directors, and a number of other groups that were asking for cost-benefit information about all this. So this was not just from one of our members, but was from a relatively large part of the industry.

Kepa, and then I have a comment, and Peggy has a comment.

DR. ZUBELDIA: I think that in the discussion, there has been a clear push from the coders and from the AHA to go to ICD-10. There is clear support from the coders, which is a very important part of the constituents.

There is also a set of two very different issues, which is ICD-10-CM and ICD-10-PCS, very different issues. Sometimes when people are talking about the transition from ICD-9 to ICD-10, they are focusing on one issue. Yesterday morning we were all focused on ICD-10-PCS, Volume 3, how we are running out of numbers. That is a very different issue than the diagnosis coding.

There is also the issue of CPT-5 or CPT-4 versus ICD-9 or ICD-10 on the non-institutional procedures. I think that is kind of -- the way I see that has fallen is that people don't want to change the CPT-4 for the non-institutional procedures, and continue that way, and probably just migrate to ICD-10 on the institutional procedures.

So I think that there is a clear -- from one side of the house, which are the ones that are creating the codes and generating the codes and using this terminology to benefit their clinical and medical practice; they clearly want to do it. On the other side, which is the administrative users that are using these codes for reimbursement, the feeling that I get from the reactions from the hearings is that mostly they also want to do it. They are not sure when and how.

But we had testimony yesterday from the payors saying that they don't oppose the transition; they are just concerned about the cost and how to do this. Personally, I am really, really concerned with this concept that was bounced yesterday of everybody switching at the same time, because if everybody is going to switch at the same time, it doesn't make any difference whether it is going to be in three years or in five years. It would only happen one month before the switch, like we see in HIPAA. You can postpone it as long as you want; people will just sit on it until one month before the switch, and then it won't work. It won't work if everybody switches at the same time.

I think there has to be a transition period. Nobody likes very long transition periods, but there has to be a transition period where there is the mapping, and you have the assurance that either the payors are going to switch first or the providers are going to switch first, but there has to be a planned staged transition.

That is the biggest concern that I have. At this point, based on the hearings that we have had, even for the insurance companies, the testimony was that they are very concerned with the cost. I think that the biggest concern is how is the transition going to happen. There is this part of the users of the code that are passive users that we haven't heard from, which is the employers. The employers' benefit plans are contingent upon these codes, and that can trigger a cascading effect for the entire payment process. That typically can only be adjusted once per year, maybe in one or two year cycles. So that is a slow cycle, and nobody wants to go such a slow transition.

So the biggest concern that I have is how is this going to be transitioned. I think it is going to happen. The concern is not whether it is going to happen sooner rather than later; I think it is going to happen relatively soon if there is a realistic transition method.

DR. COHN: Well, maybe I can reframe some of what you are saying, because I agree with much of it, though I think you are jumping to the ways to ease the transition, potentially.

One of the things that I am wondering about, I actually sit somewhere between Stan and Jeff in terms of feelings about this. We have heard a lot. There is certainly a strong feeling that there is a need for more information in codes. There is no question about that. Exactly how we are going to do this to me is a real unknown at this point.

I am wondering if maybe one of the questions we need to begin to ask people, in addition to their views on cost benefits and impacts and all of this stuff, if we were to move forward as a country, your question of how could we mitigate or minimize any negative consequences of all of this stuff, and then as a piece of that, when, and the transition discussion becomes part of that.

If we just keep hearing from everybody about costs and benefits, it doesn't move the discussion forward very well. I'm not saying that we are necessarily -- I don't know what we are going to recommend at this point, but I do think some of that information begins to help with, now that we are getting some feel for costs and benefits, what are the ways to increase benefits while decreasing costs by doing something different. I don't have the answer to that one.

Peggy, I'm just bringing that up as maybe one of the things we need to ask them for October.

DR. HANDRICH: One other area of ambiguity is the regulatory framework in which this would be rolled out. We are talking about rulemaking and all of the formal input that goes into that, which would certainly include opportunity for everyone to ask questions and get answers.

It seems like one of the things that the -- if a public hearing were to go forward, that might be helpful would be for someone to articulate the regulatory hoop that would need to be gone through in order for this to happen for two reasons, because it would be educational for everyone to have a common understanding about that, and secondly, I think were that to be done, it would create a longer time frame than some might be thinking we are talking about before this would be implemented.

DR. COHN: So a realistic view of the how and when and some of the regulatory --

DR. HANDRICH: Yes. I am really thinking about some of the states, the budget situations that they face. They feel that HIPAA was done to them, and they feel no direct benefit of it. They are very worried about operating their state budgets. I think it would be fair to say that most legislators at a state level, if they were faced with a choice of some highfalutin new system or paying for services, will not be immediately attracted to the benefits that have been identified of a new coding system.

They are going to need some time to listen to the arguments and to hear about the values and so forth. So I am actually wondering whether inviting people to come to a hearing without some other kind of way to begin to talk with states and state Medicaid programs about this issue really might be a good idea. In fact, to say, people are thinking about moving forward with this, we know you don't know about it, we would like you to come in and give us testimony, and then we'll talk as we begin to start the rulemaking process, isn't always the best way to go.

DR. COHN: Well, Peggy, I agree. I'm trying to think what to do with it, but I agree.

DR. GREENBERG: As I understand it, the rulemaking process is a HIPAA rulemaking process, where there is a notice of proposed rulemaking, comments. It would be the same.

DR. COHN: I think Peggy is probably talking about bringing some reality, based on what we were told at the beginning of HIPAA versus what really happened. I think a realistic view of what the time frame might look like and the various steps.

Maybe I'm off on this. Probably every rule has a different time frame.

MR. BURKE: Based on my regulatory experience, I can see this rollout taking a substantial amount of time. In my dealings with the parties involved in negotiating the rule, I would believe that a large portion of the adoption of the ICD-10 would have to include a very comprehensive impact analysis that would include the experiences of 10/16.

MR. BLAIR: Of what?

MR. BURKE: Of October 16. I think it would be worth consideration as part of that impact analysis to get some testimony of what in fact actually happened and the effects of that, because the next round of standards adopted, particularly something as big as this, people are going to want to have some extensive information.

DR. COHN: Kepa.

DR. ZUBELDIA: Reading this, listening, our hearts are beating, our brains are mostly working. However, HIPAA doesn't require us to do that. What I am thinking is, if there is a push from the industry to move to ICD-10, why does HIPAA require to have to move to ICD-10?

The law provides a mechanism for the adoption of a new standard under HIPAA that requires some sort of cost benefit analysis, and requires a trial period where the new standard is tested, and if it is effective, then the Secretary adopts it as a new standard. Why can't this be done exactly the same way?

Let's say for instance that the hospitals decide to use ICD-10 for coding. They could start using ICD-10 and map for the administrative transactions to ICD-9, since that is a many to one mapping that seems to be working. They could use ICD-9 for the administrative transactions, and then there could be payors that want to participate in this pilot study of ICD-10 that accept ICD-10. Once that is proven to work, the Secretary when ICD-10 is adopted would require all payors to accept ICD-10. It could be a semi-voluntary migration plan until it gets to a point that in effect, the migration is mandated by HIPAA.

The same thing is happening with the ABC codes. There is voluntary use of ABC codes if they use to use for alternative medicine. There could be voluntary use of ICD-10 up to a point that the Secretary determines that yes, this is the new standard, and everybody is required to accept the new standard.

DR. COHN: So that is one perspective on the how.

MR. BURKE: From experience, any time that the federal government requires the use of a standard, either voluntary or mandatory, it has some procedural implications as far as the APA- PRA processes. That in and of itself would take an extensive amount of time to facilitate for even the voluntary use of the standard at this point.

When the standards were adopted, OMB made a ruling that the standards needed to be adopted under the APA and the PRA, which gives them two bites at the apple.

DR. COHN: I think that we are not talking about a new regulation. This is actually part of the HIPAA legislation and regulation, that the Secretary can grant waivers to various entities for trial use of new standards.

I'm not saying that we should do this, but I am saying that it is an intriguing idea. Similarly, I think the Secretary is intending to do large-scale demonstration projects, I would imagine.

MR. BURKE: I would argue that the bulk of those are covered under procedural requirements.

DR. ZUBELDIA: Today for instance, there are some private clinical terminologies that are being used by health care providers, and you use your vendor's terminology. In adopting the SNOMED-CT, they're going to do a mapping to a reference terminology. We could say the ICD-9 is the reference terminology for diagnosis for the interchange of information. That doesn't prevent the hospital from using ICD-10 internally, and use the mapping to ICD-9 for interchange, except that if the payor is capable of receiving ICD-10, they can send ICD-10 to that payor. As that grows, that demonstration period would show the effect and they would have time to see what the impact is on the industry before the standard is adopted.

I think that is the process that HIPAA initially requires for the adoption of a new standard.

MR. BURKE: Right. And a demonstration probably would be a viable way to go, and there probably are ways to structure that.

DR. COHN: Yes. I'm not saying we should do it, but it is an intriguing thought, as well as hearing from some others about their ideas. This gets back to that how and when, and the how issue, how to make a new transition in an industry where everything is hard coded and wired in. Some people question the cost-benefit studies that have been done. It is certainly an interesting issue.

DR. ZUBELDIA: I'd like to know if this is a HIPAA requirement for introduction of a new standard or not.

DR. COHN: No, this is not a HIPAA requirement. As a reader of the legislation and regulations, there is nothing that requires a standard to go through a demonstration period.

DR. ZUBELDIA: There is a process.

DR. COHN: I think there is a process to enable that, if people want to try a standard out as part of the demonstration of value. So I don't think there is anything that precludes that, except we would have to think about whether --

PARTICIPANT: Is there a statue?

MR. BLAIR: I'll look it up.

DR. COHN: Yes, look it up.

MR. BLAIR: One of the benefits of Kepa's proposal is that the AHA-AHIMA study was only able to show us the feasibility within a short period of time, so we interpret that there are going to be benefits if we were able to lengthen the time frame. With Kepa's proposal, where we wind up having some pilot examples out there, we could see if the cost drops after a year, 18 months, two years, and how much it drops. That may be very compelling for voluntary acceptance of ICD-10 in the industry.

DR. COHN: Steve.

DR. STEINDEL: Kepa, from what I'm hearing, when you constantly talked about this pilot study, you were referencing 10-CM. Do you consider including 10-PCS in this?

DR. ZUBELDIA: Yes.

DR. GREENBERG: Before the subcommittee embraces this, --

DR. COHN: Nobody is embracing anything. We are brainstorming.

DR. GREENBERG: I think it is unlikely that either -- I can't speak for CMS. Certainly NCHS, which is responsible for 10-CM, could not endorse such an approach, I don't think. I don't think this -- you are looking at a new coding system such as ABC, when there really aren't codes to collect it. But we are talking about a replacement for an existing coding system or existing coding systems that have been mandated. It is not just a question of hospitals being able to use it for their own internal purposes.

I think the point is that hospitals and CMS and others want to be able to use these -- do not want to continue using these outdated and inadequate coding systems. They want to be able to use replacements for those inadequate and outdated coding systems in all of their systems, not just for public health, as Jeff seemed to suggest, or for internal hospital operations as Kepa is suggesting. This is for the basic purposes for which these coding systems are used. This is quite different than just trying to see if some additional coding system might be useful.

They want to replace the existing coding systems that they do not feel are meeting their needs. You can't do that. You can't recalibrate the DRGs, you can't do any of that with a voluntary system that some people might use and some people might not. I just think we are not talking about --

DR. COHN: Marjorie, we are brainstorming at this point. I would reflect that at least CMS had said yesterday that they did not intend to recalibrate the DRGs for a couple of years.

DR. GREENBERG: They can do the DRGs immediately. They wouldn't necessarily recalibrate the --

DR. COHN: Which is the key issue.

PARTICIPANT: They would have to do some research first. it is not like you are trying to switch and it happens.

DR. COHN: That's right.

DR. GREENBERG: But you need a lot of data to do it.

DR. COHN: Jeff, I'll let you comment first, before I try to move this in a particular direction. Go ahead.

MR. BLAIR: I guess I was seeing Kepa's proposal as a transition vehicle, and one where we gain the support of the industry overall to make the change, because of the experience that we have had with HIPAA implementation, where even though we generally have the feeling that it is going to benefit the industry as a whole, the fact that it was done with mandates left a bad taste in a lot of peoples' mouths.

So Marjorie, I don't think that is the end of it, the use internally in hospitals. I think that is just the beginning of it. It is just a vehicle of transition, where it gained support and builds consensus.

DR. COHN: I think Nellie has a comment, and then I want to frame this in a particular way.

PARTICIPANT: Thank you. I am actually very concerned about Kepa's proposal for a pilot study, to do it internally.

Two things. Number one, hospitals would be incurring double costs, because they would be doing ICD-10 internally and not gaining the benefits of being able to submit the updated information. So that in time, once CMS can collect the data over two, three, four years, however long it takes, but you have the new codes to collect the data, and at some point would calibrate the DRGs.

So that is just hospital support for migration to ICD-10. They are not going to be able to do it when you are imposing a voluntary effort without the benefits associated with it, and then actually doing double work. Yet, the opposition is from the payors. If it is an internal pilot study for the hospitals, the payors won't be able to see how it works or how it impacts them, because it would be an internal process where only hospitals would have these new codes, and the side of the industry that is objecting to ICD-10 won't see how this impacts or how it works and how it would transition.

So I fail to see where the benefit in a pilot study like this would be, other than to say, hospitals want it, go ahead and do it, but this is your own little private study and nobody else gets to see it.

DR. COHN: Let me reframe this a bit. Nellie, thank you for your comment. I'm sure that if we were to hear somebody come and describe the regulatory process to us, we would hear that of course there is going to be an NPRM developed, and then a 60 days response process, and then the government has to deal internally with these comments, and then there would likely be, realistically I think, a two-year implementation, would be probably the expected response.

Now, contrast that with what we saw with HIPAA, which I think that legislation was passed in '96. It took to '98 to get the administrative and financial NPRM out, and 2000 was the final rule, and October 16 is when it gets finally implemented. So that is like a five or six year process.

The question I think I have, which is along the lines of how and all of those things, how to make things reasonable, is whether or not these sorts of evaluations and standards allowances and all of this stuff might play a role for the early adopters, to allow them to begin to get experience, begin to get payors and providers and all of that, while everybody is waiting on whatever sort of orderly process might occur.

So rather than framing this as a delay that would cause everything to take much longer, the question is, might there be groups that actually could start earlier, begin to learn the learnings around all of this. I don't think it is just providers that are interested, I think some payors could potentially be interested in those learnings, and that might actually help with the transition, but not lengthening the transition, but maybe getting the learnings earlier.

So I am reframing it a little bit, but I don't know -- that doesn't completely solve your issue, but maybe as a slightly different take on all of it. Rather than us going through the HIPAA process, which as I said has historically not been real quick, it might actually provide us learnings earlier in the otherwise orderly HIPAA process. Just a thought.

Steve.

DR. STEINDEL: Simon, I thank you for your thoughts, because it crystallizes some of what I was hearing a little bit. What I heard from Peggy was a very clear enunciation that there needs to be more public discussion involving more people about this.

In a way, Kepa was saying that we need some demonstration projects out there to provide evidence with regard to this in a more complete manner than we have today with the limited pilot studies that are going on.

The problem with going into the rulemaking process is, once we start the rulemaking process, the government is frozen. It can't really talk about it publicly. it has difficulty. I know John is probably saying there are ways we can go around it, but generally speaking, once we issue an NPRM and we go into the comment period and we get the comments, we have to go through a formal evaluation of the comments. Until we decide that we need to issue the final rule or decide we can't issue the final rule and go public again, there is a period of time when the government is not able to gather evidence.

If we go the route that we are discussing today, where we say this is the way -- we want to transition to this, but it is going to take some time and we need some more evidence, and we need some more hearings, we need some more public information before we can go to the government and say, start the rulemaking process. It at least allows us to carry on the dialogue for awhile.

MR. BURKE: Right. Steve, I agree with you 100 percent. I think the rulemaking process like you said will stop us in our tracks. What I was alluding to earlier is what Kepa was saying. It would be prudent for us to do a demonstration and take care of some of the industry's concerns, to make it worthwhile for them to try this out.

At the same time, that would help solidify the impact analysis, so that when the rulemaking process does come along, that the transition will be a lot smoother and a lot quicker.

DR. GREENBERG: I really need some guidance from the subcommittee now. We had heard that what was needed was a cost impact analysis. We at expense to NCHS and the Department have conducted a cost impact analysis. We have been asked to extend that contract so that they can take into account testimony that they received yesterday and that we hear in October; this will be an additional expense.

If having this cost-benefit analysis completed is really not a factor for you, or you feel like now you want to introduce other factors or whatever, I do not want to ask Grant to spend additional time, and I don't want to spend additional funds on this cost-benefit analysis.

Everything was, let's hold it up until we get this cost-benefit analysis. We have done that. We delayed by a year and a half a preliminary recommendation that the subcommittee was prepared to make, to go ahead with the notice of proposed rulemaking, because as was pointed out by Peggy, the rulemaking process does allow everybody to come out and give their comments. furthermore, you could ask in an NPRM for people to comment on various transitions options. In fact, this discussion has been instructive on that. I think you could, as has been done in other NRPMs, say this is the transition that the Department is planning on, but we would welcome recommendations on other transition approaches, or even other transition approaches could be postulated, and then get comments on those.

But that was held up, the decision to recommend going ahead with the rulemaking process, until you got the cost-benefit analysis.

We are now in the process of trying to finalize this cost-benefit analysis. But if it is no longer an important factor, or you feel like yet some totally different process, or much more extended, or six more months of hearings, or 14 demonstration projects or whatever -- and I am sorry if I am showing a bit of peeve about this, but since I commit staff time and resources to these activities, I want to know which hoop you want us to jump through, and I want you to make a decision on that, because I am not going to ask staff and commit funds to jumping through a bunch of other hoops, that then are not the hoops that you want them to jump through.

DR. ZUBELDIA: Can I make a comment? Marjorie, I don't think that the adoption of ICD-10 as a standard would be mutually exclusive with the proposal that I made. In a best-case scenario for the adoption of ICD-10 as a standard under HIPAA and its implementation, going through the regular process at the lightening speed that things move would take probably two to three years. You would have to modify the implementation guides, you would have to go through an NPRM and a final rule.

I think that process should start right away, because it is going to take two to three years. What I am saying is, between now and the time that the two to three years lapse, there is the possibility that we could have immediate benefit of the ICD-10 for the hospitals, because I don't see why they would not use it for their needs, immediate benefit for those hospitals and for whatever payors want to participate, and hopefully all the payors want to participate in a pilot project that would let them take the benefit of that transition right away, and know that it will be mandated in two or three years.

I don't see them as mutually exclusive. I see it as a facilitating process.

DR. GREENBERG: It is a different scenario than you were painting before.

DR. ZUBELDIA: I wasn't painting that scenario before.

DR. GREENBERG: I really do need to know whether we should commit more resources to completing this cost-benefit analysis or how you want to proceed.

DR. HUNGATE: My question I think is germane. I am a little worried that it is based on ignorance, so I am going to charge in anyhow.

There are people who want to do it and there are people who don't want to do it, fundamentally. I can't tell how much we make the cost of doing it rise by indecision up front. The reason I can't is that I don't know how much of the work will be done by vendors who supply information equipment to institutions. I don't know how much will be done by institutions themselves. I don't know the incidence of the cost. So I don't know how much we could speed implementation by clear decision making that lets software development take place with a known market prospect, which would then help the cost structure.

DR. COHN: And just realize that our decision is only an early step in the process.

DR. HUNGATE: Oh, I understand.

DR. COHN: So just be aware that we at the end of the day are not deciding whether ICD-10 gets implemented; we are basically just trying to recommend to the Secretary whether an NPRM should be adopted.

We are beginning to run out of time here. Jeff and then Maria, and then I want to wrap up so that people get lunch before we start again at 1 o'clock.

MR. BLAIR: Marjorie was asking for our opinion on this. My feeling is that we probably reap at least 90 percent of the benefit of what the RAND Corporation cost-benefit analysis could provide to us now. And addition extensions of this I think are diminishing returns.

I would candidly indicate that I had hoped that the benefit analysis would have yielded a clear definitive compelling judgment in terms of the benefits clearly outweighing the costs. Instead, what came through in the RAND report is a modest and soft benefit. It is there, but it is not beyond the challenge of those that oppose it in the industry.

So the ability for us to make a decision to go forward based on the study doesn't give us a whole lot of strength and support. It is one that we could refer to, but not without a lot of challenge in the future. Given what we have gone through with the HIPAA process, my thought was -- which is why I made the suggestions that I made -- is there some other way for us to think of this in terms of enabling and facilitating and transitioning, rather than just the standard way of going forward, which is, we make a decision, it is a PRM, and it is a mandate.

So I thought that we could still -- Kepa's suggestion doesn't preclude us going forward with an NPRM and a mandate, but it gives us the ability to start to build industry support and consensus, so that we don't wind up in the same situation that we are winding up right now with October 16, where a good portion of the industry is frankly not cooperating with the transition.

So my thought is that whatever it takes to close the RAND recommendations at this point I think would be fine. I think it has been helpful, it has been useful, but I don't think that extending it with more studies -- and one of the things that Martin wound up saying is that if we want to really get answers to a lot of the other benefit issues, or if we want to quantify the value of quality of care or patient safety or other issues, it would be a much bigger study. I don't think it is necessary for us to spend lots and lots of money and lots and lots of time for a much bigger study.

DR. GREENBERG: We don't have any intention of doing that. Our only intention was to -- frankly, we haven't gotten comments from anyone on the subcommittee on the report. I really haven't had it that long. You got an earlier version two or three weeks ago, and we did not receive any comments from any subcommittee members. We did get some comments from the staff, and those were for the most part accommodated, although I didn't have time to accommodate all of them. Then you got the version which you received last week.

If you feel the study is of any value at all, we need to bring it to closure, which means we need to get your comments. We need to ask RAND to respond to the extent that they can without doing a massive new study, to some of the comments they heard yesterday about things that they may have left out or that they may not have accounted for, and we were prepared to have them do that with what we hear in October as well. That would be the end of it.

MR. BLAIR: I could say that it has been of value, but part of its value was that the benefits were modest, not significant, not major. And because they were modest, I think we have to do more than just go forward in order to make this successful, which is why I thought by supplementing going forward with Kepa's suggestion, where we build consensus, that that would be helpful.

DR. ZUBELDIA: I think the industry would probably be better informed, at least those that want to participate in an ICD-10 pilot, would be better informed and would have a better feedback in the NPRM phase.

I agree with Bob. There are some that want it, some that don't want it, and the majority don't even know what we are talking about. This will at least give an opportunity to be better informed.

DR. COHN: Let me try to put this together, and it is not going to be very easy.

I am reminded about why we asked for the cost-benefit study, because these are the sorts of conversations, not quite at the same level, but the same amount of diversity within the subcommittee that we were having when we were trying to draft the letter to the Secretary. It is what caused us to ask for more information.

I do hear some interesting thinking. I think some of it is a little bit out of the box, and I don't think there is anything necessarily wrong with that. I do think this is one of those occasions where we really do need comment, and this is why we are holding the hearings in October. We need to hear a little more from the industry.

We all read the cost impact study differently. As I commented yesterday, I am not an economist, and I certainly don't play one on TV or in front of this subcommittee. But to me, the wide variation in the benefits had a lot to do with the fact that code sets are enablers, but in and of themselves don't transform health care or any other industry. It is like IT systems.

So one of the questions I had in the analysis was, is the business really willing to come forward and reap the benefits of this enabler. I think I personally still feel like I need to hear more about whether industry is really willing to come forward.

I am interested in CMS, after they finish their cost impact study, coming back to us and talking more about the business case that they see, recognizing that they are major players in health care. It is in all of our interests to make sure that the Medicare fund lives a long and very happy life as a solvent fund. We will all at one day in our lives experience being under Medicare, if we aren't already. And I do have a couple of years I do have to publicly disclose.

DR. GREENBERG: I've aged a few years just this morning.

DR. COHN: Exactly. I do think that one of the questions we need to be grappling with and we need to hear from them though is this issue of how and when. I think we heard the transition discussion as both something that holds off moving to an NPRM and a final rule, or something that is part of that and early learnings and figuring out how in the heck we are going to do this transition in a way that is hopefully maybe smarter than what we did with HIPAA, because we realized that didn't have that opportunity very well in HIPAA.

But we need to ask the industry once again about their views about how all this may play out, or they may even have better ideas than all us experts around the table. So we really do need to ask them for their thoughts, and I think that is going to be an important thing that we begin to hear from them in October.

I am also going to suggest, recognizing that we have not reached consensus, we are not anywhere near consensus, but I did want to dust off the old letters that we have. I think they may be somewhat dated, but I know Maria can write well with two days' notice; I think it might be helpful for us to at least review copies of the letters previously to see where we were, so that we can build on it, as well as see what wasn't right. That might be a helpful thing for us to come into October about.

Now, I agree with Peggy that we need to get the states and state Medicaid in on this one. I guess my own concern -- and once again, this is something we need to talk about in October when we get together as we begin to reflect on everything -- I don't think at this point we can start a round the country bandwagon of explaining what ICD-10-CM and PCS is for the first time. I think even if we did that, at the end of the day we are just the NCVHS, we are not CMS or the end of a federal regulatory process.

Our experience here has been that we have obviously heightened the industry, knowledge, interests, concerns, everything else in this process. When we started out, no one had an idea of the costs. The benefits were somewhat vague for many. Now people are being forced to come to a slightly clearer view of what all these are about. So we moved the industry forward, but the industry gets really engaged when there is an NPRM. That causes everybody to get really interested.

So it may be at the end of the day, if the government goes that far, that will engage parts of the industry that haven't been engaged up to now. But I think we need to begin to get state Medicaid and the states involved and have the discussion. Maybe there are ways for Donna or Maria to have conversations with them, to answer some of their background questions, so they don't walk in here going, I have never heard of this before.

DR. GREENBERG: We do have that background document.

DR. COHN: The background document is more of a chronology of our efforts internally within the NCVHS.

DR. GREENBERG: It is a chronology of the development of why there was a need for a new -- the development of the coding systems, the history.

DR. COHN: It was the one that was sent out and all of that.

MS. PICKETT: The time line actually includes both the development of the respective classifications as well as the history of discussions within the National Committee relative to transitioning to newer code sets. So it includes both.

DR. GREENBERG: Is the subcommittee going to identify the questions they want the testifiers to address in October? I think up to now, probably what we have been telling them is, either react to the impact study or to present their own study. If there are additional questions or issues you want them to react to, then those need to be identified very quickly.

DR. COHN: And I brought up an additional question. I think you all heard that additional set of questions about the how, when, ways to mitigate any sort of transitions and all of that. So that was another question that was articulated.

MS. PICKETT: Actually, last year in the testimonies relative to ICD-10-PCS and 10-CM, we did have very specific questions related to issues related to transition, preparation, et cetera. So we do have a battery of questions that were posed to testifiers last year.

We certainly can add the additional questions, Dr. Cohn, that you have raised today, but we did have a list of questions, and those things were addressed as part of the testimony from last year. Those were addressed by all of those who had responded, including Blue Cross Blue Shield, the AMA and others.

DR. COHN: Peggy and John.

DR. HANDRICH: There is a meeting of the National Association of State Medicaid Directors in October here in Washington. It is in the first part of October. I don't know the exact dates, but it is soon. Perhaps CMS could come to that meeting and just give background on this issue and what is being done, the reason why those letters were sent out, and just a view of the thinking right now of state Medicaid directors, and invite them to decide how they would like to organize to participate in this decision making process.

DR. COHN: Great.

MR. BURKE: In addition, maybe we could in October have somebody from CMS or the Department come in and give their thoughts on what the rulemaking process would entail.

DR. COHN: The realistic view of the world. I hope that shouldn't take a long time, and maybe even have Tom discuss that when he comes back, a realistic view of what this would all take from beginning to end. Or I'm sure Marjorie would have a comment from the CMS side also. The time frames and all of that. We all know the process.

DR. HANDRICH: I think the discussion today about the kind of options before the Department are very informative, to just lay all that out, that changing a standard doesn't necessarily require a change in rules, but precedent would suggest this or that or whatever. Just a general framework on the regulatory approach that is often taken would be very good for people to hear.

DR. COHN: Other questions that we want to have people talk about in October? Are we missing something major? We do need to stop, because we do need to eat lunch.

DR. ZUBELDIA: There is a small minor issue. We need to make sure that the next version of the HIPAA implementation guides supports ICD-10.

DR. GREENBERG: Michelle, do you want to respond to that?

DR. ZUBELDIA: Otherwise we are on for another big loop.

PARTICIPANT: We have already submitted a business case, and had approval with X-12 and ICD-10 as an external code source, and PCS and CM. So we are basically waiting on the decision of the committee that we have a business case to take to them to add them to the implementation guide.

DR. ZUBELDIA: Those implementation guides are going to be published at the end of this X-12 meeting next week, so we need to make sure that they include ICD-10 just in case. Otherwise we are on for another two-year cycle.

PARTICIPANT: We can discuss that next week at X-12 to see if they will allow us to move forward.

DR. COHN: John, a final comment.

MR. BURKE: I just wanted to shift gears here for a second, since we are concluding, about this issue of whether we are going to do security related testimony at the October meeting.

DR. COHN: We were going to do it in December, I thought.

MR. BURKE: We moved it to December?

DR. COHN: Yes. We talked about that with Maria.

MR. BURKE: Thank you for reminding me.

DR. COHN: I think we need to adjourn so that we can grab something quickly to eat and get back down here in 20 minutes. Thank you all.

(Whereupon, the meeting was adjourned at 12:30 p.m.)