[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 505A
200 Independence Avenue, S.W.
Washington, DC 20201
Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda Dr. Lumpkin
DR. LUMPKIN: Well weve had a lot of dramatic changes since the last time weve had our meeting. Hes back in California, Ill be back, see you know its like the Terminator jokes just arent any fun anymore, now hes Governor. Also of note Proposition 54 was defeated, so congratulations to you in California who engaged in that, well, it really as quite amazing, the polls in a period of about two or three weeks completely flipped, so that was -
MR. BLAIR: Those of us who are California ignorant -
DR. LUMPKIN: Proposition 54 was the proposition on the California ballot at the same time as the governors election that would prohibit the collection of race and ethnicity data in many officials businesses. While there may have been an out for health care there was some concern that this was a significant slippery slope. There was a large outpouring including in the final days the California Medical Society, a large coalition of groups who just thought now was not the time to pretend like we have a color blind society, which we dont.
So having done that and seeing that we have as, still dont have the internet, were going to just start off with the meeting, were going to start off with introductions. My name is John Lumpkin, Im senior vice president of Robert W. Johnson Foundation and chair of the committee, and why dont we start off with Marjorie.
MS. GREENBERG: Im Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
DR. MAYS: Vickie Mays, University of California, Las Angeles, member of the committee.
MR. HUNGATE: Bob Hungate, Boston Massachusetts, Physician Patient Partnerships for Health, and member of the committee.
MS. BEREK: Judy Berek, liaison to the committee, from the Centers for Medicare and Medicaid Services.
DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, member of the committee.
DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City. I will need to recuse myself on any votes relative to ICD-10-PCS, LOINC or HL7.
MR. LOCALIO: Im Russell Localio, University of Pennsylvania, committee member.
MS. SANCHEZ: Linda Sanchez, Office for Civil Rights.
MS. FRIEDMAN: Maria Friedman, CMS, and staff to the committee.
DR. SONDIK: Ed Sondik, director of the National Center for Health Statistics.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the committee and staff to the Subcommittee on Standards and Security.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, on the committee.
DR. ZUBELDIA: Kepa Zubeldia, Claredi Corporation, member of the committee.
DR. COHN: Simon Cohn, national director for health information policy for Kaiser Permanente, and I actually need to recuse myself if there are issues coming before the committee related to CPT. As you imagine Stan and I have a problem in being on the same subcommittee together since we cant talk about anything.
MR. SCANLON: Im Jim Scanlon from HHS, director of the Office of Science and Data Policy in ASPE and Im the executive staff director for the full committee.
DR. LUMPKIN: Were going to now have the introductions from the audience. I just wanted to say that were going to come back to the issue of conflicts, we already have two, but I just want to take some additional ones just to make sure that we dont have others.
MR. BLAIR: Is the NCVHS able to make a recommendation to turn on the air conditioning?
DR. LUMPKIN: It would take an act of Congress to do that. Richard? Introduction?
DR. HARDING: Good morning, Im Richard Harding, department of neuropsychiatry, University of South Carolina and a member of the committee. Conflicts -
DR. LUMPKIN: Well get to the conflicts later.
MS. CANNON(?): Im Susan Cannon, writer for the committee.
MR. EMORY: Im Jack Emory with the American Medical Association.
MR. ALFANO(?): Bill Alfano, Blue Cross/Blue Shield Association.
DR. FANNING: John Fanning, Department of Health and Human Services.
MS. FYFFE: Kathleen Fyffe, Department of Health and Human Services, lead staff to the NCVHS Privacy Subcommittee.
MR. PEDACORD(?): Doug Pedacord for the Coalition for Health Information Policy.
DR. EDINGER: Stan Edinger, AHRQ.
MS. GOODMAN-LUKE(?): Marilyn Goodman-Luke, AAHP/NHIAA.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the Subcommittee on Standards and Security.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, and staff to the Subcommittee on Standards and Security.
MS. BLUM: Amy Blum, National Center for Health Statistics, CDC.
MS. FISHER: Beth Fisher, National Center for Health Statistics, CDC.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, committee staff.
MS. JONES: Katherine Jones, NCHS, staff to the executive subcommittee.
MS. BERNSTEIN: Amy Bernstein, NCHS.
MS. CLAUS(?): Linda Claus, American Health Information Management Association.
MR. RODEY(?): Dan Rodey, AHIMA.
MS. PROPHET-BOWMAN: Sue Prophet-Bowman, also AHIMA.
MS. LEON-CHISEN: Nellie Leon-Chisen, American Hospital Association.
DR. LUMPKIN: Okay, at this time lets go through conflicts, Simon listed a conflict because of his membership on the CPT committee. Stan, if you could just sort of give us the background of your conflict.
DR. HUFF: In terms of ICD-10-PCS Im an occasional, Im an occasional consultant for 3M that originally produced the PCS as contract. With HL7 Im a former chair or chair of the board of directors and currently a vocabulary technical committee co-chair. And with LOINC Im a co-chair of the LOINC Committee.
DR. LUMPKIN: Did your consultancy with 3M involve PCS?
DR. HUFF: No.
MS. GREENBERG: That confuses me.
DR. HUFF: It said that in the letter that they sent me, they said, I mean those are all three things in the letter that came back to me from -
DR. LUMPKIN: It certainly wouldnt be my task to try to convince you to go against a letter from, even though the logic escapes me. Do we have any other conflicts? I just have a disclosure just because Im still within that timeframe, I was on the board of HL7 for about two months, and then decided it was too conflicting to remain on that but I havent extended a year since Ive left that so its just a matter of disclosure.
MR. BLAIR: This is a disclosure, I have never considered, at least I havent considered this a conflict of interest, but back in 97 when I was with IBM there was a consulting engagement with SNOMED, the College of American Pathologists, but Ive not had any relationships with CAP or SNOMED since that time.
DR. LUMPKIN: I think youre outside the statute of limitations.
MR. BLAIR: I think so, too.
DR. LUMPKIN: These kind of things are not like kids where youre conflicted your whole life since you had them.
Okay, were going to go to the updates from the Department. Jim?
Agenda Item: Update from the Department Mr. Scanlon
MR. SCANLON: Thank you, John, good morning everyone. Well, lets see, I think we met in late September so its only about six weeks ago since we met previously but there are a couple of short reports I want to update you on this morning.
First of all I think I mentioned previously that we have formed within the Department the Council on Application of Health Information Technology. As you can imagine in a department as large and as complex as HHS we often try to get coordination and improve management through councils, and the Council on the Application of Health Information Technology is the most recent of these councils. This was established at the Secretarys request, we have the chair of NCVHS attending the meetings of the council as well so we can promote some cross fertilization as well. But the goal of the council, again this is an internal group, is to coordinate our own HHS activities in investments in health information technology and to ensure a coordinated approach across HHS and in our collaborative HHS work with the industry. All of the agencies in HHS are members and the council is co-chaired by my office, ASPE, and by the head of AHRQ. I might mention that John and I will be heading off this morning for a meeting of the steering group and they will be looking at the suite of CHI standards that have been recommended and kind of where they are and the committee itself, let me say a few words about CHI because I dont think were going to get another report to the full committee on CHI.
Youll remember that after the first set of five standards that were adopted by the Secretary, well, all federal agencies, last March, the CHI Working Group has been busy looking at additional standards in very specific domain areas in health care and the working group has already forwarded within HHS and DOD and VA a set of three additional candidates for standards dealing with an HL7 demographic, message lab tests and units of measurement, and more recently has proposed an additional set of candidate standards, particularly in the area of medications, which is probably the most complicated so far of the CHI standards. I think the Subcommittee on Standards and Security has been briefed on what the thinking was and has given us some reaction to those initial CHI standards. And now were going through the internal process of vetting and assessment of those standards to see which of those could be adopted for use in the federal health care enterprise.
So in addition we had a joint meeting of the HHS Data Council, which kind of focuses on the substantive data and statistics in NHII issues, as well as our CIO Council, in HHS, who are the folks that actually deal with the implementation of information technology and their systems, with the budgeting for information technology with strategic planning for information technology. Again, and the service of the program mission and so on, that was held last Friday and the group was briefed on the suite of CHI standards that is being considered for adoption, they were reacting to it, had a lot of interesting questions, but a pretty favorable reaction from the two groups. So in terms of the internal process of adopting CHI standards were actually moving along pretty well.
The questions on the CAHIT Information Technology Council, or the CHI, before they proceed to some of the other issues. On population based data and race ethnicity data weve actually had a couple of things moving along. Youll recall that HHS is supporting a study at the National Academy of Sciences, this was a Congressionally mandated study, it is looking at the adequacy of race and ethnicity data in Health and Human Services data systems and activities. Its not just focusing on HHS and I think we would be all disappointed if thats all it focused on. A big part of the study is to see what the adequacy is, what the current practices are, what the policies and the barriers are in the private sector, in health plans and health care providers and so on, as well as in the public sector and sort of where we are and what are the needs and where are the gaps and what is the adequacy of these systems. And the full panel is expected to have a deliberative report and a set of recommendations, I think Vickie its probably sometime early in the next year, probably February, March, so on, it will have to go through the full Academy policy review as well.
But we did ask them to hold a workshop on the issues that, the issues in race ethnicity data in the non-public arena, in plans, in health care providers and hospitals and so on. They had a workshop and they have released the results of that workshop, which I think I have now, youve got this at your place as well, there are no recommendations as you know in workshops from the Academy but I think youll see there are actually some interesting issues that arose, including legal issues, potential legal exposure issues that some of the health plans and health care providers belief theyre facing when it comes to collecting race ethnicity data. So I think theres a big job yet of kind of clarifying what the legal situation is, what the current practices are and so on. And theres a discussion of HIPAA as well, but I think its a good start at looking at what are the issues in terms of private sector data collection as well.
In terms of public data collection we actually have a good start on that, weve got a lot of advice, we have policies and plans within HHS, I think in general we would know what we would want to do if we had the resources and in general its largely though not exclusively a resource issue.
So at any rate well be looking forward to the full committee and were referring this in the meantime to the Populations Subcommittee.
I was hoping that I could report to you today that we had a budget for fiscal year 2004 but again Im kind of doing a tap dance as I did, the fiscal year 04 has started of course in October and we, HHS and many other federal agencies are on a continuing resolution, which means that we more or less are authorized to continue our spending at the level of the same period for last year, so were somewhat restricted in what we can do. Were not generally permitted to undertake new activities or new large obligations as you can imagine. And weve just had a, the original continuing resolution was for the month of October and now weve had another one week continuing resolution which will take us through a week from Friday. I guess the hope is then that we would actually have an appropriation.
I will say that were hopeful that the final appropriation for 04 will contain some of the data and NHII initiatives that Ive mentioned to you previously and we have every hope to think that that will be the case. Recall that there were a number of very positive initiatives in HHS 04 budget relating to the information technology and standards and NHII, $3 million dollars in ASPE, my own office, for NHII related activities, Department wide and working with states and communities and the private sector. Another $10 million dollars, this is a Department initiative in standards, this is a $10 million dollar initiative that ASPE and AHRQ put together for standards work, this would be to support some of the standards work. In fact it would relate quite directly to some of the CHI standards that are being considered now, particularly in the medications area.
And then at AHRQ a $50 million dollar research and demonstration program to focus on how improvements in hospital and health care patient safety through health information technology, $50 million dollars there, that would be a research and demo program. And in anticipation of the funding coming later the agency is preparing request for applications, which is the way you normally solicit such proposals and demonstrations.
So again, were all hopeful that we will get a final budget soon and that we can actually move off on these. The Secretary in those demonstrations by the way may give preference to smaller rural hospitals. And again, the focus is not on silo type technology but its on interoperable health information technology. The integration and interoperability and a look at common standards and approaches as well will be emphasized, not on niche type of applications and one of a kind type applications.
Two projects from the Data Council that were making progress on. An issue that has come up I think in the full committee as well as in the federal agencies is geocoding, to what extent do our data systems, our data holdings, include information on geographic level. This could be anything from an address to a zip code to a state or a nation or country, and we actually have some sort of data of this kind in virtually all of our data systems but theres a movement across the federal government under the OMB auspices, a kind of a standardized look at what capabilities we do have in our major data systems and to look at best practices and to try to standardize around, there actually are a number of standards in this area as you can imagine, but there are a number of reasons why we generally dont go below the national level or the regional level, confidentiality is one of them, sample size is another, and of course comparability is another. So were looking at, weve awarded a contract and we are now under the auspices of the Data Council taking a look at our metadirectory of data systems, these are our major workhorse, statistical and epidemiological and research and administration data systems to look at what do we have now in terms of geocodes, what are the best practices and how can we kind of describe that information and move forward.
The second project, were again starting with the HHS electronic gateway to statistics which Ive described previously to you. Were now expanding that and upgrading that to make it more user friendly and to organize the data a big better. Youll recall that we had something like 2500 web pages from HHS agencies that included either the presentation of data or a description of the survey or the data system or policy or web pages that actually allowed you to do your own tabulations or to get access to the data in a secure and confidential manner. Generally its anonymized data. Were now going to be expanding that to updating it and expanding it and providing some better user friendly features as well. I think this is an attempt to pull together at the front end, well, actually at the end back I guess I should say, at the dissemination end, the front end of integration is much harder, data integration, but at the back end where people are looking for data that we have an HHS on the web and we have extensive holdings as you all know, its quite extensive, this is to kind of organize that information and provide more or less a one-stop user friendly place to begin to look at, sort out the kind of data.
For those who are aficionados and know all of the data systems and know exactly what youre looking for we have pretty much direct pathways. But for folks who are coming in and theyre kind of trying, browsing or trying to see what we may have on various topics we have a search engine and categories that actually make that a little easier as well. And thats what well be focusing on in the improvements.
So I will just quickly in terms of recommendations from the full committee, Im looking at the last half a dozen or so, but going back to September, I think the Secretary or the Department have answered most of them, at least replied to most. Theres a set that was developed in September, two of them relating to population based data which Ive seen drafts, not quite ready yet to go to the Secretary but probably in two weeks we should have some responses there. Again, dealing with increasing HHS presence on the federal networking R&D committees, Ive seen a draft there, that needs a little more work, that should be coming to the Secretary soon. So at any rate those last four or so are being, letters are being drafted, I tried to track them down yesterday. One of them relates to the NCVHS concurrence with the last set of CHI standards that were being talked about and the Departments already moving forward on that as well.
So let me stop there and see if there are any questions.
DR. LUMPKIN: Okay. Maria?
Agenda Item: Update from the Department Ms. Friedman
MS. FRIEDMAN: Good morning everyone. Well, the last time we met it was right before the October 16th compliance date, which has come and gone in relative quiet, at least from our perspective. I guess its like that almost everywhere else the best we can tell. To date we have gotten seven complaints. Of those two are privacy, and of the remaining five one filed twice by the same person, so were trying to figure out how to count that.
DR. LUMPKIN: Were they from Chicago? Because then you can count it twice.
MS. FRIEDMAN: In any case, we have a process for people to file complaints, both on the web and by paper. Were committed to not only talking to the people when they file a complaint because we want to make sure that they have complete information, but we get back to them in two weeks to give them a status update of how their complaint is going. And if they file electronically they can check on the website to see where they are, theres a way to, electronic compliance tool that allows people to file their complaint and then check back later. So thats pretty much where we are with compliance.
DR. LUMPKIN: Do those complaints have to be filed in a standardized format? Mike.
DR. FITZMAURICE: It seems like the train wreck that was forecast really hasnt occurred, that people are working through their contingency plans. I know that some people are keeping track of what percentages of claims being filed are compliant with the HIPAA standards and is that moving up along the way. Do you have anything to present to us on the percentage of claims coming in to the Medicare program that are compliant with the HIPAA standards and does that seem to be moving up?
MS. FRIEDMAN: Its moving up when last I checked, we get reporting every two weeks so as of last week it was about 30 percent, its moving up, and I believe that its that way everywhere. People are taking advantage of the contingency plans to work through some of these issues.
DR. FITZMAURICE: And theres been no reports of big cash flow problems to date?
MS. FRIEDMAN: Not that weve heard.
DR. FITZMAURICE: That was a big industry concern.
MS. FRIEDMAN: I think the contingency plans have gone a long way to take care of it.
DR. LUMPKIN: Okay, any other questions? Jeff?
MR. BLAIR: I think maybe Id like to see the NCVHS consider a commendation to HHS because this was a tremendously difficult thing to do and as Michael just referenced there was predictions of train wrecks, it was contentious, it was hard to move one seventh of our domestic economy to accommodating these HIPAA codes and transaction standards and I think the fact that there hasnt been a train wreck we should recognize in some way. Im not saying a full motion or anything but Im just saying that I think thats a real achievement that you were able to manage this tremendously complex difficult task as well as you did.
DR. LUMPKIN: I was all the way up with you Jeff until you said not a full motion. So Im going to accept that -
MR. BLAIR: Oh, you can do it.
DR. LUMPKIN: Im going to accept that as a motion to commend the Department of Health and Human Services for forging ahead and taking a major step in the transformation of one seventh of the economy into an informatics automated environment.
DR. STEINWACHS: Second.
DR. LUMPKIN: Is there any further discussion?
MS. BEREK: Can I make a comment? Since Medicaid is now bigger then Medicare it might, could I just say we say HHS and our partners or something, to recognize that the states in fact played a major role in this? Just put it on the table.
DR. LUMPKIN: How about HHS taking a lead in working with its numerous partners? Okay, all those in favor say aye.
COMMITTEE: Aye.
DR. LUMPKIN: Opposed say nay. Great, well put it up on some stationary and send it up to the Department. If its okay with the body then obviously there may need to be a little bit of wordsmithing once it gets to the paper. Okay, any other questions of CMS? Okay, Linda.
Agenda Item: Update from the Department Ms. Sanchez
MS. SANCHEZ: Hi. Im trying to imagine my work life if we have five complaints, that would be so great, like we ever just had five. At this point weve had a little over 2700 complaints, were averaging about 100 a week, and overall weve resolved and closed approximately 37 percent of those complaints.
The top issues in the complaints have remained fairly steady since the last time I was here. The biggest category would be impermissible uses and disclosures and then the related issues of safeguards and minimum necessary. Access continues to be a big concern with complainants as is notice, the failure to provide notice or an inadequate notice. Were also seeing a number of cases involving authorizations and complaints about policies and procedures.
I was asked the last time I was here about types of covered entities that are subject to complaints and weve actually run some special reports to get that data. Were seeing an incredibly wide range of covered entities being subject of complaints, just anything you can imagine weve gotten complaints about them. The top categories are private medical practices, general hospitals and pharmacies, and this does seem to make some sense as these are the entities that have the most direct contact with individuals. Those three types account for roughly 40 percent of recorded institution types and were still working with our data to get a better sense of what institutions have been subject to complaints.
I want to move on now to talk a little bit about outreach. At this point our joint OCR and CMS call center has handled over 15,000 calls regarding privacy. Over 8,000 calls have been handled by our regional offices and that includes calls referred from the hotline and calls weve gotten directly at the regional offices. Our call level has dropped to about a third of the initial influx, so we started out getting about, in the first week we got over 1300 calls, in the last week we got 380, which is about what weve gotten a month ago. And the most frequent topics handled by the call center at this point are questions regarding how and where to file a complaint, what rights are provided by the rule, and questions about the model authorization form thats available on our website. Weve also gotten lots of questions about what is the website and how to find it.
Since January our frequently asked questions on the web have been accessed over 1.4 million times, pretty popular site, and this week weve added several new questions regarding disclosures to family and to friends, and also some treatment related FAQs.
Im happy to take questions.
DR. STEINWACHS: When you resolve a complaint, could you tell me a little bit about what that process is? The complaint resolution? Are you going back to the provider?
MS. SANCHEZ: Yes. Generally speaking the process for handling a complaint, we receive a complaint, we do an initial assessment to determine whether we even have jurisdiction. If we do have jurisdiction and we feel that theres an issue at hand that we want to look into we will get back to the complainant and well also send a notice letter to the covered entity letting them know that theres a complaint against them, letting them know how to contact HHS and that well be contact them as well. Generally our goal is to work with the covered entity to help them come into voluntary compliance, so that once they are aware of what the problem is they can figure out what they need to do to take appropriate steps.
DR. STEINWACHS: So the ones that are closed, are a fair number of those ones where youve actually gone through this process and providers have come into compliance? I know some are probably because you didnt have jurisdiction.
MS. SANCHEZ: I would say there are, I didnt bring the exact figures, there are some number that were closed through voluntary compliance efforts, I would say a large number at this point are still complaints that were not within our jurisdiction. But yes, we have certainly closed some through voluntary compliance efforts.
DR. STEINWACHS: So its working.
MS. SANCHEZ: Yes, it is working and I mean generally speaking covered entities work with us, we get a variety of responses to their receipt of the initial notice letter but once the shock has worn off normally they are quite willing and eager to work with us to come into compliance.
MR. HOUSTON: A couple of questions. For your calls, do you have some type of metrics or some type of commitment in terms of the responsiveness to when somebody actually calls into the hotline or to OCR, a question?
MS. SANCHEZ: We do, I dont have those standards with me, but we do have metrics.
MS. FRIEDMAN: Yes. Im the project officer on the hotline for both, so we do have metrics in terms of response to the individual and also for the transfers and that kind of thing. What happens after they transfer the calls, I dont know if you have internal metrics on how you handle this.
MS. SANCHEZ: Our internal goals are to get back within a couple days -
MR. HOUSTON: Do you differentiate between a consumer question to the hotline versus one from a covered entity?
MS. SANCHEZ: Not in HHS, Im sorry, not within OCR, I dont know if the joint hotline would, I cant imagine -
MS. FRIEDMAN: What was the question?
MS. SANCHEZ: Whether theres a differentiation between calls from consumers versus covered entities.
MS. FRIEDMAN: No, they all just get sent over. It really depends, I mean the types of calls that OCR get are really more consumer oriented, the types of calls that we get are more provider oriented. The ones that the hotline cant respond.
MR. HOUSTON: And I guess the other question I have is out of the posed calls do you have any metrics as to how many calls frankly there was no complaint, they called and theres a beef, the patient who had the complaint really frankly there was no privacy issue underlying their complaint?
MS. SANCHEZ: Im sorry, youre talking about calls or the complaint -
MR. HOUSTON: I think calls or I think theres, I guess on the complaint side, I guess Im more interested. So of all the complaints that are filed do you keep metrics on frankly how many of them just didnt result in a violation of HIPAA or -
MS. SANCHEZ: Well, of the ones weve closed so far roughly 60 percent were not within our jurisdiction, so that would generally mean that there was no HIPAA violation alleged, or it happened before the, the activity complained about happened before the compliance date. Thats why weve been able to close them so quickly. The open cases generally are ones where we do believe they are within our jurisdiction.
DR. HARDING: Just a point of information for me. I rode up this morning with a human resources Colonel from the Army and he was saying, I mentioned where I was going and he said funny, he was going to the Pentagon and that they were trying to come up with policies about notification of family members for active duty soldiers wounded, that they were having some difficulty with that. I had not thought that HIPAA was involved with active duty but was only with dependents and so forth and that kind of situation. Is that too much of a discussion to get into right now or is there a simple answer for that? Notification of wounded like in Iraq, who to notify, what permission to notify.
MS. SANCHEZ: Im not sure it makes sense for me to get too deeply into this, Im aware of the issue. The medical services provided by the Department of Defense are covered by HIPAA and there are special provisions in the privacy rule regarding the ability of those covered entities to provide information through the command structure to the military operations. Its not clear to me who would be making these reports back regarding wounded. There are provisions in HIPAA for talking to family members.
DR. LUMPKIN: Well, we are now on the internet, I want to welcome all those of you who are listening for our patient as we worked through the technical difficulties of getting back on. Michael?
DR. FITZMAURICE: This has been April through November, so its been a good half of a year and been a lot of outreach, a lot of complaints, a lot of hearing whats been going on, and a lot of resolution. Linda, has this been done without filing the first fine of $100 dollars or have we gotten into the fine business yet?
MS. SANCHEZ: We have not yet assessed any CMPs, no we have not.
DR. FITZMAURICE: Thats an amazing good working with the public.
DR. LUMPKIN: Thats a fine performance.
MR. HOUSTON: Has anything else been referred to DOJ? I know two youd previously indicated, has anything else happened in that regard?
MS. SANCHEZ: There have been cases referred to DOJ, yes.
DR. LUMPKIN: One of the things, and I just wanted to again a note of appreciation to OCR about trying to get the message out, there was a recent series about two or three weeks ago in USA Today about the privacy rule and I think that while the headline was alarming what I saw in the article was the fact that there are providers who are, in that particular article they mentioned a particular ambulance service that was no longer able to go to Mrs. Jones house, and it was in a rural area where they didnt really have good signage, because they thought that was a violation of privacy regulations and there was clarification from the Department that no, no, that was okay. But I think it really described the process of in some cases over reaction by the industry and the role of OCR and Department in clarifying and trying to get the system running in an environment in which we protect privacy but continue to take care of the business of caring for people who are sick and injured. So, well done.
DR. ORTIZ: Eduardo Ortiz from the Agency for Healthcare Research and Quality. Mines just a little bit of follow-up to the question asked earlier because Im still trying to get a sense. Of the complaints that youve actually looked at, and Im kind of, I dont know if you can kind of let go of the jurisdiction because thats sort of difficult for me to understand, but of all the ones that youve kind of looked at Im just trying to see if you can give me a sense in terms of even a guesstimate percentage wise of how many of these complaints are kind of legitimate violations of HIPAA versus how many of them are just misunderstandings that can be resolved through just educating the complainant. Even if youre looking at maybe the ones that maybe they are violations but they occurred before HIPAA, Im just trying to get a sense for what the average is, what the percentages are there.
DR. LUMPKIN: Can I maybe rephrase the question, those complaints on the face of them have merit to continue as a potential violation versus those which on the face of them do not?
DR. ORTIZ: Right, that can be resolved probably just with maybe educating the complainant.
MS. SANCHEZ: I really cant tell you of open cases what percentage are ones where we would be moving forward and how many we wouldnt. Generally wed try, if we get a case where we think theres no merit at all, it doesnt have anything to do with privacy, its a complaint about something thats about disclosing information but its clearly permitted by the rule for instance, we try to close those very quickly. So there would be some number of those within our open caseload but hopefully not too many. I cant really tell you, Im discouraged from guessing in public -
DR. LUMPKIN: And I thought that was a federal rule.
MS. SANCHEZ: As I said about 60 percent of the ones weve closed we felt that were non-jurisdictional meaning they didnt have anything to do with privacy, or the complaint was against an entity that wasnt a covered entity, things like that.
MS. FRIEDMAN: Can I jump in for just a second? As far as the hotline goes they get a lot of calls of people who think they have a privacy violation and one of the things the hotline does is walk people through some of the issues. For example, did it take place before the deadline, before the April 15th date and all of that. So of the calls from the hotline, the ones that get transferred to OCR because people didnt think that, we either needed more information or they really wanted to go on and file a complaint, theres only been a handful of calls that get transferred from the hotline over, so we do a lot of first line defense in helping educate the public as to whos a covered entity, what are some of the issues involved with privacy and all of that and who can weigh in, so we do a lot of that at the front end.
MR. HOUSTON: Just a comment. The statistics sound, I work for a large system and very similar, a lot of people will come in with just a general beef and they throw HIPAA out because they think thats going to get them some additional attention or whatever but there frankly is typically no privacy complaint. Thats why I was interested in finding out because again, I think they use this as a surrogate, HIPAA as a surrogate for getting somebody to listen to them or try to beef up what their issue is.
DR. LUMPKIN: I would like to thank the three of you for the updates and Im going to turn it over to Simon to do the next part and Ill be back in about an hour.
DR. COHN: Well see you at 11:00 or thereafter. Our next discussion is with our director of NCHS, Ed Sondik, obviously Ed were delighted to have you joining us and giving us a view of whats been happening over the last year.
Agenda Item: Presentation by the NCHS Director Dr. Sondik
DR. SONDIK: If you dont mind Ill stand up. Can you all see that? Okay, there are also some handouts, the slides, the handout approximately follows this, Ive added a few slides here and there. Im under strict instructions to be succinct so we have time for discussion so Im going to go through these quickly.
What Id like to talk about today is the progress that weve been making and what the challenges are, talk briefly about each of the major programs that we have. I want to focus a big on one aspect of dissemination that has to do with Health, US and Diane Makuc is here for the, I saw her a minute ago, shes still here, if we want to have any discussion about Health, US. I guess part of the theme in my talking about the programs is really the reengineering that were going through on all of the aspects of the center. I want to talk about the budget briefly and just overall the challenges. I also promised to say something about summary measures of health, qualities, values, expected length of life, so Ive just said it. No, I have a little bit at the end to talk about that, and I also want to talk about the new board of scientific counselors, in essence a committee parallel to this one and talk a bit about the first meeting that was held.
The programs, youre all familiar with the programs so I wont belabor it other then to say that lots of different activities within the Center. You can summarize them by the way I have on this slide as vital statistics, activities related to health status, activities related to the health system. Theres a terrific matrix, which I didnt bring today but I think all of you have seen in the past, that outlines, Id be happy to get you copies, that outlines in much more detail all of the, particularly the data collect efforts in the Center so it includes things like the National Survey on Family Growth, for example, which Im not going to talk about, it includes SLATES(?), the National Immunization Survey and so forth and so on. Im not going to talk on those today but of course I would be happy to cover any or all of those in detail.
Im also not, Im talking more about what Im not going to talk about then what Im going to talk about, but Im not going to go into all of the data that was produced over the year other then to say that there were lots of, documented lots of lows of one sort, lots of highs, we had information on antibiotics and drugs that came out, a very, very wide range of things and one of the most surprising things that happened this year for me I think was the focus on size. We have been collecting information related to obesity as have many of our sister or brother agencies, of course this is, NHANES is critical to this because were actually getting clinical measurements of this, but it seems as if the tipping point came, and Id like to know what caused the tipping point, but it seems as if it came this past year with just the appropriate focus on obesity, so I have this cartoon of the whale looking at the people looking at the whale and saying look at the size of those things, and somebody reading an article that says 65 percent of Americans are overweight. Im not sure thats the right figure but this is poetic license.
So let me talk about vital statistics. Weve actually had a major change in the vital statistics community in the way that community views reengineering. By reengineering I mean really something actually very simple here, going from in some cases systems that are DOS based to a system that is web based. And in some cases it needs to go through Windows based before it actually gets to web based but thats what were aiming for. And from Id say a couple of years ago the thing we were hearing was well, you know, we all want to do this but every state is different and this is very complicated. Were not hearing that anymore, were really hearing that the states feel that theyre very much alike, this was clear at the NAFSIS(?) meeting last May I think it occurred. They really feel that they are very much alike and want to be able to pool the resources and knowledge to do this, so theres a great deal of effort been going on and sort of building a model system, at least on paper, and some states are actually taking off and doing this but the idea is to build something that would be highly compatible, could be implemented in different places by different vendors but the system would be highly compatible, so we really have some momentum here on the design side and in some states its more then that. And as part of this we of course have to look at security and transmission issues, it needs to be compatible with the other activities that are underway but in general Id say the National Health Information Infrastructure and more specifically NEDS and the Public Health Information Network.
Funding is an issue here, were doing okay at this point, weve been able to find some funds to move along on the design phase. In particular we are enormously grateful to the Social Security Administration and having the information from a reengineered system is important to that Administration in a dollars and cents way, major dollars and cents way, to know about events when they occur. And they have been extremely helpful and generous in moving this effort along to this point and were looking for other national partners to continue this.
This is a table, I wont go through all of the elements on it, EBRS is on the birth side, EDRS is on the death side, but it shows the different status of, I showed this actually last April although it didnt say October, it said April, whatever it was, and weve updated it since then. And its actually quite something to see the number of states that are actually working with vendors at this point on this, 23 for birth and 11 for death, and even some that have found money but what theyre waiting for is the model so they can actually implement. So all of this I think is very positive but we still have 36 states, for example, which have not been able to take any action on the death side.
Were currently collecting new data on race and ethnicity and data on education, and actually were expecting this data in 2004 and you can see on these maps more of the states giving us the information on death in 2004 then states giving us information on births but were making good progress.
A very important analytic activity that happened at the Center this year was working on bridged race categories, youre all familiar of course with the new way of collecting race data with multiple choices and possible, so we needed a way to bridge from the current back to the old or from the old to the current, however you want to look at it, and some very, very nice work was done in the Center and we sort of took it on for Census so this is being used by us and Census and its on our website.
Now health care statistics, Ill come to the major challenge in this at the end, but I think you know that we have a family of six different components to the health care statistics or the Health Care Survey, or surveys as we call it, the emergency department and ambulatory care, in Hospital Discharge Survey, long term care, home and hospice, I may have missed something. And all of these are really necessary to give us a picture. We dont have all of them in the field at one point in time by any means but that does not stop us from making improvements in what we do have. In the ambulatory care theres been a focus on emergency departments and pediatric services, were adding a supplement of rural and proprietary hospitals to the NHAMCS, and we actually have a very interesting activity underway, at least I think its going to be interesting when we actually see the results from it, on bioterrorism and as part of the NHAMCS, the National Hospital Ambulatory Medical Care Survey, were asking questions that relate to the preparedness of the hospital to deal with bioterrorism and mass casualties. And on this slide it shows some of the question is here, is does your emergency bioterror response plan specifically address each of the following types of incidence, biochemical, biological, chemical, nuclear radiologic, explosive/incendiary, national disaster, this sort of thing. So Im pleased that were doing this as many of the things we do are a bit removed from bioterrorism. But I think certainly in our health care area we can do it and Im sure theres much more we can do, and this is in the field now in 2004, I mean 2003, Im sorry, and we expect the results in 2004.
In the Hospital Discharge Survey we have new items on admission and type of service, creation of linked files including to the area resource file, and ongoing research to evaluate the collection of drug data. Im really pleased on our redesign of the long term care component. Actually we did this and then we became later on in the activity partners with ASPE in doing this and we hope to be getting this into the field relatively soon.
Part of the activity in this is it says in the bottom bullet ongoing research to develop a typology of long term care facilities. I think Ive mentioned here in the past this activity, not only on the typology but to do an inventory of inventories of long term care facilities, assisted care, but this is really one of the areas where its really critical that we come up to speed on understanding better the long term care situation in the U.S. We just dont have the requisite amount of data to do this.
The principle issue with health care statistics is the maintenance of the complement of health care surveys. We simply dont have the resources to do all of these at one point in time. Were doing three, if we were able to do five I think we would be in better shape, but were doing is were carefully using the resources we do have and judiciously choosing the ones that are in the field.
Let me turn to HIS, the National Health Interview Survey. Theres a slide on the screen that shows children with public health insurance. Im putting this up because it shows, well, it shows one of the measures that we are producing now on a quarterly basis. Were able to produce information on the insured or the uninsured very rapidly. This reflects a real change in the HIS, its a change in how things are done and its also a change I think in the culture of the HIS, but it doesnt reflect, the changes have not impact the rigor of the HIS, I think this is really possible. The emphasis is not on doing everything at once and when its ready then we publish it, but to do things on a more sequenced basis so that we can get the information out very rapidly. And to get information out within six months of the end of the year and then be able to do that on a quarterly basis for a survey this size is really quite an achievement. So Ive given HIS my own commendation, but it really is quite a change.
Along with this has been the reengineering of the program, not the things that you actually see but its the way the program actually does its work and working on database technology and I wont get into all of it, but its been really again quite a change, it sort of goes along with the culture change. Part of it is staff training because were using tools that people havent used before, database tools and that sort of thing, and were also changing the basic program thats used by Census to collect the data, were going from cases to BLAISE, or BLAISE, however its pronounced, its Belgium, B L A I S E, I think it is, and its a very large, its a program thats able to, Simons looking puzzled, youve never heard of it. Its actually used, its a program thats used in the CAPI, Computer Assisted Personal Interviews, and its able to handle much more effectively then certainly the prior program that was used, the very large survey like HIS, and the changes in it and supplements and this sort of thing. And its being used actually quite widely, and we made that decision I think well over a year ago in concert with Census and Census seems very pleased by it, at this point if I can speak for them. So this is also going to help us considerably.
Benefits of all of this are better data quality, timeliness, these early release estimates which we think are very important, and the fact that with these databases that were putting in well have much better analytical capabilities within the program itself. Now what weve had to do in order to do all of this, and one thing I didnt put on this was a challenge here is that we have to redesign the sample, this has nothing to do with the reengineering, its that every, the way the HIS sample is drawn its every ten years we draw a new sample and based on the most recent Census. And then that sample together with supplements over the time keeps us going throughout the year.
Drawing that sample is a costly enterprise, very costly enterprise, and in order to continue work on that, continue work on the reengineering, which I consider absolutely vital, what weve done is weve experimented with some sample size changes. Changes is a euphemism for cuts, and weve cut a few weeks and you can see what weve done here over 2002 and 2003, 2002 we had a total of five weeks, 2003 weve cut another five weeks, and we have a question number of weeks in 2004, which are dependent on the budget in part that Jim talked about that we dont have yet at this point. I think in all likelihood well probably continue to do this.
The question that were doing in this is number one, does it hurt the survey by making these cuts. Well, it certainly doesnt help, theres no question about that in terms of precision. But how much do we say by doing it? And it turns out that this is anything but a simple question because these surveys of 40,000 households, 100,000 people in the field all the time, in so many locations around the country are complex logistically. So if you cut one week you dont cut two percent of the cost by any means. That would sort of be nice if it were true but it doesnt work that way. And theres question of the number of weeks in a row that you can cut and of course if you do too many of that then we get concerned about the nature of the sample because HIS is a representative sample of the U.S. every week, thats how we can cut weeks is we, in a way that was sort of designed in from the word go.
So I want you to be aware that we are experimenting with in effect the fiscal impact of these sample size changes as well as the change impact on quality.
Weve also done things like canceling the interviewer, retraining for January 2003, which probably is not the best idea and I dont think well do that again, and postpone as I mentioned of the implementation of the sample redesign from 2005 to 2007, which has implications for the quality of the sample. But we still feel we have enough in order to be able to keep this going.
Now these are the things that were doing based on the grand decision that we dont want to take anything out of the field, we want all of the components, the components that give us health status, the vital statistics, and as much of the health care statistics as we can muster to be in the field at the same time. An alternative of course is to not have them in the field at the same time. Then that raises more logistical issues, for example, the cost of reprogramming everything to get it back in the field once its come out of the field. So were dealing with a lot of operations research in addition to statistics.
Let me talk about NHANES, its going great guns, weve also made some adjustments in NHANES as well, but NHANES kind of has a new schedule I guess you could say, new basic schedule. It views everything in terms of two year data sets although data can come out after a year, because as I mentioned to you I think at least twice before we changed the survey since 1999 so that its a representative sample every year. But since its only 5,000, 5,000 is not a lot, so we like to think of it in terms of sort of two year increments of 10,000, but there is data that is useful. For example the exposure data, environmental exposure data has been going into an annual report. That may not be annual in the future but its been going into that and we that with our colleagues in the National Center for Environmental Health. We also are able to produce annual figures on diet and nutrition, which is very important for our collaborators in USDA. The 2001-2002 NHANES release is going to be available in 2004.
Now repeated in a somewhat different fashion an exercise that we went through with NHANES back in 97 I think it was in which we convened a forum, a large forum, of people both from outside the government and inside the government, the private sector, researchers, some people from foreign countries from that matter, on NHANES, and weve done that. We used a different process this time that people reacted to very positively, we call it an open technology process, but thats sort of not here or there, people who were there really enjoyed it, everyone felt that they really were able to get their two cents in on ideas for NHANES in the future. And I was pretty taken by it and I think were going to try this with our other components as well as kind of a widespread net for ideas.
But the thing with NHANES is that a high proportion of it, well almost every proportion of it is done with a collaborator within the federal government, and the collaborators within the federal government also work with people outside the federal government, and NHANES is very intensive in terms of the methods that are used. But its not unlike what happens with our Childrens Supplement, or our supplement to HIS on childrens mental health for example, which is done with NIMH and a panel of outside experts.
In any case the forum was held just this past, I guess it was in August we did it, and there are proposals that are going to be submitted. Were also in the process of contract competition for the conduct of NHANES, and thats underway. Now a very, points that Ive talked to you about in the past is Community HANES, or rather, you can see something I typed, it says Community NHANES, I should have typed Community HANES, I like it better that way. But in any case this is something in which we have a set of trailers that are self contained and the thought is that we can take the methods in NHANES and apply it to communities around the country, and either that we could or others could take these ideas and apply it.
And Im really pleased to say that we now have an activity with New York City, this is not being done with the trailers but the way its being done is actually replacing the trailers with storefront clinics, but its happening in New York City and weve been very intimately involved with this, were very excited about it, were kind of consultants to New York, and its in a way an experiment to see how well this goes. But it will provide a very firm baseline on the health of New Yorkers and well evaluate it in that sense.
Weve received many, many inquiries about Community HANES and Im hoping that well find ways of doing this in the future. This is one of the community HANES trailers, which is self contained as opposed to the mobile exam centers which are four trailer trucks that become interconnected and then they need to be plugged in to all of the sort of services from sewage to electricity to water. These on the other hand can go anywhere and we have a variety of these it turns out so we actually are very well prepared to do this, we just need the right kind of invitation somehow, its like weve gone out and weve dressed, were ready for the party but no ones invited us if you will. Well, people are talking to us but I guess were in the early stage of dating I guess you could say. I wont push that analogy, I dont think its going to go anywhere.
Let me mention the Board of Scientific Counselors, the charge to this board is to provide scientific guidance to review intramural research, which is becoming more and more important and part of what Dr. Julie Gerberding, the head of CDC, one of her emphases has been on extramural research and wanting to see a larger budget for CDC be able to fund extramural research. Im a big proponent of that, I have been ever since Ive been in this position, for us and for CDC. But in doing that it highlights what goes on in the institutions intramural research and the review of intramural research falls to boards of scientific counselors or the equivalent. So I think its very important that weve started this activity at this point in time. It will assist in guiding extramural research and along with you and the community at large help us in providing guidance and setting priorities.
We held this organization meeting at our building and the content of the meeting really was an overview of programs and orientation. Were currently even though weve just begun were now seeking four new members to join in April, which is part of the committee process of course, and the next meeting is on January 22nd, 2004, and of course like this meeting these meetings are open.
I view you and the BSC as very complementary. The BSC, its sole purpose is to give advice to NCHS on the statistical and science base of what it is we do. You advise the Secretary, the rest of HHS and of course us on data policy issues, but of course also get into these aspects of the science of what we do and the direction of that. And I see this as sort of coming at us if you will from two directions and I think we, its not added in for us, it sort of multiplies, so I see great benefit coming from this and Dr. Mays was there for this first meeting as a liaison.
Im not going to talk about today our Office of Analysis and Epidemiology of Research and Methodology, technology in the center and international activities. Although I must say theres a lot of action here in many different ways, particularly in the Office of Technology and Information Services as the department sort of reconfigures how it carries out its information activities in light of the Presidents management agenda.
Briefly on dissemination, its a very important aspect of what we do of course, to collect it and keep it where would we be. The web continues to be more and more important to us, this is just a picture of the web page, but we have a number of tools on there to access data and when I look at this slide I was struck by the number of different tools and how many of them are named after peculiar animals, like data ferret, and whiskers, and I guess its only those two. And I say to myself this is great, but on the other hand would I love to have a kind of uniform entry, data system so that we could use it to still get everything and it would be more and more transparent to the user. And I hope that we head toward that in the future.
A brief word about the Research Data Center. Since we began this in 1998 to allow researchers closer access to data that cannot be given to the public because of confidentiality reasons, weve had, the number is here, 12,600 SAS programs have been used, we have had 82 government clients all the way down to ten private sector and 11 non-profit clients. I see this is more and more happening with this in the future and what I hope in the future is that were able to have a string of these data centers very close to the people who are actually using them. Using our remote entry were able to achieve a portion of that but theres nothing like actually being there and holding onto the paper if you will even though were in an electronic age, theres something about actually being there and being surrounded by it that I think is very positive.
One of the important dissemination efforts is in our support of Healthy People 2010, which is at the core of the President and the Secretarys steps to a healthier U.S. In fact this afternoon at 1:00 we have one of our Healthy People reviews in which I present the data and theres discussion internally on whether or not, to what extent were making progress in a particular area. And we have the role of being responsible for all of the data even if its data that we havent collected.
Now on the screen is a slide of Health, US, 2003, so while Ive extolled all the virtues of the web there still is a use for, or maybe there isnt, this is going to be up to you, as to whether or not we need something thats in paper like Health, US. At the Board of Scientific Counselors meeting Diane Makuc, whos in the back, who has overall responsibility for this as part of the Office of Analysis and Epidemiology, talked about Health, US and its release, its the one on my right here, and how it differs from past issues. And what we were planning in 2004, in 2004 a special feature on drug, pharmaceutical drug utilization. The question though, and I really thank Diane for raising this, was something that we should ask periodically which is what should be the directions for Health, US, how should we do this, how should we get input, and what aspects should we look at. Should we think about the audience, should we think about the content, and in particular should we think about the format. So perhaps in the time we have we could discuss that and Diane is here to help with that.
Let me talk briefly about budget, this is a graph of our budget from 94 to 2004 and its got from about $80 million up to $125 million over that time. Since 2002 its been pretty much level. What doesnt really show in the way Ive drawn this is that it really wasnt a smooth rise from about 98 to 2001, it was relatively small amounts of money at the end of the year if you will. Now if you take our 94 budget and adjust it for inflation our budget today would be about $152 million compared with $125 or $126 million that we have. So in order to deal with the minus 26 million weve had to make changes in the program. And weve made these changes and Ive mentioned some of them weve also I think have a much more productive program then its been in the past. Part of that I think is technology but part of that is just doing things differently and adopting technology.
The money is distributed in this fashion over these different areas within the center. What doesnt show up here in this picture is that on top of NHANES, the NHANES bar, we need to add so called reimbursable funds, which come to us from other agencies as part of the collaboration. And these are, these in effect are part of the NHANES budget but theyre not part of our appropriation and theyre solely for NHANES. So if you looked at just the major data collection components, HIS is 11 percent of the appropriation, the Health Care Survey is nine percent, Vital Statistics 20 percent, and NHANES 16 percent, but the NHANES budget is actually, itself is actually much larger then that. Its also true to a degree for HIS, which gets a considerable amount of money from outside the NCHS.
Facilities, we have a brand new building, and I would love to have this committee come and meet in our facilities, it really is terrific and Marjorie I think would agree and Im not asking her to agree, its incredible how positive everybody is about this building. Its right next to where we were before but its really bright, light, airy and we have a great set of meeting rooms. I wont go into, we actually moved in in the great blizzard of 03, I wont belabor that.
This is our building in North Carolina and this is a brand new building. Unfortunately were no longer in this building because we had an environmental problem in it. There was an odor that was there when we moved in and it got worse, so weve moved out, lock, stock, and barrel, and were just not connected with this anymore and were in the process of looking for space in that area. Just check your local papers for the ads. And that search is actively underway of course through the GSA. This is really too bad because this is a very nice building but it was one of those unusual situation.
I want to just take a minute to talk about the CDC Futures Initiative, you can find this on the CDC web page. This is something that Dr. Gerberding initiated and she did it for all of the goals that you see on the screen here, kind of small print, but she wants to ensure good solid improvement and really measurable improvements in the publics health. And these goals all the way to being sure that the CDC workforce can handle all of this and that its state of the art if you will. So theres a lot of activity underway, meeting with groups from outside of the government in the private sector on the future directions for CDC. We are full party to this, of this, with this, and what comes from this is going to be very important to us. Well see a variety of strategic themes established and I want to see this frankly as much in tune with the vision for health statistics for a 21st century and particularly the framework that weve outlined in that.
So if I could sum up where we are, there are a variety of challenges that we face in terms of reengineering, they are the things that other statistical agencies but weve been doing actually pretty well with. But part of our resources have been going into seeing to it that we are doing pretty well. But response rates are tough, theyre headed down for a variety of reasons but as I said were doing pretty well. It takes more and more resources to do that. Keeping our staff at a level of, the appropriate level of technology and with the depth that they also need in terms of their individual specialties is very important and its a continuing challenge. And the federal government is working differently then it did in the past. When NCHS as born people joined the Center and then they stayed for a career. Most of those people, not all, have retired, NCHS is 40 years old. But thats not the way people work today and we need to find ways, as does the rest of the statistical system, of assuring that we have staff with the requisite knowledge and this can happen in a number of different ways but it also takes of course resources to do that.
In terms of how weve been meeting these challenges, Ill just recapitulate in this fashion, in vital statistics we found ways to find the money to be able to make the changes. In HIS were experimenting with this reduced sample size. In NHANES weve made some changes in field procedures and staff. And in the health care surveys weve reduced the number of surveys in the field.
Now one thing I promised I would talk about is summary measures of health and I want to report very briefly on a workshop that we held this March. This was convened by an interagency workgroup across the departments, not solely NCHS by any means, many, many people from NIH and CDC and other agencies. The purpose was to identify priorities for moving this field forward -- summary measures of health. And what we did was we had the conference, from input that we had during this conference we identified seven themes, and these seven themes have to do with comparison of preference base versus non-preference base instruments, analyzing the properties of the instruments, you have this on the handout. And what I wanted to do was just show you the results.
The results from the input that we received and then voting by the various experts and attendees to this meeting came out with number one priority was to compare these various measures. Number two, which is very much related, is to look at the properties of these instruments. The point of both of these is that while these instruments are widely, some of them are widely used, for example SF36, and I would put into the mix, some of my colleagues might not, but qualies, dollies and so forth, exactly what the properties of these are is not clear. In particular qualies and dollies and expected length of life and so forth in their use in decision making was considered to be a priority, that got a rating here, ranking of 16.3 on a scale. And conceptual issues in the measures, research to improve the measures and improve data collection in general and training, these were the seven themes that came out of the recommendations.
What we hope to do, this was our purpose, was to turn these back into the decision making components of the Department and it turns out that Dr. Zerhouni of NIH actually kind of got, jumped the gun here if you will, and one of the pieces of the NIH roadmap, which is also on the web in case you want to look at it, has to do with a very significant aspect of this, particularly on the instruments such as the SF36 and so forth, building a better database for these.
So were pleased about that and that in a 35 minute nutshell is where we are. Id be happy to take questions and of course Diane is here so that we might say, if we want to discuss HIS and I have a few copies and Ill hand them out around the table. But I think most of you are familiar with HIS.
DR. COHN: Before we get into the general discussion, I see Vickie you are on the agenda here as comments regarding the role of scientific counselors, do you want to make some comments and then well get into the general discussion?
DR. MAYS: Sure, Ill keep it also brief because I think a discussion is important for Dr. Sondik. Dr. Sondik actually handed out to you just so that you know the list of who, the roster of who is on the new Board of Scientific Counselors as well as what the agenda for the meeting was. Having attended as the liaison from this group what I would say is that is that I was very pleased and impressed with the individuals on the board in the sense of their commitment, their diversity of expertise, so I think it will be a very good board.
Theyre just starting so I think the issue of what the liaison role will be between the two of us, I think Dr. Sondik kind of laid out what he thought was the ways in which we can work together and I think the actual activities that will occur, I think we still probably will kind of field our way.
One of the things I think probably we will recommend is a presentation to the group about this committee so that they actually understand the range of activities that this particular committee engages in and also how we work with other agencies so that they have a sense of that. There was a suggestion, which I think, I dont know if Dale Hitchcock is here but Dale had made a suggestion about the possibility of having an update from this group to the Board of Scientific Counselors at each of the meetings so that they would have a sense of the landscape of what weve dealt with. I think for us well probably also think about those points at which we should cc them on letters that involve recommendations that are key to NCHS.
So I think that thats pretty much kind of in a nutshell because it really was, they were just brought in with introduction to all the different data sets and activities and NCHS and so I think over time well work out what I think will be a very complementary relationship.
DR. COHN: Great. Was it about this or something else?
DR. STEINWACHS: About the next
DR. COHN: About the next, are there any other comments about the Board before we move on to just general discussion? Don, you have the floor.
DR. STEINWACHS: You got me stimulated Ed, Ive got my little list here but Im sure Simon will say stop, Don, stop. Your lead off showed the pieces in the press and elsewhere, is NCHS getting credit for this? Is it really apparent when people read the news articles and other things that this is NCHS data and if not are there things that we could do to try and make sure that American is aware that you are the resource?
DR. SONDIK: Well, you know we are one department, I mean the federal government is producing and, Im being facetious, sometimes it says NCHS, sometimes it says CDC, the sort of the recorders of record know where its coming from and we have a very good staff, Sandy Smith is really, I dont know how many of you know her but she really is a national treasure and I mean that because she actually is in effect the lead on this type of activity working with the media for the statistical agencies in general and people turn to her for her expertise on how to do this, not only in HHS but with the other departments as well and the other statistical agencies. So we make every effort to be sure that if were not mentioned specifically that CDC is mentioned.
DR. STEINWACHS: Just to add one another thing. Out of curiosity, do press releases really accompany any of these reports? Is there a metric to try and push this visibility? So when you talked about the uninsured, which we now can produce timely stuff, its not where most people go for the uninsured.
DR. SONDIK: We are working very actively to do that. We actually, one of the points that I think has become clear over the years is that, and actually the BSC discussed this as well, is that the value of the information that we produce is sometimes not immediately apparent and that we should be doing more to emphasize what the value is. I think its interesting that we have a number of, a few I should say, economists who are on the Board of Scientific Counselors and this is really important. Even though we dont collect any economic data its in our, if you look at our legislation were mandated to if not collect it to report on it, so we will of course work with CMS, who is really the major fount of this information but AHRQ of course is very important in producing this as well through MEPS(?). But it was very interesting because the economist were vocal at this meeting and gave a perspective I think that was very useful.
So we have been working, in addition to that, weve been working with groups and the community in general to emphasize the importance of what it is we do, I think this also comes across in the vision document as well, so were trying to make this point. For many things we do theres a press, we contact the press, we have very good relations with that. Some things its funny, though, some things really hit and some things dont hit. For example we do this collaborative activity, its on my mind because we just discussed it two days ago, but we do a collaborative activity with the other agencies from Producing Americas Children. And we have a highly coordinated effort in terms of getting it out and working with the media doing that, very important, because all of us, its sort of a labor of love, Producing Americas Children, because we all feel its important that decision makers see the multiple dimensions of things that apply to kids, housing as well as health, criminal justice as well as education. And what we saw this year was that we got, we actually had very good television coverage but our print coverage was not as great as it had been in the past. So were looking at that and trying to figure out what it was about the timing, it turns out when it came out there was a lot of things going on, including issues, international issues, Iraq, so we do take interest in this.
DR. STEINWACHS: Let me ask you one other thing, and you had mentioned NHIS and I guess I wanted to discuss it, its still I guess not clear to me what the price is that were paying for not being able to update the sampling frame and it would help me to have a better understanding because what youre saying I guess is that its less and less representative of America.
DR. SONDIK: Well, when the sampling frame was drawn we added a couple of years to it, not looking ahead to this but you never know, so it was longer if you will then it sort of needed to be. Id like to be able to give you sort of a quantitative estimate of what it means in terms of the precision of what it is were getting. It probably says something in terms of the cost that goes into filling out the sample because theres more that needs to be done in terms of new construction and that sort of thing. But I could try to get back, I would get back to you with as quantitative an estimate as I can but all of my advisors tell me that were still in good shape using it, but the fact is there is no more after I guess it is 2006.
DR. STEINWACHS: So youve got to do something no matter what.
DR. SONDIK: Yeah, we do, if we dont do it we dont do it because I mean its integral to doing the survey.
Weve also asked the Census and our advisors to think about perhaps other ways of drawing the sample that are of a more dynamic nature, its always a little jarring to think that you lay out a sample ten years ahead, but it turns out that this is a reasonable thing to do in terms of doing these large surveys and the fact of the matter is that were in a continual update over time throughout the ten years but we lose the base in another year or so.
DR. MAYS: Like Don I think Im stimulated with several questions. Im actually going to pick up on this point about the NHIS. Has there been any work to look at what the loss is analytically? I mean we may have a representative sample but for some questions what happens is as it gets smaller and smaller were not really able to do certain kinds of multi-varied analysis, so is there any way to have a sense of what we might be losing analytically?
DR. SONDIK: In terms of the sample size reduction? Yeah, we can do that, there has been, and its pretty straightforward. Its actually much more straightforward then the other question of as you get further away from the base census year what does this say in terms of the precision of your sample. And Id be happy to have us get back to the committee on that.
DR. MAYS: Yeah, I think that could be important -
DR. SONDIK: We feel comfortable, well, we feel, I cant say we feel comfortable but we feel that its a loss that we can accept at this point. Now its fine of course for us to accept it but youre the users, so the question really is can you accept it, so we would be happy to get back and perhaps we can do that at the next meeting, because this I think will be a continuing issue.
DR. MAYS: My other question has to do with the Data Centers. I actually looked, I was looking from 1998 the usage and I know one of the things that weve talked about in the Subcommittee on Populations and I think weve brought this up with Jennifer is that particularly for some of the smaller groups where one has to actually use the Data Center to be able to do analysis, that thats a much needed activity. The problem is that we need more Data Centers in order to probably increase the use. One of the things we had raised was the possibility of NCHS actually sharing space with Census since Census has increased its Data Centers both relative to them being an academic environment as well as having some that are in, operated in community based organizations. Is there any progress on your ability to be able to do that in the face of these new guidelines about data sharing?
DR. SONDIK: Well, no and yes. I wouldnt say theres any direct progress, I think weve still got the Title 13 issue, but on the other hand it seems very reasonable for us to be able to somehow merge the space and to be able to appropriately partition it with respect to the data thats actually being addressed. And Id be happy to report back on that.
DR. STEINWACHS: Is this like a fire wall -
DR. SONDIK: Well, we need something like a firewall, but I dont think that the data sharing agreement helps us because Title 13 gets in the way of that, which is the law that controls how Census shares its data. But I cant imagine that there isnt, that there arent economies of scale and Id be happy to eat those words, unhappy to eat those words if it turns out there arent but we should pursue that with the Census, I agree.
DR. MAYS: My last question is in terms of the Futures Initiative, is Dr. Gerberding herself actually being very involved in that initiative?
DR. SONDIK: Shes very involved in that, without a doubt. Its impressive the amount of activity that is going into this, there are a number of groups, there have been subcommittees that have been formed, there are these focus groups that are going on with people that we all work with, customers so called round the country trying to identify the issues that you all see in these future directions. Shes very much involved and the person that is leading it under her is Kathy Cahill(?), whos a special advisor in effect for looking at CDC in the future. But this is not a small activity and its, shes from the beginning when she created this shes put a lot of her personal time and effort and reputation into it.
DR. STEINWACHS: Simon, can I squeeze in one more?
DR. COHN: Is it a follow on, Don, or can we let Clem -
DR. MCDONALD: Well I may not be able to actually be heard so it may be moot, excuse me for the voice. I had a question, I read your report, both this year and last year, and its very impressive, theres really some good news in it about how well were doing in health care and public health, I mean in terms of the death rate, that reduction in heart disease in the last 30 years I guess. Recently the big drop off in death from AIDS, cancer reduction and death rate, I think the press doesnt like good news so thats maybe part of the problem because you hear everything bad that happens in health care. So the question was have you ever thought of engaging and trying to magnify the voice about this good news through the hospital associations, the medical professions, maybe the drug industry, because they can all take some credit for that.
DR. SONDIK: I think thats a very interesting suggestion. I think weve strategized more related to Americas Children and the companion document on the elderly then we have with respect to the other reports that we do although we certainly actively consider it. We have actually gone to the Hill with this report, Health, US, in the past and had a briefing with Hill staffers, its been very well attended, the APHA was instrumental, critical actually, in setting that up. I think it would, what we dont have is an address if you will, or is a document that says something sort of like this is the state of health of the American public. Now you certainly can get that out of this, this is aimed at that. But somehow it isnt viewed as sort of the state of health document but that could be a matter of reorienting how its put together in the literature.
DR. MCDONALD: Well, the front section more or less does summarize some of this and theyre really pretty remarkable, like three years in a row longevity has increased, or four years in a row, and when you think about the little bitty itsy changes we can do with clinical trials and all the rest to show through the whole population, these are pretty remarkable improvements and no one is noticing it.
DR. SONDIK: Well, they are improvements but for example, we had a review the other day on childrens health and Im always struck by infant mortality, how the figures on infant mortality continue to get better, its terrific, but the disparities persist. If anything on a percentage basis the disparity gets worse. Now we try to emphasize that but somehow when people look at it and some people see the glass as half full, some see it as half empty. I look at it and I see a persistent case of disparity in a measure that many people use to characterize an entire, a countrys entire health and its one of the major measures that we use to judge how well a country is doing.
And Im struck by, and I dont know exactly what to make of it, but Im struck by the focus on obesity. The focus on obesity is really a health focus, its not one thats concerned with how people look or dress or whatever, it really is a health focus, its a diabetes focus and so forth, it seems to me it is the right, its exactly the right kind of focus and I think its one thing that we should try to capitalize on at this point, understanding how it is that this has tipped so that we have this national, its become a national issue, and how we can relate the broader health, the more full health picture of Americans, and in particular the issue of disparities and whether weve been doing any better with respect to disparities, which we havent overall, over the last 20 years or so. They continue to persist and there have not really been major gains in reducing the disparities.
Im willing to consider any and all suggestions, the thing I think its important for us to do as a statistical agency is for us to maintain the posture that we call it as we see it, we collect the data, we produce the data, I think its important though that those who then take it analyze it further, look at the implications of it, that they consider they import. And I think weve tried to strike that kind of balance in this document, sort of a workman like but very attractive, at least in my personal opinion, very attractive presentation, its very easy to read, very easy to get the salient points but without sort of standing up and saying okay, this is what we think the priority should be, I dont think thats our role, but it is our role to point out where there are problems.
DR. COHN: Do you have a quick question?
DR. STEINWACHS: Ill make it quick, or maybe Ill make a quick comment.
DR. COHN: Okay, why dont you make a quick comment and then we need to wrap up on this one.
DR. STEINWACHS: Simons reigning me in. I like the efforts youre making trying to focus more on health recognizing that looking at disease is a decrement we know in health. One of the concerns that I have and I think some of the things that we are discussing in the Populations Subcommittee is around the mental health piece because you infrequently die of an identified mental illness even though, for instance people with schizophrenia on average die ten to 12 years earlier then other people, and so it isnt quite clear to me how mental health or even mental illness become more core to what youre capturing and so when you talk about potentially in the future getting into dollies an disability and health you pick up more of those dimensions because disability, mental illness is a major contributor to disability but it doesnt up on the mortality, it doesnt show up on some other places. And I notice NHANES this next time around is likely to go without a mental health piece, so I think it would help, it doesnt have to be now, but to get a sense of how you see moving mental health and mental illness into a more core position for health and illness.
DR. SONDIK: But I think you really put your finger on a question where you all can be very helpful in this, which is how best to represent health. We still continue to use pretty much the outline if you will, the sort of time honored outline of looking at mortality first and then we have some morbidity measures and so forth. I think there are major issues about how to combine the morbidity into a single measure and/or whether to combine it with health and we have some work going on in the Center on summary measures of health.
I personally would like to see much more research going on on summary measures, not necessarily to produce a single measure but on better understanding of how to represent health in a way, particularly in a way thats understandable to the public and to decision makers so that we can move away from the disease of the month or the year type of thing and see a broader picture of health in the balance. My problem with dollies and qualies is that it boils it down to a single dimension and thats only useful for comparing one thing --
DR. STEINWACHS: For cost effectiveness.
DR. SONDIK: Well, but also, I mean Ive been approaching this really from a standpoint of whether were comparing counties or comparing countries, its making those kinds of comparisons. The problem is once you make the comparison and you say that country A has a higher ranking then country B that tells you essentially nothing, you need to pull it apart and understand whats in it, and I think you can do that from the word go and present it in such a way so that you can see that. We have plenty of tools today that enable us to do that and at the minimum we can see in three dimensions. So there are ways to put this together that I think would better inform us.
And I think if we do that an emphasis on mental illness, emphasis on functioning, at this point were getting very little information related to functioning and we can adopt a whole different point of view that says we ought to look at things not in terms of disease, but in terms of functioning, and I think that would be an important dimension. But I think it would be very productive if we could sometime in the future, maybe in the Populations Subcommittee or elsewhere, focus in on this particular, exactly what youre raising, how do we best represent this, and the way to do that might be to focus in on Health, US, and in particular the front part of Health, US.
DR. COHN: Actually Ed, and this is actually sort of a wrap up, the one issue that obviously Ed brought forward which was this questions for consideration on the health document, we obviously havent discussed it all. Vickie, is this something that you can work with them on in the subcommittee?
DR. MAYS: Yes, and we actually are considering mental health tomorrow morning.
DR. SONDIK: Well, I hope that Diane, Im not sure what her schedule is but I hope that you can be there for that, because Dianes given a lot of thought and many, many years of her life considering how best to do all of this.
DR. COHN: Well, Ed, I want to thank you very much, appreciate you coming and updating us on the state of the National Center. Obviously what well do is take a, were running a little bit late here, well only take a 15 minute break and then well come back slightly after 11:15. Thanks.
[Brief break.]
DR. LUMPKIN: The next item on the agenda is the letter thats at your position on ICD-10. I just want to call your attention, if you have not looked at Tab three its very important that we all understand how we got to this point. Were you going to talk about that Simon?
DR. COHN: No, actually I wasnt, only at the briefest levels. Didnt we talk about that at the last meeting?
DR. LUMPKIN: Yes, but Im just wanting to call everybodys attention that the first item on this timeline is 1990, and it is my hope that its been on the table that one way or another we can fish and cut bait on this issue and come to some decision at this meeting. So thats just my plea as we move into this issue that I think its, there are some decisions that you make no decision until its time and I think its time. So Simon, go ahead.
Agenda Item: ICD-10-CM Letter Dr. Cohn
DR. COHN: Well, John, thank you, Im obviously pleased to bring you this letter as well as very pleased on this that youre chairing the activity.
This is the first actually of three action that well be discussing today from the Subcommittee on Standards and Security. First well talk about ICD-10 and then after lunch well talk about the PMRI core terminology recommendations and then from there well go to the final letter which is the CHI recommendations and comments from the full committee.
Let me just talk about a couple of comments about this letter and about the process, Im not going to go back to 1990 in terms of these comments, but just for, I mean I know many of you have been involved with much of this, at least since 1997, others have only been exposed to the discussion more from our last meeting and on today. First of all I think as you all know this is a very contentious and complex issue, and let me just sort of say that straight out. If this were simple we would have dealt with it long ago. Obviously while weve been discussing this issue, John mentions 1990, I tend to think of it really as starting around 1997 in terms of more serious conversations, and really having been a focus of the work of the subcommittee and full committee from time to time in the last two years. But once again its not something weve held one hearing on and solved the problem.
Indeed I think I would say one of the major pediments of this activity has been to raise the level of awareness of the issue by the industry. We have heard or received written input from over 80 organizations and individuals, some of them multiple times, and have had eight days of hearings on this, so its certainly an issue where the industry and health care community at large has had significant opportunity to provide input.
Now early on it became clear that there was lots of concern but very little data related to the costs and benefits of moving to ICD-10, and this really prevented the subcommittee from making much progress and knowing how to make recommendations on this subject. Clearly because of this as well as the requests from large segments of the industry the committee took the unusual step about a year ago of commission a cost/impact study which RAND Corporation did, and which we received a report on at the last meeting. Obviously you heard our presentation on that as well as a reactor panel, and there have subsequently been other reports related to independently developed data, one of which you have on your table from Blue Cross/Blue Shield, which you received a paper copy of today, but had heard an earlier report at the last meeting.
Since the full committee meeting last time youll remember we spent a number of hours talking about the issue and reactions and our cost/impact study. The subcommittee held additional hearings and discussed this issue, in fact actually last week for a full day. At the hearing we heard additional testimony from Blue Cross/Blue Shield, from CMS, and NAHDO, as well as heard other testifiers during an open session. We obviously spent much of the day trying to talk and identify next steps, which is what this letter is all about.
The subcommittee felt at the end that it was really our responsibility to synthesize the information and make a judgment about what is best for the country, recognizing once again that there was no industry consensus on this. The letter which I will read in just a minute attempts to provide an accurate summary of the issues we heard and tries to make reasonable recommendations on the next steps.
So with that any questions before we move into actually reading of the letter? Okay. I think the good news here is that sometimes as clarity increases brevity increases also, so were looking at a letter thats only slightly over two pages.
DR. HARDING: I have a point of information, are we going to vote today or tomorrow?
DR. LUMPKIN: The usual process is that we would discuss today and vote tomorrow, unless theres like an overwhelming desire to get it done today we usually, so Im always willing to entertain a motion to vote if there is a reasonable sense of readiness of the committee on the first day.
DR. COHN: Well, let me read the letter and what I will do is to read the background, which takes, is basically the first page and then well stop and take comments rather then going paragraph by paragraph if thats okay by everyone since this is primarily background information.
Dear Secretary Thompson:
As part of its responsibilities under HIPAA the monitors the continued effectiveness of the health data standards adopted pursuant to the requirements of HIPAAs administration simplification provisions.
During the past several years NCVHS Subcommittee on Standards and Security has focused consideration attention on the feasibility and desirability of replacing the current diagnosis and inpatient procedure classification system, ICD-9-CM, volumes 1, 2, and 3, with a newer and expanded version, ICD-10-CM and ICD-10-PCS. ICD-9-CM, volumes 1 and 2, was adopted as the HIPAA standard for diagnoses in all settings and ICD-9-CM, volume 3, as the standard for inpatient procedures reported by hospitals. At issue are the one-to-one replacement as HIPAA code sets of ICD-9-CM volumes 1 and 2, with ICD-10-CM for diagnoses in all settings, and ICD-9-CM volume 3, with ICD-10-PCS for inpatient procedures reported by hospitals. This would not affect the usage of other code sets under HIPAA, such as CPT-4 and Level II HCPCS.
The ICD-9-CM was developed in the 1970s. Despite an annual update process ICD-9-CM volumes 1, 2, and 3 have structure and space limitations that increasingly constrain their ability to accommodate advances in medical knowledge and technology. ICD-10-CM is recognized as the logical successor code set to ICD-9-CM for diagnoses. In fact ICD-10 already has been used for mortality classification in the United States since 1999 and has been implemented for that purpose throughout much of the rest of the world since the mid-1990s. Many of these countries also have adopted ICD-10, or a clinical modification of it, for reporting diagnoses in health care settings. ICD-10-PCS was developed by the Centers for Medicare and Medicaid Services, CMS, as a successor to ICD-9-CM, volume 3.
More than eight days of hearings have been held by NCVHS since 1997, and letters and oral and written testimonies have been provided by more than 80 public and private sector groups representing the health care industry, the federal and state governments, the public health and research communities, insurers, and providers. A chronology of the development of ICD-10-CM and ICD-10-PCS and a synopsis of testimonies and letters are attached. Also attached is a complete listing of groups that have provided input.
Let me stop there.
DR. LUMPKIN: Any questions or comments on the first page introductory language? Clem?
DR. MCDONALD: Last week when we discussed the letter of support, since then I got a hold of the letter of support from the 55 organizations and I should say Im a board member of the ACP so thats why I became aware of that, and the tone of that letter was not supportive for any of it, it was just saying whatever you do dont do this, and I would just like to get that in the record that it wasnt saying do this half and dont do that, it just said we hear youre going to do this, dont replace the procedure codes. They said it pretty strongly. So I just thought it was a little, the way I read it last week was they actually were supporting the other part and I thought it was a little misleading that it was presented that way until I saw the actual letter. I sent the letter to some of you -
DR. LUMPKIN: I think we all received a copy of the letter from the medical specialty societies, I think the full committee did receive a copy of that.
DR. COHN: Obviously youre commenting on the accuracy of the appendix, which is something that were going to have to be very careful of.
DR. MCDONALD: Its just a shading but I wouldnt call it supportive the way they wrote it.
DR. LUMPKIN: Other questions or comments on the first page of the letter? Okay, lets forge on.
DR. COHN: Okay, page two.
The issues surrounding the migration to a replacement diagnosis and inpatient procedure classification system in the Untied States are complex. For example, there are concerns within the health care community that ICD-9-CM is an antiquated system that cannot meet the current and emerging needs of payers and providers in todays fast-faced highly specialized, and technologically sophisticated environment. There also are concerns that ICD-9-CM is increasingly unable to address the needs for accurate data for health care billing, quality assurance, public health reporting, and health services research. This has been well documented in the testimonies and letters provided to the committee over the past several years.
At the same time, the committee has heard concerns from the health care community about the costs, potential benefits, and implementation issues associated with transitioning to ICD-10-CM and ICD-10-PCS. Given the widespread use of ICD-9-CM there could be significant implementation costs in terms of hardware and software changes, lost productivity, and training among others.
Benefits are harder to quantify but appear to outweigh the costs. They include improvements to the quality of care and patient safety, fewer rejected claims, improved information for disease management, and more accurate reimbursement rates for emerging technologies. These costs and benefits and related issues also have been substantially documented in testimony before the subcommittee as well as in a cost/benefit study by the RAND Corporation that was specially commissioned by the NCVHS. A copy of the RAND study is attached.
In addition, many in the public and private sectors are concerned about the additional administrative and resource burdens posed by this implementation since they would follow on the heels of HIPAAs other mandated requirements. Along with testimony about the timing and cost concerns, the subcommittee received considerable input about the timeframes that would be needed to effect a successful transition to ICD-10-CM and ICD-10-PCS.
Let me stop there.
MR. HOUSTON: Just one minor point is in the second paragraph on the page, you talk about, the first line speaks to the committee has heard concerns and then in the next line you talk about the potential benefits, I think you should strike potential benefits because its described in the next paragraph down.
MR. BLAIR: I think that thats a valid point, I think that what it meant to say there was concerns maybe about the accuracy or validity of the potential benefits, and I dont know exactly the words to help there.
MR. HOUSTON: Could you put lack of potential benefits?
DR. LUMPKIN: I think the word maybe is magnitude.
MR. BLAIR: Thats good.
MR. HOUSTON: Because the way its written it seems like its out of place.
DR. COHN: John, thank you. Other comments? Okay, let me continue on.
While taking into account the diversity of input and lack of industry wide consensus, [its either a major of or the] NCVHS concludes it is in the best interests of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation in place of ICD-9-CM volumes 1, 2, and 3. As a result the committee recommends that the Department of Health and Human Services initiate the regulatory process for the concurrent adoption of ICD-10-CM and ICD-10-PCS. By issuing a NPRM the Department would provide a structured environment in which critical implementation issues may be addressed. We further recommend that the NPRM specifically invite comments on the key issues presented in testimonies and letters before the committee.
Now should I got into these bullets or stop there?
DR. LUMPKIN: Why dont we stop there and then well go into the bullets. I would just like to interject, I think that, at least as I remember, all of our work comes out as recommendations from the committee and its fully recognized that any number of people may choose to vote, opposed to something, but I think its confusing to say in this case the majority of.
DR. MCDONALD: I might have had a lapse, on be on benefits are hard to quantify yet? Or past it?
DR. LUMPKIN: Were on the last full paragraph on page two, which starts out while taking into account diversity.
DR. MCDONALD: Can I still talk about that paragraph?
DR. LUMPKIN: If there is something you want to talk about and weve already gone over it well be happy to go back, at least Id be happy to go back, youll have to check with the rest of your colleagues.
DR. MCDONALD: I worry about, second sentence on the third major paragraph -
DR. LUMPKIN: Okay, thats the paragraph that says benefits are harder to quantify but appear to outweigh the costs?
DR. MCDONALD: Right, the second sentence after that. Specifically I have trouble perceiving how we code discharge diagnoses would change the quality of care in patient safety. I think one could say wed have better understanding of the care process but how those would directly improve care or safety I think is a stretch, because the patient has already been cared for.
MS. GREENBERG: Future patients.
DR. LUMPKIN: Well, the issue is is that the quality improvement process is an iterative cycle, so if you know what happened in the past it can influence what you do in the future.
DR. MCDONALD: Well, they will teach us, I think theyd help us understand the care process, which could lead to those things, but I didnt hear either testimony or do I know any papers that suggest changing your coding after the fact changes care quality.
DR. STEINDEL: John, I think this was specifically addressed in the RAND report from the point that Clem is bringing up and what the RAND report said was that people were saying that there are potentially improvements to the quality of care in patient safety by moving to the new coding systems, but that they could find no evidence that the coding systems themselves would yield any of these improvements. And that relates to what Clem is bringing up about theres no direct evidence that the coding systems themselves could improve it, there is a suggestion that they could and I think thats what the paragraph and the sentence says. That there appear to be benefits, some of these benefits include, so I think both sentences are accurate, and I think Clems point is accurate, too, I believe it is addressed in the RAND proposal, which weve attached.
DR. LUMPKIN: Now Im a little bit confused, is there a suggestion to change the language, recommendation to change the language in these two sentences recognizing that what were talking about is the fact that there is, what were suggesting are potential improvements. Simon, did you?
DR. COHN: Well, Im actually trying to figure out what Steve said, I think Steve is saying that this is okay -
DR. STEINDEL: Im saying this is okay.
DR. COHN: Its a qualitative, possible qualitative benefit that was recognized in the RAND report. I think I would further state and I think this goes along with other people, the intent here was not an individuals quality of care concurrent with the delivery but more this general view of better understanding of best practices, the ability to understand what the best practice is so you can implement the best practices and all of that stuff and I think that was really the intent here, the statistical piece.
DR. SONDIK: Maybe it would be better, the first phrase at the end of the sentence rather then at the beginning. Because you sort of put the most tangible thing right at the beginning rather then at the end.
DR. LUMPKIN: Im sorry, which end of which phrase?
DR. SONDIK: Rather then say they include improvements to the quality of care in patient safety say they include fewer rejected claims, improved information for disease management, more accurate reimbursement rates for emerging technologies, and improvements to the quality of care in patient safety.
MS. GREENBERG: It was that way and they changed it.
DR. COHN: I think we felt that care in patient safety, quality basically needed to come first as a leader on this one. Im trying to think of how we wordsmith this to resolve it.
MR. HUNGATE: A suggestion, what difference would it make if we injected the word facilitating improvements, seems to me that deals with the real cause and help.
DR. LUMPKIN: Could you read that the way it would read?
MR. HUNGATE: They include facilitating improvements to the quality of care in patient safety, fewer rejected claims, and the rest of it.
DR. COHN: Is that okay? Okay.
DR. LUMPKIN: Thank you. Anything else? Kepa?
DR. ZUBELDIA: This may be just a very subtle point but it goes along with the point that Clem made on the letter from the medical specialty societies. The paragraph that begins, the recommendation paragraph begins while taking into account, the fourth lines says ICD-10-CM and ICD-10-PCS should be adopted as HIPAA standards for national implementation in place of ICD-9-CM, volumes 1, 2, and 3. Perhaps instead of just saying in place of we could be more specific and say as replacement for, and it goes along with not replacing HCPCS or not replacing CPT codes, were only replacing ICD-9 procedure codes.
DR. LUMPKIN: Does anyone have a problem with that? Okay. So that would read while taking into account the diversity of input of industry wide consensus the NCVHS concludes its in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation replacing ICD-9-CM volumes 1, 2, and 3. As replacement for.
DR. MCDONALD: This paragraph in recommendation, how does it reconcile with the first, the second major paragraph where we say it will not effect, because it seems not to have that qualification in these last paragraphs.
DR. LUMPKIN: Can you say that again?
DR. MCDONALD: The second paragraph of the whole document -
DR. LUMPKIN: Thats on page one.
DR. MCDONALD: Yes, has a strong qualification on the scope of our recommendation, the last paragraph -
DR. LUMPKIN: Can you read that qualification?
DR. MCDONALD: At issue are one-to-one replacement as HIPAA code sets of ICD-9-CM volumes 1 and 2 with ICD-10-CM for diagnoses in all settings, and ICD-9-CM volume 3 with ICD-10-PCS for inpatient procedures reported by hospitals, thats the qualification, and it goes on to say further qualifying this does not affect the usage of other code sets under HIPAA such as CPT-4 and Level II HCPCS. What Im worried about, I dont see that same qualification in our final recommendations. I mean was it meant to comply -
DR. ZUBELDIA: Clem, thats by saying as a replacement for ICD-9 volume 1, 2, and 3, its replacement for current uses of ICD-9.
DR. MCDONALD: Well maybe we should say that, current uses, that would make it flow in this last sentence.
DR. LUMPKIN: Simon, can you read that the way it would -
DR. COHN: So while taking into account the diversity of input and lack of industry wide consensus the NCVHS concludes it is in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation as replacements for current uses of ICD-9-CM volumes 1, 2, and 3.
Boy is that a long sentence.
MR. HOUSTON: You could actually take what Clem talked about on the first page, the sentence this would not affect, you could move it below that then.
DR. MCDONALD: I think its alright, you get the qualification here and you get the qualification -
DR. LUMPKIN: Okay, anything else on that paragraph? Okay, dot points.
DR. COHN: Then basically, Ill read this sentence and get into the bullets. It says we further recommend that the NPRM specifically invite comments on the key issues presented in testimonies and letters before the committee. One is what could be done to minimize the costs of a transition to ICD-10-CD and ICD-10-PCS? Two is what could be done to maximize the benefits of implementing ICD-10-CM and ICD-10-PCS? Three is what are potential unintended consequences of such a migration, and how could they be mitigated? Four is what timeframes would be adequate for implementation? And then in parentheses NCVHS heard in testimony that the industry would need a minimum of two years for implementation, however, such timing could be further clarified and refined through the regulatory process. Fifth is what additional steps would be required to ensure a realistic and smooth migration?
And then the final sentence is NCVHS wishes to thank you for the opportunity to submit these recommendations.
DR. LUMPKIN: Any comments on those dot points? Clem.
DR. MCDONALD: The second to the last bullet, rather then saying such timing could be further clarified and refined, why dont we say such timing could be adjusted based on the response to the NPRM.
DR. LUMPKIN: Let me ask this question, it really is inconsistent with the structure of the rest of the dot points to even have that clause in there, and I just wonder what it adds.
DR. COHN: I think one of the things that weve heard, I actually was going to make it stronger rather then weaker here, I guess, you may be right, this somehow is hear, I think what we meant to say is the NCVHS heard in testimony that the industry needs a minimum of two years for implementation and agrees, I think, and then we want to say however, such timing could be further clarified.
DR. LUMPKIN: Then that should be moved I believe up into, as a sentence, in the paragraph that precedes it, which is the recommendation paragraph which would be the NCVHS would recommend that implementation would take a minimum of two years, however that should be adjusted based upon testimony heard in the process. The question should be -
DR. COHN: Okay, so maybe its the next to last paragraph?
DR. LUMPKIN: No, in the last paragraph, which is bottom paragraph on page two, the NCVHS concludes it is in the best interest of the country as a whole that be adopted as standards and so and so. Okay, Marjorie suggested it goes in with the sentence on the testimony about timing, and so we could take that clause which says the NCVHS heard in testimony the industry would need a minimum of two years for implementation, however such timing could be further clarified and refined through the regulatory process. That paragraph reads in addition many in the public and private sectors are concerned about the additional administrative and resource burdens posed by this implementation since they would follow on the heels of HIPAAs other mandated requirements. Along with testimony about the timing concerns the subcommittee received considerable input about the timeframes that would be needed to effect a successful transition to ICD-10-CM and ICD-10-PCS. The committee recommends that a minimum of two years be considered for this process with additional time based upon input from the regulatory process.
MS. GREENBERG: Actually if youre going to make it a recommendation it probably does need to go in this paragraph. If you were going to just take the paragraph --
DR. FITZMAURICE: Could I suggest just separating the two? At the end of that paragraph put the statement about what NCVHS heard and then put the recommendation for the timing in the next paragraph.
DR. LUMPKIN: Okay.
MR. HUNGATE: Could you just replace the timeframes with a minimum of a two year period, rather then use the word timeframe?
DR. LUMPKIN: Well actually HIPAA already has a minimum of a two year timeframe does it not? Six months for code sets, okay. Steve?
DR. STEINDEL: We actually heard testimony on two issues concerning timeframes, one issue was the timeframe for implementation after the adoption of the regulation and the other was the time in which the process would start.
DR. LUMPKIN: Which process?
DR. STEINDEL: The implementation of the ICD-10 series. I mean you could have a regulatory process that weve seen can go five plus years, which would probably make the industry happy, but we could also see a regulatory process that might just take a year. And the industry was concerned about the actual time that the two year clock would start as well as the length of the two year clock and I think this bullet is meant to elicit comment in both areas, which is why the timeframes is plural, its not timeframe, its timeframes.
DR. LUMPKIN: I think that the statement thats in the bullet would fit at the end of the sentence in that fourth paragraph as a statement about the regulatory process. Id like to suggest we move that sentence and then we take as a separate issue whether or not we put timeframes in our recommendation. So if its agreeable well move that sentence in the parentheses up to being the last sentence in the fourth paragraph on page two.
DR. HUFF: My sense of the subcommittee was that we did want to recommend that it not be any shorter then two years so I would say wed put that as a new sentence into the last paragraph on page two.
DR. LUMPKIN: After the recommendation and before by issuing we could say as a committee the committee recommends that the Department initiate regulatory process for the concurrent adoption of ICD-10-CM, ICD-10-PCS. Further the committee recommends that this adoption occur with a minimum of two year, over a minimum two year period, with an implementation period of at least two years.
MR. BLAIR: Thats the implementation period after the final rule is issues.
DR. LUMPKIN: Thats correct.
MR. BLAIR: Yes, and I think you and I understand that, Im not sure that everyone does. We may want to add a little phrase -
DR. LUMPKIN: With an implementation after the adoption of the final rule, the committee recommends that after the adoption of the final rule that the implementation would be a minimum of two years.
MS. GREENBERG: There were many people who spoke about two years and even some who said less then two years, I think one or two who said more then two years, so Im sort of questioning the emphasis here from the committee on a minimum of two years.
MR. BLAIR: I think its just the sense of the committee that we all seem to, there seemed to be consensus that there should be a minimum of two years, at least that, as a minimum.
MR. SCANLON: But the Department would get comment on that -
DR. COHN: I think we can leave that as an issue for public comment.
DR. LUMPKIN: Okay, and thats the reason why we have the question which will remain in the dot point of what timeframe should be adequate for implementation. So is everybody clear on what was in the parentheses under that dot point on timeframes moves to the end of the fourth paragraph on page two, which is the one that discusses timeframes, and that we add the additional sentence in the recommendation paragraph that would say that the committee further recommends after the adoption of the final rule that implementation period would be a minimum of two years. Did I say it twice the same way? Okay.
DR. COHN: Well wordsmith it and bring it back.
DR. LUMPKIN: I think we got it. Are there further discussions on the dot points?
MR. HOUSTON: I propose that this letter be adopted.
DR. LUMPKIN: Theres a motion that we adopt this letter, with the edits.
MR. BLAIR: And I would second it.
DR. LUMPKIN: Its been moved and seconded. Richard, if you have, I see -
DR. HARDING: I was fully ready to vote for this letter unchanged, Im a little, could we go through it one more time and just say strike these words and add these words just so we make sure, this is an important letter and weve said a lot of things and not everybody has written them down.
DR. LUMPKIN: Okay, were going to start from the beginning, were not going to read the whole letter -
DR. HARDING: Right, just say strike these words or add these words.
DR. LUMPKIN: Okay, so if someone has a copy of the annotated one -
DR. COHN: I think what were actually doing to do is were going to put the letter up on the, and then we can take a look at it to make sure its okay.
Ed I think you need to give Julie space.
Well get that up in a minute but I think what were saying first of all is the first page is clean if I understand.
DR. LUMPKIN: Right, I think the first page, Im not even going to mention, no, were not going to do that. First the issue of attached and enclosed but we dont even want to go there.
By my notes I think that brings us to the second paragraph on the second page.
Okay, so were down to the paragraph at the same time, the committee has heard concerns from the health care community about the costs, about the magnitude of, about the cost, the magnitude of potential benefits. Okay?
Then we go down to the next paragraph, benefits are harder to quantify but appear to outweigh the costs. They include facilitating improvements to the quality of care and patient safety, fewer rejected claims, improved information for disease management, more accurate reimbursement rates for emerging technologies.
So we add the language from that bullet on timeframes into the last sentence and then we go down to the next paragraph, we scratch a majority of to just say the, thats a style thing so we dont care, were focused on substantive here.
Then it takes us down to before the sentence that starts with by issuing, then we need to add in the sentence, at the end when it says and ICD-10-PCS, thats where we put the sentence about the timeframe.
DR. ZUBELDIA: Can we simplify that a little bit? Further recommends an implementation period of at least two years after the final rule, an implementation period of at least two years after the final rule.
DR. LUMPKIN: Okay, Clem.
DR. MCDONALD: Go up to the sentence that begins with benefits are hard to quantify -
DR. LUMPKIN: Okay, its there.
DR. ZUBELDIA: You have an extra parentheses after the fourth bullet.
DR. LUMPKIN: Thats okay, were not going to worry about that opening parentheses, that hanging parentheses, thats okay. We actually have a motion on the floor thats been seconded, and at the request of one of the members we have in front of us exactly what were voting on, and thank you because I think were very clear now what were voting on. All those in favor signify by saying aye.
COMMITTEE: Aye.
DR. LUMPKIN: Those opposed say no. Those abstaining? We have one abstention.
DR. HUFF: Im recusing myself, if thats different -
DR. LUMPKIN: Okay, the motion passes, we have a letter, and Id like to really thank the committee, the subcommittee for all their hard work and diligent effort to get this before us and now its behind us, for now, and unless Im wrong, I have to double check my agenda, the next item is lunch, so were back at 1:00. Thank you.
[Whereupon at 12:11 p.m. the meeting was recessed, to reconvene at 1:00 p.m., the same afternoon, Wednesday, November 5, 2003.]
DR. LUMPKIN: Lets move on with our agenda. One of the things that now that were done, I did want to especially thank Simon for his work on shepherding through the ICD-10 process, it was a very difficult process. I know a number of organizations that Simon belongs to threatened to revoke his membership and through his successful negotiations he has maintained his status and its greatly appreciated Simon.
DR. COHN: Thank you.
PARTICIPANT: Ive heard that its aged Simon a little bit, hes really only 28 years old.
MS. GREENBERG: And he used to have a full head of hair?
PARTICIPANT: I wasnt going to go there.
DR. LUMPKIN: I was just wondering, I dont think Simon thought it was a hair raising experience.
PARTICIPANT: People in glass houses shouldnt throw stones.
PARTICIPANT: Since hes left Illinois his pun level has really increased.
PARTICIPANT: Not the quality.
PARTICIPANT: No, not the quality.
MS. BEREK: Just as the CMS liaison I wanted to thank all of you, I think the real work is yet to come for us in terms of beginning the rulemaking process and I was listening to the discussion about how long it was going to take and Im thinking two years, you really think well get it done in less then two years, so I think that the work is ahead of us and Maria and I are very happy that its now Tom Gustafsons problem. And we are looking forward to watching him do that. But thank you very much for moving it forward, I think it makes a real difference to the agency.
DR. LUMPKIN: Now I am disappointed in one thing, Simon it would have been a perfect opportunity for the top ten list on ICD-10.
MS. GREENBERG: Let me just say on behalf of Dr. Sondik who had to go to a Healthy People 2000 review but also the National Center for Health Statistics appreciates your moving this forward as well and well look forward to working with, continuing to work with CMS on the rulemaking process.
DR. LUMPKIN: Okay, Simon, youre still on the hot spot.
Agenda Item: PMRI Report Dr. Cohn
DR. COHN: Okay, this is document two of three that were working on today. I think in front of you, and Ill hand this off to Jeff in just a second, is something called PMRI Terminology Recommendation Letter Summary, which is something that Jeff put together and Jeff, thank you, to try to digest what is a seven to eight page letter at this point, it hasnt grown since I last looked at it. Its just a seven page letter with an additional page of references and all of this. So we thought it would be useful to sort of walk through the high level and then we can talk about what parts of it we actually really need to read.
Jeff would you like to give everybody some background and discussion?
MR. BLAIR: You betcha. My remarks really are to help those folks that are not on the Subcommittee on Standards and Security because obviously weve gone through this, all of this detail, for the last number of years. And many of you are new to the committee so Im going to try to concisely give you a quick picture of why were doing this and how we came to these recommendations.
And were doing this because the HIPAA reg from 1996 told us to. They directed NCVHS to study issues related to the adoption of uniform data standards for, and the words they used in the law was patient medical record information and the electronic exchange of that information. No definition and many of you will look at that and wind up saying well this is clinical data, other folks will wind up saying that this is electronic health record data, computer based patient record data, whatever, thats fine, no one has put a constraint on the definition.
Now, they gave us four years to give our recommendations and after four years, August of 2000, we produced a report. The report had three elements in it, it was about a 60 page report, and it was a strategy for how we would go forward on this because this was complex. It had a framework, it had guiding principles for the selection of PMRI standards, and it had a number of recommendations because we knew this was going to take years to do and while we were going through the selection process in phases we felt that there were things HHS could do to accelerate the standards development process.
We produced that report, that was our foundation. Then on February 27th, 2002, we used that foundation to then put forth our recommendations on standards for PMRI message format standards. And about a year later, March of this year, Secretary Thompson announced that those standards would be adopted by the federal government but interestingly they were not designated as HIPAA standards, they were designated as CHI, or Consolidated Health Informatics Initiative because thats part of the federal governments eGov initiative, and those standards were put within the context of the National Health Information Infrastructure. So they were pretty central to moving forward.
Now for the last 15 months we have tried to take the next step, which was to make recommendations for PMRI terminology standards. In so doing, and by the way that information is basically covered in the first part of the letter, I labeled this on a summary as introduction, theres not a label on the letter saying introduction, thats just a style piece.
So the next section is the background information and Im going to give you less detail on this, but essentially the background tells about the process, and Im just going to briefly give you some feeling for this 15 month effort. We hired a consultant, Dr. Walter Sujansky, to help us with the technical assessments, we solicited guidance from the health care industry when we started to say what should be the scope, how should we modify the criteria for selection to make them appropriate for terminology standards. We put forth a comprehensive 16 page questionnaire that all terminology developers could submit if they wanted to be considered as a PMRI terminology, and we had over 40 terminology developers respond to that. We were also given guidance by the industry that we should focus on a core set of PMRI terminologies because the core set would be like a reference terminology, in other words it would be the anchor, the part thats stable, that doesnt change, so this would be not the linguistic level, which could be subject to different interpretations and changes within terms of context, but this is the concept. So among the criteria we used was to pin down the terminologies to make sure they were concept oriented, in other words not ambiguous, that they were consistent and they had version controls because this was going to be a core that other terminologies would refer to for resolution.
The other pieces that we had in that background piece was continuing the philosophy that we derived after our other HIPAA experience, was to not have this go forward as a mandate, but were going to wind up instead trying to build consensus within the industry for these things and use it as guidance to the industry. Guidance and incentives. Im not going to go into the detail on that as to what those are, thats just background for you.
The next section is the recommendations and Simon is going to take you through those in detail but Im just going to give you a very quick outline so you have this in perspective. These recommendations focus on the core set of PMRI terminologies, in other words a central reference terminology thats concept oriented. It looks kind of simple and straightforward in that theres three basic recommendations, SNOMED CT, the lab portion of LOINC, Logical Observation Identifier Names and Codes, and then the drug terminologies. Now the drug terminologies turn out to be developed within the federal government and there was a considerable amount of work to be done in pulling together this portion of the letter because there had to be agreement between the different federal agencies and Steve Steindel really helped put that portion of the letter together. So youre going to wind up when you get down to that portion youre going to see a little bit of history, a little bit of explanation, a little bit of pieces on that, and then you get to the three drug terminology pieces that were recommending, Rx-Norm, pieces of NDF-RT, some areas from FDA, and then the other pieces are how do we integrate these terminologies into a core set.
The next section after that is given that were going to have an integrated core set how do they map to the other important related terminologies with the first priority being the pre-identified HIPAA code sets, the second being other terminologies that are important, that are in common use, and are enablers for a lot of clinical functions.
The next piece after that is to designate a body to do that work, and as youll see is the NLM.
The next piece is how does this relate to the PMRI message format standards.
And then the last piece is to identify important areas that we couldnt include in this letter but were identifying them for visibility and recognition of additional research.
And Ill turn this over to Simon and I hope that that helps.
DR. COHN: Any questions before we start into this? Now the good and the bad news is that Jeff I think has done a very good job providing I think a very good background to all of this. The bad news is that thats only the first page and a half of this document. Seriously, I guess I would recommend given that this is a six page that we not rework all the background comments but I do think that if were going to consider voting on something that we should probably read through the recommendations. And I will try to read section by section, I will also do my best to avoid those areas that are more explanatory if thats okay with everyone. Does that make sense, John, is that, Im not excited about even reading through all six pages, or four pages.
DR. LUMPKIN: Well, for instance, the first is a core set of PMRI technologies in SNOMED, LOINC, and federal drug terminologies, I think are fairly well explained within the document so I would just take that as the first recommendation, see if theres any questions. Were taking as the first, as were walking through the document the first set of recommendations really referred to the core set and those are three things, SNOMED CT, LOINC, and federal drug terminologies, which include NDC, a couple of other internal technologies that the FDA is now making available to the industry as a whole.
MR. SCANLON: Jim Scanlon. Are there any, for the first three here and the federal drug terminologies is a complicated one, are there any conditions or provisional recommendations? Are they more or less being proposed as production stage terminologies that anyone can get access to?
DR. COHN: Its my understanding that these either in production stage or slated to be fully released by the end of 2003, beginning of 2004.
DR. LUMPKIN: And I think maybe lets walk through each one separately, first lets go to SNOMED and see if theres any questions or comments about SNOMED.
DR. COHN: Would you like me to read the paragraph or -
DR. LUMPKIN: No. Were on page three now, top of page three, SNOMED CT. If there are any questions about SNOMED and weve had a number of discussions about SNOMED in the past so its -
MR. SCANLON: -- target date for availability on the UMLS website is, for SNOMED, Steve do you remember?
DR. STEINDEL: Its with the January release of UMLS, January of 2004.
DR. STEINWACHS: Let me try one question and then you can tell me all the things I dont know. SNOMED is essentially a diagnostic classification system, no, it covers everything. Does it cover the reason people go to health care?
DR. COHN: It can.
DR. STEINWACHS: That was really what I was concerned about, the reasons people seek care.
DR. COHN: And Stan may have some comments also, I see him sort of nodding his head. You can comment, youre not recused from discussing this one.
DR. HUFF: SNOMED is by far the best terminology that I know of for these things. There are things missing from SNOMED so I mean SNOMED contains signs, symptoms, diagnoses, syndromes, etc., and to the extent that youre coming and complaining of a sign or symptom its most often going to be in there. But its not, there are some things missing in it. Theres a process in place whereby as those things become apparent they can be added to the terminology. So I think its ready for use.
DR. STEINDEL: In one sense it depends on how youre asking the question. If youre asking the question from a clinical viewpoint about why people seek care Stans answer is very appropriate. It covers the area, its probably not complete, and its of great interest to the UK, which is part of the conglomerate that put together SNOMED CT and theyre working very hard to improve that area. So from a clinical point of view its very well done. If youre asking about it from a population health point of view, about using it from a statistical viewpoint, thats one of the things that Ive brought up repeatedly about SNOMED CT is that it needs a lot of work before it can be used for population health or public health purposes, and theyre aware of that but we need to realize that it was primarily designed as a clinical system.
DR. LUMPKIN: Marjorie?
MS. GREENBERG: A related issue is, and may be cleared from actually what Steve said, but we were having a discussion about this actually within the Department, if youre asking does it cover the patient reason for encounter, in lay terms, in the patients own words, I think thats not what SNOMED is intended for. Its for clinical use, is that what you were asking?
DR. STEINWACHS: Well, its both the -
MS. GREENBERG: Well although often its the same thing, I mean if the person says they have a headache then the headache is in there.
DR. STEINWACHS: Well, both the minimum data set recommendations for ambulatory care that talk to capturing routinely what people come in, because we assign a diagnosis and if you lose that then you dont really understand, and I guess I thought Steve was addressing that, too, as you pull information together and as you talk about issues around preparedness, some of that information becomes more salient to understand why people are coming in as different from a clinical assessment of signs and symptoms. So it seemed to me it should be a priority area and I dont know how that gets dealt with, but I think youre saying it could be something added to SNOMED, its just not there from the point of view of why people come in.
DR. MAYS: Its just a little off and I wanted to actually follow up on Steves comment and just ask the question, what do we intend to do in terms of being able to capture the public health aspect of this? SNOMED is not the best and Steve has said he has been putting it on the table, can I just ask the committee --
DR. STEINDEL: I think thats why Im going to show up at your committee meeting maybe a little late tomorrow morning. I think its a very open issue that we need to start a very good discussion about how these clinical terminologies relate to our means of capturing public health and population health statistics.
DR. LUMPKIN: But I think that it might be fair to say not that SNOMED is not the best, I mean it is the best, its just that were filling in this puzzle and SNOMED is a piece, its not the only piece, and there may be some pieces that we havent quite figured out where we left them.
MS. GREENBERG: This might be a place Steve to put in a little commercial. Actually, I will, shamelessly, but the Public Health Data Standards Consortium is actually sponsoring a session at AMIA next Tuesday afternoon, 5:30 to 7:30, on public health vocabulary, so thats one of the vehicles for trying to engage the profession on that issue. And Steve is actually one of the speakers.
DR. LUMPKIN: American Medical Informatics Association. Clem?
DR. MCDONALD: To reinforce what you said about the pieces of the puzzle and as you get through this report youll see theres another ten or 12 vocabularies and there maybe still be other ones invented, its the gluing together the puzzle, finding the pieces and putting together is what this is eventually all about, so the first one we come across doesnt have to cover everything.
DR. COHN: And I guess I would also suggest that this is actually what the CHI is involved with, I mean this is one level of it, CHI, but it begins to enliven the discussion of CHI, which are these one page recommendations that we all made, but really what theyre trying to do is as the domains are dealt with, figure out what of this terminology, what of this terminology, what else needs to be brought together to make things work. And thats really taking all of this from a high level into how do we implement it.
Okay, LOINC -
DR. COHN: Half the committee cant comment on this one, they have to recuse themselves -
DR. STEINWACHS: Being the one whos going to ask the stupid questions, LOINC is essentially just a laboratory system that identifies -
DR. COHN: Its the lab test terminology.
DR. STEINWACHS: Lab test terminology. And that includes radiology, all sorts, or just laboratory.
DR. COHN: Lab.
DR. LUMPKIN: Let me see if I can clarify, turn it over, you can answer factual questions.
DR. MCDONALD: LOINC actually includes radiology and all kinds of measurements and observations, its the question, not the answer. This proposal is limited to just the laboratory -
DR. COHN: Thats clinical LOINC.
DR. LUMPKIN: Okay, anything else on LOINC? The federal drug terminologies are a little bit more complicated in that they involve a number of component parts because you need to, when all is said and done you have to talk whats in it, what it is, how its packaged, and how its given, so there are many pieces to it and the recommendation will fill in a number of those pieces, some of which as I mentioned before for instance the FDA has developed an internal coding system for the ingredients of drugs and they are going to be in the process of making that available within the first quarter of 04 as a public domain terminology for the ingredients, active ingredients. Active and inactive ingredients.
DR. STEINDEL: Initially theyre focusing on active ingredients but they intend to cover inactive as well.
DR. LUMPKIN: Thats correct.
DR. STEINWACHS: That was one of my other just stupid extension questions. Is there in the future going to be available in coded form sort of what are the on label uses or the indications of these drugs that you can match then? If I wanted to do a little quality study, is that something that exists that would be coded in some way? I see it in text but I never -
DR. STEINDEL: I think it is coming, it is coming, the FDA has an electronic labeling projects and one of the sets of FDA terminologies that we note needs to be involved with the PMRI terminologies is the electronic labeling project. The actual codes for the section of the label are part of LOINC and they will probably be passed and balloted by HL7 in the near future but they have been in LOINC for a while. But those are just the section labels, what actually goes and fills out the section is going to require regulatory action by FDA, so until that occurs we wont see an electronic label but once that occurs we will be seeing the electronic label.
DR. COHN: Don, it might be something that we, and this is a relatively complex area, its footnoted in nine point type at the bottom of page four, maybe its eight point, I couldnt decide. But what I was going to say is that this is probably an area, weve taken a cut at it with the PMRI terminologies but theres obviously a lot more here and it may be something that we actually want to have the FDA come and brief us on the whole model, which is really what were talking about because it includes NDC, it includes all of these other pieces that arent really part of PMRI core terminologies, but as you commented are essential and we probably ought to ask them to explain both what it is as well as what theyre doing to make it happen. There may be a letter that falls out of that.
DR. STEINWACHS: Thank you for your indulgence.
DR. COHN: Im sorry, did you have another question, Don?
DR. LUMPKIN: So moving forward in the recommendations then, we talked about those, there are some sub-recommendations under there related to Rx-Norm -
DR. COHN: Right. Im sorry, I thought youd already gone through that.
DR. LUMPKIN: Okay, I was thinking on page four, did we already go through those two?
DR. COHN: Those are basically the core of the federal drug terminologies that are the -
MR. BLAIR: Could I just help? The other recommendations that are related to this are to indicate that the National Library of Medicine and FDA need to be appropriately funded because were going to be making some additional demands on them because this is going to wind up being, this core set of PMRI terminologies is going to be widely used and its going to have to be updated on a more timely basis, especially the drug information, and so its pointing out that were recommending that appropriate funding be made to cover these additional responsibilities.
MR. SCANLON: Is that a condition of a recommendation?
MR. BLAIR: No, we didnt state it as a condition, its just an additional, its a supporting recommendation, lets put it that way.
DR. LUMPKIN: Okay, anything else under the drug terminologies? Steve?
DR. STEINDEL: John, I just would like to make a point, the actual recommendation word that you noted on page four, what it refers back to is recommendations made by this committee in the August 2000 reports, so the federal sector did not undertake this project de novo, it actually did it upon recommendation of this committee.
DR. LUMPKIN: And who says the federal government isnt responsive?
So that moves us to page five, which is the integration of core set of PMRI standard terminologies and mapping priorities.
DR. COHN: First of all we feel that the core set of PMRI terminologies must be integrated and integrated basically by creating relationships within the UMLS, so thats an issue of integration. Then obviously to make this useful we feel there needs to be mappings to important related terminologies and theres two priorities here, one is mapping to the HIPAA medical code sets, including many of the things that we were just talking about this morning. And then priority two are terminologies in common use and these are obviously, not examples, but this is a list but its not necessarily just limited to this list but we felt this was sort of a high value list and things like DSM-4, the private sector drug information databases, the terminologies in them, the ISB128, which for those of you who dont know what it is, and Im not sure I would know what it is not being a pathologist, is the coding system for describing blood products and tissues, Medcin, Medra, and the nursing terminologies not otherwise included in SNOMED CT. So thats sort of the list of recommendations around mappings. People from the NLM thought that this all might keep them busy for a while.
DR. LUMPKIN: Okay, any questions? Marjorie?
DR. STEINWACHS: Could you say a couple words about how the split between priority one and priority two is done? I was trying to scan that paragraph -
DR. COHN: Priority one is the HIPAA medical code sets, theyve already been identified as administrative code sets within HIPAA, they are ICDs, its the CPTs, its the NDCs, that basically enable, to be able to use these terminologies at all youve got to have high quality mappings to these because these are whats used in commerce.
DR. STEINWACHS: And the others are -
DR. COHN: Are helpful clinically.
DR. LUMPKIN: Marjorie.
MS. GREENBERG: I just wonder if in light of the previous letter that was just approved, where you have ICD-9-CM you should say and its replacements. A lot of people dont understand, and I dont know whether this is not the place to do it but a lot of people dont understand the relationship between recommendations like this and the previous recommendation.
DR. LUMPKIN: I think the problem is is that there needs to be NPRM that has to be implemented as a final rule and were talking, if one were optimistic based upon our last letter, two years, but knowing that nothing happens that quickly probably more like three or four or five.
MR. SCANLON: And the other thing is I wouldnt presume to separate the committees recommendation from what ultimately may happen. You cant assume that a recommendation from the committee will necessarily be implemented as drafted, a lot of things, so I wouldnt presume anything.
DR. MAYS: I just want to go back to the mapping, I want to make sure I understand this, Im trying to make sure I understand it also because of DSM-4. In the section, the next section, designation of a central coordinating body for PMRI chronologies. In the next section what is recommended is that National Library of Medicine be the organization responsible for funding, coordinating, or performing mapping between the core set of PMRI terminologies and the important related terminologies. What is the time scale that you imagine that would be? I mean its really important because if you want this to be coordinated and you dont say anything about how important it is in the time span you want to do it, I mean that could occur over lots of years or it could be a lower priority and Im a little bit concerned if these priorities twos are really important -
MR. BLAIR: Vickie, I think a lot of the members of the subcommittee share your feeling, theres this sense of urgency, and Im not saying this is right so Im just going to give you sort of some feedback on a little bit of the discussions and some of the words about this and then you may continue on to see whether Im giving you a satisfactory answer or not. The way we looked upon it was we dont feel that the NLM or the FDA or even the VA can at this point make any commitment, even if we, in terms of timeframes, so what we tried to do was give them latitude and we recommended additional funding for the integration, we recommended additional funding for the mapping, and to accelerate the availability of both of those functions and to accelerate the interim of time for them to update it to serve, for clinical uses. But we thought at one point of putting a deadline but we stepped back from a deadline because we dont know how much funding would be available, we sort of left that to the discretion of HHS, at least Im explaining our thinking process and then you can determine whether you think thats satisfactory or not.
DR. MAYS: Can you at least talk about the urgency and the acceleration or something like that so that theres -
MR. BLAIR: We did use those, I think those words are, double check me, if you look under the other recommendations under the drug terminology pieces, we tried to accelerate but maybe thats where you want to look at and see if you want to strengthen it.
DR. STEINDEL: Jeff, the language that we used for increasing for funding for both the National Library of Medicine and the FDA were very specific for the federal drug terminologies. We did not put in any recommendations for funding in the area of mapping or the designation of the central coordinating body and really Betsy did not ask us, from National Library of Medicine, she didnt ask for us to put in specific funding language but she felt that the designation of the National Library in this manner would serve as enough evidence for the National Library to seek additional funding in later budgetary processes -
MR. BLAIR: -- reference to Betsy, thats Betsy Humphreys of the NLM.
DR. STEINDEL: Of the NLM. And one of the reasons for this is the way the language is worded some of the funding for this may come from other areas of the government because the charge to them is to coordinate the mapping and if private sector groups find that the mapping is very important and needs to be done in a timeframe thats faster then the National Library can address it, the National Library might coordinate the mapping through the private sector and not actually involve funding itself so they didnt really want their hands tied in restrictive language in the recommendation letter itself but wanted a strong enough wording in the recommendation letter that they could use it to map their own course over the next short period of time. And they realized their priorities for this.
DR. ZUBELDIA: The other point I wanted to bring up is that the same as the terminologies are still subject to improvement and additions, the mapping is not something that will be done once and completed, its something that will have to continue, so the urgency was to do as much of the mapping as possible to make it usable and then continue with the process to continue with the mapping as an ongoing basis, but at least the core part of the mapping to make it usable should be done as quickly as possible.
DR. MAYS: Where is that said?
DR. ZUBELDIA: The recommendation on page four says increase the funding to the NLM for the Rx-Norm project to accelerate the development of terminology content. We didnt explicitly say it with those words, to make the core of the mapping possible, but that was the discussion that we had with Betsy.
DR. COHN: Vickie, I think youre bringing up a good point, Im listening to all the conversation and Im not persuaded given that weve already asked for additional funding for the NLM regarding to Rx-Norm, why we didnt ask for it, relationship to them being a central coordinating body or for the mappings, and it may or may not be needed, but I think given that were asking them for fairly sizable body of work youre bringing up a very good point that we ought to insert some language in here as a recommendation which would certainly not be very hard to do. I guess the question I would have for others is whether we should insert that at the end of the mapping section or in the designating of a central coordinating body for PMRI terminologies and it seems like it might actually be better in that second section where we actually put a recommendation there that says we believe that the NLM needs additional funding for this and for mapping and to accelerate mappings. But I dont think that we need to put a date but I do think additional funding will obviously help make all of this happen.
DR. STEINDEL: Simon, I think from a structural point of view just at the end of the section designation of a central coordinating body for PMRI terminologies, because we list what those actions are and we can just add a sentence at the end that says give them more money, more funding for this.
MR. BLAIR: And Im assuming, Steve, are you able to add that to the letter?
DR. STEINDEL: Yes.
DR. COHN: It sounds like thats, is that something that the committee feels is appropriate?
DR. LUMPKIN: Okay, anything else on the section about designating NLM as the coordinating body?
Okay, the next section basically focuses on the issue that there needs to be harmonization between the currently adopted HIPAA transaction standards and these terminologies.
MR. BLAIR: Actually in this case it was the PMRI message format standards.
DR. LUMPKIN: Oh, Im sorry, the message format standards, yes. The message format standards which refer the recommendations in these terminologies. Any questions on that?
Okay, the next section is on research, oh, Mike.
DR. FITZMAURICE: Is there a reason why this is set in smaller type then the rest of it?
DR. LUMPKIN: Actually it was a test, a vision test.
MR. BLAIR: Michael, they wanted to see if I would notice it.
DR. ZUBELDIA: The smaller font on the in front were contributions from Microsoft Word.
DR. LUMPKIN: And I thought whoever did this was a fount of knowledge.
Okay, the recommendation for additional research -
DR. COHN: Should I just go through this real quickly here? A dental content is an area that were actually going to be holding a hearing on in January, there are some issues within the dental industry that we need to be, we need to hear from some of the players before we can move forward on recommendations.
DR. LUMPKIN: Im just curious whether or not the correct term would be dental or oral health issues, I dont know, it may be appropriately dental, always just dental. Okay, well leave it dental -
DR. COHN: Clinical LOINC is another one which as I said half the committee cant talk about, but we felt that there needed to be additional research into the need for and value of some of the clinical subsets of clinical LOINC, so that was another one that actually work is going on now to ferret that out and from earlier today.
Device terminology was something that we heard about, there seemed to be two camps that arent, Im trying to think how to say this nicely, there are two different terminologies, one would hope at some point that they might merge eventually. At this moment that doesnt seem to be happening and maybe its in the process of that, we will be revisiting that when theres a clear direction in recommendation there.
Then the issue which I think weve been talking all about is the fact that theres other content from other terminologies and in some cases you may want to incorporate the whole terminology into the core, PMRI terminologies, in other cases there may just be a subset that may need to be imported, so thats part of the further investigation there that needs to occur.
And then we wish to thank you.
DR. LUMPKIN: Any questions on the research section?
MR. LOCALIO: I have an overall question. Its not apparent to me from this document whether the committee has opinion or wants to have an opinion on the issue of who is going to own the pieces when this is completed and what is going to be the access to those pieces. Now I know from, and Jeff sent this in advance so I know a little bit about this but some of these pieces are either in the public domain or freely licensed, I dont know about the mappings, when this is all done are all of the pieces in the public domain? If not, why not? Are there going to be pieces that will not be in the public domain? Will it cause problems? And does the committee have a position on this and should something overall about that issue be in this letter?
DR. MCDONALD: I think Id like to clarify the public domain I believe is not what you want because that means you can get copies in variance, what you mean is free for use.
MR. LOCALIO: Freely licensed or some licensing arrangement or some situation such as has been with SNOMED as I understand, LOINC I guess is freely available, I dont know about the others, I guess the VA is free
DR. COHN: Rx-Norm and NDF-RT and obviously the FDA terminologies are all free. Now I think the issue you do bring up is around the mappings and Im a little shy about beginning to make pronouncements in a letter here about either all or nothing recognizing that SNOMED, even though there is a license is privately owned and maintained. Certainly some of the things that the core terminology would be mapped to are a combination of things that are freely available and things that have license fees associated with them. I guess my preference would be to leave it vague and not address it at the moment but I guess I would look to others to see what their views are.
DR. STEINDEL: In answer to your question everything thats being recommended for the core at this time is freely available, its not in the public domain but it is freely available in the United States. SNOMED as pointed out is a privately owned, the license covers its use in pertuity(?) for the U.S., so thats okay, LOINC has always been freely distributed, and Rx-Norm and NDF-RT and the federal terminology as all federal terminologies are available for free, anything that is charged in the federal government is just basically distribution costs and I dont even think any of these have it. Rx-Norm at this point in time is not directly available because as was mentioned earlier the VA wants to protects its intellectual property right to prevent people from changing it and distributing NDF-RT and theyre in the process of trademarking that right now. Once thats done it will be freely available on their website. Rx-Norm has been available in the UMLS for about a year now and always will be.
Now the issue of mapping as was brought out, that depends on the license terms with the two terminologies that are being mapped, so if we map from a core terminology to another terminology it is the licensing terms of the other terminology that would determine whether the map is freely available for use. If it exists in the UMLS which we are recommending as a central coordinating body then the map will be freely available but whether you can actually use it depends on whether you have a license for the other terminology. Now out of the HIPAA terminologies I believe the only one that requires a license is CPT and, CDT? CDT is strange, CDT requires a license but CDT actually is in SNOMED, so thats one of the things we need to investigate. But most places that practice health care have a license for CPT so once the map comes out it will actually be readily available.
MR. BLAIR: CPT was designated as a HIPAA priority -
DR. COHN: But see many of the priority two are privately -
DR. STEINDEL: I was focusing on the HIPAA.
MR. LOCALIO: Does the committee want to mention anything about this issue in the letter now that weve talked about it for a couple minutes? Or is this something that everybody knows? Or is this something that nobody cares about? In other words what does the committee want to do here?
DR. LUMPKIN: Well, lets maybe start off with what do you want to do?
MR. LOCALIO: I just want to raise the issue, no answers.
MR. BLAIR: One of the things, I dont know if this will help or not, when we had our initial guiding principles for the selection of PMRI standards one of those guiding principles was that the standard be available at little or no cost and one of the reasons why we frankly didnt get to this issue of selecting and recommending PMRI terminologies was because until that license with SNOMED was put in place where it could be available at no cost, that was a showstopper for us, so its in the criteria, which was the document that was published August of 2000, the criteria for selection of the standards -
DR. LUMPKIN: Im just thinking, the question is I dont hear any disagreement from the committee that these terminologies should be available at little or no cost, the question is do we want to put a statement in this document reemphasizing that this is an important issue for us as a committee. Clem.
DR. MCDONALD: To answer your question, I have two minds, but I dont think its a good idea to lock it up into this particular document because things are so complicated and theres so many different cases, a SNOMED license runs out in five years and others, so theres a lot of issues. I think it would make it more difficult to move propitiously with all this if we got too specific.
DR. HUFF: Im of the same mind, I mean I couldnt be more emphatic in my belief that having these things be freely available and unencumbered with intellectual property issues or other things is really essential, I mean its absolutely essential, if we adopt things where there are intellectual property or price barriers were not serving the country well. I think though what weve done is correct and if we were going to actually say that in a way that was appropriate it probably should be a sort of, it deserves more then a one sentence thing here to express the importance and complexity of the issue and so I would say leave this the way it is because whats being done here and whats being adopted is in fact in accordance with that idea, but that idea is important enough that I think it would be hard to put it into this document and give it the appropriate weight and elegance of expression that it deserves.
DR. ZUBELDIA: I agree with Stan and I think that has already been expressed in our principles for selection of a terminology. One of a principles is that specifically that it be available unencumbered by intellectual property binds and in a non-discriminatory basis and so on. So I think weve already been on record expressing that concept.
DR. LUMPKIN: Good enough for you? Great. Okay, how do we want to deal with this? Again our options are to pass this today, send it back to the committee to rework the draft, and bring it back tomorrow. Do we feel comfortable moving it forward?
DR. COHN: I think the only change I heard was the addition of a recommendation to fund, additional funding for NLM which seems to be simple enough to put in.
DR. LUMPKIN: So Simon makes the motion that, oh, Stan, Im sorry.
DR. HUFF: One other change I would recommend is just to make it more prominent is that on page three, the top of page three where it says the initial terminologies recommended for the core set are SNOMED, Logical Observation, and federal drug terminologies, I think it would help there to actually include under the federal drug terminologies basically the sub-bullets that are in the summary that say basically, there would just be bullets there that said Rx-Norm, the representations of the mechanism of action and physiologic effects from NDF-RT, the ingredient name, manufactured dose form and package type, so that just those three bullets from the summary be placed into the document right there to clarify, reiterate, make easier to see exactly what were recommending for the drug terminologies.
MR. BLAIR: Steve, do you see where hes referring to?
DR. COHN: Probably bolding it would good, too.
DR. STEINDEL: Stan, the specific recommendations were for Rx-Norm, the representations and mechanism of action and physiologic effect of drugs from NDF-RT and ingredient name, manufactured dosage form, and package type from FDA. Thats what youre saying put -
DR. HUFF: Id say just put those as bullets, those three bullets under federal drug terminologies in that, right at the top of page three.
DR. LUMPKIN: Its been moved by Simon that the document be moved forward with the following two changes, that under the section of designation of the NLM as the central coordinating body that a sentence would be, or sentences added urging appropriate funding to ensure expeditious mapping. The second is the one that we just heard which was to expand the bullet on page three, federal drug terminologies to include the three items indicated in the summary, Rx-Norm, representations of mechanism of action as from NDF-RT, and ingredient name, manufactured dosage form and package type from FDA.
DR. ZUBELDIA: Second.
DR. LUMPKIN: Seconded by Kepa. Is there further discussion? Marjorie?
MS. GREENBERG: Was the addition here related to additional funding for NLM, specifically was to say to assure expeditious mapping?
DR. LUMPKIN: Yes, because theres other language talking -
MS. GREENBERG: Because the designation of them as a central coordinating body is for more then the mapping.
DR. STEINDEL: I was actually, I was typing but I was going to raise my hand and comment with that. I heard the addition that the National Library be adequately funded, the way Ive worded this is in the last sentence of that present paragraph that lists four tasks for the National Library of Medicine, the language that I added was the NCVHS recommends the federal government increase funding to the National Library of Medicine so that they can adequately perform these tasks in an expeditious fashion, so actually all the tasks.
DR. LUMPKIN: Are we in agreement on that? Okay, everyone know what were voting on? All those in favor signify by saying aye.
COMMITTEE: Aye.
DR. LUMPKIN: Those opposed say nay. Any abstentions? And we have Stan and Clem -
DR. HUFF: We voted in favor of the parts that we can -
DR. LUMPKIN: We have two abstentions, recusals, whatever, they abstain because of recusal or whatever the appropriate legal term is.
Great, super.
DR. COHN: Actually I want to just thank Jeff for I think whats been some really wonderful and amazing efforts in terms of his leadership in terms of moving this forward and obviously the next stage now is more on PMRI activities but I think hopefully well put terminologies to rest for the moment and then move on to the other issues related to PMRI. So Jeff, thank you.
[Applause.]
MR. BLAIR: I just want to also recognize the critical role that Steve Steindel played in pulling together many parts of the information that helped us get through this tremendous amount of work and I also want to thank Dr. Walter Sujansky for the wonderful job that he did in analyzing all of the complex issues related to the PMRI terminologies as well.
MS. GREENBERG: And I would add Mike Fitzmaurice also.
MR. BLAIR: Michael Fitzmaurice, yes.
[Applause.]
DR. MCDONALD: And Id like to give special thanks because I didnt think this would happen until after I died.
DR. STEINDEL: Id like to point out there was another change, it called for elimination of a bullet and changing in font in the letter, and Jeff looked it over and saw that it was adequately done.
DR. LUMPKIN: Okay, before we move to the next item on the agenda we need a head count for this evenings social event.
MS. GREENBERG: La Collin which weve been to in the past, its right over across the mall.
DR. LUMPKIN: And I will extend my apologies to the group because there is a grant makers meeting on health care disparities this evening that I have to attend, Im trying to coordinate those efforts, which wont be as much fun as going out to dinner with all of you guys, well, it could be.
MS. GREENBERG: Were going to celebrate these letters that have been approved.
DR. LUMPKIN: This has been a heavy day, so can I see a hand count of people who will be joining us so we can make a reservation? Were looking like 12 would be the safe bet.
Next item is CHI update. Before Simon goes into this, well, no, Ill do it after Simon goes
DR. COHN: I was going to say, why dont we do this and then we can talk about all the work left to be done.
DR. LUMPKIN: Thats correct, go ahead.
Agenda Item: CHI Update and Recommendations Dr. Cohn
DR. COHN: Well, Ill just give you a hint, Im sure that all of you have read this document, it will be a lot thicker next time. Anyway, it probably just makes, this the form letter that you saw last time, and I might as well, its short enough that I think I can just read it and then well go through the bullets and make sure that everybodys comfortable with it. And basically its Dear Secretary Thompson:
NCVHS commends you for your commitment toward government wide adoption of clinical data standards that you first announced on March 21, 2003. NCVHS recognizes and appreciates that there is new momentum to adopt clinical data standards that is driven by you and CHI. Consequently, NCVHS is now working closely with CHI to study, select and recommend domain specific patient medical record information terminology standards. We have mutually developed a process that allows NCVHS to discuss in open, interactive sessions CHI recommendations as part of the CHI Council acceptance process.
The NCVHS has the following comments on the attached sheet of CHI domain area recommendations, and these were domains that we heard major presentations on last week.
The first one is that the NCVHS concurs with the CHI recommendations for interventions and procedures, part B, lab test order names, and Im sure you wont be surprised when I say that thats LOINC.
Two is the NCVHS concurs with the CHI recommendations for the medical domain as modified in the attached document, and we made a bunch of wordsmithing changes there. We further note 1), the need for additional funding for the FDA to expedite the publication of a publicly available version of their unique ingredient identifier code and to provide continued funding to maintain the UNII code standard. 2) That the dosage and administration sub-domain be investigated in the next phase of the CHI process, and the NDC process be investigation and improvements identified be expeditiously pursued.
And then the third recommendation is, and by the way those medication recommendations are substantially in agreement with our recommendations that we just made, I think theyre a little bit, is there anything beyond, theres a little more in their recommendations but in a sense it applies specifically to the federal sector, I think its all consistent. Now, Steve -
DR. STEINDEL: Its completely consistent with what we just approved, and a fine difference is we are a little bit more specific in the CHI recommendation about exactly what the funding should be used for then we were in the general recommendation and I think that was done deliberately.
DR. COHN: And then the last one is the NCVHS concurs with the CHI recommendations for the immunization domain as modified in the attached document.
DR. STEINDEL: That was wordsmithing changes, too, Simon, there was one sentence we felt was a little ambiguous and they cleaned the wording up on it. And Cynthia didnt send me a mark-up version so Im not exactly, it was right in the very beginning. Its HL7, the HL7 immunization messaging mostly for, its geared towards immunization registries and the CDC code sets that are being used to designate immunizations, and both standards have been in wide use, have been in use for a long time. We had some question about this widespread use but theyve been there for a while.
DR. COHN: So anyway, those are the recommendations, once again the first two are really consistent with what we were talking about before, the third is immunizations which we think makes a lot of sense, clearly this was an HL7 standard that was developed by the industry with significant CDC participation.
DR. LUMPKIN: Any questions or comments? This is completing the loop for a number of these and its a very iterative process, weve been working directly with CHI, weve made recommendations to them, its gone all the way through the process and in many ways we are sort of the last step before the Secretary of HHS adopts these for us in their leadership capacity, which is exactly what we asked them to do a few years ago, which was to adopt them for federal use and lead the industry by example rather then as has been done with some of the HIPAA required codes, transaction standards, which were by imposing those. So this is all consistent, some of these things have some of the same ring because again its somewhat of an iterative process. Its been moved by Simon, seconded by Jeff -
MR. BLAIR: I second it.
DR. LUMPKIN: Further discussion? All those in favor say aye.
COMMITTEE: Aye.
DR. LUMPKIN: Opposed say nay. Any abstentions? Okay, great, Simon more on CHI future work. You aint seen nothing yet.
CR. COHN: CHI is on a fast track and they I guess are expecting to, the subcommittee will be meeting in early December, spend at least one full day with them. Right now apparently they have 13 additional domains coming up for final review by the subcommittee and it will be just an interesting question about how many, how long, a case of how much we get to, how long it all takes, how much we can stand. Actually this is important work and were happy to help support the government in terms of moving forward but this will be a lot all at once.
Now the question I think John for you is whats next after that, do we wait until March for final agreement by the committee or do we need to do something before that?
DR. LUMPKIN: Well, heres my thinking that I want to sort of have us all kind of think about. This is a very large quantity of material, there is a possibility we may have new members by then, and given that we want to move it to a vote I suspect those of us who have been around for at least a year or two or longer pretty much understand and know the process and the background and I think we could move the last letter, such as we did expeditiously but thats because weve been discussing these kind of issues related to the last letter, not only in prior meetings but we spent a fair bit of time talking about it in the prior discussion on PMRI and so forth. As such Im thinking that if we try to do all this at the March meeting that we will not have room to do the other business of the committee that is also being directed towards the March meeting, so Im suggesting that we look to add an additional meeting, which could be a combination in person as well as by audio because it probably will take a couple hours of work to do. One of the suggestions, and well just have to look at the alternatives, would be to append it to the Standards and Security Subcommittee, which is meeting on January 27th and 28th, so thats one of the options and we can look at some additional options, but I just wanted to toss at you that given that this is really such a historic effort on the part of the Department and CHI to really make a big difference in picking up the pace of adoption of clinical data standards that some additional action, recognition of that by our committee through an additional meeting may be pertinent.
DR. COHN: John I would actually also add that it might also be appropriate at that time for us to hopefully review and pass our final, our annual report, if we were to have such a meeting. So we have two main agenda items.
DR. LUMPKIN: Two main agenda items and so that will be -
MR. BLAIR: Question?
DR. LUMPKIN: Yes.
MR. BLAIR: When we typically add, if we add a day and we add it to the end its not really a whole day, its until maybe 2:00 or 3:00, is this something which, if it deserves a full day then I would suggest that you add it to the beginning rather then the end.
DR. LUMPKIN: Well, first of all, there may be items that will be still be on the subcommittees agenda that will apply to what we would have to discuss so I think adding it to the beginning, and second is Im thinking somewhere around an hour and a half to four hours ought to do it for both items. An hour and a half to four hours is kind of the timeframe Im looking at and that would be consistent with getting out and 2:00 and letting people get their airplanes going west.
MS. GREENBERG: So are you talking about Thursday, January 29th?
DR. COHN: I would certainly support that date rather then the Monday.
DR. LUMPKIN: Yes, yes, I think thats the date we need to look at and I say that without checking my own calendar, but the issue is is I think we need to have an additional meeting of the full committee between now and March and that we will explore that date, give you a change to check your calendars and if thats possible try to do that recognizing that we may need to bring in some members electronically into that process.
MR. SCANLON: And John the presumption is that the subcommittee of course would have at the December meeting and then earlier in the general meeting would have the already -
DR. LUMPKIN: What Jim would have said if he had talked into the microphone was that the assumption is is that the subcommittee will have processed all of these recommendations prior to our action.
Okay, let me just make one additional comment before we move into the report to Congress. Sometimes in the press of work we dont always see the import of what weve done and I think today up until this point weve actually done quite a significant load of work. And as you can see from this attached item were halfway through the various domains from CHI and I think Clem said it very appropriately that many of us thought we wouldnt see this work as quickly as it has been and a lot of thats been due in part to the work of the committee and the fact that this committee has been a really true partnership between those of us who come in from the outside and those within the federal government who are charged with doing this every day, and what we are doing and have done has had a, and will have a tremendous impact on this accelerated transformation of health care and the import of that really cannot be minimized, so I just wanted to thank all of you at this point as we move on to the next item. Good work.
Okay, yes?
DR. FITZMAURICE: I would suggest that NCVHS might, given the body of work thats been done by CHI up to date, might want to recognize the leader of the CHI of this, that person has left the government at this point, Im speaking of Jared Adair, but the good working relationship shes had with the Subcommittee on Standards and Security, the volume of work and the excellence of it deserves at least our applause I think.
DR. LUMPKIN: And the letter.
MS. GREENBERG: It was sent but in her retirement she hasnt received it yet.
MR. BLAIR: John, Michael was just testing you.
[Applause.]
MS. ADAIR: From the CHI point of view can I say thank you to the NCVHS for helping them move forward. Thank you very much.
DR. LUMPKIN: Simon.
Agenda Item: Draft of HIPAA 6th Report to Congress 2003-2003 Dr. Cohn
DR. COHN: Okay, were obviously beginning to work on the HIPAA, the annual report, this is typically a collaborative effort by everybody on the committee with the subcommittee chairs trying to take the lead and the Executive Committee being involved in trying to put together the product, and of course our staff and support at HHS.
This one has been taking a while to come only because of all the activities occurring this past year in relationship to HIPAA implementation, and I guess assuming that we actually do have a face to face meeting in January the hope would be is that we could talk through some of this today with the idea that we would have a final version in January to review and hopefully sign off on. Jim, would you like to start off on this one?
MR. SCANLON: Thanks, Simon, and I have fortunately, I have enlisted, now that the annual report on HIPAA covers privacy and the transaction and code set standards, and actually the PMRI standards as well, it covers virtually all of the subcommittees now including populations, and Ive asked John Fanning and Ive recruited Maria Friedman as well now to kind of, to help bring the report forward.
But let me say a couple things, I dont really want, I think what we have to agree to today is kind of a structure and a plan for proceeding, I dont think you really want to go through the report itself. But because this was a very, this was the year in which the effective dates actually came on board for both privacy and for the transaction code sets. Youll recall that weve been putting off, but weve been trying to agree on what would be a good ending point for the report. Obviously cutting off the report on October 15th just before the transactions and code sets for example went into effect would have not been a very satisfying kind of a place to end the report but weve been sort of trial and error deciding well what would be a good point, weve now passed October 16th, so far so good, but would we want to carry it for example until the end of the calendar year in December.
And I think we would probably want to do that, bring it to a close, it would cover the year 2002 and all of calendar year 2003, and I think we would in terms of content we would of course do the factual part, which would describe all of the NCVHS and the regulatory activity relating to HIPAA that occurred during the year, including guidance for privacy, including guidance for contingency planning for the transaction and code sets and so on. We might even want to include the contingency plans relating to Medicare. But basically the idea would be to more or less in headline fashion take the reader through all of the major developments relating to the implementation of HIPAA right up through December.
Thats more or less the factual, this is what actually happened, this is what the committee did, these were the hearings, this is what HHS did. Of course theres an interpretive part as well on the part of the committee and I think thats the more difficult part given where we are with respect to the implementation of the transaction and code sets and if we could agree I think on, or at least start discussing what, do we simply what to have this as a factual report and indicate this is where we ended up as of December and just indicate that the committee will monitor the implementation, further implementation of both the transaction and code sets of privacy and continue to make recommendations, or are there some issues that the committee would want to identify as transition issues.
DR. LUMPKIN: Well, if I can jump in first, I think that just sort of skimming through this document I think the scope is a little bit narrow in that theres currently a fair bit of action on the Hill in relationship to the NHII and I think that the introduction should put this work and what HIPAA has done within the context of the NHII and how its helped move the agenda forward, that there are other pieces in NHII thats been addressed, that need to be addressed and the committee and others are working on that and then jump into whats happened with HIPAA and PMRI standards and so forth as the document does.
MR. SCANLON: And again, I dont think weve prejudged what will happen to those legislative proposals but we acknowledge that they are, that increasing attention is being given -
MR. BLAIR: I have a question. In this report to Congress I dont know how to represent PMRI because it started out as part of a directive under HIPAA but it was adopted as CHI standard within the context of NHII. What do you suggest as how we refer to it from this point on?
MR. SCANLON: I think what we can say Jeff is that what started out as the PMRI direction, that the CHI is sort of the implementation of that in the federal health care sector, in other words the concept of the PMRI has now been morphed into the CHI, implemented for federal agencies at least and with the expected tipping point through the CHI Initiative now. So we can sort of show how what started out as a legislative initiative turned into how it was actually implemented. And I think its a big part of our report, it was a small part of HIPAA, but on the other hand its a big part of NHII.
MR. BLAIR: Let me ask for a little broader guidance then and, how do I want to phrase this, would you encourage those of us on the subcommittee whenever we refer to PMRI from now on in the future to not refer to it as HIPAA PMRI standards, not have the HIPAA tag on it from this point forward and refer to it as well, I dont know, how should we refer to it?
DR. LUMPKIN: Let me jump into that because I think that one of the, my perspective on legislative bodies is when you have a hammer, I mean when you have a problem and all you have is a hammer, every problem looks like a nail. And what legislators have are legislation, and so what they look at a report and they say well, do we need to have more legislation in this area, and I think none of us would argue that we do, so that if we frame CHI as the implementation of what you guys in Congress told us we should do, we the committee, they the Department, then I think that thats a clear statement and it gives more direction as to where there may be other areas for them to look at but things are moving along just swell. The difficulty is is that if we look at CHI as being something separate then the question that could be raised in Congress is where is the legislative authorization to do it. And since theres none, gee, wouldnt it that be great for me to put a bill in to embody that, and then you put it in the legislative mill and who knows whats going to come out.
MR. BLAIR: Could I almost paraphrase what youre saying, because I think that this really is important? When Tommy Thompson made the announcement in March I think there was some, there must have been some real thought because they chose different words then weve been using up until now and they announced the PMRI standards as CHI standards within the context of NHII, and NHII I think at this point is very well regarded on Capitol Hill and in Congress and CHI is an important part of the Administration, and maybe it serves us well at this point to be consistent with the way that Tommy Thompson phrased the standards.
MS. GREENBERG: Well, I think that the HIPAA legislation gave certain responsibilities to the committee. Now the committee is able to undertake anything that is allowed, with any area thats allowed within its charter and doesnt have to get specific designation from either Congress or the Department as long as its covered by its very broad charter. However, I think the fact that the PMRI responsibilities were in the HIPAA legislation gave the committees efforts in this regard definitely more legitimacy. And I think that also although the committees recommendations are to the department and made to the Secretary it has always had a much broader influence I think and scope, or at least intended to, because its recommendations have been looked to by others in the public and private sector. So for that reason I think that CHI is a very important effort within the federal government but I think that the recommendations of this committee related to PMRI and electronic exchange of clinical data go beyond the CHI process and have implications for, or can be influential, or can be guidance, for the entire health care industry. Now again, thats what youre recommending actually, that they be guidance, not that then some type of rulemaking process be initiated. So I think that the initial charge coming out of HIPAA, I see no reason to turn your back on that and I think that in fact, and I think it would be a mistake to strictly now cast your recommendations or your work in the CHI mode either, although the fact that theyre complementary, etc., is very important.
DR. COHN: I was actually, I think Im agreeing with you, Marjorie, I was actually just at a meeting recently that included HHS and many of the major payers in the country and I know that theres been an effort within HHS to distance the concept of NHII from HIPAA, but theres actually a lot of concern, at least in this group, which insures most of insured Americans in the United States, that there wasnt a closer relationship between all of this, that they were very concerned that with the investment that has just been made in major HIPAA initiatives, that there was a concern that HHS was now turning its back on really very important things that HIPAA has provided. So I think we need to position to both but I dont, I dont think its one or the other but I think its, we need to recognize that out in the industry and out in the health care community HIPAA is actually a very important activity and a very important initiative, and then when we talk about privacy and do hearings later on this month, obviously HIPAA privacy is going to be a very important concept that everybody is still grappling with. I guess Im saying we sort of need to be, put it together rather then trying to position is apart.
MR. SCANLON: And again, I think, its complicated because some people think very positively of HIPAA and others sort of associate it with a highly regulatory mandatory kind of an approach. We dont want to, I think the committee here views HIPAA as perhaps one of the elements of the NHII, its that first stage of administrative data, electronic data interchange of standards and I think we could actually say that in how the committee views this. HIPAA is part of the NHII, I think thats what we see as well as these other areas. The PMRI was our toehold in essence for the committee, though it could have gotten into this anyway, it was our toehold in essence to get into the clinical data standards and interoperability standards area. Its manifestation in the federal agencies is through the CHI, it doesnt mean its not a broader, doesnt mean its not a broader scope in coverage as well. I dont know how far into the NHII though we take this report. And again, this is an annual report to Congress, I neither want to minimize nor maximize its import, reports to Congress are sort of what they are, generally theyre not the basis for new legislation, theyre basically, theyre important when the legislation is being drafted and if there are specific reports asked for its important, otherwise I think its kind of documenting what happened and perhaps identifying some areas where the committee will look fro the future. I dont think it will have an effect one way or the other on what Congress does, they seem to be headed in a certain direction.
MR. BLAIR: Thank you, and Id say all four of you while you hit it from a slightly different perspective I think that there was nothing inconsistent in what all four of you said and it does help me to be able to fit it together. Thank you.
MR. SCANLON: It does leave us though to do, in terms of the basic approach, at its first level it is a documentation of what happened on HIPAA related activities for the past two years.
MR. HOUSTON: Well, I guess were holding and have held testimony on a variety of subjects over the past year related to HIPAA, and again, were going to hold more, I would think that if there are issues rather then just simply being documentary of what happened I think, or better if we find that things have gone very well, wouldnt we want to include that in this report? I mean we do want to put some closure or make sure that we dont bring premature closure on issues that otherwise need additional attention.
MR. SCANLON: In past years reports wherever we ended the reports coverage chronologically the committee always sort of foreshadowed issues that it had and what it would be looking forward to or monitoring in the months ahead and certainly you may want to do that as well. But again, what exactly, see here we are, not quite a month after the actual implementation effective date for transaction and code sets and I dont know that well know a lot more.
MR. HOUSTON: Like in the case of privacy we have a great body, we have what, eight months of experience now and I think it would be reasonable I think personally to draw some conclusions or identify issues that may not be going away.
MS. GREENBERG: Well, the November 19-20 hearing of the privacy -
MR. HOUSTON: Exactly, well have more insight so we may, I think it would be appropriate to add that into this report as commentary.
DR. COHN: I think everything were talking about is absolutely the right things to be talking about, I would however think that given that this not just a report on what the national committee did this year but more how administrative simplification has been going that we ought to, for example, we heard this morning about how many complaints were being filed on privacy with the Department and that sort of information should be included. Obviously well be holding hearings on privacy later on, those issues should be included. We should be looking at the end of the year on how many of the contingency plans are still in place and what percentage of compliant claims are going through and that information should be included. Once again, not things that we necessarily ourselves holding hearings on but information that really is pertinent to progress in administrative simplification.
DR. LUMPKIN: Okay, further comments on the upcoming report? Then were expecting to have a movable draft by our January meeting.
DR. LUMPKIN: Okay, real quick item on ASCA compliance plans for HIPAA transactions. As you know were required to develop a report, we had a report, we submitted it, it will go live sometime soon on CMS website. And are there any questions? It was in our book. This is really more of an informational point. Jeff?
MR. BLAIR: Is this the report that Michael Fitzmaurice and Steve Steindel developed?
DR. LUMPKIN: Thats correct.
DR. FITZMAURICE: Wed given a presentation to the national committee I think a little less then a year ago on this so it should be somewhat familiar.
DR. STEINDEL: Again, its descriptive, there are no recommendations, its analysis of what they were, and I assume it will go on the NCVHS website.
DR. ZUBELDIA: What were the requirements of the NCVHS regarding ASCA? Can somebody refresh my memory? I know we had to have a report and then something else -
MS. GREENBERG: Identify best practices or something -
DR. ZUBELDIA: So should we do that and how are we going to do that, or is it just the report?
DR. FITZMAURICE: In the report we give as much information as you can draw from the compliance plans about best practices but since only a small proportion, about 20,000, said they completed testing we compared their factors with other factors and said these are the factors that seem to lead to getting completed with testing. Its a very small number, thats the best that we could draw out of this and so theres no additional information from this sample of over half a million to draw on it. Now you could say that as we have hearings and look into implementation issues that further reports will come out, or you can say that theyre embodied in the reports to the Secretary, letters to the Secretary.
MR. SCANLON: It was a year ago, represents the situation as of a year ago.
MS. GREENBERG: You also I think refer to technical assistance materials that have been provided by WEDI and CMS as assisting people.
DR. ZUBELDIA: So how can we comply with that requirement to identify best practices? We cant.
DR. LUMPKIN: I think that looking at ASCA Congress was asked to give a years delay and how do you justify a years delay, well one of the ways you justify is by using that to identify best practices. The problem is that trying to put together that and hitting a moving target, so we do the best we can. I think that the proof of the pudding is in the tasting and October 16th was the tasting. And so in that regards were just closing the loop. And I think that this report will meet the intent of anyone in Congress who remembers why were sending them this report.
MS. GREENBERG: I havent obviously read through the HIPAA report yet but were obviously going to have to address this in that report as to that was a requirement of the committee, this is how the committee addressed it, and this is why the committee addressed it the way they did and were continuing to monitor it or whatever. But I think thats probably the place to kind of summarize.
MR. SCANLON: Were dealing with it more in the future rather then looking back at what those questions were a year ago. I mean we can show, and its much more sensible, there werent any best practices -
DR. FITZMAURICE: Just submitting a compliance plan might have been a best practice.
DR. LUMPKIN: Okay, well theres no action required on this point, if theres no other questions or comments. Vickie?
Agenda Item: Subcommittee on Populations Report and Activities Update Dr. Mays
DR. MAYS: I think well probably use most of our time tomorrow because were meeting in the morning, and then at that point I think well know what things were going to actually bring forth. So can I save my time until then?
DR. LUMPKIN: Yeah. I think weve made up some time today because of our actions -
MR. BLAIR: Not so fast, Steve has a question.
DR. LUMPKIN: Ill get to Steve, so yes, I think that thats doable. Steve.
DR. STEINDEL: You closed the last discussion with the statement that no action was required, there was no action required by the committee but there is the action that the report should be posted.
DR. FITZMAURICE: -- some kind of approval by the committee.
MS. GREENBERG: On the NCVHS
DR. FITZMAURICE: Yeah, on the committees website.
DR. LUMPKIN: Its been moved by Simon, seconded by Clem, that this be posted. Thats what you get for sitting on my left hand side.
MS. GREENBERG: And since its a requirement of Congress then can it just be referred to in the HIPAA report, so thats how we report to Congress?
DR. LUMPKIN: Sure, right. Okay, all those in favor say aye.
COMMITTEE: Aye.
DR. LUMPKIN: Opposed say nay. Okay, the action has been taken. We will now break into our working group sessions. The Subcommittee on Standards and Security will meet here, the Workgroup on Quality will be in 425. At 5:15 we will have a brief meeting of the NHII workgroup, its not going to be a long meeting so for those of you who are waiting around for that just to give you a warning, were mostly going to focus in on how were going to do our work in the future and talk about some future hearings I think.
MS. GREENBERG: And then 6:30 La Collin.
DR. LUMPKIN: 6:30 at La Collin.
[Whereupon at 2:46 p.m. the meeting was recessed, to reconvene at 10:00 a.m. the next morning, Thursday, November 6, 2003.]