[This Transcript is Unedited]
Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda - Dr. Lumpkin
DR. LUMPKIN: Good morning, we're going to get started having a quorum. This is a transition meeting and so I'm going to as we go around the room and make the introductions I'm going to ask our new members to just tell us a little bit more then just their name and where they're currently working, just a brief background if you would and also we're welcoming Dr. Robbins, who is from the Board of Scientific Counselors for the National Center for Health Statistics, Centers for Disease Control, Department of Health and Human Services. And also please if you could just spend a few minutes, a minute or so with a little bit more detailed introduction of yourself and welcome.
So we're going to start off with Marjorie. Oh, by the way, I'm John Lumpkin and I'm senior vice president of Robert Wood Johnson Foundation, and chair of the committee.
MS. GREENBERG: And I'm Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation and as of today no longer member of the committee or the subcommittees.
DR. MAYS: Vickie Mays, University of California Los Angeles, member of the committee.
MR. REYNOLDS: I'm Harry Reynolds, vice president of Blue Cross and Blue Shield of North Carolina, one of the new members. I've been in the health industry 30 years, worked at two large teaching hospitals, and have been with Blue Cross for 26 years. Probably the only one on the committee that's a national HIPAA implementer and I lived, so I look forward to working with everyone.
DR. ROBBINS: Good morning. My name is Aldonna(?) Robbins and I am as Dr. Lumpkin said the new liaison from the brand new Board of Scientific Counselors for the National Center for Health Statistics. My background is in economics, I have done my tour of federal duty in the Labor Department and at the Treasury Department. For the last 16 years or so my husband and I have had an economic consulting firm where we look at the economic effects of federal, of fiscal policy on the economy and my special areas are Social Security and Medicare.
DR. LENGERICH: Gene Lengerich, Penn State University, member of the committee.
DR. STEUERLE: I'm Gene Steuerle, I'm a senior fellow at The Urban Institute. I guess my claim to fame is a little over 20 years ago I worked with Aldonna Robbins at the Treasury Department. My background is mainly in economics and public finance, I've written a lot on health care but more or less from the financing side, and have done other statistical work such as chairing a Social Security Committee examining the methods and assumptions and working with the IRS Statistics Division.
DR. VIGILANTE: Kevin Vigilante, Brown University, a physician. In my clinical work and research dealt mostly with special populations including HIV and incarcerated populations. The last several years been consulting to various federal agencies with regards to IT infrastructures relevant to health care and research and also with some applicability to bioterrorism.
DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City, member of the committee.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, and member of the committee.
MS. MCANDREW: Sue McAndrew, I'm with the Office for Civil Rights, I am the senior privacy policy specialist for the Office.
MS. TRUDEL: Karen Trudel, acting director of the Office of HIPAA Standards, Centers for Medicare and Medicaid Services.
MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the Subcommittee on Standards and Security but I'm here today to fill in for Judy Berek, who is the CMS liaison to the full committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, and member of the committee.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the full committee.
DR. WARREN: Judy Warren, University of Kansas, School of Nursing, and I'm a new member to the committee. My background is nursing informatics and I've done a lot of work in developing terminologies, both nursing terminologies as well as SNOMED, and have also done work at developing standards through HL7.
MR. HOUSTON: I'm John Houston with the University of Pittsburgh Medical Center, I'm a member of the committee and on the Standards and Security and the Privacy Subcommittees.
DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology to the director of the Agency for Healthcare Research and Quality, liaison to the full committee and staff to the Subcommittee on Standards and Security.
DR. CARR: Justine Carr, I'm a new member, I'm a hematologist at Beth Israel Deaconess Medical Center in Boston. And I've been there most of my medical career, actually all of it, and I work with our administrative datasets to develop quality measures, I work with our medical records department on coding issues. I was director of our blood bank and hematology labs, which became automated, and I'm happy to be here.
DR. HARDING: Richard Harding, chair of the Department of Neuropsychiatry at the University of South Carolina, member of the committee since 1997.
DR. COHN: I'm Simon Cohn, I'm the national director for health information for Kaiser Permanente, a member of the committee and a member since 1996.
DR. LUMPKIN: And I can name that committee membership in six years, seven years, eight years. Jim Scanlon had to run away for a short meeting, he will return, he's the staff --
MS. GREENBERG: Executive staff director.
DR. LUMPKIN: Executive staff director and about five positions in ASPE, at least. Why don't we go to the back?
MR. BUSSOWITZ(?): Roy Bussowitz, National Association of Chain Drug Stores.
MS. JONES: Katherine Jones, NCHS, staff to the committee.
MS. CANAAN: Susan Canaan, writer for the committee.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, staff.
DR. KILE: Frank Kile, American Dental Association.
MR. FANNING: I'm John Fanning, privacy advocate of the Department of Health and Human Services.
MR. ALFONO(?): Bill Alfono, Blue Cross/Blue Shield Association.
MS. SKILLEN(?): I'm Elizabeth Skillen, I'm an HHS Emerging Leaders intern.
MS. WILLIAMSON: Michelle Williamson, NCHS, CDC.
MS. ZIGMAN-LUKE(?): Marilyn Zigman-Luke, AAHP/HIAA.
DR. FERRER: Jorge Ferrer, CMS.
DR. ORTIZ: Eduardo Ortiz, Agency for Healthcare Research and Quality.
MR. ROUDY(?): Dan Roudy, American Health Information Management Association.
MS. WARK: Cynthia Wark, Consolidated Health Informatics Initiative and the Centers for Medicare and Medicaid Services.
MS. WHITE: Gracie White, NCHS.
DR. LUMPKIN: Okay, we also have an open line on the speaker phone, is there anyone on that? Okay. As in all previous meetings of the committee just note we are broadcasting over the internet through the kind auspices of the Department of Veterans Affairs, and so please make every effort to speak into the microphone so people outside can hear you clearly.
The first order of business, just a note, for the new members of the committee, new members and newly reappointed members of the committee who's IDs have expired, Jackie will be when they are ready pulling you away from the meeting in ones or twos to get your ID picture, so if you see people getting up and leaving it's only because we didn't want you to vote on a certain issue, but you will all find it much easier to come into the building when you can just flash your ID instead of having to stand there and wait for somebody to come pick you up.
At this point any declarations of conflict with the subject matter of this business meeting? Okay, I see none. Then we will proceed with updates from the department and we'll start off with Karen.
MS. TRUDEL: Thank you very much. I'm going to recap some updates that I provided yesterday to the Subcommittee on Standards and Security, I apologize to those individuals in advance for repeating myself but the status just didn't change from yesterday to today.
I'm going to talk a little bit about the Medicare implementation statistics for the HIPAA transactions and code set standards, I'm going to talk a little bit about the transaction complaints that we've received to date, and then talk a little bit about the National Provider Identifier final rule, which was published on January 23rd.
I'll start out with the compliance statistics for Medicare, we do track these weekly, and we are now up to, to be exact 61.35 percent of the electronic claims that Medicare is receiving are being received in HIPAA compliant format, which is quite an advance over even three months ago. Continuing to look at the proportion of compliant claims week to week as we go along and looking to identify a point in time where it appears appropriate to begin to make plans to lift the Medicare contingency. We are not there at this time, I don't have a specific date or a percentage that will trigger that process. We're very much looking at it on a week by week basis and trying to assess where we are and where we expect to be in a quarter or two.
Turning to the complaint, we have and I know Susan is going to laugh at me when I say this, we've received a total of 46 complaints.
MS. MCANDREW: That's less then we get in a week.
MS. TRUDEL: Yes, I know, I'm very sorry about that. Of those 35 actually did turn out to be valid transaction and code set complaints, they were not outside our scope of authority. Of those 35 27 did allege that a compliant claim had been rejected by a health plan. There were several companion guide issues, five code set issues, and almost half of the complaints indicated that cash flow was an issue in their filing of the complaint which is to be expected. And the vast majority of the complaints were from small providers filing against health plans.
As we receive these complaints we go back to the covered entity that's complained against, we indicate what the complaint was, talk to them, try to work through to a voluntary compliance, we've gotten very good results so far, all of the complainees that we've contacted have been responsive and many of them have already taken steps to resolve the problem. So I think that's actually working fairly well.
Let me move along to the National Provider Identifier, this was in the works for many, many years. The final rule was published on January 23rd and this rule establishes a standard identifier, standard unique identifier, that will be assigned to and used by all health care providers in all HIPAA administrative transactions, so it's not just a Medicare or Medicaid identifier, this crosses the entire health care industry as does the rest of HIPAA. The effective date of this regulation is not until May of 2005, that's very unusual to set up an effective date that's that far in the future, but it will take CMS that long to be able to establish a process and a system so that as of that date providers can actually begin to come to us and apply for an identifier. That date then starts the normal two year HIPAA implementation process. So we are not cutting into the normal two year process for either providers or health plans, we're basically giving them that entire two years starting at the point in time when they can actually get an NPI.
There was a lot of discussion in the rule making process about what the NPI and the system that goes along with it will and won't do. The identifier itself will replace the use of legacy provide identifiers in transactions and we hope that it will simplify transactions including claims and COB and save money, which was the intent of HIPAA. But it will not, the possession of an NPI will not guarantee reimbursement to a provider by any health plan, it will not enroll providers in a health plan, it won't make a provider a covered entity, and having one will not require a provider to abide by HIPAA and conduct electronic transactions unless they're a covered entity.
What does the identifier look like? It's ten positions long, which is different from our proposal. We proposed eight positions alphanumeric, we have gone to ten positions all numeric based on the comments that we received from the comment period.
MR. BLAIR: -- numeric or alphanumeric?
MS. TRUDEL: Ten positions all numeric, one of which is a check digit. The identifier does not convey information about the provider, if there's a one in the first position that doesn't mean that you're an internist, etc., and it is compatible with health insurance card issuer standards worldwide. Any health care provider can obtain an NPI whether they're a covered entity or not, only covered entities are required to obtain an NPI. They're required to provide updates of any information within 30 days of a change to the National Provider System, and they must use those identifiers when they conduct HIPAA transactions.
In addition to providers which are legal entities we allow for subparts of a legal entity to obtain an NPI if they need to do so, for instance if there's a hospital system where the system itself is the legal entity, any subparts of that system which are discreet providers and need an identifier can obtain one as well.
Well, how will a provider obtain an NPI? There will be an application form for them to complete, we are hoping to make as much of this entire process electronic as possible. The application will be received by the system, it will edit and validate data, determine whether there is already an identifier or record on file for this profile, and send back a notification of what the identifier is. We will be collecting the minimum amount of information necessary for two purposes, one is unique identification, and two is communication with the provider. That means that there is a certain amount of data that we previously proposed to collect that didn't make it through to the final rule. Some of those items are race and ethnicity, certification information, education or school information. We are not collecting information about every single practice location that a physician might have, we only collect one plus a mailing address. So those are the types of information that people thought at one point would make the database richer for research purposes but that we scaled back on consistent with the notion of minimum information necessary for unique identification and communication.
The National Provider System that I referred to is being developed under a contract with HHS, it will process the applications and assign the NPIs. It will store information and it will also provide information to people who need it. There will also be an enumerator, that will be an organization that operates the system, receives applications, resolves errors, helps with problems, handles data requests, and that is not yet contracted for, we're still working on that procurement.
There will be three levels of data to be disseminated, one obviously will be the full dataset will be available to HHS and the enumerator. There will be a second level of data to the public, which will be completely releasable under the privacy act. There will be a middle range of data where we're still developing a strategy for how to handle that where we may need to obtain data use agreements with organizations like health plans that need more data then the minimum to be able to match their provider records to the new NPI records, so more will be coming on that.
There is information about the regulation on the website, which is www.cms.hhs.gov/hippa/hippa2, and we'll be developed additional frequently asked questions, outreach materials to providers, but since we do have some time for that, the compliance date for covered entities is not until May of 2007, we believe we have a little bit of time to get that done.
Any questions before I turn it over to Sue?
DR. HARDING: Just a very good report, just one question, something that comes up all the time. Is there any way linkage between NPI and Social Security in any way, is it the Social Security plus a check digit or is there anything that a certain group of people will be concerned about in that issue?
MS. TRUDEL: No, the NPI will be generated basically randomly, except for the check digit. The reporting of the Social Security Number will be voluntary and if a provider does give us their Social Security Number or Tax ID number we will validate it but that's not something that would be provided for instance in public use files, no absolutely not.
DR. HARDING: Thank you.
MS. TRUDEL: You're welcome.
DR. LUMPKIN: So are there provisions for vanity numbers like 007? I'd like to get that one. Kepa?
DR. ZUBELDIA: Karen, could you give us an update on the reports changes or guidance that is supposed to come in the spring concerning DDE and some of the other things?
MS. TRUDEL: We're working on a second modification rule, the proposed rule I don't believe it will be ready by spring but some of the items that we will be addressing in there will be some clarifications to direct data entry, some issues related to the treatment of supplies in retail pharmacy transactions, and also some items that were raised by the Secretary's Regulatory Reform Committee that required some reg changes. At this point we're still drafting that regulation.
DR. ZUBELDIA: Do you have an estimated date?
MS. TRUDEL: Actually I believe it's on the, it's slated on the agenda for late summer but it's very difficult to assess when things are actually going to turn up.
DR. LUMPKIN: So Kepa are we going back to the days when you used to always be up at the microphone? Oh good, don't be a stranger. Sue?
Agenda Item: Update from the Department - HIPAA - Privacy Rule Compliance Update - Ms. McAndrew
MS. MCANDREW: Like Karen I'd like to start by reporting on how we're doing on compliance and enforcement efforts. As of the end of December, the end of our calendar year 2003 we had received some 3745 complaints --
MR. HOUSTON: Could you repeat that?
MS. MCANDREW: 3,745. We have closed 40 percent of those and are continuing to work on and investigate the remainder. The bulk of the closures were for jurisdictional reasons, either the complaint alleged an occurrence that took place before the April 2003 compliance date and we do not investigate allegations that occurred before the rule went into effect for entities. Many of the complaints were against entities that we do not cover, were not covered entities, and we do not investigate those. Other of the complaints were closed because the allegations did not make out a violation of the rule. In some of those instances will we closed the complaint we were able to contact both the complainant and the entity and provide technical assistance. A lot of the complaints in this category concerned things like the hospital not talking to a spouse, or not telling a spouse that the other spouse had been admitted to the hospital, or a complaint about one provider not sharing files at the request of the individual with their new provider. Since the rule permits but does not require these kinds of disclosures by a covered entity they don't technically make out a violation of the rule but we were able to contact the providers and give them assurances that these were permissible uses and disclosures of PHI and could be done. And I think it brought a significant comfort level to the covered entity. We'd also been hearing, seen a lot of stories in the press about these kinds of difficulties in families and friends being able to get information from covered entities and trying through various mechanisms to try to dispel some of the myth that may arise from over compliance if you would.
In addition to the categories of cases that we closed because we could not investigate them there were also those cases where there was a complaint made out, we notified the covered entity and in follow-up contacts with the covered entity we were able to resolve the matter, and so we were able to achieve voluntary compliance like Karen. We are really encouraged by the reaction that we're getting when our investigators do call. The entities are very cooperative, the privacy officers are anxious to find out about complaints and to make sure that individuals do get access to their records and that if there are weaknesses in there training, that employees get retrained and that their security and safeguard provisions are adequate to protect this information. So they really have been very cooperative and willing to take the necessary corrective actions to resolve the complaints. We did not have to resort of fiscal sanctions so we have not yet issues any civil money penalties for violations.
In terms of the types of complaints that we get most often clearly impermissible uses and disclosures of information makes up the bulk of the complaints. Safeguards, complaints about the lack of safeguards of the information, this can occur, people come into a doctor's waiting room and see files at the reception desk, or they're in consulting with the physician and claim that they can see PHI on the monitor, some complaints come in about hospitals and people concerned about things that they have heard or things that they have seen that they think the information is not being adequately protected. So we do get a lot of safeguard complaints. I think access to information is probably the third most frequent complaint that we get.
The types of entities against whom complaints are lodged, not unreasonably turn out to be private practices, general hospitals, pharmacies, places where people come and have interactions with the health system on a daily basis and so this is where the individual is most likely to be concerned and we get a lot of complaints against those three entities. Group health plans is also now beginning to show up as an entity against whom complaints are made.
We continue to get complaints now at a rate of about 100 a week, so that means that as of today, I didn't check the numbers before I came because I was running a little late but earlier this week we were up over 4,000 complaints received. Needless to say that's keeping us fairly busy but it is not the only thing that we are devoting resources to, we are continuing to be as aggressive as we can in continuing to provide technical assistance. We now have over 200 frequently asked questions up on our website and we continue to work on questions, we are working in areas, some of which we're looking forward to the upcoming hearings. We are working on questions, frequently asked questions around the FRPA, and I can never remember what that stands for but the educational privacy, privacy of educational records and questions that have come to us from schools and universities about are they covered entities and what their obligations may be if they are, or even if they're not there's a whole set of questions concerning the exchange of information between school systems and providers that we are looking and hoping to get some guidance out on. In addition law enforcement, which is another topic I think that will be visited at the hearing, we have been pretty constantly since the fall been dealing with matters, mostly from the media, about reports, interactions between law enforcement and hospitals and others in obtaining information. And so that's an area that we will be concentrating on as we move forward.
Other then that we are busily trying to balance an aggressive enforcement program as well as trying to dispel the myths and concerns of covered entities with regard to things that they are permitted to do under the rule, the rule was designed to allow information to flow as freely as possible within in order to achieve the health care that's needed and to facilitate the payment flow for that health care and we want to make sure that the entities that we regulate are comfortable in knowing what they can do and how they can communicate, and that the rule is not designed to thwart their business, it was designed in a way that hopefully facilitates their ability to do business and continue to provide quality care and allow individuals to have free access to that care.
We don't have any regulatory changes in the offing in the immediate future other then continuing to work with CMS and the general counsel's office with regard to the final, proposing the other half of the enforcement rule. There were procedural interim rules that were put out last year and we are now working on to complete the entire rulemaking for the civil money penalties and the administrative hearing.
DR. LUMPKIN: Thank you. Questions? Simon.
DR. COHN: I was sort of listening and then sort of heard what sounded like the enforcement rule at the very end there. Can you tell us more about, I understand there's a single enforcement rule coming out, spanning the whole HIPAA implementation, when do you expect to be providing more details on what this next phase of the enforcement rule is going to look like?
MS. MCANDREW: I think what we had promised when we did the interim procedural rule was that to complete the package there were elements of the enforcement process that effected more substantive rights of the entities against whom civil money penalties may be imposed, and this just works through those issues and revisits the procedural rules to the extent that we got comment on those interim final rules so it just brings it all together in a package.
DR. COHN: Just to make sure I understand, is this the next phase of the enforcement rule or is this the sort of putting everything together into a final enforcement rule?
MS. MCANDREW: This would be putting everything together in a final enforcement rule.
DR. COHN: In a final enforcement rule, okay.
DR. LUMPKIN: John.
MR. HOUSTON: A couple of things. First of all I'd be interested in knowing what the breakdowns are on the closed complaints on a percentage basis, you'd listed out four separate types of complaints that had been closed. I'd also be interested in knowing by percentage what types of complaints, as well as types of entities, you listed out the entities themselves that had been the subject of complaints. I'd sort of like to understand exactly on a percentage basis what those were, I know I've asked that question in the past and you may not have it at your fingertips now but it would be interesting to sort of try to get some type of report that lays that out.
MS. MCANDREW: We can approximate some of that, I was just trying to think. On the closures, it's only a little difficult because unfortunately as in any computer system when you put in an other category, people are in a hurry, they push that other button, they don't think about it. So we have been trying to sort through and reclassify the clutter that's in the other so that the other statistics firm up a little better, but putting the big clump of other aside I think our no jurisdiction cases are probably, they're over half of the closures. I believe the no violation allegations we don't classify those as jurisdiction, and I think they're probably the next most frequent category and the corrective action technical assistance is the third.
MR. HOUSTON: And again, I'd like if at all possible at some point understand by type of entity as well as type of complaint what the breakdowns are.
MS. MCANDREW: It's possible for the, I think we can probably work on the institutions, the types of entities against whom complaints are made, again, we're bothered by this other, we have a big other health category, but I think if you take those out you'll still find the breakout is, there are private practices and general hospitals.
MR. HOUSTON: By the way, the reason why I think this is important is we're taking testimony and trying to understand where the problems are with the rule, it also would be helpful to understand from this side of the equation complaints, whether there is any clear relationship between what we're hearing in terms of problems with the rule against where you're getting complaints, and just try to scope and get a magnitude of these problems.
MS. MCANDREW: I think we're a little difficulty in sorting out, providing percentages on the types of issues only because a single, it's not one complaint one issue, so it's a little bit more difficult to correlate.
DR. LUMPKIN: But perhaps if we could request something in a little bit more detail reporting of the complaints so that the committee as they're doing their deliberations can review those and guide their questioning and direction.
MR. HOUSTON: And I do have then a second question. You'd discussed over compliance and you gave two examples and I guess a question and I guess a comment at the same time is often where something is permissible under HIPAA there may be a state law issue that precludes say a release of information outside of a hospital, and I guess I'm wondering whether OCR when they provide guidance whether they look at where the questioned complaint comes from and whether there is some other state law issue that may be causing the hospital to take the position that it is, and again by your example, a release of information outside the hospital, I know in the state of Pennsylvania that there are other laws that are implicated there. So I'm concerned, and I often have, I know my own institution, have to go back and somebody says well HIPAA says I can do and you need to come back and say yes, you're technically correct but there are state law issues. So I'm just wondering whether OCR has that capability or does provide that other type of guidance, too.
MS. MCANDREW: Basically if we have, in those areas the most that we have done is to place a call to the entity to talk them through to make sure that they are not refusing to maintain a facility directory simply because they think it will violate HIPAA. And we are, that is how we're using the technical assistance. Clearly if in the course of the conversation the entity says that they have a conflicting obligation then clearly the more restrictive practice by state law or other federal obligation that they have does control --
MR. HOUSTON: I was just a little concerned hearing what you'd indicated before because again, oftentimes what happens is somebody gets advice and they come back and say well HIPAA says I can do this, and then we're forced to go back and say well no, yes, you're right but there are other state law issues that are implicated that we need to be concerned with. And I just again, I think unfortunately what happens is the consumer will often go to multiple points and gets very frustrated when they get different answers before they, or they, there's I think a source of frustration when that occurs.
DR. LUMPKIN: Richard?
DR. HARDING: As a member of the subcommittee just want to recognize the very positiveness that we heard from people about OCR's availability when complaints came in, the way they were handled, and also the frequently asked questions were constantly referred to as being extraordinarily helpful, the 200 FAQs that are on the web. And those things kept coming out in the early testimony in our first hearings and I wanted you to know that and hopefully be complimented by those things, especially since April when the rule became finale.
The one concern I was going to ask you if you had any knowledge of would be that so far as you say it's been kind of educational and there have been no penalties and so forth. Of course implied in that is so far there have been none of those things and there is concern that there could be the start-up of things like audits of covered entities or other ways of dealing with things other then waiting for a complaint to come in. Is there any activity going forward for OCR to begin that kind of process of going out and looking at covered entities and auditing kinds of activities?
MS. MCANDREW: We do of course have the ability to do compliance reviews, right now there are no plans to use that authority other then as maybe necessary to investigate an event that is brought to our attention, it may not be a complaint, it's likely not to be a complaint although it may be an anonymous complaint or something that we can't handle through the normal complaint process. But it might be a media report or some other kind of report of a particularly egregious event that we would want to look into, but there are no plans right now from changing from a complaint or event driven compliance effort to something that would be more of a overarching audit and periodic review type approach.
DR. HARDING: You understand my concern with fraud and abuse in the past and in TALA(?) and other things, the black helicopters start circling and all those rumors start up, that there are people being trained at the present time to do that, etc., etc., but there's nothing like that at the present time.
MS. MCANDREW: No --
DR. LUMPKIN: Okay, we have time for one more question and then we're kind of running late. Harry.
MR. REYNOLDS: You didn't mention employer groups, the original rule large employer groups, many of them that are self funded were covered by the rule and it's understanding that --
DR. LUMPKIN: Can you speak into the microphone?
MR. REYNOLDS: Large employer groups that were self funded and of a certain size had to be in effect by April of '03, a lot of the other employer groups April of '04. Do you have any indication of how employer groups are dealing with this? Because you mentioned complaints, have you had any about how employers are handling this information or anything?
MS. MCANDREW: One of the, I mean group health plans, and I don't think the category necessarily would distinguish those that are self funded from those that are fully insured, does garner a number of complaints. Clearly if it's a small group health plan we would not take those complaints because their compliance requirements don't kick in until this coming April, but we have been getting them against large group, the larger group health plans. We have been getting, I will say one of the probably larger components of the non-jurisdictional cases that we have gotten are complaints by individuals against their employer but it is that, it is against their employer not their employer acting through their group health plan, it's just mostly on the job workplace gossip about medical conditions and it's not a covered entity situation so we treat those largely as non-jurisdictional cases unless there's some indication that the source of the information was from that part of the employer that was dealing with the group health plan.
DR. LUMPKIN: I have just one last question. As part of the implementation process I believe just about every state in the nation has done an exemption analysis, preemption analysis. Has OCR looked at those and done any analysis of where, what the impact of this rule has been on state law?
MS. MCANDREW: No, we haven't asked for nor has anyone volunteered to share with us their state law preemption analyses, it would be very interesting to take a look at those. I would say that we have only had one request for an exception determination from that preemption analysis.
DR. LUMPKIN: Really? Wow. Okay, thank you very much, we're going to move on to update on the NCHS Board of Scientific Counselors. Vickie?
Agenda Item: NCHS Board of Scientific Counselors - Dr. Mays
DR. MAYS: It's always nice to start off with exciting news and the fact that the National Center for Health Statistics as its Board of Scientific Counselors is something that is both rewarding and exciting for the committee.
They've had two meetings up until this point in time, the first one began in October, I think it was October the 10th, and the second one was just last week. The group that has been appointed to the board has a good mixture, is very diverse, what's really nice and my counterpart is one of those individuals, is they have economists. And I think that some of the issues that we have been concerned with in terms of particularly in the Subcommittee on Populations about social economic position and increasing some of the data in terms of measures of wealth and things like that, it's nice to see the complement of talent that will be present in terms of the discussions that we will have in the future.
As the liaison I think the role that so far has evolved for us relative to that committee is that of, very similar to what we do here when Jim Scanlon does the departmental updates. We thought that at least at this point that that would be a good starting point in terms of our relationship with that committee is to do an update of the types of things that the committee has been involved in to give the board a sense of the scope of our work, the mechanisms that we use in terms of accomplishing our goals, and to also keep them updated in terms of areas that overlap.
For the last two meetings the agendas have pretty much been that of a presentation of NCHS, so they've gone through many of their surveys, what the issues are, one of the things that I've heard Dr. Sondik talk about is the board being involved in also some of the intramural agenda setting activities. So it seems like the board will have a pretty full plate, but I think its direction and the areas of focus at this point in time I can't quite comment on because it really has been more of an orientation. What I'm looking for from them is kind of a better sense of how as the liaison we can work together and I think that's just a matter of it will evolve over time.
DR. LUMPKIN: Aldonna?
Agenda Item: NCHS Board of Scientific Counselors - Dr. Robbins
DR. ROBBINS: Vickie has given you a good overview of what has happened so far. I think there's some materials that are being passed out that are simply the composition of the Board of Scientific Counselors, or BSC as we call ourselves, and a printout from the internet describing the purposes and just general information on the board. As Vickie said we are definitely the new kid on the block compared to this committee, which has seen around for over half a century, and our purpose is to advise, make recommendations to the Secretary of HHS, the director of the CDC and the director of the National Center for Health Statistics about the scientific and technical program goals, objectives, strategies, and priorities of NCHS. And as Dr. Sondik, who's the head of the center pointed out to us, in the past this committee has provided guidance to NCHS but your agenda has definitely broadened to cover areas throughout HHS and so what the National Center felt it needed was to get some guidance that was specifically directed at research, that effects, because it views itself essentially as a research agency, it is the principle, the country's principle health statistics group.
The board has 15 members and as Vickie said we are a diverse group. By my reckoning the disciplines cover statistics, biostatistics, gerontology, epidemiology, public health, and as Vickie pointed out economics. Our chair is June O'Neil, who is a former director as many of you probably know of the Congressional Budget Office, and an economist.
As Vickie said we so far have been concerned with getting some orientation and the staff have been doing a great job in bringing us up to speed on NCHSs many programs, which include the National Health Interview Survey, the National Health Care Survey, the National Health and Nutrition Examination Survey, and the National Vital Statistics System. We are still very much feeling our way but so far there are several topics that have generated interest and will likely receive more attention in the future. One that we seem to have gravitated to is the dissemination of data. At our first meeting for example the board recommended that the NCHS staff prepare a feature article in connection with the release of Health, US, which is one of its major publications, and the purpose of the article would be it would be directed and circulated to media. This was done and the result was a number of articles that appeared in major publications like the Washington Post, which highlighted information from Health, US, on obesity, diabetes, teen smoking, teen pregnancies, that were in addition to the life expectancy data that are often just focused on.
And going forward the board is likely to examine who is using the data, what data is being used, how it's being accessed, and for what purpose. The board will undoubtedly be looking at questions of sample designs, of how can we extend, change, the data collection efforts at the National Center, to better address needs that are coming up. And as Vickie pointed out I think a prime area of interest is going to be economics, we're hearing about budgetary pressures, which often unfortunately fall heaviest upon data agencies and these are likely to intensify as concerns over the deficit mount. And then there are the requirements of the President's management agenda to assess product quality and program performance, and so being able to measure the costs and the benefits of NCHS programs or just to have a way to decide how should we next spend the next research dollar is going to go a long way toward dealing with these realities.
And so I think the board's direction will become clearer in the coming months, and we are going to appreciate any guidance that this committee can give us, and I look forward simply to watching you old pros at work today. So thank you.
DR. LUMPKIN: Thank you, any questions? Marjorie?
MS. GREENBERG: It's not really a question but I want to thank Vickie and Aldonna, I wanted to mention that I had the opportunity to attend this last meeting and shared with the Board of Scientific Counselors the interest obviously of this committee in working collaboratively with the board, and in particular we had discussed at the, I think it was the Executive Subcommittee meeting, which you'll probably be going into more later and Ed actually discussed this previously but addressed it again at that meeting, having a joint meeting at some point with the board probably in 2005 given that they're really getting organized now in 2004. And that was very well received, there was a lot of receptivity to that. Actually one of the board members is a former member of the national committee, Dr. Trevino, he sent his regards.
Also I just wanted to mention that Dr. Sondik, who as you know is the NCHS liaison also to this committee, sent his regrets, he's hosting a meeting on I believe cancer surveillance out in Arizona today, and the deputy director had hoped to come and has illness in the family. But in any event I assure him that they're well represented.
DR. LUMPKIN: But you're here.
MS. GREENBERG: But I am here.
DR. LUMPKIN: Vickie?
DR. MAYS: One of the discussions that took place at the board meeting was about vital statistics, and one of the members later reminded me, I shouldn't say reminded me, informed me because it was something that I didn't know. But at one point in time there was a liaison to our group from vital statistics, and then I think then Dan came on, and Dan kind of served that role. So the question was raised as to whether or not there can be a liaison from NAFSIS(?), which would be the group that in the past I guess had represented vital statistics.
DR. LUMPKIN: Marjorie?
MS. GREENBERG: We don't actually have liaisons from organizations to the committee and as we discussed yesterday in the orientation each member represents areas of expertise as opposed to representing a particular organization. We have in the past pretty regularly had a state, a director of a state center for health statistics who usually also is the state registrar or overseas the state registrar or works with the state registrar, George Van Amberg(?) of course was a member for a number of years and prior to him Marianne Friedman, and then Dan Friedman although, no relation by the way, although he was not the registrar he was very much involved with the state, director of the state center for health statistics. So that is a, it wasn't really a liaison but certainly if we don't have someone from that constituency we certainly need to make sure we reach out to them. And I believe that they had, it might have been the person that brought it up, but the current president of NAFSIS is a member of the board.
DR. LUMPKIN: And you forgot to mention it, I was a state registrar.
MS. GREENBERG: Were you? You were the state registrar?
DR. LUMPKIN: Yeah, for 12 and a half years.
MS. GREENBERG: No, you weren't really, you were the state health director. We didn't consider you the state registrar.
DR. LUMPKIN: If you check the record of every kid who was born in there in the state of Illinois, on their birth certificate, my name, was born in Illinois over the last 12 years you would see my name and underneath it says state registrar. But Jim.
MR. SCANLON: Let me change the subject. Again, I think the development of the Board of Scientific Counselors is actually a very good development for the center and my only concern and I think we'll just have to work on this relationship, NCHS is one part of the national health statistical system and data system, and they're one part, a big part, here in HHS as well, but the health care sector is a little different from other sectors in terms of the data and statistics so we actually rely on a whole panoply of research, surveillance statistics, evaluation and so on, administrative data, and again, my only urging here would be that we have a good liaison relationship with the board that, my point here is to avoid sort of heading in different directions in terms of recommendations to NCHS where it may not be in the best interest of the whole system. So I think the way we solve that is to have a fair amount of liaison interaction, it's our responsibility to keep you informed what's happening, and it's your responsibility to kind of work with us through Vickie and others as well. I think it adds to the power and the decision making apparatus, particularly on scientific and methodology issues, but again, this is a highly related area and so we have to keep the liaison and the relationships open.
DR. LUMPKIN: So welcome.
DR. ROBBINS: Thank you very much.
DR. LUMPKIN: Jim? Your update? Just a quick agenda check, since we're running a little bit late, my intention would be to go to Jim's update, take our break, and then do CHI until lunch.
Agenda Item: Update from the Department - Data Council - Mr. Scanlon
MR. SCANLON: Let me give a quick report on a number of developments in data policy since we met I think in November, and I'm actually happy to report that progress is continuing on a number of issues in the data policy area and in the NHII area, I think you've already heard from Susan, Karen, in a few minutes about HIPAA standards and CHI, but there a couple of other things actually going on. I think we're actually going to have a budget for the fiscal year '04 shortly and that helps the committee as well in addition to HHS, and actually the outlook for '05, though it's not a big growth budget actually has some positive, if the President, when the President sends the budget up next week for '05 I'll talk a little bit about some potential areas there which the President has already alluded to in some of his talks about what will be in the budget.
But first of all I think we've probably already, John, welcomed the new members, when I had to run downstairs. We have a number of changes on the committee --
DR. LUMPKIN: But they won't feel welcome until you do it.
MR. SCANLON: Some changes on the committee, four new members, hopefully you've already introduced yourselves, and four retiring members, which we'll honor a little later today --
DR. LUMPKIN: Graduating.
MR. SCANLON: Graduating members, we never retire, you go into the active reserves for the NCVHS, you're always on call, the Surgeon General can always activate you in retirement status.
I wanted to report also that the Secretary has renewed the charter for the committee for another two year term so we're legal until 2006, and we really didn't require any changes to the charter other then some technical ones because I think the charter allows us to do virtually anything, cover virtually anything of substance in this area as well.
In addition the department has done a solicitation for staff to support the subcommittees of the full committee, and I've actually gotten a number of staff nominated to be, for various subcommittees. I was hoping we could actually finalize it for this meeting but it probably will be for the March meeting. There were some nominations for staff to be on the Executive Subcommittee, which obviously doesn't work that way, and I have to do a little more sorting out but my guess is there are probably a dozen new names suggested and I would just have to clarify some of this. So we'll work with the subcommittee chairs and the executive committee on getting the staff sorted out but I think we'll clearly have a number of new staff joining the various subcommittees as well.
Let me just bring you up to date on some developments within the department and then let me talk about the budget. As I have alluded to previously the council, we have established within HHS a Council on the Applications of Health Information Technology. We have other councils, interagency councils, within HHS dealing with research coordination and with other applied information technology within the agency, the Data Council and some other councils, but the leadership thought that in recognition of the potential of information technology applications that the department really needed a focal point to get agency views together, kind of organize our own investments, and identify opportunities within HHS for health information technology applications, and have a place where we could work out sort of a coordinated voice and relationships and dealing with external partners as well.
So the council was formed several months ago, it's meeting more or less on a monthly basis, Dr. Lumpkin as the chairman here is invited to participate in those meeting, and we have a small steering group to kind of plan the agenda and look at some of the areas where we need to move ahead. The focus so far has been on looking at some of the proposals in the pipeline and trying to get them on a more coordinated basis, but in the months ahead I think a more strategic view of looking beyond what's in the pipeline to how we could use these things more systematically and plan better will be on the agenda for the council. So I think that was a very positive development and Dr. Lumpkin brings us, virtually at every meeting could bring us the benefit of the thinking of the NCVHS as well.
Let me talk a little bit about the 2004 budget, the Congress passed I guess a week ago and the President is expected to sign the fiscal year 2004 budget, and I think we actually have some very positive developments in the information policy area and the NHII area in that budget. I've mentioned them to you before when we were only hoping that we would get them and now I think we're actually going to see these. First of all, in my own office, the Office of the Secretary level, we have a $3 million dollar initiative that is included in the budget and it's for overall work related to leadership and convening and so on for the National Health Information Infrastructure, and this would be kind of the glue that brings the agencies together as well as our work with the private sector. We would be continuing the activities begun at the conference last year, the NHII conference last year, as well as a number of other activities. The whole goal here is to use a variety of activities to promote and accelerate the development and the use of electronic health records, NHII, interoperable standards and so on to support health care, and to some extent human services more broadly as well. So we're very pleased, we've already begun putting together a plan in our own office as to how we would distribute the funding, but we had a number of ideas from the committee and from other places as well. So we're very happy.
Again, as a departmental initiative in the '04 budget, our office ASPE worked with AHRQ, Mike is here, and we have in there, and actually this is probably, this is actually a considerable ramping up in terms of the support here, $10 million dollars for standards related work. And this is included in the AHRQ budget, Mike and I are working together and we're looking at the recommendations for standards work and promotion and support and gaps that have been identified through various processes, the CHI work for example has identified a number of areas where literally if we didn't support the standard on a more continuing basis it would be hard to actually implement it. So you'll remember some of the medication standards that came forward as the CHI, Rx-Norm supported work, some of the mapping and so on, so I think we're planning, we put together kind of an initial funding plan with Mike and AHRQ and we'll be moving forward as soon as that funding is released to kind of get some of the standards that either continuing the support for some standards, in some cases providing initial stabilization and support for some of the standards work as well. So we're very happy about that as well. I think we're setting aside a bit, Mike, as well for kind of initiatives that may come up during the year but I think we're very pleased with that as well.
And the largest increase is actually a $50 million dollar increase in the AHRQ budget for a program of demonstration grants and research relating to health information technology in health care settings, started out as hospitals, to improve patient safety and quality, and the request for applications have already been released, I think two months ago, Mike, so hopefully some very capable researchers and evaluation specialists and clinicians and informatics folks are putting together proposals, submitting them to AHRQ, and we'll get that underway.
DR. FITZMAURICE: Can I add just a word, Jim? You can find the three requests for grant applications on the AHRQ website, ARHQ.gov, under funding opportunities. There are implementation grants, there are grants to show the value of health information technology, and can you believe it, grants to write grants. We give you planning grants to pull together partners, formulate the idea, and then come back to us with a grant. We would like to have your letters of intent in by February the 6th, and the grants are due in for all three of those by April the 22nd of this year. And there's quite a large set aside for rural hospitals and rural areas, partnerships in that area.
MR. SCANLON: The Secretary can give a priority to small and rural hospitals as well. And I think, Mike, it's actually broader then just hospitals now, isn't it? I think we, so that's actually a very positive development.
Let me say a few words about the NHII related activities. We're planning again, I think we already talked about this at the NHII Workgroup, we had an inaugural, probably an annual conference on the National Health Information Infrastructure we sponsored this last June, late June early July here in Washington, and we're planning again to have a second annual conference on the National Health Information Infrastructure, hopefully we'll have the Secretary again as a keynote. At that meeting the Secretary actually launched a number, well, made a couple of announcements for where we actually launched a number of NHII related activities. I know we're working, our own staff is working with the NHII Workgroup and the full committee on planning the agenda for that conference so that we can actually move forward. It's kind of a convener role as well for bringing all of the interest in the NHII together and moving forward.
Let me mention two quick activities within the Data Council and then I want to talk about the '05 budget quickly. Our Data Council is our internal department wide committee for coordinating data statistics and standards and other related activities, and we are following up on a couple of issues, though there was a broad interest existing in the department even before, on a couple of issues raised in the Vision for Health Statistics Report that the committee filed, I think it's almost two years ago now. And one of the issues was for geocoding and the general look here is to looking at our major data resources, our data collection systems, our public health surveillance systems, our administrative data and so on, to sort of evaluate what sorts of geographic level detail we already may be using in those systems to look at ways of standardizing that information, to look at how we tabulate the information, and there are some issues there, and to make some recommendations for moving forward. So we've just awarded a small contract under the Data Council, they've just begun the project and I think we'll report to the full committee here and to the Populations Subcommittee as we move a little further along. So again, we'll get the full, we'll get the participation and the input from the Populations Subcommittee and the full committee generally.
The hope here, there is actually a government wide, it's actually called the Geospatial Geocoding Initiative, and all federal agencies are to look at their data holdings, again, this is statistics and research, this is not administrative data, for how the information could be better accessed and how it could be more standardized and comparable so that if you're interested in HHS data there's a certain way to go, if you're interested in EPA data it's comparable, but at any rate I think the committee will be interested in helping us with this as well.
Secondly we are continuing our efforts to improve user friendly access to the extensive data resources in HHS. We as I reported previously have created an HHS statistical website, that website includes links to all of the major data collection systems and data and tabulations and analyses that our agencies produce. They're unified in one place, you can search by terms or if you're an aficionado and you know exactly what data source you're looking at or you want to find you can go directly there as well. There are short cuts to our major data systems, the Health Interview Survey, the Medicare Term(?) Beneficiary Survey and so on, MEPS. We actually take you to, one of our pages will actually take you as far into the agency data in terms of tabulations as you may want. Some of them actually allow you to do tabulations, not only looking at the tabulations published or any of the research reports or statistical reports published, but in some cases you can actually do tabulations. AHRQ has some capability in this regard, NCHS does, and SAMSA does as well and actually CMS does as well. So this is an attempt to if not unify at least bring together in one place a gateway in essence, user friendly access to our major data systems in HHS. This is anonymized data, I hope no one misunderstands this, this is statistical data, published data, tabulations, there's no individual data here.
In many cases in the three agencies I've mentioned there actually is a facility whereby researchers and analysts can request access to data through one of the research data centers, we have three of them now in HHS, so you might be able to create tabulations and analyses, particularly small area and small number analyses, that are not public but are done under confidentiality protected provisions. It's not done over the computer but it's done upon request to the agency and so on, we can brief the committee on those further.
But we're expanding and extending the gateway, we're organizing it in a little better user friendly fashion. I think I'm going to ask the Populations Subcommittee later to kind of give us some ideas about how if they wouldn't mind looking at it in terms of improving the friendliness, the user friendliness of the data particularly. We're not creating any new data, this is just linking to the data we already have.
We also provide, if you're really coming to the HHS website and you really want to look at the scientific literature or research, we provide a link to the NLM and PubMED(?) and MedLine and all of the facilities there. We also have a link to our policy research database, which my office particularly has sponsored over the years. This has most of the major evaluation policy research that HHS has sponsored all the way back to the ‘70's. Some of the major evaluations and RAND health insurance experiments, the New Jersey Negative Income Tax Experiment, those were supported by HHS and their, the documentation is there on the website as well.
Quickly, the '05 budget, John, if I can. It turns out that a number of folks are getting interested in the National Health Information Infrastructure, our Secretary got interested last year and is really a proponent now, and actually the President is now beginning to mention the NHII in a number of addresses in the health area. In his radio address on Saturday he talked about five points to improve health care in the U.S., but one of the points was actually by moving American medicine into the information age, and he said that my budget for the coming year proposes doubling to $100 million, this is the $50 million that we've counted for the demonstration projects, the money that we spend on projects that use promising health information technology. This would encourage the replacement of hand written charts and scattered medical files with a more unified system of computerized records. By taking this action we would improve health care, help prevent dangerous medical errors, saving both lives and money.
So when the '05 budget is sent up to Congress next week, February 2nd I think it will be, we expect to have this initiative included and possibly some others as well. So it looks like what began as a collaboration between this committee and the Data Council and our network within HHS is now turning into a very broad and very high level initiative. So let me stop there and see if there are any questions.
DR. LUMPKIN: Vickie?
DR. MAYS: Three questions, one in terms of the AHRQ National Health Disparities Report. Can you at all tell us if there is any follow-up to that report? I mean it's been received by Congress and there's been a lot of discussion about it and I understand there's possibilities for some activities so I wonder if you could update us about that. Second, did we get a response yet from the Data Council, the Secretary said I think it was in about 90 days he would be responding to one of the, the first letter that we sent --
DR. LUMPKIN: Which one Vickie --
DR. MAYS: That was the one on targeted surveys. And then my other question, in terms of the Geospatial Geocoding Initiative, will that contractor that you have, will they be looking at all about what variables should be used as opposed to what's there but making any recommendations about --
MR. SCANLON: It will be, let me answer that one first, Vickie. Let me start with the third. Yes, we're looking at sort of, one feature is looking at what we currently have, but I think in many cases it's fairly limited and I'm not sure how standardized, other then the usual sort of geographic and geopolitical kinds of descriptors. So yeah, we're looking at what the standards are, what are reasonable categories for, and what's missing, for example. There could be metropolitan area designations that would be useful but may not be used. So it's meant to be both descriptive and normative in the sense of where should we be. And again, the idea here is to not create some special categorization in HHS, it's to use broad categories that more or less are compatible with what other agencies are using as well. And the idea here is to promote the best use of that information.
Let me work backwards, and I'm going to ask Mike to answer the Disparities Report, I know they've been sent up to Congress and I know work is beginning on the second annual reports.
But let's see, on the targeted surveys and on the improvements to statistical systems, I think we probably are not going to respond until after the President's budget for '05 goes up because I think there's some very positive, well, I hope, there were some positive directions being considered and I think it would make more sense to wait until that budget is finalized next week and then we can say what's actually in the President's budget, but it actually looked quite promising.
And Mike, about the Disparities --
DR. FITZMAURICE: About the Disparities Report, it certainly has received quite a bit of attention and discussion and AHRQ is pleased to present, pull together the facts and present them. We plan to do it again, that is another annual report, and we look forward to again, a lot of public attention to what's going on in our nation.
DR. LUMPKIN: Okay, seeing no other questions, nicely done Michael, we will take a ten minute break.
[Brief break.]
DR. LUMPKIN: Let's get started again. The main reason for us having a special meeting today is actually this particular item, which is the discussion of the Consolidated Health Informatics. We have before us or will have before us a letter on CHI which we'll do after the presentation, but we're going to have an update, Simon, do you want to lead in?
DR. COHN: We're going to be sort of talking back and forth but I think the process here for the next hour and 15 minutes, hour and a half, Karen will start out I think with sort of a broad overview of CHI. I think many of the current members are pretty familiar with pretty familiar with all of this but for the new members I think it's a useful update and certainly for those on the internet I think this will be very useful.
Then we'll sort of move into a conversation between Cynthia Wark and myself as we move through the recommendations, and this is the time, yikes, where there are lots of recommendations coming forward, this is sort of the end of phase one of CHI, and I believe we have 14 recommendations coming forward. So you know we sent out about a 40 page email to everyone, we of course know that you all read it and memorized it, but just in case you didn't we wanted to give you a flavor of what we're recommending, as well as an occasion for you to ask any questions with the end result hopefully being that you'll approve the approach of the subcommittee and agree with the letter that we composed.
With that, Karen, would you like to start out?
MS. TRUDEL: Yes. Again, I'm Karen Trudel and I'm not wearing my other hat which is that of the program manager for the Consolidated Health Informatics Initiative, and I'm joined by Captain Cynthia Wark, who's the deputy program manager. I'm going to talk a little bit especially for some of the new members about the CHI strategy, how we got here, what this means, why this is different then HIPAA, and again, CHI is part of the President's eGov portfolio, there were 24 eGovernment initiatives, our particular goal was different then most. Most of them were involved in building systems that crossed department and agency lines, like e-grants. In our case when we started to look at potential applications to consolidate we discovered that what we needed to do first was to get ourselves all onto a platform where we were talking using the same clinical vocabularies, and we felt that that was an absolute, it was a necessary preliminary to doing any kind of consolidated actual applications.
So we're adopting existing clinical vocabulary and messaging standards to enable interoperability in the federal health care enterprise. That is where this is different from HIPAA because these standards are only for use at this point in the federal health care enterprise although we do understand that the federal enterprise provides a significant tipping point where if we are all adopting the same standards and using them there's definitely a reason for private industry to follow.
Rather then converting to these new standards all at once they are built into individual IT architectures, in other words as agencies bring up large new systems or large system rewrites, when they begin to do their planning and get their approvals through the federal IT system they will need to demonstrate that they are using these standards in those new systems.
We decided to be very careful about preserving individual partner agency business rules, so that the standards that we adopt don't change how agencies do business, that's somewhat similar to the way HIPAA operates. And we have used the NCVHS very extensively to both get a reality check as to how the standards that we're proposing will work in the real world, and also to use this as a forum to communicate what we are proposing to do with the industry as a whole, and I'm especially grateful for the committee in setting up this additional meeting because without this meeting we would not have been able to come anywhere close to meeting our deadline of getting the first round of 24 standards done by the end of the fiscal year, we'll come within a month of it, which I think is pretty close considering what we've undertaken here.
This is just a slide about how this works, OMB has an eGov office, they oversee all of the individual eGov initiatives. In this particular initiative there is a CHI Council that is the governance body for this particular initiative, the lead partners are HHS, VA, and DOD. A vast array of supporting partners, and many of them have been active in this initiative.
Again, quickly, we've deployed teams of experts, we identified 24 domains where we needed to look to adopt standards, each one of those domains has a team of subject matter experts from across the CHI Initiative. They defined the scope, they identified candidate terminologies, through the deliberation process there's been analysis and feedback by the CHI Council, from NCVHS, from internal department organizations, and then finally there is a government wide roll out of standards as they are formally adopted. If you see the arrow at the bottom that says final reports to NCVHS, that is where we are today with the last 14 of the domains.
The range of possible recommendations when we looked at a particular domain was was there a standard that was already in place that was perfectly acceptable and all we had to do was make sure that there was a way to keep it up to date. In some cases we were able to make that kind of recommendations. In other cases we could adopt a standard but we identified gaps at the same time, the gaps did not preclude us from going ahead and implementing the standard but we have now a list of action items that we will need to take back to standards developing organizations to say this standard would be a lot better if you could address this gap. In some cases the standards were just not ready for prime time quite yet, there were conditions that precluded us from being able to actually use the standard until the conditions are addressed. And there were temporal issues where we thought the standard looked okay but we had to wait for a ballot to take place. In some cases there was absolutely no solution at all and in those cases we talked about what some of our next steps were, who we could partner with, how we could go about moving toward something to adopt in the future.
We started out with our 24 domains as our marching orders and we were very lucky to avoid any scope creep, so we had 24 to start with and we still have them. The first five were adopted last March, and I'm going to plagiarize a little bit from Steve Steindel who talked about this yesterday, in some cases we were looking for not only low hanging fruit, but fruit that somebody else had already picked for us, and these first five standards actually are that. They were ready to go, they were no brainers, and so that's why they didn't take very long. LOINC for laboratory result names, HL7 messaging standards including scheduling, medical record and image management, patient administration, observation reporting, financial management and patient care, the NCPDP scrip in the retail pharmacy industry, IEEE 1073 for connectivity, and DICOM messaging for image information to workstations. Those were the fruit that someone else picked for us.
Interestingly after that, and again getting back to Steve's analogy, we looked for the low hanging fruit and when we couldn't reach any more low hanging fruit we had to go and get a ladder, and in some cases the ladder didn't reach and we had to get an even bigger ladder, so that's some of what we're bringing to you today. We have already brought six domain standards to the committee for approval over the last three to four months, so those will not be discussed today. Those are recommendations for medications, laboratory test order names, laboratory result content, units, immunizations, and demographic. And if there's any interest in the reports on those I can be reached and I can provide you with what the process that the group looked through, the whole process.
The next slide shows the recommendations under consideration, these are the ones that we're going to talk to you about today, in some cases again we have recommendations, and in some cases we found that there really was nothing there, so I'll turn it over now to Simon and Cynthia.
DR. COHN: And Cynthia, let me just make a couple of comments here. Obviously I think what you're seeing here is really the type of synergy that we'd like to have with HHS and I think this is an excellent example of the private and public sector working together to do something that needs to happen. I mean Karen mentioned about prepackaged fruit, and I think that we should observe that the people that did the packaging for that fruit was actually the NCVHS. We've had a long history of leadership in both the administrative and clinical data standards, I mean that's been true through its 55 year history, 54 year history, Marjorie? I don't know the years but under HIPAA, as part of HIPAA we were actually rechartered and actually we've had a major role and responsibility for administrative medical code set standards under HIPAA as well as the standards themselves, and there was a part there that talked about we should study clinical data standards and patient medical record information standards and the electronic exchange of such standards, which I know Jeff has memorized and I'm sure I've misquoted it slightly.
But we had a first report in 2000 that sort of set off sort of the framework for moving forward, but without specific recommendations in terms of the actual content. In '92 and '93 we actually came up with specific recommendations but the real question got to be was how to implement, and I think our recommendations were that the government needed to lead with the implementation and really set the example, and that this was not going to be a HIPAA style implementation where things were mandated throughout the industry, but that we thought that it was actually important that the government both set the example and that there were actually good business reasons for people to migrate towards standards, and if you think about it for clinical care, decision support, identification of best practices and outcomes research, as well as financial reasons because increased standardization saves money on the implementation of these sorts of systems, I think the government has been taking the lead and obviously we've been very pleased to be able to provide advice and guidance.
Now the NCVHS recommendations are sort of at the, have been at the 3,000 foot level, I'm not sure that I consider the CHI recommendations at the ladder level but I think we're moving down to maybe a high ladder, which is the sort of the 300 foot level of these recommendations, and I'm expecting as we move sort of forward we'll get more and more concrete and move down to greater levels of specificity and concreteness because at the end of the day what everyone wants to know is exactly how to implement these terminologies in which standards and how to use them so that we're dealing with standards that are sort of aligned to how you use an electrical plug. I mean nobody sits around and goes well, geez, will that plug work in that outlet, let me guess here, and really we want to get to the point where this is sort of how things work in health care and how people can best leverage their IT investment.
So anyway, with that what we're going to do is to really go through in relatively rapid fashion a lot of the domains. This is sort of my idea of how best to handle the letter and I will apologize, I think the toner cartridge on the printer seems to need new ink, so it's going to be a little hard on your eyes. But really what we're focusing in on is the bullets in the page and a half letter, and basically each bullet is a domain under consideration. What Cynthia will do is talk a little bit about what the domain is, what the recommendation is, and then we'll talk about what our recommendations are around that. And as I say we'll try to handle this relatively quickly, some of them are really very non-controversial, others we will talk about a little bit because they are controversial, but we will also cap the conversation because we do want to allow people to have lunch and a lot of times where there is a lot of controversy the recommendation was is that more work needed to be done in that area.
Questions before we start off? The hope is that when we're done with this you will have reviewed the letter and be comfortable with voting.
Cynthia, would you like to start off?
MS. WARK: Okay. I will start off with a few slides on the anatomy and physiology recommendations, I would like to say that each of these slides sets that you will see are excerpted from the written reports. You have a copy of the written reports attached to the letter and all of those are posted on the NCVHS website.
The reports reflect an enormous amount of work on the part of well over 100 subject matter experts in the federal enterprise. We had team leads throughout the federal government who stepped up to the plate and led these workgroups and went through all of the steps that Karen talked about, and I have to give public recognition to someone who repeatedly performed the task of team leader, as we moved through the schedule in 2003 moving from one domain to the next, we had one person who on three occasions raised their hand to be a team leader, and believe me this was no easy job, convening subject matter experts from around the government who have their day to day jobs that they are doing and to try to meet with those people and even just to find the time to get everybody together to work through the steps, and work through some very difficult issues. Steve Steindel has led personally three of these teams so I do want to --
[Applause.]
MS. WARK: The first of the domains is anatomy and physiology and Steve led this team. Team members were Dan Pollack from CDC, Kathy Johnson from NASA, Lee Wells from the VA, Ross Barner(?) from the Department of Defense and Sherry Decoronado(?) from NIH.
The team started off with a description of the domain, anatomy being a terminology used to describe anatomical locations for clinical, surgical pathology specimen descriptions and research purposes, and physiology being a terminology used to describe or infer both normal and abnormal human physiology at least at the organ system's cellular and biochemical levels. They scoped out the domain to address anatomical location of a procedure and injury, anatomical description of specimen, subcellular anatomy, measured or inferred physiology or organ or organ system, measured or inferred physiology of cell and morphology.
The alternatives that were considered were MESH, the NCI Anatomical Terminology, SNOMED CT, Clinical LOINC, Foundational Model of Anatomy from the University of Washington, the HL7 Site Table, and the Veteran's Administration NDF-RT Medication Physiologic Effect Access. This really required the group to evaluate each of the alternatives they identified to gather information to interact with subject matter experts from those organizations, because as we said we were not developing the standards but evaluating standards that have been developed by external standard development organizations to the government, so this did require an enormous amount of work.
The recommendations for anatomy and physiology, under anatomy is SNOMED CT will form the core anatomy terminology, the HL7 Site Table will provide a more simple anatomical Site Table for general usage, and the NCI Thesaurus for research purposes, it extends present anatomy terminologies into subcellular structures, and that could be used in conjunction with or mapping to SNOMED CT. In the area of physiology there was not a recommendation for a standard coming from the workgroup.
DR. COHN: And of course the expectation here is that these will all be well mapped by the National Library of Medicine when it goes into the metathesaurus. Our recommendation was basically we agreed with what CHI had come forward with. We thought that there were recommendations for anatomy and we agreed with them, we also recognized that really did not appear to be an answer for physiology at this point, I guess which is what you're saying up there. But we also felt that there was an issue related to the physiology definition of the domain that really needed to be revisited because we just weren't sure that that was really, we questioned whether the focus of the investigation was the right focus and it needed to be evaluated. Cynthia? Any comments? I'm sorry, I thought you might have another comment on that domain. Are there any questions about this one? Comments?
DR. LUMPKIN: Any concerns? Because what we're going to do is after we're done walking, we're essentially walking through this letter, we're going to take a vote, so if you have concerns about this particular time, the recommendation that's before you is that we concur with the recommendations from CHI for anatomy and physiology and we concur with the need to revisit physiology in 12 to 18 months. Okay.
DR. COHN: Okay, good.
MS. WARK: Okay, the next workgroup was billing and I led that workgroup myself along with a host of representatives from the Centers for Medicare and Medicaid Services, the Social Security Administration participated, and there were several representatives from the Veteran's Administration and the Department of Defense.
We defined the billing domain as standards that are used to implement electronic exchange of health related information needed to perform administrative functions in the federal health care enterprise. This was in the category of a validation effort. We approached this with the assumption that the HIPAA transactions and code sets would serve as the basis for these standards.
For the scope of the billing domain we included all of the areas that are currently covered by HIPAA and we added two additional areas appeals, a certificate of medical necessity that the workgroup thought it was worthwhile to take a look at and see if there were any standards available that could be adopted by the federal government.
The alternatives for billing included all of those that are already identified as approved transactions and code sets under HIPAA, we also added ICD-10-CM and ICD-10-PCS.
The recommendations from the billing workgroup are that we adopt the HIPAA approved transactions and code sets, both those currently approved as well as future updates so that any of the areas that are not currently implemented under HIPAA but do have standards implemented in the future, that those would automatically be adopted through CHI. We did not come up with recommendations in the two additional areas that I mentioned.
And that's it for the billing workgroup.
DR. COHN: Okay, and as you can imagine we concurred with these recommendations with just I think a couple of minor wordsmithing changes to the report. And those other two domains, other two possible standard transactions are probably things that we need at some point to sort of review at the subcommittee level to identify what may be possible in that area.
Comments, questions? Kepa?
DR. ZUBELDIA: Sorry, I missed the meeting a couple days ago in the morning, but the question I have is in the health plan identifier and provider identifier domains, since those are part of HIPAA and for one there's already a final rule that came out last week, what's the reason for not including those in the scope?
MS. TRUDEL: This is Karen. The reason is that at the time the reports were written the plan ID obviously had not been published and we did not have a clear date for the provider identifier. What we are doing is rather then continuing to revise these reports on the fly we will go back periodically and correct anything that has occurred to change recommendations, so that's something, because we said and future update, we will go back and have a way to annotate reports to show subsequent actions that have effected the initial recommendations.
DR. LUMPKIN: So this particular recommendation, which is to concur with the CHI recommendations for the billing domain as modified, those modification include wordsmithing such as on the second page adding in the word identifiers in front of transactions and code sets, just to clarify since that's what the recommendation is. Any questions on this recommendation? Concerns? Next?
MS. WARK: Okay, the third area is nursing, this was led by Lieutenant Commander Alicia Bradford from CMS along with representatives from the Veteran's Administration, the Department of Defense, and the Indian Health Service.
The nursing domain was described as a standard that will be used to identify, classify, and name the delivery of nursing care. The scope was identified as assessment and observations, plan and goals, diagnosis, interventions, and evaluation and outcomes.
There was a long list of alternatives considered including SNOMED CT, the ABC Codes, NANDA for diagnoses, NIC for interventions, NOC for outcomes, the Omaha System, the PCDS or Patient Care Data Set, the HHCC or home health, the Perioperative Nursing Data Set, the International Classification for Nursing Practice, and Clinical LOINC.
The recommendations for nursing are to adopt SNOMED CT and specifically the nursing concepts that are contained within the findings and procedures hierarchies. Also that collaboration between the source nursing terminologies and the SNOMED CT convergent terminology group for nursing is essential. These efforts should continue and the mappings should be maintained in the UMLS. And essentially what the workgroup found is that the majority of the alternatives considered are already incorporated into SNOMED CT or have plans to do so in the future, so that was the basis for the recommendation of SNOMED CT.
DR. LUMPKIN: Are we going to come back to medical devices?
DR. COHN: I hope so. Just in terms of nursing and then we'll talk about medical, I don't know where medical devices is in this presentation but we'll find out. Obviously as you can imagine our work was made easier by the fact that there was already work underway to really integrate all of these nursing terminologies into SNOMED so it made it easy for us to concur with these recommendations. Judy, do you have a comment? Please.
DR. WARREN: Yeah, it's a picky one but since I've worked hard to do it, I don't know if this is, I mean this goes into knowledge I have and I don't know what my waiver covers so I'll make a comment and if I should keep my mouth shut tell me. The example for a NOC outcome in the letter is in error, the NOC outcome is not under the procedures hierarchy, it's an observable, and so if we want this to go out and be accurate I can get you an accurate example by tomorrow.
MS. GREENBERG: And certainly information like that is welcome.
DR. WARREN: A lot of people would be very upset because we've spent a lot of time really looking at outcomes and how they need to be modeled because they're a strange kind of, they're difficult, they're not as easy as findings or procedures.
DR. COHN: Okay, so you're basically supporting the recommendation but have some wordsmithing additions or modifications to the report related to accuracy.
DR. WARREN: The other thing, it's just nice to know that a lot of the hard work that we've done within the nursing community is finally coming to fruition and being recognized, so I mean this took a lot of effort to get these recommendations to where CHI could look at them so it's wonderful.
DR. COHN: Steve Steindel?
DR. STEINDEL: Simon, that will change the line to concurs with the CHI recommendation for the nursing domain as modified, instead of as presented.
DR. LUMPKIN: And procedure, since what we're adopting is the letter and not the attachment we can, if it's acceptable with the sign off of Simon and myself we can accept the wordsmithing change to that example language if that's agreeable, so we'll include that as part of the motion.
DR. WARREN: And if I can make telephones work I can probably get it for you this afternoon.
DR. LUMPKIN: That'd be even better. Thanks.
DR. COHN: Questions?
DR. LUMPKIN: Anybody nursing any grudges about this section? Okay.
MS. WARK: Okay, here's the recommendations from the supplies workgroup, and originally the domain was titled medical supplies and resources, the resources term was excluded, that was looked at as staff resources and so we re-termed the workgroup medical supplies. And the team was led by Brock Hefflin and Larry Kessler from the --
DR. LUMPKIN: I'm sorry, can I interrupt you just for a second because the heading we have says medical devices and supplies domain, is that the same domain?
MS. WARK: Yes it is, I'm sorry, there was mention of staff resources in some earlier versions of the portfolio and I just wanted to explain that staff resources was not included in the phase one work, so it is medical devices and supplies.
DR. LUMPKIN: Great, thank you.
MS. WARK: Was led by FDA along with representatives from the Centers for Disease Control and the Department of Defense and the Veteran's Administration.
They defined the domain as any instrument, apparatus, appliance, material, or other article intended to be used by human beings to diagnose, prevent, monitor, treat, or alleviate a disease, injury, or handicap, or to replace, modify the anatomy or a physiological process.
The scope of the supplies domain is all medical devices and supplies and they noted that there are nearly 7,000 generic groups, and that the names are used primarily to inventory the products and document their utilization by health services establishments and to regulate their availability and utilization in the community by public health agencies.
The alternatives considered were the FDA Medical Device Classification, the Healthcare Common Procedure Coding System, HCPCS, ICD-9, UNSPC, the United Nations System for Product Classification, SNOMED CT, the GMDN Global Medical Device Nomenclature, and the UMDNS Universal Medical Device Nomenclature System.
The analysis was that both the GMDN and UMDNS were similar in scope, the UMDNS is available through the National Library of Medicine and supported by an established business plan. The GMDN is an international standard and is strongly supported by the FDA for global communication and as an eventual replacement terminology. And the workgroup noted that efforts are underway to start to merge the terminologies. Therefore the recommendation from the supplies workgroup is that no one terminology is recommended, rather we should wait for the Global Medical Device Nomenclature and the Universal Medical Device Nomenclature System to merge and adopt the resulting terminology.
The terminology resulting from a merge of these two terminologies will enable the U.S. federal system components to utilize one set of medical device supply names, definitions, and codes, and to use these same product identifiers to communicate with foreign establishments. So that was the recommendation from the supplies workgroup.
DR. COHN: And this is actually consistent with actually independent hearings the subcommittee held during the fall. I will say quite frankly most of us were disappointed that we weren't able to more clearly define the right answer for implementation today, and indeed I think this is sort of a frustrating issue nationally, and probably internationally for that matter, that we can't provide more guidance and direction on this. Because this is obviously a critical area for patient safety and others to basically come to a single standard for this terminology, but clearly there's work underway and we're very hopeful that there will be increased collaboration, hopefully merging of these two terminologies.
We did observe in our recommendation, and this just has to do with how specific these nomenclatures get, that these are still a level above if you're really talking about patient safety issues identifying sort of that type of device that you might do for patient safety investigations, so this is helpful, it helps you categorize, identify related devices, but it still stays once again a level above that specificity. And therefore we sort of recommended that HHS further investigate device type, which actually is a level more specific then these nomenclatures, as a component of device identification with the idea that we can hopefully help drive this effort into greater specificity.
Anyway, that was our recommendation, good as far as it goes but more needs to be done here. Questions, comments? Harry?
MR. REYNOLDS: Is there a time, in other words are you willing to wait a year, two years, three years, or indefinitely, for these to merge?
DR. COHN: Should I ask the CHI that question? How long are you willing to wait for them to merge? I'm an emergency physician so I sort of have a short fuse --
MS. WARK: Well, the majority of the standards that we're recommending for adoption have been developed by organizations outside the government and it didn't make sense to us to go in any different direction or to take any action when it was clear that there was a significant effort underway and the government was involved in that. How long that will take is not known exactly but I think they are estimating somewhere between a year and two years.
DR. COHN: Aside from this joking basis, actually I wasn't even joking that much, but I think we'll be tracking this in the subcommittee and I think if there's things we can do to help encourage that effort I think we will take action to do that.
DR. LUMPKIN: We don't want this to be divisive.
DR. COHN: Thanks, John. Karen?
MS. TRUDEL: The CHI Council will be looking at these and tracking them periodically also and in all cases where we made this kind of a recommendation it was because we had seen good forward progress being made. And if at some point in the future it appears that that progress is totally bogged down then that would require a reassessment.
DR. LUMPKIN: Okay.
MS. WARK: Okay, the next area is history and physical and this team was co-led by Dr. Viet Nguyen and Linda Nugent from the Veteran's Administration, and there were representatives from the Department of Defense, the Indian Health Service, and the Centers for Medicare and Medicaid Services.
This group very quickly determined that a standard did not exist at the present regarding the content and structure of a history and physical document thus they recommended that the domain be addressed in the next phase of CHI once standard development efforts in this area progressed and the foundation is determined via the domain of text based reports. So that was what the workgroup brought forward as the recommendation.
DR. LUMPKIN: Questions or comments?
DR. COHN: Obviously we concurred with this one and we'll be talking more about text based reports in a later recommendation.
DR. LUMPKIN: Okay, we're on a roll.
MS. WARK: Okay, the next area was disability and the team was co-led by Jennie Harvell and Samuel Shipley from ASPE with representatives from the National Library of Medicine, Social Security Administration, the National Center for Health Statistics, the Veteran's Administration, the Centers for Medicare and Medicaid Services, and other representatives from Department of Defense and ASPE.
There was a lot of slides here that I'm going to go through fairly quickly and sort of get to the bottom line. This workgroup did a huge amount of work beginning with looking at the use of disability data in the federal health care enterprise, and included in the paper is a description of that data use by CMS, CDC, NCHS, SSA, VA, and DOD. They sampled disability terms from the instruments that are used in those federal programs, including the Nursing Home Minimum Dataset, the Home Health Outcome and Assessment Information Set, the Functional Independence Measure for Rehabilitation, the Residual Functional Capacity Form, and the National Health Interview Survey and National Health and Nutrition Examination Survey.
The alternatives that they looked at were SNOMED CT, the International Classification of Functioning, Disability and Health, and other sources in the UMLS. They proceed to undertake a rather detailed analysis of the terms in those instruments and they mapped them through a meta-map transfer program that the National Library of Medicine uses. And there's a lot of information in the report, part of the reason that we had so much detailed information stemming from the workgroup's findings is that essentially it really wasn't clear to what extent the terms were available in the terminologies that they looked at and this slide shows the study findings and the percentage coverage of the terms from the various federal instruments in the terminologies, and the workgroup analyzed where there were complete terms available, partial, or none, and the total line at the bottom of the chart shows that SNOMED CT had complete coverage of 56 percent, partial coverage of 39 percent, five percent were none. And in the ICF complete coverage was 35 percent, partial 52 percent, and 13 percent none.
The timeframe for this study was rather limited, they did not have a validation effort, so therefore they were working with an individual's evaluation of these terms. There was some other research that they looked at that had been conducted by the Mayo Clinic that found for three selected clinical domains captured by the MDS that SNOMED CT provided a complete match for 46 percent of the MDS terms, the minimum dataset, and that ICF provided a complete match for two percent of the MDS terms.
Ultimately they came forward with a recommendation that there isn't anything ready for adoption in the federal enterprise, and their thinking in all of the deliberations and information gathering that they went through was certainly laudable and will be very helpful in the next phase of any work that is done in this area, but they did not come forward with a recommendations to adopt any of the classification or terminology systems that they looked at.
DR. COHN: As you can imagine there was a lot of discussion in the subcommittee about all of this. This is clearly an area where more work needs to be done and actually there was some discussion about getting the Subcommittee on Populations involved in this discussion also obviously as it goes forward.
Our own view is that there was sort of a little confusion in the workgroup around both what they were supposed to be doing in scope and possible approaches because there was sort of an overlapping of two issues, one had to do with this issue of questionnaires and scales and responses, and then there was an issue of terminology, and the workgroup was having trouble sort of parsing them apart, which is why we were trying to provide some advice in our bullet here. And you sort of see the recommendation that we're obviously agreeing that more research is needed, which is really what that recommendation is.
We recommended investigating, you think about it in question and answer style because they really were having a lot of trouble with the scaling and question and what is the response type thing and they're actually, to expect a clinical terminology to support all aspects of questionnaires is probably somewhat of a tall order and yet there are some terminologies, and since Dr. McDonald isn't in the room we can actually talk about things like LOINC for example, and that sort of style of question and answer, is actually a very good model for that sort of questionnaire but even with that once you have that then you still need a clinical terminology within the answers and things like there may be a number of terminologies that were evaluated, which may find great utility and it would be relatively comprehensive in those areas, but once again it's a question of creating expectations and asking the right questions here.
So this is sort of what we understand them to be doing in the next phase is to sort of revisiting this. We were recommending that they think about it in that way and obviously we also added a comment just because we didn't think that the evaluation was really inclusive enough of all the stakeholders, so our final sentence is we further recommend the future activities consider the unique needs and perspective of the different disability groups and other domain stakeholders. So I think we should be expecting more work going on and I would expect in the very near future in the disability domain with sort of a reevaluation and re-approach. Questions, comments? Vickie, did you raise your hand to volunteer to help on this one?
DR. MAYS: I was thinking deeply about what you need from us.
DR. COHN: Okay, well hopefully the structure isn't the issue, it may be more the issue of representation and making sure it reflects the needs. Comments, questions? Okay.
MS. WARK: The next workgroup was genes and proteins, this was led by Dr. James Sorace from the Center for Medicare and Medicaid Services, with representatives from the National Institutes of Health, the FDA, Department of Defense, Veteran's Administration, and other representatives from NIH.
They described the domain as allowing the federal sector to exchange information regarding the role of genes in biomedical research and health care.
The scope of genes and proteins was defined as inherited genetic variation, for example genetic disease, pharmacogenomics, disease susceptibility traits. The second are was acquired genetic changes, for example cancer. The third was infectious disease where genes and proteins are involved in pathogenesis, drug resistance, or identification. And protein nomenclature and gene nomenclature.
The alternatives that were considered were the Human Genome Nomenclature, the Gene Ontology Nomenclature, and SNOMED CT.
The recommendations from the workgroup are that we adopt the Human Gene Nomenclature sponsored by the Human Genome Organization which is jointly funded by NIH and the UK.
DR. COHN: And we concurred with the recommendation for the genes and proteins domain. Obviously the domain if you look in the documentation and all that included a number of other areas, inherited genetic variation, infectious disease, and protein and gene nomenclature, and those weren't, I don't think that any recommendations were made in those areas, we just wanted to observe that obviously something like one quarter of the work was really done specifically, we are presuming that the other areas are being deferred for future work.
MS. WARK: Correct.
DR. COHN: Questions, comments?
DR. STEINDEL: I have a question, Simon, is the HUGO Nomenclature available at low or no cost?
MS. WARK: We worked with the National Institute of Health to get clarification on the funding and availability of the nomenclature and it is free, not only to federal entities but also for commercial use. It does require a license but the license is free and the organization has since changed the language on their website to clarify that.
DR. COHN: Okay, next.
MS. WARK: The next area was non-laboratory interventions and procedures and this workgroup was led by Dr. Jorge Ferrer from the Centers for Medicare and Medicaid Services, along with representatives from the National Center for Health Statistics, the Veteran's Administration, the Department of Defense, and Indian Health Service.
It was defined as a standard that will be used to describe specific non-laboratory interventions and procedures performed or delivered in the provision of health care.
The scope of the domain was procedures by site, method, intent, focus, device, and regimen or therapy.
The alternatives considered were SNOMED CT, MEDCIN, ICD-10-PCS and CPT-IV.
The recommendations are to adopt SNOMED CT and the specific location in the SNOMED CT hierarchy that formed the basis of the recommendation is the procedures access, so that would exclude the administrative and laboratory procedure areas in SNOMED.
DR. COHN: We concurred with their recommendation. Questions, comments? Okay.
MS. WARK: Okay, the next area is diagnosis and problem list. This workgroup was co-led by Karla Porter and Beth Acker from the Veteran's Administration with representatives from the Indian Health Service, the National Center for Health Statistics, the Department of Defense, and the Veteran's Administration.
The domain was described as a series of brief statements that catalogue a patient's medical, nursing, dental, social, preventative, and psychiatric events and issues that are relevant to that patient's health care.
In scope was clinical diagnosis or problems, subjective symptoms or observed findings, and synonyms. Out of scope was nursing diagnoses because that was being considered in a separate workgroup, also out of scope was modifiers and descriptors, dental, and alternative medicine.
The alternatives considered by the workgroup were SNOMED CT, ICD-9-CM, ICD-10-CM, ICPC, MedDRA, MEDCIN, and DSM-IV.
The recommendation is to adopt SNOMED CT, the diagnosis and problem content within the hierarchies of diseases and findings.
Gaps for the diagnosis and problem workgroup specifically were noted that mappings are needed between the classification systems and the clinical terminology.
DR. COHN: And we concurred with this recommendation. We actually also suggested that we, I mean we recommended that we add to this list for mappings the International Classification for Primary Care, ICPC, for the mapping recognizing that it would likely find value and utility in primary care for diagnoses and there's certainly a fair amount of work going on outside of the United States that shows some value to that.
Comments, questions? Judy?
DR. WARREN: I just want to clarify the reason that nursing was not in, out of scope, was the fact that it was assigned to another work team, not the fact that it's not part of a problem list?
DR. COHN: Exactly, it's just that it was already handled.
DR. WARK: Okay, the next workgroup was clinical encounters, and this workgroup was led by Greg Seppala from the Veteran's Administration, with representatives from CDC, Indian Health Services, the Centers for Medicare and Medicaid Services, the Veteran's Administration, the Department of Defense, and the Agency for Health Research and Quality.
The domain description, the workgroup sort of struggled a bit to define what it was that we were calling a clinical encounter and they adopted the definition for a clinical encounter from the ASTM E1384-02a standard guide for content and structure of the electronic health record. The encounter services as a focal point linking clinical, administrative, and financial information. The encounters occur in many different settings, ambulatory care, inpatient care, emergency care, home health care, field and virtual.
In scope for this workgroup was clinical encounters, admission, discharge, and transfer information, provider information, accident information, death and autopsy information. Out of scope was areas that were being considered by other workgroups such as demographics, allergy information, diagnosis and problem list, financial or payment information, insurance information, interventions and procedures, and also practitioner to practitioner interaction, practitioner to records interaction, and ancillary service visit.
The alternatives considered for the clinical encounters domain were the ASTM standards for the guide for content and structure of the electronic health record, the standard specification for coded values used in the electronic health record, the X12N 837 health care claim message, SNOMED CT, the CMS Form HCFA-1450, the CDCP data elements for emergency department systems, and HL7 version 2.4 and above.
The recommendation is that we adopt Health Level 7 version 2.4 and higher with identified gaps to be addressed in the future. The gaps are that, essentially the workgroup noted gaps but also stated that the standard is usable at present. There was quite a bit of discussion generated in our NCVHS hearings and within the workgroup and with others about the fact that the standard does not currently account for home health field and virtual encounters and not that anyone would say that that didn't need to be done but that the standard just had not been developed to that level and the workgroup noted that. Clinical services that do not meet the definition of clinical encounter, such as a practitioner to practitioner interaction, again was not something that the workgroup found in any of the standards that they evaluated. The National Provider System Identifiers for practitioners and health care organizations of course is not currently in the standard, standard location identifiers and standard hospital service names. So those were the gaps noted by the workgroup.
DR. COHN: The subcommittee had considerable discussion about this one and I think part of the problem is the term encounter, just because most of us think of an encounter as potentially having something to do with billing or a billable service or something that somehow relates to that, and had some trouble with the actual definition which defined the scope of the work because it actually doesn't include all billable encounters, doesn't include encounters in the lab, doesn't include, I mean that sort of thing and so we're sort of scratching our head almost more of what was the business case of why you would artificially restrict that scope as opposed to, and obviously I think the fundamental discussion. We actually have no issue with the standard being recommended, which was the HL7 ADT standard, but it was really more, we just couldn't quite figure out why they would artificially restrict the scope like that.
Having said that at the end of the day we had to sort of figure that this is government and the government needs to determine its own scope for these things and not everything has broad applicability in the private sector, and so we made comments and moved on. And so our recommendations are is that it concurs with the recommendations as modified to really include the explicit notation of the gaps that you see here which were basically not in the original document, and also the notation of the fact that the personal health records were also out of scope, which was another piece that was not included.
We understood, can I finish the sentence and finish the recommendation and then you can ask?
DR. FITZMAURICE: It was about that sentence.
DR. COHN: Oh, I'm sorry, what did we say about that --
DR. FITZMAURICE: I might suggest that the inclusion, could we frame it as exclusion because we are recommending exclusion of the personal health record, because it is out of scope.
DR. COHN: We didn't recommend that, we just noted that they excluded that.
DR. FITZMAURICE: If the inclusion is okay, fine, that sounds better as exclusion I think.
DR. COHN: Oh, I see, okay. I will consider that to be a wordsmithing modification to all of this. But basically we're saying CHI understands the CHI definition of an encounter refers broadly to all types of practitioners interacting with the patient, however, some explicit clarification may be in order because there was a little bit of ambiguity in that. We note that the CHI Workgroup scope does not include many encounters observed in health care as might be enumerated in an electronic health record, and then we also noted that NCVHS notes that a similar concept of an encounter exists within the HIPAA process and harmonization should occur between the two, or at least some sort of mapping.
I think as I look at these gaps also I would sort of look forward to seeing what the government does with standard location identifiers as well as standard hospital service names, which has been certainly a historic issue in most settings of care where you have more then one facility trying to come to some common agreement about that. We presume that will be in some subsequent set of recommendations or actions from CHI.
Comments or questions?
DR. LUMPKIN: I think that perhaps the best way to list that, to put that would be, because exclusion/inclusion gets a little bit confusing, would that the explicit notation of CHI included gaps and the listing of the personal health record as out of scope.
DR. STEINDEL: That's fine, Mike and I just talked about it, we said noting the exclusion.
DR. LUMPKIN: Okay, yeah, comments on this recommendation. It's a little bit murky but clearer then what we had before. Okay.
MS. WARK: The next workgroup was text based reports, and this was co-led by Dr. Viet Nguyen and Linda Nugent from the Veteran's Administration, with representatives from the Indian Health Services, the Centers for Medicare and Medicaid Services, the Veteran's Administration, Department of Defense, and the Social Security Administration. They also brought in a representative from GSA to address some of the e-authentication efforts.
The text based reports domain was described as standards and terminologies used to define the messaging architecture and syntax of clinical text documents. Clinical text documents were defined as generated by health professionals, comprised of free text, and primarily unstructured data.
In scope was text document structure and syntax, electronic signature, document section headings, and clinical document types or titles. Out of scope was clinical signs and symptoms, vital signs, physical exam observations and findings, laboratory findings, diagnosis, and problems and orders.
The alternatives considered for text based reports were the HL7 clinical document architecture, the ASTM guide for content and structure of the electronic health record, the Continuity of Care Record, SNOMED CT, Abstract Syntax Notation One, the CEN, the Portable Document Architecture, Rich Text Format, XML Extensible Mark-up Language, and HTML hypertext mark-up language.
The recommendation is that we adopt HL7 clinical document architecture, the current version is 1.0 and we are also recommending that subsequent releases that are approved be adopted. It is noted that HL7 released the ballot for CDA release 2.0 on December 8th of 2003 and it is anticipated that this new release will be ANSI approved before the end of 2004. The workgroup did not make a recommendation specific to electronic signatures, they stated that they considered the GSA OMB e-authentication policy and the NIST FIPS Pub 199 as the defining documents for authentication control.
DR. COHN: We concurred with the recommendation of the text based report domain as presented, we did note that the committee will be further studying the HL7 CDA as well as the Continuity of Care Record as part of our ongoing work later on this year. We further note the need for e-signature is an important component that has been investigated by the committee in the past and actually is going to be an important upcoming issue for e-prescribing. Obviously HIPAA had this as an issue but now suddenly there's a business case on it, and we're re-exploring these further, both the federal government authentication policies and how all of this relates to e-signature as well as other possible approaches to this as part of our e-prescribing work over the next year.
DR. LUMPKIN: And this could be a Texas sized problem.
DR. COHN: Yes.
DR. ZUBELDIA: I have a question on the electronic signature part of this, that second bullet talks about the authentication policies as defining documents. Is this based on a presumption that the electronic signatures will have to be digital signatures that are self authenticating? Or are there other authentication requirements associated with this text based reports that are implied?
MS. WARK: There isn't any of what you said implied in this statement, the workgroup determined that this was really outside of their scope and they're deferring to the e-authentication effort that is ongoing.
DR. COHN: Kepa, I received an email last night from Alicia, who had pointed out where this is on the web and I'll be happy to forward this to you, I mean this is the first time I had heard about it. Apparently it's a working document or an advanced draft or something in relationship to that and I think we need to evaluate it and sort of see where it is. It sounds like this was not fully evaluated but was really more of a reference that there is another workgroup in the eGov initiative that's focusing on this area.
MS. WARK: Correct.
DR. LUMPKIN: Okay.
MS. WARK: The next workgroup was population health and the team was led by Steve Steindel from the Centers for Disease Control, and there were representatives from across the federal government. This workgroup convened in I believe it was late spring and held off for a while because it was determined that as the other clinical domains progressed and recommendations were made to the council that the population health workgroup wanted to take those into consideration, but you can see here that there was a large number of representatives from across the government, Indian Health Service, the National Center for Health Statistics, FDA, HRSA, Department of Defense, Agency for Health Research and Quality, and other representatives from CDC.
As I mentioned the approach to the population health domain was that they defined it as code sets used to report public health data and for the purpose of population health statistics. They noted that population health data is a combination of clinical data and additional data, therefore the population health domain would be partly dependent upon standards used for other clinical domains. And that was the reason that we put the group on sabbatical over the summer and then reconvened in the fall.
The workgroup noted that there was a large number of solutions they anticipated evaluating and they also noted that any adopted standard would need to integrate historical data for trending purposes. They anticipated that it would be difficult within the project timeframe to make a specific recommendation on a standard and rather then trying to bite off more then they could chew in that timeframe they decided to produce a report in phase one that could serve as foundation for guiding future work and their goal was redefined as preparing a list of population health data collected, including purpose at all levels. They would note the terminologies and classification systems used to collect population health data and relate aspects if any of a clinical event that related to the population health data.
In scope was public health reporting, population health statistics, and billing data or statistics. Institution health statistics were not in scope but recommended to be similar to external uses.
The alternatives for population health, they started with SNOMED CT, LOINC, the ICD series of classifications, HL7, CPT, HCPCS, MedDRA, and multiple others, and they compiled a matrix of current terminologies that reflected the workgroup members and agency's input that participated in the workgroup.
Their findings were that the current terminologies were numerous and not coordinated, that the list that they developed contained some recent public health reporting systems used by health and human services that contain one or more standardized terminologies, but that there were others that were not using standard terminologies that, I'm sorry, that there were some on the list that HHS uses that do not contain standardized terminologies.
The recommendations also noted that the diversity of terminology needs found lead to the conclusion that a specific CHI recommendation is inappropriate at this time and as noted in the report there are a number of recommendations that the workgroup came forward with for future work to be completed.
DR. STEINDEL: This is a minor clarification on what Cynthia gave in the report, the matrix which probably forms the bulk of the handout that you have, I think it's about ten plus pages in that handout, those who are familiar with the population health reports coming out of HHS, you will probably notice that there are some major ones that are not there, one of which and I use as an example deliberately, I picked on my own agency, CDC, the National Notifiable Disease Surveillance System is not on that list. Because right now we do not use standard codes, we are moving towards standard codes, and we do have standard codes for some of them, but it is not totally moved into a standard coding system and we wanted to point out that as an example.
DR. COHN: Effectively, I mean let me just say our recommendation and let me just talk about it for a second, which is basically we're agreeing with the recommendations for CHI. Let me just bookmark this one because I think this one is one we're going to probably almost need to put on the full committee list for the year because this is really the big enchilada as far as I'm concerned. We've got clinical data, we've got clinical terminologies, now how exactly are we going to make this work for population health? Exactly what are we going to do, how are we going to ensure at the end of the day that all of this fits together? I mean this is, I don't think of this so much as a domain as a strategy and I don't know whether this is the 21st Century Statistics phase two, the next phase of the NHII report, I mean it's really I think a very big issue.
I think Steve appropriate identified, he sort of felt that NCVHS, the Board of Scientific Counselors of NCHS, National Library of Medicine, probably others need to all be involved in this conversation. And it's not, I mean I think we can all make this happen, this is that issue of mapping, interlocking, appropriate use of terminologies, appropriate aggregation of data, clarifying to make sure that meaning is the same as data that is captured with administrative code sets, it's all of those pieces that at the end of the day need to be in place and we need to have assurances in place to assure that we have better quality data five years from now then we have now. Karen, do you have a comment on that one? Am I appropriately referencing the topic? Okay. John?
DR. LUMPKIN: Well, I have a question because I'm a little bit confused by this recommendation. There is data that flows through the population health system that is derived from clinical data. But in trying to look at this I would expect let's say diagnosis of disease would be out of scope even though it flows through the population health system. Now there are other codes that for instance if you have someone who has a case of diarrhea and as part of the investigation you look at the water that they drink from a private water well. And those private water wells have different kinds of construction types, they could be buried, they could be buried slab, they could be board, they could be drilled, they could be dug, all those have implications because they have different rates of contamination that you can expect. So that's just some sort of coding that obviously would need to be there in that system which no one that I know of has ever even thought of trying to code water well construction types in some sort of consistent fashion.
But my question is, are we saying in this recommendation, do we actually say that the clinical data that flows through the population health dimension should be consistent with standards for clinical data?
DR. STEINDEL: Yes.
DR. LUMPKIN: Okay. Then this is a small on my face.
DR. STEINDEL: Yes, it explicitly states in the report and notes that in many cases the population health and public health reporting systems use data that is identical to clinical data and that the CHI domains in those areas have already made recommendations for standards, and those standards should be used for that reporting system. And it also explicitly states in the report that one of the things that needs to be investigated is tabulating a more detailed list of what's being gathered in terms of population health statistics. And what you point out is just one example and it notes that much of the data in that area comes from the non-clinical domain and that that needs to be noted and areas where standardization needs to occur needs to be noted.
MR. SCANLON: I think, I don't disagree with the conclusion here or the recommendation that where a lot more further study, and I think it's almost strategy rather then standards, those standards would be part of the strategy and it's certainly more then one domain. I think once we rename this the population health rather then public health reporting I think it took on a whole new range that is not, probably needs to be much more differentiated. But again, there are standards issues, there are statistical standards that are not health statistics standards that are already used, more or less best practice standards, they're age standards, race ethnicity standards, there are statistical classification standards, that are coming more from the statistical not clinical side, that are used or could be used in many of our data systems. And there are of course clinical types of diagnoses standards and others that we hope we will ultimately get to the point where we're using when the information comes from that source. But there's a whole array of other variables I guess I would call them, or measurement scales, that are largely defined by the nature of the inquiry in that field, and I'm not sure those are subject to the standardization that we're talking about here. You think of what is the concept you're measuring, what's the best measure, and it's integral to a whole field, other fields of science and I'm not sure that the CHI standard is necessarily the model for where you go there. At any rate I don't disagree with the conclusion, I think it's just a more complicated strategy that you have to look at.
DR. LUMPKIN: Gene.
DR. STEUERLE: Thinking about this, this is strategy rather then anything else, I'm just, and given that you're not really making a recommendation at this time, I'm just curious if someone is conducting a new survey, particularly a government sponsored survey, whether there is some benefit of having that group or whatever to go through some intermediary committee, not necessarily for approval but to say how does what we're doing map with respect to what we know from what's out there now. And is there an effort a presume at this time to do mapping across matrices, just trying to figure out what's out there so people have some comparisons. So if I'm doing a new survey, I'm asking a question that might have been asked somewhere else, someone can immediately point to me how that question has been phrased before, the terminology that's been used, even if there's no approval. I guess I'm sort of asking what's, in absence of a recommendation what's the strategy for the next survey that's going out, is there some place they should be going for information?
DR. STEINDEL: I think Jim and I are probably thinking the same way. First of all the report does recommend the creation of the type of list that you're talking about, so we do have enumeration of what reports are out there and what's being used for those reports. So that answers one part of the question. I think the second part of the question at least within HHS is whenever a new statistical survey is proposed it goes in front of the Data Council of HHS and one of the questions that's asked is what's been used before or what's been done in this area before to try to harmonize.
MS. GREENBERG: Well, also of course there's a whole process of OMB approval that part of which is exactly what you've described --
MR. SCANLON: Yes, I'm painfully familiar with that process. As Gene probably knows from his stay in the Treasury Department virtually any new data collecting, not just the survey that any federal agency wants to undertake, has to go through a fairly exacting process and approval by the Office of Management and Budget and there's a whole structure and a whole set of rules. But one of the criteria clearly is are you using existing standards, again this is not a CHI issues so much as there are other statistical standards for economic data, age data, and so there's always a comparison of are you employing the standards in that data collecting, why are you using the measures and the variables you are, is there another survey like that, or any data collection for that matter that is duplicated. Now you can argue anything can be improved obviously but there's a fairly extensive process for doing that.
And in addition we have, on our Data Council website we have virtually all the major data collection systems in HHS on the website, and you can actually look at what they are, anyone else can before they're starting a new survey. It gets a bit tricky because literally some of this is amenable to standardization, some of this is not. Some of this is new science, it's new data, it's research, it's administrative, so there's always kind of the tension between what's innovative, what's new measurement versus what's more or less routine statistical and you standardize.
And then I know the workgroup already raised the point and I think I'll stop here, of the, for the data collections where we have used certain standardization categories there's an issue always of the changing them and the effect on time series and comparability, so there are a number of bridging kinds of techniques where you can look at those things. But I view this as an entirely different, this is not so much a CHI direction as a strategy for how you standardize where you can, you coordinate where you can, all of the other data collection that the federal government is involved in and it's more of a strategy.
MS. GREENBERG: Your answer about OMB was not why I had my hand raised.
DR. LUMPKIN: Oh, you've got to use finger code now. Go ahead.
MS. GREENBERG: Just going back to the exchange between John and Steve related to clinical data and the alliance with CHI domains, and you mentioned diagnosis in particular, now as you heard the recommendation for the diagnosis domain was to use SNOMED CT, but in some cases SNOMED CT, data coded in SNOMED CT is collected by some population health systems. But this level of aggregation that's required by the particular system, or the need to map from the clinical data to the terminology that's actually used in the population health system is another area of complexity so that ICD is, for example mortality data uses ICD-10, it does not use SNOMED even though that's clinical and diagnosis data. And at this point I don't think we're recommending that that should change, but those are the things that have to be looked at and the types of mapping, and do you want to go directly from the clinical data this is being collected --
DR. STEINDEL: And that's what the report calls for, is a study to say what the impact of that is and how it should be done.
MS. GREENBERG: Exactly. So I think the report is clear on that, I just didn't think the exchange necessarily made that clear.
DR. LUMPKIN: So I think we're comfortable in how we're going to population this section of our recommendation.
DR. COHN: yes.
DR. LUMPKIN: Shall we move on to the last one and hope it doesn't compound the discussion.
MS. GREENBERG: The only thing I can say is that since NCHS has recommended to do something about this it might be something that you want to engage the board on, the Board of Scientific Counselors, currently there aren't resources to do it, or plans I don't think.
DR. STEINDEL: And the Data Council I guess --
MS. WARK: The last team here was chemicals and Steve's true calling as a chemist came to bear on this workgroup, he was the lead from the Centers for Disease Control, and there were representatives from FDA, EPA, and CDC.
The domain description is chemicals of importance to health care outside of medications, because medications had been dealt with by another workgroup, health care purposes, chemicals will be those found in the work place or the environment that might be related to health, and commonly the first and perhaps only use of a chemical code would be during a first encounter and perhaps be part of a history and physical.
Again, non-medicine chemicals were in scope and drugs or medicine chemicals were out of scope.
The alternatives considered were SNOMED CT, the Registry of Toxic Effects of Chemical Substances, the Chemical Abstract Service Numbers, and the Environmental Protection Agency's Substance Registry System.
The recommendation is to adopt the EPA's Substance Registry System. The analysis showed that as of November of '03 the number of substances currently in the SRS are in excess of 87,000, the number of submitting organizations represented in the SRS are 37, and the number of information resources included in the SRS are 965. The benefits are that is federally maintained, does not require a license fee, it has been widely used for years by EPA programs, and is available on the internet.
There were some critical conditions and gaps noted, the first being that establishing interagency communication so that medical needs are addressed in a timely and coordinated fashion would be needed, and the workgroup did not that that communication has started between the EPA and the FDA. Also developing a mechanism so that similar tables from other agencies can be matched against the SRS table and missing elements added. There is a note that this will require new unidentified resources. The workgroup also noted to investigate the availability of a subset or view of information from the database in an acceptable format for health care use as a no or low cost distribution item. EPA is willing to provide this view as a periodically updated, perhaps every six months, compressed file for internet download. And lastly there should be a requirement for registering an object identifier if it is to be used in HL7 messaging.
Non-critical gaps were identified is a task EPA is undertaking is a review of the commonly regulated chemicals and the selection from the many synonyms available of an EPA preferred name. These kinds of problems highlight the need for an agency wide system like SRS and the need for someone to review any changes to chemical content in SRS. Also a non-critical gap is the introduction of common chemical download format, such as the MDL MOLE(?) File or developing a chemical XML format.
DR. COHN: And we concurred with these recommendations as presented, we noted and support the specific need for resources at the EPA to obviously accomplish the additional work required. I think we all think this is going to be critical work, certainly John, the next time he has to deal with a well, which may be a while from now, he may not be able to describe the construction issues but at least he'll be able hopefully to identify the chemical contaminations with this.
DR. LUMPKIN: That's right, as long as we get the right reaction.
DR. COHN: We'll send you down first to find out.
DR. LUMPKIN: Any comments on chemicals?
DR. COHN: The final note here on the letter is I think something that was brought up during our conversations day before yesterday as we reviewed these areas, and we do recognize CHI as looking for sort of additional comments on future directions, next steps. We did observe that the personal health record, and it isn't so much the personal health record but it's the person's interface to whatever it is, be it personal health record or whatever, the terminologies for that have really not been explicitly discussed and obviously we encourage future investigation by the CHI.
I guess I would, I mean we'll be moving this now but I just wanted to take an opportunity to really congratulate Karen, Cynthia, and others, Steve Steindel, for what we think has just been incredible work, obviously we're delighted to see this sort of work occurring in the government, the government taking leadership in this area, and hopefully providing a tipping point in the industry. So an amazing amount of work, we look forward to the next phase.
MS. WARK: And I'd like to say thank you for recognizing the efforts that have happened over the last year or so, not only in the government with the team leads because the idea was that the representatives would come together and hash things out in the workgroup, they dealt with some very, very tough issues and they came up with some really solid recommendations and some reports that will help future work. And I'd also like to thank the committee members of the Standards and Security Subcommittee who were very forthcoming with explanations, clarifications, information, all of the representatives from the standards development organizations that helped us out, it was just an enormous effort and I'm really in awe myself of all the work that happened over the past few months and people like Steve who really took a leadership in this initiative. So thank you all.
DR. LUMPKIN: It's been moved by Simon that the letter with the following changes under the section on nursing, that that would read as the nursing domain as modified. Under the section on clinical encounters the word inclusion would be changed to listing for the personal health record as being out of scope. Is there a second to the motion?
MR. BLAIR: I would be happy to second the motion.
DR. LUMPKIN: Moved and seconded by Jeff. Is there a discussion on the motion to adopt this letter? All those in favor signify by saying aye.
COMMITTEE: Aye.
DR. LUMPKIN: Opposed say nay. Any abstentions? Well, I think I would like to add my congratulations in addition to Simon.
[Applause.]
Let me just in addition to Simon's comments let me sort of add my perspective on this. It was a number of years ago that the CHI came before, we were aware of that as a committee, and it started off as sort of a kind of small initiative, not a lot of support higher up in any of the agencies involved. We as a committee saw immediately the importance of that and Simon and the Committee on Standards and Security offered to be the advisory committee to this initiative even though it was beyond the work of the Secretary.
As we developed our recommendations on Patient Medical Record Information we put forward in the process that was closely assisted by staff from the department the concept that the Department of Health and Human Services should take the lead and that the next round of clinical data standards, or clinical standards, or health information standards, should be those standards where leadership is shown by the government. And they used that as part of their business processes rather then the mandating process under HIPAA.
And what we've seen now is the completion of that first phase and I would say that this event and what we have helped accomplish today is nothing short of historic. And as we look back upon the years of transformation of health and health care through the use of information technology the CHI process, the recent events over the last 12 to 18 months with our work in the NHII, this period of time will be seen certainly as that tipping point where we have really made a significant difference.
So my hat's off, of course I don't wear a hat. Congratulations to the CHI and also to the committee for really having made this and passed this milestone.
And with that we're also going to pass another milestone and go to lunch. Let's reconvene at 1:15.
[Whereupon at 12:15 p.m. the meeting was recessed, to reconvene at 1:30 p.m., the same afternoon, January 29, 2004.]
DR. LUMPKIN: If we can have the consulting groups take their seats. Even though we're behind schedule we're okay, and still on target for an on-time adjournment if not a touch early.
The first item on our afternoon agenda is a Privacy Subcommittee update. Richard.
Agenda Item: Privacy Subcommittee - Update - Dr. Harding
DR. HARDING: Thank you, Mr. Chairman, and I appreciate this opportunity to give a brief update on the Committee for Privacy and Confidentiality. Most of the new members here don't know our chair, Mr. Mark Rothstein who is an attorney, and also the director of the Center for Bioethics and Law at the University of Louisville. He's not here but he will be next time and he asked that I sit in for him during this brief update. There are no action items to be voted on after this.
Part of HIPAA is something called administrative simplification, which you all know, and part of that is including asking that we look over and monitor standards for privacy and individual health information or the privacy rule, which came out in April 15 of this last year. We have as a group been helping with the coming out of that rule but also since its come out have been assigned the task of helping monitor how that rule is rolling out so to speak here in the country, and so we have had hearings in November to look at both public health and research and some of what covered entities are going through. And then we have another hearing coming up in February, which will look at law enforcement, school and minority issues, and how banking refers to the privacy issue.
We have three members of the committee who are here by the way, John, Simon, and Kepa, are all members of the committee, and at the end of my five or ten minutes if they could say a word that would be great.
We will also having a report coming to the committee at the next full committee meeting that will summarize the hearings and recommendations that we would suggest be made to the Secretary through the full committee, and those things come through the full committee, all recommendations.
Briefly, there are several areas of concern that were brought to us by public health officials and researchers as well as other covered entities, and I have tried to narrow them down to as simple and quick as possible, and they would be the following. One is that there is less anxiety among those groups then there was a year ago. When we were out doing some of the hearings a year ago there were times when it was clearly a we and they with us being the they and on the committee, and there was a time in Utah that we had some concern that one of the testifiers was packing heat during the testimony although that was, Marjorie I don't think that was ever verified, but everybody was concerned, there was that much affect going on at the time about that. So that was in Utah though and Kepa will have to speak to that there in a little bit. Now there's less anxiety although it still clearly is there, there were a great deal of complimentary statements made for the Office of Civil Rights for their education and frequently asked questions page they have as I mentioned this morning.
There was felt in the public health area to be lots of misunderstandings, not that the law was wrong but there were issues, or the rule, but there were issues where there was an adverse effect, I tried to write this down, adverse effect on reporting of notifiable conditions to public health officials. That is people had some concern about sending in information about individuals because of fear that they did not have proper authorization to do that and there was a debate that went on whether that was being just too conservative about the authorization or if that was some way to avoid having to send that information in and that was discussed. That conservative stance err on the side of caution was one that was frequently brought up.
In research there was a great deal said and more will be coming to you about this but one of the things was the divergence between the common rule and the privacy rule and some of the difficulties that people had in interpreting that. One of the amusing things to me was one of the concerns that one of the researchers had about keeping DNA anonymous. If you think about that keeping DNA anonymous is kind of an oxymoron or whatever. A great deal of information and concern about the burden of accounting for disclosures, that came out from multiple, multiple sources, that the accounting it was understandable but the burden of that was overwhelming to many of the researchers as well as public health officials.
There was concern about notice in non-traditional settings, such as health fairs or shopping malls, when someone gets flu shots at the mall is that, do we have to have notice and so forth in that kind of a situation. There were concerns about business associate agreements, the proverbial Pakistani transcriptionist who came out of the fourth line of subcontracts out of University of San Francisco. The minimum necessary issue was one that was very difficult for people to figure out what was minimally necessary. Disclosure accounting again came out.
And then the February hearings as I said, we were going to begin, we will begin the issues of law enforcement, school and minority issues, and banking issues as they effect privacy. In addition beyond that other issues that we will be monitoring will be fundraising, non-traditional settings, the payment chain, and employer access to health care information.
With that I will stop. Mr. Chairman if any of the other members of the committee would like to mention something that I didn't I'd be glad to have them say a few words.
MR. HOUSTON: Did you speak of the common rule at all?
DR. HARDING: I only said that there was concern about the divergence between the common rule and privacy, go ahead.
MR. HOUSTON: I just wanted to, not necessarily expound upon but sort of restate the importance of that. I think that there was a pretty clear consensus from the individuals who spoke regarding the research that there was definitely a problem with the difference between the common rule, federal policy regarding HIPAA, especially as it related to preparatory research functions which is an animal that the common rule doesn't even recognize. And I think that that's something that has to be, it sounded pretty clear from the individuals at the meeting that that's something that had to be dealt with other then simply getting guidance, which was I think what, I think three was the OHRP, NIH document regarding research which something was there from OHRP but suffice it to say I think that was an issue that was at everybody's sort of fore.
MR. SCANLON: I think part of this is just a matter of working it through, some of these things are not true but you're right, I think that providers are behaving in an understandably defensive position until things are clearer.
But there are a number of guidances that have been issues relating to research and public health, one of the guidance documents that was published I guess not to long ago in public health was meant to clarify the streamlined burden of accounting issues that you could undertake for public health or for research, so I think it's a matter of kind of working it through.
And maybe we'll even schedule a little briefing on what other guidance documents are being considered in HHS for the subcommittee.
MR. HOUSTON: And in fact to dovetail on that there was just came out a weeks ago a repository guidance document relating to research repositories which I think actually answers one of the points that we made in the draft letter, or at least I think it addresses it and I think we could probably pull that out of the letter frankly based upon the guidance that came out from NIH, so I think that was good.
DR. FITZMAURICE: If I could just read off the five that are available now, they've been put together by NIH, AHRQ, FDA, and CDC. The first one is Protecting Personal Health Information in Research, Understanding the HIPAA Privacy Rule. Second, Health Services Research and the HIPAA Privacy Rule. Third, Research Repositories, Databases, and the HIPAA Privacy Rule. Institutional Review Boards and you know it. And finally Privacy Boards and the HIPAA Privacy Rule. Those are the five that are available and we're working on one right now, Health Services Research and the Privacy Rule.
DR. HARDING: -- there's one more then and we'll stop, or Vickie has --
DR. LUMPKIN: Okay, Vickie?
DR. MAYS: I just wanted to ask a question when you were saying that you were going to deal with minority issues, we've actually been concerned with some of the privacy and confidentiality issues relative to surveys, particularly when it comes to small racial and ethnic minority groups that the problem is that then it's very difficult to do analyses. One of the members of the subcommittee, Russell Localio, has been working on that so if there's a way in which we can have him maybe have some time on your agenda the next time your subcommittee meets to share with you our concerns that would be great because then we can kind of work with you on that.
DR. HARDING: Great.
DR. MAYS: Okay, thank you.
DR. HARDING: I will give that to Mark and Kathleen, Kathleen had an illness in her family and so wasn't here today, our main staff, but we'll --
DR. LUMPKIN: Gene?
DR. STEUERLE: Did you call this the common rule?
DR. HARDING: Yes, for research.
DR. STEUERLE: I thought you said something else which is --
MR. HOUSTON: The federal policy which is --
DR. STEUERLE: Which is the difference between, well I was going to say I'm actually on a different topic, I thought you said common good and privacy issues, which is also to me a really interesting issue. Some privacy efforts seem to me do raise cost and they're not just administrative costs, they're cost for the public health, we don't get information that we might want as a public or in some cases individuals aren't getting information that perhaps if they had would lead them to behave better in ways that would effect people, I think of as an example the fact that blood tests don't give you AIDS information, as an example. It could be very costly for some people in society so I'm just curious, what does this group do to gather statistics on that side of the issue, what are the costs for some of these privacy concerns. You're getting anecdotal information about the extent to which defensive medicine is practices but do we gather statistical information on that? Do we try to gather information on both sides to try to figure out how society can weight this balance? Or are we mainly just trying to implement a set of rules that has sort of come down? Does the question make sense?
DR. HARDING: Yes it does, I don't think though that we have, to this point we have not had the capacity or the will I guess to gather that type of specific statistical information and have often looked to other agencies for that.
DR. STEUERLE: I know some of it might even be qualitative, but even qualitative sometimes --
DR. LUMPKIN: Marjorie?
MS. GREENBERG: Well, the committee did send a letter, I don't know, last year, to the department about the importance of doing a systematic evaluation of the impact of the privacy rule on various areas, research, health, health care, public health, etc., I don't think it specified some of the more quantitative aspects that you're suggesting but that would certainly be a part of it and I think it probably, the role of the Privacy Subcommittee to follow-up with the department, to keep that on the agenda. I mean part of the problem is the longer you go without initiating such a study the baseline slips away from you also.
DR. LUMPKIN: Jim.
MR. SCANLON: The rule itself, the final rule, Jane made an attempt to quantify the benefits and the costs, it's kind of in a very general net way as all regulations do, but since then it's more anecdotal and you could argue that because there wasn't a baseline really, I'm not even sure what the statistics would be to be honest in terms of a quantitative approach, but I think the thinking is that this is still a fluid situation with providers still learning and adapting to guidance and other things and that probably hasn't stabilized enough to do anything quantitative. But we are interested in quantitative, I think it's just an initial attempt, it just wasn't clear what exactly the design would be.
MR. HUNGATE: Just a short, in the upcoming recommendations from the Quality Workgroup there is one that asks for further investigation of the interpretations of the privacy rule that go beyond the rule, that have limited disclosure in health care situations where the patient may be deleteriously effected by the failure to disclosure, which is the same problem and is a cost to the rule, so that's part of the upcoming report.
DR. LUMPKIN: John.
MR. HOUSTON: Sort of a different thread but I think maybe related somewhat is with everything that's going on within NHII I know that one of the concerns with coming out of the original conference, when was it this last summer I guess, was issues related to how NHII would work with the privacy rule as well as the fact that you still had state, sort of preemption, more stringent state laws, and I guess maybe one of the questions that we need to maybe explore, or start to try to explore in a structured fashion, is how do we deal with, or how do we deal with NHII in the context of the privacy rule and frankly potential issues related to how we can share information to support NHII. I don't know what the framework is to do that but I think it's important to start thinking about that.
DR. LUMPKIN: I think it's a good point. Let me sort of toss something to the committee as a follow-on to my questions earlier this morning and you mentioned the preemption analysis, there have been, now that things have settled down, I know in Illinois we did a fairly extensive preemption analysis, my guess is the final document was close to 800 pages or some and I think almost every other state in the nation has done that. There's an incredible volume of analysis there comparing state laws to the federal privacy rule, and so I think one of the things that we would be concerned about as a committee is that you have multi-state organizations, who just don't know what the rules are from state to state, and that could be an issues. So I think there may be some value of either looking at that ourselves or perhaps as a recommendation at least taking some testimony, enough to the point where you could craft a recommendation to the department in relationship to that. I was particularly surprised to hear that there was only one request for a waiver of preemption, that was really quite amazing because I know in Illinois we probably looked at over, at least 100 to 200 laws, somewhere in that neighborhood.
MR. SCANLON: And it's hard, often states don't even know all the laws that may apply so even a state analysis is difficult.
DR. LUMPKIN: Well we spent, we had an outside contractor and we literally spent hundreds of thousands of dollars on this preemption analysis just in one state. John?
MR. HOUSTON: I don't even think it matters whether you have multi-state operations for a facility, again the whole concept of NHII is making information available as necessary for the purpose of treatment, and if you've got, if a patient is in the hospital in one state and the information is at a facility in another state, frankly right then and there you have to deal with a multi-state issue even though the organization itself is handling the information but may only be operating in one state. I think it really is germane.
DR. LUMPKIN: Well, the complication is is that with the full preemption that's provided by the privacy reg that we could have a discussion, make a recommendation to the department, they could follow up on it in order to free the flow in certain clinical situations, and state law would totally prohibit it. And that could be --
MR. HOUSTON: That was my point and I think it came out this morning even with the guidance that OCR gives, it doesn't necessarily consider the state law issues which I think in many, many cases if not most cases still take precedence. I know that in Pennsylvania that is in fact the case and more stringent, so even though you answer the HIPAA question it really doesn't completely answer the entire question, or there's still preclusions.
DR. LUMPKIN: Okay, anything else on privacy?
DR. HARDING: The only other issue that I wouldn't want to talk about much but just the fact that civil litigation for breaching privacy is becoming a HIPAA issues, and it's a very anxiety producing thing for physicians, as well as other professionals, because there's already been one malpractice company in Louisiana who said that they do not cover that type of problem, that if you're accused of having a breach of privacy in your office that is not included in your professional liability insurance. So that's another topic for the future that we'll, and that's the kind of thing that really gets doctors worked up, they have unlimited liability over something they don't have complete control over.
DR. LUMPKIN: That sounded like my practice all the time.
DR. STEUERLE: -- you could do a survey of insurance companies and see whether they're actually adding to their charges because of privacy, it's something worth tracking.
DR. LUMPKIN: And I think what we would want to do is make that as a recommendation since we don't have the resources within the committee to do that, but we do advise an agency that has one of the largest economies after the United States.
Well, thank you. The next item on the agenda, the claims, oh wait, we have one other item before we go to this item. Jim.
Agenda Item: Appreciation of Retiring Members - Mr. Scanlon
MR. SCANLON: I know this morning the committee welcomed the four new members and this afternoon the Secretary wanted to honor our retiring members, it looks like the only, Kepa is here as the only remaining retiring member, but the Secretary has always appreciated the work of the committee and we have here for the four retiring members, and let me mention them again, Kepa Zubeldia, whom I'll talk with in a minute, Dr. Ted Shortliffe from Columbia University, John Danaher, who filled out his term and then left, and then Dr. Clem McDonald who was at some of our meetings yesterday, so that's the four that are graduating I guess you could say from the committee.
And really it is, I was joking that you never really sever ties with the committee because really we call on you even after you've graduated for testimony, for consultation and for other matters as well. But I'd like to read to Kepa the letter of appreciation and the certificate of appreciate that the Secretary has written and we have similar letters and certificates of appreciation for the other graduating members as well.
Dear Dr. Zubeldia:
It gives me great pleasure to award to you this certificate of appreciation for your four years of service to the Department of Health and Human Services as a member of the NCVHS. The committee is one of the oldest and most prestigious advisory groups serving the department. Its recommendations have helped shape health statistics, health data standards, and epidemiology for our nation and have had a profound effect on new legislation. Your knowledge, expertise and experience have contributed greatly to the excellent work of the committee.
We wish particularly to commend you for the time, effort, leadership, and counsel you provided as a member of the Subcommittee on Standards and Security, the Subcommittee on Privacy and Confidentiality, and the Workgroup on the National Health Information Infrastructure.
Only the very best are asked to serve and we are proud to have had the opportunity to associate with you in this endeavor. Should the occasion arise we would like to feel free to call upon you for further assistance.
Sincerely, Tommy G. Thompson, Secretary of HHS
[Applause.]
DR. ZUBELDIA: It's been an honor and a privilege to work here, and as you new members will find out it's a wonderful, wonderful place to work, and it's a great opportunity to have an impact on something positive for the entire country. So thank you for the opportunity.
MR. SCANLON: Thank you, Kepa.
DR. LUMPKIN: For those of you who weren't at dinner last night, not for lack of trying, Clem did leave this with us so his parting remarks are --
Okay, so that's what Clem had to say. And we weren't sure if that pig was saying oink or LOINC.
Okay, the next item, the claims attachment letter, we're going to --
DR. COHN: We're not bringing forward a letter today, we'll be having hearings on March 3rd to further delve into the claims attachment issue and hopefully coming forward with a letter for the next meeting.
DR. LUMPKIN: Great. Okay, the sixth report to Congress, which was sent via email I believe.
Agenda Item: HIPAA 6th Report to Congress - 2002-2003 - Dr. Cohn
DR. COHN: Well I guess I'll start off since my name seems to be here, this is one, I'm trying to think why I'm responsible for this one, I'll have to think about it.
Obviously we really want to thank both John Fanning and Kathleen Fyffe and Jim Scanlon for their work helping put this together for us. This is a little unusual in the sense that every year we are supposed to come up with a report. We decided to put together two years into this report only because this last year has been so involved with the initial implementation of a number of the rules that we thought that it needed a little perspective upon which to advise Congress about all of this.
I think you've all received a copy of what I consider to be, it's clearly a draft document, and we'll sort of talk about how we move from here but this document is not ready for approval today but really much more a, it's something we should take a look at, b, we would hope that any of you who have comments about it would provide sort of a redlined document to us with the idea that we will compile it all together and hopefully have a final version for the March document. And obviously Mark Rothstein needs to provide input, etc., to make sure that it represents not only standards and security but privacy and other pieces.
PARTICIPANT: [Inaudible.]
DR. COHN: John, thank you for doing that. Do you want to talk about it?
MR. FANNING: No. There's the text.
MR. SCANLON: Remember, this annual report covered two calendar years, 2002 and 2003, so it will take us up through December and remember this was a very active year for implementation so it was always, the committee always had to give some thought to when would be the best place to sort of stop the reporting, or should we let that phase of implementation proceed. But I think we are going to try to end it as of the end of December, John, as the reporting period and we will have, and I think the focus at this point, the draft you have was circulated and we asked everyone to provide at least the updated factual information on where everything was, what had occurred, what had literally been done process wise and where we were in the implementation stages of both privacy and transactions and code sets and so on.
So I think we've, I hope we've succeeded in getting the factual information in there. We have not done an executive summary, which would go at the beginning of the report, probably a three page, four page, executive summary, nor have we John I think put any recommendations. I think we identified areas of where the committee has expressed some desire to monitor but it's sort of an unusual year compared to previous annual reports because we've actually implemented, we've actually begun implementing, so that's the kind of the spirit and the tone of the report. But I think Simon you were going to suggest a process for --
DR. COHN: Well, the process was obviously for comments to come in and then we'll consider it, hopefully approve it at the next meeting. I was going to suggest, I mean this is obviously the awkwardness of finishing at a certain period when life goes on and what to do about well geez, there's a National Provider Identifier rule that has been now released, for example, and things like this. And what we may want to do is in the cover letter at least acknowledge what's happened since this report was produced, which would be sort of the end of the year, just sort of acknowledge that there is continuing to be work and all of that.
DR. LUMPKIN: Or we could try to be seers and we can say we're predicting that the National Provider ID final rule will come out in the very near future.
DR. COHN: The one other point I would make about this document and obviously it's an issue of sort of perspective, but I do think that whatever it is that we do needs to have as much facts on the status of implementation as possible, and so for example Karen Trudel earlier today was talking about percentage of compliant claims and things like this, and I think that, if we're talking about really tracking and just to remind all of you, in the initial HIPAA regs in 1996 one of our responsibilities actually in the legislation is to report annually to Congress on the status of implementation. So this isn't just a good idea that we sort of try to do from time to time, but this is actually part of the legislation. So we obviously need to be serious and make sure that this is as helpful as possible.
DR. COHN: John.
MR. HOUSTON: A specific comment, I noticed in the last section, section Roman Numeral four, important issues, second to last, sorry, there's a conclusion section, I don't think there's really any discussion, I know you reference Mark needing to add some input but I think that an important issue really as it relates to privacy and some of the testimony we did take prior to December 31, though we haven't formulated any recommendations yet, I do think there needs to be a placeholder in there to indicate that we recognize that there are a variety of issues related to privacy, maybe mention those subject areas and that in mid 2004 there will be additional recommendations. It really is missing in that section and so I think it would be helpful to have that in there.
DR. LUMPKIN: Mike?
DR. FITZMAURICE: One other thing that I would suggest we add is that Congress did tell us to do a report on ASCA and the compliance plans that came in, Steve and I did one and the committee approved it and I believe it's up on the website, we should probably put in a paragraph or a couple of sentences based on the ASCA report.
DR. LUMPKIN: I agree.
DR. FITZMAURICE: They just might look for that since they told us to do it.
DR. LUMPKIN: Just in my quick read through I don't remember seeing it, that was a comment I had. Jeff?
MR. BLAIR: Forgive me for not having actually read the document, Marjorie wound up pointing out some of the PMRI items, the message format standards and the PMRI terminology recommendations to be added, but the other thought, and maybe it's in there, I'm not sure, John our chair, John Lumpkin our chair, made an observation that I think it would really be important to try to capture in the document, I'm going to phrase it slightly differently but I think it gets at the same point, and that is that when we started to deal with the standards that was called PMRI from the HIPAA law, which many of us began to call clinical data standards, and then became adopted as CHI standards. And when the Secretary adopted them and announced them he announced them within the context of the NHII, that transformation I think has a lot of positive connotations and I think it would be really compelling to not only include that in the document but probably want to include that in the executive summary.
MR. SCANLON: And Jeff if you have any suggested language, I think as the past few annual reports we've begun making that sort of pointing towards the NHII as the step we were heading in and we could continue that as well, maybe in the transmittal memo and in the executive summary.
DR. LUMPKIN: Maria?
MS. FRIEDMAN: CMS has some additional tweaks and we'll provide them separately.
DR. LUMPKIN: Okay. Other comments?
MR. SCANLON: Could I ask for any members, send your comments to Kathleen Fyffe, Kathleen will be pulling the documents together, I mean the edits together and come up with a revision, not just edits to the text but new areas, areas of concern, where we would be looking for in the next year to monitor, and then we'll pull it together into hopefully a final document.
DR. COHN: And I guess what we're hoping for is is that if you do that relatively soon with the idea being that I'm just going to suggest this, that the next version be circulated to the executive committee, which is basically all the chairs of the subcommittees and John to make sure that it does represent the various aspects of the work that we've been doing and then we'll be distributing to the full committee obviously in advance of the meeting, the meeting in March, with the idea that we can approve it and get it on to the Secretary.
DR. LUMPKIN: Right around the corner, March.
DR. COHN: I know, it's almost February.
MR. HOUSTON: Do we have the latest electronic version or can we get, if not can somebody email all of us the electronic version?
DR. COHN: I think you've all received the electronic version from Debbie Jackson, that is the latest version. Obviously if you have new content just send in your thoughts and we'll get them all included. I've already redlined mine and I think Maria has it hopefully --
DR. LUMPKIN: And if anybody wants a hard copy of it Jackie has it at the desk. Okay, thank you.
DR. LUMPKIN: Next item on the agenda is the Population's letter on National Child Health Longitudinal Study. Vickie, you're up.
Agenda Item: Population's letter on National Child Health Longitudinal Study - Dr. Mays
DR. MAYS: Yes, thank you. Let me talk about the genesis of this letter since we have several new people. At our November meeting we had a presentation from Dr. Peter Scheidt, who is the study director for the National Child Study.
The National Child Study is a longitudinal study that is being done by three agencies but mainly housed within NIH at NICHD. So it's a combination of CDC, EPA, and NIH that are working together to do this longitudinal study. The longitudinal cohort will actually look at some of the effects of environmental and other influences on the health and development of more then 100,000 children, and they get enrolled from pre-birth to age 21 in the U.S.
This was authorized, at least the planning stage of it some time ago, so this is not something that just happened yesterday, but this actually began matter of fact back in the Clinton Administration, Clinton and Donna Shalala and it has taken resources to bring to bear to actually do the planning to see how feasible this would be. The study itself is not funded at this point, they will have to go and get new money is the thinking for this study but for the past 12 years or so or longer they've been in the feasibility stage.
So at this point if you go onto the NICHD website what you'll see is that there is a structure that this study is function under in which there is a coordinating committee, hypotheses are sent to the coordinating committee, there are I think something like 16 work groups, those work groups include sampling, recruitment and retention, social determinants, environmental justice and health disparities, biologic factors, chemical factors, so there are a number of workgroups that are generating hypotheses, some are engaging in workshop, and again all of this is at the level of feasibility.
So since this is a study of such magnitude we asked Dr. Scheidt to come in and talk to the entire committee so that we could get a sense of the study, where it was, and the extent to which that study overlaps with many of the areas that this committee is concerned about in terms of advising the Secretary.
So based on the presentation and kind of some of the work of the subcommittee in its hearings, in which it has been given advice on how to approach some of these issues, we decided that probably the best tack would be to follow-up the presentation with a letter. But the letter isn't going to the Secretary, the letter that we want to send is actually going to the director of the institute who is in the position of coordinating all the input, because we thought at this point in time that's probably the most appropriate.
So should I just proceed now and read the letter?
DR. LUMPKIN: Yes.
DR. MAYS: No questions? Okay. Duane Alexander is the director of the National Institute of Child Health and Human Development at NIH.
Dear Dr. Alexander:
The National Committee on Vital and Health Statistics, an advisory committee to the Secretary, Department of Health and Human Services, is charged with advising the Secretary on broad health statistics and data issues. The Subcommittee on Populations of NCVHS concerns itself with HHS population-based health data issues. The committee is particularly interested in assuring that adequately, timely, and relevant data are collected and available for use by health planners, researchers, policy makers and communities in order to monitor and assess health status, health behaviors, care and access to treatment in racial and ethnic minorities and other vulnerable populations.
Should I stop there, John, or do you want me to read --
DR. LUMPKIN: Why don't we read through and if anyone wants us to stop --
DR. MAYS: Okay, sounds fine, if I don't see the hands, let me know.
The purpose of this letter is to commend the National Institute of Child Health and Human Development for spearheading efforts to plan and conduct the National Children's Study, and to offer some important insight, it should be insights, sorry, we have learned from representatives from racial and ethnic minority groups about ways in which to improve health data. Our examination of the myriad ways that federal dollars are spent on the collection of health data as well as conclusions reached in a report of the Institute of Medicine, Unequal Treatment, and in a workshop report on Improving Racial and Ethnic Data on Health of the National Research Council make clear that improvements are needed in federal data collection efforts in order to provide adequate data for the various racial and ethnic minority groups in the United States. This is particularly true for many of the geographic, geographically, sorry, distinct or smaller subpopulations of racial and ethnic minority groups.
Over the past two years the Subcommittee on Populations has held a number of hearings around the country to learn more about the status of available health data and the accompanying statistical and methodological issues involved in the analyses and dissemination of health data for racial and ethnic minority populations in the United States including the territories. The subcommittee prepared letters containing several recommendations to the Secretary that would improve data collections methods, analytic techniques, reporting and dissemination for racial and ethnic minority groups. The testimony from the hearings underscored a compelling need for innovative approaches to data collection (e.g., targeted surveys) for small groups of racial and ethnic minorities and those who live in sparsely populated areas. The need for more population-specific data was stressed to address disproportionate gaps in health care outcomes within and across racial and ethnic minority groups. These letters and other information about the subcommittee's work can be found on the NCVHS website at http://www.ncvhs.hhs.gov.
The Subcommittee on Populations invited Dr. Peter Scheidt, NCH Study Director, to present an overview of the NCS to the full committee of NCVHS on November 6th, 2003. The NCVHS members found the presentation to be enlightening and were appreciative that Dr. Scheidt shared with the committee the overview of the study. This important longitudinal cohort study will examine the effects of environmental and other influences on the health and development of more than 100,000 children, from pre-birth to age 21 across the United States. It is a landmark undertaking with much complexity.
The NCH has the potential to be a rich dataset for answering questions related to children's health and development. The NCS stands poised to offer populations in the United States comprehensive child health guidance, interventions and policy directions of a magnitude that could assist the Secretary's agenda to reduce and eliminate health disparities in racial and ethnic populations.
The NCS study, as shared with us by Dr. Scheidt, has a number of substantive and methodological areas that relate to the work of NCVHS in our advisory capacity to Secretary Thompson. These include but are not limited to protecting participant privacy and confidentiality, the standardization of data collection and usage of terminology, the inclusion of diverse racial and ethnic subpopulations in adequate numbers for meaningful statistical analyses, the use of language translations to ensure broad participation and the inclusion of social determinants, particularly measures of socioeconomic position and the measurement of health disparities. Guided by our hearings as well as several of the recent IOM reports we have identified a number of issues that if addressed early in the planning stages can enhance the recruitment and participation of racial and ethnic minorities as well as provide data that can be used by health planners on behalf of these subpopulations.
NCVHS recognizes that despite attention of the last decade the research initiatives on eliminating health disparities are in early stages of development. It is because of this early stage of development, the Secretary's initiatives in the area of health disparities, and the compelling data needs for racial and ethnic subpopulations that the Subcommittee is interested in NICHD's leadership efforts to establish a cohort study to longitudinally assess the health of children and their families. We are also interested in the status of preliminary planning work done through work groups and methods for recruitment and retention of specific racial and ethnic minority subgroups.
Health disparities have been documented in several HHS reports. Its elimination is a HHS priority initiative and has been highlighted by Congress in a number of pieces of legislation. The NCS is an excellent vehicle through which much can be learned that can contribute to the reduction and elimination of health disparities. The following points highlight recommendations that we obtained through hearings that may be of use to you as you continue planning for the implementation of this landmark study.
- Use a population health approach to ensure the adequate distribution of the sample of study participants across race, ethnicity, geographic context, and socioeconomic characteristics.
- Use a population health approach to ensure that the sample size is sufficient for analyses of casual relationships particularly for the core hypotheses for all subpopulations of interest.
- Identify and examine casual relationships that include behavioral, social, and economic factors as they interact with biology and the environment.
- Develop a plan for public use data that is timely and allows for broad access.
The NCVHS Would appreciate feedback on these issues and welcomes continuing dialogue with its Subcommittee on Populations on how these issues might be addressed. The NCVHS remains committed to the importance of a population health approach to improving health across the United States. We will follow the NCS with great interest and would appreciate receiving periodic updates on the progress of the study.
Sincerely, John R. Lumpkin
DR. LUMPKIN: Okay, we have a letter before us, it's been moved by Vickie, is there a second?
DR. COHN: Second.
DR. LUMPKIN: Seconded by Simon. Is there any discussion on sending this letter forward? All those in favor signify by saying aye.
SUBCOMMITTEE: Aye.
DR. LUMPKIN: Opposed say nay.
DR. MAYS: Thank you.
DR. LUMPKIN: Thank you.
DR. MAYS: Can I do any update or are we not doing that?
DR. LUMPKIN: I don't think we're going to do committee updates.
DR. MAYS: Okay. Can I do one, there's one --
DR. LUMPKIN: Now that you mention it since you weren't here through no fault of your own, you can give a short update because our new members don't really know that much about your committee and you might want to do some recruiting. Because the other subcommittee chairs actively engaged in --
Agenda Item: Update of Population Subcommittee - Dr. Mays
DR. MAYS: Well, let's see what we can do then. Okay, let me just do a short brief update and in that welcome anyone who wants to join us in some of the ventures that we're going to do.
One of the reasons I did want to do the update is because we want to come to the March meeting with our report, so I guess we always say those things that we need to have on the agenda for the March meeting. So we should come forth with our report, which is on one of our first hearings which looks at the issue of race and ethnicity in a lot of the federal surveys.
Also we are engaged in trying to look at this issue of mental health statistics, particularly trying to move mental health statistics from being a persona non grata to really ensuring that it has a place in the federal collection of data. I mean we're kind of at a point now where health includes not just physical health but it also includes mental health and emotional well being, so we want to start taking a look at this issue with the inclusion of mental health statistics, which I think kind of follows on our early work on cultural status anyway, so it's a continuation of that.
Also we were able to discuss briefly and I thank Simon, even though I was not able to be at the executive committee retreat I did read with great interest Simon's comments and then we talked about it when the report was discussed for the subcommittee on what had taken place. But Simon's comments about for example this issue of thinking more about the capture of race and ethnicity and how best to capture it. We were moving to I think directions of thinking about that and the decision was that one, I will talk with Simon's group a little further but that we will move ahead on thinking about that and hold some hearings on it. So I think that that will also cross a couple of the subcommittees so we look forward to further dialogues on that.
There's also the issue of the collection of data on race and ethnicity, we have only begun to talk a little bit about how the mixed race data is going to be used, what some of the issues are in terms of collapsing mixed race data, so that is rising on our agenda also to have some further discussions on.
We also discussed the notion of identifying some of the liaisons for people that we want to have some continuing relationship and again, this comes up from the discussion at the executive subcommittee, so we're going to be reaching out and identifying some people, particularly within Census. So we had a pretty good discussion about what is it that we need and the difference between Census itself and some of the Census committees like the RAEIT(?), I think that's the way they say it, that committee. So we're going to talk further I guess maybe at the executive committee level about those individuals.
Letters to the health plan, those are still there and we think that if we're also starting to engage the health plans in discussions about capturing issues of race and ethnicity it might do very well to send out letters and then to tell them about our plans to hold hearings on this, so I think we may still be somewhat timely in that information.
So that's an abbreviated version of our work plan, our work plan is a little bit longer. We're a fun group, what else, we've met in California a couple times. And Colorado, Philadelphia, unfortunately the next APHA is here in Washington, D.C. so we can't tell you that that's going to be anyplace different.
Thanks.
DR. LUMPKIN: Questions?
DR. BICKFORD: Carol Bickford, American Nurses Association. When you take a look at population and address ethnic minorities and vulnerable populations are you addressing those that are in the corrections facilities?
DR. MAYS: We haven't done that specifically, we've actually been, our work has been flowing from the OMB guidance so it hasn't in terms of specific place based populations gone there, it's just been in terms of race and ethnic group.
MS. GREENBERG: One of our new members actually worked with incarcerated populations. I'm recruiting him for you.
DR. VIGILANTE: The National Children's Study has also thought about incarcerated populations in terms of parents and then ultimate outcome of the child.
MR. BLAIR: Some people consider the National Committee on Vital and Health Statistics to be an incarcerated population.
DR. LUMPKIN: But that's the kind of incarcerated population that like former Representatives and Senators go to, and Governors, not the one that, the uniform population goes to. Country club.
MR. SCANLON: I was going to say, we're going to check to see that the doors are locked, Jeff.
I was going to say in terms of the scope of the Populations Subcommittee one of the emphases currently is on race ethnicity but the scope includes all populations, any vulnerable populations, institutional populations, any subgroups, so the current emphasis on some of the issues related to race ethnicity is certainly not meant to preclude the coverage and the scope, all of those areas are within the scope of the Populations Subcommittee, including economic perspectives on populations --
DR. MAYS: We actually welcome kind of bridging out, we have this as a particular task but with your expertise it can be a great home for you.
DR. LUMPKIN: Okay, next item on the agenda is an update on the retreat by the executive subcommittee and then we're going to review our meeting agendas and then we're going to be out of here, my guess is with discipline by 3:00.
Agenda Item: Executive Subcommittee Retreat - Dr. Lumpkin
DR. LUMPKIN: Just wanted to go over a few items, the full minutes of the subcommittee retreat, or summary, is under tab four. I've already discussed with you the fact that I think that we've made a lot of significant progress and noted that, we had some discussion on that.
We started off the discussion with talking about staff for the committee and staff support, which is very crucial. A couple things I wanted to let the full committee know is that again, as we discussed here, that the committee could not do its work without the active participation of department staff, but that letters of appreciation were sent to each of the staff members at the end of last year, and in addition as part of the results of the retreat we've also sent off letters to the heads of each of their operating units to note the accomplishments. Because we've heard sort of second hand in social events and other things the fact that some of the staff have a day job with the department and then they work in our committee and their home agency may not appreciate the work they do with the committee the same way that we value it so we wanted to make sure that their heads of their operating units understood how much we appreciate their work and how vital it is and how much it makes a difference in the work of the department as a whole.
We had some discussion about a GSA report that was done on all advisory committees. Debbie and Jackie were the ones who really did most of the work in submitting the report. And what we found out is that in the last year the NCVHS made 12 sets of recommendations totaling 77 recommendations, and 71 percent of those were at least partially implemented by the department, which is outstanding for any sort of committee. And we kind of looked at that and said that well, we think we're comfortable with that level, we don't want to be at 100 percent because that means we're not pushing the edge enough but certainly 71 percent says that we are being heard in the way that we want to be heard and we continue to raise issues that sometimes the department can't respond to but we'll certainly think about that.
We spent a fair amount of time talking about aligning the health information strategies with the department's health objectives. This was on our agenda at the prior retreat and one of the things we noted is that we're actually in better alignment now then we have been in the past and that was a very positive one. The department has a set of eight goals that came out of their strategic planning process and we believe that the work of our committees is actually aligned with each one of those eight goals, and I'll just read them to you very briefly, they're in full text.
The first one, reduce the major threats to health and well-being of Americans, obviously we're doing that, through Populations and NHII. Enhance the ability of the nation's health care system to effectively respond to bioterrorism and other public health challenges. In a number of our work from the subcommittees are addressing that. Increase the percentage of the nation's children and adults who have access to health care services and expand consumer choices. Again, NHII, Populations, Standards and Security all address those. Enhance the capacity and productivity of the nation's health science research enterprise. Work of the NHII, Standards and Security, and Privacy are addressing that goal.
Goal number five is to improve the quality of health care services, the Quality Workgroup is most directly effecting that. Six, to improve the economic and social well being of individuals, families, and communities, especially those most in need. Populations and the committees integrating perspective, the 21st Century Health Statistics recommendations, all spoke to that one.
Goal seven, improve the stability and healthy development of our nation's children and youth. Work by the Populations and NHII and Privacy addressed that. And finally goal eight, achieve excellence in management practices, and particularly recommendation 8.5, which is concerning information technology use, and the work that we just did on CHI is a good example of trying to improve the efficiency of the department.
We reviewed plans, we discussed the budget, which you had an update on, and also some follow-up on the Health Statistics for the 21st Century Report that we had. We're making plans for a presentation by Barbara Starfield and Dan Friedman, both former members of the committee, plus someone from the private sector as sort of a follow-up of that very important report. And we favor continuing to monitor progress of the health statistics vision as a task of the full committee rather then of a particular workgroup.
Finally, the last area that we spent a significant amount of time on was talking about optimizing the committee's effectiveness, well actually next to last. One was that we agreed to have a panel at the June meeting on the current status of the standards process and how to have an impact on that, sort of a catch up. We've had some significant impact and it's time to sort of catch our breath as we're rushing forward. Of course we said that before the Medicare bill was passed and now it's not like we have any option of looking at the standards agenda, there are some really significant requirements have been placed upon us by the Medicare bill and the e-prescribing.
We wanted to invite Barbara Paul to brief the committee on CMS initiative on using data to measure quality and have a discussion about patient safety and a briefing on the patient safety task force and the Institute of Medicine report as some of our future activities in the coming year.
We wanted to look at some of the issues related to privacy gaps, and that would be some of the work that we would raise as cross cutting issues. And we also looked at some issues related to Census Bureau and Vickie touched on that because Census Bureau obviously has an important role, for those of us who've trained and gotten their training in public health, I always learned that the definition of epidemiology is a search for a denominator, and the Census Bureau is very important in achieving those denominators.
Finally the executive subcommittee agreed to designate Dr. Cohn as the regulator Data Council representative since now we have the Data Council and the CAHIT, the Counsel on Application of Health Information Technology, it was a little bit much for me to try to be at two monthly meetings in D.C. because I do have a day job, as the rest of us, so that designation was made.
The last area was coordination with the NCHS Board of Scientific Counselors and as Marjorie has let the cat out of the bag we want to look at a joint meeting with the Board of Scientific Counselors in early 2005, and one of the issues we tossed around as maybe a potential was one that a former chair of this committee, Judith Miller Jones raised, about e-coding and the declining number of autopsies, and what is the impact upon the vital records systems if they aren't having autopsies how do we know what people died from and therefore we're basing a lot of our projections about how we're going to deal with death, significant diseases leading to death in this country.
So that's a brief summary of our retreat and if there are other members of the executive subcommittee who'd like to add --
MR. HUNGATE: I would like to add we did talk at some length about the Quality Workgroup and somehow that got dropped in the summary. So I'd like, at least in what I see here --
MS. GREENBERG: It is here on the last section, implications of the quality agenda for NCVHS.
DR. LUMPKIN: And I skipped over that.
MR. SCANLON: -- new generation quality --
DR. LUMPKIN: Well, we spent some time talking, yeah, I think actually it's the last whole section. And we talked about looking at risk adjusted outcomes --
MR. HUNGATE: My document is incomplete.
DR. LUMPKIN: If I can digress, one of my most interesting moments as a state health official was when we discovered that in translating the State Emergency Medical Services Act in 1980 from the legislature to the then the company that printed up the laws, they lost the last page, and included in that last page was language that sunsetted the State Emergency Medical Services Act. When that was discovered it was the first time that I've ever been responsible for the legislature going into a special recalled session in order to enact the State Emergency Medical Services Act, so I'm very sensitive to the fact that sometimes very significant portions get left off in translation. My name was mud there for a while. Jim?
MR. SCANLON: Perhaps for the new members and certainly for any of the current members, John was referring to objectives from the HHS strategic plan when he talked about aligning committee activities with HHS strategic objectives so maybe we should actually share for the new members particularly a copy of the HHS strategic plan, or I can give you the website. I'll send everyone the website address.
DR. LUMPKIN: Great. Okay, any other questions or additions? One other item I just wanted to give you a brief update from the NHII Workgroup, because there has been a somewhat significant change in our work plan and I just wanted to make sure the committee is comfortable with that.
As you know when we issued our report in December of 2001 we had a lot of concern about using the term NHII, in fact we titled the document Information For Health. Since that time the NHII has gotten a lot of traction and the workgroup has been basically monitoring the adoption of that. One of our difficulties in developing the tasks for the workgroup is every time we decide to work on something somebody else was already plunging ahead and so we realized that we weren't really setting our vision far enough into the future as we had done with the first report. So the work group will be working towards developing a seven to ten year perspective on the vision, what the NHII should look like in seven to ten years, and then working on those kinds of tasks, but to fill in some of the gaps. Some of the gaps that we'll be looking to fill in are the interactions between the three current dimensions, the population health dimensions, the personal health dimension, and the provider health dimension.
We also revisited the fact that the initial work of the committee, we had a lot of trouble coming up with the term dimension and one of the terms that we used were views, basically the dimensions aren't entities, they're actually if the NHII is going to work it has to work for this group of individuals and they have to have the right ability, this aspect of the National Health Information Infrastructure.
So in addition to developing a long range perspective, a long term road map, the committee, the workgroup will also be working to explore adding three additional dimensions. One is a purchaser/payer dimension, the second is a health policy dimension, and the third is the research dimension. We're going to be looking at developing various models, now in order to accomplish this we're looking towards with your approval partnering with the NHII Task Center led by Bill Yasnoff in ASPE, Assistant Secretary for Planning and Evaluation.
And they had a conference on the NHII last year, which the Secretary spoke at, and they're planning another conference coming up roughly the same time, late June, probably more like July, with the thought is is that the workgroup will work closely with Bill Yasnoff and the NHII staff in developing the conference to help us as part of our work plan of developing models. We also want to look at some of the fiscal and financial models and incentives related to implementation of the NHII, issues related to architecture and those sort of models.
So we have had a significant change in our work plan and wanted to raise that. Since the time we had that full day meeting there have been some other developments which have been of interest. The Connecting for Health has evolved and it's going into its second phase, and they after hearing the results of our planning session have chosen to focus in on a very short one to three year timeframe for developing a road map. But in the interest of trying to make sure that all of this fits together they would be very interested in sending their work product to us for our review and comment to forward it on to the Secretary, so that will fit somewhere into our work plan.
So that's just really kind of a brief run down, I think it's also important to note that because there's so much going on as Jim mentioned, this issue is now raised from the department into a White House level issue, which will also help provide some consolidated approach as other agencies that have some commitment to this as the partners in CHI, the White House will be assuring that there is consistent direction and approach.
So that's sort of a brief run down and sort of the directions and lest we hear any objections to that approach then the workgroup will be moving forward.
Agenda Item: Upcoming Meetings - Dr. Lumpkin
Okay, the next item on our agenda our upcoming meetings. Our next meeting is March 4th and 5th, you've all received the agenda. We have a couple of action items that have been postponed, or put to this meeting, so we'll just need to fit those in.
MS. GREENBERG: Actually we have a very full day on the 4th, which I mean a lot, and as you said a few action items from this meeting that have gone to the March meeting as well as Dr. Mays said that you're trying to bring forward the Population's report. The main impact of that on the first day because we tried for the benefit of the new members, anything that's going to be an action item, and of course this was only a one day meeting today but we try to bring it forward on the first day so that it can get hopefully if it's more then a letter you will have received it in advance, any kind of report, but we discuss it on the first day of the meeting so that members and staff can comment and make suggestions and then the appropriate subcommittee or workgroup can in their session deal with those comments if it's possible and bring it back for approval the next day.
So bringing all those, putting all those things on the first day as well as our presentation on Health Statistics for the 21st Century and our normal updates, will probably reduce to some degree, which in a way is kind of a catch 22, the time for the workgroups. Actually what I think we may need to do is reschedule this, not have the NHII workgroup that afternoon, we'll talk about it --
DR. LUMPKIN: I don't think we necessarily need to --
MS. GREENBERG: We don't have to worry about that now --
DR. COHN: The Standards and Security Committee can give up its time.
MS. GREENBERG: Oh, you are now meeting the day before, so you would give up your time entirely? Maybe not.
DR. COHN: Give us an hour.
MS. GREENBERG: That's right, because we had spoken about needing a few hours. Okay, so that might work and the Subcommittee on Populations will need some time basically to react to comments. The Workgroup on Quality if there need to be changes in the report will still need some time as well, and of course there's overlap in those two so we'll do our best.
On the second day, and we can actually extend maybe the morning of the second day for subcommittees and workgroups, we already have a meeting of Privacy and Confidentiality, but at this point we have not finalized our agenda for the second day in addition to meetings of the workgroups and subcommittees and then report back, etc.
We have talked about, and some of these have come up, having a report on the Patient Safety Report and it's certainly and timely in relation to the Quality report --
DR. COHN: I guess I would especially speak to the IOM Patient Safety Reports since I think that they actually may have some work that they have done that may be of use actually even to our e-prescribing activities.
MS. GREENBERG: Okay, so let's pursue that.
MR. HUNGATE: A comment from the quality point of view, I would like, there is some coherence between the Patient Safety Report and the work of the Quality Workgroup and putting those together would help the discussion, in fact putting the Patient Safety presentation prior to the discussion of the report --
MS. GREENBERG: We can't actually do that. I mean we can't move the Patient Safety to the first day, but before the approval of the report we would have the Patient Safety --
MR. HUNGATE: Because one of the, in our meeting in working on the report it's less clear what the real next steps should be and there's some time here for setting our agenda, and I think it would be very helpful to have some of that discussion at the full committee level in the context to things like the Patient Safety Report, the ARHQ Health Quality Report, the rest of the arena. Maybe that's not appropriate for the full committee but it seems to me we cut across the other committees and that therefore it would be helpful. So that's why I raise it as an agenda issue.
DR. COHN: Can I ask a question? And I apologize, if indeed there is an agenda for the March meeting it's on my email and I've never actually seen a copy of it on paper.
DR. LUMPKIN: You've got to be in your home office more.
DR. COHN: That's what my boss says. And I guess, and I apologize, I'm a little confused, is the Quality report the Population Report that's coming forward?
MS. GREENBERG: No, no, two separate reports.
DR. COHN: This is another report. I guess I would ask then, and once again having no idea how much time is on the agenda, that has historically been a pretty controversial report, at least the last couple times we saw it, and is there going to be adequate time for us to either review it prior to the meeting or to discuss it at the meeting?
DR. LUMPKIN: Both. It will go to the executive subcommittee before it gets released to the full members so you will have an opportunity, Simon, to see it and to clue us in to whether or not this is toned down enough to be less controversial.
DR. COHN: Okay.
MR. HUNGATE: But that leads to the discussion of next steps and that's part of what I'm trying to position. That there needs to be enough time for articulation and thought about what the next actions are beyond what we've recommended.
MS. GREENBERG: And they certainly will be, between time on the first day where we'd already scheduled an hour, I mean we're going to have to work with this agenda, but then there will also be time on the second day.
MR. HUNGATE: The other comment relates to the report itself wherein we have organized the recommendations that cross reference other interests within the committee with the intent of asking especially if you see your subcommittee listed by a recommendation we especially want your feedback on that in particular. Because it will speed, I'd rather do some of that by phone even before the meeting if we have issues that really require discussion.
DR. LUMPKIN: So that will be going out, I forget what's --
MS. GREENBERG: -- but to the executive subcommittee I believe it's like the 17th, the 13th --
MR. HUNGATE: Now don't have it so far in front of the meeting that you leave it until the last minute please.
DR. LUMPKIN: So it will be going out about two weeks ahead of the meeting or so.
MS. GREENBERG: I think with all of this and the patient safety, that will round out the agenda.
We've invited members, other members of the Board of Scientific Counselors if they're interested to come to that first day, the morning session, on Health Statistics for the 21st Century, so we will have some additional attendants.
DR. LUMPKIN: Do we have anything else to talk about at future meetings?
DR. VIGILANTE: Could I just ask one question about the schedule? This morning at the NHII Subcommittee meeting there was mention of the 18th, a meeting on the 18th, is that fit into this grand plan or --
DR. LUMPKIN: Yes, there is a workgroup meeting on the 18th of February --
DR. VIGILANTE: For NHII.
DR. LUMPKIN: NHII Workgroup, and that will be in D.C.
MS. GREENBERG: I think I've pretty much confirmed that both that meeting and the privacy meeting will be in this meeting, I know it's a challenge because people are, some people are going to need to cover both. Well, unfortunately the privacy is the 18th and 19th, and the NHII meeting is the 18th.
DR. LUMPKIN: Which is the only day we could get in because of the timeframes of trying to get involved in the planning of the conference. And the new members of the full committee, our brand new members, will not have received the notification about the date of that meeting because it only went to the workgroup.
MS. GREENBERG: And it's not actually on this agenda because --
I think we did send it to everybody. You may recall that we had invited Dr. Gerberding, the director of CDC, to the March meeting. She's not able to come to the March meeting, we're looking into whether she can come to the June meeting.
DR. MAYS: She can't send a rep to the March meeting?
MS. GREENBERG: I think our first choice --
DR. MAYS: We're talking about our future initiatives so if we're in the past by the time she's already decided the future --
MS. GREENBERG: I should mention that both John and I are going down next week to the meeting of her advisory committee, the CDC Advisory Committee, or the CDC Director's Advisory Committee, in which there is going to be a discussion of the future initiatives and I guess we'll see after that whether there's something we need to bring forward to people. And that's where that situation is.
I was just thinking, I'll just throw this out and it could be, doesn't have to be discussed but it could be discussed by the executive subcommittee and certainly we welcome anyone's thought on this, as we were talking we realized that this committee, this illustrious long standing committee, the national committee, was established in 1949, so actually 2004 is our 55th anniversary. We had a rather ambitious actually symposium, 45th anniversary symposium for the 45th anniversary and we also had really an excellent symposium at the National Academy of Sciences for the 50th anniversary and the report was, actually the NHII vision and the 21st Century Vision for Health Statistics were rolled out at that meeting, the initial reports, then of course the history also and you have copies of all of those.
I don't think that given everything that's on our plate I would recommend anything quite that ambitious for 55 but I think we should think of doing something to mark the 55th and one thought that I had was just during this meeting, either for June or September, might be to have a panel with former chairs of the committee, some of whom are still very involved in the issues that this committee deals with, such as Dr. Detmer, I think he'll be back in the states by then, as well as Dr. Blankenbaker(?) and even Dr. White, Carr White, I don't know whether he'd be able to come up or not. But we could have a panel at as I said either the June or September meeting and then a dinner again such as at Magiano's(?), which everyone seemed to enjoy very much.
So we can discuss that but that's something I just wanted to put on the table. Are there other items?
MR. HUNGATE: One other scheduling item, when the Workgroup on Quality talked about meeting the afternoon before on March 3rd, and the scheduling as proposed overlaps the Workgroup on Quality with the NHII Workgroup --
MS. GREENBERG: We have to work this out.
MR. HUNGATE: -- it causes a problem and --
MS. GREENBERG: Everything overlaps with everything at this point, but we will try, I know there's staff and members are impacted by that. I think we're going to move one of these to the next morning.
MR. HUNGATE: Well it might make sense to move the Workgroup on Quality to the following morning because I think it has less conflict with Privacy and Confidentiality then with NHII.
MS. GREENBERG: This is true, but if you're going to have to work on the report you may want an opportunity to meet.
MR. HUNGATE: I don't think we're going to need to do much work on the report.
DR. LUMPKIN: I don't think we need the full committee to negotiate this agenda.
MS. GREENBERG: We will send a new agenda to the executive subcommittee and I don't think we need a conference call of the executive subcommittee before the March meeting because it looks like we've got the agenda pretty well set but we certainly will need either a conference call or even an in person meeting before the June meeting I think.
DR. MAYS: -- you just want to do it by email? Okay.
MS. GREENBERG: I think we'll do it by email --
DR. LUMPKIN: Because we won't be adopting, we're just going to identify where there may be some problems.
MS. GREENBERG: Unless there's a need, I mean we'll set something up, I should mention that the agenda includes the dates for the September, for the June meeting, June 16th and 17th, 2004, I believe we're still solid on that. The dates for the September and November meetings we know we have to change but we were waiting until the new members came because there was no point agreeing among ourselves and then several people were going off and new people were coming on. So we will poll people, we'll check with Dr. Lumpkin's schedule and then we will poll people for new dates, there will be meetings in September and November and it might not be too early to start thinking about 2005 dates. I think the board is, the Board of Scientific Counselors is already thinking about 2005.
DR. LUMPKIN: Okay, John made a request that because we get sort of bits and pieces of having some sort of consolidated calendar that's sent out on a regular basis might be useful. The agendas when they're completed show up on the website but if we had a calendar that listed the dates --
MS. GREENBERG: We actually internally maintain something like that so we can certainly --
MR. HOUSTON: That would be real helpful, and especially when we go to these types of meetings, like today there was an 8:00 NHII I almost missed it, that was partially my fault but it would be nice where we do have a full committee and we sort of know where some of the subcommittees are going to be meeting, to put that out there just, even if there's not a lot of detail, just so we can make sure we're not missing something would be real helpful.
DR. LUMPKIN: Sure. Kepa?
DR. ZUBELDIA: Bold the changes. Draft agendas, there's just the topics that will be discussed and the different panels, it would be very useful for those of us who have to make a decision whether to come or not.
MS. GREENBERG: We have a new policy, it's really an old policy but we're trying more then ever to enforce it, which is that agendas for all the meetings will be posted definitely at least a month before the meeting, even if we only have topics. We've tried to do that and then often staff just want to get that last speaker confirmed before we post it, but it's as you said, it's very difficult particularly for people who are not members and it's somewhat optional for them whether they're going to attend or not, so we have committed to get those agendas up, just with topics even, at least a month before even if we don't have the speakers. And of course you have to recognize that things change because of speaker availability and new topics that arise and all of that but we will definitely, we've already committed internally to do that.
DR. LUMPKIN: Okay. Simon.
DR. COHN: I was going to say, just hopefully not to create further confusion but just so when you see the emails you'll understand what they're all about. Obviously we've got meetings being rescheduled for the full committee in September and October, whenever, last half of the year. We're also going to poll for additional meetings for the Subcommittee on Standards and Security for members of the subcommittee. Obviously we have not scheduled anything for the last half of the year, we'll be looking at the e-prescribing work plan to make sure that we have enough meetings scheduled. So those who are on the subcommittee, or those who are thinking about whether they want to be on the subcommittee, and I may or may not know who you are, please let me know so we send them out to the right people and get these things scheduled.
And I just want to let you know, this obviously will be a separate set of emails, this is not the same meetings that Marjorie is going to be trying to schedule. So just so people are aware.
MS. GREENBERG: And the Subcommittee on Standards and Security has definitely agreed to meet on March 3rd? Or is that for polling?
DR. COHN: No, this is definitely, we're definitely meeting, I think in terms reluctantly but yes we are meeting.
MR. HUNGATE: The Quality Workgroup was saying they would meet --
MS. GREENBERG: Also planning to meet on the afternoon of March 3rd.
MR. HUNGATE: That was the plan.
DR. LUMPKIN: Okay. Do we have any other business before us? It is now minute before 3:00, I promised we'd get done at 3:00, so please sit quietly in your seats until the clock strikes 3:00.
[Whereupon at 3:00 p.m. the meeting was adjourned.]