[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 dat