[This Transcript is Unedited]
Quality Hotel
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Agenda Item: Call to Order, Welcome and Introductions
DR. LUMPKIN: We have a shorter meeting this time and we'll get out early tomorrow, but what we do have for today is fairly tight. So we do want to get started on time and proceed. My name is John Lumpkin, I'm Director of the Illinois Department of Public Health and chair of the committee. We're going to start off with introductions. And why don't we start as we usually do, to my right.
MS. GREENBERG: You're going to trick me in the future because I knew when you looked at Jim that you were going to start with me. I'm Marjorie Greenberg from the National Center for Health Statistics, Centers for Disease Control and Prevention and executive secretary to the committee.
MS. COLTIN: I'm Kathryn Coltin and I'm with Harvard Pilgrim Health Care in Boston.
DR. ZUBELDIA: Kepa Zubeldia from Claredi Corporation and a member of the committee.
MS. BEREK: I'm Judy Berek with Centers for Medicare and Medicaid Services.
DR. HARDING: I'm Richard Harding. I'm a member of the committee from the University of South Carolina. I'm a psychiatrist.
MR. CAMPANELLI: I'm Rick Campanelli. I'm the Director of the Office for Civil Rights at HHS.
MS. FYFFE: I'm Kathleen Fyffe. I'm in the Office for Civil Rights at HHS.
MR. GODESKY: Douglas Godesky, Deputy Project Manager for Consolidated Health Informatics Projects.
DR. ROTHSTEIN: I'm Mark Rothstein from the University of Louisville School of Medicine, member of the committee.
DR. NEWACHECK: Paul Newacheck with the University of California San Francisco, member of the committee.
DR. SHORTLIFFE: Ted Shortliffe from Columbia University in New York City, member of the committee.
MR. AUGUSTINE: Brady Augustine, Gambro Healthcare, member of the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
DR. COHN: Simon Cohn, Kaiser Permanente, and a member of the committee.
MR. SCANLON: Jim Scanlon, HHS, executive staff director for the committee.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services.
MS. YOUNG: Nellie Leon-Chisen, American Hospital Association.
MS. PROFFIT: Sue Proffit, American Health Information Management Association.
MR. MCLAUGHLIN: Mark McLaughlin(?), --.
MS. CHAIN: Gail Chain, CDC staff.
MS. KANAAN: Susan Kanaan, writer for the committee.
MS. SALVA: Virginia Salva(?), Georgetown University, Nursing.
MS. JACKSON: Debbie Jackson, National Center on Health Statistics, CDC, committee staff.
MS. BEBEE: SuzIe Bebee, National Center for Health Statistics and staff to the subcommittee on standards and security.
MR. WILDER: Tom Wilder, American Association of Health Plans.
MR. ZERKOWSKI: Mark Zerkowski(?), Food and Drug Administration.
MS. HOROLECT: Gail Horlick, CDC, staff to the subcommittee on privacy and confidentiality.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to standards and security in the national health information infrastructure workgroup.
DR. KOLODNER: Rob Kolodner, Department of Veterans Affairs, staff to the subcommittee on standards and security, and also representing CHI here today.
MS. CRUTE: Sherree Crute, writer for the subcommittee on populations.
MR. EMERY: Jack Emery(?) with the American Medical Association.
DR. NARROW: Bill Narrow, American Psychiatric Association.
DR. YELK: Scott Yelk(?), American College of Physicians, American Society of Internal Medicine.
MR. EDINGER: Stan Edinger, AHRQ, staff to the quality work group.
MR. RIAPEL: Chris Riapel, Chief Privacy Officer of Gambro.
MR. AVEROL: Rich Averol, Research Director at 3M.
MR. HITCHCOCK: Dale Hitchcock, HHS, staff to the subcommittee on populations.
DR. MONGELO: David Mongelo(?), College of American Pathologists.
MS. WEIRS: Chris Weirs, Healthlink, Inc.
MS. WHITE: Gracie White, NCHS.
MR. YASNOFF: Bill Yasnoff, HHS staff.
Agenda Item: Review of Agenda.
DR. LUMPKIN: Thank you, let's proceed. If everyone will take a look at the agenda, this is the point in time in which members of the committee will declare any conflicts to agenda items.
DR. HARDING: I'm Richard Harding. I am past president of the American Psychiatric Association. I guess that's a conflict.
DR. LUMPKIN: I can understand how that would make you basically conflicted.
[Laughter.]
DR. HARDING: We all are conflicted.
[Laughter.]
DR. LUMPKIN: Would that constitute --
DR. HARDING: Financial or ethical conflict.
DR. LUMPKIN: Okay, for the DSM?
DR. HARDING: Yes, if that were to be discussed that would be the only thing. I'm no longer the CEO of the APA, but I am on the board of the APA.
DR. LUMPKIN: Thank you. Ok, let's proceed with the department update.
MR. SCANLON: Okay, thanks John. Good morning everyone. Well, actually there is a lot of interest in data policy and NHII related issues in the department and on the Hill and a number of other places in the industry. There are a couple of things to report and I think in the fiscal year coming ahead we'll actually see even more progress. I'm going to mention a few things but we're going to get an update on, as you know, the HHS privacy regulations, final modifications were issued in August. Richard Campenelli is going to talk a bit about that as we move forward. Karen is going to talk about the data standards under HIPAA and you're going to have a briefing as well, on our consolidated health informatics initiative which is focusing on message standards and content standards for clinical data exchange.
Let me just bring you up on some of the other broader sorts of things that have occurred either since the last update in June or extensions of what I reported then. First of all let me do a little bit of personnel. We have a couple of new faces. I'm very happy to first of all announce that Bill Yasnoff, Dr. Bill Yasnoff, has joined our office in ASPE as a senior advisor for national health information infrastructure issues. I think all of you know Bill, he's worked with the committee on the NHII report. We're pleased that we were able to get him on a detail from the Centers for Disease Control. Bill is serving as a substantive expert to ASPE leadership on a variety of NHII issues. He'll be picking up a lot of the initiatives that we've already started here in the committee, for example, the PMRI standards, what some of the other agencies are doing, as well as the NHII recommendations as well. So we're very pleased and we're off to a good start. We're kind of putting together with Bill and the leadership, kind of a work plan of what would be the two or three most important things to do as practical steps. And of course we want to make sure that whatever we do with NHHS related to the NHII, is consistent with the overall framework and supported and coordinated, so Bill will be working on all of those things. He's got a full agenda, he's already had a month here in ASPE and he still surviving so we're very pleased to have him there. Of course this was at least partly motivated by the committee's report on improving health through the NHII.
I, too, am wearing some additional hats these days. I'm in addition to my usual data policy division directorship, I'm now the acting director of the Office of Science and Data Policy within ASPE and I'm the acting deputy assistant secretary for science and data policy in ASPE, as well. So I'm now, if I look a bit confused at point in times, I'm not remembering which hat to take.
Before I go into the other items let me introduce Judy Berek. Recall at the executive committee meeting in July, the committee asked if we could have agency liaisons from some of the major agencies within HHS. We already have a liaison from AHRQ, Mike Fitzmaurice, but the committee asked to have an agency liaison from CMS and from NIH and I'm pleased to have Judy Berek here from CMS here to represent the agency. We will have Virginia Cain has also been designated as the agency liaison from NIH. Virginia is the deputy director of the Office of Behavioral and Social Science Research at NIH. She works with Raynard Kankton(?) in that office as well, so she has a good trans-NIH perspective as well.
We've asked CDC to designate an individual, well I asked Claire Broome to designate someone, so hopefully we'll have that occurring pretty soon as well. I understand, as you know, Mike Fitzmaurice is the agency liaison from AHRQ, his father died unfortunately, so we'll extend our condolences to him, but obviously he won't be here the next couple of days. We asked that Dr. Ed Sondik, director of the National Center for Health Statistics, serve as the direct liaison from NCHS and he's agreed to do that as well but today he's not here this morning, but he'll be here, as well. So we'll actually have most of the major data and information policy agencies represented directly here as well as at our meetings.
Let me mention one more thing and then go into some updates. You're going to get a briefing tomorrow on the update of the HHS strategic plan. This is the three-year forward look at the overall goals and strategic objectives of HHS. It's still in a formative stage, we're taking comments on some of the material there and we're still filling it in. You will see that there is included, at least in the draft, a section dealing with the national health information infrastructure, under the general theme of realizing the benefits of 21st century healthcare. Bringing technology and all of the other quality and science related issues to healthcare. One of our themes, actually one of the objectives, is to accelerate the development and use of the national health information infrastructure. So we now have that formalized in the HHS strategic plan, at least in the current draft.
There are three sub objectives, we'll discuss this more tomorrow but one is to provide leadership to promote the rapid development of the technology and standards necessary for electronic health records consistent with secure and confidential treatment of health information. Again, that's come largely out of the work of the NCVHS and work with NHHS.
A second sub objective there is to promote the voluntary adoption of national data standards within the private and public health sectors as the building blocks for NHII. And a third objective is to conduct research on the practical NHII applications that serve consumers and patients at home as well as professionals and other decision-makers. Again, there is more activity relating to formalizing activities on the national health information infrastructure.
Questions before I go into some updates on things I've reported previously? I think at the last meeting in June, I reported that all federal agencies are now required to publish, to post on their web-sites guidelines for how they assure the quality of the information they disseminate to the public.
MR. BLAIR: I did have one question. In the strategic plan, when I had an opportunity to make some comments about that, I wound up asterisking all of the other elements of the plan that would be enabled or facilitated by an NHII and I was wondering if that has been recognized or adopted into the plan?
MR. SCANLON: We can check tomorrow, Jeff, when Dr. Channah is here. The draft I have is the previous, the one that was actually commented on. We're also developing some appendices in other chapters that relate to some data challenges and other issues, too, we can make those points there. But Dr. Channah of VHN(?) is going to be here tomorrow. She'll give you an overview of the whole process for the strategic plan and kind of where we are.
Guidelines for information quality - you will remember more than a year ago the famous Shelby Amendment that was passed in Congress and it had all of the research community worried because it basically opened up the research records of extramural researchers, many of you around the table, in fact, are principal investigators. It opened up your records theoretically to FOYA requests. This was a law that was passed at the request of industry who felt that they were not being given access to data that was being used for major regulations, so they went directly to, they found sympathetic ears on the Hill, and this was passed into law. It's a fairly blunt instrument but nevertheless it makes for much of the research you do, if it's used in any major agency decision-making or actions, it becomes subject to FOYA. And literally the industry or anyone else can request your records. You don't have to provide identifiers obviously, FOYA doesn't require that you provide identifiers or other confidential information but it basically makes your basic research information subject to FOYA.
So you'll remember there was a lot of concern about that but actually I think there have been few if any actual requests, at least none at HHS that we've learned of. But there was a second part of that statute that actually directed all of the federal agencies to develop information quality guidelines to assure the quality of the information they disseminate. So you have the extramural side and now all the interim. OMB published some government wide guidelines in January, but they basically directed every federal agency in turn to develop their own information quality guidelines. It's not a regulation, it's internal guidance largely, but there was a process that OMB spelled out as well. All federal agencies had to post their draft guidelines on their web-sites as of May 1st for a comment period. I think many of you probably got a look at the HHS and after the comment period we revised the guidelines and we're now on a trajectory to publish, well post our final HHS guidelines on the web-site as of October 1st. That's the effective date, so after that point any information that we are disseminating will be subject to the guideline and I'll mention the two parts in a minute.
This basically applies to substantive information that an agency disseminates such a statistics or scientific reports or authoritative health and medical information, it has to be substantive information, not administrative, phone director or that sort of thing obviously wouldn't be subject. It also focuses on information that the agency has disseminated in some way, has sponsored, so there has to be an agency imprimatur. This would exclude the vast majority of extramural research where the dissemination of the findings is largely in the hands of the researcher, the journals, so most of the NIH and AHRQ and some of the other research that's conducted on an extramural basis wouldn't be subject. But on the other hand, every one of the agencies around the table disseminates a significant amount of information, they would be subject.
There are two elements to the guidelines. One is every agency has to have in place some pre-dissemination review of what is to be disseminated focusing on quality, not on clearance or public affairs but on the quality, the objectivity, the utility, the accuracy and so on of the information. This could be external peer review if that's the way the agency operates, it could be an internal peer review, some other sort of an expert review, but there has to be some sort of an expert review, you can't simply have someone writing a report and putting it up on the web-site. There has to be some sort of a quality review process.
So within HHS we've set up a work group, we've actually done most of the work. We held up pretty well in the public comment period, we got about two dozen comments, but the comments related largely to how OMB had interpreted the scope, not so much as how we approached them at HHS. We're now on a timeframe where next Tuesday I believe we will post our final guidelines on the web. We view this as kind of an interim process at any rate so you may want to take a look, I can even brief the group on the full features of our HHS guidelines as well. Ted?
DR. SHORTLIFFE: Jim, I'm struck by how it is this process of internal review and quality control which accounts for the length of time it often takes to get information out of, for example, the National Academy of Sciences, when they do studies and it's a common criticism. The NAS struggles with this quality control issue and yet the sense that because they have such extensive reviews that it can take a long time to get reports out. It strikes me that HHS and other federal agencies will have exactly that same tension. There are just times you're going to want to get information out, if the internal process is itself awkward, slow, because of an effort to really be sure that information really has been adequately reviewed and cleared, it may actually, under certain circumstances, go against the need for urgent dissemination of information I guess. To what extent has that been recognized, discussed, and are there rapid mechanisms for getting these out through rapid review under those circumstances?
MR. SCANLON: We have the, first of all, we've tried to, and OMB urged agencies to do this as well, they asked agencies not to create any new processes if that's possible. So if the agency already has quality review procedures, and actually many of our agencies do, it's just a few instances it probably needs to be beefed up, but in most cases before publication is issued there is a fair amount of research and probably many of the agencies would almost say too much review and stirring before it's released. But again, this is the focus on quality. So we're using existing processes wherever we can.
In some instances there will have to be a new review created, but the other thing, Ted, is we kind of created an exemption at HHS, at least a temporary exemption, in cases of emergency, public health emergency, safety kinds of issues, where the time is of such urgency that we have to get the information out right away, even if it's quite preliminary. Maybe it's six cases we've had reported of this or that, where exposure has resulted in death or disability, well, there again, we don't need to do a case control study, we have to probably get the information out. So what we did was we reserved for HHS the authority to waive temporarily the provisions of these guidelines in those sorts of instances and we've applied it to virtually every one of our agencies. So that's kind of a case where we could do that at least quickly.
But I think you're right, though, I think it will add, this is balancing, it will probably cost on the average, it will probably add some time to the dissemination of virtually any product. This applies to web-sites as well by the way, not just journals, not just the sort of -- the official reports but web-sites as well.
DR. SHORTLIFFE: And by inference our reports and the materials that we generate that then go up on the NCVHS web-site?
MR. SCANLON: That's an interesting question. Are you a federal agency? I don't know. We actually have your web-site, the committee's web-site as part of the HHS web-site. We'll have to think about that. Not that there is any question about the high quality of --.
[Laughter.]
DR. LUMPKIN: To the extent that our materials represent the opinion of experts, that ought to be valid enough.
[Laughter.]
MR. SCANLON: I think the process itself kind of creates, I think we can make a case where, the process itself, it doesn't have to result in perfection, it just has to be process where there is a quality-oriented review. We have plenty of other clearance processes in HHS where the focus is not necessarily on quality, it's on some other factors, so adding another clearance policy was not the thing most agencies wanted, but I think in this case it's going to be integrated. I think we could actually brief the committee at some point on the details, but they should be up, the guidelines and all of their glory should be up on October 1st.
There is an interesting feature that every agency is required to have. This is the second feature besides the quality review. Every agency has to have a mechanism by which members of the public can request correction of information that they believe is not meeting guidelines or otherwise has quality problems. This is open up to every agency, so we have at HHS, we've kind of standardized the template for how someone would make a request to HHS. You can do it by e-mail, you can do it by U.S. mail, and we're sort of approaching it a little differently depending on the agency. At NIH for example we don't want everyone writing to director, so we start you out at the appropriate institute, the Cancer Institute, or the Heart Institute, or so on, that's where we start. In other places we have a central point of contact for e-mail, but we've actually, we have some demands, you can't just write in and say I disagree completely with the NCVHS report, whatever, they did a poor job and this and that. You have to say what it is you're referring to, what information that you think is incorrect, what do you believe the information should be and whatever evidence you have, and then we can at least respond. I don't think we can respond to just a general dissatisfaction. So we've described what that template is and part of the HHS will have how someone can make a request like that. I think as we've gone through this I think there will actually be instances where we would not disagree with the requestor. For example, if they say that you should have more recent information, the information you have is two years old, we probably wouldn't disagree. But again, we don't have the resources and in some cases it's not physically possible to develop the information that quickly. In other cases we would agree that the survey should include state or data estimates, but again, that's a resource issue. At any rate, those will be up and we can brief the committee fully on that.
Let me mention quickly two more things. Remember that the National Academy of Sciences is conducting a study sponsored by HHS to look at the adequacy of race and ethnicity data in health and human services. This is not just the HHS data systems where I think we already know a lot and we know what the issues are there. But it's helpful to look at the practices and policies of private health care providers, plans, and insurers to see what the barriers might be, what the needs are and what the barriers might be for improving race and ethnicity information there. Again, they're talking about medical records, claims data, health plan information and it's not all that, there isn't necessarily all that much information there. A work shop is being planned under the panel, Dr. Lumpkin is one of the members by the way, Dr. Ed Parrin(?) is the chairman of the panel. They are planning a workshop to look at exactly this issue of private sector practices and policies so if you know of any thoughtful and knowledgeable experts in that area again, it's not so much research or statistics, it's what actually happens in health plans and hospitals, doctor's offices and insurance companies in terms in race and ethnicity information. Is it collected, is it not collected, why are they collecting it or not collecting? Do they think there are barriers? And so on.
One final report and I think I will just give a brief report now and then update the committee later. We are about to unveil I think in October our HHS web-site that basically is a gateway to all of the HHS data and statistics. We were asked to pull this together by the department leadership so that we could create a user-friendly web-site that will give you access to virtually all of the statistics, research and so on that HHS agencies produce and have on the web. This is limited to what agencies have on the web. It's meant to be a one-stop gateway, it includes our policy research reports, it includes the META directory of our HHS major data systems and statistics. It includes short cuts to our major data systems and it includes a link to the NIH published literature and research in progress. It includes links to the NLM web-site and we actually have developed a feature that provides search capability so if you're looking for youth, smoking, information on youth smoking, health insurance estimates in the states, you can use that information, it's kind of like -- well you can literally put this in and it will list virtually every web-site that HHS sponsors and states as well that relates to Health and Human Services data on that topic. We also have a feature that takes you to state health data where there are web-sites. I better stop there, I promised to yield some of my time to Richard.
Dr. SHORTLIFFE: That sounds like a very big project, what you've just described. We were just commenting that that's impressive especially if it searches across all those sites.
MR. SCANLON: It's been in development for about 18 months. We did a test internally and then we did a kind of a larger test within HHS but now we're going to take the Microsoft approach and we're going to issue it and let you guys test the rest of it.
DR. LUMPKIN: Just very quickly, if the new members who arrived, if you could just introduce yourself so people listening on the internet will recognize your voices.
DR. MCDONALD: Clement McDonald from Indiana University and Regenstrief Institute.
DR. MAYS: Vickie Mays, University of California Los Angeles.
DR. LENGERICH: Gene Lengerich, Penn State University.
DR. LUMPKIN: I think we're next on the agenda. HIPAA privacy. Richard?
MR. CAMPANELLI: Thank you. Well, everybody, I'm Rick Campanelli, I'm the new director of the Office for Civil Rights at the Department of Health and Human Services, which as you know is the entity that's primarily responsible for promoting compliance with the HIPAA privacy rule. Thank you very much for the opportunity to be here today. We are grateful for the work of this council and its subcommittees and the role it plays in helping to inform and advise us and the department of concern in many areas and particularly this area of the privacy rule.
In being here I hope to communicate that the department both invites and values your input and I want to address that specifically at the end of my remarks today. Our goal in moving forward with the compliance activities now is to protect the rights of individuals to their personal health information and to do so in a way which doesn't create undue barriers to health care. We can talk about that in the context of the rule as you have time after this. I know, among other things, and I've been asked to specifically focus this morning on these compliance activities, and that this council is focused on those issues, on the importance of public education and technical assistance in assisting the health care industry and individuals understand what the privacy rule requires and what the rights are.
So I'd like to focus on two things this morning. First I want to emphasize that we at OCR and the department are quite focused on the public education need and voluntary compliance. It's in our interest to be focused on that and I'll talk about that. And I want to identify the specific efforts that are underway along that line, and second to talk a little bit more about how we might invite this council's comments and participation more effectively.
First just context, as we all know in February of this year the department went out with an NPRM, -- Proposed Rulemaking, announced proposed modifications to the privacy rule. We received about 11,000 comments and including comments from this committee, the final modifications to the privacy rule were issued on August 14th, that was an entire two weeks after I arrived at the department and it's been a great ride since then. Many important recommendations of this committee are reflected in the rule and I'll talk about how you can readily access the rule and comments on the final mod, I'll mention it now, you can go to our web-site, I'll give you the site to the web-site later that gives you some good information about that.
As I mentioned and as the secretary pointed out, when the final mods were issued for the first time the regs implemented a fundamental federal framework and foundation that establishes the rights of individuals to protection of their personal health information and we hope and expect it establishes a workable framework that doesn't erect these new barriers to health care.
How are we going to get the information out about that? How are we going to promote voluntary compliance? Let me focus on some things because we've moved quickly now with the issuance of that rule to really give the full weight of our privacy focus on this compliance effort.
First, you should be aware that imminently, by which I mean in the next few days and I think the main impediment right now is when does the web-site go up in the next few days that Jim was talking about, we are going to issue FAQ's which are responsive to many of the comments that we've gotten on the web-site and our 800 number. So you can be looking for that in the very near future. This should be of interest to both covered entities and individuals.
Second as you may recall, OCR's web-site had privacy rule guidance up on its web-site which reflected the original version of the privacy rule. When the privacy rule modifications came out we took that guidance down and are now updating it. We've made great progress on that, we expect to get that guidance out in the next month. It's in the clearance process that Jim also talked about in the department and we expect it to come forward quite soon. I think that will be helpful. It's on particular topics of very significant interest that both were identified before but updated. In both this area, the FAQ and the guidance, we expect this to be a process where we provide updates as time goes by and we see how we can more effectively help. That is an area where this council and subcommittee can help, too, help us identify what areas need to be addressed.
We are just again imminently to post a very helpful flow-chart that's been developed in the department called, I think it's entitled, Who is a Covered Entity? It's a flow-chart where you can go through and work your way through, it's being made Section 508 compliant now so it's accessible, I think that will be a wonderful asset that we have had lots of comments and questions about that question, who is a covered entity. I think that will be helpful. All of that you can, or soon, will be able to find at the OCR web-site, at www.hhs.gov/ocr/hippa.
Other things that are available at the web-site are a fact sheet on the modifications which is a helpful quick summary if you want to compare and identify what the modifications were. There's also for instance a sample business associate contract, sample provisions, that are helpful and responsive again to requests by many business associates and covered entities about how do they establish that relationship.
Another significant area that we're going to be engaged in, we are now in discussions with the general contractor to produce a variety of technical assistance documents that address targeted areas. Again, there is a good deal of flexibility here. We've identified targeted areas like consumers, health plans, hospitals, physicians, including smaller providers, state and local agencies, business associates and employers. What we're hoping to do is produce very readable, readily accessible, not unlike some of the private counterparts requiring a great cost by those together, stuff that's available to the public and really responsive to targeted needs. We are talking with the contractor now, that's going to be a few months out before we get there. Your specific input could be helpful in focusing where that arises and I know the subcommittee has had one hearing, it's going to have two more hearings, to gather this information.
Other technical assistance, we're engaged in outreach, I'm going to steal a little CMS thunder here, but they get most of the credit for it is that they have established, they have phone conferences in various of the HHS regions and most of the HHS regions to make broadly available technical assistance opportunities and OCR is participating in those. The secretary's regional directors in five of the regions right now where this is targeted are going to try to provide a conference with, and we're looking at what is the broadest outreach we can accomplish with these conference? The secretary's regional directors are going to do that. OCR and other elements of the department are going to be available to provide information in the various locations. One-day conferences, we're looking to partner with universities or others who can help us get the word out as best as possible.
I'm rushing because I know we have a limited timeframe for this but I just, let me just mention a few more things. This is part of our overall strategy of outreach. I was talking to Mark Rothstein before the meeting about how we are trying to identify what are those private speaking opportunities where we can really have our candle lit and be most effective in reaching the broadest segment of the public. We're working with the states, I know that a concern is how our states and local governments covered and what can they do to meet their obligations and to get information out, we have met and our meeting with the representatives and national Governor's entities and similar entities in the next few months.
I guess I'll just pause and just mention that internally what we're doing at OCR is we are providing training for our own privacy specialists, we're bringing them in, there are going to be privacy specialists in each of the HHS regions around the country so they are more readily accessible and we can enhance the, we're going to staffing up further in our own office. I might mention today, Kathleen Fyffe is with me today who has served on this committee and I know you all know and were grateful for Kathleen's work, she is giving me time, she said she'd let me take the entire speaking opportunity today, she's letting me swim with it.
Anyway the summary of all this I think is really that, let me just emphasize, we are aware of the need that's out there and we're trying to really marshall our resources in a whole variety of different ways. I think perhaps you weren't aware of some of the things that are about to happen in the very near future, these FAQ's and the guidance and the very specific things I mentioned.
This really brings me to my second and final main point, which is that your comments are important to us and I'm here, I hope my presence here today suggests that I, we, the department and I, we want to hear the comments, we know that on your agenda is reviewing and providing a letter to us which we will certainly look at closely. I hope I've also demonstrated today that we are clearly focused on the importance of and the need for technical assistance and public education in this regard.
One thing that I would say that would be helpful is, given that we are aware of that need, the particular emphasis and help you could give us as you're thinking about providing comments or input to us is to give us the benefit of your advice of specific needs or specific audiences that you think really need our focused approach. As I said, we've done a lot, we think we've done a lot in that way, we're going to be doing more, and we have an opportunity now to target and tweak what we'll be doing over the next month and we're going to try to remain flexible so your input right at this time is particularly important.
Just one last point is that I, just before taking this job, I happened to have a check-up with my family doctor who is a good friend, has become a friend over the years, and I had sort of ambivalence I must say about telling him that I was becoming the director of the Office of Civil Rights which was charged with compliance in this regard. So I was curious about his reaction. He did have a cold stethoscope in this hand but he didn't hit me with it or anything. It's interesting, he's a great guy and he said to me, Rick, we have long been concerned about the privacy, our information in our office, we are concerned about how to comply. It was before the rule became final and he was concerned at the time about the whole consent issue and whether there would be pre-authorized requirements of individuals to pre-authorize the disclosure of information externally for treatment purposes. And I was able to say go to the OCR web-site, you'll see that the NPRM suggests the change may be coming and he seemed really -- the key thing though that I see, there is a person who is a small provider who needs good information and wants to comply. That's the person who is sort of in the middle of my target, or those kinds of things, I see the importance and I just want you to know that I see and the department sees the importance of being able to provide good information to a person like that so they can understand their compliance.
It's also in our interest and this is my concluding thought. It's really in our interest, my office particularly is charged with promoting compliance with the HIPAA privacy rule. It's certainly in our interest by the April 14 compliance date to have has many people fully aware of their compliance or other responsibilities that will minimize the other compliance or responsibilities we have. We're pulling out the stops to make that work.
So thank you for this time, and I'll be glad to take questions as time permits, I know that you have others on the agenda.
DR. SHORTLIFFE: Thank you for the overview. You've inherited some real challenges obviously. There's an issue that I've been observing at my own large complex, health care organization and I wonder to what extent this has been recognized and is being addressed? There is of course, a strong desire -- I'm at an academic medical center, our academic hospital is very concerned about understanding and properly complying with the new rule and its new form. And has, as most places, have hired people and there's quite an investment going on to try to make sure they are appropriately responsive. But time and time again when a question arises they seek legal counsel, they go to the lawyers and they say help us to interpret the rule and tell us what we should do. Wwhat concerns me is that that same question might be being asked of different lawyers at different institutions around the country and they are not all giving the same answer or the same interpretation. Of course, therefore, this is the one rule with presumably a uniform intent and yet I am quite concerned that we may be seeing rather different interpretations and responses and practices actually put into place because of the interpretation process that seems to be built into the way in which organizations are trying to deal with this. I assume there is recognition of this problem. What centrally can be done on the part of OCR to try to provide a kind of more uniform interpretation process? Is it just FAQ's, do we tell people don't go to your lawyers, submit a FAQ, they can go up on the web-site? Some how or another, I don't think that's the way these kinds of organizations are going to deal with this problem. I just wonder how you are wrestling with it and what advice I might give even at my own institution about this.
MR. CAMPANELLI: Well, it's a great question, and as a lawyer I have never uttered the words don't go to your lawyer. But I obviously, anytime a rule, never mind a complex rule like this, is issued, the goal is, it's not uniformity, it's consistency all the way through. I might mention particularly with regard to this rule, the rule establishes a federal framework, or a foundation, and it recognizes that state law may be more restrictive or more stringent is the word used in the rule, at various times and so there will be variations according to what obligations an entity must meet according to the state they are in depending on what the state law is.
DR. SHORTLIFFE: Ok, I agree with that but I'm really not talking about places where the state may intervene with its own interpretation but really where they are just trying to interpret the privacy rule as it is currently.
MR. CAMPANELLI: Right, I meant to get to that. I think you're describing a very important need and I think it's a common need that happens whenever a regulation is issued. It's just that this has such broad impact that your question is particularly pointed. What we can do, what the department is doing in various ways by putting out these FAQ and the guidance is to try to, as much as possible over time and it will increase over time, provide the kind of guidance that certainly guides individuals but also will guide lawyers, who we know are looking very closely at these issues and will promote consistency ultimately. It's the beginning, or we're somewhere down the road at the early stage of a very long process and so the more we can be helpful in that way in providing guidance and being responsive the better off we'll be. I can't say to you that I can think of another way that we can affect the responses of lawyers throughout the country, but I think the only thing we can do and that we are trying to aggressively do is to provide as much guidance as we can which will promote consistency.
DR. SHORTLIFFE: Would it be helpful to aggressively seek the legal counsel that are being asked these questions? To basically share with you the questions that they are being asked to address, is there a way to sort of publicize the need to understand where the quandaries are that are going to lawyers? I don't know if that will be useful or not but it just occurred to me that if you could bring them in centrally it would certainly help fill up the FAQ part of the site I suspect.
MR. CAMPANELLI: It could, it would. That's really what the whole, it's both what the public comment process is like and we received comments you can be assured from many lawyers and we've received requests from lawyers who were concerned with the industry trying to come up with this guidance to help identify particular areas. That's partly what's guiding how we decide how we prioritize with FAQ's we're responding to, what guidance we're putting out. I can assure you that process is going on and that we hope that the web-site and other opportunities and this opportunity as a good example are where we can invite comments. I and Kathleen and many of us are out there speaking, doing a lot of speaking, Karen Trudel is also, and we're hearing these kinds of requests, and we are inviting that kind of assistance, so thank you.
MR. ROTHSTEIN: Thank you very much Rick. We appreciate your coming here this morning. I just have one brief simple question. In our March letter to the Secretary, commenting on the proposed modifications, the committee recommended that after the final modifications were published that OCR prepare and publish an integrated rule, in other words, so that people don't have to have the proposal and the modifications and the guidance, to make it easy for people to do. I was wondering if that's in the pipeline or where that is because it would be very helpful to the folks out trying to comply.
MR. CAMPANELLI: Great, and it's the kind of question I love to answer, because the answer is well yes, we have it. We have actually prepared the integrated rule and we are in the process of trying to work it into the web-site to get it up and running. But we have focused directly on that problem. We've got the text of the integrated rule and now it's just a question of getting it available and that should happen soon, I didn't mention that before. Thank you.
DR. MCDONALD: A couple different things. In defense of lawyers and things we've done, I'm not being solicitous, things we've done in Indianapolis with a lot of complicated issues, the typical reaction to ministrations is no and burn the tapes. They are very nervous, not necessarily specific to Indianapolis, but they are extremely regulation conscious and extremely worried about everything, and the easiest answer is no, which does not make easy progress. The lawyers often clarify things and make it --, making up stuff, that they really do see to the extreme evil end of any kind of outcome and I think overreact, so that's a good thing for lawyers. But the second thing, you mentioned about the frequently asked questions and this is sort of a spin-off of Ted's questions, is there a place that people are asking that you count the frequency? That is, do you have a place where people can ask questions on your web-site and thereby find out the frequency?
MS. FYFFE: Yes.
DR. MCDONALD: You do. The follow-up on that is, how does one handle the things that are really kind of really unusual or novel or new and aren't easily, they don't easily fit into the various cubbyholes of the regulation? Can that be done through the questions too, the web-site?
MR. CAMPANELLI: That's a more difficult question because obviously we're trying to prioritize our responses to reach the most significant issues, not necessarily the greatest frequency issues, but the issues that are of most significant concern and trying just to prioritize. Which are the right questions to answer to be of greatest assistance? We do have occasionally idiosyncratic questions, my favorite question I was asked so far is do I have to read this? I answered yes, you do. But it is difficult, but how we're handling a lot of the questions that come in to our 800 line or otherwise will be we expect that to increase, is we have our folks available where we can respond individually where there's a particular question and we are occasionally referring, and will be doing more so, referring some of the questions out to the regions where these can be handled. That is a balance really in terms of the FAQ.
DR. MCDONALD: Another way to ask this question, is there a way to get a ruling on these issues that might be complicated and difficult? I know in some other things we have tried with CMS in its previous name that for issues about -- billing and legal we could not get a ruling. They'd say well, it looks ok, but we still might kill you when you do it. It seems like sort of a bad game for us. So there's not a way to get a ruling?
MR. CAMPANELLI: Right now there isn't a process for providing that and our anticipated approach right now is to push for being as responsive as we can in the guidance arena and the FAQ arena.
DR. MCDONALD: One last suggestion, question, and I've suggested this in comments about the document. I've read it and I didn't read the last one and I tell you, you've forgotten the beginning by the time you're finished the end if you don't have really good long-term memory. But the most helpful thing I think you could do in that is what's really hard to do is figure out what qualifies what and a simple table, because there's like four or five, six, seven, or eight different cubbyholes, public health, government trials, there are things that have special exceptions and it's very difficult to track what trumps what in these different areas. So you've got these different categories and you have the different things it applies such as, now I've already forgotten after reading the whole thing, minimum necessary, when does that apply and there's a whole bunch of these things, treatment, I've lost it. I think treatment's kind of pretty open, the next one gets knocked down somewhere but which things do you have to watch out and deal with.
MR. CAMPANELLI: Just briefly it's always a challenge to say what is the clearest way we can get the information across and I certainly recognize that it's a complicated and complex rule. I think we are thinking, for instance, the Who is a Covered Entity thing we're put up on the web does exactly what you're saying. It moves you through a process and where we can do that we will. The other approach we're going to take is in these targeted publications and I'm not sure whether it will be a chart or checklist.
DR. MCDONALD: This wouldn't be to replace it but it really, when you read it there really are like seven or eight cubbyholes and there's like eight or nine different things that apply. You wouldn't have to say it but it would give people an idea of what to read and where to find things. I tried to do it, I actually did do a little bit of it going through it the first time just to keep track, but I really think it would be tremendously valuable. I don't think it would be that hard, it would a week or two weeks of somebody's time. Not to say that this is the rule but these things apply to these things and then they can go to those sections to read and find out the details.
MR. CAMANELLI: We'll look into that, how we could do it, if you could identify the particulars where --.
DR. MCDONALD: If guess if I can dig it up, I'll dig up my draft tables I was just trying to figure it out myself.
DR. LUMPKIN: I have a quick question and then we'll have to move on. Illinois, like many other states, is in the process of completing their studies on preemption that will generate a number of waivers and the question is, are you ready for those waivers to come through?
MR. CAMPANELLI: The waiver requests?
DR. LUMPKIN: Right, because obviously various entities doing business in Illinois for example would like to know what the rules are and those won't be clarified until we finish our preemption analysis and then get the waivers approved or not approved so they know which one of the little state rules apply and don't apply. It's probably more of just a heads up that that's something that is going to be coming through and it may not be hitting any volume but I suspect the closer we get to the compliance date more and more states will be starting to say we need to send in those waiver requests.
MR. AUGUSTINE: One quick question. Is there any effort underway to create some type of national database on privacy statues? I know HIPAA has kind of raised the bar in the awareness, I know a lot of states are starting to take this up. Is there any effort to kind of compile that information?
MR. CAMPANELLI: We are not engaged in -- I know that there are numerous entities out there that are trying to do that and I've seen some that are made available but we haven't reviewed them ourselves.
MR. SCANLON: I think the Georgetown Health Privacy Project has actually looked at all the state laws, well, that's a very difficult thing to do and they've got a web-site where they've tried to do a compare and contrast, but it's very difficult because it's usually not one statutes as you know.
MR. CAMPANELLI: And it's a moving target.
MR. SCANLON: Exactly.
DR. LUMPKIN: Thank you very much. Karen?
MS. TRUDEL: Thank you. I'll be as brief as I can, I realize the committee is running late. I want to talk about three issues. One is regulations, another is the compliance extension requests that we're receiving and the third is the outreach efforts that are underway for the administrative simplification transaction and codeset part of HIPAA.
As far as the regulations are concerned I would be a lot happier if I could say that the status has changed since the last time I was reporting to the committee. We have not published any additional final rules. We are pushing most expeditiously the modifications to the transactions and codesets which include the issue of the national drug code and the modifications that came through the fast-track process that was recommended by the subcommittee on standards and security. Second behind that is the security regulation, again, we're pushing very hard on that final rule. The remaining regulations are still in the process, still moving, and I have come to the point that I do not make estimates of publication dates at this point.
Moving on to somewhat better news, the extension requests. The number that we're receiving has taken a sharp upturn, we're now receiving about 7,000 a day electronically and that's during the week, we get about a 1,000 a day on the weekends. So altogether we have almost 200,000 I believe at this point, somewhere around 13,000 on paper. We're definitely making progress in the right direction.
As far as outreach goes, I'd like to build on some of the things that Rick said. When we started to do outreach for transactions and codesets we first did some focus groups and we found that the people who were most starved for information about HIPAA were small providers and that is where we targeted our fiscal year 2002 activities in awareness with respect to small providers and especially rural providers. We partnered very heavily with our regional offices, our ten regional offices have done an absolutely outstanding job of going out and getting the word out. We challenged each regional office to do an outreach event in every state by September 30 and some of them went way over and above that and did numerous outreach events, it's been absolutely wonderful. The most recent one I went to was in Indianapolis, it was last week, and there were about 400 people, about 100 people more than they were expecting, about 400 to 450 people, to hear a very basic this is HIPAA, this is what you need to do, these are the pros and cons, this is how you go about it. The feedback we've been getting back from the conferences has been truly wonderful.
We've also, as Rick mentioned, provided to our regional offices the ability to do regional audio conferences. Each region had the opportunity to do two. We're also doing audio conferences nationally, our last one which was in August got almost 2,000 people at the point of greatest participation and our next audio conference will be on September 30 and we're hoping that OCR can participating in this one as they did our last one.
Our hot-line is receiving three to four hundred calls per day and I think that indicates that we are getting the word out as far as awareness is concerned, we are getting calls, people saying I just heard I have to file this form how do I do it? I just heard about this HIPAA thing, what is it? Can you tell me? So in a sense the intent of having covered entities submit the compliance extension plan is definitely working.
As I said our next round-table is the 30th of September and I just one last thing, to sort of address Ted's question about how you get consistency of message, of interpretation across the nation, obviously it's a wonderful goal, it's something that we are never quite going to get to but we have found with respect to the transactions and codesets that one of the best ways we've been able to do that is through the Strategic National Implementation Process, the SNIP group, because what that does is it provides a very broad open voluntary non-product linked forum for some of the best thinkers in the industry to sit down and try to hammer out some best practices, to develop white papers, and as an example of that with respect to transactions and codesets, the SNIP group has published several white papers, one on how to sequence the transactions to implement them and another that talks about different levels of testing. And not everyone has by any means espoused these best practices but they are available and they are serving as kind of a de facto best practice for people to at least think about and see if it makes sense to them. So I think the inclusion of the national organizations in this sort of process is very helpful.
DR. LUMPKIN: Are there any question?
DR. ZUBELDIA: Karen, at the rate you're getting the ASCA extensions of about 7,000 a day and it's assumed that's going to pick up a little more, you're going to get probably about 400,000 extensions. Is that what you were expecting and if it's not what's going to happen to the others?
MS. TRUDEL: Kepa, that's really hard to answer because we never had a really really firm handle on the denominator part of the equation. I think we, and it was probably to our benefit to do this because it’s the conservative risk averse way to do it, we assumed that there were going to be an awful lot of covered entities. We assumed pretty much that all physicians might need to do this, and in many cases they don't. A lot of the calls that we're getting on our hot-line are from people who only submit paper claims, they are very small providers, they're not actually covered entities, and so I think that was something that we weren't able to estimate in any comfortable way before hand. I'm feeling cautiously optimistic that we will be in a pretty good place as of the middle of October.
DR. LUMPKIN: To follow up on Kepa's question, I wonder if it might be of some value to conduct, obviously to an intermediary so there would be no regulatory implications to this, a study, in some randomly selected communities that would identify the people who did apply for waiver who might be covered entities, so that universe, that denominator could be defined. The question, I think it's a pertinent question, if we have 400,000 waivers does that represent that maybe there's 400,000 covered entities and another 100,000 who think that they're in compliance and then an X number of how many who aren't in compliance but didn't bother to do the waiver. At some point that universe might be useful to define.
DR. COHN: I think that universe is in some ways a difficult issue only because I think some people, and we saw this at the privacy hearing, are wondering whether they are covered entities or not still, so it's an interesting ongoing issue. Karen, I actually just wanted to congratulate you, I think you're doing a great job and I think the work to inform the ASCA as well as inform the industries is going along very well at this point. We will certainly be talking about it at the subcommittee.
I actually just do want to mention to people in implementing privacy that there are obviously a lot of very good practices that you should be looking at as you figure out your own implementation strategy. I think the good and bad news of course is that with electronic transactions we're given a year extra to really handle this whereas you are in an eight month implementation timeframe. I think that's going to be a little bit more of a problem but Karen, I really think as I look at what's been going on with the help desks, the answers, the publicity and the ease that people are having asking for extensions, I'm relatively optimistic. Of course, the hard work is going to be between October and next October and maybe you have some comments about that, about how we're going to assure satisfactory implementation in another year and a couple of months.
MS. TRUDEL: First of all, thank you and I'll take that back to our staff, especially our regional offices who have been on the road more than they've been at their desks for the last few months and I'm sure they'll be looking forward to a little bit of a breather after October 15. One of the things that we're doing, in fact our associate regional administrators are meeting right now in Baltimore which is why Jared Adere(?) is not able to be here today, one of us had to stay there for that meeting. They are helping us to craft a strategy for fiscal year 2003 for outreach and what we are thinking in a preliminary way is that we are going to move beyond the hey, this is HIPAA awareness and file your compliance plan into a little bit more robust technical analysis, providing covered entities with check lists of things that they need, providing somebody suggested a count down to HIPAA where we provide information each week or each month between now and the compliance date in October 2003, so those are the kinds of things that we're looking at. And also, within CMS how we measure our own compliance in terms of the state Medicaid programs, managed care plans that do business with us, and our own fee for service contractors.
DR. LUMPKIN: Great, thank you very much. Simon and Doug?
Agenda Item: Consolidated Health Information (CHI) - Update
DR. COHN: Well, let me just introduce this very briefly and then I'll hand it off to Doug since we're I think running a little bit late, a half an hour late at this point. I will be very brief. I think as you all remember at our last full committee meeting back in June we were introduced to the Consolidated Health Informatics Initiative (CHI). At that point we were asked to be sort of an advisory committee to the initiative and particularly the subcommittee on standards and security has taken on that mantle. In August we convened a hearing that included the CHI and other non-federal consortia that are working to promote standards and improving our operability in health care IT. I think it's apparent to all of us to ensure that we have interoperability in health care IT we need to have both the federal activity and private activity sort of converge on the same standards and approaches. It's not going to be very useful at the end of the day if the federal government has a set of interoperability standards which are a little bit different than the private sector.
I think the good news is, is that at this hearing we heard wide-spread interest both in the issue, fair amount of sophistication on their standing of the issue, and I think we saw that there were many opportunities for synergy between CHI, private consortia, as well as of course the NCVHS in moving this forward. We also heard I think wide-spread support for the NCVHS recommendations that we had made both in the year 2000 and more recently and having that serve as a basis for moving forward. I find the comment, at least to my view, I think we heard a fair amount of confirmation of the current priorities and approaches that the NCVHS is taking in relationship to next states of PMI standards. With that, Doug, it looks like you've now assembled your group for the presentation, and obviously this presentation is going to go into a lot more specifics about learning and I think some questions that came up from the August hearings. So Doug would you like to introduce your team?
MR. GODESKY: Thank you Dr. Cohn and Dr. Lumpkin and the full committee for having us here today. I'm here with Gary Christopherson, the chief information officer for health from the Department of Veterans Affairs and Dr. Robert Kolodner, the association chief information officer for health again from the Department of Veterans Affairs.
The Consolidated Health Informatics project as one of the 24 e-government projects sponsored by OMB has found itself with the Department of Health and Human Services, the Veterans Administrations and the Department of Defense as key partners and I have Dr. Kolodner and Mr. Christopherson here today to help me give you this update.
What we'll do today is run you through a very quick update on what our presentation in the public hearing was about, what we heard others were doing, the questions that came to us during that hearing and then move into a discussion about the next steps and assistance from the NCVHS and partnership we can have with you down the road. Thank you.
MR. CHRISTOPHERSON: John, good to see you again. We had dinner one night to talk about some of this kind of stuff not too many months ago, so it's good seeing you again and Simon as always, since we tried to develop partnership with Kaiser and develop anything -- as a matter of fact. Let me just go through a few things. Next slide please.
Let me walk through two parts, one I want to talk a little bit about CHI and it's sort of a collaborative effort that's come together between HHS, DOD, and VA, we've got some DOD counterparts, Lois is here from DOD as well. Let me walk through that and then I'm going to walk you through a little something called HealthePeople which is an initiative that we did which really brought ourselves into this partnership.
Again, the key is, when we started out looking where our common interest was between HHS, DOD and VA, was we felt the need to share health information. That was clear when DOD and VA came together on there, when Jared and the group came together and we're talking to OMB we clearly felt that was the case. We wanted to try to do this to enable this. Next slide.
We clearly wanted to try to deal with this based on the electronic and interoperability standards. This is really we saw as key and worked this through in a fair amount of effort in DOD. Some of you are aware, by the way, there's been a lot of interest from a lot of different parties, Paul Tibbits(?) was here from the Presidential Taskforce has been one of the interested parties, Congress has been an interested party, how VA and DOD communicate, and some of us who have been in both organizations have always had an interest in how we can share information back and forth and improve patient care. Next slide.
What you look at when you got the partnership is rather an interesting potential. First place is a lot of crossover here with the actual committee and the people who are involved there in each of the agencies, but you're really bringing together three of the biggest players, HHS which plays a number of different roles with the Indian Health Service, with Medicare and Medicaid, CDC and other folks at FDA, you clearly have two of the biggest providers in the country, which is DOD and VA, both roughly in the neighborhood of $23 billion health care organizations, put you up in the neighborhood of the Kaiser's of the world and a few others like that. So again, it was very key that these come together. What I am going to talk about in a second is that some of the principles we pulled together is to how we work were very key and I want to come back to that so we can draw that a little bit home.
The other part was it gave us access to a great amount of talent throughout these three organizations and the reach and beyond that to state, SSA and GSA as well. Next slide.
The key thing we're trying to do here and the four key elements is, how do you adopt for health information interoperability standards, a vocabulary that includes specific health data models and communications standards. That was the key driver. A little bit later I'm going to come back to some discussions that Kaiser and we and the Institute of Medicine had about a year ago. along this line. Clearly as we talked about in your previous discussions, we're trying to be sure we're aligned well with HIPAA, once we offer the transaction records and code sets, security and privacy is an issue to HIPAA, so we're really trying to bring all that together in what we're trying to do.
I think we're really also trying to change the culture. We'll come back to that a little bit more, but we're really talking about two things. How do you get standards out there so we can exchange information, but very honestly there is an underlying sort of infrastructure of systems out there that need to have -- or others this doesn't make a lot of sense in the first place. That's something that I know in particular CMS has a lot of interest in. Next slide.
So again, the key that we are looking at here is to adopt common standards amongst the federal agencies. We've already begun that, DOD and VA have already worked out the first three standards, which is LANK(?), X-12N, and HL-7, was our first three out of the box, more coming. Very key about, by the way, is we want to make sure we weren't disconnected, so all these relationships, these threads we have with you and a whole lot of the other standards development organizations say, when we do this we're not building in isolation, we're just really kind of adopting the most obvious, the best there, building that talent, we're not trying to create new paths we're really just trying to put our force behind all this effort as well.
Clearly we're talking about not just with us, but we have a high interest in what's going on with other public agencies, we've got some competition going on with state agencies for example, about what they maybe are doing there, local agencies, including public health, we're clearly into what the private sector is doing, a lot of this discussion came out with conversation with the American Hospital Association and others, and we just have to sort of walk through all these different groups who are now starting work in this issue here, the key thread here is to do that.
It's important for a number of reasons. If you look at some narrow interest for DOD and VA, DOD is buying at least $3 billion a year in care in the outside world. Very difficult to exchange information. We buy about a billion dollars of care a year in the outside health care world, plus we have all our affiliate members, our university affiliates. So there's a high need to try to figure out how you work with both public and private sectors outside of our immediate interests there.
The other point which comes into play and there's a lot of discussion about this back in the October meeting as well as all the subsequent meetings, that there was a need, that if the federal sector went forward with a common set of standards and if they did it smartly, which means they really were adopting what the SDO and others were trying to develop, that very honestly the federal government could become the tipping point. What is key about that -- actually I don’t think that is necessary -- I would probably delete those two words and say, it really is to try to create that tipping point working with the private sector. Just say, we do it, if we do a good job, the private sector says, why not? That's the road we're going down. Next slide.
So what I want to shift now is from the collaborative effort that Jared and Doug and Rob and Jim -- who is my counterpart at DOD, I've been working on, and sort of talk about a more particular case. HealthePeople is a term we adopted about a little over a year ago to describe the opportunities here to try and see, to move a couple things forward. The key emphasis, by the way, for those that follow why we name things the way we name them, the focus on health, the focus was a people orientation, the patient oriented, the consumer oriented kind of approach, and e was the nailer, the electronic nailer to all this. This really represents -- the meeting we talked about back in November. This was a meeting that Kaiser Permanente and Institute of Medicine sponsored out in Colorado, it followed on another Institute of Medicine meeting that I was a speaker at as well, and we said, if we want to get to paperless record by the end of the decade what would we need? How would we get there? What sort of necessary conditions? And we sort of got down to a very simple model of what we thought it would take, there's a whole lot behind it, but it's a simple model. We had to have common data and communication standards. That was really the key, if we didn't that the rest really wasn't going to happen because you really couldn't exchange records and that was key to the issue of going paperless.
And the other part you had to have, you had to have some good information systems out there. There was a lot of concern at that time, we had a lot of sort of the prestige health care providers out there as well, joining us, there was a lot of anxiety about the fact that the current health information system were either not adequate, not complete, too expensive, too hard to maintain, you can kind of go on and on and on. But the key point was we didn't have what we needed.
There was a lot of discussion with us and has been since that time as well about where VIASA(?) fits in in terms of the VistA system today and the HealtheVet-VistA, which is the next generation we're doing, as well. And we sort of took the stance at that time as part of our HealthePeople initiative that we were going to help in any way we could in VA to try to move this agenda forward. Again, part of the issue that we are doing with DOD and part of the issue we're doing with HHS and some of the issues we're now opening up with Kaiser Permanente as well, as sort of one of our big partners in here.
If we do those things, then the feeling was over the next several years you would see that adoption in part because whatever you need out there, the model health information systems is to get the private sector vendors to be more aggressive in what they are producing. We need to have more standards so we have the ability to move stuff back and forth, not just information, but parts of systems, laboratory plug-ins, pharmacy plug-ins, radiology plug-ins, all those kinds of things. So models, model interfaces, all those things are part of the puzzle. Next slide.
The strategy is very simple, it's how do we get to the standard of high performing systems, collaboration, working with consumer groups, developing standards in the areas of data, communication, security, looking at how we go about and actually get high performing systems, how do we get sort of enough critical mass of those, I don't think we need 100 but we probably need two, three, four, five good systems out there that we can adopt. Then we need in addition a lot of subsystems out there, people are developing pieces of the puzzle that will fit in. And we will argue, by the way, that there needs to be public ownership of at least one system, and at this point, the one that clearly fits that criteria is the current VistA system and the future HealtheVet-VistA system there. Next slide.
What I'm showing here is a slide that shows how some of the big partners are working together. What we're really saying here is that DOD and VA which have a long relationship are working right now towards a sort of convergence of their software applications and a convergence of data standards. In fact, we've agreed to go to identical data standards. Indian Health Service is going to join up with us and probably before all is said and done will go live on top of the VistA system when all is done here. And again, comments of the standards per the Consolidated Health Informatics kind of operation there.
In the area of Kaiser Permanente it's not a convergence of software systems, it's more a convergence again of standards, but also we're doing a lot of talking back and forth about how these systems work and how we can help each other out since we're both spending lots of bucks trying to build the next generation or implement the next generation of our health information systems. And then, by the way, there's lots of other players out there as well who are in dialogue. We've got states out there, the State of Maryland has an initiative that they're trying to get going through the Maryland Hospital up there, medical center, John's Hopkins, and others. We have people like Oklahoma and Texas who are showing interest in certain areas, and there's lots of party planning out there, we just did our first initiative with the D.C. Department of Public Health to offer them free software for the system. Next slide.
This is really my last slide but just to give you an example of one relationship that's being developed here. This is the VA/DOD relationship and in many ways this will be the first full instance of how the HealthePeople collaborative effort is trying to work. This is very key because some of you are aware VA and DOD haven't been talking a good period of time, haven't always had the best attraction there, Paul Tibbits could indicate the -- been concerned, others have been concerned, OMB has been concerned. About a year ago, we started to develop a potential plan for how we might work together and that plan resulted in the following. And again, it sort of serves as a potential model to look at how others may relate. We decided that we both needed separate repositories, that would be kind of what you'd see if you were also working with private sector agencies who have their own databases there to do. You want to have common federal, by the way we'd argue national kinds of standards for communication, security and data. You have to have an exchange mechanism and there's a couple different ways to play that game out before all is said and done. In the case of VA and DOD and likely Indian Health Service we started talking about shared software. There is some software that we don't really need to do uniquely that we can either build or buy, we can share other kinds of things, so we're really starting to work ourselves toward having a body of software that supports at least the public sector. The plan at least we're looking at right now at least in the VistA system here is to have software that would be available as VistA has historically been to be available to other public agencies, popular university affiliates out there, some places out there that don't really have the money, like community health centers, the tribes, and others who really need these things but don't have the money to actually do them. And the D.C. Department of Public Health is one of our first sort of tests of that model there.
But with that I'm going to stop and I think Doug you take the next part there.
MR.GODESKY: What the committee enabled us to do is assemble a panel of five organizations, one of which was the Consolidated Health Informatics. We convened a panel on August 29, and these next few slides will review what they told us and what some of our observations were.
The eHealth Initiative, they were a assembly of providers, suppliers, payers, manufactures, physician organizations, research institutions with a mission to improve quality, safety and cost-effectiveness of health care through information technology. They want to increase the awareness of IT's role in driving quality, safety, and cost effectiveness. They want to make the foundation for an interconnected health information infrastructure. They want to promote the adoption, develop implementation guides and share success stories. They want to build the case for economic incentives.
Connecting for Health, now the Markle Foundation's activity about three months old is again an assembly of providers, hospitals, employers, federal agencies are enjoining now, suppliers, researchers, standards development organizations, manufacturers, and consumer groups. The purpose is to catalyze national action for an interconnected, electronic health information infrastructure. They have a vision that we will have access to timely, relevant, reliable and secure health care information for providers, researchers, and notice in here consumers. Their goals is to drive better health and health care at reduced care with a structure of having a steering group with various working groups, in fact they have three working groups right now for data standards, privacy and security and professional health. Next slide please.
The National Association of Health Data Organizations, a non-profit to improve date uniformity and comparability, they offer technical assistance, and help systems survive and improve. This is a state organization, their membership are the users who promulgate reporting requirements. Their state budgets they told us were very limited right now and data is not a high priority in the state government budgets. Their data lacks clinical detail, and has inconsistencies in diagnostic and procedure coding, and they have many state-specific standards. The presenter often used a reference to 50 versions of a particular standard amongst all the states. Their goal is improving the ability to overcome the problems and fill the data gaps with NCVHS help and they saw the outpatient arena as having the highest level of public health activity but having the largest data gap for the state government.
And finally we heard from the National Alliance for the Health Information Technology Initiatives, award for the longest name I guess here. They are in the formation stage, providers, payers, IT technical companies and suppliers. Their view was that standards were vital to reforming quality and patient safety. Their mission was to mobilize and address the fragmentation that was out there, to improve quality through standard-based information systems. They were looking for outcomes of it being able to exchange data, have patient accessibility to the information, avoid errors and lower costs. Their strategy was to convene, go after real benefits, implement distinct projects, don't duplicate and work through a consensus approach.
The final slide I believe is our observations. Next slide please. We observed that all of these presenters for collaborative partnerships and there was membership overlap. They were all expressing the goal of seeking to avoid duplication which they acknowledge would be a challenge. They all wanted to lower costs, avoid errors and enhance research. They worked under similar structures, usually breaking off into working groups, very similar to this committee here, a steering group with many subgroups with emphasis areas. They wanted to enable a national health care information system infrastructure and adopt interoperable standards, similar across all the groups. They were all telling us the time is right now for various reasons and that mandates would not work was the message they gave us and they all expressed a willingness to help and work with us and to have, when they looked at the Consolidated Health Informatics project, I think they would express if appropriate a willingness for us to join them.
And with that I turn it over to Rob and Gary.
DR. KOLODNER: What I'm going to briefly summarize are a few questions that were posed to us during the South Beach subcommittee hearing. First of all there were questions of whether CHI plans to be a partner in the development of standards and use of standards in a number of areas. One by participating in the Standards Development Organizations and the answer to that is that in fact the federal agencies have a fairly robust representation at the SDO's and that we plan to continue to do that so there is meant to be a very close and robust communication between CHI and SDO's. In terms of joint other efforts, first of all with NCVHS help there will be coordination, but in fact, on a number of the groups that were listed, federal entities do have participants and oftentimes the same people who are working together both on CHI as well those other initiatives.
Questions whether we are going to be a partner in funding systems efforts and the systems are not within the CHI scope. One of the reasons for presenting the HealthePeople was to show an example of how the CHI activity is then used by the particular federal agencies and put into systems, but CHI itself is focusing on the data and communication standards not on the systems.
Finally, in terms of demanding interoperability in purchases, although we didn't answer it at the subcommittee hearing the intent is that after through CHI the agencies have ratified the adoption of various standards that there will be a time set after which all of the agencies architectures, IT architectures will need to begin compliance and therefore their acquisitions will be in fact incorporated into their standards so within the needs for the federal agencies.
One set of questions had to do with what the government role is in terms of the need for coordination, whether there is a role for the government to focus its energy in one direction and really we are building the same standards into the federal architecture, we are focusing the energies in a uniform manner. The idea is not to fragment but in fact to unify, a force that helps to move things forward as we mentioned creating a tipping point by the federal agencies adopting, therefore demonstrating that the standards do work in providers, payers, regulators, research environments, and in some cases being the earlier adopter and taking some of the hits in the learning and then being able to show the private sector it works and hopefully it will attract voluntary adoption of the private sector. Then also by CHI members who have participation in the other groups, as I mentioned.
In terms of specific assistance, some of which are similar to what we talked about with the committee back at the last meeting, the suggestions that we had were first of all, for NCVHS to provide periodic guidance and feedback regarding our directions and plans. Hopefully that isn't just at the meetings but there's actually communication going on in a variety of settings so that the standards we're looking at, the priorities we're setting, in fact align with the ones that the committee recommends and can bring to bear from background of each of the members.
Another area is to identify areas where new standards are needed where CHI ought to focus if in fact we haven't already targeted those or listed those as possibilities.
A third area is for NCVHS to help market the need for adopted standards to the rest of the public and private sector, that's something that I think the committee does all the time, every meeting, so I'm not sure that that's anything different than what you've been doing but certainly a force to align our efforts in that.
And partnering with us or being supportive of us and of the federal agencies, encouraging, requesting and helping us to move it through the various forces that are necessary in order for the federal agencies, not only to adopt but to implement those standards. And with that, I will turn it back over to Simon for discussion as we might have.
DR. COHN: Thank you, I think that's a wonderful presentation, a succinct summary of actually a half days worth of hearings. I would probably add to our next steps for the NCVHS, that I think as we saw at the beginning that there's a need for focus on how the intersection of work between CHI and a variety of private efforts are going, to make sure that things continue to converge. We recognize that that there's a, certainly it's one thing to come up with new standards or focus on the need for new standards, but there's a tremendous amount of effort that needs to occur to really do a good job with implementing currently existing or merging standards. We just sort of need to make sure that everybody continues to focus on those essential items as opposed to the words.
Now the subcommittee after the hearings sort of felt that it would probably be a little redundant at this session to have a couple of hours with everyone from the initiatives coming to talk, and I would mention that Himms(?) also testified, and I thought provided some very interesting and useful conversations and information. I think our hope was that this would be an issue that might be also included in future committee agendas where we take a couple of hours and hear from everyone on a periodic basis to make sure the people continue to be aligned lest some divergence occur. I'd be curious of what the views of the overall committee are on sort of that as well as the issues brought forward.
DR. ZUBELDIA: Thank you, this is a fascinating topic and I think it has tremendous potential. But a concern that I have with the HealthePeople initiative is that it, from the presentation and I haven't looked at any more detail than what you just presented here, is that it seems to be using the Microsoft method of developing standards, where everybody uses the same software and therefore it's a standard, and I hope that's not the case and that's a concern. If DOD, VA and Indian Health both converge into the same software, the same platform, and everybody does the same, that platform and software and standards that they converge on, has to be fully documented and open so the rest of the industry can also participate. I'm not saying it's about method, it's a very effective method because it creates a very powerful tipping point, but you also have to have it open for other people to participate in otherwise they will be forced to adopt your software.
MR. CHRISTOPHERSON: Let me come back to the point. First of all this is not meant to create the Microsoft of their, God forbid we should even think about that, what we're trying to drive is two things. First place is there was a lot of concern expressed at the October conference, that meeting we got together there, that they we're saying, well, we don't have one. There was a lot of unhappiness about the software period, out there. There was a lot of people who knew the VistA system well, those of us who know it really well, by the way, have other thoughts but those who knew it well, said gee, that's really great and we've been hit frequently by Congress and others saying why don't we just adopt this as a national system. We said no, we've been very explicit. What we've said is a couple things. First is you need to have some good systems out there, we want to show at least one and by the way we want to encourage software vendors out there to improve their products as well, I mean that's what we're really talking about, we really want to be talking about better standards because a lot of the things we are doing do require us to pull stuff in, whether it's laboratory equipment or radiology equipment or pharmacy equipment and software, and right now that's not so easy to be done. There is a lot of different interfaces, they are not standardized, I think that was one of the testimonies of one of the conversations that occurred during the meeting. The third part of it is the issue of data standards. If you have at least some good examples, you improve the software, you improve the interoperability of the standards, you allow software to plug in to each other so they can work well together there and you do the data communication standards, that's the combination that we think works well. There's an incredible amount, let me go back. Healthcare, at this point, remains a cottage industry in the information world. It's bits and pieces scattered around, some better than others, but it's still a cottage industry and when I sit down with a lot of the big companies out there who are looking at what the financial model is or economic model for them might be, I just say it's one-sixth of the national economy, it's a cottage industry, it remains one of the fastest and consistently growing parts of the economy out there, what part don't you get out of this? Why are you sitting here fooling around?
I want to go back a little bit, Simon had a point there, there are some key points about in terms of how the national committee and we can all work together. We clearly need the leadership of your organization here to help move forward the public private sector part, and that means not just here but it really does mean outreach kind of effort that goes there, not only your membership but way beyond the membership there. There was a point made in the slides about the fact, should this be done through mandates, we have argued strenuously against that and there have been some rather interesting discussions that have occurred around that theme. We have said from day one, it's about collaboration, it's about leadership, it's about being smart about how you do standards, and that's what's really going to drive the future of the train that we're trying to go on there. That's really what whether it's HealthePeople which is a bit broader in scope or whether it's CHI, which focuses on the data communication standards, consistent theme in all of those efforts is exactly what I just described here.
DR. COHN: Gary thank you for some very eloquent comment. I was also going to comment and make distinction between this model versus the Microsoft model. The Microsoft model is typically a closed standard. This is an environment where people are really trying to adopt open ANSI(?) accredited standards and make sure they are usable and put them into systems. I think the observation of course in all of this is, A, you have to have standards, I think everybody is trying to get ones that are well documented, are ANSI accredited, and are not private standards. I think there still remains an argument in the industry even now, what 12 years after the publication of the first computer based patient record document from the Institute of Medicine, calling for the computer based patient record by 1995, I think it was. I think we're all struggling to find usable systems that don't break the bank and improve the efficiency and effectiveness of the health care system. I think that the standards are a piece, but that doesn't solve the problem, it's only a piece of the problem. Anyone who can take standards, move them into a place where they can be replicated beyond the site and can show improved efficiency and effectiveness, I think we should applaud the effort.
DR. LUMPKIN: I think maybe it might be fair to make the analogy of the IBM PC model, where there are systems that are out but it's an open system.
MR. BLAIR: Gary, could you help me understand a little bit better what appears to be an evolution from the excellent work that was done by the GCPR project in terms of coming up with common standards and what appears to have matured into CHI on a broader basis, but I don't really, I'm not sure that I understand how that has evolved or if the GCPR is still in place or what?
MR. CHRISTOPHERSON: Very good question, by the way, because there's a lot of confusion about, let me go back a little bit in history, since I was there, as Rob unfortunately knows at the beginning, when the president sent out this little directive, it was the White House had called me and said what should we say, so I helped them say what they ought to say. GCPR has gone through a couple different iterations. There was clearly a part of GCPR that was trying to respond to a Gulf War related problem. How do you move information from DOD to VA so that VA clinicians could better take care of patients and watch out for patterns of problems that could be identified with unique illnesses related to particular deployments there.
The second question was looking broader than that, which was where might be want to go in about future health records and standards and this kind of thing. The latter one was probably a little before its time and got itself in a little bit of trouble because it was so big and no one could quite get their arms around it there. So what we did about a year ago, Jim Reardon, my counterpart and I, sat down and said let's deliver the first deliverable, let's get the DOD data over to the VA to do that. GCPR changed names, and now it's called the Federal Health Information Exchange, that system is now in operation, we have over 1.8, 1.9 million person records that are now available to VA clinicians towards electronic information that exists. There will be a little more data added into that as well and that's kind of the end of GCPR now FHIE, Federal Health Information Exchange.
The next generation, which is what we described here under HealthePeople, which actually HealthePeople Federal, which is really what the VA, DOD, Indian Health Service effort is about, is going the next step. It says let's talk about standards, let's put those into place, we've got agreement to do that, not just to talk about it but to actually do it and like I say the first three standards have come out of the box.
The other part we said is, but we need to start getting our systems to really be interoperable which means we have to figure out how to marry not just the standards, but the software to talk to each other, look for some economies in there, and in the VA/DOD/Indian Health Service base we started to do that. Look at, we're sitting down, application by application, database there to see where we want to work together, where do I want to actually go with a common application, where do we just want to be able to have application that can share information easily back and forth and in the end this model will create some of both. I suspect some of that may be true in the private sector world before all is said and done as well but again, data standards, the tools to do the exchange and better systems are really the three parts that really make up we've come to term as HealthePeople, and HealthePeople is the VA moniker because we really want to sort of push this term out and let's get people focused on what's this is about in the same way that we're now doing CHI for the data communication standards area. That's kind of the life span it's gone there. This, by the way, just to indicate also what's key about this in GCPR, there was always a question about who was supporting it and how much support it had. The HealthePeople Federal initiative now had the support of the Office of Management and Budget, not a small point, it has the support of the senior leadership of both VA and DOD, I don't think it has the objection, Paul, of the Presidential Taskforce, I'll leave Paul to speak to that point. But I think you've achieved here is now there is consensus this is the right way to go, we didn't have that before, we have a more realistic sense of what it's going to take to do it and we're building on existing building blocks, we're not throwing things out, we're really building on VistA, we're really building the best of CHCS-1 and DOD to build these tools.
MR. BLAIR: Can I ask a follow-up question on this if I may? Thank you, now that I have a better understanding of the role of CHI, can you comment on how the CHI views the recommendations that NCVHS put forth for the National Health Information Infrastructure?
DR. KOLODNER: We started with those Jeff and what you'll see, right now we're in the process of ratifying the recommendations VA/DOD have ratified but we need the rest of the federal agencies to go through their process and since this is the first time through we're actually defining a process as we go then we'll be able to release that from a CHI point of view. What I can say from a VA/DOD point of view since those have already been signed off on, is that for the most part we endorsed the standards that were in the letter from NCVHS. There were some slight modifications, for example, HL-7, we went with version 2.4 and above XML encoded and for Diecom(?) we specified that that was really for internal use because right now with there being some differences between whether the text information should be in the Diecom standard or with HL-7, we believe that that needs to be resolved before it's used for interorganizational use. So there are some small tweaks that are part of that and LANK is specified for test result names, so we basically clarified it in something that we could then endorse and use, but I would say that the overlap is 95 percent or above from what was recommended and obviously if CHI then endorses what will happen it's not only a response from HHS to NCVHS saying yes we agree with your recommendations, we're going to adopt it, but in fact, this would be federal wide.
MR. GODESKY: This is Doug Godesky again, Jeff to follow-up on that. One real strong parallel that the work of the committee has with the Quick Silver projects which CHI is one of, is OMB's director Mark Foreman(?) demands that our projects have modular results and that we don't duplicate, so we very readily are able to survive and be successful as an OMB sponsored project when we stick with those tenets to not reinvent things and to look for quick results, modular build upon one another.
DR. LUMPKIN: I think we're going to have to cut this off at this point. We're a little, well, we're a lot behind schedule so at this point we're going to do one other point of business and then we are going to take a break and come back with the report from the executive subcommittee retreat. I think we need a hand count of those who will be going to dinner tonight. So if you could, hold your hand up for a second -- we'll take a ten minute break.
[Brief recess.]
DR. LUMPKIN: Ok, let's get started. First item on the agenda is, I'm just trying to figure out where to put all these papers we got at lunch. The first item on the agenda is welcome Virginia Cain, you can introduce yourself on the microphone, we are live on the internet, just so people will know who you are, and welcome as our liaison.
MS. CAIN: Thank you, I'm Virginia Cain, I'm deputy director of the Office of Behavioral and Social Sciences Research at NIH. My training is as a demographer so I've been working in the area of health and demographics statistics for probably 25 years now.
DR. LUMPKIN: Great, welcome. The first item that we have after the break is to talk about the committee operations and strategy. The executive subcommittee met on July 26th this year in the Hotel Monaco. Perhaps the most significant event that occurred is that the evening before they were doing reconstruction on Wacker Drive, you had the single largest pour of concrete I think in the history and so people had to walk to the hotel, but other than that it was a beautiful day in Chicago and we don't have many mosquitoes downtown so everybody was safe. The committee had a fairly full discussion. Copies of the minutes of the committee meeting are available in the agenda book. Some of the issues that we discussed, we had considerations on looking at, following up on the initiative by the standards subcommittee on addressing issues of moving forward clinical standards and support on the approach of differentiating between those standards which we would recommend for adoption by HHS versus those that would proceed onto rules and wanting to make sure that we could expedite the processes as we've all learned that process can be quite extensive and time consuming.
We also talked about the role of the committee in relationship to the industry in identifying standards for adoption and the question was raised wouldn't it be maybe a reasonable thing to have a consumer representative on the committee as we begin to proceed with adoption, particularly following up on the work of the NHII work group which is addressing issues related to the personal health record.
We had a fairly extensive discussion on the issue of populations versus population health. In looking at work of the subcommittee on populations, we know that much of their work has been looking at sub-population for various groupings of the public but we haven't really spent as much time as we've had prior to HIPAA, on looking at issues related to population health, surveys, broader population issues and that we want to begin to access and you'll see within the recommendations, to move forward in trying to re-establish that as part of our agenda.
We continued to have on-going discussion about cross-fertilization amongst the subcommittees and work groups and trying to re-explore how we schedule the meetings which make it almost impossible to, either you're on standards or privacy or you're on populations and quality and those committees unfortunately the way they're set up tend to be opposite of each other so we're going to continue to try to work to encourage members being on both of those subcommittees or work groups.
We talked again about the issue of population health to identify the population health perspective and then how those issues can be worked through and infused through the committee as well as the important role of the NHI framework, laying out overlaps in personal health care in the population health dimension.
So the goal was to move beyond the intricacies of data at the micro level while continuing to advise on HIPAA, but also to move to other priorities related to population health. To operationalize these the committee agreed on the following actions. First, over the next three to four meetings, the full committee will study the determinants of population health and relevant data sources, followed by a summarizing process and decisions about next steps. This would involve inviting speakers to the full committee meeting who would then make presentations, for example, we talked about inviting such notables as Evans and Stoddard, who developed a model of determinative health, and perhaps such as the upcoming report from the Institute of Medicine on the guaranteeing the health of the public into the 21st century, which has a new model for determinants of health. That way we will use that process to begin to readdress the issue of broader population health issue.
The committee will also look for ways to make population health and information needed to improve it in a more explicit frame of reference for evaluating the success of subcommittee and work group projects.
The executive committee agreed that the committee's structure is working well and no changes are needed at present. The subcommittee agreed that it was preferable for subcommittee and work group projects to emanate from the full committee or at least be vetted there, the issue had come up on whether or not there should be reports and so forth from the various subcommittees and the conclusion was that they should still continue to come from the full committee.
Panel presentations should allow adequate time for discussion to encourage interaction and elevate the discussion of issues with all members on the same level. This really is sort of looking at the work over the last few years and really coming to the point that what we wanted to do was continue to have panels but try to perhaps have fewer people on the panels so that the time isn't completely taken up by the panel members talking to us and we have no opportunity to interact with ourselves and the panel members on the topics so that's one of the goals we are going to be setting for the next year to try to restructure those.
As you know, we've expanded the liaisons and looking for liaison, we now have from NCHS, CMS, NIH and we're looking for a designation for the Centers for Disease Control. We're encouraging them to continue to have high level individuals who can consistently attend the full committee meetings and executive subcommittee.
Finally, the theme that we felt should be conveyed in our report, our committee report from 2002 activities is to reflect the committee's established reputation for thoughtful leadership. We believe that that has been the hallmark of this committee and we want to continue to emphasize that.
Those are the recommendations and a sort of brief summary of the executive committee report and I'd like to throw that open for comments, questions, I'm not sure we need to take a formal vote on the recommendations from the executive committee but to just to allow you have to input on those directions to reestablish population health as part of our agenda.
DR. COHN: Just a comment, and I will apologize only because I was a little preoccupied for a moment there while you were talking. This is just the issue that I think on top of everything else we had also I think had some views that there were probably a number of issues that ought to be full committee issues, that are above and beyond some of these other things. I was just sort of reflecting on, for example, the last session that we just heard on regarding CHI and all this, now obviously the subcommittee is happy to move forward with that, but is that an issue which is crosscutting enough, for example, is it something that we should be elevating and spending time at full committee meetings hearing hearings on, spending significant amount of time on, or is that something that should reside, for example, back in the subcommittee. That was just more of a question. I couldn't tell from the meeting what the level of interest was.
DR. LUMPKIN: Members of the committee is that something, do we want to continue to keep track of the CHI at the full committee level? Anyone?
DR. SHORTLIFFE: I think I would argue yes and the reason is that I think this is simply more than, when you look at its potential for impact, it's more than simply standards. It has to do with a kind of philosophy of cooperation and coordination where the committee as a whole is seen as a kind of focal point for trying to make sure that all these groups are properly interacting and I think we all have a real interest in seeing that happen well and needing to be informed about it. I do believe it's a full committee issue in spite of the focus on standards.
MS. GREENBERG: It strikes me that the CHI and related issues are kind of compatible with the goal that was expressed by the executive subcommittee that the focus on sort of success of outcomes of projects should relate to how do these projects really enhance the populations health, and whereas some of them may be narrower administrative standards, although I think they too can have a positive impact on health population, the CHI and the related activities which are really trying to move the whole collection and exchange of clinical information definitely fits that kind of criterion of trying to use standards, use interoperability and projects to improve the populations health. That would argue for it being kind of kept at the full committee. At least on the full committee's radar screen although I would think specific and ongoing kind of coordination might be also through the subcommittee because it's so related to the work the subcommittee is doing in trying to develop PMRI standards. It does seem to relate to this broader view that was articulated by the executive subcommittee, at least that's the way it looks to me.
MR. BLAIR: It we do decide to go down the path of having continuing feedback and reporting from CHI we might invite them to talk a little bit about the needs they are addressing with the standards, the applications and their priorities, and that might broaden the interest for the other subcommittee members, the other full committee members.
DR. HARDING: I think the subcommittee reporting back to the full committee has done a pretty good a job in general, not critical, bad at all, we'd be reluctant to have everything coming back here, I understand that I'm taking it to the extreme, but that's a concern. I would like to have a little more help sometimes though in having, somebody was saying a radar screen, and the word that you hear all the time now is the dashboard kind of phenomenon, some kind of help with what the real issues are here for the full committee after testimony from the subcommittees. The dashboard indicators are that this is an issue that is going to be critically important and have to come back to the committee, etc., etc., that kind of thing. A little more help with that would be helpful to me.
DR. MAYS: My point is similar to what Richard is saying. I get a little concerned if everything is going to come back to us and it's a reporting as opposed to -- like today I thought it was very useful in a sense that I think it really hit what the issues were and kind of much more at the macro level. So it would be great if what we did is came up with some set of procedures or recommendations or something of, if it's at the full committee level this is what we want as opposed to the reporting. I think sometimes that's what we get, here's where we are, here's what we've done, and you don't really know, especially if you haven't been in the committee meetings, I don't know how important that is, and I smile and I say, oh that's nice. I don't have a clue as to whether, what the real action is. I think it might be helpful as we kind of go through this new process of working out what's a full committee kind of level of discussion and what's a subcommittee kind of level of discussion.
DR. LUMPKIN: I'd like to perhaps, following up on that, toss an idea for us to work on. It seems to me as I think back on our September meeting over the last few years, the agendas tend to be a little bit light because for some reason it's hard to schedule the kind of outside speakers that we have at other meetings of the year. This may be an opportunity for us to schedule our members as speakers to have the subcommittees and the work groups present their issues that they are sort of struggling with, kind of a summary of what's been going for the last year, these are the issues that will be coming up, so that at our November meeting or our February meeting, standards may have an issue related to some vocabularies, which we haven't really covered the background for. This might be a good time at the September meeting to cover those issues, looking at the agenda as we expect it to be for the next year.
DR. MAYS: I think it's great, let me see if I can add one more thing to it, that that might be the time then to do the cross-fertilization where what we could determine is if we needed ad hoc's or something like that between various committees so that then we kind of see September as kind of the beginning of working on the issue and then by the February or June meeting if there was some ad hoc work you kind of have a timeline to get that done. I think it would be great if we did that.
DR. LUMPKIN: Any other comments or questions from the retreat? We made up a little bit of time.
MS. GREENBERG: I guess I just wanted to make sure as we are planning the future agendas we actually were going to try to launch this series of discussions on determinants of health at this meeting, but as John indicated it really is just very difficult to get people lined up for September meeting when they are always gone in August, etc., and I'm not even sure whether we're going to be able to pull this off for November, it may go until February. For those who weren't at the executive subcommittee meeting, is there general support or interest in that type of focus over a series of several meetings, looking at these broader population health and determinants of health issues? Ok, good.
DR. LUMPKIN: Ok, let's move on then to the draft privacy letter.
Agenda Item: Draft Privacy Letter, Action Item September 26th - Mr. Rothstein
MR. ROTHSTEIN: Thank you John. I know everyone got a series of letters. The one that we are going to be talking about says revised version 9-19-02 at the top. I think everyone should have a copy at their place. While you're putting your hands on a copy, I'd like to mention to the members of the committee the purpose of this letter.
The subcommittee on privacy and confidentiality has scheduled three subcommittee hearings this fall, the first of which was in Boston on September 10th and 11th. It was our intention to wait until the hearings were completed and then submit a proposed letter to the full committee at our November meeting, which I believe is the 19th and 20th, for approval by the committee. In September, at our Boston hearings September 10th and 11th, it became sort of the consensus view of the subcommittee members at the hearing that things are sort of a lot worse out there than we thought they were in terms of the ability of people to comply with the privacy rule but there's a great deal of confusion and frustration and that time is of the essence. That things need to be happening much more quickly than they are currently happening and that the scale of efforts of the department is just not appropriate for the scale of the problem and a number of issues that are till left to be resolved.
We decided as a subcommittee to prepare an interim letter which you see a revised version of in front of you for consideration by the full committee and if approved then presumably it will be sent within a week or so and then a follow-up which would include material from our next two subcommittee hearings which are scheduled the end of October and early November in Baltimore and Salt Lake City respectively. So that is the purpose of this letter, it's our version of a wake-up call to the department that we need to be really concentrating on these implementation issues. John, for the benefit of our listeners in various locations, do you recommend that I read it?
DR. LUMPKIN: Actually I was going to suggest that.
MR. ROTHSTEIN: Okay. Do you want to stop after each paragraph for comments as we sometimes do or go straight through?
DR. LUMPKIN: I don't think we need to do that.
MR. ROTHSTEIN: Okay.
Dear Secretary Thompson:
As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996, HIPAA, the National Committee on Vital and Health Statistics monitors the implementation of the administration simplification provisions of HIPAA, including the standards for privacy of individually identifiable health information.
The subcommittee on privacy and confidentiality of the NCVHS held hearings in Boston on September 10 and 11, 2002. The testimony of 28 witnesses from throughout New England afforded the subcommittee an opportunity to learn about the level of implementation activities by a variety of covered entities. Although additional hearings are scheduled in late October and early November in Baltimore and Salt Lake City, the NCVHS was so troubled by the Boston testimony that we are sending you our initial findings and recommendations. We anticipate sending you additional recommendations after our hearings have been completed in November.
The witnesses at the Boston hearing expressed widespread support for the goals of the privacy rule and some health care providers said that it gave regulatory support to an ethical imperative. Some providers, especially larger ones, reported making substantial progress towards compliance. There was also praise for the guidance provided by the OCR in July 2001.
Overall, however, the NCVHS was both surprised and disturbed at the generally low level of implementation activities and high levels of confusion and frustration. Some covered entities decided to wait until the privacy rule amendments were published in August 2002 and only now are beginning to contemplate their compliance duties.
While some professional societies have made laudable efforts to educate their members, many physicians, dentists and other health care providers, especially those in small town and rural areas, have never heard of HIPAA, do not think it applies to them, or confused their obligations under the privacy rule with their duties regarding standards and security and claims attachments.
State and local governments reported lacking the budget or personnel to draft their own HIPAA documents and design training programs to comply with the privacy rule. The failure of the OCR to make available sample forms, model language and practical guidance has left covered entities at the mercy of an army of vendors and consultants, some of whose expertise appears limited to misinformation, baseless guarantees and scare tactics.
The unprecedented scope of the privacy rule raises the likelihood of widespread disruption of the health care system as we approach the April 14, 2003, compliance date. For example, tens of millions of Acknowledgement of Privacy Notices will need to be signed, including by patients picking up prescriptions at retail pharmacies. Public health agencies at all levels have indicated that some providers and hospitals already are failing to report essential public health information because of the erroneous belief that it is prohibited by HIPAA.
Representatives of public health clinics told the subcommittee that they lack the resources to translate essential notices into the numerous languages spoken by their patients as well as to provide the necessary training to employees with low education levels and minimal fluency in English. Home health care providers said they are unsure how to protect the confidentiality of protected health information when it is stored in the homes of their patients.
Large employers with self-funded employee benefit plans have received no guidance on when their benefits related activities are subject to the privacy rule. Furthermore, nobody seems to know whether HIPAA or state law applies in the numerous instances in which the laws conflict.
It is not the intent of the NCVHS to be alarmist or critical of OCR or the department. We believe, however, that the department's HIPAA implementation assistance efforts need to be increased by several orders of magnitude and quickly. A massive public education program is needed to inform the public about HIPAA. Providers and other covered entities need targeted education programs in various formats and media. OCR needs to produce and disseminate sample forms, notices and documents in simple language. It also needs to provide prompt technical assistance, including responding to the thousands of requests for explanation and clarification sent by covered entities.
Unless vigorous new efforts are undertaken to ensure that the implementation goes smoothly, the public acceptance of viability of the entire privacy rule will be threatened.
Mark Rothstein, Chair of the Subcommittee on Privacy and Confidentiality, and I would be pleased to discuss these matters with you or your staff at your convenience. We appreciate the opportunity to offer these comments and recommendations. Sincerely, John R. Lumpkin
DR. LUMPKIN: I think it's a very well worded letter. I would just say that Mark Rothstein, Chair of the Privacy, and responsible for all the negative comments in this letter.
[Laughter.]
DR. LUMPKIN: Any questions or discussions on the letter?
DR. HARDING: The only thing that I would say is that, Mark in crafting this letter, was very cautious and dampened down the enthusiasm of many of the people who were testifying so that I think it's a very clear message but doesn't quite have the affect that maybe they had when they came to us. I think one of the other things is this issue of scare tactics, the concern that many people have that is kind of like Y2K except instead of your computer crashing you're going to go to jail. I think my own feeling as a member of the subcommittee is that that's a very well crafted letter that I think should go forward.
MR. SCANLON: I guess I would make two points here, too. It seems to me you're indicting the industry efforts as much as anything else. Am I wrong? Apparently the -- associations and everyone else are not, you don't believe is doing --.
MR. ROTHSTEIN: I don't think that's entirely accurate. Many of the associations have undertaken efforts but the burden is on the providers to contact the associations to get their materials, to integrate their materials, to change their systems and so on, and I think the providers that we heard from don't know exactly where to turn. Some of the associations have done a terrific job and I didn't intend the letter to have that implication. Some of the consultants obviously are excellent although we did hear reports and we continue to see that sort of thing repeatedly about abuses, someone testified that they hired a consultant, spent all this money, and they found out that the consultant knew less about HIPAA than they did, etc. Just this morning Simon provided me with his copy of Medical Economics, Breaking through the HIPAA Hype, and the first thing that is discussed in the article is the scare tactics of the consultants that are preying on helpless docs.
MR. SCANLON: I ask that for a different reason, Mark, I thought you have in the letter an opportunity to address not just the secretary but the industry leadership and professional associations as well, and why don't you recommend that the industry take a more proactive role in convening its members and in developing materials suitable to their status?
MR. ROTHSTEIN: Well, that certainly would be a substantive point that I'm sure all the members of the subcommittee would endorse. I would ask you whether you think it's appropriate for us to put that in a letter to the secretary with the recommendations that we're making for the department.
DR. LUMPKIN: Maybe the way to do that would be to make it as a recommendation for OCR to work with industry organizations. I think the key issue is, and let me give an example not on the privacy but on the transactions standards. Our state medical society developed a document which our region five CMS thought was good enough and in fact I think they may have done this nation-wide, they reproduced it under CMS on how to address the transactions standards. Well, there's an interaction between the agency and an organization that sort of validates their interpretation of that, so I think some sort of partnership like that between OCR and the various industry groups who are trying to develop model standards and model presentations and model forms, may allow OCR to really expand and exponentially their reach in a consistent fashion.
MR. ROTHSTEIN: I think that's an excellent suggestion that we can work into the revision, and in fact, were I in such a position with an unlimited budget, there ought to be working groups at OCR with all the various affected entities, a working group with employer groups, and a working group with physician groups, and a working group with state governments, and so on, just trying to facilitate these. To the extent that we can encourage that I think we ought to do it as well.
MS. GREENBERG: This sort of fits in with what I was going to say as well, I just thought that you might want to mention in this letter we did appreciate the opportunity to meet with Mr. Campanelli at this meeting since the letter was obviously drafted before the meeting but now it's going to be approved at the meeting, and that the committee was glad to hear about the activities that are being planned but our concern that this really may not be adequate to meet these tremendous needs that were identified and kind of a segue into partnering with some of these major groups who are professional associations, are trying to work with their constituents, could be a way to expand the reach of their activities. Because I think one of the recommendations in here that's real important is this idea of model forms, etc., we heard this time and time again at the meeting. Once the model forms are out there than the professional associations can try to tailor them to their particular constituencies. The alternative is that everybody kind of comes up with their own thing and it's kind of like what somebody was mentioning, the risk of everybody coming up with their own version which may not all be saying the same thing, they don't have to be identical, but may not be giving the same message. I would just suggest that there be a mention of having met with Mr. Campanelli and appreciating the work that is going to be done but a lot more needs to be done in this idea of partnering.
MR. ROTHSTEIN: Thank you for that suggestion, we'll incorporate that as well.
DR. MCDONALD: I also think it's a -- crafted letter, its got verve and good words in it and everything. But the thing is, I was sort of surprised by the strength of it coming from the committee that developed all these goals and it makes me wonder having heard today the special advice is not revised yet for these new, maybe next month, now we're in October almost, this is only six months away. It sounds to me like it's not going to work. You can urge them in the timeframe, I hate to bring this up but that's how it sounds, you have this thing going on and we're going to run out and make everybody does everything right and we don’t event have the final document things that we need to have it done right done. So would this be a bad thing to say, but what's plan B?
DR. COHN: I actually don't know what plan B is. I do know that after listening to the testimony I had similar questions but decided it was premature at this point until at least we've completed our sets of hearings to make any conclusions related overall industry readiness based on just what we saw in New England. If we have a plan B, I guess my suggestion is that we bring it forward in November or maybe it's a plan A-1 rather than a plan B.
DR. LUMPKING: Kepa, then Jeff.
DR. ZUBELDIA: One of the, probably the critical or the most important element of the letter as far as I'm concerned is the change of direction that is in the next to the last paragraph where it asks the secretary to do a massive public education program to inform the public, not to inform the providers, we can't reach the public through professional associations and I remember a year ago when I got the notice of privacy for my credit cards. That was proceeded by the Wall Street Journal, Time Magazine, Newsweek, all of those, maybe even Oprah talked about it. Everybody talked about it, you're going to get this in the mail, read it, this is important, this is the bank telling you what they are going to do with your data. I think this letter is putting that emphasis and we're getting a little bit lost in that emphasis because I think it's extremely important that the patients know what they are going to get, why they need to pay attention. If the patients know, and providers are lost in the little world or something, patients will bring it up to the providers' attention. I think it's a constituency that we can not reach through professional associations, it's a constituency that the department has probably not addressed yet. I think that's a very important emphasis of this letter, it's a change of the action, that may be plan B.
MR. ROTHSTEIN: May I respond to that? I think Kepa's point is a really good one that we tried to get into this letter. One of the witnesses who testified was from the CVS pharmacy chain and the subcommittee members may recall, he said if you are thinking about having a prescription filled, you better have it done before April 14th, because we have to get acknowledgments signed by 40 million people who use our pharmacy services before we will give out their prescriptions. None of them will ever have heard of HIPAA and we're going to have to explain to everybody before they sign what it is that they're signing, authorizing, or acknowledging that we are providing them with, and unless we have some sort of public education program this is going to be repeated in so many different health care settings it's just going to be a very difficult situation and we need to move beyond the professional groups and have a more general awareness in the public that this is coming down.
MR. BLAIR: I wasn't able to be at the meeting in Boston but I'm actually very pleased that that message that's conveyed in the letter that you heard those things because that's pretty much what I was trying to express back in the June meeting. I do feel like there's a real sense of urgency and I think that the way the letter reads, it is beautifully written, and I feel like it is the right balance of the sense of urgency describing the problem very clearly so I really want to applaud the way the letter is written. I think that Marjorie brought up a point that we need to consider because I guess I, my interpretation of the objective of the letter is that it's calling for resources so that Rick Campanelli will have those resources to be able to go forward in a quick timeframe, not to criticize the work that's been done within OCR. Is there any possibility that this letter can be reviewed with Rick before it is sent so that it could be done in a constructive manner that is helpful to him and he doesn't, he or nobody in the administration perceives it as being critical?
MR. SCANLON: Well, it is critical, there's no question it's critical, I guess my point was more that I think it's not just an OCR job, I think it's an industry job. It wouldn't be the first time that drug stores begin in advance, for example, pharmacies, publishing information that something was happening. I think that maybe the strategy is that you want to suggest activities that have a multiplier kind of effect. I don't think OCR, as much as they will do, I don't think they can, they cannot sort of take over the industry on all of these things. I think your tone would be somewhat better if you recognize this was a regulation that everyone wants, because of its scope and complexity it's a harder implementation effort than the routine regulation and that what are needed are efforts to sort of multiply the good graces and the outreach and the education. It's not just a federal issue, I can't imagine that OCR would ever be in a position to literally reach every drug store and provider. It's like everything else, when regulations are written, the communities themselves learn how to deal with it.
MR. BLAIR: Could I see if I could build on what you just said Jim, I'm not sure that this is pulling it together the way you and Marjorie are suggesting, but maybe it is. The perception that I have is that many of the professional association, whether it's the AHA or HEMSIS(?) have all been trying to provide education on the privacy regulations of HIPAA. But up until now, they haven't been able to get information in a clear, concise form to be able to really ramp up and do that education as effective as they could and I think what you're saying in that multiplier effect is that if OCR could provide concise, helpful, relevant, responsive information maybe to the professional associations, they could in turn transmit that information to their constituents, that might be a very expeditiously way to do it. It's not that consultants and vendors are not sometimes helpful but right now their voice is being heard somewhat more than the professional associations I fear and it's not always accurate and it's not always constructive. Is that closer to what you're trying to say?
MR. SCANLON: I think any approach you recommend that brings in the industry resources, provider resources, professional resources as multipliers, is really a much more sensible one than just telling OCR that they have to do more, I mean obviously they do, but that's not going to do it, it's not a sophisticated strategy. I think a theme that sort of involves this multiplier effect and puts the burden on the industry as much as anyone else in terms of implementation, I think would make more sense. It doesn't take away from your main point that you believe that the outreach effort has clearly outstripped the demand for the information it's just not sophisticated to say the federal government should take it over and do it when the whole industry is much more capable in terms of how it would work I would think in my view.
DR. MCDONALD: A deep problem in all these big regulatory complex initiatives is it's the only place in the universe where we do things as big bangs. We didn't do airline security as a big bang and we don't do programs, we haven't developed any big software program and just launched it without really testing it in real life for a long time. And so I think we got a bad problem because we haven't even got the guidance out yet. We don't have all these documents done yet, so I think the plan B is phasing in some fashion some aspects of it so that, plus we haven't even shaken out all the tough problems. I read in this plan, I didn't even think about it, the home health care, they are sitting around the home, how do you manage the security of that? That was one issue and there will be others that come up when it's really implemented. So to some way to think about phasing the things that really could choke the elephant it might make it more feasible.
DR. LUMPKIN: I think we can look at that in November and I'm just going to be somewhat on the other side of that issues, it's not like people didn't know that this privacy rule was coming downing the pipe. Now that the deadline is coming people are looking at it and saying now I have to address it. I'm afraid that if you push off any sort of deadline then people will push off having to address the issue.
DR. MCDONALD: What I meant by phasing was one would figure out some things you could delay the implementation of and some to start on the same date. Like for example, if you have to day one get everybody to sign these documents, that really might choke the system and one could imagine phasing that, ok, we start that over the next three years, over the next two years.
MR. SCANLON: I think this already includes provisions to do that, that's why I'm a little worried about --.
DR. MCDONALD: This is premature, I agree with Simon.
DR. SHORTLIFFE: It's my impression from the conversations that I hear about this that at least the sophisticated organizations that are trying to deal with this sort of have an impression that it's fundamentally going to end up being phased in terms of enforcement anyway, that the good faith effort to do the right think by April is essentially what's expected and there will be more effective implementation as people wrestle with the realities beyond that date, but anybody who looks as of April 15, like they're not taking this seriously, those are the ones that are more likely to be in trouble.
The flip side of this, however, that I'm also hearing, is the concern that yes, the enforcement process is permissive perhaps in that they will realize the complexity of what's being asked but that the legal community will not and that the legal exposures, et cetera, will start on April 15th when the first lawsuits start being launched, et cetera, and I haven't heard that discussed here in quite the same way. Maybe it's not our concern, but if the law in all its full glory or the rule in all its full glory is supposed to take effect on April 15th, but we don't believe that people can really comply fully even with the warning, and I think even those who have taken it seriously for some time are going to have trouble, especially because they are still trying to get directions on some of the kinds of questions that are going to legal counsel now for interpretation or conflicts with states, all these that Mark is talking about in this letter. Then we have created a real potential legal quandary for people as of April 15th, and maybe that's not our concern, but I do believe there is a lot of worry about that out there.
DR. LUMPKIN: But again, I'm not a lawyer, I've just worked in government long enough that some people try to blame that on me, but the problem with that is that much of law in relationship to medicine is based upon a community standard and once you have a more sophisticated organization adopting this standard, whether you phase-in the smaller ones or not, you're still going to be held in many of those things to that standard, even if you don't have a rule in place and you delay it a year, but the more sophisticated organizations start adopting this as the standard for privacy, that's what you're holding yourself up to as what's going on in your community. So I think the legal aspect may be just so much more complicated than any of us can or even delve with because it's going to be etched out and defined by the courts, rather than actually how or when we implement the regulations. So I think we do have to go a little bit blinded to that.
DR. COHN: I'm hoping that the subcommittee may come back with another letter in November trying to deal with this. It obviously gets very complicated as you commented, the lawyers, the newspapers, the expectations, also contracts that exist many times require that if you have a contract with an employer, or patients, or whatever, that you are actually in compliance with state and federal laws. I don't know what the solution is. I don't know that we can solve it around this table today but I do think that that's, we kind of asked about a plan B, I think that that's actually a responsibility for the subcommittee and I'm thankful that we actually have a lawyer who is chair of that subcommittee to help us work through some of these issues because there are, there's probably got to be some solutions that we could recommend that actually might stand the light day.
MR. ROTHSTEIN: I think it's our intention that the November letter will go into much greater detail in terms of the kinds of things that we are going to recommend and we heard dozens of suggestions in Boston about what specific steps ought to be taken or could be taken that I think the members of the subcommittee will have an opportunity to debate over the next two hearings. This letter is a little different than the ones we typically send, not just our subcommittee but the committee as a whole, because we generally go into the sort of what should the definition of this be or what system should this be or that be and we have a level of detail. That was not our intent here. We thought that overall there was a substantial problem and we wanted to make the case at the highest possible levels in the department that new resources and a new focus on this problem had to be given right away.
I hear what Jim's saying, and I certainly don't want this letter to have the wrong tone or have some sort of detrimental affect to our credibility, et cetera, so I will take another go at this, this evening, and see if I can work in all of the suggestions that have been made and see if we can get the right combination of the sort of the urgency that we felt at the meeting, while recognizing sort of the political realities within the department, and have this both constructive as well as urgent.
DR. LUMPKIN: Thank you and I think certainly it reflects what I've heard from the committee, that this is a really good start. So a little nibbly around the edges, not a dramatic redo.
MR. ROTHSTEIN: We'll be back tomorrow.
Agenda Item: Draft Recommendations for Code Sets - Action Item September 26th - Dr. Cohn
DR. COHN: Our next item has to do with a draft letter on ICD-10 that the subcommittee is bringing forward for discussion. First of all, I want to make a couple of introductory comments and then I'm going to hand it off to Kepa. You all are aware that through to my many times where I have to recuse myself the relationship to CPT-4, that I'm obviously, some of this letter the word CPT does show up and therefore, I will be recusing myself from the actual discussion of those parts of the letter that relate to that.
The comments that I'm going to make have more to do with the process and just a couple of just general questions. First of all, I want to apologize to the subcommittee since many of you first received, full committee, many of you first received the advanced draft via e-mail about 48 hours ago. I think the intent of the subcommittee was to have this a little more polished for this meeting, you just have our apologies from the subcommittee, as well as the staff.
While the subcommittee has not formally approved this particular draft of the letter you're looking at, and indeed there are a couple of mark-ups and comments made on it, it has been extensively reviewed by individual members of the subcommittee and I've actually elected to keep most of their recent comments so you could see them and judge whether they are appropriate or not. You should be aware that this is actually the 12th version of this draft, hence our interest in bringing this forward for some direction, input and guidance at this point.
The ICD-10-CM and TCS recommendations are clearly the most controversial and contentious issues we have addressed recently, except for maybe privacy. So this is a good balance for the day. In this year we have had three major hearings on ICD and code set issues, the subcommittee has had, and there's actually been additional sessions where we've had additional testimony, as well as spent I imagine numerous hours trying to draft something that we can agree to and bring on to the full committee.
At this point we need your input and direction, as well as some agreement about next steps. We believe that this letter, while not perfect, is close to representing the thoughts of the subcommittee. If you indeed feel that changes to this letter are only cosmetic, we probably could work on it this afternoon and perhaps have it back by tomorrow. However, there are a number of questions here. First of all, are there other issues or concerns that you all have that are not being appropriately reflected in the letter? And indeed, is the tone the right tone? I will say that consensus on this letter has been a very difficult, I'm not even certain that, much of this letter has been passed by divided votes by the subcommittee, so this is an area where consensus has been very difficult to find.
Also, given the amount of controversy, and indeed you have letters on your desk from a number of different organizations expressing concern about the contents of the letter, and really the fact that as I thought about it, it really impacts all data collection and analysis initiatives, somewhat akin, though a much bigger example of the issues that Vickie Mays brought forward to us a couple meetings back, related to changes in ethnicity codes, this is sort of like take that and maybe square it or to the 4th power.
The question comes, is this an issue that is really of wider concern to the full committee and does it really merit some wider investigation by the full committee before we move this forward? Certainly at the executive subcommittee we believe there were certainly issues that are really cross cutting across the subcommittees, and this may be one of them. We need some of your input certainly if we decide to defer this or to take it on as a full committee we would also need guidance, the subcommittee is happy to arrange further education, put together panels, or whatever, whether that is something of interest to the full committee. So, with that, Kepa, would you like to read through what we have?
DR. ZUBELDIA: Should I stop after every paragraph or stop at certain points or not stop or what?
DR. LUMPKIN: I would suggest you just continue all the way through and then we can have a discussion. People should mark their drafts if they do have particular items.
DR. ZUBELDIA: Dear Secretary Thompson:
As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996 the National Committee of Vital and Health Statistics monitors the continued effectiveness of the health data standards adopted pursuant to the requirements of the administrative simplification provisions of HIPAA.
The subcommittee on standards and security's agenda for this year includes the exploration of a wide variety of code set issues. The subcommittee held three hearings during the first six months of this year seeking advice from a wide range of organizations and individuals that had a stake in diagnosis and procedure code classification. The committee will continue it's deliberations on code set issues and provide additional recommendations in the future.
Based on the input received from the health care industry, state governments, and the public health and research communities, we conclude that there is an urgent need for HHS to begin the regulatory process to consider replacements for ICD-9-CM Vols. 1, 2, and 3. Due to structure and space limitations, annual updates to the ICD-9-CM no longer can effectively accommodate the advances in medical knowledge and technology. As a result, ICD-9-CM is increasingly unable to support the need for accurate data for health care billing, quality assurance, public health reporting, and health services research.
The committee recommends that HHS take action now to ensure that a replacement of ICD-9-CM as soon as possible. We are recommending as a first step in the regulatory process that the department conduct a comprehensive cost benefit analysis for the migration to ICD-10. This analysis should include a careful study based on input from the health care industry of the time and costs for the migration to ICD-10-CM and IC-10-PCS in preparation for the development of a Notice of Proposed Rulemaking.
The testimony heard by the committee generally reflected consensus on the need to move from ICD-9-CM Vols. 1 and 2, to ICD-10-CM for diagnosis codes. The ICD-10-CM is the only recognized success of code set and ICD-10 already is being used for mortality classification in the United States.
The major issues are related to timing and cost. There are more substantive concerns about the movement from ICD-9-CM Vol. 3 to IC-10-PCS as the code set for in-patient procedures. We intend the regulatory process to elicit opinion on many of these critical issues. The regulatory document should contain a thorough discussion of pros and cons for adopting ICD-10-PCS, some other code set such as CPT which currently is used for professional services, or remaining with the current code set and including the pending review of data about the time, costs of calling from the ICD-10-PCS code book with nearly 300,000 procedure codes compared to ICD-9 with about 3,000 procedure codes. The document also should address the full range of implementation issues and plans for the respective code sets.
Background: NCVHS issued reports in 1990 and 1993 noting problems with the continuing ability of ICD-9-CM to keep pace with medical science and indicating that both the diagnosis and procedures section of ICD-9-CM would need to be replaced.
In December of 1990 NCVHS issued a report to the assistant secretary for health entitled "Report of the National Committee on Vital and Health Statistics Concerning Issues Relating to the Coding and Classification Systems." This report noted that while the ICD-9-CM classification system had been responsive to changing technologies and identifying new diseases that impact heavily on the community, there was a concern that the ICD-9 classification may be stressed to the point where the quality of the system would soon be compromised. Testimony obtained during the April 1997 hearing of the initial candidates for adoption of medical code sets under HIPAA acknowledged the need to move to newer versions of the ICD-9-CM at a later time with recommendations of the initial HIPAA code sets be those currently in use.
Comments received in response to the NPRM for standards for electronic transactions published May 7, 1998, supported the need to replace ICD-9-CM with ICD-10-CM and ICD-10-PCS. Additional comments about medical code sets identified the need for improvements in the update process for certain designated HIPAA code sets and the need for a concerted effort and resources to achieve the elimination of local code sets, and the need to fill gaps in coverage among the designation HIPAA code sets.
Summarizing the preamble to the final transaction rule published on August 17, 2000, it suggestions took action to address some of these concerns immediately, and indicated it was premature to take action on others. The preamble indicated that the NCVHS would monitor the situation.
Accordingly, the Subcommittee on Standards and Security of the NCVHS had public hearings on February 6 and 7, 2002, April 9 and 10, and May 29 and 30, 2002, to obtain input on the status of efforts to improve code set update processes, eliminate local codes, and fill code set gaps. The hearings also addressed the current need and appropriate timetable for moving from ICD-9-CM to ICD-10-CM and ICD-10-PCS, as well as the system impacts of such a code set change.
Findings: The code set hearings held on April 9 and 10, May 29 and 30, NCHVS received written and oral testimony of ICD-9-CM and ICD-10-CM, and ICD-10-PCS from a variety of stake holders. From these testimonies as well as additional written statements and letters the committee concluded the following: ICD-9-CM both for diagnosis Vols. 1 and 2, and procedures Vol. 3 can no longer be effectively updated to accommodate the changes in medical knowledge and technology. The U.S. implemented ICD-10 for mortality reporting in 1999. This has introduced challenges for states as they endeavor to maintain compatibility between mortality statistics in ICD-10 and morbidity statistics in ICD-9-CM.
ICD-10 or clinical modifications of it are already used for morbidity reporting in most other G-7 countries. There's an urgent need to begin the process to move to a newer and better standard for both diagnosis and in-patient procedures. A common theme expressed was when, not whether, ICD-9-CM Vols. 1, 2, and 3 should be replaced.
The replacement of the diagnosis classification and the in-patient procedure classification should occur simultaneously. The replacement of ICD-9-CM Vol. 3, for in-patient procedure classification should not wait until the solution of the long standing debate over the identification, selection, or development of a single procedure coding system that would be suitable for coding procedures in both in-patient and out-patient settings. The need for a better procedure coding system for in-patient procedures reported by hospitals must be addressed as soon as possible.
Replacing ICD-9-CM is essential but it will take significant time to implement the system changes that will be required. The reason that the NCVHS recommends that the compliance date of ICD-10-CM and ICD-10-PCS not occur before October 2005 is to give the health care industry at least two years to migrate to the newer standards after they have met the October 2003 deadline for compliance with the first phase of HIPAA standards implementation.
There is a need for the department to work with industry stake holders in the development of an implementation plan that provides details and the steps required for a successful implementation of the replacement code sets. Establishing a date for the transition well in advance will be extremely helpful.
There are some stake holders, while acknowledging the limitations of existing code sets, who believe there's a need to more fully explore issues related to costs, benefits, timing, and resources required to move to newer code sets before recommending issuance of NPRM.
There's a need for the department to hear directly from the many stake holders that may not have had the opportunity to participate in the hearings conducted to date, which the regulatory process will accomplish.
Recommendations: The committee therefore recommends of the department as the first step in the regulatory process, solicit input from the health care industry on a cost benefit analysis, including a careful study of the time and costs for the migration of ICD-10 for both diagnosis and procedures. This study, when completed, will assist HHS in determining whether to 1) accelerate the migration to ICD-10-CM and ICD-10-PCS; 2) extend the time for the industry to migrate to the new classifications; 3) identify and provide migration guidelines, tools, and/or incentives to assist with the migration to ICD-10-CM and ICD-10-PCS; and/or 4) determine whether to migrate to ICD-10-CM and ICD-10-PCS simultaneously or on a phased approach.
The committee further recommends that the department also prepare to publish a Notice of Proposed Rulemaking, soliciting information regarding replacing ICD-9-CM Vols. 1 and 2 with ICD-10-CM for diseases, injuries, impairments, other health problems, other manifestations and causes of injury, disease impairment or other health problems, and replacing Vol. 3 of ICD-9-CM with ICD-10-PCS for procedures or other actions taken for diseases, injuries, impairments, on hospital in-patients reported by hospitals.
The development of the cost benefit study and subsequent publication of the NPRM would serve several purposes. It would provide the health care industry with a clear understanding of the departments direction related to new code sets, assist the department in obtaining additional information about the impact on the industry related to the transition, and obtain additional comments from the industry on the steps required to develop a migration plan that would ensure a smooth transition.
NCVHS wishes to thank you for the opportunity to submit these recommendations within the framework of HIPAA.
Dr. LUMPKIN: Thank you.
DR. COHN: Kepa, just a question, in your reading did you intend to take out the fifth recommendation?
DR. ZUBELDIA: I skipped over all the change marks. There are a few change marks, changes that have been proposed by some of the members of the subcommittee that have not been accepted as change marks in cleaning the document, and one of them that Simon just pointed out is a recommendation number five, which is to consider alternative approaches. That's one of the things that we need to discuss, what to do with these change marks, because some of these change marks are not in full accord by all the members of the subcommittee and they have been introduced in version, what, 17? Just kidding.
DR. COHN: 12.5.
DR. LUMPKIN: Let me first ask a question and then we can talk about how we're going to manage this issue. The question has to do with the issuing of a proposed rulemaking, is that the only way for the federal government to get comments on this issue?
MR. SCANLON: No, there are other ways. I was going to ask a similar question, John, the regulation that is processed, that is being a one and two, is this the HIPAA transactions and code sets? Is that what's envisioned that this would be adopted as the latest version? That's the reg that's being thought of.
DR. ZUBELDIA: It would to replace an existing code set, which is to replace the ICD-9 Vols. 1 and 2 with ICD-10.
MR. SCANLON: Which was adopted in our first transactions and code sets. So, well no, actually to do that it would obviously require a regulatory process. There are other ways to use such standards in program operations and various things like that without a regulation in fact that's how we used it up until HIPAA, now it's done by practice and by policy.
DR. LUMPKIN: But as I see this recommendation, the intent is not to develop an NPRM to implement the changes, it's really saying to the department, you need to study the impact of the changes and solicit input from the industry and so I'm just curious about the use of the NPRM for soliciting information.
DR. COHN: John, maybe I can comment, we spent a couple of hours at the subcommittee and Wayne probably has comments on that one. This was argued back and forth, wound up being brought forward with a vote of 3-4, 1 against and 1 abstaining, so just to give you a sense of the strength of that recommendation.
MR. AUGUSTINE: One of the ideas behind the NPRM was the fact that there are two separate issues here. There was a consensus that the Vols. 1 and 2 of ICD-9 need to be replaced, we need to start that process along and get that moving. The more contentious issue, of course, was ICD-9 Vol. 3 and we figured during, or my understand was that during the NPRM process for replacing Vols. 1 and 2, we could also solicit cost benefit analysis and elicit opinion on replacing Vol. 3 as well. Regardless, we need something to move forward to replace Vols. 1 and 2 because there's no contention there.
DR. LUMPKIN: I would just point out that paragraph in there doesn't say that and I think it would just need to be clarified saying that the NPRM would be to replace Vols. 1 and 2 and solicit input on Vol. 3.
DR. ZUBELDIA: Even to replace Vols. 1 and 2, some of the testifiers with a very clear message, that the cost of the replacement has not been grasped completely by the subcommittee, that we may have to postpone it beyond 2005, take another look at that, based on a cost benefit analysis. The intention here is to get a cost benefit analysis, ideally if we could have it today then we could move forward with a more informed decision.
MR. SCANLON: But I think John was leading, there are other ways to conduct studies or gather information than an NPRM, I guess that's my point. If you really, if you think this can be done by a serious study, an economic impact study, that can be done through contract without necessarily getting us into the NPRM where the advance notice or notice of intent kind of situation. If you actually would like to have the study before you enter into the rulemaking process, that's clearly what you would do. But there are just different ways, it just sort of depends on what you're goals are.
DR. LUMPKIN: On the issue of the NPRM?
DR. MCDONALD: Well on this issue of this letter, I was going to suggest that one of the things that we need to address as a committee before we actually discuss the actual contents is how we're going to manage this issue.
MR. SCANLON: Well, it's bigger than the letter specifics, it's the issues, the reasons why there are issue there are not explicit, are not fully exposed in the letter. I think that the issue that no one is talking about is CPT versus ICDMA(?). I'd like to just bring up the issues that surround that and what makes this somewhat complicated.
DR. LUMPKIN: What I was going to suggest not that we don't need to get into that at some point is how we're going to manage that issue. Our normal process would be to have some discussion today, send it back to subcommittee and have a letter brought forth. There are I think a lot of issues here, so the question though may be whether or not we want to have a fuller discussion at our November meeting that would delve into the issues of CPT-4 versus ICD-9, ICD-10, for the full committee, or whether the committee is comfortable with the subcommittee thrashing that out.
DR. MCDONALD: With one minute of what some of the dimensions are that they may not be aware of, namely is that the ICD-9 is only used for medical procedures in surgical procedures for all practical purposes in the hospital. All those procedures are also coded somewhere in the world, CPT-4, and so we are destined to go on with this sort of duality unless this is grappled with at some point. There was really six big testifiers and there were two in favor against going toward ICD-10-PCS and four in favor of making the change. I actually sense a titanic clash between two large organizations whose names I won't mention, but I don't understand all the dynamics underneath all that that is part of it, if I understood all that it might be simpler to understand. But I won't go into that part.
DR. LUMPKIN: Now knowing that additional bit of background, what is the role of the committee, do we want to have a session where we have outside presenters, maybe one or two present the pros and two present the cons before we take action or are we willing to work based upon the extensive hearings that the subcommittee has had?
DR. ZUBELDIA: John, I'm not sure you're going to find two that will present the cons. I think there is somewhat of a consensus to do it but maybe on an extended timeframe.
DR. LUMPKIN: Well, actually the con is the action that's being suggested by this letter. I think that we could probably, my guess would be from my correspondence we could find two cons for this action.
MR. BLAIR: I realize that we could spend additional time to refine whether or not we should recommend an NPRM or some other approach and to get further information on whether or not we should be looking at CPT versus version three. However, the thought that I had is that the way the letter is crafted now, it will achieve getting the ball moving forward and getting the study underway and getting the issues out and commented on and I almost feel as if the process might be able to do a much richer job of clarifying these issues than we can by delaying our deliberations or our recommendations which therefore delays the cost benefit study which therefore delays moving forward the process. One of the things I might suggest is that where we wind up saying an NPRM we might expand that to say an NPRM or some other appropriate method, we could expand that because I don't think we're wedded to NPRM as the only method, it's just that we are trying to move the ball forward and get this thing moving.
DR. LUMPKIN: Let me go back to my question because I think everyone has spoken to this question that I'm posing has been on the standards and security subcommittee. And my question is really posed to the other members of the committee who have not been involved in this discussion other than what has been presented to them, and that is do we need more preparation of the full committee before we taken action or do you feel comfortable with the process that the subcommittee has engaged in, in taking this action? Because if we get to tomorrow and we want to vote out, are people going to be comfortable in voting? So unless I hear from someone of the committee that someone wants to have a more detailed discussion, then we will proceed with our process. -- This is a question for the committee and the members of the committee are charged to vote on the issue. This is really not an issue that can be debated or ought to be debated by people not on the committee.
DR. HARDING: We are being asked to vote on an issue that has many ramifications that Clemm was referring to that I'm not sure what the issues are. So I would have difficulty voting on that.
DR. LUMPKIN: That's exactly the kind of, either you are or you aren't, how we get through today's discussion and tomorrow's will be dependent upon, if we already know at this point, given the complexity of this issue that there are people who have some certain desire to better understand the issue, then let's proceed and do that rather than get to that point tomorrow afternoon.
DR. NEWACHECK: I agree with Richard. I'd like to hear a little bit more before I'm ready to vote on this issue.
DR. LUMPKIN: Well, given that we've had at least two comments, I think what we will try to do is do a panel at our November meeting before we would take a vote on this issue if that's agreeable, I don't think we necessarily need a motion but it's just in deference. Vickie?
DR. MAYS: Are there any implications to waiting?
DR. LUMPKIN: Simon? The question was are there any implications to waiting?
DR. COHN: I don't think that there's a major negative impact for the committee to be certain of whatever it's recommending, at least that's my analysis of the information. I think what we'll do then is probably spend part of the subcommittee discussing what sort of panel we put together to make sure that the issues are brought forward. I worry that almost any of the issues we talked about, we talked about five or six in this conversation, could probably be a full days discussion and we probably wouldn't even get a consensus, so we will somehow figure out what the key issues are, try to make sure that we have a range of opinions, not necessarily opinions but perspectives on a number of these issues. I also I think, once again, I look to Vickie with some surprise, I think if I were a researcher who was considering a move from one coding system to another, I would want to make certain for example that there was an adequate mapping in place that didn't completely destroy my database. And hopefully we'll have as part of that some reference and reflection on those particular issues.
DR. MAYS: One of the issues that I was going to raise is whether or not what we really need are outside people or maybe at least some significant portion of the time for the committee to really, again, I'm a little concerned, people come with very specific issues and a very narrow perspective on that and again, I think what we really need to hear are probably reflect on the debates that you've had and the real issues were that you were concerned about and who those issues impact. Then maybe a few people to talk about it as opposed to all the information in the panel.
DR. NEWACHECK: I was going to suggest that it would be helpful, I don't know if you guys have the time or energy to do this, but if you could put together a page or two pages that would just outline the issues for members of the committee with a couple sentences about why they might be controversial or what the two sides might be on each issue.
DR. FRIEDMAN: I think those are both excellent ideas and I also completely agree with both Vickie and Paul and I think it will be much more valuable to those of us who are not steeped in these issues to hear from the members of the subcommittee and to be briefed by them and I think that would in some ways provide us with a better basis for evaluating the issues.
DR. LUMPKIN: So I'm sort of hearing the format may be a briefing by one or more members of the subcommittee, with some of the divisions it may be helpful to have one or two members of the subcommittee and then perhaps someone from outside to come in, or two people.
MR. AUGUSTINE: I don't think we're going to gather a lot of new information from a new panel, maybe provide them with the letters that have been presented by panelists and let them read those and then the subcommittee members could kind of walk through some of the deliberations with the full committee.
DR. LUMPKIN: I think that's consistent with comments, too.
MS. MALINA: Permission to speak from the chair. Cynthia Malina, CEO of Alternative Link. I'm a little puzzled in the letter that has been written that there's no reference to the ABC codes for alternative medicine, nursing and other integrated health care practices. Our understanding is that on the implementation date, the compliance date, there will be approximately three million practitioners of alternative medicine, nursing and integrated health care practices that will be without adequate codes to describe their interventions and they will therefore be pushed into what could be perceived as fraudulent billing practices to get compensated for their services. So I wonder if the committee or subcommittee would consider adding ABC codes to that set of codes that are being evaluated. The ABC codes were discussed at two of the three subcommittee events, there's been considerable data submitted to the subcommittee about those codes, we've completed a crosswalk on the codes to CPT and to HICPICS(?) Level 2. I believe there's adequate data to make a decision about the codes as a designated code set and certainly sufficient data to justify it at the very least an exception to allow them to be an optional but not mandatory code set under HIPAA.
DR. ZUBELDIA: Cynthia, the subcommittee has been working on other code sets, not just the ICD-9, ICD-10 transition. We've heard and we're discussing the issue with the alternative medicine codes, with the DSM codes for psychiatry, and this letter is addressing the ICD-9 and ICD-10 transition, we will be addressing the other code sets too.
MS. MALINA: Is there a timeframe established for that?
DR. ZUBELDIA: We're trying to schedule our agenda, we'll be working on that during the subcommittee meeting this afternoon and the full committee meeting is also scheduled in, what we're going to do in the next meetings.
MS. MALINA: So by the end of these two days we should have a timeframe?
DR. ZUBELDIA: Yes, you will know what we are working on when.
MS. MALINA: Thank you.
DR. LUMPKIN: I think given what we've decided to do, we've dealt with the letter to the extent that we need to at this meeting. We have a logistics issue, that is we are convening, my agenda does not include the rooms where the subcommittee meetings are meeting --.
Ok, we are going to go into the subcommittee meetings after lunch and we will reconvene at 10:00 a.m. as a full committee. The bus will meet tonight at 6:30 at the lobby. Thank you. We stand adjourned for lunch.
[Whereupon, the meeting was adjourned at 12:43 p.m., to reconvene the following day, September 26, 2002, at 10:00 p.m.]