[This transcript is unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201
Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda - Dr. Cohn
DR. COHN: Well good morning everyone, I want to call this meeting to order, this is the first day of two days of meeting of the National Committee on Vital and Health Statistics, the national committee is the public advisory committee to the U.S. Department of Health and Human Services on national health information policy. I'm Simon Cohn, I'm an associate executive director for health information policy for Kaiser Permanente and chair of the committee. I want to welcome fellow committee members, HHS staff, and others here in person and of course also welcome those listening in on the internet. And as always I want to remind everyone to speak clearly and into the microphone because we know the acoustics in this room.
Let's now have introductions around the table and then around the room. For those on the national committee I would ask if you have any conflicts of interest related to any issues coming before us today would you so publicly indicate during your introduction. I want to begin by observing that I have no conflicts of interest for any of the items today. Jim?
MR. SCANLON: Thank you, Simon, good morning everyone, I'm Jim Scanlon, I'm with the HHS Office of Planning and Evaluation and I'm the executive staff director for the full committee.
MR. ROTHSTEIN: Mark Rothstein from the University of Louisville School of Medicine, member of the committee, and I have no conflicts.
MR. BLAIR: Jeff Blair, Medical Records Institute, and I'm not aware of any conflicts.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the full committee.
DR. HUFF: Stan Huff with Intermountain Health Care and University of Utah in Salt Lake City, member of the committee and not aware of any conflicts for today's discussion.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the full committee.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member of the committee.
DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the committee, no conflicts.
MS. MCCALL: Carol McCall, Humana, member of the full committee, no conflicts.
MS. MCANDREW: Sue McAndrew, Office for Civil Rights, liaison to the Privacy and Confidentiality Subcommittee.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, liaison to the full committee.
MR. LOCALIO: Russell Localio, University of Pennsylvania School of Medicine, I'm a member of the committee, I have no conflicts.
DR. VIGILANTE: Kevin Vigilante, Booz-Allen & Hamilton, no conflicts.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee, no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield North Carolina, member of the committee, no conflicts.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the committee and no conflicts.
DR. WARREN: Judith Warren, University of Kansas School of Nursing, member of the committee, no conflicts.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
MS. SQUIRE: Marietta Squire, NCHS, staff to the committee.
MS. SIDNEY(?): Cynthia Sidney, NCHS, staff to the committee.
DR. BICKFORD: Carol Bickford, American Nurses Association.
MS. KANAAN: Susan Kanaan, writer for the committee.
MR. ALFANO(?): Bill Alfano, Blue Cross and Blue Shield Association.
MS. BOYD: Lynn Boyd, College of America Pathologists.
MR. BRUCKLE(?): Mark Bruckle, Academy of Managed Care Pharmacy.
MS. GOVAN-JENKINS: Wanda Govan-Jenkins, NCHS, CDC.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, staff to the committee.
MS. PICKETT: Donna Pickett, NCHS, CDC, and staff to the Standards and Security Subcommittee.
MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the Subcommittee on Standards and Security.
MR. DICKMAN(?): Barry Dickman, Department of Veteran Affairs, HIPAA Program Management Office.
DR. KILE: Frank Kile, American Dental Association.
MS. WILLIAMSON: Michelle Williamson, CDC, NCHS.
DR. COHN: Well welcome everyone and I guess we're getting close to happy holidays because we're moving to mid-November though I'm obviously delighted at least for this moment the weather in Washington seems to be very pleasant and almost balmy, though I hear by the time we leave this afternoon we may notice a slightly different weather pattern coming through. Now I guess I have to remind everyone please put your cell phones on mute or stun or however that works best for you.
Now before we do agenda review I do want to make a couple of comments and sort of help set the stage for the discussions for today and tomorrow. I think for all of us this continues to be an interesting and exciting time and certainly the pace of events in our area, national health information policy, continues to accelerate. Indeed I am describing this sort of publicly is what I describe as living in an accelerated environment and all the things that we've talked about over the last couple of years are suddenly really beginning to come to pass. In a little over the two months since our last meeting of the full committee I think much has happened and I'll just sort of run through them and probably talk about them for a second knowing some of them we will be talking about more during the deliberations of the day.
First of course is Secretary Leavitt's 500 day plan which includes as all of you know as a centerpiece the next phase of the HHS/HIT strategy. This is continuing to unfold, obviously what we're talking about here is an acceleration of activities and efforts to move health care into the information age and transform the health care system. This is the vision we foresaw when we wrote our document information for health in 2001 which we laid out a strategic vision and having reviewed that recently it's very interesting that while things aren't happening exactly as we suggested most of the elements are actually coming into play so I think we can congratulate ourselves on some of our vision as well as obviously congratulate the department on moving forward in this very important area.
The executive subcommittee, Jim and Marjorie, has been working with me on how we can best support and assist the secretary and the department going forward in this accelerated environment. And as I've commented before obviously because of our content expertise and experience we do have a lot to contribute going forward. In addition of course we have a reputation for a strategic focus and also being practical, which is something I think that is well appreciated by the department. We have had ongoing discussions with HHS leadership on how we can best make a contributions and these conversations continue. I did however one to share with you a statement made by Secretary Leavitt at the first meeting of America's Health Information Community on October 7th, I know Jim shared this with some of the subcommittees but let me just quote a couple of sentences from his introductory comments, and I quote from Secretary Leavitt, we will use the depth, expertise, reach, and experience of other people and organizations that are critical to our success. The National Committee on Vital and Health Statistics has significant expertise and more then 50 years experience as a public advisory body. I am pleased to say the NCVHS chair has expressed to me NCVHS's support and engagement, we will invite NCVHS to be actively engaged in our work. So we obviously we appreciate the comments from Secretary Leavitt and obviously we step forward to be actively engaged in helping anyway we can.
I believe it is safe to say that we will be playing an important role in helping to assure the success of the Secretary's new HIT strategy and initiatives. And certainly this will be a topic as we hear from Dr. Brailer later on today about ONCHIT and all the new initiatives and contracts that they've awarded over the last couple of months. So that's item one out of a number of items. Item two is e-prescribing and the final rule. Now I know Karen Trudel is going to be discussing this but I obviously wanted to first of all congratulate CMS on having completed the final rule and published it, so congratulations. We also wanted to thank HHS and CMS for including so many of the NCVHS recommendations in that final rule and being a prolific reader of final rules these days, all 165 pages of that one, I did want to point out that the NCVHS is being asked to provide ongoing advice and guidance to HHS related to versioning and maintenance updates of this suite of standards and it sounds like much the same sort of pattern as we've done with HIPAA. So I obviously want to thank the government, the federal government, for their faith in us.
Item three is the claims attachment standard, we'll be talking about that, that's a Notice of Proposed Rule but we get another thing that's out now that we have to deal with.
Finally is the Commission on Systemic Interoperability that released its report and its recommendations three weeks ago. This federal commission was charged with taking a fresh look about how to accelerated progress towards an interoperable future. I was honored to have been a member of that though not with my being the chair of NCVHS but a representative from a private entity. We were pleased that CSI in their recommendations specifically named the NCVHS, in particular those recommendations related to data standards and it did request that NCVHS collaborate with AHIC to ensure acceptance and use of a set of interoperable non-overlapping data standards.
While I will not be reviewing these recommendations in any detail with the committee today, I think we've had a presentation with Scott Wallace previously, I know Marjorie had sent around the website for this. I will however knowing how busy we all are make sure that we package the executive summary and the recommendations and we'll send them out as an email so you can all review. I think it's important probably that subcommittees and workgroups review these only because some of them may impact or provide you additional thoughts for what your 2006 work plan potentially should involve, and so we'll sort of do that after the meeting for at least your review and thoughts.
All in all as I commented there's a lot going on related to national health information policy. This is an exciting and fast moving time and I want to acknowledge all of you for your hard work and vision in helping make all of this a reality so thank you.
Now let me shift gears. Obviously while this is going to be somewhat old news because we've publicly announced this in September, sent this person a letter, mentioned it on executive subcommittee calls, we haven't seen him since all of this happened. So since we're actually seeing him today I wanted to take a moment and congratulate Jim Scanlon, our director, for his well deserved promotion at HHS. He was previously acting deputy assistant secretary for science and data policy in ASPE and he's now the deputy assistant, got rid of the acting, deputy assistant secretary for science and data policy. We're obviously delighted about the promotion and Jim since we're seeing you here in person congratulations.
[Applause.]
MR. SCANLON: I think I set a record for longevity in that acting position and I hear that I've been nominated for thespian --
DR. COHN: Congratulations. I also want to thank the full committee for all of your comments and suggestions at the end of our last full committee meeting in terms of meeting planning. I think many of those suggestions were taken to heart by myself and by the executive committee as we planned out the meeting today. We will obviously continue to fine tune this and this will be sort of an ongoing conversations likely at the end of each of our meetings about how we can make the meetings more useful and helpful. But I'm hoping that all of you will feel that we will at this meeting have considerably more time for discussion and reaction about the topics and issues that are coming before us.
Now the other thing that sort of came out of that meeting was I think a discussion about what I described as strategic planning. Based on your input we are at least discussing the possibility of a full committee strategic planning session attached to one of our full committee meetings in 2006. I'm not formally announcing it at this point but I think it will be an ongoing part of conversation about how we can do this in a way that is useful and successful.
Well with all of that background let's talk about the agenda for a minute. This morning we begin with an update from the department, we start with Jim Scanlon, our executive director, followed by Karen Trudel, thank you for joining us, and Susan McAndrew from the Office of Civil Rights. After the break we'll be talking about the health claims Notice of Proposed Rule Making, as this is an open comment period we'll be reviewing a draft letter that the Subcommittee on Standards and Security is bringing forward in relationship to that. Late this morning we are pleased to have David Brailer join us for an update on the many new initiatives and contracts underway, sort of once again an exciting time.
After lunch we'll be beginning to discuss a couple of issues, we start off with Mark Rothstein, we'll be discussing the status of work underway by the Subcommittee on Privacy and Confidentiality relating to privacy and the National Health Information Network. This will be followed by once again a presentation and discussion being led by Stan Huff relating to hearings being undertaken by the Subcommittee on Standards and Security on secondary uses of clinical data.
Now from there we will break up into subcommittees and workgroups for the remainder of the afternoon and we'll talk about that potentially in the afternoon about where we'll be going, what the various meetings are as well as the starting time tomorrow which is actually at least to my knowledge unchanged from your current schedule for a change of pace here.
Oh, I did want to before I finish here mention at 6:30 there's a dinner for the full committee and staff and I guess we'll be identifying people, getting a number after lunch.
Well with that, Jim about if I turn it over to you and thank you.
Agenda Item: Update from the Department - Mr. Scanlon
MR. SCANLON: Thanks very much, Simon, and good morning everyone. As Simon indicated a number of developments have taken place, progress continues to be made on health information technology and policy here at HHS and I think it's fair to say that we're now seeing the fruit of many of the collaborative relationship between NCVHS and the department over a number of years, many of the ideas that you now see manifested in contracts and in structures and in directions you'll remember had their nucleus in many cases in the discussions here at NCVHS and I hope the collaboration will continue forward as well.
As Simon indicated the AHIC, the American Health Information Community, had its inaugural meeting on October 7th, I think we'll get a report from David later today. The focus there was pretty much as an initial meeting always is on kind of getting organized, but then they began to turn their attention to what are possibilities for fairly quick progress use cases and applications. And I think they have another meeting scheduled late in November, the 29th I believe it is, and I think hopefully some progress will be made in those areas where what is the committees, what the community's desire in terms of moving forward. There's no meeting I think scheduled in December and then I think there's working on a meeting in mid-January.
Aside from that there are a number of activities that Karen and Susan and David will describe later today. Again not only e-prescribing and some of the HIPAA progress but also on the FDA side you'll remember a number of initiatives at FDA aimed at, and many of them again coming out of the committee's recommendations, aimed at bringing the benefits of interoperable health information technology to that world as well. You remember seeing the bar coding, the proposal for bar coding that would incorporate standards. There are some other initiatives that will be coming forward again from FDA that will support Rx-Norm and Daily Med and it's kind of bringing all of these various strands of health information technology potential together across a lot of department's programs. Mike?
DR. FITZMAURICE: Jim I wonder if I could add to what you reported, I'm going to be leaving today about 11:00, 11:30, to go to a celebration at FDA, they have just had the first structured product label come in from a manufacturer, be approved by FDA, and then put up on NLMs Daily Med website.
[Applause.]
DR. FITZMAURICE: This is the start of the pipeline for getting all of those little package inserts up on a website where people can read them, it's also a place where knowledge vendors can go and form a common base with all the other knowledge vendors and add their value to it and resell it to electronic health record systems and others. This is quite a momentous achievement, could not have been done without the expertise of NLM and FDA and many others, and the financial support of AHRQ, that came from NCVHS, it came from recommendations by the Institute of Medicine, and many policy committees within HHS and our partners at VA and DOD. It's truly as Jim said a collaborative effort spearheaded around NCVHS's recommendations that the department do something and AHRQ working in collaboration with ASPE and Jim were able to make it happen. A lot of kudos for NCVHS. Thank you for your support.
MR. SCANLON: Let's see, let me turn to just for some contextual information the budget world. As you know we're, this is sort of what supports all of our activities, we're now in fiscal year '06, HHS like many other federal agencies is still operating on a continuing resolution, I think it's taking us through December and it more or less sets spending at the level of last year, a little bit, so we hope to have a regular budget sometime later. HHS is quite accustomed to this situation, we often have a later appropriation, but again we're hoping that some of the HIT initiatives, the standards efforts and others that we, and some other population statistics efforts that we worked for and got into the President's budget will find their way in the actual appropriate that's enacted by Congress as well.
Let me say a little bit now about the population statistics area, within our Data Council we have been working on data improvement and enhancement initiatives in five areas and again these are for the most part budget neutral, they are meant to try to find ways of improving and enhancing the data, collection of data analysis and the data availability in several areas that are of particular interest to the policy community, let me just briefly run through those areas. The first is in prescription drug utilization and expenditure data, this is both for program purposes and for policy utility as well. We have a number of enhancements underway, now that we'll have the Part D Medicare Benefit beginning in January much of this will support that. All of you who are eligible for Medicare I hope you've gone to the CMS website to look at your options for Medicare Part D as of yesterday.
The second area is health insurance data, we've had a lot of interest, actually it's more health and insurance seems to be the interest. As you know from our statistical systems we have estimates of the number of uninsured population in the United States, this of course is the other side of the coin of the population that does have insurance and what the nature of the coverage is. And our surveys tend to produce somewhat differing estimates of the size of the, and the relative size of the uninsured population so the Data Council and ASPE working with several of our agencies is trying to shed some light on why do they differ, what are the assumptions, are there artifacts that produce this difference. Interestingly the two surveys within HHS are reasonably close but the Census Bureau surveys, there are two of them, they're quite different at two extremes. So Census Bureau, the population, the current population survey, tends to produce the highest estimate of the number of uninsured. At any rate we're trying to work on why is that so, what are the correlates, what is this related to and so on.
A third area is really the state and to some extent the sub-state area and there are some efforts here looking at state data on health care access, utilization, health insurance coverage, so policy related data at the state and the sub-state level.
A fourth area deals with improving income information and associated information in our major statistical surveys. Again, the interest here is not pure data but data for policy purposes and we have a couple of activities there, in fact we're looking at, we held a workshop, federal workshop, about a month and a half ago where we pulled in all of the agencies that produce, that collect this kind of information on their surveys and as well as some of the policy community folks and tried to look at how we're measuring this, why are we differing. And we'll probably be doing an evaluation in the year ahead that looks at this more systematically and some ways of improving.
And finally but certainly not least we have again within the context of budget neutrality we have a race and ethnicity data improvement initiative underway under the Data Council's auspices. The Council is looking at ways that we can get better use out of our current resources, how we can draw more attention to getting the data analyzed and organizing the data a bit better on race ethnicity related to health and human services. And we're looking at some web based approaches, we're also looking at possibly some workshops in the year ahead where we can bring together the major HHS data producing agencies with the analysts and see if there are ways we could increase their interest and their ability to analyze the data. We can't really do it all here as you know in HHS.
We've also started a study that kind of combines the data standards area with our statistical systems area. We've initiated a study of data standards, again these are more content standards, not message format standards, code sets, data item standards and so on in our major HHS statistical systems. And we've identified sort of three phases I think the committee could help us here as well, the first stage will be just to pull together in one place the various code sets, standards, content oriented standards in the health area that are existing. And this would be looking at CHI standards, HIPAA standards, there are a number of statistical policy standards, for example the race ethnicity standardized data item measurement is a statistical standard. There are standards for classifying industries and occupations and so on, so we're going to be looking at what are the extent standards currently in some formal or informal a set of adoption, what are people working on, that's the first compilation --
MR. BLAIR: Does that so include identifier standards like NPI?
MR. SCANLON: Well these are statistical systems so I'm not sure, we'll probably to look at to what extent they would be applicable but in the statistical systems to be honest there's virtually no interest in individual identity other then for the initial data collection and then for matching --
MS. MCCALL: I'm sorry, I missed the question, can you repeat the question?
MR. BLAIR: My question was whether the evaluation included identifiers, for example the National Provider Identifier.
MR. SCANLON: That's probably not going to be in initially but I think we would at least include those in the focus. I could see down the road where the National Provider system for example, the data system itself, could be very applicable to our surveys, particularly our provider based surveys. But the initial focus will be on content code set standards, ICD, CPT, you know the alphabet as well as I do, that will be the first look. But the second look --
MS. MCCALL: The question that I would have is in addition to code set standards will there also be work on standard, I guess we'll call it classification of taxonomy systems, so how to group them so that you get the same answer.
MR. SCANLON: Well yeah, the whole idea of statistical classification systems is, and there's a long history actually on the statistical side as you know to help do this, on the economic side, and yes, those will be parts. We actually have, they're not all that well known but within the federal statistical community there are a number of statistical policy standards, they are classifications just like that and theoretically agencies are supposed to be using them when they collect that kind of data, so those clearly will be there. We're also, we have a contractor to help us here and we've asked them not only to look at the formally adopted standards but are there almost best practices, conventions, that people say well yeah, if you're going to do that then this is the way you should do it.
MS. MCCALL: Will those be published as well?
MR. SCANLON: I think so, yeah, we'll put together a compilation with all the references and source documents, but secondly, that's the first stage, the second stage would be to look at maybe our major statistical workhorse kinds of systems possibly up to two dozen, this would include the family of health care provider surveys, emergency departments, doctor's offices, hospital discharge data. It will include the Health Interview Survey, the MEPS(?), the Medicare current beneficiary survey, the mental health and substance abuse surveys, so we'll be looking at those in terms of what standards are they employing now, I certainly hope they're using the race ethnicity standards, that's already been adopted as policy, but to what extent are they employing some of the other standards as well. And then based on that to look at some directions for future work, this would be sort of benefits cost potential, what are the benefits, what are the limitations, what's the applicability, and there's always cost as you know associated with these things and to kind of give us some ideas for moving along.
So I think we'd like to, I've asked the Data Council to kind of serve as our internal brain trust on this issue and I would like to bring this to the NCVHS when we move a little further along to get some feedback as well.
And then finally on the privacy side and again combining privacy and statistics we've employed a consultant to begin to pull together kind of in a monograph form the current authorities in policies and practices for statistical confidentiality in our research and data systems. So this would include the statutory authorities of the National Center for Health Statistics for AHRQ, for SAMSA has some as well, and then other practices and policies related to data sharing as well, so that we hope to begin. Much of this information as you know is known but it's not really been pulled together in kind of one overall monograph as a reference and I think we're asking, we're going to have that project as well.
So let me stop there and see if there are any questions.
DR. COHN: I think there's probably a variety of questions. John Paul and Jeff.
MR. HOUSTON: The last comment that Jim made, when you were talking about confidentiality were you also looking at standards to ensure that as data is aggregated that information couldn't ultimately in the aggregate be such that it can be --
MR. SCANLON: Disclosure avoidance standards.
MR. HOUSTON: I wasn't sure whether that's what you were referring to. And that will be published as to what those standards are going to be in?
MR. SCANLON: Whatever the authority for it and the practice and the policy, we will describe those, yeah. So we'll go from, I mean in many cases NCHS and AHRQ they actually have statutory protection of information, identifiable information, comparable to the Census Bureau which is always sort of held up as a gold standard. So taking that authority out of the agencies, employ that, what are the policies and practices they use to kind of cover that through the entire effort. And disclosure avoidance would be one of those areas.
MR. BLAIR: Thank you, Jim, I think that it sounds like the way you've describe it that this is an inventory which certainly is needed. One of the things that I tend to think of because of the work on NCVHS since we've been working in this area for so long, or at least I tend to think of these not just as line items with the number of folks that are using these for statistical purposes, we tend to think of this, or at least I tend to think of it as something that is dynamic, that is evolving to provide additional capabilities where some of the clinically specific standards will be very enabling. And of course the National Library of Medicine has been doing mapping among many of those code sets. So my question is will this research paper, I don't know what to actually call it because I don't think you refer to it as an inventory, will it identify the code sets or terminologies which are mapped by NLM and will it identify the purposes for which each of these code sets will be used?
MR. SCANLON: You're referring to the data standards project, right?
MR. BLAIR: Yes.
MR. SCANLON: It's not meant to be an inventory at all, it's meant to be an evaluation of the extent to which and the potential of to what extent the existing sets of code sets and content standards and statistical policy standards are being employed and if they're not sort of what are the barriers and what's the utility. It may be that standards that are quite applicable for clinical description or reimbursement make no sense in a research or statistical program in the sense of you're starting there with it, it depends, I think you could argue for the standardization as well as for the, when you're trying, you're usually trying to pick the best measure when you're doing research or statistical work.
So I think we're keeping an open mind but it's not meant to be an inventory, it's meant to be these are the standards that have already had some measure of adoption or use and it will include the content standards that NLM is looking at. And you're familiar with them, it's everything from ICD to, and ICD is used in some, it's used in our mortality classification system, it's used in, I think it used to be used in the Health Interview Survey, I'm not sure it is now, I think in some of our provider surveys.
But it's much more then inventory, it wouldn't really be worth our time to do just an inventory, we want to see to what extent they're being used. Again there may be reasons why they're not being used, we'll have to see what exactly that is. There's always the balance in a survey or in a research project that has specific objectives, you have to find the measurement of the variables as you all know as well as I that best suits the question and that's always, that's sort of where you start, if a standard is the best way to do that and it often is certainly for continuing statistical system then there's almost no reason why the standard implementation and cost shouldn't be used. I think for example in the hospital discharge data I think that already employs some of our standards, ICD and so on.
But we'll see, I think we're just starting and I think we'll have to see where it takes us.
DR. COHN: I know Russ has a question and then I have a question and clarification and then hopefully we'll wrap this area up. Russ?
DR. LOCALIO: This is Russ Localio. Jim on your last comment about the consultant, I'm not going to ask who but when will it be finished and how will it be released and will there be a period of comment?
MR. SCANLON: We're just starting on it, we just awarded the contract, I won't mention who it is but he is well known to you and no one would argue that he's not probably one of the best experts on this area. But I'm guessing it's a sixth month study and I would be happy to come back, there's nothing confidential about it, these are well known, these are public laws and so on so I'd be happy to bring it back.
DR. COHN: Well I think Russ actually was asking some of the questions I was which is I think we all think that this is a fascinating investigation and we'd love to have some updates about it as you move forward, I don't know if it's a presentation for February or a presentation for June but potentially we need to sort of figure that one out. I think from my view, I mean given that, this is an area where obviously standards are critical and there's obviously a tension here though because beyond standards there's the issues of there's sort of the pros and cons of linkages because the standards actually do provide some ability to be able to use the data for more then one would be able to use for otherwise, also reduce redundancy of repeated data collection which I know is something that I think is populations is thinking about as one of their issues for next year but there's also privacy issues, so I think there's going to be an interesting tension and a conversation we'll need to have.
MR. ROTHSTEIN: Simon, maybe we can invite the contractor when he's finished to give a presentation to the full NCVHS on some of the findings.
DR. COHN: Well I was actually thinking that maybe even during the process we might get an update in the middle and the answer may be both. But absolutely --
MR. SCANLON: But again, this information, these are public laws and regs and so on, it's just that they haven't been pulled together, some of you are familiar with these, those of you who do business with our research and statistics agencies but again this would be a place of pulling it together and when you're pulling things together you do find comparisons and contrasts and interpretation.
I guess one other thing, Simon, if I have the time, we were planning to have the NCVHS brief the Data Council on the race ethnicity data recommendations, I think they're formally transmitted now and we have them within HHS and perhaps at a, we'll work something out but I think we'd like to have a briefing to the Data Council and I think it fits in well with our internal initiative on race ethnicity data.
DR. COHN: I think our chair of Populations would be more then pleased.
-- [Laughter.] --
DR. COHN: Well Jim thank you for a very interesting update, and Michael, congratulations. Actually before we move on I do want to suggest that potentially given the work that's happening I think an important event around package labeling that maybe the committee would like to prepare a letter congratulating the, I'm not sure what the term is, the department, I think we'll have to get some help from Mike about exactly who to send this to.
DR. FITZMAURICE: I would say it's an NLM, FDA and AHRQ, and the department for recognizing the importance of this.
DR. COHN: Is everyone okay with us preparing such a letter? Okay, great.
Okay, Karen you're on next.
Agenda Item: Update from the Department - Ms. Trudel
MS. TRUDEL: Thank you, I'll start with an update on some HIPAA issues and then move on to some general health IT/e-prescribing things that are underway.
As I think everyone is aware CMS Medicare fee for service has ended its contingency plan for inbound claims so we are receiving now only compliant 837s and the statistics show that as of last week we only rejected 5,000 claims and that's a drop in the bucket for Medicare fee for service for being non-compliant. The 835 remittance advice, we are up to 92 percent of the receivers in production so we're pushing forward towards that goal. And the 837 coordination of benefits transaction is somewhat behind that because we've been phasing in a COB contractor, so the statistics for that are about 31 percent of the submitters are in production at this point.
Very interesting to report though that in the summer we did phase in the electronic 270/271 and all of the 270/271 data is being held at a central data mart so that at this point people don't need to query the particular contractor that may be holding data. We started very slow and the volume has just skyrocketed, for this quarter so far which is just October and half of November we've received 2.8 million 270s and have been able to turn them around in just a few seconds.
We have 20 submitters in production, they're primarily clearinghouses and providers with very, very heavy volumes, they're having to do this over regular phone lines. And there are about 50 more submitters who are somewhere in the process of establishing connectivity, testing, and moving into production --
DR. STEINWACHS: Karen, for those of us less knowledgeable, 270s are --
MS. TRUDEL: I'm sorry, that's an eligibility query and response, I mean to say that right up front, eligibility query and response.
DR. STEINWACHS: Thank you, we were talking about a highway leaving town --
-- [Multiple speakers and laughter.] --
MS. TRUDEL: I apologize for throwing around numbers and acronyms.
The internet version of this will be available in approximately the April timeframe and that's intended for smaller providers who don't have the kinds of volume that would necessitate their actually establishing connectivity, going through AT&T or whatever. So I think we're doing very well with that and the fact that we've had 2.8 million queries coming in just tells you that people really are taking up on these other transactions that are coming along behind the claim as we always suspected that they would.
The attachments proposed rule I'll talk about a little bit more later, the comment period will end on November 22nd and I'll talk a little bit later about the fact that we've been receiving some industry push back on extending that so that people can make a really careful analysis of the technical documents that go along with the proposed rule.
The HIPAA transaction and code set and security complaints, I don't really have very much to report, we still are getting very small volumes as compared to OCR and for the most part we're having excellent good luck on achieving voluntary compliance and we have about six corrective action plans that are in process that are being monitored at this time.
The NPI, the National Provider Identifier, we continue to enumerate providers to issue IDs through the web based system and two of the other aspects to NPI implementation, the data dissemination process and policy and the procedures for enumeration not on a one on one basis but in terms of large files, which we call bulk enumeration, the procedures for that will not be available until sometime in 2006 but we do continue to work for those.
Let me turn to e-prescribing a little bit, as Simon did mention the final rule was published on November 7th, we were all very relieved about that, and have gotten some questions but mostly a lot of good feedback and relief that it happened. We now turn our attention to the pilot that was required in the legislation and our friends at AHRQ have agreed to help us with that process, they already have a process in place that's excellent for reviewing scientific type studies, and we're taking advantage of their expertise.
We received 16 proposals and 14 of them met the basic criteria that were in the RFA, so they moved forward into the study section process. The review panel will met on December 1st and 2nd I believe and the panel is composed of a number of distinguished experts in the area of e-prescribing including Mr. Blair. So we're looking forward to, the ones we've looked at so far look really wonderful, there's a good mix of collaborators and partners and geographic areas and there's some, there's really some potential to find out some really great information from those.
Let me talk now a little bit about what we're doing inside CMS to try to cope with the, all of the initiatives and spotlights that are focusing on health IT these days. One is the office that I am in, the Office of eHealth Standards and Services, is the group that is coordinating all of the e-health activities within CMS. We have just established an eHealth Steering Committee, had its first meeting last week, and it's composed of the senior executives in the agency who have interest in the e-health area and they will give us guidance on strategic directions and priorities and things that we need to work on, not just projects like public health, personal health records, but also some underpinning types of initiatives like making sure that we have an integrated data strategy in the area, in the agency, that will support not only what we're trying to do today with e-health, what we might need to do five years down the road, and also to support some of the department's initiatives that have to do with drug data, etc., so that's a very, very exciting area that we're embarking on.
Our second goal is to coordinate with HHS, especially the Office of the National Coordinator, AHIC, etc., and so we have also initiated some discussions and ongoing dialogues with the Office of the National Coordinator to make sure that whatever initiatives CMS undertakes are consistent with a direction that he and the Secretary are planning to go in. So I think that's probably a good thing.
On the personal health record front we did publish a request for information in July asking people in the industry what they thought CMS's role should be in the area of personal health records. We received over 50 responses and they were very robust, we are in the final stages of developing a summary of those responses, it will not include any action plan or policy on the part of either CMS or the department, it's strictly going to be a report of what was given to us so that's our first deliverable in the PHR area. I'm estimating that that will be published within the next month or so.
Our next step will be an action plan which we will be rolling out in the early part of 2006 that will say okay this is what the industry told us and we've digested it, we've thought about it in context of what the Office of the National Coordinator is planning to do, the RFPs, the contracts that are in place there, and this is how we think CMS should be positioned in the area of personal health records.
Just a couple things to report from what we did here in the responses, most of the respondents said that CMS should not be in the business of providing personal health records to Medicare beneficiaries. They felt that that was the wrong thing for us to do, that we should concentrate on educating on the benefits of personal health records, that we should concentrate on facilitating the exchange of data if the beneficiary authorizes it with the personal health record vendor that they have selected. We also received comments that I thought were rather interesting that we need to make sure that we are the ones, we CMS, pursue especially vigorously personal health records that are directed towards specific chronic disease management and similar areas where the market as a whole may not be going and where Medicare beneficiaries may have a particular need. So that was rather interesting.
I think that's all I have to report on and I'll take any questions.
DR. WARREN: Judy Warren. Go back and talk about, because I didn't quite understand, you said that one of the responses you got about the PHR was people thought CMS should not be doing that and yet they also thought that in some areas that PHRs may not show up in CMS may cover that void, is that right?
MS. TRUDEL: I think in some cases the comments didn't exactly gel with each other so that's part of the analysis process. I think the sense that I got from the comments taken as a whole were that we should not be in the process of actually standing up PHR products but that we should be working with the industry who develops PHR products and to try to partner with them or collaborate in such a way that the products that they stand up will meet the needs of our beneficiary population.
DR. WARREN: I guess I'm just concerned by some of the responses that you did share that if we have PHRs for individual chronic conditions, etc., that what we're doing is kind of supporting fragmentation of personal health data, which concerns me, that we would be making choices on partial data, I just want to be sure I understood what you were saying, the responses.
MS. TRUDEL: I don't think the suggestion was that there should be a personal health record product that strictly addressed diabetic management or COPD management but that the products that are available would be robust enough that they might have a component that would have tools in it that could help someone with that condition.
DR. COHN: Karen, before I open it up are you done?
MS. TRUDEL: Yes.
DR. COHN: Okay, I wasn't sure whether people had jumped on this one. Okay, Harry I think you're next and then Paul.
MR. REYNOLDS: Thanks, Karen. Two questions, you mentioned the 270 which is the eligibility, I don't think you mentioned the 276/277 which is the claims status.
MS. TRUDEL: No I didn't and I didn't for a reason, the 276/277 because it is the claims status can only be handled by the specific carrier or intermediary because they're the ones that have the information about the claims status as it is at the moment. And so all of the carriers and FIs have implemented 276/277 functionality and from what I'm hearing they're not receiving very many of them. I think that one of the reasons why the 270/271, the eligibility, has become so popular is that we do have the data mart where all the queries go to one place and the clearinghouses especially find that very, very convenient.
MR. REYNOLDS: Second question, out on the HHS website it was noted that claims attachment rule is now schedule sometime around 2008. Is that a position or is that --
MS. TRUDEL: The claims attachment final rule? It's very difficult, the regulation agendas that are published because they go so far out into the future very often are developed on the basis of well it will take six months to do this and 12 months to do that and three months to do that, so you really need to look at those as a guide post as opposed to a cut and dried date.
MR. REYNOLDS: Since the committee is about to send a letter forward I just wanted to make sure whether that was just kind of somebody putting a boilerplate answer down versus a position.
MS. TRUDEL: Pretty much, yeah, I mean we try to beat the dates to the extent that we can.
MR. REYNOLDS: That's fine, thank you.
DR. TANG: I have a couple questions please. The first is do you consider facilitation of online care including its reimbursement part of the health steering committee's jurisdiction or things to discuss?
MS. TRUDEL: I'm sorry, could you repeat that?
DR. TANG: So you said there's an establishment of the eHealth Steering Committee and you talk about some of the projects like PHRs, is one of the topic areas to be considered facilitation of online care including its reimbursement?
MS. TRUDEL: Actually we've had to make some fairly tough decisions about what is in the purview of this committee, which is e-health and health IT oriented, and what is in the purview of our quality council which is another executive level organization. And they tend to look, if you look at it it's kind of quality slices this way and health IT slices this way and the decision is that the quality related items stay with the Quality Council, so they're the ones who are interested in tele-health and electronic health record adoption issues, vista, things like that.
DR. TANG: And electronic visits, or electronic encounters would be in that, the quality area?
MS. TRUDEL: I think if that's something, if anybody in CMS is thinking about it that would be the group that is.
DR. TANG: And the second is, relates to, and this may be premature to ask this but you talked about some of the feedback saying that CMS should not be in the business of offering a PHR, do you interpret that as saying that the kinds of experiments you're doing in Indiana with the beneficiary health data accessibility over the web as not, do you interpret those comments to say that that's not something CMS should do?
MS. TRUDEL: No actual I don't because the beneficiary portal was never really intended to be a personal health record per se, it has some of the qualities of a personal health record but it doesn't have an awful lot of the qualities that people seem to think that a personal health record should have. So I think that what we're doing there is a tool that has some personal health record like functionalities to it and I didn't get the sense from any of the comments that we should step back from that.
DR. COHN: I'm just reminded by our letter that we passed in September about the ambiguities around exactly what a personal health record is and isn't and is it a portal, is it a, I mean is it a what, and I think that may be some of the reflection we're seeing here. Thank you, Karen. Michael.
DR. FITZMAURICE: I think Paul probably asked one of my questions which was the personal health record, I think what CMS is doing to make information available from the claims data to the beneficiary, I think it's outstanding and would hope that those comments wouldn't be construed to say gee we shouldn't do it, and I think your answer was no, you think it's a good thing and you'll keep pursuing it.
So my only remaining question is at the very beginning you gave some numbers and statistics about the claims, 31 percent of submitters are in production, but there were some at the very beginning, I'm not sure if you mentioned the 837 or what others, you mentioned the 835 remittance advice, I wonder if you could just briefly review those.
MS. TRUDEL: Right, for the incoming claim which is the 837 we're rejecting any transactions that aren't compliant.
DR. FITZMAURICE: And what percentage or what number of those have been rejected? In the past month or whatever you have.
MS. TRUDEL: I mean we're taking 99.9 something of claims are compliant at this point and they have been for some time. The number of rejects last week were just a little over 5,000 Medicare wide.
DR. FITZMAURICE: And after that was the 837 --
MS. TRUDEL: The 835, the remittance advice going back out to the provider and that's at 92 percent of receivers in production.
DR. FITZMAURICE: Very good, CMS is to be congratulated on this.
MS. TRUDEL: Thank you.
MR. BLAIR: The eligibility of the 270, what percentage is that now?
MS. TRUDEL: You can't do percentages on eligibility because you have to be signed up in order to conduct the transaction, so essentially 100 percent of the people who've qualified are conducting the transactions but we did 2.8 million transactions in the last month and a half. And that's with only 20 submitters.
MR. REYNOLDS: Which some of those in the past, Karen, probably would have been phone calls.
MS. TRUDEL: Many of them would have been phone calls, yes.
DR. COHN: Probably millions.
MR. REYNOLDS: I was serving it up for you so you could get --
-- [Laughter.] --
DR. COHN: I actually had a question for you and once again I think I was referencing that one of my joys in life is to actually read final regulations from CMS and certainly there's enough there to keep everyone busy for probably decades if not longer. But I was particularly fascinated in the e-prescribing rule and I will apologize, you can certainly say no comment to the question that I'm asking, but the committee has gone on record as have many others about this concept of streamlining the processes relating to both HIPAA and other regulations in this area and we've talked about that in relationship to claims attachment, we obviously had talked about that in relationship to e-prescribing and we've also talked about it in relationship to HIPAA.
Now I was very gratified to see that there was a discussion about potential ways that things may be streamlined for e-prescribing and for those of you who didn't read it there's a concept at least in the discussion part of the, it's 150 page discussion, the five page law, but that describes how CMS is I think considering strongly the approach of backward compatibility and if things seem to work and the public and NCVHS and everyone else thinks that a new standard or revision to a standard is really backward compatible and it's of value to the country there may be a way to allow that to occur without having to go through full rulemaking process, or at least the Secretary might have some discretion in relationship to this.
I'm actually wondering, first of all I want to congratulate you, it looks like a very good move forward in terms of lessening administrative burdens and regulatory burdens for each sort of minor change, but is this something that would be at all applicable to the actual HIPAA regulations also? Or is it, do we need to see how e-prescribing goes with this first?
MS. TRUDEL: As it happens we are also working on another HIPAA modification rule which we hope will address some of the streamlining issues and we do, we have already scheduled a discussion to take a look back at what we've thought about HIPAA from the perspective of e-prescribing, so not sure how that's going to come out but we definitely are thinking along the same lines as you are.
DR. COHN: And I presume this will be an internal discussion about regs that need to come forward. Great, well congratulations. Other questions before we move on to, Jeff anything before we move on?
MR. BLAIR: It turned out that the final rule for e-prescribing was I think November 7th and the pilot test announcement for the RFAs, the requests for applications, was I believe late September, middle September, so in an effort to try to do everything that was possible one of the things that apparently was not possible was for them to be sequenced a little differently and as a result during that pilot test piece it indicated that, I think, I'm trying to remember whether it was the medication standard or medical history, was indicated as a initial standard as opposed to a foundation standard, and when I saw the final rule it wasn't exactly in sync. This may not make any practical difference because it's going to have to be tested either way but I was wondering if you had any clarification for us on that.
MS. TRUDEL: Actually when we published the RFA because we knew it was coming early we didn't distinguish between whether something was a foundation standard or not and we simply said that all of the standards including whatever turns out to be a foundation standard needs to be tested together, so that as far as I can tell from my read we pretty much kept our options open in the RFA and that whether the medication history and the formulary benefit management which were pretty much the two standards that were a little bit kind of on the cusp, whichever way that went we provided neutral language so I think we're fine.
DR. COHN: Well Karen, thank you very much, and congratulations on the various work going forward including e-prescribing and it sounds like your new work on e-health. So thank you.
Susan McAndrew from Office of Civil Rights, thank you very much for joining us.
Agenda Item: Update from the Department - Ms. McAndrew
MS. MCANDREW: Thank you. With regard to privacy rule compliance, as of the end of October we had received over 16,000 privacy rule complaints and we have closed 68 percent of those complaints. We are continuing to receive a fair number of non-jurisdictional complaints but the percentage of closers are also increasingly including complaints that are resolved through voluntary compliance on the part of the entity.
There has not been much movement in terms of the types of issues that are raised most frequently in those complaints, it continues to be headed by impermissible uses and disclosures as the primary reason that people are concerned. We also continue to get a lot of complaints raising the adequacy of the safeguards with regard to that, that plays along usually if you have an impermissible disclosure you have a safeguard that has broken down somewhere.
We continue to get a fair number of complaints that are concerned about denial of access to their health records, we also have begun to get more complaints concerning the amount of fees that are being charged with respect to those access of records and whether those fees are reasonable.
Minimum necessary is also frequently raised in our complaints as well as whether or not a disclosure required an authorization and none was provided in the record.
The types of entities also has not changed much, the most frequent entity type complaint against are private health care practices followed closely by general hospitals. In addition a variety of outpatient facilities get a lot of complaints as well as pharmacies and following somewhat behind would be a variety of health plans led by group health plans as the type of entity that is complained against. And we also continue to refer cases to the Department of Justice and we have to date referred approximately 256 cases.
I will say with respect to these numbers that we were finally able in conjunction with this meeting, Linda Sanchez and I were able to sit down with John Houston to discuss the potential for our own type of data mining and we had a very productive discussion about what the capabilities of our current complaint database is and what the current reports look like and we will have a continuing discussion with John and I believe tomorrow morning with the Privacy Subcommittee as a whole to identify additional data areas that would be of interest that are also feasible to extract from our database. So hopefully we will be able to produce, I'm not, I'm hopeful that this may integrate into the monthly statistics for the use of all but at least we may also, it may be that for the time being it may just be periodically more robust reports if we can't generate some of this data on a monthly basis, but we are very happy to be moving forward on that effort.
On some other fronts there was released just last week a new survey done by the California Health Care Foundation using, I'm forgetting their consultant, but they did, they had done a privacy survey largely focused on privacy and electronic systems back in 1999 and the 1999 survey predated HIPAA, the regulations, it was surveyed even before the NPRM was issued, so they wanted to do an update of that survey based on experience with HIPAA implementation as well as all of the new activity in electronic health records and other HIT movement in the health industry. I think we had met with them following their announcements of their privacy results, I think we're still looking at some of those results.
They had some very strong recommendations in terms of the additional need for public education which I think echoes many of the concerns that the committee has expressed and they also had made some comments about enforcement and we did question then on that because as I was looking at the survey results there really were no questions or data points collected in that survey that would cause them to, that would support their recommendation on attitudes toward the enforcement under HIPAA. So we were a little concerned about that being a headline item based on the survey results.
In other fronts, on the regulatory front we are in conjunction with our General Counsel's office and CMS coming to closure on the final enforcement rule and it's hopeful that perhaps by the next NCVHS committee we'll be able to have a report on a final enforcement rule. This is setting up, trying to make uniform the procedures across HIPAA in terms of how complaints are handled and investigated and how CNPs will be imposed and what the hearing rights will be with respect to any imposition of civil monetary penalties.
In addition we are participating with the other components of HHS in a new, becoming sort of an annual event, a regulatory reform task force has been formed up I believe, ASPE is in the lead on that together with OMB to take an overarching look at department wide regulation that may be imposing undue burdens on the health industry, and so they have launched a series, they have asked for public comment on regulations, department regulations in the health area that they impose undue cost. And in addition to those public comments they are starting a series of four public hearings across the country, the first one was held last month, earlier this month, I can't remember, in Washington, D.C. and there are four others that will be held between now and February in Chicago, Oklahoma City and San Francisco.
The other initiative that we are beginning discussions with AHRQ on concerns the recently enacted Public Safety and Quality Improvement Act which sets up patient safety organizations and participating providers who will be working on patient safety activities and producing patient safety work products which will have confidentiality and privilege conditions attached and there is also a scheme for, an enforcement scheme that relies on civil monetary penalties for violations of the confidentiality protections and there's also a private remedy which attaches to reporters of information on quality and safety who may have experienced an adverse employment action as a result of their reporting. And so we are talking with AHRQ in terms of handling the enforcement aspects of the patient safety civil monetary penalty.
And that's it.
DR. COHN: Okay, Susan, thank you very much. Paul Tang and then Mark.
DR. TANG: Two questions, one you reported 256 cases were referred over to the Department of Justice, what happens? Do we have any outcomes to report?
MS. MCANDREW: When we refer them to the Department of Justice the department has, will make a decision as to whether or not they will initiate a criminal investigation based on that referral. If they do not the case may come back to us and we would pursue that case just as part of our normal caseload if there are civil aspects to that complaint. Some contain only criminal allegations and so those cases we would close with the referral to DOJ.
DR. TANG: So have there been any prosecutions?
MS. MCANDREW: Actually there have to date been no prosecutions based on any of the referrals to my knowledge.
DR. TANG: What about the case in Seattle?
MS. MCANDREW: The Seattle case was not based on a complaint referral because we did not receive a complaint from that individual about that incident, but we did refer to the Department of Justice the press reports related to that incident. There's also a new indictment that has been brought in Texas for which I have very little information at this point, and that also as far as I know was not based on a complaint that we had referred. So they do, they have their own investigatory means as well.
DR. TANG: And the second question relates to a high profile case that was apparently brought to your office in terms of the JCAHO, is there something that you can share with us on the details of that complaint?
MS. MCANDREW: That is not really, that's not a complaint issue, we met last week with the American Hospital Association and actually will be meeting this afternoon with JCAHO and the American Hospital Association representatives to talk through their issues. The American Hospital Association had asked us for guidance on the scope of business associate activities under their contracts with JCAHO and so we're trying to, at this point we're still in the process of trying to identify what the issue is and whether or not there's any meaningful guidance that OCR can provide. I do understand there was some announcement recently by JCAHO, I think they were having their own board meetings yesterday and today perhaps and there was some article in the press this morning concerning that one of the recommendations is that JCAHO would no longer do the kind of data mining activity that results in the sale of information to Blue Cross and Blue Shield.
DR. TANG: The reason for asking that is because later on today we're going to be talking about secondary uses of data so I just want to thank you for sharing some of that.
DR. COHN: Mark Rothstein and then Carol McCall.
MR. ROTHSTEIN: Sue, we both know that John Houston has great plans for mining your complaint data but I have a question that may be not exactly flowing from John's use and that is to what extent has OCR used the complaint data to help guide its enforcement assistance activities? In other words it seems to me that having a sort of a feedback loop from the complaints could help decide in what areas you need more guidance, in what areas you want to emphasize in our outreach programs because you have lots of complaints in a certain area, people are obviously not getting it. Is there some system in place or have you thought about a system for having the complaints in some sort of aggregate form feed into your other activities?
MS. MCANDREW: We have from time to time used that, I think we haven't gotten to the point of doing that on a systematic basis and so it's of interest to us as well to in conjunction with John's needs and the committee's needs for this data is to raise the profile within OCR in terms of getting some more management substantive programmatic reports out of the system. Right now, it was really designed largely as a management monitoring tool so most of the reports that are imbedded in the system now go to workflow and monitoring progress and various administrative steps. Which are very helpful in terms of seeing how productively the regions are working, tells me very little about how the program is working. So we are interested in making a more programmatic use of that information and making that more systemic.
DR. COHN: Okay, Carol, I think we'll let you ask the last question and then we'll wrap this up.
MS. MCCALL: It's actually very related to Mark's comments and it has to do with some of the uses of the database, before the question just an observation that in a microcosm what you're experiencing is essentially, if you design the ebb to help the workflow but don't think about how you can use it to report, that's what we're going to experience if we don't understand how a lot of EMRs and EHRs are going to be used to actually drive quality, so keep that in mind, a taxonomy I'm sure is something that maybe Jim Scanlon's team could put together for you.
The specific question though, you mentioned volumes, that they come from private practices and hospitals, and which is not to be unexpected I would think because the volume of activity in those places, utilization tends to follow that curve, it's a lot more active in physician office visits then perhaps admissions and things like that. Will you be doing things that try to create a denominator for that so that you could say relative to the amount of care being delivered in physician practices versus hospitals in terms of just visits or admissions we get a relatively higher percent, so those types of things as well as others as you go about the data mining would be valuable. But do you have any insight into which has a relatively higher proportion?
MS. MCANDREW: I think other then just common sense and logic would say that the private practices and the general hospitals not only have many more interactions with the public and so therefore that's where the rubber meets the road for many individuals and I think also the individual, that kind of face to face interaction tends to heighten the individual's interest and expectations in privacy and how that data is being handled.
One of the things we were talking to John about that may go somewhat to your point is to try to correlate or get some profiles in terms of the size of the entities within the private practices, large group practices versus small groups, hospitals, number of beds, and that kind of thing. The database right now does not capture size.
DR. COHN: You'll notice that John Paul has not asked one question during this particular session, this may be the first time. However, John Paul did ask to make a final comment before the break.
MR. HOUSTON: Just a real quick comment, I mean the dialogue was really good with Susan and Linda and I just wanted to sort of expand on Susan's last point which is that we looked at some strategies yesterday to try to, since they only capture information by hospital, it's not hospitals over various sizes, you don't really get a sense on where some of the problems that big hospitals, that are small hospitals, that are rural hospitals, one of the things that we're thinking of trying to do, as we talked about is whether we can capture like bed counts, something out of an AHA guide or zip code to try to get a sense of where these hospitals are to try to get better statistics about where the problems lie. So again, I think there's a lot of opportunities here and trying to be practical about how to mine this data and get this type of information.
DR. COHN: Well we're looking for the Subcommittee on Privacy and Confidentiality to assist us with this in an ongoing fashion. Now I do want to break, I know we can continue on with the conversation but we do need to be back at 10:45 for our last session of the morning, so we're going to break for about it looks like 13 minutes. Thank you all.
[Brief break.]
DR. COHN: Okay, we are going to get started for our next session. What we are going to do for the next little bit, for our next session we're going to start out with a discussion about claims attachments, there's a brief presentation that Karen Trudel I think will be providing and then we'll be talking some about the letter that the Subcommittee on Standards and Security has developed. I do want to sort of explain to everybody about the timing of this next period. We obviously have time for the discussion about the attachments, we'll have I think hopefully to get at least some briefing about the letter that's been prepared. David Brailer needs to be leaving here exactly at 12:00 and I think we'll expect to see him at about exactly 11:30 knowing how he runs. So just recognize that we will do is to wherever we are with this letter we will put a hard stop to the letter at that point and then if we need to we can sort of talk about it in the afternoon either before or after our break to go to the subcommittees, but I think that will be the plan of action on this one.
Now I think Karen is in the process of getting the presentation so Karen I will turn it over to you for at least the background discussion about the claims attachment NPRM and then we can let Harry and Jeff discuss the letter.
Agenda Item: Briefing on Health Claims Attachments NPRM - Ms. Trudel
MS. TRUDEL: Okay, thank you very much, I would beg your indulgence on this, I'm pinch hitting for this at the last minute, it's not my presentation and I apologize in advance that it has some somewhat distracting animation in it. Luckily people will not notice on the internet.
One thing I'm going to say before I start is that while I mentioned earlier that the claims attachment NPRM comment period date closes on November 22nd we did receive a very large number of requests from various industry representatives saying that because of all the technical documents, the booklets and different things that go along with the rule people really felt that they needed more time to review and provide comments and people asked for extensions of anywhere from 30 to 60 days. We are very sympathetic to that, we would rather have good complete comments before we go into the final rule period so that we don't have to deal with an issue like the HIPAA modifications when we had to go to the 4010A.
So we are working on putting forward a proposal to extend the comment period for an additional 60 days, it would be a Federal Register notice and it is not completely approved but it is in the review process so I'll just mention that. However until that comes out the official date for comments still is November 22nd just so you understand that.
Again I'll just start from scratch very quickly for members that weren't around back in the stone ages. The claims attachment standard is one that is required by the original HIPAA legislation and it is a health care claims attachment so it is an attachment for a health care claim, not for a referral or remittance advice or for other uses, so we're only talking about developing a standard for this purpose. And it is the additional clinical or administrative information needed from a provider to allow the health care plan payer to adjudicate a claim, so this does not have to do with, again we're excluding requests for information that come post adjudication for purposes of medical review cross periods of time, this is a request for a specific piece of information required to adjudicate a particular claim.
And I would say that, venture to say that in the administrative part of the health care industry the claims attachment process is the most manual, the most time consuming, expensive, and inefficient. It is something that is just plain not automated at all at this point in time.
So the proposed rule clearly affects all covered entities under HIPAA, we all know that. The health plans will be required to be able to accept or send the transactions, the providers as always have the option of using the transaction or continuing to conduct their business on paper. And clearinghouses if they are in the communication loop will be required to use the standard transaction. We're proposing six types of attachment standards, only six, and again everything else that's outside that scope is something that is not being regulated at all so there are no constraints on what people can continue to do outside the scope of these.
The standards that we're proposing, and I will attempt to stay out of acronym land now, there is a request for information, it is a HIPAA transaction, an X-12 transaction called the 277, so that is the request that comes from the health plan and goes to the provider. The response that comes from the provider back to the plan would be the X-12-N 275. The codes that will be used in that request and also in the response are LOINC codes which are a CHI standard and they are the list of codes that identify the specific information that is being requested, so it's a codified way of saying this is exactly what I want you to give me, totally, unequivocal.
The additional information specifications are the basically the content format and what the LOINC codes are that associate with each type of attachment transaction because their subject matter is different, the content is different, the specific LOINC codes that associate with, for instance an ambulance claim is different then for a therapy claim attachment. And the clinical document architecture, the HL7 CDA, is the XML based document markup standard that would include the clinical content, the payload if you will that goes back to the health plan in response.
The proposed attachments are for ambulance, emergency department, rehabilitation, and there are nine different categories of that including cardiac, rehab, PT, OT, psych, substance abuse, laboratory results, medications, including current and discharge meds, and clinical reports which could be almost anything in text form, op reports, discharge notes, etc. And again it's important to note that these attachment types don't actually correlate to a specific claim type always, in other words an ambulance attachment probably will correlate with an ambulance claim, however a laboratory result request for an attachment may correlate back to an ESRD claim where for some reason the service that was built for dialysis there's a requirement for laboratory results before the plan can determine whether or not they're going to adjudicate the claim. Same with medication, same with clinical reports.
There are other attachments under development, we're not recommending them at this time, they're not really relevant to the discussion, but there are HL7 groups working on home health care, DME, periodontal, and children's preventive health service attachments, and they may come up for adoption or consideration at a future time.
When we begin to talk about claims attachment data, electronic data, and how it affects business processes it became very clear that there really are two different variations. One is what we call the human decision variant which means that the information that is coming in maybe electronic but it can't be utilized but a computer so you may have a scanned image or a text or an image of a health record, it can come in electronically but a computer can't work with it. The computer decision variant is one similar to what is being used for the structured product label where the values allow for automatic processing on receipt.
We're allowing for both in this environment, we think it's asking a little bit too much to expect that health care providers will immediately jump to a computer variant process because it requires a significant reengineering of their business processes, and the same with health plans. So we allow for both, the attachment can be submitted on paper if the provider wants to, the attachment information can be coded into data and sent electronically, it can be sent electronically but the plan may convert it back into text, it really doesn't matter to us, that's all okay. But both variants basically encourage participation in some level of electronic attachments.
I will only take a moment on this because this is the flow of the attachment request and response, it starts when the service is delivered, the provider submits a claim. If the health plan decides there's a need for more information they request it using the 277, the provider sends it back, and I think we've just looked at that enough.
We've already talked about the comment period extension, again judging rule of thumb NPRM to final rule a year or more, and from the date of the final rule to implementation is two years, so that gives you an idea of the actual time in the future that we're talking about to implement.
Of course the attachment standards can be used voluntarily prior to that date, there's no stopping anyone from using them even today. And we have already conducted a CMS pilot to look at the proposed standards and came up with a number of changes that we believe need to be made. We are encouraging industry to investigate other opportunities for pilots and the more pilots we do the more we find out the little hidden problems or potential improvements with the transactions.
I think I survived.
DR. COHN: Karen, thank you very much. I actually want to say that I think some of us have received this presentation via conference call and the conference call does not do the presentation justice. I also I think would further say that every year we sort of reflect on maybe the single presentation that had the most interesting aspects to it. We may want to consider this one to really be the presentation of the year as far as, and unfortunately for those on the internet, I mean the number of, the amount of animation was really wonderful.
Anyway, Karen, thank you. Any particular questions about the presentation before we move into the letter? Paul.
DR. TANG: With the flexibility in the proposed rule meaning basically all kinds of variance in the ways it can get to you is this rule viewed as sort of an encouragement rule to get people to start getting closer to computers? Because it doesn't sound like it's moving a great towards standards, at least enforcing standards. Am I interpreting that incorrectly?
MS. TRUDEL: Well I think even the basic level of standards use is a significant advantage because it does allow for the plan to ask for exactly what it needs and it provides structure to the provider in that the provider can know by looking at the LOINC code exactly what the plan needs. Very often what happens now is that the plan asks for something, the provider is not exactly sure what the plan wants, and they send the whole medical record, or the whole record of the encounter, they could possibly send one lab value and they send the information that relates to a full hospital stay. So I think that's a significant advantage.
You have the ability to send these things via EDI where even if it's just a scanned image it is being sent electronically so you're not faxing. It's a lot easier for the plan to associate the information back with the claim which they've suspended and is hanging out there in their system. And so I think there really are a lot of advantages.
The other thing is that, and we don't go into this in the presentation, but we specify you ask for what you need once, you don't keep coming back if you're a plan. So if you need information ask for it all one time and I think providers will find that to be advantageous because you don't get into this tennis match kind of process where you provide data but it wasn't the right data so they ask you for it again and you provide it again. So I think that's going to be considered another advantage.
DR. TANG: So I can see that the value in moving along the path, is there a roadmap to a completely standard of more streamlined way of sending information and getting it adjudicated in an automated fashion on your end? I mean so I see all the advantages of where you're taking in your first step, are there future steps to follow?
MS. TRUDEL: I would say that the steps that should be taken in the future probably should not be taken in the HIPAA arena because keep in mind that HIPAA is a requirement, there are penalties, there are enforcement aspects to HIPAA, we're stating what the standard looks like, we're setting the stage, and now I think we let the industries, health IT and EHR adoption processes to feed along with that.
Another thing that's not mentioned in the presentation that's important to remember is that this standard is the first one where the HIPAA administrative transaction world meets up with the CHI clinical standard world and it's the first time we're using X-12 standards which are administrative primarily, with HL7 which are primarily clinical, with LOINC, and all of them together form the bridge to get from administrative to electronic health records. And if you don't build that bridge and people aren't thinking about it, if EHR vendors aren't thinking about how could I take my content in my EHR and turn it into something that I can pass to a practice management system so that it can create a claim you're again going to have two silos.
DR. COHN: Steve and then Justine.
DR. STEINDEL: I'd just like to introduce some clarifying words in terms of terminology because in the last few months the CHI standards have taken on a broader perspective then when they were originally introduced and Karen you used the words LOINC and you said it was a CHI standard, specifically the laboratory names portion of LOINC is a CHI standard and not all of LOINC --
MS. TRUDEL: I stand corrected.
DR. STEINDEL: And the actual attachment standard points to three parts of LOINC, the clinical LOINC, the laboratory part, and the attachment part of LOINC. The attachment part of LOINC if this is approved will by default become a CHI standard because it will be a HIPAA standard but the other parts would have to be looked at.
DR. COHN: Okay, Justine?
DR. CARR: This is really helpful and clarifying, I appreciate it, and maybe this is a naïve question. When you say the proposed attachments, there are six types and four others proposed, is this the current state or is this derived from current state of what would be able to be transmitted? Just some clarification on how these, why these six --
MS. TRUDEL: That's an excellent question. When we started looking at this it was pretty clear that no one was exchanging any attachments electronically and the group that was doing the groundwork for this essentially did some surveying and found that there were literally hundreds of potential different kinds of attachments, some extremely specialized. And so they tried to do some kind of 80/20 analysis to figure out if we only adopted a certain number of them where would we get the biggest volume and the six that we're proposing are the ones that if those were automated those are the ones that the industry would be most likely to adopt and the ones where the types of data that's most often requested in a claims attachment.
DR. COHN: Other questions? Bob Hungate.
MR. HUNGATE: As I looked at the flow chart the presumption is that the claim when it originally goes in says nothing about claims attachments, that the claims attachment process is triggered by someone asking questions. Now I can visualize a data mining methodology where a hospital might mine its data and find that this vendor always asks these questions about this kind of claim. Is there provision in the claim information to say this claim will have these attachments? Is there a way to link the information from the claim to the required attachments based on a specific vendor?
MS. TRUDEL: That's an excellent point and that's something that is debated in the proposed rule. What we found in some of our initial discussions was that providers said oh for heaven's sake, I know every time I send an ambulance claim this plan is going to ask me for this piece of information, why can't I just send it all at one time and that's more advantageous to my processing and my cash flow. What the plans said was yes that's true but if you send me attachment information that I don't expect I don't know what to do with it and it seriously affects my business process because then I'm sitting here with this piece of data with no claim to associate with it and I don't know what to do with it, all I can do is store it and hope that the claim will come in.
We've tried to split this down the middle and our proposal was that for the most part an attachment would be based on the plan asking for information from the provider. However in situations where a plan is willing to tell its providers in advance this is how I ask for information then the provider could send it in at the time of the claim and we request comment on this because it's really a very tricky issue for business processes on both sides.
MR. HUNGATE: That's good, glad to hear that.
DR. COHN: Carol McCall?
MS. MCCALL: You talked about bridges and I think that they're going to be absolutely critical. The question that I have here around the standards and the taxonomies that are being used, do you know the extent to which these are being integrated in some of the AHIC work and the RFPs and the certification essentially of EHRs?
MS. TRUDEL: Steve is going to answer that for me.
DR. STEINDEL: Yeah, I can give a comment on that, Carol. In terms of the clinical information that's going to be transferred in the claims attachments the RFPs call for the people who were awarded the RFPs and for AHIC to consider the CHI standards in any discussions that they have about what standards to recommend in an area, and that's the standard government approach for this. So I would imagine that we would be seeing a congruence between what's coming out in the claims attachment and what's coming out in the electronic health record world. And at this point in time certification has not pointed to particular standards because that's a private sector activity and we haven't had any clear direction on that but they're planning to.
DR. FITZMAURICE: I would also add that the AHIC probably at the end of this month will be deciding on the use cases to be used throughout the standards activities and that will be the opportunity to see where the attachments and the clinical information within fits in with the use cases.
DR. COHN: Any other questions? Okay, well now, let's now turn to the letter.
DR. COHN: Let me tell you we obviously have a number of options with this letter, I mean this is a letter being proposed by Standards and Security, excuse me, Subcommittee on Standards and Security. Obviously we'll go through it sort of basically paragraph by paragraph, we may make it through it in the next 15 minutes, I mean we have to at least go through it once today. If everybody thinks it's great we can obviously pass it, we can provide comment, take it back to the subcommittee, bring it back tomorrow. We could even decide that given that there's more time we could even decide that we need an additional letter. On the other hand if we do that we would have to convene a conference call of the full committee probably over the holiday season to deal with that --
MR. HOUSTON: Mr. Chair, are you threatening us?
DR. COHN: No, I'm just giving you your options. So I mean I think we can keep that in mind or if indeed there's a 60 day period we can do a follow-up letter with a conversation. The point I'm making is is that even if there is a 60 day extension we do not have a face to face meeting occurring until middle of February which is long after that window closes so if there are additional comments that really do require an additional letter we need to come up with another process to deal with that. So that's just sort of setting expectations.
MR. BLAIR: One thing Simon also, NUCC, NUBC has also written a letter which covers a number of topics which I think Steve or you might be able to point out that a number of issues are covered in that letter and we chose to not be redundant and cover them in ours. Did you want to make a comment about that?
DR. COHN: Well actually the comment I would make is that a wide swath of the industry, including many health plans, providers, organizations both public and private are obviously in the process of reviewing this and providing comments and I think that it's very appropriate, there are probably many people around the table whose organizations are providing comments to the Secretary as well as many of you are members of other organizations which are providing comments also. Jeff that's not quite the comment that you wanted me to make but I mean I think we're all aware of that and obviously these are meant to be NCVHS comments.
Okay, everybody okay with this so far? Okay, well Harry do you want to start off with this?
MR. REYNOLDS: Do you want me to actually read the letter or just go by paragraph by paragraph talking about the highlights?
DR. COHN: I actually would like you to read the letter given that it, yes I would like you to read the letter and then ask for comments or clarification paragraph by paragraph.
MR. REYNOLDS: And it's also great to follow Cecil B. DeMille(?) and read a letter. And we're going to actually put those highlights in the letter when we send it.
Paragraph one. As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) the National Committee on Vital and Health Statistics, NCVHS, is responsible for studying, selecting and recommending standards for electronic health claims attachments. We are pleased therefore to comment on the new claims attachment Notice of Proposed Rule Making, NPRM, which was published on September 23, 2005.
Any comments?
Second paragraph. NCVHS's interest in the topic of claims attachments spans several years including numerous hearings. Our recommendations most recently were provided in our letter on claims attachments dated March 5, 2004. We further evaluated the need for streamlined updating of transactions and code sets to keep pace with industry requirements and new use cases. This issue was addressed in the context of our recommendations on HIPAA related topics and included in the recommendation number two in our letter on electronic prescribing dated September 2, 2004.
Comments?
Paragraph three. We appreciate the efforts undertaken by the Centers for Medicare and Medicaid Services, CMS, in developing this claims attachment NPRM. We believe that the use of electronic claims attachments will help decrease the administrative overhead associated with clarification and adjudication of approximately a quarter of the health care claims submitted in the nation today and help advance initiatives related to the development and adoption of electronic health records.
John?
MR. HOUSTON: This language, a quarter, I would say one quarter.
MR. REYNOLDS: Okay, next paragraph. NCVHS supports the proposed standards for electronic transmission of attachment information for the six types of services as set forth in the NPRM but having only a limited time to review the standards offers no specific technical comments. We do recommend flexibility for adopting new claims attachments transmission and messaging standards in additional types of attachments. In particular the NCVHS recommends a streamlined process for adding new standards and attachment types and for modifying existing standards. The committee urges the department to investigate other ways that adoption of new versions could be accomplished without the need for the lengthy and cumbersome rule making process.
MR. BLAIR: Question on that? I notice that some of the recent bills in Congress seem to be continuing the process of having Congress specify a new version of, I think it was CPT codes and going from ICD, well, is that correct?
DR. COHN: Jeff, I think that's ICD codes you're referring to.
MR. BLAIR: And also there was an NCPDP code that they specified in the House bill that I saw for a different version. And so my question is whether it is sufficient for us to direct that recommendation to the Secretary or whether it's beyond the Secretary's ability to be able to make that modification without the support of Congress to modify the law, I don't know. Is there any guidance on that?
DR. COHN: Harry do you want to comment or should I try to comment?
MR. REYNOLDS: No, you go ahead. I have your wing.
DR. COHN: There are obviously a variety, in any year there are a variety of pieces of legislation that come before Congress and obviously without them passing one it's hard to comment specifically on pending pieces of legislation however obviously there is significant Congressional in both the issue about moving forward with ICD code sets and I of course would remind the committee that we have previously had hearings, had a RAND report that we sponsored in relationship to the issue of moving from ICD-9 up to ICD-10 which is part of, which we have gone, we are previously on record as supporting the move from ICD-9 to 10 in a measured and careful fashion.
It also turns out that there is a, to move to that one needs to have new ANSI X-12 standards just because the current standards cannot accommodate ICD-10 and so I think there is Congressional interest and discussion around all of this, the recognition that these two pieces are interrelated. And I think the recognition probably that something as important as moving from ICD-9 to ICD-10 really is of interest to a wide variety of people across the country may fall into legislation as well as regulation.
MR. BLAIR: The ICD-9 to ICD-10 I know that definitely is but it was like going from one version of NCPDP Script --
DR. COHN: It's actually ANSI X-12 I believe unless I'm mistaken, and you may be referencing another bill potentially. Was there something else? Karen, do you have a comment
MS. TRUDEL: Yeah, I just have a general procedural comment and Marjorie may want to correct me if I'm not quite right on this, but the NCVHS as an advisory committee to the Secretary should feel free to make whatever recommendations it feels are appropriate to the Secretary, the Secretary then makes the decision or the assessment as to whether he has the authority under his current legal authority to take that kind of action or if not then he may wish to pursue legislative change.
DR. COHN: And we can continue this conversation, I suspect that this issue you're bringing up Jeff may be a little beyond the scope of this letter but it is something that should be talked about by the Standards and Security Subcommittee only because I think you're bringing up obviously a much bigger issue which may be the purpose or point of another letter. Mike Fitzmaurice?
DR. FITZMAURICE: On the last paragraph in the sentence next to the last it reads in particular the NCVHS recommends a streamlined process for adding new standards and attachment types and for modifying existing standards. Well then my mind naturally asks what streamlined process are we recommending, so I would suggest a change in the sentence to in particular the NCVHS recommends that a streamlined process for adding new standards and attachment types and for modifying existing standards be found, or be developed.
MR. REYNOLDS: Everybody in agreement? I've got a question, were you going to respond to Jeff and Simon? Okay.
DR. TANG: Actually I'm piggybacking on Michael because I was talking about the last sentence, and Karen's response to the question I asked about is there a roadmap you're planning and her response was no, we'd prefer this to happen outside of the HIPAA process. Would that satisfy what you're requesting in the letter?
DR. COHN: Are you recommending some changes here or --
DR. TANG: Well I'm trying to make sure I understand what the letter is requesting, so when I asked Karen is, this is a rule, it is not a complete standard, set of standards, it is a direction and she explained how the incremental benefits would accrue. And she also added that in order, this is my interpretation, to make sure this is done in a streamlined and expeditious way their thought is that further development of the next steps and roadmap would occur outside of the HIPAA process. Did I misunderstand that Karen?
MS. TRUDEL: No, I don't think you misunderstood it but I need to clarify what I said a little bit. My point was that there's some leeway in terms of how prescriptive we want to be inside a standard and we chose not to be particularly prescriptive within this standard. If for some reason the industry decides that there's a need to go to another version of the claims attachment that has to be done by regulation and that's what the issue of the modification process addresses. So the current version of the standard provides a fair amount of flexibility but if at some point in the future there's a decision that we want to step further or we want to adopt new standards for new attachment types we're back in the HIPAA realm again and there is a specific modification process that the committee is already on record as saying needs to be more flexible.
MR. REYNOLDS: And I would say as a committee we tried to step, this is not, we prefaced in paragraph two carefully that we mentioned in e-prescribing we had the same issue, the same recommendation, that as the industry, as NCPDP or anybody else starts rolling out version, if every version has to be dealt with through a large legislative process how will people move forward, we used the term backward compatible as one of our terminologies that we used so that you could allow people to move forward but you're not penalizing everybody behind.
On the other hand we didn't want to be too prescriptive because how this actually works with all the HIPAA regs and all the other things that are going on as to how things get approved, we were not trying to be prescriptive in stating exactly what should happen, instead we were recommending that as you look at more and more versions coming out, for example the attachments came out on, mentions 4050 which is not actually an approved version yet, also people are already working on 5010 so you find yourself in a situation that you got lots of things in place.
So we were just trying to make a point, a clear point that the whole process needs to be considered because there's a difference between adding a significant thing like an 837 versus possibly just changing some data elements.
John had a question first.
MR. HOUSTON: Just real briefly in the first sentence, the last part of it, but having only a limited time to review the standards offers no specific technical comments, I'm not sure whether that's meaningful, I mean because you're talking about having a streamlined process later in that paragraph so when I read it it sort of seems like it's sort of whining a little bit.
MR. REYNOLDS: Comment on that Marjorie.
MS. GREENBERG: My concern on that is that does this raise the expectation that if the comment period is extended, which there's a strong possibility, then you'll be coming back with specific technical comments, and do you have any intention of doing so.
MR. REYNOLDS: No, I'm not sure the committee ever had the intention of diving into this at a significant technical level and anybody else on the committee can jump in --
MS. MCCALL: Then it's not because of lack of time. I would recommend then that we drop it because it does set the expectation that we would come back.
First some of this is relatively new to me and I guess the whole concept of taking this out of the realm of legislative activity and out of HIPAA. Is that going to be well embraced? Or is that something that we need to make sure not to bury the lead if that's one of the key themes here. We did it this way the first time but by God let's not ever do it this way again because it will never be nimble enough to adapt. Is that going to be easy to accomplish or is it going to be hard?
MR. REYNOLDS: I would say until, the whole reason we have stayed out of prescriptive is the way this all works, and if you make, if you allow the adoption of new versions then how do you get everybody to move towards it because there's one school of thought that says if it's not mandated it's not going to happen, there's another school of thought that says let free enterprise move as long as things are approved. And so I think it is an issue, in other words in a lot of other situations I know from our committee we have been a little more prescriptive in what we may or may not have said, this one opens a whole new process, a whole new situation and a whole new structure as to how it all plays together and whether it's Karen looking at it from CMS, whether it's Congress looking at it, whether it's the department looking at it, whether it's the industry looking at it, it's going to take some vetting and it's going to take some issues. But the point is continuing to have everything have to go through a three, four year cycle is not where we want to be so that's kind of the initial message that we're sending out.
Please, anybody on the committee agree or disagree.
DR. COHN: I'm just trying to think of how we're referencing here it, I think we're referencing it by reference to other documents that we've sent about all of this stuff and I don't know that we really necessarily need to go extensively into this document rehashing other pieces though I do think we may need a sentence at the very end where we talk about, I mean we're sort of saying department go off and come up with something streamlined and maybe we need to say something along the lines for our part we will continue to work with you to help identify and refine that streamlined process, and that's sort of the thing. Obviously the government itself it sort of, I mean there's pieces called legislation, there's pieces called regulation, but then there's also pieces called streamlining the regulatory approach, and I think what we were talking about primarily and have referenced previously has been trying to streamline the regulatory approach on this.
MR. REYNOLDS: Before we get too many subjects on the floor at once does everybody recommend in that next to the last paragraph that we strike the limited time and whether or not we would come back with --
DR. STEINDEL: I have a comment on that. Actually in the various drafts I was the one suggesting adding that wording and the reason why I added that wording is without it it says we support the proposed standards. There are numerous aspects of the proposed standard that if we had, and other groups are asking for more time to review and we would never have the time as Harry points out, that I think we would find we wanted to comment on. So I did not want the word that NCVHS supports the proposed standard to be interpreted that we were fully behind all aspects of it because we haven't had enough time to review all aspects of it from a technical detail.
MR. BLAIR: What if we took the entire sentence out so it doesn't have the statement that we support, just the entire sentence goes?
DR. STEINDEL: Or we compliment CMS on introducing, something like that.
MR. BLAIR: I think his idea of compliments, Steve is saying we compliment CMS because this is making progress, this is moving the ball forward, and we don't have to say anything more.
MR. REYNOLDS: What I'd recommend is that the committee take this and bring it back, this sentence back tomorrow for consideration.
DR. COHN: Karen, did you have a comment on this?
MS. TRUDEL: I just have one suggestion for pursuing additional language and rather then saying that there's an agreement in every aspect, what are the aspects that the committee does agree with, does the committee agree that the first six are good, that it's good to take a phased approach, that it's good to use established standards like X-12 and HL7, I mean I think there are some things that the committee could weigh in on and say that they're good without giving the impression that we buy in down to the lowest possible level of technical detail.
DR. TANG: In my mind there's a critical question of scope of this particular piece of, particular provision of HIPAA, because an attachment can be as expensive as basically the EHR and clearly that's not, that may be what we need but that's not what we're expecting I think of CMS. And that bears on the whole process of what's included and what's excluded from this regulatory process and modification. So I don't know what the answer to that scope question is because I think that will bear on what we want to comment on with respect to the process. Do you have a clear definition for what standards is within the scope of this regulatory process on claims attachment?
DR. COHN: There are a number of standards referenced, things like HL7, LOINC, there's obviously X-12, this is a CDA document and I think they're asking for comments about that. I think there's I mean a whole set of issues about all of this stuff but I think as Karen has comment this is meant to be something that sort of links the clinical and the administrative side. Now I don't know whether you're asking about the issues about whether or not, how much information you could ask for which of course is governed by minimum necessary, but are you talking about the --
DR. TANG: It's more they could get into data content standards for example and is that the intent and so if that were true would that be, have to follow the regulatory process and notification process, so that's my real question is how expansive is standards regarding claims attachment because that can be key.
DR. STEINDEL: Paul is getting into some of the nitty gritty things. May I recommend that we defer it until the subcommittee discussion? Because you're bringing up some of the technical issues.
MR. REYNOLDS: Are we continuing then?
DR. COHN: I think we should continue, I'm sort of looking around --
MR. REYNOLDS: No, when David walks in I'll stop. We were interested to see that the development of the NPRM, this is the last paragraph, we were interested to see that the development of the NPRM was informed by a small scale pilot project with Empire Medicare Services which focused on the human decision variant for sending text or converting data to text. We believe a pilot, we believe pilot testing is critical for both the human decision variant and the computer decision variant in which data can be used in an automated fashion and read and understood by the computer. Because clearinghouses and vendors may not have the experience with LOINC code sets we believe that pilots should include testing of the full range of LOINC codes required by the clinical and laboratory attachments along with any other untested claim attachment types.
NCVHS therefore recommends that pilot studies should be funded and conducted using both the computer and human variants for the full suite of claims attachments and attachment types that are proposed for adoption in this NPRM as well as the other attachments that are under developing including home health care, durable medical equipment, periodontal, and children's preventive health services. The committee expects that the department will be able to leverage partnership opportunities with the private sector that should be stimulated by rulemaking in the areas of claims attachments.
John?
MR. HOUSTON: I have two comments, one is a real nitpicking thing which is as you talk about a pilot project in one place and a pilot study in another, make it consistent. The other one is I don't understand what that last sentence means and I guess I'm not sure what it is, what it adds to the paragraph, or whether it just needs to be clarified.
MR. REYNOLDS: I guess our comment is that obviously the private sector is very interested in this and focusing on it and it's not like you're having to possibly look real hard to find people that would be willing to pilot some of these things. I think that's where we were heading.
MR. HOUSTON: I think we should probably just clarify it, say it more clearly.
MR. REYNOLDS: Simon, I'll turn it back to the chair.
DR. COHN: Harry, thank you for your good work on this one, we'll finish off the remainder of this probably some point in the afternoon.
Well with that I'm pleased to welcome Dr. David Brailer, David thank you and whenever we see you we usually congratulate on your good work and I think never more so then now, so please.
DR. BRAILER: Thank you, that's a very kind way to start the meeting, I appreciate you all taking time to hear the update about what we're doing in the Office of the National Coordinator. That is our new acronym, ONC, we have stopped the acronym ONCHIT for fear of constant abuse of the name.
-- [Laughter.] --
DR. BRAILER: I'd like to just give you all a quick update on two things that we have underway, first is a very quick briefing on the contracts that we've signed since I last met with you which constitute a very large share of the infrastructure that we will be laying out and playing from over the course of the next year, and then also on the activities of the American Health Information Community which is one of your peer advisory committees and we'll be working very closely with you to advance the health information technology agenda. And I'll be very brief and I'm passing out a copy of both the major initiatives that are going on through the contracts as well as the breakthroughs that are detailed for the American Health Information Community. So I'm going to just very briefly comment on six contracts, one policy change, and then I'll turn to the community, and it's largely following this major initiative sheet.
So I think you all know that we awarded a contract to ANSI, the American National Standards Institute, a couple of months ago to create a new group which is the Health Information Technology Standards Panel, and that panel will be our harmonizing agent for standards in the United States. The purpose of this group is to not change or intervene directly into the affairs of the SDOs, to let the SDOs continue their entrepreneurial spirit and to be part of whatever global alliances they may be part of, but to create a coherent single set of standards for the U.S.
And our challenges are three fold, first to make sure that the standards are non-duplicative, non-overlapping, non-ambiguous. Two, to make sure that they are complete, I'll come back to that. And thirdly, to make sure they are specific in detail. And I think standards in the U.S. generally speaking fail on one or more of those nearly every time. They're often duplicating or ambiguous standards, standards exist but they are not complete enough to be used to solve certain problems, and they often because of the consensus process stop at the level of detail needed for two different software engineers or coding teams to implement them in a way that allow them to be interchangeable.
And standards harmonization will focus its efforts on those three challenges and we've asked them to be not data driven but business driven and what we mean by that is don't say what can we do to standardize lab data but say what can we do to solve the problem of lab data arriving in an emergency room, so to work from business cases, to help focus this and ultimately link the pain of standardization, and let's be honest, standardization of data is painful, it's costly, requires changes of systems, of business process, the only way we think this will diffuse the U.S. is if we link that pain to a benefit and the benefit comes from solving someone's problem.
So we do want the standards community to directly integrate itself into the problems that doctors, patients, and hospitals live with every day and to see themselves as an ingredient of their success, and if they don't see if that I think we will not achieve the level of standardization that you've called for since I was a child, which wasn't that long ago.
Secondly, compliance certification, I think you've heard a lot about this, we had the privilege of contracting with a group that has already distinguished itself for the quality and detail of its work and the very, very well developed public process and that's the Certification Commission for Health IT. It's really a remarkable group of people who came together with a passion, its what the private sector has done best I think in health IT recently, and we have now contracted with them to develop first criteria for what constitutes ambulatory electronic health record.
And to make it as simple as possible what they will do by developing those criteria is change our language about health IT. We will no longer get into debates about what's the difference between an electronic health record and electronic medical record, a computerized patient record and other things, we will talk about functions and whether or not functions constitute those tools and I think we need to get that level of specificity.
They have a very short deadline for delivering to us ambulatory PHR certification criteria in a draft state, i.e., next month, and to finalize those by no later then mid-2006. And expect to see prototype certification results done by July of 2006 such that a system could ask to be certified such that it gets a Good Housekeeping Seal of Approval as certified or not. We think this is a benefit to physicians and hospitals that are trying to sort out their options and are feeling confused and overwhelmed with all the different choices they have and they want to kind of know what's going on with products, it will be the investment community put their capital against tools that help the American public become more healthy, and it will help policy makers have specific policies that can be enforced and operationalized in a way, and I'll come to the primary example of that that's underway now which is the physician self referral and anti-kickback safe harbor that we've proposed.
We will then follow compliance certification into inpatient electronic health records, and then into national network architectures. But the Certification Commission is required to lay out a roadmap for a variety of different technologies that it can look at over the next three years.
Third is privacy and security solutions and we have contracted with RTI to launch a new organization called the Health Information Security and Privacy Collaboration. And this organization is novel in that it will be an organization of states and state leaders to come together to begin understanding what we need to do to move the paradigm for privacy and security from the paper age to the digital age. It's our sense that a lot of debates occur about what's right or wrong with current policies but the issue in the middle of these is the irreconcilable challenges that paper introduces. We have a debate about enforcement, that enforcement means cost and it means significant barriers in a paper world. That debate changes dramatically in electronic world, it is also is the same with disclosure accounting.
So if you look at many of the issues we're facing we believe that they're imposed in part by our dependence on paper and so what this group is going to start doing is looking at what should the policies and procedures and practices look like at the state, federal, and business levels in a world that is digital, what are the policies we should begin expecting and who is it that should do things about these, what are federally driven, what are state driven, and what are business policy driven. Because we want to make sure that our paradigm for privacy and security keeps up with the technical innovation that's occurring today.
Now I need not say that to you as a group who is already well along in this work but we have to be able to get this to live and breath at the level where these laws are largely made which is at the state level. And so we want to be able to get focused quickly on each state that wants to engage on this having their own health information security and privacy collaboration that rolls up into a federal effort to begin creating a living breathing effort. In many ways I view this as the first cousin of compliance certification in that it is an organization process we're trying to create that gives us a platform to begin addressing this problem over the course of time.
We announced last week four awards for prototypes of the Nationwide Health Information Network. This was a very tough choice because we had more then 80 excellent proposals from well developed teams and consortia of providers with very good health markets. But given the current status of our range of '06 appropriations we awarded four contracts, those were to Accensure(?) and colleagues, CSC and Colleagues, IBM and colleagues, and Northrop Grumman and colleagues all working with three distinct health market areas. And these market areas will work with these consortia to develop architectural requirements for nationwide connectivity, they will submit those for review across all four of them, and they will prototype those in the actual markets.
The output of this group will become inputs into the Certification Commission in its dialogue about how do we certify architectures and our thinking is that this is not unlike the electronic health record except we don't have a large share of providers offering the service today. In the end the best analogy I can give you is that our vision for the Nationwide Health Information Network is not unlike cellular telephony where the electronic health record is like the handheld device, you have many choices, some that have a lot of features, some that don't, but all of them can connect to a cellular network and you can have complete interoperability of sharing calls back and forth and passing them off to any network.
So there will be a set of competing network operators who compete on the price, the quality, and the data completeness of their service to doctors such that they can connect to electronic health records and delivery them, the labs, the pharmacy data, the other doctor's notes, the other components that are now done in one up specialized and highly cumbersome and costly direct integration and interfaces. This project will take some time to play out, it's an 18 month project to start, and we expect to see this evolve significantly over the course in time.
We just finished the report on an effort on health information technology and health care fraud asking questions about what do we believe the impact of health IT will be on the rate, incidence and prosecution of fraud, what do we expect it to do with respect to fraud losses, and on the flip side what is it that the both private enforcement and federal, state law enforcement authorities should do to begin preparing for the world of cyber fraud. This looked at legal regulatory issues, it looked at business practice questions and it looked at economic models.
And the findings of the economic models would not be surprising to you that with partial interoperability, with information silos, the exposure to fraud, could go up, but more important the cost of policing fraud could go up dramatically. But in an interoperable world where we're able to get more complete data and move information tools towards the point of care that can help providers know while they're seeing a patient and coding them whether or not fraud could be being perpetrated, we can begin to move into a world not of prosecuting fraud but of prosecuting fraud as preventing it at the source of care which is much cheaper for everyone. And so there's great potential, we'll be following this on with a much more specific demonstration project to begin understanding what that means sometime in 2006.
We also awarded a contract to George Washington University, to Sarah Rosenbaum and to David Blumenthal at Massachusetts General Hospital to pull together an annual report on health IT adoption. Now there are many, many surveys that exist about the level of health IT adoption and some of you know that I wrote a paper on the level of health IT adoption, in fact I think Paul Tang asked me to do that for his Patient Safety Data Standards Committee, and what I ended up doing was writing a paper on how bad all of the statistics were. And then of course like any good scientist I drew conclusions from it anyway.
But our sense was that we clearly have an obligation to report to the President and to the American people about whether our policies are working and what's happening with adoption, in particular not just to focus on broad levels of adoption but specific drill downs on adoption gap issues in urban versus rural, large versus small, safety net versus general care environments, etc. And the way to do that was to not just fund another survey that supplements the ones in CDC and CMS and the private sector, but was to put together an expert panel whose job it was to create a meta analysis framework for all of the standards, or all of the surveys, and to be able to compile them into an aggregate view of what's happening.
The best analogy I can give you is the Council of Economic Advisors who pulls together many, many data points, forecasts, models, leading indicators of economic function and tells America what's happening with the economy in an objective quasi scientific way. And I say quasi because it is a meta derivative product. And so this group will do this but hopefully over the course of that not just tell us what the statistics say but through their meta standards allow all of the data collectors to begin adopting common questions and common survey techniques in working together. And we have given them authority to do specific surveys if they need to drill down on a specific area or if they can't resolve a finding based on the data that happens to be made available. So this group is going to be underway with a report due in mid-2006 on the first pass level of adoption as an official report.
Those are the contracts that are underway, pending the '06 appropriation I'll have other announcements to make but again what we're doing here is using the procurement mechanism to procure process, we're creating entities, organizations and process whose purpose is to create platforms and leverage points so we can begin driving private sector adoption. This is a very different way then publishing a regulation or a very different way then the government procuring a network that it would use itself, it's a hybrid of the two. But in the end we think this will give us much more ability to manage an evolving and organic world, it will give us much better ability to bring many players along on a voluntary basis rather then a mandatory basis, and it will let us begin dealing with the real so what's of health IT which are the impacts on efficiency, quality, on access to care and other things as opposed to dealing with the technology itself.
So this is where we're heading, we're well underway now, my office has now shifted directly into a focus of implementation. We have a new management team in place and I think some of you have met them but the team that's come in, some people who are here, Robert Wase(?), the acting deputy, Robert could you stand up, from DOD, we have Jody Daniel who is from OGC who is now the acting director of policy and research. Dana Haasa(?) is the acting director of programs and coordination and handles the American Health Information Community. And John Luntz(?) who is the acting director of interoperability and standards and most of the contracts that I just announced are under John's portfolio so he's going to be a busy guy. And then Karen Belle who came over to us from CMS who is the acting director of health IT adoption. This is a first class team who are here and they are very implementation focused and locked in on these goals.
We had one other announcement that was made recently where we announced the proposed self referral and anti-kickback safe harbor that would allow hospitals to donate software and services to doctors for health information technology use. That rule change contemplated a world before we had certification criteria where there'd be a very limited donation allowed, in a world after certification where there could be an expansion of that limit or that cap or easing of further restrictions for certified technology. So we're putting our policy interest directly in line where we are because certification gives us a tool to do things and the basic argument here is any time we open up an exception to a safe harbor, an exception or a safe harbor to these abuse rules we expose the public to a risk of abuse.
So they need to get something back that is better for them then what they theoretically could have lost and in this case what they get back with a certified system is better protection of their health information, access to state of the art clinical rules and prompts that their doctor could use about how to make sure they follow current evidence, and interoperability to allow their data to be portable and to move as they move through care. And our sense is that that is a much better result for the American public and so that proposal is out asking for comment.
Finally we have the American Health Information Community underway, it is having its second meeting on November 29th starting at 8:30, and this meeting will be a detailed discussion about five potential breakthroughs. A breakthrough is defined by the American Health Information Community as a health information technology innovation that could be seen by the public to have tangible values in two to three years. And the five that we're focusing on are some area of consumer empowerment, a personal health record on the north end, a record locator service on the bottom end, in the middle my registration data, my drug data type things. And we're going to have the American Health Information Community target one of those areas and charge a workgroup to go off and come back and tell us what federal policy, what business practice, what financial, what legal, what cultural barriers need to be knocked down for that to happen on a widespread basis.
Secondly is quality measurement, this is around how does health IT help deal with this. Many of us know that quality measurement is largely rate limited by lack of agreement on quality metrics which comes from lack of agreement on practice standards. So we're not sure that health IT can play the critical catalyst role here but we're going to look at it. Chronic disease monitoring which is remote patient monitoring, disease management, and remote forms of management of the patient, this is an area that's quite fruitful, e-prescribing, and then bio surveillance, both for bioterrorism and for pandemic events that is largely built around being able to know that events have occurred an to triage resources around those as they occur and probably most importantly to allow the public health apparatus to manage those situations as they occur given that they occur over time.
So the American Health Information Community expects to have its workgroups operational by the end of the year, at least two or three areas, with others being cued up as opportunities exist. So I ask you to follow that and we do expect to have the NCVHS work closely with the American Health Information Community to achieve the goals that we've all sought for a long time.
With that I'll stop and be happy to take your questions or comments and again thanks for having me come.
DR. COHN: And David again, congratulations, I also want to welcome your new staff and directors and obviously congratulations on your new roles.
David as I commented and I think once again, I mean the work since you've last updated us, I mean it's always been sort of planning and future vision and suddenly you have the processes in place, you have the contracts awarded, it really sounds like we're into implementation so congratulations.
Questions from the committee? And I know you only have a couple of minutes so just let us know when we need to stop. Jeff?
MR. BLAIR: Thank you. Dr. Brailer, very impressed with all of the initiatives you have in place now, it's very exciting to see all of this.
One of the areas that I was wondering about was whether the folks that have been awarded contracts for the architecture, whether they will be exploring how we could wind up either integrating or facilitating complimentary interoperation of some type between tele-health networks, e-prescribing networks and health information exchange networks. Do you have any information you can share with us about that focus?
DR. BRAILER: Well, Jeff, first thanks for the recognition of the work that many people have done and I would say that while I'm the pretty face for what it is on all this I've just summarized the work of probably 300 people in the federal government who have worked tirelessly to get where we are so I think we should just acknowledge that a lot of this stuff has been underway for a long time before I got here and in the end the work just to for example award the NHIN contracts involved dozens of federal staff reviewing lots of proposals. So thanks.
We are filled in health care with one up point to point information networks and our current operational model is to continue that. And it's not just in the list of examples you gave, if you look at bio surveillance and things in public health, if you look at what we're doing with collecting quality data, if you look at what we're doing to collect data for adverse events, for creating web portals, for being able to wire things around, doctors around patients, the mode of practice in the U.S. is proprietary enterprise systems with a lot of custom integration for point to point purposes.
The question that the NHIN contracts are asking is what is the high water mark, how far can we go towards a generalized general purpose network that acts like the internet for tying together the parties with multi functional information sharing attributes such that if we want to collect data between, share data between two doctors for a patient we can do that in the same environment where a lab can make their data available to those doctors, in the same environment where if it has data that is of statutory interest to the FDA it can get that data, etc., etc. We spend in the government, federal government alone, more then $5 billion dollars a year on health IT and most of it supports these custom one up networks and data collections and we don't know the cost we impose on the private sector by having many agencies engage in what I consider to be quasi regulation by asking them to submit data to agencies to comply with certain interface standards and I think that's going to continue.
It could be that we'll find that there are legitimate business, financial, jurisdictional, legal reasons why we need all these fragmented networks, not just in the government but in the private sector. I hope we don't, I would be grossly disappointed. I hope we find that we can largely build out a lot of the general context for what we consider to be silos, e-prescribing, health information exchange, ongoing community, into a generalized environment where we can the ability to share the cost across many players and across many business functions, and we can get much tighter integratedness and capacity.
In the end my view, and I know this is being overly simplistic, is if we can pop a personal health record on top of that network and make it useful for a patient we have passed a goal where we start to become patient centered in our networks. I don't know if we'll ever do that but that is at least is a simple metric that we might think about.
We're really asking ourselves here first how far can we go and we're going to be pushing these contractors and those of you that read the RFPs know that the bias was showing in this to go as far as they could even if we had to scale back as we began looking at how to make this practicable in real life in health care.
MR. BLAIR: Thank you.
DR. COHN: David before we go to more questions what time do you need to be out of here?
DR. BRAILER: I'm okay, I've got a few more minutes.
DR. COHN: Okay, good. Judy Warren?
DR. WARREN: One, I think the briefing paper on AHIC is a wonderful document. I do have one concern though, when you talk through all this, and you may already know where I'm coming from, this is a briefing document that talks about the impact that AHIC is looking at for physicians. Are you also going to be looking at the impact that other clinicians have?
DR. BRAILER: It's a good question and I guess I would first by commenting on the premise, I think most of the benefit the American Health Information Community is looking at is aimed consumers. When we --
DR. WARREN: But the concern that I have is when you look at this briefing paper, and if other people look at it, all they're going to see is that this is about physicians doing things with and for patients, it's not accounting for any of the other clinicians that impact health care. So I would just say take a look at it and maybe the word clinician is a better word then physician in that it becomes more inclusive.
DR. BRAILER: For example in the first line of my personal health record allowing an authorized clinician, yeah, I think unless we've made a mistake we meticulously referred to physicians where it is something that physicians do --
DR. WARREN: But nurse practitioners also do that, they also do e-prescribing, so do other --
DR. BRAILER: Point well taken but I think I come back to rather then dealing with the issues that I think most of the public consider to be inter-nesting between doctors and nurses, what the consumers want to know is what's in it for them, can they get their information, can they get the tools to make decisions, and that's where we're putting most of our focus is to bring the consumers into this and make health care much more transparent, much more accessible and much more controlled by them.
DR. WARREN: And that's what I applaud for the paper is it does put that out. I'm just worried about the messages that were given in written documents that people will take a look at and how it narrows their interpretation.
DR. BRAILER: I can assure you that Lilly Delanis(?) is not letting us get away with anything from a doctor bias on the AHIC.
DR. WARREN: I know Lilly, I'll keep up.
MR. VIGILANTE: Not to choose any more doctor bias but, as usual David great presentation, thank you so much. I was interested in the anti-kickback rules that generally apply to doctors and is this something from the point of view of regulatory hierarchy that is going to be hard to do, does it require legislative action, what are the barriers to this actually happening and what might the timeframe be?
DR. BRAILER: Well we have, Kevin, we have put out the proposed rule but it's in an abstracted form, there's a lot of details that in the final release of what we thought could be an answer we just scaled back because we want to have real dialogue about this. But we did this within the bounds of what we believed we could do statutorily with no change and no authorization from Congress. Congress is able to do things obviously that make those rules much cleaner and there's legal hurdles that we have to be able to cross that sometimes result in ambiguity, it's just how the regulations work.
But the instructions that the staff followed was to make it as clean as possible and as specific as possible and that's why you see for example both self referral and anti-kickback open from CMS and OIG at the same time in that proposal, that's why you see it linked to something specific like certification as opposed to something general like EHRs or health IT. That's why you see it being set up in a way that there will be contemplated specifically enumerated caps. So from a legal and regulatory point of view we are on solid footing, the question is going to be what are the unintended consequences that could result from that which will surface during the comment period, what are the implications that haven't been contemplated that could be adverse, where is it that our estimation that consumers dramatically benefit from this more, much more then they could be harmed, where that calculus is not correct, those are the things that are being probed and those I think turn into become either a feasibility judgment of the overall initiative or they turn into specifically modulated language that put restrictions or illumination or specificity around any part of it.
And so the comment period Jody is ending, is it mid-February --
MS. DANIEL: I think it was just extended, I don't know the date, it's still open but it was just extended I think by a month. I think it should be closing soon.
DR. BRAILER: And then the process after that depends on the weightiness and the degree of texture of the comments that we get.
DR. TANG: David, I want to join the congratulations to you, your team and the many federal employees that have been working on this, I think your accomplishments have been nothing short of phenomenal, I think you've set out a very cogent and feasible strategy getting us very far.
One comment is you've put into place this certification process and a lot rides on that, clearly if either the extremes of zero or 100 percent get certified we wouldn't be moving along your plan. In your mind what do you think the sweet spot would be for getting through for certifying, what level would be a sweet spot in your mind to certify companies as having functional EHRs?
DR. BRAILER: Well as an eternal optimist I'm a Lake Woebegone thinker, I think America's Health IT Community is well above average and I would expect to see a lot of people, a lot of products be certified. But there's a reality beneath that which is the question as we contemplated certification was what is the interpretation of certification because that translates into the percentage that crossed the line if you would. And our sense was that if we engaged in stating what is the best product we would not serve the needs of doctors or the public or the investment community, the regulatory community, because we would be largely picking winners and we don't want to pick winners, or losers. If we engaged in kind of a middle tier to say who's a C or better and who's a C or less, that could help us probably have better specificity from a regulatory point of view but it would be quite harmful to the doctor and hospital that wants to be able to understand what they get for what they buy because a C minus and a C plus could be quite similar systems and therefore but could be charged at different prices.
We chose in the end to view certification as a minimal requirement, in other words if a product meets all of those certification criteria it is minimally configured to do the work that we would believe is necessary based on interoperability, privacy protections, and clinical decision support to support doctors and their practices in an ambulatory setting. Or said another way, and this is the important point, if it fails to meet it it should have such a level of concern to the vendor of that product or to the investment community or to the doctor that it should be something that they would agree should be trued up in their product.
Now the complaint against minimal certification is that it doesn't stimulate innovation, it doesn't help us pick the best, and my view that's what markets are supposed to do, that's not what government is supposed to do, we're not supposed to pick. And so the market will hopefully based on certification begin asking the next question which is why do two certified products cost different amounts of money, and it could be you get a lot more for twice the price but we've never had a basis for asking that question and now we will. The market will sort out essentially price performance, and I think the market will also stimulate innovation, in fact I believe minimal certification starts to stimulate modularity and starts to stimulate minimally configured products that are aimed at very low price points which is an area we've identified many times as a concern for very small offices, and so in the end we chose this.
Based on that I would certainly hope that a large share of existing products can cross the line and to those who have, the very few who have chosen to criticize that as simply just endorsing a whole swath of the sector I believer there will be those that don't make it, probably those who know they won't make it will never seek certification, there's no reason to have it pointed out in public. And I think the important thing is that certification criteria evolve and become more stringent over time and raise everyone's profile and over time you might expect to see stratifications of that or much more detailed cuts of who is certified for what.
DR. COHN: We've got Russ and then we've got Carol and then we will take a break. Russ?
MR. LOCALIO: I just want to see if I can put 16 pages of Federal Register in one sentence, I think it's your goal that you want to have a physician, nurse practitioner, podiatrist, nurse be able to be given a palm pilot by a hospital, to be able to do prescribing without going to prison, I think that's the gist of it.
DR. BRAILER: Or getting a civil penalty.
MR. LOCALIO: Correct. Now is it also your hope that the physician, nurse practitioner, podiatrist could use the same palm pilot with the same software in all of the hospitals at which he or she works, is that the goal?
DR. BRAILER: Not per se, that is certainly the hope. Let me just step back and remind everyone that the Medicare Modernization Act required that a safe harbor be published and an exception to self referral for e-prescribing. And like all slices of technology reality that get ensconced into the permanent statement of statute that was a time when e-prescribing applications were almost all handheld PDAs which is no longer the case and so there are things that have carved out e-prescribing as a unique part and we serve that and met the statute requirement by publishing the statutory exception. It is clearly the expectation in e-prescribing that those tools will be physician centric, they will not be to the peril of the e-prescribing community and those that want to benefit from it There's no requirement in the law that it be done that way but the interoperability standards that are already underway with a regulatory push for prescription data and the prescription drug plan sponsor process that can aggregate themselves around that I think will find a business solution.
Now in the electronic health record side that was done outside of statute and again that is aimed at things that do include e-prescribing but go across the whole gambit and there it's certainly our belief that any product that's used will be used in the physician's office and will tie to any other data that they need. And that's why we have modularly separated the electronic health record from the network aspects to share information so we don't deal with this issue that literally the physician has five EHRs depending on who the patient came in from. So I think there the law of practicality will be much more stringent then the law of statute in terms of requiring that to happen.
DR. COHN: Carol, last question.
MS. MCCALL: I guess one more congratulations, this is relatively new for me and just to see the progress, things come from concept to actual readiness to go implement is just incredibly exciting. I want to kind of think about what happens not only in that execution but even beyond that and in particular the comment that you made about these breakthrough initiatives, there was one comment in particular that I found very interesting and it was related to quality and the fact that, and to your point that today there's a lot of information that we don't have, benchmarks and standards and metrics that haven't been developed and so you're not quite exactly what will happen in that sphere.
So with that as a backdrop I have two questions, the first question is have you or will you kind of charge these major efforts and these contractors to anticipate and try to link with those efforts? And the reason I ask that is because there's so much of the development of those metrics and best practice that will come from this data, so that's question number one.
And question number two is what other activities do you see AHIC taking on in order to push that particular agenda forward? And how can we help?
DR. BRAILER: The particular agenda being quality measurement?
MS. MCCALL: Yes.
DR. BRAILER: The contractors are required to work both the general deliverables, for example certification of electronic health records or develop of a generalized network and also to incorporate three specific breakthroughs into their use case planning. And our goal immediately with the AHIC is to identify those use cases, those breakthroughs, so they can be passed to the contractors, therefore certification as my one example but it's true for privacy, it's true for standards, all of them, even there are adoption survey group to certification for example would say okay we have bio surveillance as one of the breakthroughs, what do we have to do to add to the minimally configured electronic health record for '07, for example, that would allow it to be compatible with generalized transmission of the data that's needed, and etc., it will work through all that.
So the simplest answer is if the AHIC ranks quality measurement as one of its priorities it would work through this process that way, and the contractors would touch it, and I expect a large share of the time to be touched on working breakthroughs, these won't happen just by bully pulpit, they'll happen because we build the infrastructure and deal with the regulatory barriers and start looking at cultural and financial economic issues in the industry.
If it doesn't prioritize it and I signaled that I thought it may not only because the community itself has come to us and said be careful there's a lot more here that's outside the scope of IT then is in. I don't know how it would regard that, we haven't visited that, I think the meeting on the 29th is going to determine it. It clearly made the list of things that are top importance and I wouldn't think that anything on that list will go away and I know the Secretary is quite interested in that but I don't know the mechanism for that going forward and therefore I don't know how the contractors would touch it per se.
It's fair to say that if the key constituents were trying to drive consolidated standardized and unified quality metrics agreed and it was telegraphed in such a way that we would certainly work with the IT community to ensure that those became minimal features, or to work with other communities to build SDKs, that's a software kit, or some kind of a plug in that could extract the data and send it forward. But right now there are so many different ways that even the same thing like the did you give aspirin to a beta blocker or an aspirin to a heart attack patient, that's measured completely different ways and so there's still a lot of noise to be able to turn it into something that software engineers could do really easily and cheaply for all of us.
DR. COHN: David, thank you very much for a major accomplishment and congratulations from all. Thanks.
[Applause.]
DR. COHN: Now we're running a little late as you all know, what we will do is to take a break now for lunch and reconvene at 1:15.
[Whereupon at 12:23 p.m. the meeting was recessed, to reconvene at 1:23 p.m. the same afternoon, November 16, 2005.]
DR. COHN: Okay, first a housekeeping item and then we'll talk about sort of what we'll do for the next session and talk about later on this afternoon. Now the first housekeeping item has to do for the committee members and staff about the dinner tonight at McCormick and Schmitt's, we actually need I think a show of hands for those who are going to be coming so that we can make sure to reserve a large enough table. Okay, thank you.
Now given that we have not, we've sort of almost made it through the letter on claims attachments I think we need to finish off our discussion of the letter prior to going into the sort of general discussions.
I also want to comment what we will do is, obviously the subcommittees have plans for meetings obviously after our full committee meeting, we'll of course respect the amount of time that is being allotted for those meetings and what we're going to do is likely to squeeze down the length of time for the NHII Workgroup so we'll set that up before we adjourn today but I just want to tell you all that we will obviously assure that Populations as well as Standards and Security has adequate time on their calendars.
So with that Harry would you like to go back and we'll sort of --
MR. REYNOLDS: Yeah, beginning with the paragraph that I'm sure you all would applaud called finally, it's always a good place to start --
DR. COHN: Well Harry did you get full comments on that paragraph beforehand?
MR. REYNOLDS: I thought I did but if anybody else has anything else.
Under finally the NCVHS recommends that the department extend the comment period on this NPRM for up to 90 days to allow the industry to take the necessary time to, and I've already gotten one recommended change comment on the business and technical implementation issues associated with the standards proposed in this NPRM. If you remember Karen mentioned up to 60 days in her presentation so I don't think we're too far out of line with that request.
Any comments on that? And playing off an earlier discussion it was recommended that before the final NCVHS wishes to thank you it was recommended that we put something in there we will work to help define this process or somebody brought up something that they thought we should add right before the end.
MR. BLAIR: Simon did.
DR. COHN: Well actually I had a comment but I think it was really more along the lines of in the fourth paragraph in terms of this, I mean are we referring to the rulemaking process piece or are we talking about something else? That if we're going to make a comment it's probably there relating to something about for its part the NCVHS intends to work, offers to work with you in the department --
MR. REYNOLDS: And you say the fourth paragraph starting NCVHS supports --
MR. COHN: Yeah, I think so, I mean we can wordsmith that at the subcommittee meeting, you may convince me that it really is at the very end but we can sort of take a look at that.
So the subcommittee will take that under submission and come back with a revised letter for your review tomorrow, I think this will likely be the lone action item of the subcommittee though, I think we've already passed a letter congratulating HHS on their structured product labeling in the beginning of that so we'll make sure that we come out with a letter congratulating on that achievement.
MR. REYNOLDS: Thank you.
DR. COHN: Okay, Harry, thank you very much. Now what we'll do is spend about an hour and 15 minutes and this will be led by Mark Rothstein talking about, what we're going to do is spend about an hour and 15 minutes talking about the work being done, being obviously led by Mark Rothstein for the Subcommittee on Privacy and Confidentiality on investigations into privacy in the National Health Information Network, and then we'll switch gears and spend about an equivalent amount of time being briefed and talking about what the Subcommittee on Standards and Security has been identifying around this issue of data reuse and secondary uses of data. Mark.
MR. ROTHSTEIN: Thank you, Chairman --
-- [Laughter.] --
MR. ROTHSTEIN: Today's topic for discussion is a privacy and confidentiality and the NHIN and the Subcommittee on Privacy and Confidentiality has spent virtually the entire year working on this issue. We've held four one to two day hearings, two of them in Washington, one each in Chicago and San Francisco. We've heard from numerous witnesses including, and I'll probably be leaving some groups out, privacy experts, patient advocates, various health care provider associations, health care plans, organizations and systems, and health policy experts, and we even heard about NHIN developments in the UK, Canada, Australia, and Denmark. We've also held our share of conference calls and subcommittee meetings and now we're actually making serious progress on putting together a draft document.
I'm not sure when it will be ready for the full committee's consideration but the issues are so complicated and contentious that we thought it was a good idea to brief you beforehand about where we're going so that you can be following along with us.
Our meetings on this topic have been lively to say the least but the subcommittee members have agreed that we will present only consensus views to the full committee and that we're going to remain united in support of our recommendations so that we don't have members criticizing our own report once we issue it.
Today John, Paul, Harry and I will each present a different area that we're planning to cover in the report even though we don't have a draft for you to consider so we'll each have maybe 15 minutes or so to cover this area. And only the first five minutes will be our telling you what the issues are and we want time for each area for you to ask questions and then if there is time after the clarifying questions if time permits to have discussion on the issues.
After today I think you will see how important and baffling these issues are and we would invite you to send us questions or comments and certainly to attend our meetings if you want. Tomorrow morning from 8:00 to 9:50 we'll be meeting in Room 443E and I know some of you have a meeting that begins at 8:30 but if you want to come at 8:00 to 8:30, when there are people from the full committee there as opposed to purely subcommittee members we will sort of set aside our agenda just to answer your questions if you have any.
One other thing I should say before we get to the individual section presentations, I know this is a very astute group and you may see quite early on that some of our recommendations may appear to be inconsistent. That's because they are. But there's a reason for it and that is if you think about it, if we control or limit the collection or use of disclosure at Point A we don't have to worry about it when it gets to Point B, but if we don't limit it at Point A then we have to have some rule in effect when it gets to Point B and as well as Point C. So we may be putting in suggestions about doing things downstream that would be mooted if we adopted a system of controlling it early on.
And because he has to leave early for another responsibility we've asked Harry to begin first to talk about establishing and maintaining public trust in the NHIN. John, did you have --
MR. HOUSTON: Do you want to describe generally the five categories that we are going to discuss?
MR. ROTHSTEIN: Okay, well I can tell you the five areas that we're going to talk about today, establishing and maintaining public trust that Harry will address, then John will address disclosures and regulatory issues, Paul will address secondary uses, and I will discuss the fun issue of patient control of information in the NHIN. Harry?
MR. REYNOLDS: Okay ready? Kind of the body, the ideas in the body of our draft letter as it relates to establishing and maintaining trust in the NHIN. We heard clearly that EHRs and NHIN creates significant and qualitative change in information contained in the health records of Americans so it's really quite a big of a paradigm change. The general public is clearly concerned about privacy, confidentiality, and security of all their records, the papers, the issues coming up in the paper now about banks losing things and other things have not helped that and we heard that testimony, but health information for sure so they further differentiate there.
The public really doesn't understand the benefits therefore they're not going to easily give their trust to the NHIN. We'd even talked about things like a lot of things that have happened in the past, seatbelts you had crash dummies, fires you had Smoky the Bear, but how do we get something that tells people there's something good about these electronic health records and where they're getting to because the public tends to rally around those kinds of things.
HHS and other involved entities need to begin efforts to establish the public trust, there's got to be something out there to start getting people more education because you can't just hand it to them, we heard that clearly, you can't just hand it to them and say congratulations, you're in, congratulations you like it, we've got to make sure some things get in place, some key and obvious activities to do that.
So the three areas of focus for building trust are really to try to prove that there's better health care for each individual based on that and measurable improvements so that if you really got good honorable key stories to say on how it actually improved it, not that somebody said it, not that it was in an article, but that it really did it.
The second is meaningful participation by the public or representatives of that in the design, functioning of oversight of NHIN, rather then just committees of selected individuals, make sure that there is a public representation there in those early stages and throughout the process so that the average type person has some kind of representative on the committees that are doing things.
And then third an ongoing program of measuring and assessing the effectiveness of privacy protections of NHIN and public understanding of those protections. So not just announcing that they're there, but basically make sure that there is a continuing program to discuss how people's records are being protected.
So if you summarize it from a public standpoint we want ways to improve their health and treatment, let them help, and continue to diligently protect their data, so those are kind of the themes, those are the discussions, and any of our recommendations would be based on those as a criteria we heard from the many hours of testimony from the people that we heard throughout the country because we did go across the country in these hearings.
So that would be kind of a summary, Mark, of that section and you want to open it for discussions?
MR. ROTHSTEIN: Please.
MR. BLAIR: I was muttering over here yeah, hurray, I enthusiastically support this particular topic that you're addressing and I wouldn't have said anything except yeah, yeah, yeah, may I suggest that since the topic is public trust that just the sequence that you outlined, put the issue of improvement in privacy and confidentiality and security protection not as the last item but as the number one. That's it. Applause, great, I'm very excited.
DR. STEINWACHS: I too think that this is a crucially important area. Now you were looking for sort of a poster child for this and it seemed to me out of all the things I've heard over the past few years is that the thing, patient safety has much more traction with people then almost anything else, quality doesn't quite, the word doesn't emote quite the way safety does. And you made me start thinking of these commercials, this was something different then the American Express equivalent that said my luggage didn't arrive, I'm on a Caribbean Island, but I have my American Express card. But you could think of something a little different that is sort of like the grateful patient, I wouldn't be here today if it weren't for the fact that the emergency room doctor had access to my record and knew that, and actually there are probably lots of good live real examples that could be drawn on and just make them confidential in a sense that you're reenacting something or replaying something without identifying.
But it strikes me that without something like that I'd be reluctant to say you can have my records and use them for whatever. And then I would probably still be very cautious and say well I only want you to have those parts that you can really convince me fit the criteria, otherwise I need to control that and it comes back to --
MR. REYNOLDS: That's Mark's subject.
MR. HOUSTON: Do we want to respond at all? I mean we want to obviously get input.
MR. ROTHSTEIN: Do you want to respond to it? Sure.
MR. HOUSTON: Yeah, I think it's important to recognize, I mean I think we all had a lot of discussion in our deliberations over this letter about really what's the core reason why we're developing an NHIN and it is to improve quality of care, reduce error rates, improve efficiencies and all of those things and I think it's in a way I guess assumed a lot of what we'll be talking about today is that there's a reason why the NHIN is being developed and we're trying to focus on the privacy aspects, we're trying to focus on privacy because we recognize that it is that if we don't do it correctly it is going to be great inhibitor. I think the message obviously absolutely has to get out that there's a lot of reasons why we do NHIN but we're really trying to focus on the concept of privacy and how do we remove that, or how do we try to address that if there's a potential inhibitor to individuals wanting to participate. So I mean that's really at the basis for why we're here.
DR. STEINWACHS: Part of what it made me think of is that the AHIC is trying to develop use cases and it seemed to me that in a part for the privacy you have to do both because one is how are you protecting the privacy in order to make that information available in a way that could maybe save my life or make a real difference to me personally, that maybe part of a model.
MR. ROTHSTEIN: I think that's a very good point, Don, we have to make the case, or someone has to make the case, to the public as to what they are personally going to get out of it, quality and outcomes research are just too nebulous to the average person but this could save your life they might be able to --
DR. VIGILANTE: Didn't MARKIT(?) present to us their, didn't they do survey research or consumer research on messaging, it was about a year ago, so along those lines, what is the message that affects consumer --
DR. CARR: Do we have information on what percent of the population that were affected by Katrina had electronic health records?
MR. SCANLON: You happen to have the data guru here. No, no, that's the answer, no. There are actually some interesting things done in databases and David didn't talk but there was actually a prescription website capability set up for folks who were displaced, in fact that was a very good site. The industry was able to put together a website based on medication histories of folks displaces and then they were able to check those when the folks arrives in Houston or other places. But no, there's no, there's not even good information on how many hospitals overall have these sorts of capabilities, it's getting to be better now but certainly not on that fine a grain.
DR. CARR: But perhaps even doing just some modeling, I mean we know among the practices or the hospitals there that did or didn't have electronic health records to say how many lives affected or would have been favorably affected had it been available. And then secondly in the intervention how electronic health record really did help organize in a mass, or whatever the prescribing things. But I mean just to your point about how do you make a public case this is a very public issue and it would be a profoundly different story I think for folks if they had their electronic health record.
MR. ROTHSTEIN: Okay, I've got Steve, I had Russ, Bill, Paul. Did I miss anybody?
DR. TANG: Can I answer Justine's question? There is one example and that's the VA which was able to come up the next day --
DR. CARR: Right, I think that would be a compelling juxtaposition of two systems without getting into the detail of the others.
DR. STEINDEL: Mark, I really wasn't paying much attention to just basic terminology, are you going to refer to this as the NHIN or the NHII? And I ask that very specifically because as we heard a few minutes ago from Dr. Brailer there's going to be very specific architecture that defines what the NHIN is, at least in a test case point of view and certain parameters. And some of those parameters may have implications on what we want to say in terms of privacy, your downstream concepts, where if you're talking about something a little bit more abstract you might be able to talk at a different level. And my main contention here has to do with whether we're talking about instantaneous ability to exchange information anywhere around the country or connected electronic health records that are able to exchange information, not necessarily instantaneously.
MR. ROTHSTEIN: Well that's a good question. We were asked to address the NHIN and I think the value of some of our recommendations that you're going to see, that we're going to discuss later in the next few minutes, deal with how you work privacy into the architecture of the NHIN. And so I mean I could be persuaded that we should change the terminology but I think it's very important for us in our recommendations to the department to make it clear that privacy is not something that sort of is tacked on at the end, that it's part of the development process and if we don't do it now we're going to be going down the wrong path and that's why it was linked to NHIN.
DR. STEINDEL: My question really had to do as a reaction to what Don was saying about marketing messages and marketing messages might be different in those types, in different scenarios.
MR. ROTHSTEIN: Well for starters we're not going to get to anything approaching that level of detail, that's not going to be our job to come up with strategies other then to say that we think it's very important that it be done promptly, enthusiastically, comprehensively with proper funding and so forth.
DR. STEINWACHS: I thought you were just going to delegate this function to the CDC Center for Public Health Marketing. Marjorie, is that the right name?
MR. LOCALIO: Well I will just bring up where I left off in September and that is that sometime you have to bring up the problems of legislation because those of us who have been following this for the last ten year know that there are deficiencies in the current legislation which is why we have HIPAA. I just want to make sure that somebody, as you go through your process you consider this, I also want to point out some other issues that have occurred to me and that is one of the most flagrant abuses or transgressions of privacy was that horror story of the California transcription going to the service in Texas that then subcontracted to somebody who subcontracted to somebody else in Pakistan who said I'm going to put it on the web unless you pay us. So we have to consider that when you have something on a network that means there could be global exposure as well as national exposure and what can be done about that. This is a serious issue, look at when we have, how many people have had viruses attack their computer in the last year and how many of those viruses have originated from outside the jurisdiction of the United States, I mean this is an issue. So I just wanted to make sure that that's covered sometime. Thank you.
MR. ROTHSTEIN: Yes, without going into the answer because it may come up in later discussions we have specifically addressed those issues. Bill?
DR. SCANLON: I think your three steps are good sort of process steps in terms of trying to instill sort of public confidence and trust, three is an issue though of the substance and I think that in terms of involving the public, I mean I think they've got to come away from this process feeling pretty confident about things. And actually this is keying off something that David Brailer and Paul were talking about in terms of certification, I think it's a sound strategy of saying we're not going to go to an extreme in terms of certification and pick a winner but we're going to set some minimum standards and then we'll let the market work to a degree.
The minimums need to be high enough that people have confidence, I think that's a key because markets are wonderful but they don't always work and in health care we've probably got great examples of when they don't work, or that takes them a long time to work. And you don't want to sort of having involved the public in the process to have them come away feeling skeptical about this. So I think maybe it's not part of this message but this is something we should be continuously sort of focusing on in terms of advising the department that if this is going to be successful the public has to be confident because there's enough of a safeguard here that they don't have to worry.
MR. ROTHSTEIN: That's a good point, I mean you can't sell something that doesn't have any substance and we certainly agree with you.
We're going to take one more comment from Jeff and then move to the next topic area.
MR. BLAIR: I kind of come back to my applause for the way Harry set forth the issue, in short HIPAA privacy regs have among the physician community and health care institution community been a set of rules that they have had to implement and many of them are not very happy. I don't know if we're going to be able to do very much to change that. The unfortunate thing which I think this addresses is that the privacy regs do a lot to improve privacy, confidentiality and security for the patient and the consumer. Unfortunately that message has not gotten out as profoundly and clearly and pervasively as it should, this is something which is an achievement, this is something which is positive and yet we sort of are enduring the discomfort of those who are implementing it without receiving the appreciation and trust of the consumers and patients that it was meant to protect.
So the bottom line is I think this is a public relations issue, I think it is a marketing issue, whatever word, or an educational issue, whatever word you want to say and I do think that it needs to, a great deal of resources and funding need to be put behind this because the consequences of us failing to get this message across could be tremendous for the entire movement of transforming health care into the information age. So much is at risk that it could be lost not by a covert act but by an act of failing to get the message out, the education, the public relations. So you can tell I feel very strongly about this particular issue and it is true that Harry did pay me, it was 15 cents, so anyway, that's my very, very strong support for this particular initiative.
MR. ROTHSTEIN: Thank you, Jeff. And now we're going to go to John to talk about disclosures and regulatory issues.
MR. HOUSTON: Thanks, Mark. I guess we're going to break them up by section so I'm going to talk about disclosures first and get some comments back. Really I think when we discussed this matter we really looked at disclosures really of being of two separate types and we thought they really needed to be addressed separately. The first type as sort of I would characterize it as being a primary use and that would be uses that are related to treatment, payment, or health care operations which are defined and provided for under HIPAA today. And then the second type of use is one which we've sort of characterized as secondary uses or something that is provided pursuant to I think what Mark has as being a compelled authorization.
So to the first part, primary uses, we recognize that not all individuals necessarily need to have access to all PHI for a patient in order to deliver care. We could look at the extreme example where you might say the physician needs to look at the entire medical record in order to deliver care because they don't necessarily know what's relevant, they need to have access, but that doesn't necessarily mean that somebody who's processing claims or a dietician or somebody else, a phlebotomist in a hospital, necessarily needs to see the totality of that patient's record that's available through the NHIN.
So we thought that there needed to be some type of role based access criteria scheme implemented in an NHIN in order to try to limit the access to information that was relevant based upon the caregiver who was actually looking at the record for purposes of delivering care or payment or whatever. And we believe that this is a principle that needs to be inherent not just within the infrastructure or the structure of the NHIN but also with regards to EHRs, and an EHR being the internal systems that a hospital might use to deliver care rather then NHIN which is the vehicle to deliver information from third parties back to an EHR or to a provider in order to deliver care.
So that's the concept of a primary use.
Now to secondary uses, the issue of compelled authorizations, again I think that there's a lot of cases where a patient or an individual is asked to disclose PHI unrelated to TPO and those by example are such things as employment, getting insurance, seeking a loan, things of that sort. And while we recognize that those are typically provided, the information is provided pursuant to some type of authorization, those authorizations are often again what Mark I think has said as being sort of compelled, if you want the insurance, you want the job, you're going to provide the authorization.
And in a lot of contexts they're entirely reasonable to expect that in order yes to get those types of things you need to provide information. But what we recognize though is that often these authorizations are overly broad and so really the key here is that there needs to be some concept of limiting authorizations to what is reasonably required in order to address the need and we thought in terms of what we think the NHIN needs to have is this concept of a contextual access criteria. So based upon who the individual or the organization is that's requesting the information, is there a way to limit the disclosure to the types of information that are reasonably related to the purpose that's being requested so you don't have to see the entire medical record related to employment if there's actually a very small segment of the record that's relevant to the job that this individual is going to fulfill.
So again we think that, I think it's entirely reasonable to expect that authorizations are going to occur but we need to have some mechanism to try to limit what information is actually disclosed.
MR. ROTHSTEIN: John do you want to take comments on this before you get to regulatory issues or do you want to do it separate?
MR. HOUSTON: Yeah, I think we do, I want to stop here. There was only one other point I think we talked about, we thought it was important because we really didn't see a lot of activity to date with regards to both role based and context based criteria, that we thought that it'd be good that HHS in some ways should support research into how you would develop these types of schemes or whether they were workable. So again, that was the only other comment I wanted to make.
MR. ROTHSTEIN: Thank you. And now the floor is open for questions or comments from committee members.
MR. SCANLON: Mine were in the nature of a friendly amendment, it sounds like these are, the way you're heading is you're trying to identify some principles that should govern the thought and the direction for privacy issues in the NHII or NHIN which is quite good, and then presumably there could be recommendations that follow depending on the form follows function kind of an idea of what exactly it's applied to. But you are thinking about principles I guess, what you're now describing almost reflects implicit principles and how you do that.
PARTICIPANT: Louder please.
MR. SCANLON: I was asking the framework that they're using basically will result in some principles for privacy in whatever the application may be which I think would be a good way to think of this.
DR. TANG: Would you suggest that we stop our work after we've come to consensus principles or would you also suggest that we provide recommendations for actions that follow those principles? Where do you think would be a --
MR. SCANLON: Well let me introduce this strategy idea, you've given me kind of, you've opened the door. I think the, and you'll be sorry, I don't want the committee to get in the position of almost filing preemptive reports and recommendations while we're in this transition strategy relating to the AHIC and what the NHII or the NHIN might looked like. And I think as the Secretary indicated the committee will be asked to provide some advice on the privacy thinking here and I think that should factor into the committee's thinking in timing here. I think if you, I don't think you want, and principles generally are a good way to proceed because if you need to get agreement on principles or at least hash out where you disagree, and then whatever, again this is to some extent a form, you have principles and then depending on whether the application is a network or an electronic health record generally or transactions, then the principles will make some sense. I'm afraid that if you lock in specific recommendations assuming a certain application you would not only be heading in the wrong direction but it will look almost preemptive like you've answered the question before it was asked.
So it's more of, I don't think I have the answer but I think if you would factor in your deliberations the concept of leaving open whatever requests might come from the Secretary and the department relating to privacy advice, factor into the planning and the report, and sometimes, it depends on what the nature and the level of recommendations might be. On the other hand you can't go wrong with principles live privacy by design, balance and other things like that, so just kind of an overall strategy, not dealing with any specific recommendations.
MR. ROTHSTEIN: Thank you, that's very helpful. I've got Simon, Marjorie, and then Steve. Simon?
DR. COHN: First of all I really like that, the title, Privacy by Design, actually I found myself sort of liking much of what was being said though I do find myself sort of going that this appears to be principles with the need for further research and/or demonstration projects or whatever which is I mean useful to help flesh things out because a lot of things sound good, the question is is are they workable, when you really get to the implementation are they doable.
I think with this idea of, was it internal, the access scheme and the, actually for the internal one, the role based or whatever, I know it has been worked on for a long time, one of the questions is is how well does it really work and even though it's very easy to say well geez a diabetic nutrition educator only needs to see X but then you go well what exactly don't they need to see when you're trying to educate them on nutrition and all of that and so you get into sort of the good idea versus the reality of the situation.
Similarly and I guess it's really just sort of a question and I will apologize because I haven't been part of all the subcommittee's deliberations, as good as the idea of under the compelled authorization area this idea of as you described it I think these were contextual access criteria, I guess I'm sort of, on one hand yes that's a really good idea and then I'm going well geez, any insurance that you get, is there things that they wouldn't be able to see and I'm going well jobs, well what wouldn't they be able to see and it's sort of goes down into the reality area, I'm not saying that it isn't a good idea but it's a sort of demonstration --
MR. ROTHSTEIN: No, Simon, let me clarify, when we say insurance we're not talking about health insurance, we're talking about life insurance, disability --
DR. COHN: No, that's exactly what I was talking about. I'm just sort of thinking, I mean once again I could be way off, I'm just trying in my own mind thinking about exactly you, there probably is an answer, I just don't know --
MR. HOUSTON: A couple points that I think are relevant here, the first being I think that the NHIN to succeed they're going to have to start to think about context anyways because if 20 providers all hold information about a patient to go out and search and get all that information to begin with I think could be, could overload that type of an environment. So I think we need, I think there is already an architectural need to start to think about how you gather data and gather only the relevant data related to the particular request. And I think towards that end I think if you layer on top of it something like well there's access, you can say okay, it does sort of fit in with some of the architectural design criteria they're going to arrive upon so I think there is some opportunities to try to couple it together to solve this issue, for solving some other issues.
DR. COHN: And let me just sort of say, I mean nothing I'm commenting should be said to really in any way negate the idea, it was just sort of an observation that in this one like anything else it's sort of like at a high level it sounds good and I think it really speaks of I think evaluation, demonstration, etc., that's really where I was trying to go.
MR. ROTHSTEIN: Well also keep in mind that we're giving you the one inch depth analysis of each of these problems, we could spend an hour talking about how it might be done, where it's done, what would be working and so forth. Marjorie?
MS. GREENBERG: I actually didn't have anything.
DR. STEINDEL: Simon actually picked up a lot on what I was going to say. The thing I thought it was very good about talking about context within the, what words you were using, the forced disclosure, compelled authorization, I think it's very good to talk about context there. But I also think there's a contextual component of the first criteria as well, not just role based, and this goes to what Simon was saying. When a health care practitioner is asking for information for treatment purposes it's done both in a role and a context and that can help limit the amount of information that could be disclosed to just what really is pertinent.
And one reason this is becoming the big issue is we're starting to focus in in the area of certification which was brought up before, especially in the area of things like audit trail which in itself is so broad that no one can really do it. But then if you say you need an audit trail to track the legal requirements of an electronic health record then you can describe what components need to go into the audit trail, so it has a contextual basis as well. And that's the only reason I'm bringing it up that you should not forget that component in the first part.
MR. ROTHSTEIN: Thank you. Carol and then Don and then we'll go to John's second issue.
MS. MCCALL: First a very specific question, John, you used an acronym, I think it was TPO, what does that --
MR. HOUSTON: Treatment, payment, or health care operations, or operations, each of those are defined within the HIPAA privacy rules.
MS. MCCALL: Just a new TLA right? The actual real question, you had referred to this I think when you opened up that there would be some recommendations that might seem on the surface to be contradictory because it had to do with authorizations, I think, and where you actually, what you do upstream then essentially makes moot what you might have to do downstream. Given now the context of contextual access criteria, compelled authorizations, those types of things, can you just for a couple minutes talk about contextual access criteria and some of those either upstream or downstream, can you just give some visibility on how those things relate or don't?
MR. ROTHSTEIN: How that might work in real life?
MS. MCCALL: Yeah, what you guys talked about, what you wrestled with as you tried to --
MR. ROTHSTEIN: Okay, very quickly, not to belabor this, in my personal view, now I'm not speaking for the subcommittee, we hear a lot of talk about breaches of security and invasions of privacy and so forth as if it all were caused by computer hackers and snoops and so forth. I think the greatest threat to health care privacy is through lawful compelled authorizations that people have to sign as a condition of applying for life insurance or a job or to get social security disability, you go on and on. I estimated that at least 30 million who have to sign per year where you have to sign an authorization releasing your medical records, and the idea is sort of akin to minimum necessary, if we could somehow release only the information that these providers, these entities legitimately need to decide whether I can do whatever the job requires and to evaluate what my mortality risk is or whatever, and not send them all the other sort of irrelevant sensitive stuff we'd be doing an immense job of protecting privacy. Unfortunately in a paper based system you can't do that because it's a mess and so what people tend to do is they send everything regardless of the scope of the authorization, so even a more narrow authorization where they ask for less they get the whole package anyhow.
And if you want my personal use case here is how an electronic health record system could protect privacy, everybody is worried about electronic health records compromising privacy, here's how it could further privacy where let's just take life insurance as an example, life insurance companies really don't want or have the time or want to spend the money to review everybody's file, there are only ten things that they want to look at. And if you could find a way to push a button and extract those ten things, oncology, heart disease and so forth and skip all the rest of the stuff they would have all they need and just think of all the private stuff that would be retained and the confidence that people would have in the system.
But to do that, nobody has the capacity to do that, we need to do a lot of research to see if that could be done, and there's no research being funded in this area. And if we could research it and integrate it into the architecture of the NHIN then wow, wouldn't that be terrific for everyone. Don?
DR. STEINWACHS: We're developing classifications, I could tell by role and context, and you've touched on it also, Mark, I think there's the question of the age of the information that you're abstracting and so to me one of the scarier things is to think of the search that goes from age birth to age 60 or 70 and you look at the physical records that are on some people, and the other is the age old problem of mistakes and inaccuracies in records and I assume somewhere in this it comes up in terms of what patients can do to try and correct that. But it's also a very tough thing if you're talking about these disclosures to an insurance company, well you pull up something and then is it attached to it a patient disclaimer or how does the patient know and so on.
The last piece of this longevity issue it seems to me is I could see a private industry starting where people are convinced that they ought to have their old records automated and made available and so I think there may be in this area also a great lack of research. But this idea of what is the useful life of medical information I think needs attention in this country before we automate everything or have a Google machine that searches that to come up with all the related pieces. And I see an industry here I'm afraid of.
MR. ROTHSTEIN: That's a great suggestion and I think it will work into the discussion of the other sections.
John, can you move on to the second issue?
MR. HOUSTON: Yeah, regulatory issues, and really that's broken down into in my mind three separate distinct areas, one is jurisdiction, the second is procedures, and the third is enforcement, and I'll go in order.
And as an overview to all of this I think it's important for people to understand that there might be recommendations in the report that are inconsistent with some of the provisions of the HIPAA privacy rule, it might be in addition to, it might be inconsistent with, but it suffices to say that we looked a the HIPAA privacy rule to help us sort of guide us to rationale behind certain of our recommendations and things, we recognize that there may be cases where we simply think there is some incompatibility in terms of our recommendations.
But with regards to jurisdiction I think that what we decided upon was is that really there's a lot of conflicts between the various sources of health privacy regulation, whether it be state/federal or state to state and that those issues are going to be more pronounced with NHIN. And we also believe that a national single standard would facilitate compliance. And since we're aware that the Secretary has awarded a contract to the governor's association to study the variations in state laws and with HIPAA the committee obviously is going to defer the two to see what the recommendations or the outcomes of that study is.
Now having said that one of the things that we also recognized and as Justine had brought up is that events like Hurricane Katrina have also demonstrated the importance of having a comprehensive medical, electronic medical records environment, and one that may have to traverse state lines to be effective. So those are sort of some of the principles under jurisdiction.
The other issue that we saw under jurisdiction was one whereby once information is passed outside of a covered entity to an entity that is not covered, and there's a lot of those, the information loses protection. So there is a great possibility that organizations that would participate in the National Health Information Network may not be covered by HIPAA and we think as a general rule we believe that coverage needs to be extended to all such entities rather then those that are currently covered by HIPAA, so again jurisdictionally we think that's a very important concept.
Under procedures I've got a couple of themes, we do believe, I think it was brought up earlier, that there really does not need to be participation for cross section of the population. And while AHIC is a really powerful step in that direction we believe that there needs to be meaningful participation to ensure that there's adequate representation and that people of vulnerable and minority populations are, their interests are reasonably and adequately represented. So again thematically that's one of the concerns that we had and one of the things that we think is a cornerstone.
Secondly we also think that it's very important that the NHIN and individual participants in the NHIN make sure that, make their information practices available, and there have to be fair information practices, so that individuals would know that they have the right to see an accounting of disclosures and the right to correct errors and the right to understand what procedures might be available to them to redress some type of harm. So again overall we thought that all of that information needed to be reasonably available to individuals in order for them to understand their rights and obligations.
And also we thought that patient notification in the event of a breach was also an important concept. But while that was an important concept we're not really going to discuss it in this letter because we really think it warrants a separate letter to the Secretary discussing security more broadly.
The third area we looked at under this topic was enforcement. We believe that strong enforcement and meaningful penalties are absolutely essential to the NHIN and we also believe that while there are enforcement provisions within HIPAA we believe that they're either inadequate right now or they're simply not demonstrating to the public that enforcement is occurring, there have been no civil monetary penalties and things of that sort so there's a concern that they don't appear to the public as being adequate. They may very well be very involved and meaningful but to the public I think there's a perception potentially that really just enforcement is inadequate.
So we believe that there really should be more civil and criminal sanctions imposed on individuals and entities for violations of the confidentiality and security provisions of the NHIN. There should be some type of progressive and severe penalties for egregious violations or violations that continue to occur. There should be a variety of different types of enforcement mechanisms that don't necessarily have to be through the government, potentially it could be through licensing boards, accreditation boards, or other types of contractual arrangements. And that frankly I think one of the strongest measures that we can take is that continued participation in NHIN can be conditioned upon compliance with privacy and security rules and that if you don't comply then participation in NHIN could be curtailed for some period of time because of that.
And I think the final key concept here is that we also believe that individuals need to have some type of remedy, direct remedy. Now we don't believe in necessarily a private right of action but that does not preclude individuals for being compensated for actual harm. And again there's a fine line between private rights of action, not having a private action but also having some type of mechanism in order to evaluate whether an individual has actually had some type of actual harm that's compensable such as in the case of an identity theft and are there mechanisms to where an individual actually has true out of pocket expenses associated with something and making sure that they're made whole.
So those are the enforcement principles and I think that's about all.
MR. ROTHSTEIN: Thank you. Questions or comments from committee members?
DR. STEINWACHS: I couldn't leave it without one comment, for some reason in this discussion and maybe it's because you're a lawyer and it springs on me, you made me think about the Witness Protection Program and people going undercover and what kinds of protections there are for people who play special roles or have special roles in our society, and I've never heard discussion of that in this kind of context of if you were in the Witness Protection Program how do you deal with the NHII, if you went under cover how would you do with the NHII without leaving the person without, so that's what you caused John and I have some friends that really want to know the answers.
MR. HOUSTON: We're going to give everybody your name.
MR. ROTHSTEIN: That is something that to be honest we have not considered. Russ, did you want to --
MR. HOUSTON: We asked some people from the Witness Protection Program to come in but they wouldn't.
MR. LOCALIO: Well one suggestion that just came to my mind is that you may want to have the enforcement apply to the information, in other words the reason that the Miranda rule works is that confessions that are given without a Miranda warning cannot be used. Well you could have some instances in which information is disclosed improperly cannot be used.
MR. ROTHSTEIN: We will talk about that. Other comments? Okay, now we're going to go to Paul.
DR. TANG: The final topic here is secondary uses of data and for purposes of this discussion we define it similar to the way Stan did which is confidential health information that is used for purposes other then direct patient care. We all recognize there's lots of good reasons to use it, research, public health, but indiscriminate use of that information poses very serious privacy risks.
And the origin of this concern is this basically that the entities that are not covered by HIPAA, so you can imagine a third party who gets it through legitimate reasons, or reasons that aren't legitimate, but HIPAA does not extend protection, doesn't extend restrictions on the use of that data once you've done something with it. And that's where the concern lies. And because as Harry said our primary objective is to ensure that citizens, consumers, patients, trust this NHIN, that we need to ensure or try to assure them that their data won't be used for purposes other then which they had consented.
So this leads to the conclusion that's similar to what John mentioned which is we need uniform comprehensive, comprehensive means it covers all those entities, everybody who has access to or stores that data, privacy policies, that applies to any entity with access to confidential health information anywhere and regardless of how they got that information. So it basically is the protection follows the data and everybody is accountable.
Now the point that Russ brought up in terms of outsourcing to foreign territories is a problem, some states actually have tackled that by saying you can't do that with health information and that's an approach. But anyway, so that's an unresolved issue but we recognize that in our discussing it as part of the process. So the primary principle we're throwing out there for discussion is really very uniform comprehensive protection of data no matter where it goes.
MR. ROTHSTEIN: Questions or comments for Paul. Okay, I think some of those came up earlier so that would explain why everyone is assenting to everything.
DR. COHN: I guess I would just sort of, as I was listening to this I was just sort of observing obviously, I think Mark described it all this is not necessarily internally consistent and I was just sort of thinking of uniform national privacy policies and also reflecting on John Paul's comments about how we were going to wait and see what happens with the federal and state work that relates to all this stuff. I mean I will just observe that those are not necessarily completely consistent patterns and I guess they could be.
DR. TANG: They're principles, so they create law, these are principles because it addresses an issue that raises serious concerns.
MR. ROTHSTEIN: We're cutting it two different ways. In one respect I think we're saying independent of the federalism issue that the scope of the HIPAA privacy rule is not sufficient, that it's too limited, that we want to cover all of these entities who are not covered by HIPAA who get protected health information. There's a separate issue about the federalism whether it should be the preemptive and so forth. So I don't think they're in this area necessarily inconsistent but I've got several others that clearly qualify.
Okay, let me go to the last area and I was hoping that we'd be out of time before we got to this but it seems that we haven't. And that's the issue of patient control of their records in the NHIN and Don alluded to it earlier with old records. And this has caused us the most difficulty. One way of looking at is we want to promote privacy and autonomy and individual choice and that suggests flexibility and people should be able to do lots of things. On the other the more flexibility that you have, the more complicated the system becomes, the more expensive it is, the more it's going to be hard for individuals to understand what their rights are, it's going to be hard for providers and other entities to comply with it. And you lose the health benefits of the comprehensiveness of the NHIN, both on an individual and on a system or societal level.
So there are two things I want to discuss relative to this, two questions. The first one is to what extent if any should individuals have the right or ability to elect not to have their health records disclosed through the NHIN? Should they have a right to be out of the NHIN? And it would be easier and more valuable if everyone were in the NHIN but mandatory exclusion with no ability to be excluded from the NHIN, if we just said you're in it and you can't get out and we're going to start using your stuff, I think it would raise very serious legal, ethical, and political concerns and would likely undermine public support for the NHIN. And the Privacy and Confidentiality Subcommittee is unanimous in the view that inclusion in the NHIN should not be mandatory without some sort of option to be outside of the system.
Now that only frames the issue and it doesn't resolve it because the subcommittee is not in agreement on whether we should have an opt in or an opt out option. Opt out, the advantages of opt out are it's easier because you put the burden on the patient, if they don't do it they're in. It's simpler, it's cheaper, and it's more likely to result in a higher percentage of individuals within the NHIN which we consider a good thing.
On the other hand opt in advances the important interest in autonomy, in choice, in respect for persons, and may lead to greater public support for the NHIN. Under either approach public education is very important so that's the first issue.
The second more difficult issue is to what extent if any should individuals have the right or ability to exclude certain information from transmission via the NHIN? Or to block certain information to providers or other recipients? Subcommittee members are not in agreement here, it's good thing there are only four members because there are only four different views. Arguments in favor of not permitting this, in other words not permitting people to cut out certain things, the sort of the all or nothing approach, is that it's easier, it's less costly, it eliminates liability concerns of providers, you're going to sue me if I make a mistake because I didn't have enough information, and it better promotes individual and population health.
Arguments in favor of allowing exclusion or blocking are that a patient's ability to exclude certain information is essential to protect the privacy of sensitive health information, it is needed to encourage people to get mental health, substance abuse, STD treatment, and all these other kinds of services that they might be reluctant to undergo if you couldn't exclude or block that information. Without exclusion or blocking people will opt out of the NHIN all together and this is one of these sort of upstream/downstream issues. And blocking, that technology where you can block certain information has been successfully used in other countries, in fact all the other countries that we talked to, and they generally told us that it's rarely used but people love it as an option.
Now that only gets us half way because if there is some exclusion or blocking then the next question or series of questions is suppose we adopt that in principle what issues can be blocked, how do you block it, will decision support such as drug interactions include the blocked items where in some ways you can have the decision support run under the blocking, can an extension of this blocking block certain providers from getting access to this, I don't want my ex-wife seeing my medical records, can you have that kind of block. Will clinicians be notified that certain types of information has been blocked, are you going to flag something and say STD information not supplied at the request of the patient or whatever, that might not be that helpful, will there be a break the glass feature to allow emergency access, yes or no, and also even if you include a blocking feature it's not an airtight protection for privacy, and this was a point that Harry made yesterday, because let's pose you are seeing a mental health provider and you want that excluded. If you've had a prescription filled for an SSRI it's going to be at the pharmacy, at the PBM, at the payer, and they're going to be able to infer that you've got, so even if you block it it's not going to be perfect and people need to know that.
Now the subcommittee members are not in agreement on this issue as well. Both parts, whether you should be able to block anything and if you do have the ability to block something how would you go about doing it.
Okay, Don, Simon.
DR. STEINWACHS: Just one thought that sometimes it sort of feels like it's all or none and it seemed to me that people have been trying to figure out what is the in between ground about what would be the shared part and so family physicians have their continuity of care record sort of proposal and so it seemed to be interesting in a set of principles is to think about are there options so that my whole, I'd sign up for NHIN but my whole record in detail would never be retrievable, only this relevant sort of summary of things that were somehow derived like this continuity of care record, so it'd be recent stuff, diagnoses maybe. So if we had some options it'd seem to me that might open it up a little bit because the other ones always sound Draconian sometimes when you don't have --
MR. ROTHSTEIN: Well I actually support that view but the members of the committee will recall that in Chicago we had that hearing specifically in Chicago to hear from all the medical associations and stuff. And we asked sort of everybody what do you think of that and they didn't like that at all because no matter what specialty representative you talked to they were able to come up with some scenario in which if somebody had chicken pox at age five that's going to explain their heart disease at age 85.
DR. STEINWACHS: Let me try another twist on you because, and then I'll quite. At least working around hospitals and never being a clinician I've had a sense of how those huge records that patients have, you have a visit no one actually looks at that whole record and oh, Justine does, thank goodness, Justine does. But if you think about the compilation of many people's records, even when it's electronic, if the assumption is any provider you go to has access to that under the full NHIN then isn't that provider accountable for interpreting and understanding in your current context, whatever that context is, all of that history? It seems to me this opens up a huge area of liability that the medical societies haven't thought a lot about that says maybe you have to go back and find that case 45 years ago when the person was a child.
MR. ROTHSTEIN: I have Simon, Carol and Kevin, am I missing somebody? Okay, Simon?
DR. COHN: I don't know whether to react to what Don was just saying or what you were bringing up. I guess I will like Justine sort of say that even though my specialty has been emergency medicine I'm typically one of the ones who looks through the multiple volumes of the records because it isn't what information you have it's what result you get and I think we're all, I mean all physicians all know of are really interested in the best result as opposed to well because I didn't know that it doesn't matter but we're sorry, which is I think the outcome of what you're describing as a potential outcome.
As I'm listening to all of this, and I'm actually glad I was not part of this conversation, I guess I come back sort of going it seems like it's almost like we need to go back and look at problem definitions here because there seems to be a number of undercurrents that I'm not even sure I can describe at this point but that sort of are underneath all of these conversations. I'm hearing for example that sort of blocking things but I'm sort of hearing something that, I'm just not sure what we're blocking from whom. It sounds like maybe a patient A doesn't want, wants to let this doctor see this but not this other doctor see that and so there's a dynamic going on here around what providers think of patients.
I'm just saying I don't know what the issue is, I'm hearing that but I'm going well or is it geez, you want to block things going to an insurance company and geez could you even do that if you're creating a disclosure but geez, I heard even in places where they block there are uses of it for public health or population health, uses for, I mean we heard of a case in Denmark where stuff gets blocked but it's all used for, I believe it was used for population health uses as well as for drug/drug interactions and so gosh is that really blocked or not.
I guess this is one where I'm sort of going I think there's some fuzziness of thinking here that is potentially resulting in the outcome where we have fuzziness of outcome.
MR. HOUSTON: Simon, I think those are all conversations that we had and concerns and issues, I think it is the issue of patients not necessarily wanting to have all their providers see all their information. And we did raise, we had discussions about the issue of if information is blocked with the way the architecture of the NHIN seems to be shaping up we're not going to be able to do effective drug to drug interaction because you simply won't have the information provided from the source system with the drug information in it in order for the destination system to do the drug to drug interaction. So there are a lot of issues here with regards to blocking of information and limiting information, there's a lot of, when we had this discussion I remember we brought up, I remember Mark bringing up and I'll say it but he said hey, this is what we have today and I think the response that I know I had was well that's we're trying to get away from is what we have today.
And I think this is really a sticky issue though because you still have patients who still believe very strongly that they don't want one specialist to see the opinion of another specialist because they're looking for a second opinion, or there's the minor has the abortion that doesn't have to be consented to by the adult and they would prefer that that information not be known. Now obviously if the patient presents within a day and they're in hemorrhage that there might be some relationship but that for some period of time, I mean that's actually happened in one of our facilities and it was because of the abortion. But the issue here is that at some point the information can become stale and people have this privacy expectation that has been voiced as a concern.
MR. ROTHSTEIN: I'm going to close the list, I've got Carol, Kevin, Justine and Jeff.
MS. MCCALL: This just must have been some great discussions, I can only imagine. No, seriously, a lot of fun.
A lot of the things that you've walked through, part of the back and forth that I see is between execution and what's really possible, and forget what's possible, what do you want, what's true north, if I could actually have it this is what I'd love to be able to do and I think that that's important to be able to actually have an opinion on the principles around it and then turn to the community and say okay within this how far can we get and then we'll see.
One thing I thought about in terms of let's say that the principle were I want people to have the capability to block, all right, and so let's see how far we can get. One thing could be is that there are consequences to that, I mean it's almost like a DNR, that first of all if I want to elect to block I need to specifically do that and it needs to be perhaps hard and I need to be told all the consequences of that, that maybe certain things won't work. Drug/drug interactions may not work. Certain things aren't known and therefore my liability as a physician would be reduced. You can't come back at me if there are things that I may need to know, just the scope of what I can do will be less. They need to know that and there may be some boundaries.
The other thing is, this is a very specific thought, if something is blocked can a doctor ever come up to the door and kind of go [knocking] can I have that.
MR. HOUSTON: Break the glass.
MS. MCCALL: Well not even break the glass, maybe it's not, that's kind of very emergent situations, what if it's not that but look there's something that's blocked here can I see it or not. So it's a less emergent situation. So that was a very specific idea.
MR. ROTHSTEIN: Thank you. Kevin.
DR. VIGILANTE: This is really difficult, I'm wrestling sort of this and probably expressing my confusion in real time. On the one hand it's just so hard to provide optimal care for folks and part of providing optimal care is having complete information and those who practice in the emergency department really know how big a difference it makes when you can get a chart with good information in it and it really, it does make a huge difference in what you can do for that patient. And when you block information in a systematic way in some ways you kind of recreate the fragmentation of information that we're trying to overcome with this whole solution.
On the other hand I mean I can understand the sensitivity of folks thinking about certain very personal and private things that are just going to be out there in cyber space and while they may actually be more secure then they are today in a paper record there's still a lot of anxiety with it being out there.
But at the very least I think if you do block something you have to, I think it's in the patient's interests to allow clinicians to know that something has been blocked. Because at least if the patient is conscious you can ask the patient, you can say okay this is blocked, in a conscious patient you can still extract a history. In an unconscious patient or somebody who's intibated(?) or other circumstances in which they can't communicate and that blocked information is vital that's a special case that I think would deserve special treatment. So obviously not an answer to the question but I think it goes along the lines of what you were saying Carol.
MR. ROTHSTEIN: Thank you. Justine?
DR. CARR: I'd like to echo what Kevin was saying, I think so much of this whole initiative is to repair fragmented care and to then ask physicians to create this new paradigm where sometimes you have your hands tied behind your back or sometimes you have a blindfold, but at the end of the day the patients come to you for care. I just find it to be just not feasible, I think if a patient wants to have a paper record that they bring this page to this doctor that's fine but even thinking about the number of caretakers let's say on an inpatient episode of care how on Earth do you keep track of this one knows this but that one doesn't know that and all the handoffs, handoffs is a huge safety thing today so now we're going to even compound handoffs by hiding information and hoping that everybody knows that. I very strongly disagree with that blocking option, I can understand where it's coming from but I think it's eroding the role of the physician and sort of imposing a block without an opportunity to say do I want to deliver care in a fractured system. So I would vote for no blocking, either you're in or you're out and try to work, at least you have a clean dataset, you understand what your context is.
MR. ROTHSTEIN: Jeff, if you could be brief and then we'll let have Bob have a word because he hasn't spoken yet.
MR. BLAIR: We have a lot of intellectual horsepower around this table and if anybody, if any group is able to wind up to come to consensus on issues given enough time this group could do so, but I don't think we can and the reason that I don't think we can is we're trying to come to agreement on patient perceptions. Patient perceptions of what they trust, what they don't trust, patient perceptions of where they feel they have rights, where they don't have rights. And then given those first two you lay over it okay if they don't trust something what's their perception about whether role based access, class based access, location based access, would mitigate their fears or not. What about their perception of whether or not they had control of authorization for a particular health care provider to access that information if it was in the system, or not? So there is a landscape of issues of trusts and rights and the ability to mitigate it and the ability of feeling vulnerable that we don't have until a comprehensive survey of public attitudes is conducted to base our opinions on. And I figure that this debate and argument will go on forever until we understand public perceptions and fears.
MR. ROTHSTEIN: Simon wants us to wrap this up --
MR. HUNGATE: My comment is really quick, the ultimate block is a patient who doesn't tell you the things that you might like to know because they don't trust you. So it seems to me that data validity is a real issue and if you want disclosure then you've got allow for some reasonable blockage, if you want full disclosure there's got to be some provision for that, and we disagree there.
MR. ROTHSTEIN: I can assure you you will have ample time to weigh in on this later because we're going to be wrestling this for a while. John --
MR. HOUSTON: Just one real quick thing in closing, recognize that I don't think we'll ever have complete agreement on this, whether we do surveys, the reason why the committee can't come to agreement on some of these issues is because there's a good faith difference of opinion that is not unreasonable out of any of the people that are discussing it and have different opinions. I think this committee is going to have the same problem when this letter comes forward and what we're trying to do is put together reasonable recommendations that while we may disagree with or have some slight disagreement with but they're reasonable and they try to move forward the concept of NHIN and that we try to put privacy protections in place to forward that. And we are going to have disagreements and when we bring this letter forward I think we just have to recognize that and try to minimize those and try to come to as much consensus as possible.
MS. GREENBERG: Also I think, just following up on what Jeff said too, I mean I think, I've had the privilege of sitting in on a number of these hearings and been part of these discussions and I really respect all of you who've been struggling with these issues and will continue to, but you have the option too of just not making recommendations in areas where there's just clearly no universal agreement around the table, even if there's a majority. I think we should remember what Jim said also about the importance of principles and also laying out just what all the issues are and the different perspectives and what the committee has heard and what the downside is and the upside of the different approaches because ultimately any of these decisions are going to be made in kind of a political environment I guess with a small p I mean, I'm not, I was a poly sci major, I don't think that's a dirty word, political, and so I think what you can do is even in these very difficult areas is really kind of parse out the issues and --
MS. MCCALL: I think just to amplify that very quickly, Marjorie I think you're right on, I think that the goal should be to lay out what the big questions are that need to be answered, any insight to Jeff's point about what people think and some of that can come forward from the hearings, and I would say the third place to look and this may get to Justine's point, she doesn't want to practice medicine in a world where it's as fractured after all this work as it was before.
And yet there are countries that have gone before and so what I heard you say Mark was that you know what there are other countries, you spoke of people from Australia and the UK and some other countries, where they have the capability, it is rarely used, but has done something perhaps to fundamentally increase the level of trust.
And then I don't know what the consequences are form a political or a regulatory or a legal realm for somebody kind of pulls that switch, those are all learnings that can come so that we can get out of the hyperbole situations and understand how it really works and what the consequences really were.
MR. ROTHSTEIN: Simon, sorry to go over.
DR. COHN: Well no, and Mark, thank you, I think this has been a fascinating conversation. Should we clap and thank the Privacy and Confidentiality Subcommittee?
[Applause.]
MR. ROTHSTEIN: Please save it for after the letter is approved.
DR. COHN: And I want to redouble I think one of the things that Marjorie was saying, as a committee we have a variety of options, I mean we can agree on recommendations completely, there are occasions though not in my tenure has this happened where things pass a majority vote and then there's a minority report and that is an option. Another thing which I think Marjorie once again I want to redouble is the fact that there are, if indeed we are having this much trouble with the issue sometimes just a clear understanding of the issue and its multiple dimensions really does serve an important public policy purpose. And so I mean once again, and we've seen this in Standards and Security also as we've gone through, at times you discover sort of where there's consensus and as you move back you discover where there's sort of principles and ideas that need to be worked on and that need more work for a variety of reasons. So I just want to remind everybody that we have lots of tools.
Now Maya wants to make a quick comment, I want to give everybody about a five minute break before we move into the next section because I think people need it, and then we will transition.
MS. BERNSTEIN: I just want to point out since no one mentioned the reason that we had this discussion today based on the last meeting where everybody in the committee said that they really wanted to have the opportunity to talk with one another was the reason we started bringing this up today even though the subcommittee doesn't have a draft that it's ready to show you, that it wouldn't be the first time that you saw these issues and what we're dealing with in February. So the idea is to prime the pump, to get you thinking about this, and also to solicit your input over the next couple of months, if you're thinking about it and you have something that you want to share with us, if you've seen some paper, starting tomorrow morning at 8:00, please come and talk to us about it because the committee will be addressing these as a full committee at least starting in February and I'm not sure the issues are going to get any easier.
DR. COHN: Okay, well shall we take about a five minute break and allow everybody to stretch and all that, we'll start at a couple minutes before 3:00.
[Brief break.]
DR. COHN: Okay, this is our second session of the afternoon, we're going to be talking about secondary uses of clinical data and Stan Huff will be leading sort of the presentation and I guess conversation on this one. I want to thank you for being willing to step forward on this.
Agenda Item: Secondary Uses of Clinical Data - Dr. Huff
DR. HUFF: Thank you. Yeah, we'll just move ahead without further adieu. When we get to the conversation I'd be glad to hand the chair back to you, however you want to do that.
One of the things that was in the NHII roadmap was this statement, the comprehensive set of patient medical record information standards can move the nation closer to a health care environment where clinically specific data can be captured once at the point of care with derivatives of this data available for meeting the needs of payers, health care administrators, clinical research and public health. This environment could significantly reduce the administrative and data capture burden on clinicians, dramatically shorten the time for clinical data to be available for public health, emergencies and for traditional public health purposes, profoundly reduce the cost for communicating, duplicating, and processing health care information. And last but not least greatly improve the quality of care and safety for all patients.
So this really is a good introduction to the topic because the topic is basically we have this vision and I would have to say this has been a vision in medical informatics for a long time, it's a shared vision I think kind of universally, and the question is are we making any progress towards this vision with all of these things that we're doing. And we probably are and the real question is is do we truly share this vision, are there in fact things that we should do that would move us closer to recognizing some or all or part of this vision.
So just to start the discussion, primary use of data we've arbitrarily in some ways defined as collection, processing, display of data, which is specific to an individual person for the purpose of providing care and services to that person, and that includes data exchange with other sites for the care of the individual. Secondary use of data is processing and aggregation of data for uses other then direct patient care or a slight extension to that is use of the data for any purpose other then the purpose for which it was initially collected. So both of those things I think you could consider secondary use and the more you pick at this the more you could find out there's some overlap in that. But nevertheless I think at the end of the spectrum you're okay.
So we began discussing this issue in the Standards and Security Subcommittee as early as April of 2005, its just been this year, my date is wrong, but we first had some discussion, we had the first group of testifiers in July and then the second group of testifiers in September and a little later I'll share summaries, brief summaries, of what we heard from the testifiers already.
Just looking at this from a data flow perspective what typically happens now in institutions, that you have a number of systems that go through some sort of interface engine and you end up with a clinical data repository and you're using standard interfaces in that. And that could be more or less then this in a given institution, it might be in some institutions that it's just laboratory data that's flowing, other institutions it would be pharmacy and lab, other institutions it would be text reports, other things. But to some extent there is electronic data flowing now and it's happening in standard interfaces, they're not as standard as we'd like them to be but you have things going. And then clinicians can access and use that data to of that clinical data repository.
Now I know at least in our own institution there's quite a different sort of flow when we talk for instance about cancer data registries. All of those same sources of information but they flow to a person who's looking at things in paper charts and they might not always look as worrisome as this individual but there's a lot of work and a lot of going through manual things, manual processes that then cause creation of electronic records that in the best situations are standard interfaces and those get promoted on up to regional, state, and national registries.
So part of the vision of this is could we have a future where those electronic data flows that are happening go through some kind of automated process, and I think in most cases we're thinking of a semi-automated process where somebody is watching and observing but the data gets filtered and in a much more automated way the electronic data that exists ends up being placed into a hospital registry and then moved on to regional or national registries. And again hopefully we're using standard interfaces and standard terminologies wherever we can in that process.
Now jump to this, this is the actual sort of diagram at Intermountain Health Care right now. Down the left hand side of the screen there are a number of ancillary systems all of which are exchanging data with an interface engine that's sort of the hub of our system and we send admitting discharge kind of information out to those ancillary system, those systems produce results, pharmacy orders, clinical data, laboratory data, text reports, all those things come back, go through the interface engine, and they're converted there into standard structured coded data. They're already structured and coded in most cases when they come from the ancillary systems but we convert them into standard codes that are a common coding system and then we add those things into the clinical data repository.
The different between these two databases, the clinical data repository is the database that we use for real time patient care and then over in the right lower corner you have the data warehouse and the data warehouse is the name we've given to the database where we do longitudinal cross patient research. And there's a big arrow there that's showing basically a real time or semi real time exchange of data from this coded structured database that's used for the real time patient care into the data warehouse which is where we do the population, cross population analysis and research.
So at least in our institution then that leads to the opportunity to do some of this secondary use of data. To give you an idea of the scope of things our data dictionary contains 875,000 concepts that we use to represent that data. We have over five million relationships represented in the data dictionary between those concepts and those relationships are things like anatomic relationships between body parts so that you know a certain body part is a part of another part, or the fact that a particular ingredient is a part of a composite drug, those are the kind of relationships that are there. And then there are lots of different names for those same things so they have roughly five different names for each thing that we've got in there that's represented as an abbreviation or as a code or some other representation.
We've got ten people working full time that maintain that terminology for our corporation and to go back to that, we care for, we have active clinical records on about two million people in our system. We have 26 people who are maintaining the interfaces and that number includes both the clinical interfaces as well as the HIPAA financial and administrative interfaces and it's roughly half and half. But that gives you some idea of the number of folks and kind of the investment that Intermountain Health Care makes in this kind of activity.
So we've done some secondary uses of data at Intermountain Health Care and let me just recount a few of those. One is the adverse drug event monitoring and we manually tried to track adverse drug events for a number of years and we suspected that we were tremendously under estimating the number of adverse events that happened. And so Scott Evans and other people at Intermountain Health Care said well what we'll do is rather then ask people to report them we'll start looking electronically in the system to try and understand if we can see from the system when these events happen.
And so they started looking for instance at the times when their stat orders for Benadryl or stat orders for steroids that would be common treatments for adverse events and just looking at laboratory data when there was a wildly high drug level of some kind, etc. And what we found basically that electronically we could detect nearly ten times as many adverse reactions as were reported through a manual process and they've continued to improve that kind of reporting and improve the sophistication of the system in detecting those kind of errors.
Nosocomial infection monitoring, again for infection control purposes it's important to try and figure out if there are in fact nosocomial infections going on and what the source of those is. And so electronically we have a program that goes through and it basically simply looks to see if a patient was admitted with no fever and a normal white count and then sometime during the admission they get a high white count and a fever, or they get an infiltrate on their chest x-ray, we say that's a high likelihood that that person has a nosocomial infection and then a nurse is sent out to investigate and find out whether that truly is or not. But again detection of that kind of nosocomial infection is now done in large part electronically as opposed to just directly by some manual process.
We've done rule based billing in labor and delivery, this has worked, it's been done by Sid Thornton, and in this case basically we've worked closely with the clinicians and with the billing staff at Intermountain Health Care and said look, if these things are in the chart is it legal for us to bill for those things and basically set up a rule base that says when this occurs it's legal and proper for us to bill this to the insurer and that happens, again, there are people that review that but the bulk of the work is done automatically now whereas before they were dependent upon people to submit pieces of paper or to take a second step in addition to the clinical care to make sure that the billing happened and so we have much more accurate and appropriate billing.
Reportable diseases, I mean this one is great and also shameful in a way. Again we have known reportable diseases that we need to report to public health facilities and we know whether those particular diseases occur because of laboratory tests that either an organism grows or there's an antigen or antibody that's found or in these days the DNA testing that tells you that the DNA of the organism is available. So there are a number of things in the laboratory that tell us those things. We look at the computer data, if we see those things then that shows up on a reportable disease report, person confirms it, and then this is the shameful part, it's all electronic to that point and then we fill out the form and send it over to the state health department in a manual paper form. We really, I'm looking for graduate students and others who would pick this up and we could make a proper interface there.
Another one of the things that we're doing is what we call how am I doing reports and an example of one of those is the hemoglobin A1C and physicians that are practicing at Intermountain Health Care basically at any time can pull up a report that tells them for their diabetic patients what the average hemoglobin A1C is for their patient and it shows them match populations that, not match populations, that's not correct, what it shows them are averages for the corporation for hemoglobin A1Cs for other physicians so they can see the average for the corporation and they can see their average. And then if things look out of line they can go from that report and actually see their own patients and see the actual hemoglobin A1C for their own patients.
But what it allows and what we've seen is a remarkable change in physician behavior if the current average for the corporation is 7.5 and a given physician sees that this hemoglobin A1Cs are 9 something, it's a remarkable motivator for physicians to say why am I different, I mean they go look at their things and say oh this guy is not my patient, I'm not really seeing, they look at the individual patients and then they take action to try and in fact provide better care so that that hemoglobin A1C value comes down as an average for their patients.
The other thing, a couple of things we've done in terms of clinical research and these are justifications where the solution to the problem ends up being other kinds of policies and procedures but the justification for making a change in clinical care comes from analyzing the data in the database. A couple of those, one was transurethral resection of the prostate and basically from the electronic record what we noticed is that there was almost a bimodal distribution in the length of time that it took people to be discharged after surgery. Some people were discharged at three days and other people were discharged at five days and it was almost always three days or five days, it wasn't just a smooth distribution.
And investigation into that came down that it was either one way or the other in a given hospital and with further investigation it came down to basically how the staff in that particular hospital had been trained and whether they pulled the Foley catheter on the second day or whether they waited another day to pull the Foley catheter and that corresponded exactly to how long their hospital stay was and there were no demonstrable differences in outcomes between those groups. And so again they just educated the house staff, house staff and the other physicians, and lo and behold the hospital stay for that surgery reduced by about two days in the other hospitals.
Another interesting one was induction of labor prior to 39 weeks. It's well known clinically that if you induce labor in women before the 39th week that you have a much higher probability of a premature birth and the likelihood that the baby would go to an intensive care unit or that there would be a longer extended stay for the baby in the hospital. And people said well maybe we ought to put in a rule for that and the clinicians said oh no, it's nationally it's all those other bad doctors that are doing this, we don't do this at our institution.
So somebody then basically went to the computer records and pulled them out and did the study and lo and behold we were right on national average in inducing before 39 weeks and we had all of the expected outcomes from that in terms of ICU days and other things. And so then the clinicians said oh, maybe we aren't doing as well at this as we thought we were, and in fact they instituted a rule and it's a step wise function, once they instituted the rule and really started looking at that closely the exact predicted change happened in the length of stay and in the percentage of babies that went to the ICUs, etc.. So it provides again a very strong motivation to clinicians because again there's a tendency always to think well I never do that, I mean there were interesting things that came out of this.
It turned out that these things corresponded to things like how long the mother had been visiting, waiting for the baby to be born, it correlated to, people say well my mom is going to have to go home and if the baby is not born before she goes home. It also correlated to days when there were Jazz games --
PARTICIPANT: Utah Jazz.
DR. HUFF: Yeah, Utah Jazz, correlated to when physicians were going to go on vacation, I mean there were a number of things that come into this. But all of those things basically once they're recognized can be corrected.
Anyway I think that's at least just a summary of some of the things that we've done at Intermountain Health Care.
So to sort of categorize those the possible secondary uses of data could be for billing, it could be for morbidity and mortality reporting, it could be for quality, quality reporting as well as quality improvement, it could be for patient safety reporting, it could be for clinical trials and post marketing information on drugs, it could be in support of other kinds of clinical research, it could be trying to understand the health population statistics. One of the things I didn't say, I mean because our electronic record is standardized, I don't know why you'd want to do it but if we had any interest in it we could probably report daily a running average of how overweight the population of IHC is because we collect that and it would be an easy thing, you could almost have a running average to try and understand if a particular intervention was having any impact at a population level on obesity. And then obvious things in public health for bio surveillance, reportable disease reporting, disease and cancer registries, all of those kinds of things are possible and this isn't a comprehensive list.
So why should we think about studying this? It would be to know what's already done, is there a feasible approach, are there things that should be done, are there standards that are needed, are there new policies that are needed, are there demonstrations or pilot projects that should be done that might in fact improve the quality of care by the secondary use of data.
Just another principle, let me go back here a second, so this is just a little bit about data collection and understanding how data collection relates to this secondary use of data. At some level you start out with things that are, things that you can perceive or things that you can observe like colors of things and visual intensity, sizes, shapes, pain, heat, other kinds of things, and most of these things are done at a subliminal level. I mean in physical exam you're not consciously thinking about these things but you are in fact quickly integrating those things to say oh, this combination of this visual intensity and this color looks like an abnormal color for somebody's throat, looks like a pharyngitis or they've got some cervical lymphadenopathy, they've reported to me that they have pain, they've got a temperature of 38.9, they've got a white count, etc..
And from that data you can apply another process and say oh with the combination of those things I can really say that I've got an increased white count, the patient has a fever, they've got a sore throat, they've got a positive strep culture, I know that they've got an inflammatory process going on. And knowing those things you can apply yet another set of rules or a process and assert basically that the patient has acute streptococcal pharyngitis and this goes on with yet another information knowing that they had a splenectomy or other things you can assert that they're an immunocompromised patient.
Well the purpose in going through this basically is to say that if I end up with in the medical record and the immunocompromised patient is the thing that finally gets reported as an ICD-9 code or as part of a DRG grouping process I can imply some things or maybe infer some of the things down below but my ability to infer the fact that the patient had a positive strep culture or other things is actually quite limited. And so in this sort of data collection chain if you had your rathers what you would like is the most primitive data because that then allows you to apply precise logic to the things that were observed and see whether in fact the things that, whether the things that were inferred were in fact true based on the observations.
So you could take a particular finding like the fact that they had acute streptococcal pharyngitis and say what was the evidence for that and if there were people who in fact had fever for other reasons of origin and there was no evidence of a positive culture and there was no rapid strep test or other things you'd say well that's really suspect. The point being that the closer you get to the actual observations that are used the more quality assurance you can do on this kind of data.
Now the down side of that is that typically the closer you get to observations the higher cost and the greater burden it is to try and collect the data that allows you to do that. It's a lot easier to just enter into the patient's problem list immunocompromised patient then it is to collect all of this other information as specific coded detailed information. But there's that interesting tradeoff in sort of fidelity to the observations versus reporting of these things at a higher more abstract level.
Related issues are that in that diagram for instance if the purpose was a billing purpose, if you can where each of these little circles represents an inference process that's going on in somebody's brain or it could be a computer process that's making that kind of inference, if you could establish those rules as computable rules then you would have a much surer way of asserting that you know this was true, that the patient had acute streptococcal pharyngitis. And what you could in fact do is instead of a person going through doing chart review and trying to find this information in a paper chart and make that inference you could make that inference electronically. And that's what Chris Schute(?) has always talked about as “aggregation logics” is a formalization of the logic that allows you to do that kind of inference on the data.
A second sort of interesting rule is that because the cost of obtaining good data is high in fact you may have to find secondary uses of data or you may want to make secondary uses of data to justify the cost of getting the data because often a single use of the data may not justify the cost and the overhead of getting that good clinical data.
Now I want to be clear that there's no expectation that reuse of clinical data would in fact answer all of the data needs, you're still going to need surveys, you're still going to need data collection instruments, you're still going to need other kinds of public health reporting because everything that you want to know isn't found in clinical data, you're going to have to ask other questions especially in research situations that wouldn't be routinely collected as part of clinical care. And so that might be questions about diet, about hobbies or about exercise or who knows what, that you might want to ask and so there's no assumption in this that reusing clinical data for public health purposes or for population statistics would be a substitute for any of the, certainly not for all of the things that you need to collect and understand.
The final thing I want to say as an introduction in this is just to give a brief summary of the testimony that we have received already. This is a list of folks that testified, we had Valerie Wattslaff(?) from AHIMA and Mary Stanfill(?) from AHIMA, Clem McDonald, James Campbell, James Cimino(?) and Kent Spackman have already came and talked to the Standards and Security Subcommittee. So very brief summary of each of these folks.
The AHIMA testimony basically talked about the fact that there's quite a bit of work going on right now in computer assisted coding. There are two big categories of what they talked about, one is computer assisted coding itself which there are two branches of, one branch of that is where the person as they're providing clinical care sees associated billing codes and directly enters the billing codes as they're providing, basically what they're doing is seeing the billing codes that are implied by the clinical charting that they're doing and so they're sort of approving the billing codes as they're going through providing clinical care.
A second way of doing that is natural language processing where you have the patient record created and after the fact you apply natural language processing and try and infer the billing codes that would be justified by what's in the record. Both of those things, software that exists today and people are doing studies and doing, actually doing clinical trials.
The other kind of encoding is the semiautomatic coding from EHR data and so that again depends on, the assumption there is that people are encoding data in an electronic health record using SNOMED CT and that they're applying some set of rules and then asserting ICD-9-CM codes or in the future ICD-10 or ICD-10-PCS codes that would correspond to that clinical data. That is in an early phase and to my knowledge, they didn't testify about people who were actually doing that yet. Jim Campbell who is working in that area also, at the time that he testified said that there were plans to do demonstrations or prototypes but they hadn't been reported on yet.
The AHIMA folks, their recommendations were to encourage widespread adoption of EHRs, simplify and standardize the reimbursement framework, and to quickly adopt ICD-10-CM and ICD-10-PCS because those terminologies would allow a much more accurate representation of the information.
Clem McDonald talked about two different approaches and he spent quite a bit of his talk talking about the use of coded data within the Indianapolis Network for Patient Care. But sort of the way he broke it down is he was doing data reuse in a different way then sort of we defined it at the start, he as reusing it to say it's not the people who collected the data that's reusing it for patient care it's a different set of clinicians out of a different institution that are reusing the data for patient care.
So in their network when a person comes to an emergency room you can see the record from other hospitals and so it's secondary, in the way that Clem was thinking about it's a secondary use because it was collected at Regenstrief to care for the patient at Regenstrief, now they're coming to an emergency room and it's somebody else in another institution, it's still patient care but it's a whole different set of people who didn't collect the data that are using it.
He talked through their use of data and the fact that they have a centralized patient database, they've done a number of research studies, one that he mentioned was they were able to detect an association between erythromycin use and pyloric stenosis. And they're also setting up, they're doing what we wish we were doing in terms of setting up an automated electronic reporting from Indianapolis to the public health department.
So the other thing basically is that again the other idea is to capture clinical data in a coded form from the start and then use it in other areas and one of the things that he pointed out is that we don't know what's important capture and that we need more formal studies to try and understand which things are important to capture. So from the testimony that he gave for instance he was saying we need things like Braden scores and Apgar scores and Cage surveys and other things that have been tested and are known to be valid for a particular, for understanding a particular situation or prognostically important for that condition.
There are lots of things, in fact thousands of things where we don't know what's important to measure or to understand. He talked about the Ottawa ankle rules where people studied over 100 variables understanding when people came in with a sore ankle to try and understand and predict whether an x-ray was needed and whether the ankle was really fractured. And what they found is after looking at hundreds of variables that you could predict whether they actually had an ankle fracture and whether you needed to do an x-ray using five or six variables. And that we need to do much, much more of that to determine what the true signal is in all of the noise that we have flowing in clinical records and what people collect in data.
So his recommendations were use the data we're already collecting and do research to find out what other things are worth recording.
James Campbell who's at Nebraska started off his talk and basically reminded the committee of the strategy that we have for standard coded terminologies, that we have this model of terminologies where we have a core reference terminology, surrounding that are important other clinical terminologies and surrounding that are important classifications that can be made from that. And he talked through some of the barriers and successes that he perceived as we've been progressing, he talked about issues in trying to correlate SNOMED to LOINC including ICPC, the International Classification of Primary Care, into SNOMED, the nursing classification systems, NANDA, NIC, NOC, Omaha, Home Health Care, PNDS, and he went through some of the issues, barriers and successes related to those terminologies and trying to create the core terminology.
He then focused specifically on the fact that there's a map from SNOMED CT to ICD-9-CM which is created specifically as a reimbursement map, in other words it is intended specifically to try and automate the process of basically applying a map to clinical data in an EHR that's encoded in SNOMED CT and be able to assert the billing codes that would be justified based on that clinical charting data. And again there's a fair degree of sophistication in the mapping, it takes into consideration concepts that are basically a one to one where if you see hypertension in SNOMED you can pretty much assert hypertension in ICD-9. It takes into account other things where for instance you have distinctions that are based on sex or on gender or coexistence of other things and so they have a fairly sophisticated way of representing that logic.
Ultimately his recommendations were to continue and accelerate the terminology deployment plan and work to achieve accurate mappings that would support this kind of aggregations and use especially in the reimbursement map.
Jim Cimino reiterated potential uses of the data for automated decision suppose information retrieval for use in info buttons which is one that we hadn't thought of until he testified. The idea that by coding data I can much more accurately answer questions on online resources that will help the clinician care for the patient, and then other things that epidemiologic studies, syndromic surveillance, that sort of thing.
The major barrier that he saw basically was lack of standard coded data and he did some analysis to say which areas would be the areas where we could probably get the most benefit from having standard coded structured data and that was a combination of what's already close to being coded in that way, where there's standards available that people could use, the importance of the data, that sort of thing. And the areas that he came up with were lab results, problem lists, medications and allergies as the top four areas where we could probably make some good headway.
And his recommendations were to support terminology development, provide incentives for mapping to the standard codes, provide education and do research on the areas where we could find, to try and find the areas that would in fact be the most beneficial to people to pursue.
The final testifier was Kent Spackman, Kent talked about a success story which was the Clinical Outcomes Research Initiative National Endoscopic Database, and this is an initiative from the American Society for Gastroenterology and this is an active database, there are 20,000 reports from 750 physicians each month that go into this database, they support it as a not-for-profit organization. There have been over 50 research studies and initiatives that went against this database.
The downside is that it's a silo, it has, that data is not using standard SNOMED codes or other things, it's not integrated with the patient care record so that happens, it's an independent thing but it demonstrates what could happen with structured coded data. He pointed out then the need for that thing not to be a silo what you need is a reference terminology and a mapping from those representations to a reference terminology.
There are some barriers to reuse and he emphasized that there are changes in meanings over time and he went through some examples of lymphoma classification systems, leukemia classification systems, and noted that there have been 25 schemes in the last 75 years for those diseases. Now he chose that because that's one of the outliers, I mean lymphomas and leukemias have been difficult to classify for the last 75 years because our medication and our knowledge has been changing about those.
Some of the issues that he raised basically were the value of secondary data accrues mainly to parties other then those who collect it, and so that creates an interesting question then about how we create incentives for the collection of the data if the main benefit accrues to someone else other then those who are sort of paying the cost and burden of doing it. The value of the data depends on its accuracy and he brought up some very interesting issues about who should have the responsibility for defining standards for data collection, is it the professional societies that should do that, is it regulatory people that should do that, who should decide it. And how would we know, it's similar to what Clem was talking about, there seems to be a need to do research to even know what the most valuable kinds of data we should be collecting are in order to move forward and so he encouraged doing some research to understand what clinical data is essential to collect in order to support the kinds of uses that we want from that.
So with that, that's my summary, and then I would turn it back to Simon to lead the discussion of what should we do now. Sort of the main question is is this of interest, if it is how should we move forward, since real work gets done in the subcommittees how would we want to sort of divide up the work and talk about it.
DR. COHN: Okay, well Stan thank you. I do want to remind both old and new NCVHS members that this has been one of the fundamental tenets at least from my knowledge the last ten to 15 years and almost every report, be it Clinical Data Standards Report, be it NHII Information for Health Report or whatever, we sort of reference this idea of reuse and indeed if you think about it given our responsibilities around health statistics, health information policy, I mean it's really an area that needs to be important on an ongoing basis to all of us.
Now I mean this area, and I guess the other piece I would say is that a lot of the work that we've already done which is clinical terminologies, recommendations around mapping, all of this, are work that all relates to issue of reuse.
Now the question I tend to think of and it's sort of beyond potentially a research oriented question is sort of this issue of well what are, where are we now, what are remaining barriers, how do we bust through those barriers. And maybe I'm being sort of practical on this but I tend to think almost that that's sort of the way I tend to frame this sort of thinking though Stan I think you've done something to sort of remind me of the larger conceptual issues in all of this.
Now I had to give a talk yesterday to a group I will not name where I actually was reflecting, I had to do some research and discovered that at least according to a paper published last week that had been sponsored by the California Health Care Foundation that somewhere around 22 percent of health care costs continue to be around business and insurance related functions primarily response around the claims activities and eligibility and all of this stuff. And so when Standards and Security Subcommittee sort of took this on one of my questions was of course well are there ways for us to, well yeah we're going to have clinical terminologies, we're going to have, we still have all this administrative billing that goes on, is there some way for us to actually reduce costs, I mean is there a way to achieve administrative simplification.
I guess Stan I should ask you the open end question, is that something that Standards and Security Subcommittee is going to work on you think?
DR. HUFF: Well I'm not the boss, we've got to ask Jeff and Harry but I would think, that as I thought about it I thought that was the one area that clearly fell within the scope and purview of Standards and Security would be focusing on that issue of could we do the billing classification directly from clinical data in some way and what things could we do to promote that.
DR. COHN: And I didn't pay Stan anything to say that so thank you.
But I guess the question, the larger question since I know Quality was interested in this topic and Populations has an interest --
MR. HUFF: Privacy and Confidentiality seem like they're interested too.
DR. COHN: But maybe from the side of protecting privacy and confidentiality and all of this as we move forward. I mean the question is is from a more general view, A, we thought everybody needed to be updated, the question is is what other aspects, other thoughts, is it a full committee issue or are these things that need to be divided up in the subcommittee, so Stan I think that's sort of where you were going.
Paul I see your hand up and then Justine.
DR. TANG: Two questions, one thanks very much, Stan, that was very helpful. One clarifying question on the work that you said Jim Campbell was doing, you said he's doing a prototype for the SNOMED ICD mapping?
DR. HUFF: The mapping is relatively complete, what they were doing to prototype is to try and implement that in somebody's institution and see if it really worked.
DR. TANG: Isn't this a mapping that's done within UMLS?
DR. HUFF: Yes.
DR. TANG: And that's what they're using.
DR. HUFF: That's the same one.
DR. TANG: Because I think there, I mean because they distribute this with the SNOMED distribution, presumably some people may already be using it. But that's answers the question about --
DR. COHN: Paul I'm sorry, I think my understanding is that no one thinks that that mapping is out of the box good enough for highly accurate --
DR. HUFF: I think there may be more then one activity going on because there's a mapping that has been, existed for a long time that is a part of the UMLS meta thesaurus. This new work is actually being done and I don't think it's covered by the contract of SNOMED with the National Library, somebody here might know better then I do but I think this is a mapping that is along the lines, they put a lot of new work into this to try, with the goal in mind of using it for reimbursement whereas the other map was sort of done more abstractly and --
DR. TANG: So who's the new they you're referring to?
DR. COHN: National Library of Medicine, AHIMA?
DR. WARREN: The new they is on the editorial board there is a liaison to NCHS and he is responsible for ICD-9 work and so he's been working with the SNOMED Editorial Board to facilitate a mapping because there is some concern that the one UMLS may not be good enough for billing and so this is a test to be looking at that.
DR. TANG: Okay, so there's some formal credible effort going on to do mapping that would help the clinical to financial mapping --
DR. WARREN: And then Jim is taking it into their clinical site --
DR. TANG: The new one.
DR. WARREN: Yeah, the new one, to see whether or not clinicians can pick from SNOMED terms, use the map to generate the ICD and then go on to --
MS. MCCALL: And one kind of extension of that, because it really does, it has to be good enough for adjudication, is to link up with somebody that not only wants to run it for adjudication but there are payers out there that are looking at and have successfully done real time adjudication, so we have some and I know others are doing it as well so that you could literally go end to end so that's another extension of that same thing.
DR. TANG: The second question I had has to do with this reuse and clearly reuse, one of the good things about reuse is do once and get value many times, another important one is to reinforce the quality of the first acquisition from the physician. So the way you pay back the initial user is to give them part of the benefits of the reuse and we go through lots of ways of making that information useful to them and their efficient. But primarily what happens is reuse goes to the secondary users which are often payers or quality measuring folks, so the concept of how to give incentives back to the people entering the data at level one which is where it's best done, it's most efficient --
MS. MCCALL: I find that, that's a very interesting paradigm because what I would say is these are great examples, Stan, this is just wonderful, I mean I think the broad question is what would we need to do to kind of scale this everywhere, what would that take and how would it change. But when you give examples of the clinical research and inducing labor prior to 39 weeks and all of that do clinicians see that as returning value to them?
DR. TANG: Depends on whether Jazz is having a good season.
DR. HUFF: I think most of them do, I mean I think the physicians are glad to know where their hemoglobin A1C is falling relative to others and IHC has provided incentives around those things as well, they've basically said that, they've made bonuses and other things available to clinicians whose quality indicators are better. I mean that's an artificial incentive but --
MS. MCCALL: No, it's really part of the mindset on the part of caregivers that it is, part of their job is to know where things work and where they don't.
DR. HUFF: I think that's in general that's true, I think in general physicians are motivated to try and provide better care and if you can give them information that helps them provide better care then they like that.
DR. COHN: Paul you finish and then I want to let Justine have her question also.
DR. TANG: So at any rate in answer to one of your questions about what can NCVHS do I think we may have to relate to the policy of what something that Bob Esterhay(?) said a long time ago fee for data, if you recall Dr. Brailer also emphasized that making sure that there's a business case and a business model for some of the work they're doing, I think we have to create the business case for this as well and that's the only way it will flow. There can be many ways, pay for performance can be one of the indirect ways that it comes back to a physician but there's also probably a good case to be made for doing the work and then the secondary reaping of the data.
DR. COHN: Justine?
DR. CARR: Thank you, Simon. Well, it's always exciting to see what's going on at your place and I would like to make two observations. Number one is that in addition to all of the traditional sort of burden of things you have to do sort of the business world of medicine I think it's very important to pay attention to the fact that we've just had an overlay of a huge burden of collecting the performance indicators that require actually chart review in all institutions about how did you manage your acute MI, inpatient as well as outpatient. And that's sort of independent of all the coding and all of that. And it's very, very costly for the number of people that you have to hire, the charts and paper that you have to review, the data you have to submit. So that I think makes the case even more compelling to get electronic and get efficient.
I think the challenge that we've been thinking about in the Quality Committee is just what then do you say for the electronic health record, what you have is spectacular, you have every data element and it's like Lego's, you could build a city with everything that you have. But you also have 26 people maintaining it and you have very, very sophisticated analysts in decision support but most institutions don't have that, most are just struggling to get order entry for prescriptions or medication. So I think as we think about it we have the, your kind of building blocks which would be fantastic if we could do that.
And then as Simon, we were discussing at lunch, we have the other which are these G codes that have just come about from CMS where you simply attach the code that says yes I gave aspirin on admission, yes they went home on a beta blocker, so that's simple, that could answer our questions today and kind of get the information out. But I think that one of the things that we want to do with input from all the committees is to inform the architecture so that there is a way for this information to be captured and transmitted, it may not be building blocks, it may be true/false, yes/no, I did it or I didn't do it, but I think we've got to make these two processes intersect, the performance metrics and the building of the electronic health record.
DR. COHN: Jeff and then Bill Scanlon.
MR. BLAIR: It seems to me that, and I'm not sure about this, I'm really listening and struggling with this quite a bit, but I'm trying to make sure I get the horse before the cart and it seems to me that the horse is collecting clinically specific data from patient care and if the incentives are in place to do that then the derivatives become just an additional cost saving efficiency saving quality saving measure.
If the thesis that I'm making that the horse is clinically specific data for patient care use then the first set of incentives for public policy would need to be incentives for better patient safety, incentives for improving workflow, in other words the clinically specific outcomes data so that you can wind up improving clinical processes and workflow, whether that's nosocomial infections or any of the examples that you gave, until we reach a tipping point.
I don't know where the tipping point is but at some point if there's a certain amount of data captured with SNOMED CT and LOINC and RxNorm they'll be a tipping point at which point it will be not only good for quality and patient safety but it will be cost effective to maintain information with the clinically specific codes and I think at that point it's almost like you'd be going downhill because then you wind up mapping, taking advantage of NLM's mapping from SNOMED to ICD-9 and CPT codes and the secondary uses I think probably would flow probably with fewer incentives. I think the hard part is getting to the tipping point with the incentives for the use of the clinically specific data for patient care.
Do you think this is true or are there other issues and problems in the way then just incentives? I guess I'm asking Stan but anyone who, there's many of you that know more then I do on this topic so anyone who has a thought on that.
DR. HUFF: Well I think that's, I think there's a lot of merit in the idea, I mean I think there is sort of the merit in the idea of fee for data that Paul was mentioning. I guess tied into that is somehow in the back of my mind is that unless you're in a situation where you can realize the benefit from collecting the data then it's not worth offering the incentive, so it's kind of a cart and the horse, chicken and the egg kind of a thing.
DR. COHN: And let me just make a comment also because I think that to my view, Jeff, and really without trying to answer the question and be aware we're going to cut off this conversation in about ten minutes so I want to let everybody know that this is not going to be an open ended conversation for the next hour unless we all want to move dinner down to 7:30 and keep going.
But I think the concern that I have as I look at current billing processes, current quality performance development metrics, G codes and otherwise, that because we obviously are still living in primarily a paper based world there are actually potentially disincentives for us to make a transition to wherever we're going.
I mean I do know that as wonderful as mappings being supported and developed with the help of SNOMED, with NCHS, with NLM and all of that for mapping I have a sense and I think we could all point out many good examples where that is not going to be sufficient to really do what we're talking about, we're sort of partially or maybe slightly automate or help things but won't quite get us to the end point, which is obviously what I think we all, I mean as I say that it's a sense that I have and I think we can all point out various examples but I think we need to be looking at these and begin to sort of identify them and see if there's way for us to sort of fix all of that stuff or suggest those areas where there really are roadblocks. I think it's both a building issue, it's probably a quality issue, whatever.
And so I sort of say that, I sort of agree with what you're saying but I'm also think that our responsibility is to be ahead and sort of clear away the brush.
MR. BLAIR: Maybe what we need, maybe we should try to study this from the standpoint of a portfolio of incentives that would get us to the tipping point and it may also be, when I say incentives it also may be certain barriers and if we could identify that portfolio and have public policy and health plans try to provide the incentives in an orchestrated way over a period of years to get us to that tipping point then maybe that would make the big difference.
DR. COHN: Bill Scanlon you're up next.
MR. SCANLON: I think this was an incredibly exciting presentation because it showed that in some respects the new world is really possible and the question is how do we get there. But I strongly sort of emphasize that I think that new world is an incredible transformation of what we have now, there's going to be a tremendous shift in terms of the balance of power and people that are in different positions are going to recognize that and be strongly resistant to it.
You gave some good examples in terms of looking at clinical practices and changing sort of experience such as the prostate case in reducing length of stay, well for some people that's going to mean loss of revenue and they're not going to want those kinds of cases studied in that same detail, they're not going to want, in another world, not your system but in another world there's great independence between the payers and the providers and there's conflict, and the information is going to be able to used sort of by one against the other and that's going to be a source of great tension.
So I worry about what we're going to have to do to reach the tipping point because of the fact that we are going to change things so radically and that we don't sort of reach too low in terms of what we're trying to accomplish because really changing decisions at the point of care is something that also should be coming sort of out of this in part sort of because we create better medical knowledge so that people will do things differently sort of when they're facing a decision but also I think that within these systems there's the ability to create alarm bells that go off and say wait a minute, why are you doing that, and not just on drug interactions but on a whole range of things.
I mean I said this maybe in this group but I've said it a lot of times over the last few years, I'm getting tired of Wenberg(?) being able to reproduce his work year after year after year and that we don't make progress in reducing those variation. And so the possibility of doing that is going to only come if we are able to intervene sort of more at the point of decision making, informing sort of not just the providers but the patients as well and the payers so that all of them kind of have a much better sort of basis for saying yes, we think we should go forward with this, no wait a minute, let's think about alternatives.
Let me just say the last thing and this is kind of a true confession from my perspective on the Quality Workgroup. The struggle is this is such an incredible broad sort of brave new world that we're facing, what piece do we decide to chew on for the moment because there just are so many sort of opportunities there, what's our comparative advantage relative to the rest of the world.
DR. COHN: That's well said. Now we have Russ, we have Bob, Carol has the last comment and then we'll wrap this one up.
MR. LOCALIO: Stan, all I have to say is that you're doing something that nobody else seems to be able to do. I just want to say from my perspective of the ultimate secondary user the problem that I see is not the quantity of the data but the quality of the data and given the choice between two million observations generated quickly and inexpensively from a computer that are filled with missing data and misclassified data and a sample of a thousand that has complete data and perfectly classified I'd take the sample of a thousand because I can easily estimate the variance but I can't handle the bias in the big population of two million. So I would like to separate the problem of quality and the use of the computer to collect data because you ought to be able to collect certain basic pieces of information and put them on a piece of paper. You say for example that you're collecting weight on people like every encounter, but I met with one of my colleagues on Monday who's working with a data set from a computerized information system and he can't get weight on a lot of people from any time. And this is good organizations.
I'll just close with one other example, I was discussing with my colleague here, just last week I reviewed a manuscript from a large very good organization, I won't mention it but the zip code is 94612, very good organization, they had missing data on a key variable 25 percent of the time. You can't do that, you can't produce good work with missing data at that frequency and so we have to do much more about quality of data getting into these systems. My fear is that the ease of the computer is going to mean that anybody just to fill the computer field is going to put junk in there and we're going to just have a huge system of inexpensive bad data.
DR. COHN: Thank you, Russ.
DR. HUFF: Just one response, everybody should know I'm not personally responsible for any of this stuff, it's a bunch of other folks at IHC that are responsible for this stuff.
DR. COHN: Bob, would you like to continue on here please?
MR. BLAIR: Stan, how much problem do you have with bad data in your system?
MR. HUNGATE: Let me go back to your earlier question, Jeff, about incentives. Quick story, my daughter was born in Sequoia Hospital around 1960, I was here in Washington working on health policy in the mid-‘80s and the Wall Street Journal came out with a little report of the administrative and quality assurance staffing changes at Sequoia Hospital between 1960 and say 1987. It was about a 15 percent increase in the total expenses on a per admission basis all of which was NQA and administration, not in clinical care.
The point is that the incentive, if this information collecting is going to work it has to be of benefit to the clinicians, it has to be worth their time to say the data has got to be right so there isn't 25 percent missing, so they've got to have the same trust in the information system that we're talking about patients having in the privacy and confidentiality. So that's going to take more time at the clinician level. The savings has got to come from administrative expense, whether it's within the institutions or whether it's outside, and that's payment system changes.
And I don't know whether that fits within the scope of this committee or not but it seems to me that payment systems change gets to be a big piece of it. If it were episode of illness where there were a total price if it weren't built up from a cost basis, it if were a prospective price you'd have a very different dynamic at the data collection level. So it's a complicated subject, I'm not sure it belongs here but it's critical.
The other was a question, Kent Spackman's silo, did this database result in any sort of prospective information for patients about the procedures that are involved? Or was the information only for the clinicians?
DR. HUFF: To my knowledge it was consumed by the physicians, I mean there was nothing to prevent the physician from using that information for instance to give a patient, if they learned more about the fact from this database that lesions of a certain kind were precancerous or cancerous in a certain percent, they could have learned that from the database, whether they shared it with the patient I don't know.
MR. HUNGATE: My point kind of is if we're going to talk about a health system and a patient centric system we're going to have t make sure that the things get into the databases that relate to patients that let them have prospective information. And it's a gap that exists that doesn't necessarily get filled, it's another piece of this total equation.
DR. COHN: Carol you have the last comment and then we will wrap up.
MS. MCCALL: The first thing that I'd say, I have some observations on your presentation which again I think is just wonderful. What I'd love to do is have you close with kind of an answer to the question that's on the last slide which is what should we do now. Because here's my initial reaction is that if I go back to, I guess it's slides nine and ten, the first slide here, it says statistical profile and then you had all these examples of secondary uses and they really do span the gambit. And so it's like the uber intersection, it's the master of all intersections of all things that we want to do and we've been talking about for years and so it is where it all comes together. And so the question that I would have is what is it that we need to do in order to create that capability, not within one delightful organization where there's an alignment of things that may not naturally align, what does it mean to scale it? And to ask that in some very profound ways, there's cultural barriers, there's technological barriers, we talk about data, but data has many facets, taxonomies and standards and quality, there's economic issues, some people may feel that it's a zero sum game. And so it is so vast that I would love to see it become at least for a while become a full committee topic and then it may break down into work streams that go to subcommittees or workgroups or whatever is an appropriate place to say what does it create.
Let me give you two examples and then I'll toss it back. You have these ten people that maintain, that do nothing but maintain the dictionary, there's 26 people that do nothing but maintain the interface. And then there's people that do research and then report that research, all of those things those are day jobs, but they're also processes that you say we have to have somewhere. Is AHIC thinking about them? Are those going to be institutionalized somehow across the nation? How do you actually do the research, how will that get done? How many people will that take? What are the organizations across the United States that will do that?
And then how in fact will it be communicated back, I don't know how you do that today within IHC, I would love to know but I'll bet you that it won't be replicable across the nation and so there need to be some mechanisms to bring it back, to create it, to interpret it, and then transform it back. So all of these things I think are part of creating this.
DR. COHN: Well Carol I think I actually, we're finishing off the conversation, Steve, I think what I was going to just do, actually Steve do you have a quick comment?
DR. STEINDEL: I have a comment and I would like to ask Carol if she would accept this type of modification to your statement, what should we do that's different then what's being done with the NHIN?
MS. MCCALL: Okay, yeah.
DR. COHN: Okay, and that's probably a good way of framing that. You know Carol I want to thank you for handing it back over to me along with the question here, though I think you've helped I think answer it in some way. I mean really what we've been talking about over the last hour and ten minutes has been part and parcel of almost everything else that we're concerned about and this is just, in some way it's a piece of it, it's a different cut, it's a different way of looking at all of this.
Clearly I think we have tasked and asked the Standards and Security Subcommittee to take another look at this area because it has been looked at before but to see if there really are barriers and once again I may be very pragmatic and focused for the moment but recognizing that our responsibility, part of our responsibility is to make sure at the end of the day the administrative and clinical areas all come together and try to make sure that there aren't barriers that are there that actually retard this vision as well as the vision of electronic health records and this is an important piece of that. So I think that that's an important thing for us to be looking at.
Now you started out by talking about how wide this area was and where exactly it fits, my other view and once again we can talk about this tomorrow when we talk about as we review the work of the committee and what we want on the agenda this year but I think my sense is that the other piece of it for the moment is that maybe there are reports on this and particular topical items that maybe need to be generated as a regular committee set of presentations or whatever, not just out of Standards and Security but maybe bringing in other people for example to look at some of the quality issues and all of that and that we sort of have some of the conversations as we go through the year about this from all its various perspectives.
I would suggest also that knowing that you may be looking at pay for performance and maybe even some of those G codes that you were talking about earlier maybe one of the questions that you need to be thinking about in the back of your mind is geez, are these things that actually can be done out of clinical processes or are they by definition set up in a way before we are the way we are dealing with things that well yeah you can do about 30 percent of them or 60 percent of them in a computerized fashion but the way they're written, developed, whatever, there we're back to manual processes again. Once again not to say no we shouldn't do it but more that we need to be instilling that longer term vision into all of this work.
So you can think about that one tonight and see if you agree with me tomorrow when we talk about sort of what we're going, our sort of ongoing activities but I think that would be how I would frame it.
Now having said that we are running significantly late and I do want to apologize to everyone though I guess given the way the afternoon started we all knew we'd be in this situation.
Now we do want to have people break up into subcommittees, my understanding is that the Standards and Security Subcommittee is up here, Subcommittee on Populations is in 425.
Now after that we actually need to have a meeting at least briefly of the NHII Workgroup. Now my question for both subcommittee is would an hour for each of you to break be sufficient? Okay, well I was going to say when would you like the NHII Workgroup to start, let's start that at 5:20, 5:25, we will not go beyond 6:00, it will just be a very abbreviated meeting. The NHII group is not, I don't know if you realize it, even though we have able staff we are missing our lead staff and I was expecting we'd have a conference call anyway but we do need to have a face to face meeting.
So why don't we adjourn now, remember 8:00 a.m. tomorrow morning for Privacy and Confidentiality, 8:30 in the morning for Populations and Quality Workgroup joint meeting, 10:00 full meeting again. Thank you.
[Whereupon, at 4:11 p.m. the meeting was adjourned.]