[This Transcript is Unedited]
Radisson Hotel Reagan National Airport
2020 Jefferson Davis Highway
Washington, DC
Agenda Item: Call to Order and Welcome
MR. REYNOLDS: Good morning. I'd like to call this meeting to order. This is the first of two days of meetings of the National Committee on Vital and Health Statistics. The National Committee is the main health policy advisory committee to HHS on national health information policy.
I am Harry Reynolds from Blue Cross Blue Shield of North Carolina and Chair of the committee. I want to welcome committee members, HHS staff and others here in person, and also welcome those listening in on the Internet. I would like to remind everyone to speak clearly and into the microphone.
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, could you please so publicly indicate during your introduction. I have no conflicts.
MR. J. SCANLON: Good morning, everyone. I am Jim Scanlon. I am the Assistant Secretary for Planning and Evaluation Office at HHS, and I am the Executive Staff Director of the full committee.
DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, member of the committee. No conflicts.
DR. W. SCANLON: Bill Scanlon, Health Policy R&D, member of the committee. No conflicts.
DR. CARR: Justine Carr, Caritas Christi Healthcare, member of the committee. No conflicts.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee. No conflicts.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, liaison to the committee.
MR. LAND: Garland Land, National Association for Public Health Systems and Information Systems, member of the committee. No conflicts.
DR. MIDDLETON: Blackford Middleton, Partners Healthcare, Brigham and Women's Hospital, member of the committee, and no conflicts.
MS. MILAM: Sallie Milam, West Virginia Health Information Network and the West Virginia Health Care Authority, member of the committee, and no conflicts.
DR. HORNBROOK: Mark Hornbrook, Kaiser Permanente Northwest, member of the committee. No conflicts.
DR. SUAREZ: Good morning, everyone. I am Walter Suarez. I am with the Institute for HIPAA/HIT Education and Research and a member of the committee, and no conflicts.
MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation, no conflicts, member of the committee.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of the committee. No conflicts.
DR. FRANCIS: Leslie Francis, University of Utah, member of the committee and no conflicts.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the committee and no conflicts.
MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National Center for Health Statistics, CDC, and the Executive Secretary to the committee. I have returned from India with our poster. It is up there on the wall.
MS. JONES: Catherine Jones, CDC, National Center for Health Statistics.
MS. GILL: Alison Gill, American Health Information and Management Association.
MR. DI CARLO: Mike DiCarlo, Blue Cross Blue Shield Association.
MR. KYLE: Frank Kyle, American Dental Association.
MR. NEWMAN: Mike Newman, Health Resources and Services Administration.
MS. SING: Medhi Sing, Health Resources and Services Administration.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, committee staff.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MS. KAHN: Heddy Kahn, National Center for Health Statistics, CDC.
MS. SACHS: Jody Sachs, National Center for Research Resources at NIH.
MR. REYNOLDS: Each of you should have a copy of the agenda in front of you. One piece of housekeeping before we get going is, in front of you you have some pages about what is around here for lunch. There is a bistro that, if you fill out the form you can have lunch delivered here for you, so if you would do that before the end of the break, that would be a wonderful thing. If not, then get your coats and go find it, and be back by one, please. I'll leave that up to you.
With that, the first item on the agenda is an update from Jim Scanlon on the Department.
Agenda Item: Department Update - Data Council
MR. J. SCANLON: Thank you, Harry, and good morning, everyone. I am going to update everyone on some of the detail and some of the developments since we last met in September
Obviously, the biggest event is the national elections with a new President, largely a new Congress in January. I hope everyone got the word. If you haven't, see me later.
MS. GREENBERG: Even in India we were all aware of it.
MR. J. SCANLON: I understand even in other countries it was well known and well celebrated.
MS. GREENBERG: Absolutely.
MR. J. SCANLON: Let me just update a couple of things. I think we are going to get a report later today from CMS on where we are with a couple of HIPAA proposed rules. I think Karen is going to report on that.
On the AHIC front, I think Chuck Friedman will be reporting. The originally AHIC had its last meeting within the past few weeks, so they are basically closing out activities. The new AHIC, the AHIC Successor group, had its initial meeting today after the last meeting of the AHIC. So the board met, and they are planning how they will operate.
On the board of directors of the AHIC Successor organization, we have a current member, Paul, and we have Simon Cohn, a previous member. So they can carry forward all of the good thinking from the NCVHS as well.
On the Hill, obviously there is now a lame duck underway, probably a week or two. The focus seems to be on the economy and stimulus packages. In January with the new Congress, everyone is reading the crystal ball and basically looking at what is likely. Clearly some health reform. Well, economic measures first of all probably, and some security measures.
The thinking seems to be that there will be great interest in health IT. Whether there is a bill right away, or whether it is part of a larger health reform bill or whether it is later in the session, there clearly is interest in health IT, much of the way we have been thinking about it here. But again, we will have to see what bills actually emerge. But it is clearly expected to be a priority in the 111th Congress.
On the budget front for HHS and for most federal agencies, most federal agencies have what is called a continuing resolution that basically allows us to spend at the same level as last year, basically can't undertake any new projects. That continuing resolution continues until March 6. After that, it is up to the new Congress on how they will handle the remainder of fiscal year '09.
Fiscal year 2010 is in the hands of the new President, President-elect. So that will be his first budget. It will be a policy budget. We have prepared in essence a current services budget that has all of the accounting budget lines for HHS. Other federal agencies have done this as well. So the new President's team could come in and decide whether they want to increase, decrease or add new things. That will be a very compressed process, but at any rate it will be probably in January, February, March.
On the continuing resolution, that does create some uncertainties for some of our population statistics, for some of our surveys for MEPS and for the Medicare survey and for SAMHSA surveys. We are basically continuing those at the same level, which is an accomplishment. But for NCHS, unfortunately, NCHS was slated for an $11 million increase, and it was meant to get the Center's level up to a level that everyone believes necessary.
Well, the continuing resolution just delays all of that. All it does is create some uncertainty until March at least. So NCHS as they have said previously, is having to look at what is the best strategy for getting through these first four or five months, and we are uncertain as to what will happen after March. Otherwise, we are operating at the current levels.
Remember, for HHS our total is about $737 billion, but only ten percent of that is discussed here. The rest of that is associated with Medicare/Medicaid, the TANF programs and so on, so it is that ten percent that we have some leeway. So anyway, we are still unsure about what the next half of the year will bring.
What we have been doing in HHS and the Data Council, I will say a little bit about that and then some of the projects we have initiated.
We have begun as we normally do, we are looking at what the impact is of the budget on our various population statistics programs. Again, I think the NCHS issue is probably the most concerning. We are hoping that NCHS will -- I don't know if Ed is going to be reporting, but whatever action they take, minimize the effect on other programs and keep the options open as much as we can. This will be a year where it is quite possible we will get the increase, and you wouldn't want to take steps that are unreversible in March.
What we have been doing on the Data Council for example in addition to that, we have begun a review, much like the Population Subcommittee will be doing today or tomorrow, on the likelihood of some sort of health reform measures or public health reform measures, how we are positioned with our own data sources, our own surveys, our own modeling, our own actuarial capability to marshal those in support of whatever development might be needed as well as what analysis and evaluation might be needed.
In the past two months, the Data Council has been focusing on what data resources and where are we with all of them in terms of health insurance coverage, access to care, cost of care and related matters like that, as well as where are we with our actuarial support capabilities, as well as our modeling capabilities.
At the previous two meetings we have gone through pretty much what we have. We have a few more to look at, but we are looking at where we are and what might be needed. Again, the Population Subcommittee will be doing this on a much broader scale, involving other members of the policy research community beginning tomorrow, so all that should come in very handy.
Obviously we are dealing in a situation of not knowing what all of the details would be. I think the economy clearly has taken much of the oxygen away from a lot of the other reform efforts, but that will probably have to be dealt with first. But you could argue that health reform is part of an economic stimulus package, anyway.
We do have as a result of the executive branch transition -- as you know, the transition starts on Election Day and goes forward until January 20, until Inauguration Day at noon. So we already have in HHS -- so do all other federal agencies -- we have begun a transition process. It is fairly organized, systematized and centralized. All agencies were asked to do some of the same things. So we have prepared briefing books. We have prepared space for the transition team, and we have had every agency designate a senior career deputy who would be in charge of the agency when other folks are leaving so that there will be no interruption in continuity of operations or business.
In addition, our transition team has begun to arrive. You can see all of the latest news on the Presidents transition on the Change.gov website. So it is very transparent and very open. You will see all the members of the transition team, how it is structured and so on.
There is a large comprehensive of the President-elect's transition team that is focusing on agency reviews. They are looking at all of the federal Cabinet agencies and all of the Departments. They will report back to their full working group.
We have had our group arrive already, at least some of them. Many of them are folks that previously worked in HHS and in the health community, and they are very familiar with some of the issues. They certainly know the health IT area as well. So we will be briefing them, providing the information they will need, and then they will do their reviews. They are on a pretty quick time line. By mid-December I think they would like to be able to report back to the home transition team. Then that will help to prepare nominees and other folks who will be coming in in January.
A couple of projects. I think I reported previously that we have undertaken evaluations and demonstrations in the PHR area. One of those is an evaluation, well, a pilot study of electronic PHRs in South Carolina, in the Medicare fee for service area. We have the pilot underway. We also have an evaluation underway. So we are learning a lot of how this actually operates in the Medicare program, for example, the fee for service program.
We also have announced a project that will involve two Western states, Arizona and Utah, where we will offer four PHR products to Medicare fee for service beneficiaries. So they will have their choice of any one of the four, and then we will do an evaluation of how that works as well.
It will be everything from to what extent do folks enroll, to what extent do they use, how do they use, what are outcomes to the extent we can define outcomes, and what are the features of those as well in the functionality. So we use a variety of methods to try to get at this, including outcomes and satisfaction and so on.
As I said previously, the Medicare ambulatory EHR demonstration program, that is getting underway. ASPE is working with CMS on the evaluation of that program as well. So we will get a lot of good information hopefully from these evaluations.
I think I mentioned previously, we are also working with the National Center for Health Statistics. We are trying to get a better sense of to what extent do consumers actually use health IT to get health information. So we have added a few questions to the National Health Interview Survey to try to get a sense of when do they use computers and health IT, where else do they go for health information, when do they go, why do they go, and how does it relate to their overall health status and overall household economic status and so on. So we are adding a few questions.
There have been other surveys. I think all of you have seen a survey like this periodically to look at how people use the Internet, but it doesn't relate any of those findings to health status or any of the other health information. So hopefully we will have that as well.
MR. HOUSTON: What is the time when these surveys are done, and how often? What is the lag in getting data?
MR. J. SCANLON: The National Health Interview Survey is continuing, so these questions will be asked in January.
MR. HOUSTON: And what would be the time when you would get data on health information back?
MR. J. SCANLON: It could be up to a year, or if NCHS were willing, we could ask -- each two weeks of the survey is a national sample, but that wouldn't be enough cases. So possibly within six months we could get some tabulations.
MR. HOUSTON: I think it would be helpful to some of what we are doing to understand the answers to those questions sooner rather than later, even if it was simpler short term.
MR. J. SCANLON: We will try to do that. At full strength it is about a 40,000-household survey, so you really get to see a lot of differentiation and a lot of different health statuses and a lot of different circumstances. So maybe we can look at maybe a quarter of data or even a half year of data.
DR. SUAREZ: A quick question. You mentioned PHR projects and the evaluations you are conducting. You mentioned several dimensions you are looking at evaluating functionality and some of the usability. Are you going to be looking at the privacy issues related to personal health records, electronic health records? Is there an evaluation component around privacy?
MR. J. SCANLON: Well, for the one we have underway, the South Carolina PHR, privacy is covered through the -- in essence it is a business associate agreement with the PHR. So there is no variation.
But for the Arizona and Utah project, there are actually four vendors. They probably do vary on what they actually say on their websites in terms of privacy. It is a minimum privacy level to begin with. So it could be part of it. I think we could look at to what extent privacy was a factor in choosing one or another.
DR. SUAREZ: I was looking at both the questions from the perspective of the offering entity, as well as questions around how the product is going to be handling consent and disclosure issues in the product itself.
MR. J. SCANLON: And the perception as well.
DR. HORNBROOK: Jim, the National Health Interview Survey of course is the gold standard. Is there any possibility you could do a supply side survey of vendors and managed care systems? So you would talk to Kaiser and get an estimate of how many people who are Kaiser members are using their health record information systems.
MR. J. SCANLON: We have actually thought about that, to get some -- we have brought this idea as well. When we first brought this idea up, it was based largely on the NCVHS early assessment of where we stand with PHRs. The conclusion then seemed to be that this was a very evolving and developing field. We were encouraged not to try to ask standardized questions, but to monitor this on an industry basis.
Since then, there have been a couple of other -- as you know Mark, evaluations of what is happening. A lot of these PHR products are largely marketing, as you know. It is largely press releases and things like that.
So we are probably thinking, and we will see where this leads us, that we may want to do a more systematic review of who is offering, what is being offered and the functionalities of the various systems. That is a systematic kind of thing, so that would require a fairly long lead time. It would require OMB clearance and that sort of thing. But I think we may want to do that as well. It is a good idea.
DR. FRANCIS: What I wanted to say is in response to the question that was asked. The Privacy Subcommittee is going to be planning hearings on PHRs probably in January and in coordination with the Quality Subcommittee. One of the topics in that hearing is going to be exactly the question you asked.
DR. TANG: Since person centered health data is one of the main topics of the full committee and all the subcommittees, is there a possibility to tag onto the evaluation of the two state pilots, to add the quality of the data coming from or housed in those PHRs?
For example, if one of them is populated by claims information, how does that compare to what the patient thinks? is there a way we can assess the accuracy, compared either to the medical record or to the person's own --
MR. J. SCANLON: That is a good question. You don't mean from the point of view of the perspective of the patient or consumer. You mean some actual validity or accuracy kind of assessment?
DR. TANG: Yes. The person can judge the accuracy of what has been populated in the PHRs. We can also look at it from a medical records point of view. What is really important is, can the PHR be a source of information for our new population health surveillance report. This might be a really good opportunity to go look at that.
MR. J. SCANLON: We are just beginning this. We are just putting together a proposed evaluation design. So we can certainly try to add that in as well. It sounds, Paul, like that would be more an expert judgment. We would have to have people review the sources and how it was displayed, and it would be an expert judgment conclusion about validity.
Yes, we can do that. We are just starting the evaluation design now, so we can certainly factor that in.
DR. CARR: This is for Jim, following up on knowing where people go for their health information. I was just wondering if you would tie it in at all with the recent Google reports of the fact that Google was able to anticipate the flu outbreaks based on the inquiries. I think that is an interesting flip side to take into account as well.
MR. J. SCANLON: It may or may not, but it was reported that it did. Clearly we all admit that we will probably see the flu outbreak on CNN before we see it reported epidemiologically. But that is all right, that is media, and the smart folks in public health and health care use that, as you say.
Under the emergency preparedness and public health preparedness side of the office, we are starting to look at non-traditional sources of health information. Again, this is an analogy. You have a National Security Agency and a CIA for all the security information. You really have a lot of information like this that could help the health side as well. You don't always know what it means, it may mean nothing, but there is a whole analytic side that you could look at non-traditional sources, including Google, search terms and other things like that, to try to see if there are patterns emerging.
So we are starting off on that as well with our emergency preparedness folks.
DR. FRANCIS: Could I just make a quick quantitative? About what Justine mentioned, there was a very -- I don't know whether it is good or bad, but there was the following privacy point that was raised. Because the way Google gets that information is, if a consumer clicks on information about the flu, so they figure that people might be worried about having the flu and getting the flu if they click on information, Google will record the ID of the computer that clicks on that, so you will know the source of the click.
Now, the potentially scary thing is, suppose we aren't data mining or identifying people from their PHRs, but they are in their PHR and then they click on a Google ad. They are out of the PHR, and suddenly their computer identification is identifiable.
As I said, I don't know if for good or for bad, but there is a really interesting potentially questionnaire for consumers about what they might unwittingly do, moving back and forth between the protected environment of a Google privacy policy on PHRs, and then surfing the Web for info.
MR. BLAIR: Since our discussion has been on personal health record systems, if we do wind up having some hearings about this, there are two studies that have been very helpful for me in this last month to be able to have a better understanding of a very complex and dynamic marketplace.
For one of them -- you have to close your ears, Blackford -- is from CITL, which looks at PHRs from a value standpoint. The other one, I ran into in July. There was testimony to AHIC, and one of the testifiers was John Moore from Chilmark. That is a marketing study, in terms of the different market segments of PHRs and how they interrelate with each other. So those are two sources of information that I think could be very helpful to help the committee have a better understanding of the PHR system marketplace evolution, values, privacy issues.
DR. MIDDLETON: Thank you for the reference, Jeff. I would be happy to fill in the committee on that study when the time is appropriate.
I think we are bleeding into the PHR conversation from the NCHS update, but it strikes me that the idea of additional surveying of Americans regarding their web habits and practices and their use of PHRs really is of paramount importance.
I am just going to offer two data points. One, we find when a patient has access to their medication list in a study underway at Partners Healthcare, we find the patient is able to identify discrepancies in the meds they are taking approximately two-thirds of the time. So the physician has one idea of what the patient is doing and the patient of course knows what the patient is doing, usually, and can offer an update to the physician two-thirds of the time.
Secondly, when that update does occur, it has significant impact on the physician. At least in the care of diabetes care management, more often than not, in a randomized control trial we found physicians more likely to adjust more aggressively diabetic medication management if they were aware from the patients themselves what the patient was doing in taking with respect to their meds.
So I think we are going to be increasingly seeing the patient entering into clinical decision making in conjunction with the provider as well as on their own behalf, as is the case and should be increasingly the case.
So it strikes me that thinking about the recurrent studies and survey work done by NAMCS, the National Ambulatory Medicare Care Survey, that certainly does take a marker of EHR use in the provider office. There is interest in perhaps augmenting that survey instrument to understand better how physicians are using ambulatory EMR, to what degree and what level of sophistication, et cetera.
So I would like to suggest that some instrument be defined, and maybe we can co-opt other instruments in use that allow us to better survey Americans about their web practices beyond just the PHR, but be sure to address both; what are the web practices with respect to health in a very objective and quantifiable rigorous way, as well as what they do with PHRs, because I'm sure the same findings will arise. Some patients will use PHRs in a very sophisticated manner, and most probably will not.
MR. J. SCANLON: The questions we will be adding to the health interview survey, they are broader than the PHR. We are really trying to find -- they are based on questions others have asked, but it asks under what circumstances they have used the computer, why they did it. So it could have been their own health or referred by a doctor or a family member and so on, what they used it for. It could have been simply going to a health finder or NLM or WebMD, or it could have been making an appointment or using a PHR.
DR. MIDDLETON: I forgot one feature I meant to mention. It is the issue which pertains to privacy, this issue of proxy management. Might I give you access to my ailing grandmother's record and to serve as her care manager, what have you.
MR. REYNOLDS: You became your own breakout session.
MR. J. SCANLON: I know.
MR. REYNOLDS: You obviously got the group's attention. That is a good thing. That means we are all interested in the same kind of stuff, so that is good.
Tony, are you on?
DR. TRENKLE: I've got a few additional comments I can make on the PHR pilots, as well as reporting on some of the CMS activities. So whenever you're ready.
MR. REYNOLDS: Yes, please, go ahead.
MR. TRENKLE: Just a couple of comments in addition to what Jim had said.
We put some very specific privacy requirements, actually Meridian did, in the PHR pilot for Arizona and Utah. All of the vendors who participate are required to sign a data use agreement with CMS, in which we lay out very specific security and privacy requirements.
The beneficiaries also have to sign a consent form to agree to allow their data to be transferred from the CMS contractor to the PHR vendor.
So we believe that we have certain safeguards in place to make sure that the data is protected. Obviously nothing is 100 percent foolproof or safe, but we have done a lot of due diligence in this area, and have certainly worked with the Office for Civil Rights and others in terms of looking at the PHR area and some of the privacy considerations.
We are also separately looking at our entire data use. CMS does thousands of data use agreements each year. One of the things that we want to look at is how can we strengthen them for future data use agreements, working not only within CMS, but also with ASPE and other parts of the Department.
The South Carolina pilot has expanded in recent months to include an agreement with the Department of Defense to send tricare data on active medications. We signed an agreement with them several months ago, and that should begin early next year. Both the South Carolina pilot and the Utah and Arizona pilot are scheduled to continue until the end of 2009. Of course, the Utah and Arizona pilot won't begin until January; the South Carolina pilot has been in effect since April of this year.
Turning to the reg front, we have as you know put out the -- NPRM has gotten the comment period closed October 21. We received about 3,105 comments on IC-10, and I believe about 150 on 50-10. Currently the staff is going through those comments, looking at things such as the implementation date where most of the comments were addressed to other key areas that people had concerns about, some of the cost-benefit data, and a number of technical issues regarding the X-12 transactions under 50-10.
So we are in the process now of trying to go through the comments and move towards a final rule. Whether that will come out during this Administration is something that is going to have to be decided at the Department and OMB. But we are certainly working as quickly as possible to revise the reg based on the comments received.
A side area related to the IC-10. We have the AHIMA report on the internal operations of the CMS, how they will be impacted by ICD-10. We have posted an executive summary up on the website about four weeks ago. We are now in the process of doing an internal clearance on the entire report, which we will then try to post before the end of the calendar year.
We have signed a contract with Noblis to continue the work beyond what AHIMA did. AHIMA did an initial impact analysis on the CMS operations, and now Noblis will take that work and give us some more specific details on the different components of business processes within CMS.
In the e-prescribing area, there is a lot going on with that. The physicians' fee schedule rate was published on October 30. Despite the Federal Register it will be published tomorrow. That contains several things related to e-prescribing. One was the revision once again of the computer generated fax exemption. If you recall, that was the exemption we put in the initial MMA e-prescribing foundation standards, where we exempt computer generated faxes from the use of the script standard, organizations that use computer generated faxes.
We have subsequently gone through a couple of rulemaking exercises, where we have attempted to lift that exemption at least partially. Finally, this year we have decided that we will not lift it until 2012, when the MIPA, which is the Medicare Improvement Act that just passed a few months ago, begins to offer disincentives for providers that do not use e-prescribing.
That is the other major part of the physicians fee schedule that relates to e-prescribing. The MIPA incentives program for e-prescribing begins January 1. There are specific instructions in the regulations about that, but basically starting January 1 running through calendar year 2009 and then changing in the coming years, there will be an incentive offered to providers who do e-prescribing under the Medicare Part D program. Very specific information is in the regulation, and also we have a website that has a lot of additional guidance and specific details of how the incentive program will work.
The other major thing we are doing within the e-prescribing area for standards. We are continuing to look at RxNorm and codified sig. We have signed a contract with the RAND Corporation in September, where we once again are partnering with AHRQ, and will do some additional pilot testing on the RxNorm codified sig, and also using the script standard 10.5.
We expect that pilot test to begin next month, run through September of next year. This would involve much more extensive testing of those standards than we did in the original pilot testing in 2006. Of course, there has also been some additional feedback we received from both the initial pilot testing and from industry that we will use in terms of this pilot testing. So we are hopeful these can be -- as a result of pilot testing, we can then move on the rulemaking for these two standards.
The other major standard that was not adopted out of the last pilot testing was prior authorization. We are also working with AHRQ and industry on that, and we will probably be doing a separate effort in that area, since apparently it requires much more of an extensive look at the business processes around prior authorization.
We had a conference call last week with AHRQ and some of the industry players. We have to move ahead with some work in that area.
The final thing with e-prescribing. The Drug Enforcement Administration as you know put out a notice of proposed rulemaking that closed in September. I have been working along with Jim Scanlon and others on a HHS team that has been meeting with DEA. We have both a leadership team and a working group team that have been working with the DEA staff to go through the comments, to work on looking at what are some of the key areas of concern that were expressed by the commenters as far as the technical requirements for the regulation.
We have gotten some progress in working with the DEA. We are hopefully optimistic or cautiously optimistic maybe is the better word. We have a number of areas we still need to work through, but I feel much more confident that we will have a final rule out within the next year. I can't say whether it will be within the next several months or the next 12 months, but I do believe DEA is committed to getting out a final regulation, and we will continue to work with them on that.
Just a couple of other things real quickly. You probably saw we did get an OIG report on our HIPAA security enforcement function on the fact that we were not doing compliance reviews.
We had actually started the process of doing compliance reviews before the OIG came in and audited us, but we have continued to do that. Last year we conducted ten compliance reviews and we expect to conduct an equal or even greater number of compliance reviews this coming fiscal year.
One of the things that we pointed out to OIG was the fact that in order to do an effective compliance program or an enforcement program, compliance reviews are only one piece of that. Also you have to work closely with industry on outreach education, not only doing the compliance reviews, but also insuring that industry is aware of some of the things we pick up in the compliance reviews so that we can work together as partners in making sure that the security aspects or the enforcement and the implementation of the security rule is done in a way that is very -- what shall we say, continues to improve over time.
Our biggest concern with the OIG is the fact that we felt that given the resources we have, or even expanded resources, the only way you could use compliance review solely as an effective weapon would be to do compliance reviews of thousands of covered entities, which of course is basically impossible with the resources we have now or that we could get to. So a more effective program would employ a large number of other tools in addition to compliance reviews. But we will continue to work with the OIG on that.
I guess that pretty much sums up the major work that we have been doing at this point. I can open it up now to any questions.
MR. REYNOLDS: Okay, Tony, thanks, that was excellent.
DR. FITZMAURICE: Tony, this is Michael Fitzmaurice. I wanted to ask you about the ICD-10. I think I read somewhere that AHIMA originally was asking for two years for implementing ICD-10, and I think they have moved to three years. That may or may not be right. I think I only saw it in one place. But it seems that in order to implement it, we don't want to go down the path of, let's have a date, let's extend it, let's have more compliance time, unless the industry is serious about it.
I wonder if Medicare is planning to develop pilots on 50-10 once we get there, pilots on ICD-10, after we get through 50-10, and put out lessons learned for the industry, so that CMS continues to be a partner with industry in showing the way and some tips on how to make it work better.
DR. TRENKLE: You made a couple of points. The first is, AHIMA's official comment was that they wanted the ICD-10 implementation to occur on 10-1-2012. We received a variety of comments from people, anywhere from 2011 to 2015, and we are looking through those comments, trying to strike a balance between moving quickly towards ICD-10 to recognize the benefits, but also understanding the challenges and the operational implementation issues that were raised by a large number of our commenters who came in.
In terms of pilot testing, that is certainly something we need to take a look at. However, one of our concerns with pilot testing is, unless you do it on a large scale, pilot testing for ICD-10 could actually detract from the overall implementation rather than adding to the implementation.
But that is certainly something that once the final rules are out on both the regulations, we will sit down with our industry partners to work through that.
MR. BLAIR: Harry, from the standpoint of time, is there time for me to do two questions or only one?
MR. REYNOLDS: No, you can do two, since you were quick on your last one.
MR. BLAIR: First of all, Tony, I really want to compliment CMS for all of the areas where it has active, proactive, in trying to facilitate, encourage and accelerate health information technology and health information technology standards. I was just listening to your review, and being aware of all of the areas that you are struggling to move the ball forward on.
The first question is with respect to negotiations with the Drug Enforcement Administration. I understand you can't necessarily tell us everything that is involved in that, but maybe you could just verify that this is one of the topics on the agenda which would be the ability of clinicians to seamlessly include prescriptions for controlled substances, along with other prescriptions over the current e-prescribing networks, like ShareScripts and R-Sub. Is that part of the seamless use?
MR. TRENKLE: Yes, Jeff, that is correct. One of the things that that we have been pushing with the DEA is that we want this to be something that integrates with the current networks and does not impose an undue burden on industry. So that has been one of the pillars that we have had.
We have had three pillars. One is that it can integrate with the industry, the current e-prescribing systems and practices. Second, that it is scalable, and third, that is promotes e-prescribing adoption and does not inhibit e-prescribing adoption. So with those three pillars in mind, that is how we have been looking at each of the requirements that DEA has put on the table.
One final thing on the DEA. One of the things that we have been asking DEA is to try to tie back the technical requirements to specific risks that they are trying to mitigate. There may be certain instances where they are trying to mitigate a single risk with multiple technical requirements.
So these are the kind of things we have been looking at with them, is this the best way to mitigate a risk, or are there alternatives out there, both the current practices or other ways that are less burdensome that you could adopt instead. So that is the kind of thinking we are approaching this with.
MR. BLAIR: Best wishes. Good luck.
MR. TRENKLE: We are constantly optimistic. I think Jim would echo that as well. But we recognize we have a ways to go still.
MR. BLAIR: I am very glad that you are working on this.
The other area. You are looking at some of the areas of health information technology. This is just to maybe add one for the future, so that it is at least on your list.
From the perspective of health information exchanges, and I am speaking from personal -- full disclosure, this is from personal experience with the health information exchange, whereby there seems to be support among health plans and Medicaid to work together in a community to be able to support health information exchange based on the value for continuity of care, for reducing redundant lab tests and radiology tests, where the CITL study for example showed that there was value to a community.
There is one player that is not at the table, and that has been Medicare on those, Medicare benefits as well as Medicaid and the private health plans. So as everybody sits down at the table and says how do we equitably divide this up to support the benefits of state and regional health information exchange networks, Medicare is not there.
So I just wanted to mention that so that you would have that on your list.
MR. TRENKLE: Well, Jeff, it is on our list. We actually have been active, working with the Office of the National Coordinator, not publicly but privately. But we do have some issues we need to work through with them. That doesn't mean we are not supportive, but we need to be supportive in a way that it also supports applications that are being done.
Without getting into more detail, just suffice to say that we are working with them and will continue to work with them, but we need to have a longer conversation on this, because it is something that is evolving and will certainly evolve under the new Administration.
MR. BLAIR: Thank you.
DR. FRANCIS: This is a comment with respect to the compliance issue. One of the questions that has been on the table, it is not quite off the table of the Privacy and Security Subcommittee, is the question of -- I will put it in John's words, because he was out of the room when the discussion happened, the question of governance, what kinds of structures are in place to be sure that people can feel appropriately reassured that data protection practices are in place.
Obviously one piece of that is compliance. Your point was that that is of course not the only piece, but the more there is openness and discussion about for example education as a complementary strategy, as well as oversight to make sure that complementary strategies are in place and working, the better.
So that question may come up. I just wanted to flag it for people.
MR. TRENKLE: I absolutely agree with you. One of the things that I want to talk to the Department about is the fact that as I mentioned, we want to do some things to strengthen our BUA surveillance.
The agency itself, Medicare, does thousands of data use agreements each year, and we found that a large number of these data use agreements we do are with organizations that have federal contracts or grants with other HHS operating divisions, and also other federal agencies such as VA, DoD and SSA, the Social Security Administration.
One of the things that I want to talk to the Department about is how can we better utilize -- there are federal dollars involved to do a better job in terms of privacy and security as we give out this data.
Now, in terms of overall privacy and security, I agree with you, education and outreach is a part of it. But the compliance reviews are certainly a tool that we need to look at as well as governance. There is a lot of work to be done in those areas.
One of the things that I have stressed with the OIG of course is that the security rule itself did not go into effect until 2005, 2006 for the small plans, and the enforcement rule itself did not go into effect until 2006.
So there is still a lot of work that needs to be done in those areas. I look at it as an interative and evolving process, but obviously we would be interested in hearing what the subcommittee has to say on the subject, too, based on testimony that comes in.
DR. TANG: Hi, Tony. Paul Tang.
MR. TRENKLE: Hi, Paul.
DR. TANG: Thanks for your update. May I clarify something on the e-prescribing rules? At one point, electronic faxing was going to not be considered electronic prescribing as of January. I think that is what has been pushed back to 2012.
MR. TRENKLE: That's correct, yes.
DR. TANG: How does that interact with the MIPA incentive program for electronic prescribing? In other words, is electronic faxing of prescriptions going to qualify as electronic prescribing for the incentive purposes?
MR. TRENKLE: No, Paul, it won't. Actually, under MIPA what they do is base an e-prescribing system based on core functionalities that they spell out in the regulation. We do not consider for purposes of the incentive payments -- computer-generated faxes are not considered electronic prescribing.
DR. TANG: So in a sense, the prohibition has been delayed, but the incentive has not changed?
MR. TRENKLE: The lifting of the exemption was originally supposed to occur January 2009. Last year we proposed lifting it in all cases, except for the network issues for use on an emergency basis.
After we went out with that rule last year, we received comments primarily from the pharmacy industry that said that would create a problem with prescription refills that they fax to providers. They said that would create an issue, where they would be forced to go back to paper if we took away the exemption.
So we went out this year with a proposal to include the refill as part of the exemption, but then with MIPA passing and also with the comments we received, we decided to keep the exemption on until 2012.
Now, in terms of the incentive program, that is correct, they were not going to include faxing as part of it. And I don't expect this to change. But the Secretary does have the ability to modify the requirements for the incentive program each year. So things could be modified slightly, depending on the response. But at this point, we don't expect to change that.
In fact, last year there was actually an e-prescribing measure in the physicians quality reporting initiative that was similar in a way to what the program is for next year, except for the fact that now, instead of being one measure is part of physicians quality reporting. The e-prescribing measure is actually a separate incentive payment. But that particular measure also did not include computer generated faxing as part of e-prescribing.
MR. REYNOLDS: Tony, thanks again. I would like to echo what Jeff had to say to both you and to Jim. CMS and the Department are both really taking a lead in helping these things move forward. A lot of the answers aren't completely clear yet, but you are not shying away from subjects, and you are absolutely making a difference. So I congratulate both of those entities. A lot of us on the street get to see it, and you are really making a difference. Thanks for your time today. You guys are wide open up there.
With no other comments, we will take a break and be back at 10:30.
MR. TRENKLE: Thank you, Harry, and thank you for the committee's support as well, and your personal support for the efforts.
(Brief recess.)
Agenda Item: Update from Executive Subcommittee Retreat - Framework for Committee
MR. REYNOLDS: Let's get back to business here. The next portion of the program is an update. I will start off the update, but then I will ask each of the co-chairs of the committee to give a quick update on their plans for the upcoming year. Then we will have the breakout sessions this afternoon and tomorrow morning to add to that.
On October 14 and 15, we had an offsite of the Executive Subcommittee liaisons and staff. We had had a brief preliminary planning meeting on September 17 after our last hearings to begin what we were thinking.
If you look at the slide on the projector, we have had some situations in the past where we have had subjects that we had individual committees deal with, and then we had ad hoc committees, we tried that on some things, which meant that you pulled certain people out, got them all together and did something.
As we looked at the subject up there, which is patient centered health, and you will hear a lot more about that as we go through this today, we decided to approach this a little different. It is really cross cutting and it is really something that is foundational for everything that is going to be going forward.
So all the picture is trying to depict up there, when we talk about person centered health, what the picture is trying to do, maybe not in an elegant way, but is to say as it says at the bottom, we want continuous learning by NCVHS from its committees and others. So every time somebody holds a hearing and it relates to this subject, it needs to be reported back to everyone. We need to do this on a continuous basis.
This is a subject very much like the PHR discussion. You notice Jim started off and everybody jumped in, then Tony started off and everybody jumped in, because it is based on the same kind of premise that we are talking about. So this is not about individual subcommittees or full committees or other entities. This is really about continuous learning and continuous building on this subject as a basis for everything that we are doing.
So that is a little different than we have approached it before, so I ask everyone in full committee and others, as we do this to continually share your thoughts, ideas, through the subcommittees, through the full committee. Then as we need to, we will pull in other entities, and you will hear about some of that today. So that is the way we wanted to approach it.
Also, we had representatives with NCHS and its Board of Scientific Counselors, political for collaborations with AHIC 2, the National Quality Forum, and national priority partnerships and other bodies. So continuing to look at the things that are out there that will continue to help us with this subject as we create it.
Some of the highlights were, all of the subcommittees will work on dimensions of person centered health, with quality taking the lead. You will hear a little more briefly about that. I want to thank Paul and Justine for being the thought leaders in that whole committee for doing that, and for Populations kicking it off when we first had the medical home discussion.
The Subcommittees on Population Health, Standards and Privacy and Security also planned additional activities, so you will hear a little bit about those between now and 12:00, so you will understand what else is going on. Then tomorrow you will see the revised subcommittee charges. We would like everybody to be able to look through those.
So in the breakout sessions today, make sure that you clean those up, make sure that is what your charge is, and you bring it back tomorrow ready for serious review.
Also, we may still continue the follow up project on the person centered medical home in spring of 2009 in the context of the person centered health project, not assuming that the medical home will be the model; assuming that it may be one of the ways that person centered health gets delivered and/or dealt with. Paul, is that a fair way of saying it? Okay, good. Paul wasn't listening but he shook his head anyway, so we will go from there.
Special projects and assignments were approved on data stewardship which I will cover more on, revising the vision for the 21st century, and the 60th anniversary.
I am not going to spend a lot more time on person centered health, because I would like Justine and Paul as they give their overview and discussion of their upcoming hearing, and how we are going to kick it off for the whole committee, to go ahead and do that. Some other things that occurred in the -- and I will let Dawn talk about the person centered medical home.
The data stewardship compendium. If you remember, when we had the full committee discussion that we really didn't believe that data stewardship was going to be a cross-cutting subject that we would hold hearings on. But more, it was going to be dealt with more as a lens or a filter.
I think we have had some of those discussions today about data stewardship as we talked about personal health records. So Justine and I will be working probably with Susan Canaan to put together a framework for that that lays that out as far as a lot of the things that NCVHS has already done and decided, as well as some other work that has gone on, to put this together as a document only to use as a filter, not something that is prescriptive, but something that you can continue to use as a filter.
The work that we did on that was quite horizontal and broad reaching, but then if we overlay that on something like person centered health, you can really start making sure that we bring the ideas and concepts to life. So that is kind of what we are trying to do with that, so I think that will be good.
There was some discussion at the Executive Subcommittee about a data steward. We heard testimony when we were doing some of the other meetings about whether there should be a data steward. However, the group agreed to complete our document, complete our filter, not necessarily weigh in at this moment about whether or not there should or should not be a data steward or anything related to that. So that is where we came out there.
A couple of other things, and then I will turn it over for some open discussion on what I just had to say. Then we will go through each of the subcommittees and have full discussion on the subject.
On collaborations with NCHS and the Board of Scientific Counselors, we had Jim Lapkowski make a presentation to us. He expressed interest in the committee's new person centered health initiative, and offering the BSC as a resource. So we have other entities, and listed a few up there. Obviously BSC and others could do that as they think about it.
Also, as Jim Scanlon spoke earlier about some concerns about vital statistics and so on, he said the BSC may make a specific request of the committee to weigh in on certain issues related to that. To date I have not seen any yet, but that was discussed.
Marjorie, why don't you take a minute on the revising the vision of the 21st century health statistics, again, just a couple of comments.
MS. GREENBERG: I wonder if Debbie might want to come up on that. I think it is on the agenda for tomorrow. We might as well do it now because I know tomorrow will be rushing to end so we can go to the hearing over at the Humphrey Building.
Debbie and I did have a teleconference with Gib Parrish and Dan Friedman, our former member, last week. I think we have got a plan. We have obviously also been in communication with Harry and Don and Bill. Do you want to tell us where we are on this?
MS. JACKSON: Yes. I think in looking at the proposals that were submitted and looking at where the committee is in what your ideas were for 21st century, we have been trying to walk that line of what can be accomplished.
Dan Friedman was so instrumental in the original 21st century materials. You will recall that that was built up on coordination with the Department, with the Data Council and with the committees and NCHS. So so much groundwork had been laid, and we mentioned your name, Carol, as a real ambassador and strong person who has kept the report up front and center along with Dan at the Subcommittee on Populations level.
So much work had been done in developing that document that we felt that -- what are the things that can be done to bring the basic issues to the forefront and updating it, keeping in mind, so much has been developed over the last four or five years in health IT.
One of the exciting things I saw in what Marjorie's poster is, this is one of the first places we had with the NHII as well as the 21st century graphics where put together in one place. Usually you had to go to one document or the other and take a look aT them. But we are in a place now, a neat synergistic place, to pull it all together. So that is where in talking to Skip and Dan who were there from the very onset, that we think we can pull this off in a couple of years to do an update.
MS. GREENBERG: Thanks, Debbie. What we are doing is two phases. As you will hear, all the subcommittees have plans for this coming year, yet also as you have heard, we have some budget constraints, too.
This phase one, which will be in this fiscal year, will be Dan and Gib pulling together all the information that has happened, and the reports of the committee and others that have happened since the vision was published, and bringing a lot of that information together and bouncing it back. I think the Population Subcommittee will be the focal point, but also the Executive Subcommittee and of course the full committee.
Then in the following fiscal year, probably a year from now, may be a few hearings or workshops looking at a revised vision based on the changes that have happened with health IT, and looking broadly as Sondik has encouraged us, on how the whole organization of health statistics might change.
I have to share this with you. Bill told us to think broadly, and he sent a great e-mail suggesting how things could dramatically change. Then he asked me if this was more hallucination than a vision. I wrote back and said, no, I was hallucinating with him.
When we talked to Dan, just to bring this down to the human level, he said he appreciated that so much. When his late mother, may she rest in peace, she was in her '90s, I think, when he was coming down to CDC to present this 21st century vision for health statistics, he went to visit her in the hospital. He told her what he was going to be doing, she said, I hope your hallucination goes well.
So you weren't the only one, Bill, who was thinking that way.
So anyway, we hope to vision and hallucinate into the 21st century and have something that we can chew on over the next year and a half and then present at the 60th anniversary in 2010.
MS. JACKSON: We are planning on having Dan for the February meeting.
MS. GREENBERG: Yes, that's right, Dan and Gib. At that point they don't want to get too far down the road without talking with all of you. So we have proposed to them that the come down for the February meeting.
MR. REYNOLDS: The last item I will cover, and then we will go through the subcommittees. Mike Fitzmaurice had some up with an idea of possibly a letter to the new Secretary as to what was going on. I was playing off of Jim Scanlon's discussion earlier, where the Departments have done the same thing, pretty well put a plan together.
It was taken by the Executive Subcommittee that if a letter like that were going to be prepared, it would be prepared about the full committee. So myself and Jim and Marjorie with contributions from anybody on the subcommittees that want to put input, will be working on it.
I think something like the chart is a great visual that I appreciate personally now. People ask you about the committee, and I think that has done a good thing. But we have to do this with the appropriate protocol at the appropriate timing, for the appropriate reasons. This is a major change in this country, and you want to make sure you are introducing yourself in an appropriate way, not just being another letter saying, hey, we are here. That will be the art. We write letters, but that will be the art of the letter.
So any of you that would have any insights to that, we would appreciate that now as we begin that journey. So that is where we are headed with that.
With that, I would like to first kick it off with the Quality Subcommittee since they are going to lead the way. Then after they are finished, let's open some discussion on the person centered, and then we will move down the rest of the committees.
But before I do that, I would like to publicly thank Don Steinwachs and Debbie Jackson. Don physically chaired the Executive Subcommittee retreat due to my surgery. I truly appreciate that. He did a masterful job of doing that. He did a great job in working through that with me, and Don, I thank you very, very much for that. That was very appreciated.
DR. STEINWACHS: Harry, I heard it was because you didn't want me to do surgery on you.
MR. REYNOLDS: That was absolutely a fact. That is why I didn't let you know until afterwards. But I really appreciate that. He did a very, very good job. Both of them pulled it together, so thank you to all of you that did that.
With that, I would like to turn it over to whichever of the spokespersons from the Quality Committee.
DR. CARR: Thanks, Harry. I will read from what Paul has written, so we will do a combined effort.
This is just our overview on the upcoming hearing that we are planning. Just as way of background, every ten years HHS leverages scientific insights and lessons learned from the past decade along with knowledge of current data, trends and innovations. Healthy People 2020 will reflect assessments of major risks to health and wellness, changes in public health priorities and emerging issues related to our nation's health preparedness and prevention.
The importance of empowering and engaging individual Americans in their health and health care represents an increasingly significant way to achieve improvement in national health outcomes. Such programs as the National Quality Forum's national priority partners initiative set forth clear rules and goals for people in improving their health and health care.
By way of background, the next generation of health surveillance data set, which is what we are looking toward, should seek to meet the emerging health data needs of the nation by improving the accuracy, the timeliness and the comprehensiveness of national health information with new sources of data.
While electronic health records hold promise in improving the ability of clinicians to improve the quality, safety and efficiency of care that they provide, the emergence of person centric health information technology applications, like personal health records, provide individuals with the ability, often in concert with their health care professionals, to track and improve their care.
PHRs and other person centric tools evolving from outside traditional health care delivery models represent the new and potentially significant sources of data for delivering, monitoring and improving the nation's health and health care.
The goals are as follows. NCVHS seeks to better understand the emerging data needs for measuring and tracking population health in the 21st century and to inform HHS policy, decision making and projects by three things. One, determining the applicability, use and limitations of PHRs and other personal health tools and applications, either alone or in combination with EHRs and other provider systems as vehicles for capturing needed national population health information.
Two, assessing current and proposed certification standards for taxonomy, standards, security, authentication for PHRs and other personal health applications. Three, providing recommendations to support person centered and population health functionality in PHRs and other personal health IT systems.
So I will stop there. Do you want to add anything, Paul?
DR. TANG: I think the goals we had for the hearings or the activity were what Justine just enumerated. That would be getting information from other peoples' experiences without doing a roust formal evaluation, sort of consensus expert opinion.
It would be nice, where you are having three states who are doing a PHR pilot, two of which are yet to begin, is there any way to bake in an evaluation that addressees some of these goals in a real live implementation. I think that would be much more primary data to bear on the policies that we are trying to recommend. I don't know what kinds of resources we can put on that, because I know that wasn't necessarily baked into the original blueprint.
DR. FRANCIS: This is one of the examples where it is wonderful to get together for coordination purposes. The Privacy and Security Subcommittee was looking towards hearings in January. Part of what we were looking towards virtually paralleled the structure of what you all were looking towards for hearings with questions about what are the privacy and security practices, issues, what needs to be thought about from that perspective so that the benefits of PHRs can be harnessed in ways that patients don't find threatening.
One of the things that we are going to need to work through with the schedule of committee meetings, hopefully it will all work out so that we can jointly meet in maybe the second half of the afternoon today.
Maybe Quality can join us after they have been with Population. I am serious about that. I know that funds are tight and time is tight for hearings. You can't have two days of hearings and then have us have two days of hearings, having the same people come. So we have got to figure out how to make all that work, and how to integrate it.
DR. TANG: The proposed draft hearing schedule that we had offered incorporates that thinking. The first day would be about the data and the standards and coded sets that apply to getting information from patients that might satisfy the population reporting. The second half day was about PHR specifically and the certification standards related to privacy.
So we thought that second half day could be a joint meeting that would go from PHR's data and migrate into the privacy aspects of those. That was the hope.
DR. FRANCIS: We shouldn't be taking up the general committee, but to figure out for example if Google comes and tells us one thing on the first day but doesn't tell us about privacy, we are going to have to work through all that.
DR. WARREN: I would just like to say ditto to what Leslie just said. When you start talking about code sets and transmission standards and stuff, then the Standards Committee wants to get in that. I shared that at our conference call, where I joined Quality.
So if there is a dance card, Standards would like to meet with you guys tomorrow morning. The only thing you have is the last half of your meeting, because you are meeting with everybody else.
So I think we need to look at -- this is a perfect example of, most of if not all of the subcommittees are interested in the same set of hearings. So when does it become a set of hearings and when does it become a full meeting?
MR. REYNOLDS: That would be the reason that we used to do ad hoc committees. We pulled people together and we did them.
The picture is real. That is the thing we are going to have to do. But we have got a lot of names up there of subcommittees, but we have got to figure out what we are doing.
Again, remember, we have got an hour and a half today. We left an hour and a half today and some tomorrow to have this discussion, because we want the full committee to buy in, because everybody is on subcommittees and so on. So before we change what Quality is doing, I would like to make sure that we hear from Privacy and Standards and Populations before we all of a sudden take this hearing -- I asked them to go first to introduce the subject, but now all of a sudden we are changing it. Let's hear from everybody. That is why we are having this discussion.
MR. BLAIR: There are probably several ways to do coordination, but I would like to suggest one for consideration that might be easy and straightforward.
That is, as each of the subcommittees winds up developing questions it needs to get answered, if we share those questions with each other, that is I think the most efficient way. If the Standards Subcommittee is asking the same question of a testifier that Quality or Privacy is, then bingo, you could wind up saying, we don't have to do that twice. We can wind up having that done in one and just share the answers with the other subcommittee.
DR. TANG: We did have a planning call that involved Privacy and Standards. The original design of this was to do the juxtaposition of the three groups.
So one way is, day one has overlap with Standards. That is the way this proposal is designed. Day two overlaps with Privacy. So that is one approach, is to have the overlaps constructed so that it maximizes peoples' individual committee work.
The other option is what Justine just mentioned. We could just have the full committee at the hearing because it clearly involves Population. Population is almost going to be part of Quality in this. But that might turn out to be the most useful and efficient way to getting the information to all relevant parties.
MR. REYNOLDS: So after we hear from everybody, we will consider that.
DR. WARREN: I just want to reply that what I find fascinating with this, because I was on the phone call with Quality when they looked at this, you are looking at a piece of what Quality is interested in. As it turns out, that piece everybody is interested in.
So it shifts it away from the way we have always done things with subcommittees, Quality is interested in quality and only looking at that. Now all of a sudden they are getting into an area where yes, they are interested in quality, but it cuts through everything else, which is the way life is, and should be run.
So while I think each subcommittee needs to report, this particular project may be unique in a way that we are going forward. It may be the successor of the task force idea that we have had before.
MR. REYNOLDS: Justine and Paul, one comment. As I went through your document, one of the reasons I think we went to person centered health was to talk about the person, not the medical home which was a model, and not the person being a patient only, just a patient.
Personal involvement, personal responsibility and personal accountability didn't jump out. I think it is there, but what other kinds of things are going to be available? I know at home when we take health risk assessments, we are not patients, we are employees taking a health risk assessment. As you order lunch today you are not a patient. So whether or not we are talking about the full person, not just the person when they are with the doctor.
DR. TANG: They all talk about population health, and that is deliberate to not mean health care.
MR. REYNOLDS: But I am just saying, about each person's individual -- what tools are we going to give each person to do that.
So I think it is there. I'm just saying, maybe at more a layman's -- just think about it.
DR. CARR: I didn't go through the planned agenda for the hearing, but --
MR. REYNOLDS: I'm saying in the first couple of pages. I believe that the hearing does -- you are right, up in front doesn't necessarily pull out what we had talked about. Just add a couple of words, but maybe nobody else agrees.
MS. MC CALL: I do agree. You tell me whether or not this comment aligns with what you are saying.
I think that we talk a lot about data. I think we talk a lot about what we mean. But data is an exhaust off a process that meets a need of a person. So if we want the data then we need to make sure that the data is coming from something that the person finds valuable, in terms of what they can learn, what they can know, what they can do around the pursuit of their own health.
So I think that we need to add something to the dialogue that investigates and explores what it is that people would actually be doing that would generate that data. So it is not about the data first, it is about the personal use.
MR. REYNOLDS: These aren't criticisms, these are just -- it didn't jump out at me.
DR. TANG: Actually that is my day job. The reason that this was a bit more slanted toward population health and reporting is because I thought that was the scope for NCVHS. So we can use clarity there.
My particular professional interest in my day job is in managing health and wellness. So it is slanted a bit towards the reporting side, but please clarify --
MS. MC CALL: One clarifying comment then. I would say that if we want to continue to focus around data and population health, that we simply don't assume that we have the can opener, that we confirm that there is going to be some sort of tool or mechanism or capability that a person will have that would generate the data. Don't assume that it is going to naturally be embraced by a person, that that be a confirmation conversation that we have.
DR. CARR: I think we perhaps have not fully enriched the -- recapped the conversation that we had at the hearing. But we were talking a lot about individual tools and techniques for a variety of things, weight management, exercise management, as well as diabetes management, blood pressure management.
I am happy to recount them now if you would like. I didn't know if -- but I think that is where it began. The focus are mechanisms that empower an individual's focus on their health. The NCVHS has as its mandate the data; we are focusing on the data. So I think we are linking these two things, but our hearing takes on a data focus so that we stay within our charge.
DR. TANG: Let me give you a concrete example. Steps might be a very useful thing to manage individual health, but fitness is the publicly reported data. So I am still looking at this side of the table to say what is the scope of NCVHS and how do we incorporate the ideas about the wellness that Caroline and Harry brought up.
MR. J. SCANLON: You have a fairly broad set of parameters here, but you are not the health policy board or the public health board, so your focus is on measures, metrics, data, systems that would meet the needs and the gaps that you identify in those areas -- prevention, promotion. Some of it is clinically based, some of it is population-based, some of it is employer based. But yours is the data perspective.
MS. GREENBERG: When we were talking in September when we started conceptualizing this, part of it was talking about what is really important to people about not just how can providers or statisticians or agencies or whatever get more information from these people, but what is really important to people about their health and their well-being, and a broad view of health that might never -- some aspects of it would never be part of the health care system, the WHO definition of health, which includes well-being and also aspects of society and the environment, facilitating the type of health and well-being that is important to people.
So I think that probably requires maybe hearing from some consumer groups. I don't know if I am being clear about this, but not just what the health care system or even the health statistics system wants to know, but what is really important to people.
Larry isn't here now, wasn't able to come today, but the idea of why people -- if it has to do with the health care system, why they are seeking care, or what people care about from the point of view of their health and well-being. I think we want to make sure we have that voice, too.
DR. CARR: It might perhaps be helpful if I just gave you a couple of bullets about what we are intending for the hearing. We thank Matt Quinn for his help on this.
The first topic, overview of current population and health measurement strategies and data sources. Next, understanding and assessing emerging needs for measuring and tracking population health, so evaluating gaps and needs for measurement of person centered goals, supporting Healthy People surveys. Next, identifying current data standards and their gaps, so ICF, SF-12, SF-36, LOINC, SNOMED, et cetera, and then summarizing that.
Then moving on, determining the applicability, use and limitations of PHRs and other personal health tools as vehicles for capturing needed national population health information. So this is patient centered health information, but actually this should have been person centered visions and tools, PHRs, stand-alones, aggregators.
Moving on, assessing current and proposed certification standards, and summary and action items to support population health.
Some of the folks that we are looking to be hearing from on the PHR front include Cleveland Clinic and Care Group, but also PHR platforms from Google and Microsoft, stand-alone and commercial websites, WebMD. That is the idea. The purpose of our work today would be to flesh that out.
DR. MIDDLETON: I think the primary objective on the table is to figure out some scheduling, which is complicated enough. But it does to my mind perhaps also raise some framing questions about NCVHS scope and purview and orienting philosophy.
What I am struck with in this conversation is thinking back to Larry Green's observations in the NAJM article, where he talked about the premature determinants of mortality, and identified behavior and the environment and genetics as being much more important frankly than health care.
So I wonder if that doesn't help us think about a broader scope with data and data acquisition to assess the broader set of impacts on what are determinants of health and mortality. So that is number one.
I think the second thing is, even in this conversation, we are struggling a little bit in framing who to talk to and whatnot, because we are not explicitly addressing the value proposition. This is a CITL favorite topic, but do we want to introduce business and/or value considerations into our hearings process and our determinations, because it is ambiguous still, and because the data we need to assess determined value might be very important to the marketplace.
I might suggest that taking a value perspective on these hearings would be useful. That involves both patient and community perspectives as has been highlighted, certainly the traditional provider perspectives from any number of strata of provider organizations, and then payor perspectives both public and private is the natural set there. But then that value perspective can help define further data and measures.
DR. STEINWACHS: I just had a couple of thoughts. It strikes me it is an interesting environment. You are probably starting into the process soon of the 2020 health objectives. That generates I would think a huge list of what people would like to see, and that is matched against what data are available, what can be looked at, what are the goals. It would be interesting to think about how one could tap into at least some of that developmental process and thinking about what would be wanted possibly in terms of data and information if it were possible.
Carol's point, which I thought was excellent, was saying what would I be motivated to actually do. It always strikes me when you talk about health risk appraisals, at least my experience is, if they are just offered to people, there aren't that many that are filled out. So others are providing an incentive. So that brings in the third group, which is who are the stakeholders who are invest resources, energy or incentives to us, who want to provide that kind of information that would be helpful to us more broadly.
The last was what Blackford was getting at. When we were talking about data linkages and the framework that we are trying to update for NCVHS, it talks about bringing together such things as environmental data, law enforcement. We have some studies going on at Hopkins that are looking at bringing together information about the structure of neighborhoods, sidewalks, other things, where you begin to understand what people can and can't do in the place that they live.
So it seems to me it would be interesting to lay out those elements and then figure out how do we at least touch on them, trying to understand what motivates what we get, and more broadly talk about what people could benefit from.
MS. GREENBERG: This would be for discussion in the breakouts, but I look at 1:30 to 2:15, overview of current population health measurement strategies and data sources. I see CDC there, too.
I think this is going to have to be very focused as to what you want people to report on, or I would suggest that is not really enough time to set the stage or the background for the types of measures, the types of information.
It very much relates actually to the 21st century vision, but you knew I would say that, that whole influences on health which Blackford was mentioning. So you don't just want to hear about all the surveys obviously. So I think this needs some fleshing out.
DR. CARR: Will you be joining us? This was just the product of one phone call. All of this input is very -- we are just trying to keep the process moving so that we have some straw man thing for us to respond to. I think all of the input today has been very helpful.
MS. GREENBERG: I am kind of wondering, with everything that is hanging on this, why the schedule is the way it is. It looks to me like only a half day and a half day. Maybe I am missing something. Particularly if we include the interests of the other subcommittees, we might want to think of a bit more robust schedule.
DR. CARR: That is a great suggestion, thank you.
MR. REYNOLDS: Again, the purpose of today -- and as soon as we say cross cutting, that means we are going to be tripping over each other in the early discussions. So I just ask that we not be too -- they put out a straw person for us to start working with in the waterfall, so they are the first trip over the waterfall. So I want to make sure that we continue to build off of that.
Again, we have got the breakouts, so I want to get as much discussion as I can right now during this time, so we understand what we are thinking about as a group. Then when you do your breakout, what you may want to do is consider moving one of your people from your breakout session, and think about how to do this.
I have asked them to go first, because they are our first waterfall, but I don't want them to be the lightening rod for every -- we have got to figure this thing out. We are making part of this up. Nobody else has got this thing. So I ask everybody to play at that level that we are making it up. Then in the end, once we figure out what it is, we will debate whether or not we did the right thing, and whether or not we have got the right stuff in place.
MR. BLAIR: A lot of times we study areas where we know there is improvement in quality and improvement in privacy and improvement in health or improvement in health care, and they have tremendous value. But if there is a piece of that as we do that, which can pick up Blackford's comments -- he said value, and in my mind when I hear value, my mind replaces it with quantification of the benefits.
Even though so many of the other studies have tremendous importance, I am finding that if you can't quantify that value, if you can't quantify the benefits, very often everybody intuitively agrees to that, but it doesn't get funded and implemented.
So I would just say that as we do our work, if there is a piece of that where we could quantify the benefits or it could lead to quantification of the benefits, I would wind up saying that is the piece we ought to put a high priority on.
MR. REYNOLDS: I've got Mark, Paul and Carol. Then I am going to move Quality out of the spotlight and I am going to give the other three subcommittees the opportunity to move to the forefront.
DR. HORNBROOK: We have been doing some strategic planning in Kaiser. One of the things that is glaringly missing out of all our efforts to build an IT system is a measure of output. There is nothing in any of our information systems that tells us how much health we have produced.
So we are pushing and trying to figure out how in the world you can pay for regular health and related quality of life surveys that have utility scores, so you can get to a single global measure and deal with resource allocation issues, which of course is a key issue of the high cost of our health system today.
So electronic medical records are really great measures of input. Surveys of health behaviors are necessary, but they are still measures of inputs, not outputs.
Then on the 21st century thing, I have been looking at Hawaii, and they seem to be having some really important early warning issues. The population is getting older. The physicians are getting older. Physicians are not able to sell their practices, because their practices aren't worth much. They aren't hiring people to replace themselves in the Islands, so they are feeling like the physician shortage is down on them very, very fast.
So I would say that we need today to think about detecting the implosion of the health care system in our data system design, not thinking about the 21st century. We have got to get there first. We are going to go through a huge chasm before we get to the other side.
MS. MC CALL: I love the comments that have come forward. I think that the way this is structured, giving what Justine read, the little bit more background was very helpful.
I think it is possible to link three concepts as we go into these hearings. One is around our 21st century vision. Another is around the determinants of health, and the third is around the concept of value.
The 21st century vision says we have a point of view, not complete, we are still learning, but we do have a point of view around the things that we need to better understand to push forward on population health and the context of that in the environment and the community. So I think we can put that out there.
I also think that we can ask some of these testifiers what are they doing to capture data about those, either directly or indirectly, and what are they also doing to bring the concept of value that makes the person using this thing, whatever it is, want to do that and to explain that. So we can go in and link those concepts.
We are looking to learn, but we are also looking for gaps, which I think was a very important thing that you guys read off. What is going to come out of this is a sense of gap. We have a point of view. We are fleshing it out even more around 21st century, but we are going to find gaps to say, with all this good work that is great, but we have more to do, and we are going to have shone a big light on that.
So I think it is well framed out to do those things.
MR. REYNOLDS: You said 21st century vision?
MS. MC CALL: Yes.
MR. REYNOLDS: Determinants of health, and what was your third one?
MS. MC CALL: The concept of value. It is the idea that any proposition whose value relies essentially on externalities or the idea that we can begin, once I have ten million people signed up and I have exhausted all that, it has a problem because it hasn't addressed the fundamental issue of how do you start.
MR. BLAIR: Could I ask a clarification question?
MR. REYNOLDS: Yes.
MR. BLAIR: When you say value, in my mind that means the ability to quantify the value. Is that what you mean when you say value?
MS. MC CALL: For me, I think there are different values. I should pluralize it. The value to me as an individual person on some of the tools that may be there, I may not be able to quantify, but I will recognize the value because it gives me an ability to do something that I never could have before. Maybe it will be quantified someday, but that is not my primary goal. I seek to orient myself on the Map of Health Life, I seek to help my family, I need resources, I need knowledge, I need new things.
The value to the system needs to be quantified, I would agree with that.
DR. MIDDLETON: This is such a great thread. It is very exciting. In a way, Jeff, following up on Carol's comments, I think we do have to address the values of the system, that is, what are we aiming to purchase or produce, as Mark had alluded to, too, which is different and perhaps not well understood or not fully analyzed, and of course requires data to do so at a variety of levels.
That is a very large policy question, as to what we are going to do with our increasingly scarce health care dollars, what are we going to pursue. So we need information which may be based on data to inform those values.
Secondarily though, I think there is then the fundamental value question, which is to objectify the value at some level, but also to appreciate what Mark also alluded to, is a patient's personal preferences and utilities. That is increasingly going to be important as the value metrics shift toward more out of pocket or consumer expenditure in health care.
We already know that two-thirds of health care dollars spent are not into the traditional health care delivery system, they are spent on everything else. So I think there are both dimensions that we have to address.
DR. TANG: This is a possible process of procedural suggestion. We have had a very similar discussion probably three times already. I am wondering whether it would be wise to start out our breakouts almost as a full committee, meaning representatives of all the subcommittees, in a working session to try to enumerate all the concepts, find out where the overlaps are, and assign a detailed agenda to the work groups that would follow.
So let's say an hour working session together, and then the next three hours or whatever time remaining schedule so that we can each meet in our subgroups, just to try to get a bit of -- put us all on the same page, and have clearer or crisper subgroup --
MR. REYNOLDS: I like the idea. We can use conference calls for individual subcommittees which we have done in the past. Face to face on these kind of subjects is almost priceless, when we struggle to get everybody together and look across the table.
So we will think about how to do that. Maybe that will be a good lunch discussion, figure out how we actually do that and how do we construct it, and what does it look like.
Before I turn it over to the next subcommittee which will be Population, back to one of the points. Jim, you were mentioning incentives. I can comfortably tell you that -- and I just went through the surgery and everything else, but the health risk assessment that we went through in our company, and also the ability to meet with a nutritionist, has dramatically changed the way I look at things.
Now, I have seen a lot of doctors. I have had a lot of other stuff. But knowing that and seeing trend lines and seeing things that I do, so when I order this, I do that, I think different. But when I went in the hospital, they didn't care about my personal blood pressure, they cared about their charts, and we had an ongoing fight. They told me I was fine, and I wasn't at my number yet.
So back to the person thing, I was not at my number. So they are telling me I am okay and I am going, no, because my chart says I am not okay, the one I have from this entity. So those are the kinds of things.
Now, take people less prepared to do that than some of us. We talk about personal accountability and we talk about personal responsibility and so on; if we can make any difference there -- in our company right now, we have got an incredible percent of people that are obese. We have got to make a difference. So those are the kinds of things that we are all trying to think about.
So that is just personal from somebody who is in it, but that alone dramatically changed what I do and don't do, dramatically changed it, and that is kind of fun.
So with that, Populations.
DR. STEINWACHS: So Harry, can I change my lunch order now?
MR. REYNOLDS: No, I actually did not order well today, but I did it purposefully.
DR. STEINWACHS: Bill and I will try and do this. I will lead off and Bill will fill in all the things I don't say.
I think, Harry, when you went through what we covered in the Executive Subcommittee, you laid out the things that we have underway. So the follow up to the patient centered medical home hearings on the Populations Subcommittee, we see what Quality is leading off with as the next step.
Then we have been going some work and Matt Quinn has been helping on a use case. If we focus back on this idea of some sort of enriched primary care, medical home, whatever you want to call it, the medical home is the words that people are using, how could we explore a manageable piece of that in the use case idea.
So we will be talking this afternoon about that use case idea as a way to explore it. But we are waiting until after the January hearings on the person centered health to see where this fits in, so that we are coordinating this. We were talking about doing something in the springtime, I think was the plan.
We put the patient centered medical home at least in the subcommittee's concept under looking at information and issues that support health policy and health reform, and this being one direction, namely, trying to strengthen primary care coordination and continuity functions.
The other, which we are going to have hearings tomorrow afternoon and then we are talking about subsequent hearings, and these have also already been discussed, but just to say them quickly, was to look at data sources available and used within the government data collection systems related to insurance coverage and access to care. That will be the hearing for tomorrow afternoon.
We are then looking forward to doing another hearing particularly around modeling and the opportunity to use the data in models that look at policy options. The discussion has been to have both modeling that is done in the government and the different models that are used in different parts of the government for insurance coverage and some of the implications there, and on access, and also to include some of the academics who are involved in modeling, so that we get a sense of what is going on dynamically in both areas, and what are the tools that may be most useful for different kinds of questions or most useful more broadly, as health reform issues are raised, and the government and others are responding to trying to understand policy options.
The other activity that came out of discussions, and Mark Hornbrook brought this forward in the Population Subcommittee, was the interest in what kind of synergy might exist between health statistics and collection of health information and what the CTSAs are doing by providing funding and bridging commitments that talk about linking what is going on in research into communities and tracking what is happening in communities.
So the first step in that is, today we will have a person coming in to the full committee meeting here to talk about what the CTSAs are expected to do, what they are doing, and begin to get a sense of where we might find this kind of synergy, which sounds exiting.
DR. W. SCANLON: They are already sitting in the back.
DR. STEINWACHS: Okay. So I better watch what I say about the CTSAs.
We were hoping that out of that there would come greater clarity as to what the next steps were, and looking forward to this idea that there might be some potential here to develop community level, very dense kinds of information that are not available at the national level, and then to begin to think about how statistically would you bridge that. If you had 40 or 60 communities around the country and then you could relate that to national health statistics in a depth and dynamic way.
You have already heard about the updating process for the vision for health statistics in the 21st century. Certainly this is a great part of the whole committee activity, but the Population Subcommittee is seeing itself as trying to facilitate that and move that along.
Let me turn to Bill about the discussions on vital statistics and what has been going on between the BSC and ourselves. And Garland may have something to add to that, I don't know.
DR. W. SCANLON: Sure. I guess our principal issue in vital statistics is the adequacy of funding and the consequences of the inadequacy of the funding and what it is going to mean in terms of the kinds of statistics we are going to have available.
It has been a continuing concern of the BSC. They have written a letter to the Secretary, expressing that concern. They have created a work group to look into it further. We have agreed that as that work group proceeds that we are going to coordinate with them in terms of looking at the issue.
This is one where when you think about resources, sometimes you say, how can we change the process to conserve resources and be more efficient. I don't think that is really on the table at this point, because there has already been some changes that may have done that.
The issue right now is, we are at a level of resources that is falling below what one might think of as a desirable level in terms of the kinds of data that we will have available. Garland knows this in much more detail than I, but I think that is the overall assessment.
DR. STEINWACHS: Garland, did you want to say something before I knock over the microphone here?
MR. LAND: Yes. I think there are two critical issues going on. One is, the proposal is to reduce the number of data elements that are being collected on the birth and death certificate. Particularly on the birth certificate they are going to reduce it by about 75 percent of the data elements.
The other issue is that there is a proposal to cut the funding to the states that provide the data to the National Center between 30 to 50 percent, at least 30 percent, and who knows, it may be even higher than that. So that is going to affect the quality and timeliness of the data that is being submitted to the National Center. So we are quite concerned about the ramifications from the national perspective and from the state perspective.
DR. HORNBROOK: Can you be a little disclosing about whether this is the best decision or a political decision? It sounds like a Washington Monument strategy.
MR. LAND: I would say that there are other alternatives.
DR. MIDDLETON: I know as a second or third meeting attendee, I am not allowed any more naive questions, but I am going to try one.
I wonder, the severity of the impact of some of these decisions on data gathering for assessing the country's health and wellness strikes me as beyond the pale. I wonder, when does the NCVHS take it upon itself to actually assume within the appropriate boundaries a stronger advocacy position with respect to some of these decisions?
MR. REYNOLDS: One of the comments as I was going through the Executive Subcommittee discussion where the BSC may give us an assignment, I think that was one of the subjects, where they were going to ask us to consider doing some things.
MR. J. SCANLON: On the committee you can't really lobby or advocate obviously with Congress. But the committee is free to make an assessment of what they think the impact is and to send that letter forward with some recommendations to the Secretary.
Again, the irony unfortunately is that everyone has requested increased funds for NCHS for the past two years, and it just got caught in the budget process. So literally everyone supported a fairly large increase that would have at least helped with some of the situation that Garland has described. What it just got caught up with this compliance resolution and what happens later.
But you are certainly free to provide an assessment of the impact and concern and recommendation for the Secretary, of any kind.
MR. REYNOLDS: Also, out of this initiative, as we consider such things, it might be a good time to make it part of the subject also, so that we talk about the continued importance of that to drive this to the end.
Don or Bill, anything else?
DR. STEINWACHS: I think that's it.
MR. REYNOLDS: Let's move next to Privacy and Security.
DR. WARREN: We have put together something like a briefing book that is what has been said to date and what are the resources available about the kind of information and use of that information in PHRs.
So starting with that, what we were planning to be doing with respect to PHRs, and this will require some integration obviously that we need to work through today, first of all, what are the privacy practices that the various PHR vendors are currently using. So we would want to know that. Some of them are available on websites and so on. There are also typically reservations about the possibility of change, too.
Then where are these PHRs being put into effect, and what are the examples with respect to employer use of them in wellness programs. What are the privacy issues that come up in these settings? In many cases, the old idea of a PHR was, it was on a little stick and it was mine, and it was my own little silo.
The kind of things that are being talked about, about data flow in the current use of PHRs as part of a more general health practice is not siloed, it is much more integrated. So what are the kinds of privacy issues and security issues that that raises?
What are the concerns that are being raised by patients and patient advocates about this kind of use that might make this way of transmitting, using and so on data less useful than we think it ought to be? So that is a piece.
The other piece that we thought that we could have something quite focused and immediate to say is, what is happening in the Medicare demonstration projects is adequate, is it a model, or is it not. We haven't had an opportunity to look at that.
Finally, what kinds of governance structures if any are there in place for PHRs as their use is evolving? There are some private certification proposals. There are questions about whether the use of business associate models is an appropriate on, whether it is inadequate, issues like that.
So that is the territory that we have scoped out in an outline for hearings. I think John may want to add to that. And obviously we need to do a lot of coordinating.
MR. HOUSTON: To expand on what Leslie said last, I think the one area that I personally am very interested in, and that we have talked a good bit about is not just governance of the PHRs, but overall governance as it extends to the EHRs as well.
I think you can almost look at that as one governance structure, or at least try to form a new governance structure, because you have everything from the tethered and untethered PHRs and how do you deal with data as it moves in different types of environments, such that that data may or may not be commingled within an EHR.
I am just very concerned that the ship is leaving the dock, and I don't know how much governance people have really thought of in a macro sense. I really think that is going to be a showstopper if somebody doesn't try to address that soon.
MR. BLAIR: Could you just clarify what you are thinking? When you use the word governance, could you say what you are thinking about?
MR. HOUSTON: Sure. As we talked about in the Executive Subcommittee a little bit, I think there has to be everything from a central mechanism whereby privacy issues are addressed at a macro level to how does one participate in whatever is formed.
We continue to talk about the NHIN. The NHIN is made up of many, many entities that need to participate, but how does one decide who is worthy of participation, and what happens if there is an issue? How do you try to address -- especially on the privacy side, how do you address patient issues associated with passing between these entities that make up the NHIN?
I think there are going to be profound issues. Let's put it this way; in order to get public trust there has to be that in place.
MR. BLAIR: Are you thinking of governance at a national level, or are you thinking of governance at a local level?
MR. HOUSTON: I think it is a national level, because I think there is already governance at a local level. But the problem is, once data start to cross borders and boundaries of RIOs and states, all of a sudden I think you have a class of problems that don't necessarily occur at the local level.
As I said, ultimately at the end of the day you are going to have thousands upon thousands of entities making up an NHIN, or the NHIN, I should say. How do you deal with somebody who is not a good actor or somebody who is a bad actor? How do you deal with reasonable patient concerns, where a patient may be situated in Florida and they have records in three or four other states, and there are concerns that maybe a provider in some of the localities is improperly accessing that data? How do you deal with that?
So I think there needs to be some thought put into this. I'm not overlaying an architecture, but I think these are questions that remain unanswered today.
DR. FRANCIS: Let me just add to that. Fragmentation is an enormous problem.
MR. REYNOLDS: What is?
DR. FRANCIS: Fragmentation in this whole area. It is not clear to us whether taking up this question with respect to PHRs is -- that might itself be in some of the fragmentation, but it is clearly a question that underlies the discussion.
DR. HORNBROOK: Just being selfish, I remind you that I sit inside an integrated health care system with complete automated medical records. I have already had three e-mails with my doctor this morning. So it is a whole different world that I live in.
MR. HOUSTON: One of the things that we should be aware of when we talk about PHRs is, there is a whole different kind of informatics approach that we are finding is very important, and that is panel support.
We have taken the medical records system now, it is set up for each individual patient, but when you have physicians who have to manage their panels you can provide informatics support for them to make decisions about how to allocate their time across patients.
So obviously preventive service are very important, but chronic disease management is extremely important in trying to keep track of what the priority is for each patient in terms of outreach, but also in-reach when that patient shows up at the door, are you doing the right things for that patient that day.
A counsel support tool requires you to manage all your data for a physician across multiple people, integrate it and put it through an analytic engine. That is a whole different process than simply linear separation of each person's private records.
So I just want to remind us all to think about the fact that when the people are coming into a physician, the best way to use that physician is for that physician to have all the different for all their patients in some sort of analytic engine to help them practice medicine.
MS. MILAM: I would like to give some context around the PHR situation in the NHIN. When you look at where most of the health information exchanges are across the country, most of them are getting started. So to frame where they are in terms of building out their own activities versus joining the NHIN, you may see numbers of exchanges not yet joining the NHIN, focusing on building out all the different communities within their purview.
So I would suggest that we look at the PHR at the NHIN level, but also at additional levels, so that in the interim, maybe the next five to eight years we don't have a lot of people slipping through the cracks.
MS. MC CALL: I'd like to go back to John's point. I know that if I heard you correctly there are some concerns about governance at a high level. Yet, I don't think we have taken or anybody else has taken a point of view about whether or not there should be such a mechanism. Is that accurate?
MR. HOUSTON: I think that is one of the questions we need to explore.
MS. MC CALL: Right. So before we talk about how, I think a relevant question would be whether, and what is the expectation.
Also, outside of health care, is there some sort of analogy? What are the expectations of the citizens of this country? It would be very difficult I think to put together and it would be very time consuming. Whatever we did needs to be something that embraces what people would find valuable. I was just looking for whether or not there was an analogy outside of health care.
MR. HOUSTON: There is probably only one analogy outside of health care that I can immediately think of. It is in a much more controlled environment, which is banking, because banking data flies all over the United States. We have an expectation that when I --
MR. BLAIR: It is supposed to. We are trying to make it do that again.
MR. HOUSTON: Banking information I think in large measure is easy, because we are dealing with numbers, we are dealing with passing -- you pay somebody a hundred dollars or there is a credit or a transaction, there is a certain amount of money and it is quantifiable data. I think health care is fundamentally a different animal. It is qualitative, it is quantitative, it is a lot of different things.
MS. MC CALL: I think you are right. The question is whether to have one, and if so is there an analogy. We will find one.
MR. HOUSTON: This is predominantly from -- my view is from a privacy and security perspective. I think you can ask that question at a couple of different levels. You may need one for privacy and security. You might say we don't need one for the management of the NIHN. We don't need to have somebody out there adjudicating transactions for the purposes of efficiency or whatever. This very well could be a phenomenon that is unique to privacy, primarily privacy, but I guess there is a security component to it as well.
MR. REYNOLDS: If you took privacy, security and data stewardship, it would also fit in the same category.
MR. HOUSTON: Yes, linked together. You may argue that NHIN doesn't require some centralized infrastructure to otherwise operate.
MS. MC CALL: I guess my only point is twofold. I am going to go back to something Mark said. Around all of these topics we are entering into a space that nobody has ever been before. So to wrestle with the questions, I think it is important to find a way to have a discussion that is familiar, not identical, but a way to have it that is familiar. I think that is something we should actively look to do.
I think it also applies to the nature of the technologies. One thing is going to be for sure: Whatever paradigms we hold around what technology is going to be able to do, we in this room are going to be way behind. So for us to think about and talk about specific kinds of technologies, there are so many more than we will ever know about, let alone be able to grasp, and they are coming faster and faster all the time.
I think both of those things should inform how we have the discussions, the types of questions we ask, the types of recommendations we put out.
MR. REYNOLDS: Don, and then I would like to move on to Standards.
DR. STEINWACHS: Just a small thing that you made me think about. There is a sense that medical records live on forever and EHRs will live on forever, in the sense that you die and it still goes on.
But PHRs, it strikes me, is a very different kind of territory. When I leave Paul's health plan I may want to have a clear expectation that he destroys his version of my PHR but he keeps my EHR. When I die, maybe I want all of my PHR records somehow destroyed.
So it added a twist to governance I hadn't really thought about too much. There are different record expectations possibly here in those two domains, even though we keep thinking of them as interlinked; but not totally.
DR. FRANCIS: Can I just make a comment on that? It seems to me that is one of the really interesting questions. The whole concept of what a PHR is has been changing.
MR. HOUSTON: Carol said something about how fast technology is moving. One of the concerns I think we also need to have here is, another analogy towards a national system is air traffic control.
One of the biggest problems we have in the universities is, we can't seem to ever upgrade the damn system because it is so complex. It is mission critical, it can't be brought down for even a second. We have to be very careful though that when we design our environment, we do it in a way that it is technology neutral. It recognizes the fact that we are going to continue to develop new technologies over time and new levels of integration and the like. We have got to get it right now, because if we don't have an architecture, if we don't have fundamentally a good understanding of what needs to be in place for a long period of time, we could develop an environment that seems to work pretty well right now, but we can't upgrade it or we are stuck with something that doesn't work well in the long term.
MR. BLAIR: With respect to the focus on the NCVHS Standards Subcommittee during this next year, in part we are once again responding to industry calls that we are probably the appropriate forum to be able to examine how well HIT standards are being developed, selected, coordinated, implemented and used, which is quite a large picture.
For it to have value, we need to get the results upward in the Administration as quickly as we can. The way we have developed this, first I will start with our statement of purpose. We broke it down to four basic elemental questions. We want to know from each organization that either is part of this development process or affected by this development process; what are the things they do, how do they fit in the picture that I just articulated, what are the things they feel are not working well. Notice that I am using the word we, because I think we really have to look at this that we are part of the health IT community, and the solutions might not necessarily be limited to an organization, but it may be across organizations, and maybe public-private as well.
Then the last question is, what do we need to do to improve things. So that is our direction. We didn't come up with a real name for this, so for lack of a better name we are calling it the NCVHS standards initiative. If a better name for this evolves, then that is fine.
In our breakout session this afternoon, we want to investigate how we will do this. So there are a number of documents that we produced to help in this discussion. One is a calendar of what we will do during this year when we would have hearings and when we would wind up developing the recommendations. We also produced at least a proposed set of panels for the hearings that would happen on different days. I think it was Justine that indicated that for us to be able to do this, we can't do this all with hearings. We really have to up front use another technique. She had suggested we get written testimony.
So there is a draft letter inviting folks to provide written testimony to those questions, where we would do that up front. From the responses we get to the written testimony to a broad number of folks, much broader than we could possibly have hearings, we would then select some folks that would testify that are kind of mainstream in thinking and some that are divergent, so where we are getting a little bit of diversity in what we hear.
MS. MC CALL: I think it is a great idea.
MR. BLAIR: I think I am going to keep it at that level. One reason is because we are close to lunch. The other is, come to our breakout session this afternoon. We will go into it in greater depth.
Judy, do you have anything to add?
DR. WARREN: No, I think you're fine.
MR. REYNOLDS: Any comments or anything on that? In our last couple of minutes before lunch, one thing I think is important is again to remind the committee that everything we say is public record, everything we say is being put out through the Internet. I would ask that each of us keep an eye out there for things where we may be mentioned as NCVHS, quoted as NCVHS.
We have had a very rich discussion today, I want to use one of Carol's words, familiar. We may be using familiar topics that taken out of context it may appear that we could be judgmental. It may appear that we are making value statements. But in the context of the richness of the discussion, it was a free flowing discussion about the kind of things we need to get done.
So we have had an incident recently where three or four of us were quoted. Not a problem, we understand. We signed up for this. But I think it would be important for all of us to keep an eye on that.
I think the thing that we owe, and I will be happy to take it as the Chair, we would owe any entity that might take that inappropriately, we would owe them the context. I will be doing that on the particular one that is in this situation.
So we have got a lot going on. We are working on a lot of theories. We put up person centered, we went a lot of different places today. It can show up in many different venues for many different things. So just keep an eye out there. If you see anybody's name, if you see NCVHS, let me know so that we can do the appropriate legwork to make sure that any context in which we are painted is given to the appropriate people that it could offend and/or create issues with, in the appropriate context for the appropriate reason.
That is fine. We are a public domain. That is good, no problem at all. We expect that, but we also need to relish in the fact that if our message gets out, that we get it to the right people in the right way. We will take that responsibility to do so. So please alert us if anything comes up.
MS. MILAM: I certainly don't want to comment on that. I just want to go back. One thing that occurred to me after I said I had no comments is that one of the things I am still not clear about is from a Standards Subcommittee perspective, we have laid out some issues that we have had, that Jeff and I have gotten queries from industry and stuff about where the status is and where we are doing with that.
As I participate on the Quality Committee's call, some of the work they are doing that also involves standards and terminology and stuff is really a focused piece that I am not sure we would uncover in the set of hearings that we are proposing. We are looking more globally at where the standards are.
I think that is worthwhile as we start talking about how we interoperate with each other, that we have that tension; are we looking at national trends in our subcommittee or are we looking at it being purposed in a particular way.
MR. REYNOLDS: I think as we look at this subject, we may find as we continue to go around here that people may be touching pieces that they wouldn't normally do. They may be touching it for a specific reason and under a specific subject. Whereas, we have been very distinct in the past; only these people talk about this on their subcommittee and these people do this.
We are talking about a subject now and not a committee. Sometimes it doesn't map quite as easily and nicely as it did before. On the other hand, we have got talented people on each of the committees that ought to be able to handle that in the context of that particular subject that they are having the hearing on. We have got to trust each other and we have got to keep open, and we have got to do what we have got to do.
With that, we break for lunch. See you at one o'clock. Thanks.
(The meeting recessed for lunch.)
Agenda Item: Clinical and Translational Science Awards (CTSA) Briefing
MR. REYNOLDS: Starting this afternoon we are going to hear from Jody Sachs, who is the Scientific Project Officer for NCRR, National Institutes of Health. It is on the clinical and translational science awards.
So Jody, if you would, please.
DR. SACHS: This afternoon I hope to provide you a brief overview of the clinical and translational science award program. That includes the structure and goals of the program.
A great deal of NCRR's resources are involved in re-engineering the clinical research enterprise. It is a trans-NIH program, 27 ICs. NCRR is the National Center for Research Resources. I serve as a project officer within the Division of Clinical Research at NCRR within the NIH. It is an Institute within the NIH.
The CTSA program is the clinical and translational award science program. It was funded in 2006. It started in 2005. I am going to talk a little bit about why it started and what developed, what was the reason for it.
Early on, we realized that in order to get discoveries out, there was a long delay from working at the bench and making those scientific discoveries to the bedside in clinical practice, to getting the results implemented in the communities. So in order to decrease the delays, there was a lot of thought that went into turning everything upside down and making everything cross cutting by harmonization, in terms of finding a better way to navigate through a cumbersome, difficult process in clinical research.
One of the challenges at the time was that the current system for academic advancement favors independent researchers or independent investigators. The independent investigator grants are found in discrete departments and institutions, and they are often limited from collaborative research, even in the same institution.
So we decided was to increase the needs for collaboration, that a better way to bolster the research process was to develop an interdisciplinary team. In order to do so, they developed the idea of the CTSA program.
It was developed to catalyze change, to break silos, to break barriers, to break conventions. It was to advance new intellectual disciplines in clinical and translational science, to integrate resources and translational and to identify and remove impediments to clinical and translational science. The philosophy of the CTSA is a team approach. It is to work on connectivity, partnership, collaboration and break down the institutional barriers.
As I briefly mentioned, the program started in the concept in 2005. It began its funding in 2006. It is a mechanism of coordinative agreements. It is a U-54. It is between the awardee, academic institution and NIH. It is multifaceted in the research program. It is complex in the mechanism, because along with the U-54 there is also a T component which is training, and also a K component. It is a five-year award.
This shows you a brief descriptive of the governance for this cooperative agreement. It is quite vast. If you look at it, there is oversight within NIH. There is also the IC directors. The NIH is over here. Our NCRR Director, Dr. Alving, sits here. The National Advisory Group sits over here. This is a council to advice NCRR. In the center is the Consortium. The Consortium is made up of other awardees to the program. Inside that sits an executive committee. Then there is the Strategic Goals Committee, we will talk about that later, and the Key Function Committee. There is also integration of the Child Health Oversight Committee.
This briefly shows you, in 2006 there were 12 awardees. In 2007 there were 12 awardees, 2008 there were 14 awardees.
This is a group of partners. This shows you on the map the blue dots, so the 2006-7 awardees, and the 2008 are in the red triangles. The map shows you across the United States how the pattern looks for the program itself.
There are a couple of examples I wanted to discuss with you. This one is a CTSA site at Emory University. If you look at it as an example, it demonstrates that the award is actually a group of partners. This shows you the complexity of the partnership. It has collaboration from Children's Hope in Atlanta, Morehouse School of Medicine, Georgia Tech and with that, there are contacts with Kaiser Permanente in Georgia, CDC, Yerkes Primate Research Center as well as the research center at the University of Georgia-Atlanta, VA Medical Center, Georgia Research Alliance and the Georgia Bio.
There is one more example that I wanted to show you, because no two are exactly alike in their collaborations. This one is a UC-Davis CTSA. It has collaborators at the School of Veterinary Medicine, UC-Davis Cancer Center, the Shriners Hospital for Children, the Lawrence Livermore National Laboratory, the VA of Northern California, the California National Primate Center, College of Biological Sciences, the College of Engineering and the College of Agriculture and Environmental Sciences. The goal is to extend the CTSA philosophy of interdisciplinary interactions and connections to formulate more partners in collaboration beyond the actual organization itself.
This is a depiction of the CTSAweb.org website. This is a public website that is accessible to anyone. It shows you the website address, CTSAweg.org. It shows you the members as well as all the committee activity. It shows you what national activities are ongoing, members, meeting schedules, summaries. So anything you need to find out even in the news is on this website.
The CTSA is looking to create regional network opportunities. This depicts another map representation showing you the West Coast over here regional area, the Midwest regional area and the East Coast regional area. Those you can see, they have had some regional meetings, and those are about four or five different CTSA awardees who reach out to each other to see what they can do collaboratively, and work together.
Another program I oversee is through NIH Roadmap 2004 to define how many clinical research networks exist and to do a searchable inventory and a database of those clinical research networks. It is found publicly. It is Clinicalresearchnetworks.org. By that you can search and find out there are 271 clinical research networks out there; about 60 percent are government funded.
I wanted to mention a couple of the points that are on this slide. The Community Engagement Steering Committee is a key function committee. It is one of six key function committees. It is there to help successfully broaden the community outreach at the CTSA sites. It is to work in unison and try and get some agreements across all the awardees to form partners and collaboration.
One of the priorities on their agenda is to leverage partners for funding, as well as a number of other issues that they are trying to do to impact other CTSA programs, foster new research dissemination and implementation in clinical and population-based research.
The reason why I mention this is because you can see leveraging partnerships for funding is high on their priority. The other program I mentioned through the clinical research networks. We have leveraged as an example -- this is just one example to show you -- we have made it possible to leverage the clinical research network program with the CTSA program. There is an RFP that was out about a month ago, and it was due last week for proposals between the CTSA investigators who want to work with the clinical research networks that already exist.
This particular RFP is not setting up new clinical research networks. It is working on existing clinical research networks, but it is forming new collaborations and new partners with what already exists and what is already funded within the networks we have through AHRQ, through CDC, through HRSA. It is to take what we have already created and build new collaborations with the existing networks.
There are three areas of focus. The three areas for this proposal were translational science dissemination research, cost-benefit/cost effectiveness research and community engagement research.
In 2007, the CTSA Steering Committee had a desire to develop a national consortium strategic plan. So in 2008 in October, they met and they came together with a number of implementation strategies which highlighted nine priority areas. As a result of that meeting in October 6-7, 2008, the nine were combined into four areas. These are the goals that are currently set up through the consortium.
I will just read them off. Goal one is enhancing the national clinical and translational research capacity, which would include clinical research management, expand research information and include phenotyping, both human and preclinical models.
Goal two is enhancing training and career development of the CTSA sciences. Three is enhancing consortium-wide collaborations. By doing so, they would include the national resource inventory, create a data sharing network and also include social networking initiatives.
Goal four is to enhance the health of our communities and nations. That would include a national model for community engagement, inform public health policy through research.
I just highlighted a few basic ideas that are out there in the plan and the governance. I am happy to address any questions you might have, because I am sure you have many.
DR. STEINWACHS: In discussions we had at the last meeting, Mark was saying that there were some efforts to begin to think through how in the engagement with communities there might be -- and different CTSAs might use the same basic instruments to gather information. I was trying to get a sense, as you move into the community, of what that means in terms of development of health or health related data and information.
Part of it is leading into that question of whether or not what is learned at the community level could be similar across multiple communities, and therefore in a sense provide information that might have national relevance in a health statistical sense, even though it is maybe directed at particular clinical kinds of interactions.
DR. SACHS: It is a great question and it is a great concept. We right now through the CTSA program concentrate on research, not on health care.
Each CTSA has their own set electronic system, whether it is EHR or another electronic way to capture clinical information, if it relates to research. We don't have a way to -- it is not interoperable right now, and there is no way to connect the systems.
There is no plan to connect the systems currently, but there is opportunity within both the bioinformatics working group and the community engagement working group to work on projects.
If you look at some of the goals that they have here laid out, there are a couple that I want to highlight. In goal three, this means that these are goals for the whole consortium, and they need projects to work on to establish these goals. So the data sharing network and the national resource inventory is something maybe as a potential possibility to tap into, as you might promote a project to this group to work on that area. Also, goal number four, a national model for community engagement.
They are trying to reach out through the communities. I know the community engagement coordinator is trying to look for potential projects to work on and have the CTSAs participate. So they are happy to look at these issues and address the issues. Unfortunately there is not a lot of extra funding that would fund such projects, but it is something to consider.
DR. WARREN: My question is something that probably a lot of people want to know. The understanding is, as new organizations join the CTSA Consortium, they are being held accountable to some of the same strategic goals and membership participation. Yet, starting with this last round of funding, there is about half as much money available.
So as you start fleshing this out, because I know the goal was to fund about 60 research consortiums, how is that being looked at by NIH, having everybody have to participate to a certain level and yet not funding to the level that those that are already there are at? You knew you would get a money question.
DR. SACHS: I didn't expect it in this group, though. I expected it more with the CTSA money group, because every time we meet it is all about money.
We are in a flat budget. The truth is, there isn't enough money to go around for everything you want to do. So in order to fund up to 60 in 2012 and have a total top dollar amount anticipated of $500 million, there had to be some broad reaching outlook on where our spending was currently and where our spending is going to be in 2012.
We did do that look at the spending and the resources. If we continue to spend the way we started out, we would not make 60, and we would reach far beyond $500 million. So we identified cuts and we made those cuts to adjust the budget so we could fund up to 60.
DR. WARREN: I understand the budget cuts. I guess my concern is the expectation of each of these centers to produce the same amount and level of work, with some getting a lot more money than others to do that same work. Or are there going to be lesser expectations of those that are funded at a lower level?
DR. SACHS: I understand the question. It is a good question, but I think when we started out, we had key functions as part of the RFA and we asked the applicants to address these key function areas. As we continued to make budget cuts, we didn't stress -- in the applicants that are applying now, they don't have to address all those key function areas.
So I think we made it flexible enough in the applications that if you were to come in now and you had a plan to only address one or two key areas and you had a reason why, it would be perfectly acceptable. There is no demand to make an application across all five or six key elements.
DR. SUAREZ: I was looking at goal number four and particularly the first bullet, the national model for community engagement. It seems to me we do have actually a national model, at least one that could be seen as such, particularly for minority health research. It is called community based participatory research, CBPR.
I was wondering, are you incorporating the principles and the guidelines and concepts along CBPR into the development of this national model for community engagement in clinical research?
DR. SACHS: I know that the community engagement key function committee just met in October. I know a person who was at the meeting who shared that information. So I think they are going to work together and discuss that, and how they can work on a model.
They want to do metrics, and they want to identify the best approach. I know AHRQ is working with them also. So there are a number of different agencies that are working with NIH on this community based approach. I think in all, they have a very broad view. I think they want to take into consideration the work that has already been accomplished.
DR. MIDDLETON: In some ways this is reminiscent of a lot of the NHIN efforts, where islands of activity can help develop interoperability within regions and whatnot. Certainly the interoperability within these different CTSA sites is an overarching goal.
My question has to do specifically with what are the expectations of individual sites for interoperability within themselves? Some of these sites are very large. I happen to know the Harvard environment a little bit, and I know that sometimes the left hand and the right hand aren't aware of what data standards might be in place. So are there expectations that sites can access or adopt from CTSA planning, if you will? Any recommendations along those lines?
DR. SACHS: One of the key function committees is Bioinformatics. The Bioinformatics Committee is working on trying to define what the sites look like in terms of what kind of systems they have in place at the CTSAs.
All the applicants within the Consortium are asked to work together. The problem with Bioinformatics, that one particular group, has responded to say that if they work together they need more funds to work together, because they can't find a way to create an interoperable system unless they have more money to do so.
So it is a double-edged sword. Everybody needs to work together. Everybody needs to define what systems they have, and everybody needs to map out and figure out how they can work toward an interoperable system.
I am hoping the goal committees that have just been established which deal with data sharing and national resource inventory can come to grips with this term. Your question is how are they going to develop this. I can't answer that right now because this happened just within the last 30 days, and they are meeting today the first time on the first call, which is to discuss how they are going to deal with the issue of trying to work together as a consortium.
DR. MIDDLETON: I understand your response well. Of course the more money problem is a problem.
One of the things that might be considered by this committee is what guidance might we wish to offer the CTSAs in this regard specifically, both about the standard set that might apply to clinical and translational research and perhaps even about the process. Perhaps in this regard we could model the process that is going on in HITSP for the other clinical information systems, HIT; does there need to be an analogous process for clinical research HIT standards. We certainly have a mechanism in place that we could piggyback onto.
DR. HORNBROOK: The more we talk amongst ourselves, the CTSAs, the more we learn that there are a lot of similar experiences going on between the universities and their community collaborators.
Judy's two examples are really good ones. Each one of the CTSAs has their own set of external collaborators. Inside those collaborations is the ability to reach out and assess the health of large important groups in the local populations, whether they be federally qualified health centers, Medicaid folks, Indian tribes, et cetera.
The key issue of course is that as we have rolled these out, the GCRC culture hasn't changed that much, the general clinical research centers which the CTSAs are replacing. So the old funding pathways that went to provide the hospital beds, the outpatient offices, the nutrition services, the blood laboratory services, the genome wide assay services, all these things that were provided at a reduced or free cost for biomedical research, still take up a chunk of CTSA resources, leaving a lot less to go out in the community in translational work.
So to me, it seems like it is an analogy to an electronic medical record system. It is not the software that makes the difference, it is the human culture. When we rolled out our medical record system in Permanente Northwest, half the physicians retired within five years because they didn't want to women's work, if you'll pardon the expression. Of course, the modern day physicians do keyboarding in their sleep. So the generational differences in terms of attitudes toward electronic medical records made a big difference.
Here, if you are a basic scientist you should be talking to clinical scientists and if you are a clinical scientist you will be talking to population scientists. Those silos need to be broken down by the CTSAs, but they aren't strong enough yet to break through the old cultures.
Emory has a wonderful diagram. You saw a wonderful diagram. You should go sit inside those boxes, see how communication is really going on right now. It is kind of sad. Same way inside of our CTSA.
I think that the hope in the CTSA program -- if we threw more money at it, it is not going to change the culture. We have got to change the basic culture of biomedical research in this country and have it merged with health services research.
So what I was hoping, by bringing the CTSA program and this committee together, is that we could provide a symbolic leadership piece, to show the accountability of NIH to the nation's health by linking the CTSA program to our national health statistics, so that somebody would say to the NIH someday, your CTSA program has to show up in our health statistics sometime, somewhere. That is what I was trying to do, is to get this discussion started.
Of course, there is a huge chasm between us and getting there, but somebody has got to make the first step. Thank you.
MR. REYNOLDS: Any other questions?
DR. STEINWACHS: Just to add on, it seemed to me that when you were talking before, Mark, you had given some estimate of the communities or geographic areas. Just in terms of thinking about how you get enough of those that they would give you representativeness.
So that would be one goal to have, is a sense of what that is beginning to look like. Even at the national level, if you had the resources, going back to those dollars and cents, you could do health interview surveys, health examination surveys, a variety of things in those areas at high rates of sampling, as compared to what we do nationally, and to bridge from the top down. But the other part of this is from the investigators up, what would be coming up that would make this a truly unique set of interactive resources.
DR. WARREN: I would just like to follow up both on what Mark and Don had talked about.
As we have done thinking about CTSA in Kansas, I can tell you that one of the things we are beginning to look at is exactly what Mark is describing. If we really want to look at health outcomes and how to measure them, what better way to do it than to start with the research and see what is being measured there, especially as we start going from not only just bench research, but how to actualize that in practice. You are going to have to use some of those measures that were designed in research in order to collect the data for outcomes, so putting that together.
I think this is an opportunity for us to bridge what the researchers are doing and what the clinicians are doing for the betterment of the population. How's that for getting it all in one sentence? That is the goal. That is the goal.
MR. REYNOLDS: Any other questions or comments?
DR. HORNBROOK: Maybe Kansas has a better chance than some of the other places.
DR. WARREN: I don't know.
DR. HORNBROOK: We are hoping that Iowa and Kansas, because they have long histories of community sharing of data and community health planning, that they might be able to pull this off.
DR. WARREN: The advantage that Kansas has is, we don't have very much population, so it is easier to collect. Everybody knows everybody.
MR. REYNOLDS: Any other questions? Jody, I would like to thank you. You obviously stimulated some thinking. I think we need to take some of the things that have been stated as to what we could or couldn't do, three or four of you around the table that would visualize that. So you may want to put something together for us to figure out how to do that based on what Blackford said, and Don, Mark and Judy.
DR. HORNBROOK: I am part of that Northwest consortium that you saw on the map. We are having a meeting next month. One of the things that I want to do is to track those different CTSAs, how well they are able to get to their community partners and start making it real, because that is where we are going to have access to the existing data systems.
Agenda Item: ONC Update on AHIC
MR. REYNOLDS: Thank you. Our next item is Dr. Charles Friedman from ONC, gave us an excellent update last time on the work that they are doing as it relates to ONC and an update on AHIC 1.0.
DR. FRIEDMAN: Hello, everyone. While we are warming my presentation up --
MR. REYNOLDS: You might want to wait. Even though we can hear you, the people on there can't if you are not near a mike.
DR. FRIEDMAN: Thank you, Harry. It is a delight to be here again. I noticed on the agenda, my talk was listed as an update on AHIC I. I took a little license with that to broaden it to an update on ONC activities which include AHIC I. I hope that is all right.
MR. REYNOLDS: Your reputation and what you have done for us so far allows you that latitude.
DR. FRIEDMAN: Thank you very much. Otherwise it would be a somewhat shorter presentation.
The agenda of my update includes first of all circulation of a glossy hard copy of the synopsis to the strategic plan which I described in some detail last time. I have some additional copies that I can leave here. Everyone is welcome to a copy.
I will then say a few words about the final meeting of the AHIC, which occurred on November 12. I will make some comments, all of them in significant ways related to the AHIC, relating first to interoperability in standards, then to a recent report from the State Alliance for E-Health, and finally I will describe in somewhat more detail because it has now actually happened the trial implementation event of the NHIN on September 23. I will preview the next event in the NIH development progression, which is scheduled for December 15 and 16.
First of all, with regard to the final AHIC meeting, I will just go over the agenda and describe some of the things that happened. At the outset of the meeting there was an announcement of the CMS PHR demo.
For those of you who have not heard about this, CMS has contracted with four personal health record vendors. Actually they have not contracted directly with them, they have contracted through their contractor, Meridian, to enable the population of four PHR products with Medicare claims data for traditional Medicare customers in Utah and Arizona. That project is going to be rolling forward very soon. It was announced at the AHIC meeting.
The meeting then went on with two reports on the AHIC Successor. You will be hearing much more about the AHIC Successor when I finish, so I won't dwell on that.
Then there was a panel on adoption, which included closing reports and some recommendations which were accepted by the AHIC relating to electronic health record, chronic care and consumer empowerment.
Work group activities. There were some preliminary results from the first adoption survey related to EHRs and hospitals that is using our standardized methodology. Then there was an update on the secure messaging pilot, which is also rolling forward in two sites.
That was followed by closing reports from the remaining work groups and ad hoc groups that had not reported up to that time, the quality work group, the personalized health care work group and the clinical decision support ad hoc group.
The meeting closed with a really nice recognition by Secretary Leavitt of the dedicated services of the AHIC members.
So that was the final AHIC meeting on November 11.
As circumstance would have it, the first meeting of the AHIC Successor board occurred the next day, and I am sure you will be hearing from Laura more detail about that.
Let me move to an update on the status of the standards and interoperability activities as they are progressing. I think you have seen this slide before, or something very similar to it. This shows the steps in the annual cycles of standards development that begins with setting of priorities by the AHIC, the development of use cases reflecting the interoperability needs for those priorities, the harmonization of standards by HITSP resulting in interoperability specifications that received Secretarial acceptance, and following a one-year testing and implementation period those are recognized by the Secretary, following which they are reflected in use in the NHIN in certified EHRs and other health care information technology systems and through Executive Order 13410 they are required for us in federal systems and systems supported by federal health care contracts.
Where are we in this process? At the moment as I speak, the HITSP is working on developing interoperability specifications for the six use cases that reflect the priorities identified by the AHIC in 2008. The Secretary has accepted 60 standards or interoperability specifications that derived from the four 2007 use cases, and 52 interoperability specifications are currently recognized coming out of the 2006 use cases. This is as we speak.
We expect things to change significantly in January as the calendar clicks over. HITSP will have completed its work with the 2009 use cases, and will be working on several activities and areas during 2009.
They will be working on a newborn screening use case that was prioritized by the AHIC. They will be working on 12 areas of gaps and extensions in previous use cases that were prioritized by the AHIC, in acknowledge of the fact that attention needed to be paid to those aspects of the previous use cases that had not received sufficient attention, and where gaps and the need for extensions have been identified.
HITSP also will be working on quality measures resulting from further work with the quality use case. A new priority area going forward, which could touch in the future in interesting ways, or connect to it at least, work going on in the CTSA program. They are priorities that will lead to some harmonized standards for clinical research as part of this process.
So HITSP will be working in all of these areas beginning in January 2009. Having pushed out the door, and you see this on the slide in the upper right diagram, the interoperability specifications from the 2008 use cases.
We also expect, looking to the bottom right of the slide, that the Secretary will recognize in January the interoperability specifications which were accepted from the 2007 use cases, and convey to those recognized status, so there will be a full set of recognized -- or an expanded set of recognized standards now spanning the 2006 and 2007 use cases.
You may ask why I didn't list a number of those as 112, reflecting the sum of 60 and 52. The answer is that there is some overlap between the 2006 and 2007 sets. After we evaluate the overlap, we will know what the final number is, but 112 is the maximum because there is some overlap.
So that is the expected progress that we hope to see and expect to see in the interoperability agenda.
This slide I am sure you have seen before. We call this the eye chart. I can read it from here, I don't know about you from back there, but it does outline -- and you have the hard copy which I hope you can read -- the use cases and their foci in 2006 where there were three of them, in 2007 where there were four of them, in 2008 where there were six of them in those cycles, and shows the areas where gaps and extensions have been prioritized for 2009, along with the newborn screening use case.
A few words about the State Alliance for E-Health. I don't know if there has been a presentation to this group about this before. I thought it would be -- especially because they have just issued a report, copies of which I could not secure for everybody, but I will show you the URL to find it. That report has just been issued by the State Alliance.
The State Alliance was created in 2006 by the National Governors Association Center for Best Practices. It does address the role of states, and the states obviously have a very important role to play, in facilitating adoption of interoperable health IT.
The members of the State Alliance are state officials, either elected or appointed. The Alliance is co-chaired by two seated governors, the governor of Tennessee and the governor of Vermont.
In addition to a central group, the State Alliance has spawned three task forces that if you think about it align with three of the themes of our strategic plan, one relating to health information protection, one relating to health care practice, which aligns with the adoption team of the strategic plan, and one relating to health information, communication and data exchange, which aligns with the interoperability theme.
The State Alliance has just released this report, which contains a set of recommendations for action at the state level and a set of strategies, some of which I will illustrate in a moment, that lie underneath these recommendations. The six recommendations address leadership and support, privacy and security, the use of standards based interoperable technology, streamlining licensure processes to enable cross-state e-health practice, the empowerment of consumers to manage their own health, and very important, the development of workforce capacity to support all of the above.
At the bottom is shown the URL from which you can download a copy of this report.
To put a little flesh on the bones here and just give you a little sharper sense of some of the strategies that are delineated in this report, I have made rather arbitrary selections of these strategies.
Under leadership and support, a strategy called out is the notion of creating a signal coordination authority within a state for public and private efforts relating to health IT and health information exchange.
Relating to privacy and security is a strategy, one of several, that would promote the consolidation and updating of relevant laws within states.
Under promoting standards based interoperable technology, a strategy is to require public program systems within states to use the recognized standards, the number of which is about to increase as I showed you earlier.
Under licensure processes, there is a strategy to direct state licensure boards to adopt common application procedures for licensure.
Under the engagement of consumers is one strategy among several that Medicaid and state employees health plans implement PHRs for their customers, and under workforce is a strategy relating to the importance of executive leadership for state agencies who are trained in HIT and health information exchange.
These are not the only strategies falling under each representation, but rather ones that I just culled out for purposes of example.
I would like to close this quick run through with a revisitation to the Nationwide Health Information Network and the opportunity to update you on the events which occurred in September or just before that the last time, and describe what would happen. I think you might have heard my voice tremor because of the utter fear inducing prospect of doing a live demo involving 20 separate organizations in the presence of the Secretary of Health and Human Services and the general public. Other than that, there was nothing scary about this at all.
I am happy to say -- Jeff may want to comment, but I am happy to say that with just enough glitches to show that it was real and not rigged, it worked very well. I think if it had gone absolutely perfectly, people would have thought we rigged it and just cross connected all the computers in the room, instead of having the computers in the room just be the controllers of the computers that were really doing the work at each of the locations across the country that were actually exchanging the information.
So we did all that, and I will say a little bit more on that in a moment, in September 23. Just completed and in anticipation of the next big event which is going to occur in December, we completed basic interoperability testing involving the NHIN participants for the seven system priority use cases that will be demonstrated, again live, again before the public -- I feel like a ringmaster of a circus, I just need a hat and an elephant -- but will be demonstrated live and before the public at the NHIN public forum on December 15 and 16. This is a completely public event, and everybody is welcome. We already have about 500 people registered to attend this event.
I want to just give you a flavor for what happened on September 23. First of all, the entire demonstration on the 23rd was around realistic patient care scenarios. In one case, and I will get to it in a minute, the scenario wasn't exactly a patient care scenario, but it was certainly related to important health concerns for the nation.
The first set of demonstrations related to supporting the patient and illustrated emergency care, transfer of care and the wounded warrior. I will say a little bit more about the wounded warrior in a second.
In part two, we illustrated how using the existing core capabilities of the NHIN, patients could turn off and on at their own direction the flow of information about them. That is obviously an important component to have in the NHIN to build and maintain trust in the system.
Finally, in part three we illustrated how the NHIN could be used to dramatically reduce the time it takes for the Social Security Administration to assemble the information it needs about each applicant for disability insurance and evaluate that application in as I said far less time than the eight months on average that it takes now.
Once again, the 21 participants in the NHIN cooperative, all but one of which are listed here, participated on September 23. I will just give you a bit more flavor of this bey describing the wounded warrior scenario that was demonstrated on September 23. This involves six members of the consortium and probably the most variegated group. Two of the participants, the Department of Defense and the Department of Veterans Affairs, are of course governmental agencies. Kaiser Permanente is an integrated delivery system, and CCHIT Med Virginia and Care Squad which operates in Eastern Tennessee are RIOs, regionally based health information exchange organizations.
This was all demonstrated around a fictional but realistic wounded warrior named William Ozzie, who was injured while in deployment in Iraq. The importance and the case that is made for nationwide health information exchange through this scenario is really seen in this slide, which points out that of all of the care that is provided to veterans in this nation, 40 percent of it is provided outside the VA, making flow of information about these people between the VA and all of these other care providing entities, wherever they happen to be, very important.
Similarly, for service members, of all the care that is delivered, 60 percent of it is delivered outside the military health system, again making the flow of health information about these people very, very important as it needs to move between military health system sites and these other sites, wherever they happen to be.
This busy slide shows you the basic scenario, beginning with the injury to William Ozzie in Iraq. He is transferred to Bethesda, Maryland, from there to Richmond, Virginia, to Kingsport, Tennessee, to Pinehurst, North Carolina, and then to a veterans VA medical center in Richmond. Most people familiar with these kinds of scenarios considered this one completely realistic and typical of what health information exchange needs to support.
The information exchange that was demonstrated was that of a summary record, where the ultimate destination in this scenario, the VA Medical Center in Virginia, was able to in real time access the records about the care of William Ozzie as that care occurred in Defense Department environments in Virginia, in Tennessee and in North Carolina. The exchange of this information and its assembly at the VA facility and the VA system was illustrated.
To bring this presentation to a close, I would reiterate that we have demonstrated these core capabilities of the NHIN in September. We have now tested the capability of demonstrating information exchange relating to the 2006 and 2007 AHIC use cases, including quality, bio surveillance, laboratory information exchange and other areas, in preparation for the live demonstration on December 15 and 16 at the NHIN forum, which will be at the Grand Hyatt in Washington. If you go to that URL, you will be at a site where you can register for this event.
That concludes my remarks. Thank you very much.
DR. SUAREZ: Hi, Charles. Thank you very much for the update, and congratulations for all the work that has been done this year and in the last few years. The office this year has been one of the most productive of all in many respects, with all the things that have occurred, from NHIN to HITSP to CCHIT.
But I think change is coming, as they say, in many respects, nationally and in many other ways. There is a lot of talk that has already started about what kind of change might be coming to the approach that is being used by the ONC for the work that is being done.
I just wanted to give you one thought. There have been discussions all over from, let's stay the course, to let's revamp everything and eliminate everything that has been created and start over. There has been a letter recently published by a person out there that calls for something like that, and everything in between.
But I think one specific item I wanted to offer, I think it is time to consider some of the potential ways in which we can improve the process into the future, is this process of use case development and use case driven harmonization.
I think we have experienced already over 14 or so use cases and several other gaps and extensions that are coming up. I think it has been an interesting process for those of us and many people that have been involved in the development of taking the use cases and developing the work that is needed to come up with some harmonized standards, and then seeing it be attempted to be applied in the real world through NHIN and other efforts.
The thing that is challenging and has been challenging from the beginning of the use case approach has been the fact that each of these use cases is very focused. Certainly there was the need to start with some concrete areas and try to address those.
But I think it is time to consider an alternative approach, what I am going to call a domain driven approach. I know AHIC 2.0 is talking about value cases instead of use cases now. A domain driven approach in which we are focusing the attention on specific domains, for example, the laboratory domain with several types of messages, not just one message, or the pharmacy related or medication related domain that deals with several types of messages, not just one, or the radiology and lab, X-ray or many other types of domains, the public health one, will help us begin to assemble the right teams around those domains and try to avoid the spread of the thin expertise in some areas to try to capture information about the multiplicity of use cases we are dealing with, from electronic health records to lab to medication management to public health use cases to bio to quality, the same type of expertise cutting across all those.
So my thought is perhaps it is time to consider looking at the possibility of shifting to a domain driven approach rather than a use case or a value case approach. I don't know if that is something that is already in the mind of the Office of the National Coordinator or has been discussed in any other venues that perhaps could help us take this into the next level.
I think it will help us also re-energize the initiatives that are happening behind the scenes through the use case approach into this new domain based approach.
DR. FRIEDMAN: Thank you for those comments. I have a lot of reactions.
First of all, we are always open to new and good ideas. So if you would like to at some future date share your thinking in greater detail and have more interaction about it than is possible in this time frame, we will welcome that.
Second, there are obviously a lot of ways the use cases, that whole process as it unfolded beginning in 2006, could have been done. I want to acknowledge at the same time that a lot of progress has been made. Yet any process can be improved. But what we have, we have, and the question before us is how to make best use of our resources going forward.
A third point in response is to recognize that -- and I am sure Laura will talk about the value case approach when she gives her presentation -- the winds of change are blowing here, and this process in a graduated way is going to move from the A 1.0 to the A 2.0. That provides an opportunity to think about how to improve it.
So I think in that spirit, it will be very helpful to probably defer this issue until Laura has a chance in the next time slot to talk about the value case process, and see where you think the change needs to be, aligned with the changes that are already being foreseen by the AHIC Successor and their movement to the value case strategy.
MR. BLAIR: It is not very often that my comments deal with emotion. Chuck was mentioning the atmosphere on September 23 when the 19 different HIE networks around the country demonstrated that they could share information using interoperable standards and using live patient scenarios.
There were about 400 folks in the room, and there was one article that was written about it that I thought was able to capture the emotion, the feeling in that room. The article wound up saying that the attendees were from all of these networks and health care organizations. They were health care professionals, they were information technology executives, they were clinicians, and there were some politicians.
In that room, these people were too professional to do high fives. These people were too professional to wind up getting giddy, but it was close. So that was the atmosphere on September 23 within Health and Human Services.
So I want to offer my congratulations to Chuck, to Rob Kolodner and to ONC. It was a glorious day, and the Secretary of Health and Human Services ended it by saying that we will all look back on that as a historic day.
DR. FRIEDMAN: I did see a few high fives, Jeff.
MR. REYNOLDS: There was not a question in there, was there?
MR. BLAIR: No. I snuck it in.
MR. HOUSTON: Harry, there is an old saying that 90 percent of questions are really statements.
DR. FRANCIS: This is a question, a genuine one. In the trial implementation demonstration, what happened with respect to opt-in and opt-out of information exchange? What did that mean? Did it mean for example that our young warrior was asked whether he wanted his records transferred or not, or did it involve our young warrior saying he didn't want his psychiatric or drug treatment history records transferred? What did it mean?
DR. FRIEDMAN: Great question, thank you. Just to be clear, we did not demonstrate the opt-in/opt-out as part of the wounded warrior scenario. That was a separate scenario that was part two of the demonstration.
What we demonstrated, if I can remember, and those of you in the room who were there can correct me, was a scenario whereby an individual to whom the implications of allowing his information to flow out over the NHIN initially declined. So we demonstrated that -- and I forget which participating health information exchange actually executed it --
MS. MILAM: West Virginia.
DR. FRIEDMAN: West Virginia, thank you, we actually showed how in the West Virginia system a parameter could be set that turned the flow of that patient's information off. It was an all or nothing, totally opt-in or total opt-out. I think that is probably what you were asking.
DR. FRANCIS: That is exactly what I am asking.
DR. FRIEDMAN: That doesn't mean that that is as granular as it is going to get. Options for more granular opt in and opt out and finding the right level of granularity for this is going to be a challenge for us all, is being pursued.
Then the scenario continued. There was something that happened that caused this person to want to change his mind. I think he moved?
MS. MILAM: He moved to Delaware.
DR. FRIEDMAN: He moved to Delaware, and take it away.
MS. MILAM: This individual moved to Delaware and at that point decided that he wanted to participate in the Nationwide Health Information Network. Earlier he had decided not to. So we went to his physician's office in Delaware, and after talking with the folks there decided to participate and they retrieved the data, and that was the end of the story.
But this was a real high level demonstration, showing about what opt-in looks like, what opt-out looks like. There were two demonstrations. I think in December we will be dealing with a lot more of very specific granular issues in privacy, in terms of probably getting into -- well, i know at least in West Virginia, I don't know how much we are going to demonstrate, but you do have areas of especially protected information that requires separate patient authorization, and we stayed out of that for the first demonstration.
DR. W. SCANLON: Thanks very much. My question goes to the chart of the NHIN. I understand this is for the demonstration that you had. I would ask, where are we in terms of being able to put CMS on that chart because I can think of some uses where it might turn out to be very helpful.
DR. FRIEDMAN: A great question. One comment I would make to begin is that through the federal health architecture program we are developing a software solution called NHIN Connect, which will be a gateway to the NHIN, built initially or use by all federal agencies.
The Connect has two components, one that is the universal coupling for the NHIN, and then a separate component which customizes that application to the needs of the particular agency that is connecting.
So while CMS is not shown here as one of the federal agencies participating in this year's events, there are discussions underway with CMS about implementation of the Connect for specific applications. If all goes well, if Connect works as we think it is going to work and we believe it is going to work, because we think it is going to work, they will have the same level of challenge, which is surmountable and doable, implementing the Connect for their purposes that the other agencies have faced implementing for theirs.
So CMS is in the queue for specific things they are doing, and we believe we have the skids greased through the Connect solution to make this possible.
MR. REYNOLDS: Mike and then Sally, and then I would like to move on to Laura Miller. Chuck, are you going to be able to stay with us?
DR. FRIEDMAN: Yes, I am planning to stay through Laura's presentation.
DR. FITZMAURICE: I want to join in with Jeff and all the rest of us around here that think highly the way ONC has moved us forward in the past four years or more. We have achieved more in health care data standards than we have achieved probably in ten years as a result of this concentrated effort.
So I have a suggestion and then maybe a really quick question.
The suggestion is that HITSP selects the standards and the data elements that fulfill the functions of the use case. i agree with Walter that eventually, big business is going to force us to move toward domains, that they won't find the use cases fitting them exactly.
But the use cases we have, the interoperability specifications that come out of HITSP tend to be cumbersome sometimes and stack up to six inches of paper. Even if you have them in Word documents and Excel spreadsheets, it is hard to navigate across them.
What I would suggest is, for the HITSP output for each interoperability specification, could we have a table that shows the standards chosen, a second table that shows all the data elements chosen, maybe for very large classes of databases like laboratories, where it all comes from LOINC? Then all the other paperwork, thirdly, that were documents in Excel spreadsheets could be stacked up. But just getting those first two tables would let us explain to Congressional staff, to our friends, here is what we have been working on in HITSP to produce.
This would relieve a large burden of implementation, because each implementer has to go through what each HITSP expert does to get down to the data elements if we don't have that table.
My question. The process is, the use case goes from AHIC to ONC to HITSP back to AHIC to ONC to the Secretary, where it gets adopted and recognized. AHIC no longer meets. So are we going to be sending the current interoperability specifications from HITSP directly to ONC for the Secretary to adopt and bypass what would have been AHIC? This is all right with me.
DR. FRIEDMAN: Say again how you describe the process about it going back to AHIC again?
DR. FITZMAURICE: Before we had sent it back to AHIC, I believe, and AHIC would recommend that the Secretary adopt them, and then the Secretary would adopt them. So we may have to bypass that step in November-December. I just wondered if I am accurate on that or not.
I don't see that it has a strong implication, since ONC goes over those interoperability specifications anyway.
DR. FRIEDMAN: No, I don't think it does have a strong implication. I think an important implication in what you are talking about, Mike, and then I think Laura is going to address, is the graduated process for the assumption by the AHIC Successor over time of some significant elements of this, with the government remaining in a very important role.
We fully anticipate that at the end of the process that up to the lower right corner of the screen will work somewhat differently, will be the common element which will persist, that is, the recognition of the standards by the Secretary, which will enable the same things to happen as a consequence of that process going forward. Maybe that list of boxes on the bottom left of the slide, which are consequences of standards recognition will enlarge over time as well.
DR. FITZMAURICE: And I suppose it is possible that a new process or new Secretary might want to have a federal advisory committee make a recommendation to him or her about these standards. Just a speculation.
MS. MILAM: Going back to your logic model, I think it is slide 12, the Nationwide Health Information Network diagram.
DR. FRIEDMAN: Thank you for calling that a logic model.
MS. MILAM: It is exciting to hear that hopefully we will see Medicare as one of the nodes on the network, particularly from a sustainability standpoint as we are doing business planning at the exchange level. We are pleased to hear that Medicare also realizes the benefits that will be accruing to new participation.
Looking at your RX node for pharmacies, I am wondering, are you all exploring or have you considered exploring a connection to SureScripts on behalf of everybody participating to aggregate demand or to facilitate e-prescribing?
DR. FRIEDMAN: I don't have a detailed answer to that, Sally. I know the idea is obviously an appealing idea. We have had internal discussions about it. I am honestly not sure at this moment to what extent there have been formal discussions that would have extended outside the government about that.
MR. REYNOLDS: Sally, did you mean all of SureScripts, which includes Rx sub two, or just SureScripts?
MS. MILAM: All of SureScripts.
DR. DEERING: Very quickly, I think this would be of interest to people who have been on NCVHS who have knowledge of its history as well as looking forward about NHIN.
For those who recall the debates that went on for some time about bringing the research dimension into the NHII as we used to call it, I think what is exciting in December is that this is the beginning of bringing research into the NHIN.
Because this is so new, it is not even showing up on ONC slides, but the National Cancer Institute is bringing a big network into the NHIN. We will demonstrate linking research and care in December. So I think that is the beginning of moving in the direction that NCVHS was looking at a long time ago.
DR. FRIEDMAN: Thank you, Mary Jo. I had neglected to mention that. Very important.
MR. REYNOLDS: Marc Overhage, I understand you are on the phone and have a question. Could you introduce yourself and then ask the question?
DR. OVERHAGE: The question we were talking just a moment ago, about CMS participation in the NHIN, which will be a wonderful thing. I am curious if the folks from ONC could comment on where discussions are about CMS' belief that they are able to share that information? As recently as a week ago the Data Use Board from CMS suggested that they didn't see an authority under which they could make data available, for example, for patient care. I am sure that there have been ongoing discussions about that would be interesting to get updated on.
DR. FRIEDMAN: Thanks, Marc, for that question. I wish I had a detailed update to give you. I responded to the question about CMS more from a technical than a policy perspective, and used the question as an opportunity to extol the virtues of the Connect solution, and also to signal that we were talking with CMS about their implementation of Connect, which creates a potential for exchange. That is a very different discussion than the discussion related to policies and procedures that would enable the information to flow.
I understand the problems and the issues. I don't think we are at a point where I can say anything specific about that, more than what we have already said.
DR. FITZMAURICE: Chuck, you are so darn honest.
Agenda Item: AHIC2 Successor Organization - Update
MR. REYNOLDS: Let's move on to Laura Miller, who is going to give us an update on the AHIC2 successor organization. Laura, we truly appreciate your coming today.
MS. MILLER: Good afternoon. It is a pleasure to be here, especially with an organization that if I understand it has a 60-year history, which in Washington for an advisory committee is a record.
My name again is Laura Miller. I am the interim Executive Director. My background is not health information, but health care operations for 28 years in the VA, where I ran hospitals and ended my career as Deputy Under Secretary of Health for VA. So I have seen health information in action, and know what in the VA it contributed to the quality of operations. So I was very excited when the opportunity arose for me to assist the AHIC Successor in its implementation and in its startup. I would say that by the way, AHIC Successor will not be the permanent name of the organization.
I really don't need to talk about the American Health Information Community, our predecessor obviously. Just one comment I would make. The importance of this group to Secretary Leavitt I think is displayed by the fact that it was the only FACA for which he himself served as chair of the 200 and some-odd federal advisory committees in HHS. Obviously there were a number of organizations that were spun off.
There was the creativity of the American Health Information Community to identify ways forward organizationally and to serve as the facilitator for those new organizations. So AHIC Successor is one of a series of, I guess I would call them spinoffs from the American Health Information Community.
You just heard Chuck Friedman talk about some of the accomplishments this last year and over time. I don't think I could in any way add to that. ONC has done an incredible job of taking a variety of issues and weaving them into an infrastructure and a series of activities that have resulted in real movement forward in many ways for the first time.
But I would note at the very end of this list that it was always the intent that the AHIC would sunset, and that there would be a follow-on organization that would be a public-private partnership. So that was the intent of activities that started in 2007, and were designed for the AHIC Successor to become the focal point for harmonization activities to build on AHIC itself, and also to engage a broad range of health IT stakeholders to become sustainable for itself over time by collaborating with other organizations and individuals in all sectors of the health community, with a goal to continue to facilitate health IT adoption, with the bottom line goal though of improving and maintaining the health and well-being of individuals and communities.
So in late 2007 and early 2008, there were some very specific goals that were developed for AHIC Successor. These are in our cooperative agreement, these four goals, to accelerate the adoption of an interoperable health IT by insuring availability of harmonized standards; to prioritize requirements for health IT interoperability with stakeholders; to advance policies and technical approaches to promote the vision and purpose of the organization, and finally, to oversee and facilitate the Nationwide Health Information Network.
During 2008 there was a grant provided to LMI, who collaborated with Brookings to facilitate the planning of this organization. A variety of stakeholders were engaged. There were several planning groups that were developed to identify the governance, the membership, the sustainability and the transition from ONC's AHIC to AHIC Successor.
I am just going to flip through these slides fairly quickly. It gives you an idea of the level and quality of individuals who were involved across the health care industry in this planning process. Each planning group was co-chaired, in this case John Tooker and Laurie Evans co-chaired the governance planning group. For the membership planning group, Jon Perlin from HCA and Janet Marchibroda from E-Health Initiative co-chaired. For the sustainability planning group, John Glasser from PartnersHealth and Rachel Block from the New York E-Health Collaborative co-chaired. You can see a variety of people from across health care.
The transition planning group was co-chaired by Lillee Smith Gelinas from VHA and Peter Elkin from Mayo Clinic.
These groups had multiple meetings, devoted their time to come up with a series of recommendations. Those recommendations were vetted in a series of public meetings and calls, and were accepted by ONC.
In the governance process, the recommendations resulted in the composition of a board of directors that is 15 directors that are a blend of at large members, and there are two specific seats for consumer representatives. This board is not meant to be representative of any specific sector in health care other than the consumer sector.
In addition, it was designed to have strong federal participation. There are three federal liaisons, and they are called liaisons because a federal employee may not carry the fiduciary responsibility of a board along with their federal responsibilities. However, other than having fiduciary responsibility they are fully involved with the board.
Those two liaisons and one ad hoc liaisons are Secretary Leavitt himself, who attended our first board meeting on the 13th, and Secretary Peake, who has delegated that responsibility to Linda Fischetti, their chief health information officer in VHA. In addition, Dr. Kolodner is an ex officio member.
So as you can see, the powers of the board include fiduciary responsibilities as trustees of the organization, defining, monitoring and re-evaluating strategies for the organization, selecting, overseeing and evaluating a president.
Here, let me pause and say we are in the process of recruiting a president/CEO. We are still very actively engaged in that process. So if there is interest of anyone that you know, please encourage them to get their name forward to me or to a member of our board.
As you can see, as you would expect, reviewing and approving operational matters and overseeing the execution of the organization's strategic plan.
This is a visual of the board of directors for year one. In addition to the 15 members that I named and the three liaisons, the three incorporators who are John Glasser, John Perlin and John Tooker, who served as co-chairs of three of the four planning groups, were the incorporators for the organization and are serving for one year to insure appropriate transition as we go forward. The balance of the board members will serve in one year, two year and three year terms in order to insure appropriate transition.
Just to share with you quickly those involved, the board members is a very impressive group of individuals, and they are displayed for you here. Paul Tang, one of your members, is of course a member of our board. When we get to the discussion portion of the meeting, I'm sure Paul will have equally as much to say as I.
DR. FRANCIS: Could you just tell us who are the consumer representatives?
MS. MILLER: Yes, I'm happy to do that. Michael Lardiere at the top right, who is with the Association of Community Health Centers, and Steve Findlay, who is with Consumers Union.
DR. SUAREZ: Can I just interrupt with one quick question, too? There are three open seats right now on the board? If you go back to the picture, 14, 15, 16 and 17, are they --
MS. MILLER: All of those seats are filled. What open means is that they are at large, basically. I appreciate that comment. We probably should change the nomenclature there.
In addition, the board was structured to have four board level committees, nominating, finance and membership and communications, and an executive committee. Those are obviously your more business oriented committees, but we are in the process of finalizing a structure for the mission related and ad hoc committees which would deal more directly with the goals of the organization.
When the planning groups developed the framework for AHIC Successor, they identified that the board should include representation some sense of a broad range of consumers and stakeholders. Even though it is not a representational board per se, we wanted a balanced board, so we looked at all of these member segments.
I include this because these are also the segments that we will look to as we begin a membership campaign starting sometime in January. We want to be sure and include all of the stakeholder segments in our membership.
What will members be able to do? Members are going to be very involved in setting priorities and identifying and quantifying opportunities for standards adoption, and we will talk more about that when I talk about the value case process; participating in the development and governance of the NHIN. Obviously we need the expertise for developing policies relating to interoperable standards based electronic health care systems. We need help in understanding how to accelerate the implementation not only of using standards but of EHR in general.
In using and supporting their technical expertise and participating in value case development.
You may wonder how we are being funded. We are concerned with that issue ourselves. Right now we are fortunate to have a grant from the federal government for the balance of 2008 and into 2009, and hopefully perhaps to 2010 or portion thereof. However, beyond that the membership dues structure and the other opportunities for funding, including value case funding, are expected to sustain the organization. So the federal government other than its participation through membership or value cases will not be providing direct support.
One of the four groups that developed planning for AHIC Successor identified the need to look at what still remained from the American Health Information Community that should be identified as opportunities for consideration for AHIC Successor. So the transition work group looked at some very high level priorities of work that was still in process and/or had been identified as needing to be done. ONC has taken that output from the transition work group and synthesized it into priorities that could find one of several homes, some of which might be appropriate for AHIC Successor, some of which may belong more appropriately to the federal government in terms of some policies having to do with security, privacy and confidentiality, some that may belong to a federal advisory committee or to other organizations.
At our meeting on November 13, we received from Dr. Kolodner the output of that process, which provided us a short list quote-unquote, of 17 key opportunities that will need to be considered by AHIC Successor in its work as we move forward, and a longer list of some 50 initiatives that ONC had identified.
When Chuck Friedman was talking about the standards harmonization process, he referred to the ONC use case process and identified that the contract with HITSP will run for currently identified use cases through 2009. During 2009, AHIC Successor needs to begin to ramp up the value case process to be prepared to provide value cases to HITSP for 2010.
What is a value case? I would say first of all that the AHIC has been very successful in identifying important use cases, many of which have been driven in some ways by top down. This process is meant to be a more bottom up process.
It is envisioned that it will be a process whereby consortia of health care industry or government stakeholders identify a need and submit a value case to the AHIC Successor that describes an opportunity for information exchange that they see as a necessary next step in their domain, if I could borrow that term.
It will illustrate a specific scenario for interoperability similar to a use case, but also it will demonstrate a case for action based on the technical business and societal value not only to the organization, but to the users.
So it presents the costs, the value and the risks for implementing a specific scenario and describes potential measures of actual impact on improving care. Once it is recognized, it would commit the submitting organization to fund and execute the actions necessary to implement the case. That is another key difference.
In order to start this process, AHIC Successor needs to set an annual strategic direction by developing a framework. I will show you a sample of what it might look like. Then once that strategic direction has been identified, the stakeholder community will -- there will be a call to stakeholders, and the stakeholder community will submit value cases for consideration as national priorities. There will be a process whereby a committee will use criteria to conduct due diligence on each value case and recommend certain of those to go forward.
Recognized value cases will then initiate the action that will end in interoperability specifications. Over this process there will be a committee that will manage the initiative to insure timely completion.
The purpose of using a value case is to underscore the fact that AHIC Successor exists for individual and consumer benefit. We need to establish and maintain trust with our stakeholders, but we recognize that some entities may not have the capability to either develop a value case themselves, they may not have the expertise, or they may not have the financial resources to fund the process. So there is also going to need to be a mechanism to support value cases for underserved populations or for certain population health initiatives. It may include a scholarship fund if you will derived by application fees for all proposals or some other initiatives that AHIC Successor undertakes.
Value cases will be evaluated. It is important that there be due diligence. There will be subcommittees specific to a domain to assure appropriateness and due diligence over the value case. Those will be populated with experts in appropriate business and health informatics.
So there will need to be published criteria to determine value factors such as the value of the case relative to how it supports expansion of the interoperability roadmap, which you will see in the next slide, the value of the case relative to key stakeholders segments, the level of risk, the impact on industry and the likelihood of adoption, which are important. We don't need to be doing all this work and using the resources of scarce groups of individuals if we are not going to see an outcome. Then the financial viability of the funding entity.
This is a sample of what an interoperability implementation framework looks like. This is just for understanding the approach. The actual interoperability implementation framework has yet to be finally developed. In our next board meeting of AHIC Successor on December 9, we are hoping to get a final review and signoff of this approach, and then we will be seeking contract resources to help us develop the framework.
What might a value case look like? These are two examples. One example would be the clinical research arena. NIH and key members of the pharmaceutical industry or academic medical centers and/or clinical research organizations could present and fund a value case for interoperability scenarios linking clinical trials to electronic health records.
In fact, there is an initiative underway by a group now to try and address this and move forward. They had their first work group meeting at the recent AMIA meeting last week.
Another example might occur in radiology, where a group of individuals could form a work group and agree on their needs and move forward in a particular way to address how to move images across the systems.
It is our expectation that the value case approach will facilitate adoption because there is broader stakeholder input, a collaborative process with stakeholders, and a funding and impact that will accelerate and support the process.
This is just a brief overview of how the process might work in terms of the steps that are involved. I am not going to dwell on it because I think our time is running short and I want to leave time for discussion.
Let me mention that this and a full document regarding the value case process is currently on our website, and we are looking for comments and more feedback until November 24. So our website is www.ahicsuccessor.org. Again, we invite your review and your comments.
As I have said, we have had our first board meeting. Over the next three months we have a lot of work to do. We have had a preliminary review of bylaws with the board, still a couple of issues to finalize, and we hope at the next board meeting to accept bylaws and to move forward with the next segments of our strategic plan.
We want to complete our board and management setup activities. We have started populating some committees; we need to move that process forward. We would like to finalize the value case approach, get the framework developed into an initial call for value cases early in the calendar year. And we need to take into consideration the list of 17 opportunities identified by ONC and determine how to move forward in each of those instances.
Finally, we need to launch a membership program because we need all hands on board to continue the momentum that has been developed by ONC and the American Health Information Community, and that we do not want to lose during what Secretary Leavitt called the fragile period.
Again, there is our website. We are hoping for much involvement from a broad range of stakeholders. Our December 9 meeting, if you will watch our website, our December 9 board meeting will be open, and we hope to see participation both on the phone and in person at our meeting.
So I am very pleased to have had the opportunity to present the information, and be happy to take any questions if you have time.
MR. REYNOLDS: Yes, we do, thank you. I am going to ask the first couple, because I haven't asked any up until now.
I am still struggling with the relationship between ONC and the AHIC Successor. ONC right now puts out RFPs and recommends work and people win the bids, and then something happens. So now you have got AHIC Successor. Will AHIC Successor -- then I saw that ONC puts input into the AHIC Successor.
So will ONC still be doing use cases, doing other things like that, using the federal funds that you have, and at the same time we might be getting different or possibly even related value cases from the AHIC Successor? I can't quite figure out how it all cascades. Who has got the ball, is what I guess I am struggling with.
MS. MILLER: The ONC and AHIC developed a set of use cases that they approve for 2009. They did that in 2008, and those have been delivered to HITSP.
MR. REYNOLDS: Yes, because they were tightly coupled then. ONC and AHIC were tightly coupled. So now the coupling is changing.
MS. MILLER: Yes, it is. ONC has only funded HITSP and CCHIT for that process through 2009. From that point forward, from 2010 forward, ONC as I understand it, and Chuck can jump in afterward, will not be developing use cases. AHIC Successor will be developing the value case process, which would then be conveyed for -- we will be doing that during 2009 for HITSP then to carry forward into harmonization activities in 2010. So there is a handoff.
Chuck, I don't know if you want to add anything.
DR. FRIEDMAN: Sure, thanks, Laura. When I presented our strategic plan the last time I was here, I tried to stress the importance of building one infrastructure that serves many purposes. So I think it is very important to emphasize what we are putting in place here is a different but still singular way of moving this agenda forward.
There will be a gradual transition. As things move to the AHIC Successor, that part of it which moves, the government will remain a participant in this process. That is seen in the government liaison roles on the board and also in the possibility which has been a part of discussions that the government itself might sponsor value cases that meet needs perceived by government agencies to move the health IT agenda forward for the nation.
So the spirit here is very much a single complementary process which some of the activities that had been undertaken inside the government moving to the AHIC Successor, with the government very much an active and complementary participant in this process.
MR. REYNOLDS: So under AHIC, pretty much ONC was the player. Now under AHIC Successor it is one of the players.
MS. MILLER: That would be correct.
MR. REYNOLDS: My next comment. As you look at all the different things that are going to happen, the one thing that I know for example we are struggling with in our state -- I am in North Carolina -- but as we move from ONC to AHIC Successor and so on and we talk about value cases, I never see anything up there about what do the organizations look like that are going to be sustainable in the states for HIEs and everything else.
I know for example Lovelace Clinic is driving it in New Mexico, and Marc Overage is driving it in Indiana. In North Carolina NCHIA is not an organization that has any worth and has done most of it through vendors and others.
So as we are more and more asked as players to play, trying to understand what a good organization looks like that you would want the private sector and/or the government to line up to and for the players in the state to sign up for, I think is going to be a key driver to the success it is. You have seen one HIE, you have seen one.
So any help that ONC and AHIC too can do along those lines to help define that a little better, so that you could grab onto what does a good organization look like, or you could help drive by the private sector, that would be great. That would be a great thing to have, but I never seen it on the charts. When we talk about interoperability I never see what does the organization look like that might make it work.
MS. MILLER: I don't believe that I have the answer for the business models for all HIEs to share. But I do want to say that I think that the governance structure for the NHIN, as we work with the ideas surrounding that, will be an important piece that has to feed into those HIEs and RIOS, and is perhaps an opportunity for them to think about different ways of structuring themselves.
I think there has much been written about the business case. Again, I am not sure I have the answer at this point.
DR. FRIEDMAN: If I could just add one comment. ONC will continue to be active in this space, of course. We will continue to undertake activities that address needs that we see as existing and important to address.
So to that point, and it is a little too early to report to this group on this effort, but since you brought up that specific example, Harry, we are embarking on a HIE economic sustainability project, because there is such a need out there. I hope in future meetings of this group, that someone will be able to report on that to you.
MR. REYNOLDS: That would be very helpful.
MR. HOUSTON: It seems like with this idea of these different value cases that -- is there any structure around how you decide not necessarily how you pick them, but how you make sure what you end up with is a lot of value cases, and you still have gaps in terms of coverage of the different value cases.
You can have a bunch of value cases in one particular area and have nothing in another. How do you make sure that you have adequate coverage, and is there a way that you are going to plan to do that?
MS. MILLER: Yes. Looking at the framework once it is developed, I think not only do we have a responsibility to put out a call, but we have a responsibility to look at just exactly what you are saying, and to see if we need to try to convene groups who might have a natural interest in those gap areas to see if we can facilitate the interest and support for moving forward a particular value case.
MR. HOUSTON: It also seems like -- I know from the first AHIC, a lot of the use cases and things that were put together, there wasn't a lot of precision as to how we decided to do things. I was on one of the work groups; I hate to say this, but it was almost more like feeling what you decided what you were going to focus on. I think we need to make sure we get more coverage, better scientific approach towards making sure we don't have gaps.
MS. MILLER: I believe that is why this framework is a very important piece, and that it is divided up into different domains or areas. We need to take adequate time and thought into putting together the framework to understand exactly where the primary needs are.
DR. SUAREZ: I have two quick questions. One is going back to my comment earlier to Charles about the domain approach, whether that is the value case approach.
I think one of the challenges that we had with AHIC in 1.0 was the competing relationship or competing condition of various use cases to try to reach to the top so that they would then be presented to HITSP for harmonization. Some of us in the public health sector were hoping that public health will have its groups cheering for them to try to reach that level. But some of us also working in the privacy and security standardization were hoping that we would get a use cases back then, now it will probably be a value case, on privacy and security specifically, to try to address the issues of harmonization of technical standards for privacy and security.
But I am concerned that we will -- and I totally understand the business model that AHIC 2.0 was trying to reach, which is the only way to fund a nonprofit public-private partnership is to bring whoever needs a use case to put money and time into it.
It seems to me that by creating domains you would avoid competing interests in terms of having one use case or value case be brought in front of AHIC 2.0 board and have four others, and then AHIC having to make a priority determination to which ones get to move forward into the next stage.
Rather, if you have domains, the domains themselves are all going to be participating, and that domain process gets perpetuated into HITSP, then there is a flow of cases within domains that go down without having to compete with each other.
So I would still encourage you to see that that kind of approach would avoid competition between use cases and then have a problem of prioritization.
MS. MILLER: Hopefully the competition is not really a competition, but just an education against criteria and not an evaluation of one against another, as long as they meet the needs that have been identified as gaps within the framework.
I think one other point. I believe that some of the prioritization of one use case against another was as the result of the bandwidth that HITSP had and still has. I think one of our issues is to obtain the resources in terms of the people who bring forth a value case to expand that bandwidth.
But again, I would appreciate any input into the comments segment of the website on the value case.
DR. SUAREZ: A second very quick --
MR. REYNOLDS: No, there can't be very quick ones. Judy.
DR. WARREN: My question has to do with the goals that you mentioned with the AHIC Successor. The very last one was, oversee and facilitate and NHIN.
That one confuses me, because ONC funds those projects and has provided oversight. So is the oversight switching to AHIC Successor? Or are you sharing oversight, or what?
MS. MILLER: Yes, it is going to switch. In reality there needs to be -- and this has been found in the discussion among the groups who have been developing their data use agreements, that there needs to be a governance structure for the NHIN as it moves forward, to approve applications, to join in the NHIN to assure that people are meeting the requirements, et cetera, and over time that doesn't become a responsibility of the federal government.
DR. WARREN: Is there a time line for that transitioning?
DR. FRIEDMAN: Yes, but not a precise one. The plan, and I didn't mention this in my talk, is for the NHIN to go into limited production sometime in the next calendar year.
It is not the plan that governance of the NHIN will have passed to the AHIC Successor when we go into limited production, but as the NHIN matures, the plan is to move, for all the reasons Laura just described, the governance of the NHIN under the A2.
DR. FRANCIS: Clearly one of the central issues in all of this is the shift from purely public to public-private. With that in mind, I am interested in your slide about, AHIC coordinates and is informed by several related initiatives.
Judy mentioned the NHIN projects, but CCHIT, HITSP, HISPC, what is happening there? Are they gone? Are they Successor? Are they changed? Are they the same? What is the story on that? There is a general governance question that is behind that.
MS. MILLER: CCHIT at this point is an incorporated entity.
DR. FRANCIS: Okay, no changes.
MS. MILLER: And I'm not sure if it is this year, next year, at what point, but their business model is going to lead them into self sustainability.
HITSP will continue. The intent is that the funding for HITSP will come beginning in 2010 from AHIC Successor for value cases.
DR. FRIEDMAN: And HISPC -- you've got to love these acronyms -- HISPC goes back to my comment before that not everything moves to AHIC Successor. There is a project that will remain with the ONC. This is the security and privacy collaborative.
DR. FITZMAURICE: Thank you for coming here and putting up the AHIC Successor to us. There seem to be a lot of unanswered questions.
I have a couple of suggestions. One is to insert well specified on your goal slide, and make well specified modified standards, so the standards you come up with will be well specified.
Also on the goals slide, I would suggest a goal of reducing or keeping low the costs and other burdens of implementing standards and data elements chosen for the value cases. So some sense of keeping the burden low, so it encourages implementation.
I would urge greater specification of the data elements in value cases than we have had so far in our interoperability specifications. But I think it is the best shot that we have to move forward.
I noticed that there was no mention of HITSP nor the process for selecting the value case interoperability standards and the data elements. For example, there is no mention of the ANSE standards process for how the interoperability specifications will be developed. That might be something you would want to put into a future slide.
MS. MILLER: Thank you. I appreciate the feedback.
MR. REYNOLDS: Thank you, really appreciate both of you. For the committee, a little bit of housekeeping. We will break until 3:30. What we are going to do at 3:30 is, between 3:30 and 4:15 we will be here and we will have a 45-minute discussion led by the Quality Subcommittee based on the fact we wanted some more discussion on that. So I will turn it over to Justine and Paul at that point, and it will be pretty much like a Quality Subcommittee, to have everybody in the room.
Then from 4:15 to 5:30, Populations and Standards will go do their meetings for an hour and 15 minutes. Tomorrow morning 8 o'clock is Privacy, and then 8:45 Quality again, and if anybody else needs to join that at that time to continue the discussion and piggyback on what they are doing, then that is how we are going to do it.
DR. WARREN: So Standards doesn't have a full two hours?
MR. REYNOLDS: That is correct.
MR. BLAIR: When is the time for Standards?
MR. REYNOLDS: The Standards is 4:15 to 5:30, an hour and 15 minutes. Again, what we agreed to earlier was, any of the subcommittees can continue their work on conference calls.
PARTICIPANT: It wasn't that way in the agenda.
MR. REYNOLDS: No, it wasn't. Remember, we all changed what we wanted to talk about and think about doing this morning, so we changed it.
(Whereupon, the meeting was adjourned.)