[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

December 2, 2014

U.S. Department of Health and Human Services
Hubert H. Humphrey Building, Room 705-A
200 Independence Avenue, S.W.,
Washington, D.C.

TABLE OF CONTENTS

P R O C E E D I N G S (9:00 a.m.)

Agenda Item: Call to Order, Welcome, Review Agenda

MR. SCANLON: Good morning everyone. I am Jim Scanlon from HHS, and I will be chairing the meeting today. I think what we will do is we will start with our normal introductions around the table and on the phone and around the audience. Then we will review the agenda and then we will get right into the discussion. Why don’t we start with introductions? Debbie?

MS. JACKSON: Debbie Jackson, acting executive secretary for the Committee, National Center for Health Statistics, CDC.

DR. SUAREZ: Walter Suarez with Kaiser Permanente, member of the committee and co-chair of the Standards Subcommittee and no conflicts.

MS. KLOSS: Linda Kloss, member of the committee and co-chair of Privacy, Confidentiality and Security Subcommittee and no conflicts.

MS. GOSS: Alix Goss from the Pennsylvania eHealth Partnership Authority, member of the full committee, member of the Standards Subcommittee, no conflicts.

MR. LAWSON: Todd Lawson from CMS.

DR. WHITE: Jon White from ONC, liaison to the committee.

MR. BURKE: Jack Burke, Harvard Community Health Plan in Boston, member of the committee and member of the Population Health and Privacy and Confidentiality and Security Committee. No conflicts.

DR. CORNELIUS: Llewellyn Cornelius, University of Maryland School of Social Work, member of the full committee and member of the Population Health Sub-committee. No conflicts.

DR. STEAD: William Stead, Vanderbilt University, member of the full committee, co-chair of the Population Health Committee. No conflicts.

DR. COHEN: Bruce Cohen, Massachusetts Department of Public Health and member of the full committee, co-chair of the Population Health Subcommittee. No conflicts.

DR. MAYS: Vickie M. Mays, University of California, Los Angeles, member of the full committee, member of POP and Privacy and the Work Group. No conflicts.

DR. SCANLON: Jim Scanlon, Deputy Assistant Secretary for Planning and Evaluation at HHS and Executive Staff Director for the full committee.

(Introductions around the room.)

DR. CHANDERRAJ: Raj Chanderraj, member of the full committee. No conflict.

DR. NICHOLS: Len Nichols, member of the full committee, Population Health Subcommittee. No conflicts.

DR. WALKER: Jim Walker, member of the full committee and Population Health Working Group, Siemens Health Services. No conflicts.

MS. POLLOCK: Elizabeth Pollock.

MR. SCANLON: Good, we have good attendance and good participation on the phone. We have a rich agenda today. Let’s just spend a minute reviewing the agenda and see if there are any questions or suggestions.

I will start in a minute with the updates from HHS. We will hear from Todd on CMS initiatives, Jon and Jody will talk about ONC. Jon wears two hats now, which he can explain. Lucia, we are very happy to see here for our first meeting. She is chief privacy officer at ONC. Rachel Seeger will be arriving shortly from OCR as well. We will go with the updates until 10:30. We will have a break then.

At 10:45, the Standards Committee will talk about the plans for the ACA Review Committee, which we talked about at our last meeting. We are moving ahead there. Bob Kaplan from AHRQ will be coming here at 11:45. Bob will be talking about some of the AHRQ statistical analysis related to the impact of ACA implementation.

Lunch is 12:30 and then we are pleased to have Chesley Richards who will be updating us on the CDC surveillance systems. That will go to 2:30 and then we will talk about some of our own strategic planning as well. Then we will adjourn the plenary at 2:40 and then we will break out into Standards, and I think we are doing the Privacy, Confidentiality and Security as well.

We have a public comment period at 5:15 and we will try to adjourn at 5:30. We are planning a dinner as well. Debbie can get us the plan for that shortly, as well. Then tomorrow we are starting with Population Health at 8 o’clock in the morning with a breakout.

The plenary session begins at 9:15 here in this room. We will hear from the IOM. Bill Stead will be talking about the IOM Report on Social and Behavioral Demands and EHRs. Bill, I think that was released already.

DR. STEAD: It was released November 13.

MR. SCANLON: This was an issue we had been looking at. Remember, the demographic, social and behavioral information from EHRs. Susan Queen from ASPE will be talking about OMB guidance on sharing administration data for statistical purposes. Then we will talk about plans and priorities for next year.

Then we will convene the meeting of the Working Group on Data Access and Use. We will have a public comment at 11:50. Then we will adjourn the full committee at noon. At that time the Working Group on Data Access will convene in this meeting as well.

Any questions about the agenda before we go in?

MS. JACKSON: At 11 o’clock tomorrow there is an update so those that are not involved in the closed meeting can hear what is going on with the Working Group.

Agenda Item: Updates from the Department

MR. SCANLON: Let me just give an overview of some of the initiatives in HHS since we have met in September. I think all of you have heard Dr. Karen DeSalvo who was the ONC director has moved over to be the Acting Assistant Secretary for Health. Lisa Lewis who was the Chief Operating Officer at ONC is acting ONC Director as well.

I think I mentioned previously the Secretary is a very data oriented and impact oriented person. When she is discussing issues or folks are coming to her with various proposals, she really looks at what the scope is and what the impact will be and what the priority is. She likes to see the big picture and what the intended or at least the intended or expected impact of various proposals would be. Her thinking is very much in line with the thinking of the committee here in terms of data and evidence and impact.

Let me just update you on a couple of initiatives. With respect to the Affordable Care Act, as you all know, we have opened up the second enrollment period November 15 and will continue through February 15. We are getting folks enrolled as well. In addition there is opportunity for small employers to use the exchange for the SHOP program is available as well.

I mentioned previously that we update our HHS Strategic Plan that covers the next four years. We have posted it on our website. There are four overall goals and 21 objectives. We usually try to have measures and metrics to accompany all of our objectives just to see that we are heading in the right direction. We are doing that as well.

We issued our Open Government Plan Revision. We are doing that with HHS. We have a number of other strategic initiatives in addition to the HHS Strategic Plan. What the Secretary has asked our office and me to do is we have created a strategic planning system whereby we have included the features of all of the strategic plan and all of the highly visible strategic initiatives as well. It is an internal system.

We now use that to track progress on all of our strategic initiatives. We can look across at any point and see where we are with the objectives and with the metrics as well. Whenever a new initiative is propose and accepted, we include that in the strategic planning system as well.

Just as an example, we have some of the relatively new initiatives. We obviously have Ebola. We have a budget intuitive to try to deal with Ebola. We have another initiative dealing with antibiotic resistance. We have another initiative dealing with prevention of opioid misuse morbidity and mortality. We have a initiative on delivery system reform.

Remember, in terms of overall health inform, the ACA gives us the insurance coverage access, hopefully for ability dimension, but the other dimension of health reform would be delivery system reform and then public health as well. Those initiatives are under way as well.

Then we have had longstanding initiatives dealing with tobacco control, the National Prevention Strategy, global health disparities, which we have mentioned before with a number of things, Alzheimer’s and disability. We are working on a plan dealing with community living programs. We have a plan available. There is a plan.

In terms of budgets, the mystery continues. We are in the first quarter of fiscal year 2015. All federal agencies are in this situation. We have a continuing resolution until December 15, at which time we are hoping to get if not a full budget at least a continuing resolution to take us through the end of the fiscal year. Congress has basically 10 legislative days for that to happen. Hopefully we will be heading in the right direction.

In addition we are also working on our 2016 budget request. We will be expecting a pass-back from OMB shortly on that as well.

In terms of monitoring the Affordable Care Act, I think I have mentioned this previously, we have a strategy that looks at both the administrative data from the exchanges and from the insurance companies as well as surveys, such as the Health Interview Survey, the MEPS Census Bureau and so on. We have a working group that meets to plan the content and look at the data.

I think the National Center for Health Statistics will be releasing the first two quarters of calendar 2014 in about two weeks. Again, other than the commercial online surveys, that is probably the only authoritative data we have on what is happening in the exchanges and in health insurance coverage generally since January, when people who went through the exchange were actually able to obtain health insurance.

At any rate, we have most of the major surveys in that initiative. We will be looking at what information we want to continue to gather in those surveys.

I think I mentioned previously that we have established more on the analytic side of the dissemination side. We have established a NCH Research Data Center here at the Humphrey Building. It is at ASPE. I think we let CBO and others use it as well.

This allows us access to the restricted access data that NCHS and others might have. It is information that you couldn’t release on a public use data file because it would raise the risk of some sort of disclosure. What we can do here in a protected setting is have access to the detailed information that is available in those surveys, but without anyone walking away with individual de-identified records and so on. We have this available here now.

I think I told you previously we have been working on standards for demographic data collection and all of the surveys. Most of our surveys have included those standards. By now, they include sex, race, ethnicity, language, primary language and disability. This is all self-identified information. We are now beginning to see the fruits of that standardization.

We began an initiative to look at standardizing demographic data in our administrative data. That provide a little more difficult because many of the administrative systems have specific definitions of demographic terms. I think we found as a practical manner, we were close to standardization or at least comparability on a number of these things.

Continuing on the data on vulnerable populations, we began an initiative two years ago to improve data on the LGBT population. As a result of some investments, we have added a question on sexual orientation to the National Health Interview Survey. We have had added questions on sexual orientation and gender identity to the behavioral risk factor surveillance system. We are beginning to add those questions to more surveys as well.

Last month we published the HHS LGBT Annual Plan and Report, which included a lot of these accomplishments with respect to that population as well.

We continue to look at vulnerable populations and public health disparities and the impact of ACA on those. They include disabled population, rural populations and older populations as well.

We have a couple of initiatives that our HHS Data Council has undertaken. Let me mention one of them because we will be discussing this next week. I think all of us know the research and analysis. The surveys are having a harder time getting adequate response rates for a lot of reasons. Some of the commercial surveys are probably down to 9 percent response rates. At least our federal surveys are still doing pretty well.

What we have been asked to do under the Data Council is to look at what has been our experience at least in the federal surveys, HHS as well as Census, and to see where we are with response rates. Can we identify areas where we might be able to improve the response rates themselves and the approaches for assessing the potential for bias in those surveys?

We start next week at the Data Council with a Roundtable discussion of where we are with those various surveys and what we might do in terms of research or best practices to move forward in those areas. Let me mention an update on our HHS data strategy.

The Data Council was asked to develop an HHS data collection strategy about two years ago. There were three major dimensions. One was how can take better advantage of technology available now to speed up and improve our data collection? This would include web surveys. It could include telephone. It could include EHRs and other means of getting data more quickly for our big surveys and other research.

We developed a number of pilots and other initiatives to move forward in that area. For example we added a web survey capability to the National Health Interview Survey. We are looking at adding a Skype-type survey capability to MEPS to sort of speed the data collection as well.

Certainly we often buy access to data that the commercial companies have as well, although they really have to be calibrated against the federal surveys just to see how they are doing because of the response rates. We are moving along those lines.

The second major dimension is really data gaps. Where is the content that we are missing and how do we plan for that? Obviously one of the biggest concerns was on the Affordable Care Act. How do we measure the implementation and the impact of the Affordable Care Act and the different parts of it?

There are other data gaps as well. State data has always been an issue and local area data. So there we have been making progress as I said with adding questions to most of the surveys for ACA.

There area was one we discussed here on the committee. It is really the data alignment and integration. It is really looking down the road and how do we make the most out of our data investments, both the primary data collection kind like research and surveys and surveillance, but administrative data and electronic health record data as well.

What kind of a strategy do you develop so that all of these three streams of data proceed on their own at the same time they are cognizant of each other. They are coordinated. They are employing the same standards and concepts so that as a totality they are more than the parts of the three. So it is very consistent with the NCVHS alignment strategy as well.

A quick report on a couple of other updates and then I will stop. On the privacy and confidentiality side, remember there was a big interest in the extent to which even though every individual data system might take all of the precautions to protect against re-identification and disclosure, and certainly all of our federal agencies do this, is the risk of re-identification increased because of all of the other data that might be available. It is not even our data. Some of it is our data, but much of it is other kind of data that is available, state data, motor-vehicle data, hospital discharge data, all sorts of other things.

The question has always come up – it was a little hard to research –- this is referred to as the mosaic effect where you get a picture of re-identification not because of each of the little pieces in the mosaic reveal anything, but because when you put them together a picture emerges. This comes up in the intelligence community and other big data and other things like that.

We wanted to explore this a bit. We really wanted to focus on our federal survey. So we have a nice workshop where we brought in experts about folks who were using what are called data protection techniques and disclosure avoidant techniques now at a very thorough review. There is a considerable portfolio of tools there as well as some assessment of all of the other data sources that might be available and how an agency at least when it begins to release its own data and how it can take those into account and be sure those are not disclosing information or increasing the risk.

We will be publishing the report shortly. We had a nice discussion, a nice summary. We heard from a lot of folks. There are some newer techniques that folks are employing now with data use agreements, restricted data access and so on. Remember, this is the eternal conflict between data availability and data release for health and healthcare, and on the other side protecting against disclosure of the individual information of people who supply the information and protecting that kind of information as well.

As technology gets better it is somewhat like a chess game. There is a move and a counter move. I think all of our agencies are now in a better position to at least be aware of that. We are going to be looking at additional measures that we can take in terms of research to see if we can prove that area as well.

We have a couple of plans that I think we are going to try to look forward to and then I will stop here. There are two projects I wanted to mention. There is a lot of interest now in SES, social economic status and healthcare quality. A bill was just passed on the Hill to look at readmissions, for example, and the extent to which SES information could be taken into account to explain hospital readmissions.

There were a couple of very nice projects that AHRQ had undertaken where they were able to match Census block group data with hospital discharge information. We have a lot of data relating to claims. We will be looking at areas where we could sort of explore those a little bit more. No one wants to ask all of the SES information in a clinical setting. We are looking at ways to match those too. We will be taking some pilot studies there.

A second project that we are beginning to propose – this is working with ONC – it is looking at interoperability. What kind of measures and metrics and functionality would we want to think about to develop objectives and measures to measure interoperability. We would be very interested in any ideas that the committee might think about or share with us there as well. We are very early stages there.

I think what I will do is stop there and see if there are any questions.

DR. NICHOLS: I wonder if you can give us a ballpark of where the response rates are for the HHS and the BRFSS. I think all of us have been worried about his for some time. What is the state of play there?

MR. SCANLON: Let’s see, Len. Remember, Len, it used to be that they were all in the nineties. For HIS, we are probably down in the eighties. BRFSS is more like in the sixties for the adult part of it.

DR. COHEN: The sixties is generous for BRFSS. In the center of the country it is around the sixties or the low seventies. On the coast it is closer to forty.

DR. NICHOLS: Thank you, Jim. I just wanted to make the point that while I say the professionals are wringing their hands, you are still head and shoulders above what most of us consider acceptable for surveys. It is not like a disaster point yet.

MR. SCANLON: No, and the other thing as you point out, Len, is there are ways to kind of assess whether there is a bias comparing to target populations in the responses that you do have. There are ways to kind of evaluate all of that and we are looking at that as well.

In some of the commercial, I think we distinguish here between federal agencies have to publish official estimates so being wrong or being criticized really affects your reputation and your credibility. The commercial firms are concerned about quality too. Often the information there is used for tracking and whatever the bias is, if it is changing from one day to the next, at least you have a sense that it is going up or down.

They have to be careful that they don’t – based on a 90 percent response rate – that they at least point out all of caveats when they are trying to make a national estimate or a state estimate or something like that. At any rate, we are going to see if we can help how bad is it? Are there measures could take? We will do that in a systematic way. We will include Census as well.

DR. COHEN: I had a couple of comments and questions. One is around the Research Data Center. The concept of RDC is very powerful. So far the focus has really been on using the RDC for NCHS Health Survey Analysis. It would be a great place to give communities access to identify data so that they could do analysis, but just take back aggregate data.

I would love HHS to expand the use of RDCs as a protected enclave to give access to data to a variety of other datasets, not just NCHS survey data. I know we are working on one project with the reproductive health branch at CDC. They are not allowed to release their data. We are storing at the RDC and using it in that way. I really think this is an excellent opportunity to give access to data that needs to be expanded in a variety of ways. That is one comment.

The second thought is a question, which has to do with gender identity and the NCHS surveys where progress is being made if any about including gender identity on HIS or HANES. Then my third observation is doing great work. You reported on a variety of projects that are really convergent with what the National Committee is doing.

As we move forward to make recommendations to the Secretary going out of the Roundtable, I would love for us and the National Committee to be able to support some of these activities. I certainly don’t want us to duplicate recommendations that ASPE is already working on. How can we better align on a more ongoing basis rather than a quarterly update what we are doing and what ASPE is doing so we can build going on the work that you have already accomplished?

MR. SCANLON: That is a good question. I am open to any ideas. Even on the mosaic effect we talked a bit about that in the full committee. That was really kind meant as an exploratory study. What we will be doing on SES and healthcare data and interoperability measures and response rates. For some of these we will actually have a write-up of the project. We can share that with the group.

Our projects as you know they are sort of milestones. You have a number of approval processes here. You have got funding. Then we issue a request for contract. At each one of those major steps we can certainly share more.

There may be some parts of the contract where we can gather information from the NCVHS as well. We have used a lot of the discussion in the full committee here in developing projects.

On the HIS, the HIS is not planning any gender identity measures that we are aware of. The only gender identity question is BRFSS. Do you want to come up, Susan?

DR. QUEEN: NHANES already has a sexual orientation question. They are making some revisions, I believe, for other people through OMB. They ask about attraction, but I don’t think they are asking about gender identity. The Population Assessment of Tobacco Health is asking about gender identify and sexual orientation. It is modeled after what we did for the BRFSS. That is a longitudinal study that will have multiple cohorts.

BRFSS Health Center Patient Survey, which is a periodic survey, has asked gender identity and sexual orientation. Then BRFSS will continue going forward to support that. I don’t know about any plans for HIS or NHANES.

MR. SCANLON: Our estimates, as you know, the prevalence has some estimates from the community itself. Perhaps three-tenths of a percent is maybe for gender identify. We just don’t know because it is so hard to get. The BFRSS was very helpful because as you remember, Bruce, they were able to combine years of data. Massachusetts did a very nice analysis.

So we are going to be looking at the BFRSS data shortly. I think we had pretty good questions, not as standard, but pretty good questions. When other folks as about including questions, the questions we use in BRFSS are the questions that we have sent around to people to begin with.

I may also add that on the healthcare setting we believe that ONC will be looking at including an EHR certification, a capability to record sexual orientation and gender identity, not mandate. The vendors would have to include that capability. Providers would not be mandated to use it, but the functionality would be there as a way.

Remember when these were proposed as Meaningful Use demographic items, there was a lot of push-back from the provider community about these things. That is going to be the reality that we have to deal with. It is a little easier to do on the surveys.

DR. COHEN: One final comment. We, in the Massachusetts Health Department, are developing standards for collection of both gender identity and sexual orientation to be used in a variety of settings, survey and administrative data. We will be happy to share those with you.

MR. SCANLON: We would be very interested in that as well. We actually got some requests from the VA also. We shared with them. They were interested in at least thinking of using what kind of question they could use in their EHR systems. We provided some of the research reports, but also the questions we were using. Other questions?

DR. MAYS: As usual, APSE is on the cutting edge in terms of some of this. Like Bruce, almost following exactly in his footsteps but with kind of some nuances. One is in terms of Data Council as he was presenting when I began to think about it. We actually at least had -– I don’t know if we still have a liaison to the Board of Scientific Counselors for NCHS. I guess I was wondering whether or not there might be a way to do that to the Data Council.

I know when Bruce went it was really good on both sides in the sense of that and whether or not that might be a possibility. I am going to throw that out.

The other is, and this is where we need to have the reps here so they can hear this, what I am stunned by is the extent to which many of the issues you are raising that ASPE, and particularly the Data Council are taking on, used to be research issues. They used to be funded to look at a lot of that at both AHRQ and NIH. They have just fallen off of the radar.

I am just wondering if at some point in time we don’t need to have a hearing or something with our partners about the data infrastructure and what it is that we need a as a research agenda in order to be able to support the data needs for HHS.

There was methodology. There was development of a small area statistics. We don’t have any of that. Even CDC had money for that and that has gone by the wayside. I am going to throw that out whether or not that is something for us to consider.

I guess my final one is I would say that we need to kind of think about the measurement. It sounds like Massachusetts is doing it in terms of gender identity and sexual orientation. There have been some differences, particularly in the measurement of sexual orientation around the kinds of things, the decisions that NCHS has made.

Publications are starting to come out around what happens when you are only doing one aspect of it and the data that we are losing. I don’t know whether that is something that we should take up in NCVHS or whether to say it is possible to have some input from outside scientists about it.

MR. SCANLON: I think you are right. I think there is a lot less funding available for methodology and measurements in survey and social side than there used to be. I think even NCHS what they do is probably internal rather than contract.

NIH used to support some of this. AHRQ would support some of this as well. I think a lot of the funding now for measurement is going into quality rather than health status measures. We have to think about that.

I think you are right. We are just not investing in the research part of survey and surveillance as we used to. We actually had the chair of the NCVHS at one point kind of as an unofficial member of the Data Council, but it becomes a FACA.

What we will have to do is think about expert participation in terms of an expert resource for certain discussions. We actually had had the liaison to the NCVHS so we could look into that.

DR. SUAREZ: Thank you for the update. Every time you give those updates, I try to identify the top five topics that intersect with NCVHS. I actually identified six this time. Looking into the next year and as we are going to be discussing during this meeting today and tomorrow the 2015 agenda, I wanted to try and identify some of the top topics. I will give you the six that I have got from the many areas that we covered.

I think one is health reform and population health management data analytics, certainly the aspect of what you mentioned and what we can work on too; advanced technologies to implement national health surveys, data on vulnerable populations, the entirety of privacy and security and risks for de-identification or re-identification and then interoperability were the six that I captured. I wanted to try to see if those resonate with you as well in areas in 2015 NCVHS would be best positioned to assist the department.

MR. SCANLON: I think so. I think as tomorrow as we think about areas we might want to look at starting with next year, I have to sort out which would be. They are all at various stages of development. The SES and healthcare vulnerable populations kind of cross as quality plus privacy plus the population health dimension and might be a place to start.

I think we might even take a look at AHRQ has done, which was a very nice study. That is one approach, but there are others. Folks might be aware of SES type data that is available that we are not aware of. That would be helpful as well. That would certainly be an area we would want to hear from you.

The interoperability, we may be a little ahead of it. Folks are looking at what the functionalities are for interoperability? What would you focus on? Then the measures might follow there. That might be staged a little bit later. You want to have the thinking there when you are planning some of these interoperability measures.

Remember, I think a lot of progress was made through the meaningful use and the standardization and the other HITECH programs in terms of getting adoption of EHRs. As people say, the sharing of information is not a natural act. In fact, these are basically market organizations. I think they can spend their day figuring out how they can outdo their competitors. We are asking them to think about how they can share information with their competitors as well.

It is a little tricky. Even if you create the capability, the demand is not necessarily there or the incentive. I would think the SES and maybe starting with when Bill gives the report from the IOM where the thinking is. I think that would be helpful to us.

The other thing is the research agenda that Vickie was mentioning and maybe we look at the technology. We think we have pretty much got the technology that is available now. Let’s think a little bit about that and see. I would like to have maybe two or three of these areas that we can maybe look at.

MS. JACKSON: We are going to go the next speaker. What I plan to do for the agenda and what I didn’t get a chance to do this time was to make sure that Rachel got on top with Todd and the others. We have so much information. As you can see from Walter’s amazing list we connect what is going on with the Data Council and various groups as Vickie also said. We will find a way to provide as much time as possible with respect to our agency presenters as much as possible. We will start with Rachel and then go on to Todd and then go in that order again.

Privacy

MS. SEEGER: Thank you, Debbie, and good morning, everyone. It is a good quarter for me to do this because my update is very brief. First off, since we have seen one another in October, we announced the end of the enforcement delay for the Notice of Privacy Practices for CLIA Labs.

If you recall, given the proximity of the publication of the HIPAA Omnibus Rule and the anticipated publication of the CLIA final rule we used our enforcement discretion to relieve any possible burden and expense on HIPAA covered CLIA laboratories that they would only need to revise their notice of privacy practices once within this period of time.

The compliance data for that was the CLIA final rule October 6. That has come and gone. The expectation is that HIPAA covered laboratories will have compliant notices of privacy practices. Again, we have model notices available up on our website that we developed in tandem with our friends at the Office of the National Coordinator for Health IT. We have extremely successful analytics, and the downloads of those, on both the provider and the payer side.

We also published an important new bulletin on November 11. This is new guidance on privacy and emergency situations. In fact, it really is old guidance, but it was an important reminder. We were seeing a lot of press around Ebola where there was a lot of information about patients that was being shared with the media.

We were receiving quite a few queries about this. It was an important opportunity for us to issue a reminder to HIPAA covered entities and their business associates about the ways in which PHI can be shared in an emergency situation and to underscore that the HIPAA privacy rule protections for patients aren’t to be set aside in an emergency.

We also underscored the important balance for the appropriate uses and disclosures of information for treatment, public health and other purposes. This was widely distributed through our partners at ASPR, the Assistant Secretary for Preparedness and Response, of course CDC and their entire network as well as OCR’s list for broadest possible reach.

We did see quite a few important organizations using our new social media channel Twitter to push this out. If you are not following us on Twitter, you can @HHSOCR. Who would have ever thought that OCR would have a Twitter handle?

Coming up we have guidance in the queue on cloud computing. This has been much anticipated by our industry. We are looking forward to pushing this out, hopefully by the next time we see one another.

We have a very important enforcement action that we are going to be announcing later this week, hopefully tomorrow. Unfortunately it is embargoed and I can’t talk about it. I think it will send another important message to our industry on the importance of compliance.

Lastly we have the NICS Final Rule, which we can’t anticipate publication at this time, but it is also in the queue. That is short and sweet.

DR. SUAREZ: What was the topic of the NICS?

MS. SEEGER: The NICS Final Rule addresses the mental health prohibitors, the possible prohibitions. Many states and others have felt that HIPAA has been a barrier to reporting information in to the National Crime Index Survey that is the database for individuals to get a firearm. We had, if you recall, an RFI on that, or an advanced notice of proposed rulemaking and then NPRM. Now, we have the Final Rule which will be forthcoming.

MS. KLOSS: Thank you. This is Linda Kloss. I have two questions for you, Rachel. Thank you so much for your update. I don’t know if you are able to stay with us through the day today, but when the Privacy, Confidentiality and Security Subcommittee meets this afternoon, one of the areas we are going to consider for 2015 is some review or advice on the 1179 Exception to HIPAA relating to financial institution and that data. Is that an area that the Office of the Civil Rights would have an interest in recommending for the committee?

MS. SEEGER: Absolutely. We look forward to being able to work with you on that. We have heard requests from across the industry for the need for more guidance. I think it will be very worthwhile for the sub-committee to look into that area further.

MS. KLOSS: Thank you. The question we ask periodically, is the office working on any of the guidance material for minimum necessary?

MS. SEEGER: Yes, we have a number of guidance’s that are in the queue and that will be forthcoming.

MS. KLOSS: Thank you. We look forward to working with you on both of those topics.

DR. SUAREZ: Could you say a word about the status of the count of disclosures?

MS. SEEGER: I don’t have an update at this time.

MR SCANLON: Any other questions for Rachel. Todd, we are very happy to welcome you here. Todd is the Director of the Office of E-Health Standards and Services.

CMS

MR. LAWSON: Thank you and good morning. Thanks for the opportunity to be here this morning to present to the committee and give you an update.

Before I share a brief updated on the Office of E-Health Standards and Services, I first wanted Elizabeth Holland to provide you an update on some of our HITECH EHR incentive program status. She is actually joining us on the phone from CMS.

She works in our Center for Clinical Standards and Quality. Basically her office directs the HITECH Program from the CMS side of the house. Elizabeth, if you are still online, please take it away.

MS. HOLLAND: As Todd mentioned, I am Elizabeth Holland. I am the Director of Health Information Technology in the Center for Clinical Standards and Quality. My group used to be part of the Office of E-Health Standards and Services so we used to work with Todd, but we were moved to a line of quality reporting within CMS.

My staff administers the Medicare and Medicaid Electronic Health Record Incentive Program. Through the end of October, we have paid over $25.7 billion dollars in incentives to over 418,000 providers. That would be eligible professionals, eligible hospitals and critical access hospitals for adopting, implementing or upgrading their certified EHR technology under Medicaid or for this acceptable demonstration of meaningful use under Medicare or Medicaid.

For eligible hospitals and critical access hospitals, the deadline to attest for program year 2014 was extended from November 30 to December 31 to give hospitals a little bit more time. With that extension we had a surge at the end of November with over 3700 hospitals successfully attesting.

You may recall that this year we actually enabled providers to have flexibility to attest using their 2014 edition certified EHR technology or their 2011 certified EHR technology or a combination of the two. Then depending on their choice of certified EHR technology editions that helped determined the definition of Meaningful Use that a provider can attest to.

So despite the flexibility to revert back to 2011 certified EHR technology many hospitals did complete their upgrade to 2014 certified technology. Over 1600 of the hospitals so far have chosen to attest for stage two. That is good news for us. It is good news for them. Eligible professionals have until February 28, 2015 to attest for program year 2014. Although we definitely don’t recommend that anybody wait until the last minute.

As a reminder Medicare EPs must initiate participation in the program in 2014 if they are going to earn an incentive. Right now we are currently working on stage three of Meaningful use. We have a proposed rule that is currently going through clearance. That rule is delayed. It won’t be until 2015 sometime. We are hoping early 2015 though I am sure we will come back and have an update on that later.

At the start of fiscal 2015 that coincided with the first application of the Medicare payment adjustment for eligible hospitals. These payment adjustments were called for, for Medicare Providers who are not successfully demonstrating Meaningful Use. The hospitals we started October 1 and a little over 200 hospitals are getting their Medicare payments negatively adjusted.

For EPs, their Medicare payment adjustments will begin in January. We are currently determining the number of EPs that will be subject to this adjustment. We will have more information on that. The letters are scheduled to be mailed to EPAs later in December, at which point once they get the letter that says they will be subject to payment adjustment they will have a period of time when they can file for reconsideration.

All of that information will be in the letter that we actually mail to EPs. That is pretty much my update. Thank you, Todd.

MR. LAWSON: You are welcome, Elizabeth. I know you are appreciated and your time is very limited this morning. If it is okay if anyone here on the committee has any questions may be we can get those to you here now before you jump off.

MS. HOLLAND: If people are talking, we can’t hear at all.

MR. SCANLON: Elizabeth, I don’t think there are any questions, but we will follow-up.

MR. LAWSON: I have a few administrative updates that I want to give the committee in the area of outreach in education. One of our goals over the next year is to expand our Administrative Simplification Library. It is located on our website. That is on the cms.gov website.

We are also expanding our admin simplification toolkit and training resources to explain key benefits such as the benefit of using electronic funds transfer and electronic remittance advances, simplify enrollment or providers. So far the CMS administrative simplification video on YouTube has resulted in over 200,000 views, which is a pretty good size.

We also have some new materials coming out soon that will include an interactive guide to help organizations determine if they are covered entities and also a redesigned administrative simplification website as well to make it a little easier for folks to find what they need.

In the area of health plan ID, folks are probably aware on October 31, HHS issued enforcement discretion to review this committee’s NCVHS recommendations to rectify rule making at all covered entities being health plans, providers, clearing houses and their business associates that do not use the HPID in HIPAA transactions. That enforcement discretion basically gives us some time to allow HHS to fully review the NCVHS recommendation and consider appropriate next steps in that regard.

Moving onto ICD-10. In September we briefed congress, CMS, on ICD-10 and they also had a request to do so on a quarterly basis. We will continue doing that. As ICD-10 continues down the road to the go live date, CMS is very much focused on testing and post-implementation planning activity.

In the area of testing, our November acknowledgement testing period precluded with some pretty good preliminary feedback. We expect our official results that should be coming out in the next couple of weeks. The volunteers who are accepted to participate in that January Medicare fee for service end-to-end testing have already been notified and are making plans now.

Our ICD-10 post-implementation planning is currently underway and remains underway. Some items of note have been heavily focused on small physician practices and training for them. We have completed over 76 free onsite sessions in 25 states. We want to give a special thanks out to our training collaborative partners such as AHIMA, Paycom, AAPC, et cetera.

We are defining scenarios, messages and establishing protocols, to quickly communicate with the industry on our ICD-10 planning. We are establishing and testing common procedures for monitoring and reporting ICD-10 implementation status as well.

CMS also continues to partner with the Workgroup for Electronic Data Interchange, WEDI, to create the ICD-10 success initiative, which is basically a partnership between payers, providers, coding organizations and other stakeholders to ensure successful ICD-10 implementation for all healthcare industry stakeholders, including healthcare providers, payers, clearinghouses and vendors. The initiative promotes awareness of ICD-10 transition and answers questions and delivers educational materials as needed.

Continuing on with ICD-10 we have some outreach accomplishments of late. We released three new Medscape ICD-10 online, continuing medical education, continuing education activities in September. Within just six weeks we have over 30,000 physicians, nurses and other healthcare professionals that had accessed those activities.

I guess over the past four years CMS has been placing ICD-10 ads in national and regional print journals such as the American Journal of Medicine, American College of Physicians, American Nurses Association among others, as well as online resources reaching as many readers as possible.

The subscription to our ICD-10 email messages continues to grow. It exceeds 186,000 readers. Those messages have all been picked up likewise by various trade media to extend the outreach exponentially. Upcoming events: On December 10, we are cosponsoring an industry clinical documentation improvement webinar with the American Health Information Management Association, AHIMA to help providers prepare for ICD-10.

In addition to that, at the HHS level, internal, CMS continues to participate on the HHS ICD-10 enterprise workgroup. This workgroup guides and monitors HHS’ overall operating divisions and implementation of ICD-10 within the HHS space and helps facilitate exchange of shared services and look for opportunities for interoperability as well.

Moving on, on the version 6020 EDI Pilot there is some update there. Background: The intent of that 6020 pilot was to reduce the likelihood of technical issues going undetected prior to HHS adoption of the standard and to eliminate any negative impacts such as technical issues they would have on the healthcare industry.

That project actually analyzes the functionality, usability and interoperability in overall business uses of the sample of draft version of HIPAA standards for various transactions to include claims, claim status, claims payment and remittance advance, eligibility and referral authorizations.

That project was supported by CMS. Also, we awarded a scope of work to a contractor, Emdeon to perform that analysis. The program pilot identifies several major errors in the ANC 6020 standards that would have caused it. It seemed like it was well worth it.

As a result of that pilot project the critical areas have been resolved and included in the next ANC X12 version. Joint outreach sessions were conducted by CMS as well as contractor Emdeon, X12 as well.

Moving on, one of the last things I would like to mention is that folks may have seen a recent CMS organizational change that was picked up by several media outlets on November 19. CMS announced the formation of a new office within the agency, the Office of Enterprise Data and Analytics, EDA.

That will be led by a man named Niall Brennan. He is our agency’s first Chief Data Officer for CMS and is tasked with overseeing improvements in data collection and dissemination as our CMS agency strives to be more transparent as well as the department as a whole.

The hope is and expectation is a new organization that Niall will be heading up will help CMS better harness its vast data resources to guide decision making and promote better external access and use of data and support quality initiatives and patient-centered care. We are all trying to do that to drive the cost down.

As we all know there is a growing need for data and for CMS to analyze data across multiple programs and provide better access to that data whether it is aggregate or in a granular form depending on the particular circumstance and approval.

We think the organizational change builds on steps CMS has already taken in recent years to better leverage its data resources at the enterprise level and be more timely and more transparent and help facilitate lower costs not only for data researchers but for federal grantees, while at the same time making sure that the privacy of the data is protected.

Those are my closing remarks. If anyone has any questions, I will try to answer them.

MS. GOSS: Thank you, Todd, for that good update. It was very extensive. I am particularly interested in the testing aspect. I know that historically this has been a substitute barrier to effective adoption and that we haven’t really road-tested a set of transactions before they are promulgated.

I am glad to see that we did the 6020 version knowing that we are probably looking at a version seven or beyond from ASCX12. Can you talk to me about the intention for doing further pilots and engaging actual business entities in doing data exchange using those standards.

MR. LAWSON: I can say I know that we are definitely interested in presenting other pilots going on out there. We would be more than happy to be involved in and take a look at that and work with organizations on doing that type of activity, so we are certainly open to it.

MS. GOSS: I take it there are no plans for another pilot such as this with testing future standards.

MR. LAWSON: We don’t have anything underway or under contract right now. Like I say we are certainly open to looking over it with the resources that we have.

MS. KLOSS: Thank you again for the thorough report and particularly the detailed coverage of all of the initiatives in the ICD-10 space. My question is there anything more that NCVHS could do to help support the letter that we have issued recently in support of going forward with ICD-10.

Again, from the trades, we understand we may be moving into another dicey period where there is some proposal I understand being circulated that this be deferred to 2017. If there is anything that we can do, we are looking at our 2015 agenda and would entertain suggestions about how we might support you.

MR. LAWSON: I look forward to it.

DR. SUAREZ: Thanks, Todd, for that update. My question is about the status of the Health Plan Compliance Certification Rule. I know it is in final development and you might not be able to talk about part of it. Is there any estimation about when that might be released or issued?

MR. LAWSON: I share your question on that one. That is a very high priority to CMS Certification Compliance Program. With the recent enforcement discretion that was released on HPID, as you may know, the HPID and certain compliance were not technically coupled together, but they kind of are from the enumeration standpoint. The certain compliance relies on the HPID enumeration.

That is not to say that it has to be that way. What we are trying to do is take a very careful look at this with the HPID. We want to get that right, not that it wasn’t done right before. Given what we have recently heard and the concern about HPID, we really want to take a pause to make sure going forward.

I want to get it done a long time ago. I haven’t been on the job too long, but I just know it has been around for a while. At the same point we want to be very smart about doing it and doing it right. Once we get past that HPID issue, I think it will very much inform and in some regards determine the course for the certain compliance.

To answer your question, I would not expect us to have that rule finalized in January, but certainly as early and as soon as possible in calendar 2015.

MR. SCANLON: Any other questions for Todd? Thanks very much, Todd. Anyone on the phone?

We are happy to have Dr. Jon White here. Jon is the Chief Medical Advisor for ONC. He remains with us. He is the Chief Advisor for Health IT and AHRQ as well.

ONC

DR. WHITE: Hello, everybody. I am Jon White. I have a slightly new title, which changed as of Monday. You all probably know that there has been renewal and change at ONC. Jim mentioned that Karen has been the acting Assistant Secretary for Health, although she remains the National Coordinator as well and continues to engage with us.

Jacob Ryder was the Deputy National Coordinator for Health IT, and he left on Friday, that was his last day. So I am now the Acting Deputy National Coordinator to help support ONC and my colleagues.

My detail which was half-time from AHRQ now became full-time AHRQ. I am happy to support my colleagues at ONC. We continue to change. There are going to a lot of great folks that will come on board soon. There has been some very active recruitment.

The short of this is that there are a number of things that are interesting that are happening that I want to briefly tell you about. You can pretty much ask any questions that you want. ONC has been working on a couple of things specific.

The Federal Strategic Health IT Plan is something that is required of ONC by HITECH. Coordination is in the name of the office and really ONC is supposed to be working with all of our federal colleagues within the administration on various health IT activities.

There was an initial plan that was issued in 2011. The department just issued an updated strategic plan from 2014 to 2018. ONC has then subsequently been working on an updated strategic health IT plan that will cover from 2015 outwards. Basically what I can tell you is that it is coming soon, within weeks when we are hoping to have it out.

We are going to have it out for public comment. It is going to be a good opportunity for folks to take a look at not just what we are doing, but what dozens of partners within administration are doing in health IT and how we are trying to work together. We are looking forward to any comments about that.

Also on that is the interoperability roadmap. You are probably aware of the 10 year vision for interoperability in a paper that ONC posted earlier this year. Erica Galvez is the lead staff at ONC working on that had a very successful presentation to the Joint Health IT Policy and Standards Committee in October where we laid out a vision for looking ahead.

At that time we said we were working on going from a vision paper to a roadmap. If there isn’t a vision then how do you get there? We have been working on that furiously and have that out less soon than Federal Strategic Health IT Plan. It will also be coming in the relatively near future for public comment. I am looking forward to your thoughts on that as well.

For our FACA Committees, the Health IT Policy Committee next meeting is going to be on December 9 and that is going to be virtual. Before that there are two day virtual hearings on big data. Lucia is going to tell you all about that so I am not going to share more than that, but it is very exciting.

Then the Health IT Standards Committee is going to meet also virtually on December 10, Tuesday and Wednesday of next week. So those are the FACAs.

I should mention that next week there is a very exciting meeting on unique device identifiers being convened by the FDA, ONC and Pew Charitable Trust that started off as a small meeting, and there is apparently a lot of interest in these identifiers. That will be discussed quite robustly next week.

ONC is having our annual meeting February 2 and 3 at the Washington Hilton Hotel. If you go to healthit.gov, you will be able to find details about it if you are interested in participating. In addition to the strategic plan and the roadmap, there is also some rulemaking afoot that you may have heard about.

ONC is of course is not responsible for Meaningful Use, but is responsible for the certification regulation. All this says is that we are working on it. We anticipate release in tandem with Meaningful Rule NPRM when it goes out there.

Finally, I just want to add two other things. I am very pleased to be able to tell you that as we are sitting here, in 2014, a new JASON Report was posted on healthit.gov. Last year you may recall the report was titled A Robust Health Data Infrastructure and spurred some pretty vigorous discussion that culminated in some (1:23:06) recommendations in October.

The new report is called Data for Individual Health. It builds on the 2013 report (inaudible) was one of the briefers for that report. Thank you very much for your participation. I hope you all get a chance to take a look at that.

The final two things I am going to ask, first I am going to wave the AHRQ flag a tiny little bit and wet your appetite for Bob Kaplan. Ask him how many lives have been saved and how much money has been saved by decreases in adverse events in 2010. That is a teaser for that.

The final thing I am going to say is a year ago Mike Fitzmaurice retired and I became the AHRQ liaison to NCVHS. Then things happened and I became the ONC liaison to NCVHS. Now that I am going to be the Acting Deputy, you are better suited to have a different liaison. It has been a fun year. Thank you very much.

After this meeting, the liaison will transfer over the Office of Policy. Elise Sweeney Anthony is the Deputy Director of that Office, and Jodie Daniel, between the two of them they will probably be tag-teamed.

That is enough out of me. Any questions for me before I hand it over to Lucia?

DR. COHEN: One question. Jon, you said there is going to be a meeting about unique identifier.

MR. WHITE: Unique device identifier.

DR. SUAREZ: Jon, did you say that certification regulations would be expected by sometime in January of next year.

MR. WHITE: I did not say a specific date.

DR. SUAREZ: The mic maybe.

MR. WHITE: All I said is we are working on it. We anticipate releasing it sometime soon. It is a NPRM.

DR. SUAREZ: My last question, the last report you mentioned the 2015 report, which is that report?

DR. WHITE: The JASON report. It is a 2014 study that was conducted this summer. It builds on last year’s robust health data infrastructure. This one is data for individual health. It is posted right now on healthit.gov.

MR. SCANLON: Let’s turn to Lucia now. Apparently folks on the phone are still having difficulty hearing us. Please speak loudly and directly into the microphone.

Privacy

MS. SAVAGE: I have never been accused of having a quiet voice in my life. I am Lucia Savage. I know some of you. I have worked with Walter for many years. I have worked with Len Nichols. I worked with James Scanlon. I will give you little bit of my background.

I have been practicing law for 25 years. When I graduated from law school, Al Gore had not invented the Internet. There was no HIPAA. My early practice was actually representing plaintiffs in benefits litigation so fiduciary breeches of pension plans, long-term disability for chronic fatigue and all kinds of weird cutting-edge things.

From there, I moved into a compliance position at Stanford University where I managed their benefit plan compliance for 13 years including their transition to a HIPAA regulated environment.

I left Stanford in 2002 and joined Pacific Business Group in Health in 2003 where I served as its general Council for the BPGH family of companies, which at that time included the old California Insurance Exchange Pack Advantage, for those of you who might remember when insurance exchanges were not covered by federal law.

I left PBGH when we closed that exchange in 2007 and joined United Healthcare in 2008 where I brought with me the experience from PBGH of very large data transactions ranging from now the people who have been doing this a long time will remember the Better Quality Information Initiative. I did all of the contracting work for that. How do you do risk management in an insurance environment, et cetera.

I brought that skill set with me to United where I had a portfolio that exclusively covered very large data aggregation projects, Health Information Exchange, both transactionally and strategically. It was a backwater when I started. Health reform came. HITECH came and increasing portfolio with a bigger staff to cover all payer claims database CMS, MPC, et cetera.

I left United to join ONC in October so I am really excited to bring all of that background with me and make it available to the American public. I was describing myself to someone. I said if I had a ribbon in a beauty pageant it would say Miss Practicality. I like to be really practical. I like what I am doing to be able to be implemented.

My clients in private practice would say that is a hallmark of my work which is “she will tell you what you can actually do. The first thing she will ask you is what are you actually trying to accomplish? Let’s look at your goal first and figure out the right path to that goal.”

That is who I am. I did want to talk a little bit about what we have been doing in the Office of the Chief Privacy Officer. This is the beginning of my seventh week. I am still very much only up to my knees in the water, but the water is fine. I am a good swimmer.

I want to talk about our hearings Friday and Monday on big health data. This is being done at the request of the Executive Branch and in collaboration with our FACAs. We have two four hour listening sessions where we convened experts from all over the country to speak to us about the benefits and possible harms of what we see as the learning health system and the big data needs of that.

A few of the things we are trying to get to in that testimony are issues such as what are the privacy and security implications of doing analytics from data that is not just from traditional healthcare sources when you are trying to get to health status and population health and individual health. Another one is the pros and cons of big health data in addressing needs of under-served populations. Is it going to cause red-lining? Or is it going to improve the care in those communities?

I lived in Oakland, California for 20 years in one of the bottom three income census tracks in that state because that is where you could afford to buy a house with 17 different languages represented at my local elementary school. I have a lot of experience with under-served communities.

I believe at the end of the day today you will see posted on the Privacy and Security Work Group Section of healthit.gov the actual list of speakers for the two days and materials that they will be coming as soon as we get those. They are public listening sessions. They are very brief. We have a lot of people to talk to. At the end of each day there will be an opportunity for public Q&A if any of you guys want to join in on the public line.

Once we get that list of speakers, obviously it is a public line, you can come and go and schedule permits relative to the interests that you have. Friday afternoon I think it is 1:00 to 5:00 and Monday afternoon it is 1:00 to 5:00.

DR. SUAREZ: Sorry to interrupt you. Are these both web-based?

MS. SAVGAE: It is all virtual so you will be able to just dial in into WebX, as our workgroup normally meets.

MS. KLOSS: May I announce to the NCVHS that Leslie Francis is going to be one of the testifiers and she will bring in our toolkit work and the other work.

MS. SAVAGE: That is the immediate coming down the pike that I think this audience would be really interested in. I have a couple of other things that I have been working on that you will see in addition to what Jon has mentioned already, fast and furious work, on the interoperability roadmap and the strategic plan. My office doesn’t work so much on the certification role, thank goodness.

We are working on some other things. We are going to be spending a lot of time talking about making do with the rules we already have in place and making sure that people have a better understanding of them and the consensus around them is stronger and that we can take that consensus and make a computational meeting.

Our computer systems are adjudicating that consensus for compliance purposes, working great with Rachel’s boss and the whole team at OCR. In the spring you will see a new release. We have a privacy and security guide which is specifically focused for small practices and a new security risk assessment tool which is also focused on small practices.

Those will play starring roles in some of the educational work that we will be doing in the early part of 2015. I think that is probably what I want to cover today. It will take us through to your next quarter meeting. I am happy to answer any other questions.

DR. SUAREZ: I must say I worked with Lucia a number of years. It is a great honor to have you join the Office of the National Coordinator. As much as we were sad to see Joy leave, I think we could not have found a better person. When I say “we”, the United States. Thank you for joining that position.

One of the challenges I think we are going to face is make computational, make electronic, and make standardized the entire area of privacy choices and patient privacy choices for the protections. There are two electronic standards being developed right now. Actually one of them is finalized and the other one is underway. This committee has talked about it – data segmentation -the technical standard to allow the health records to segment data for purposes of privacy and then there is data provenance. I wanted to see your perspectives on those and your sense of what might be coming up next in those two areas.

MS. SAVAGE: I think you are going to hear a lot about those capabilities as part of what is planned for the roadmap. I am very familiar with the DS4P work. We are working on our use case on provenance right now. You will see as our workgroup gets farther into that that will be piloted in 2014.

I think the key thing to remember, if you have to go back to fair information practices from the 1970s and what the entire team said about those in 2012. You have to really remember that there are eight principles in Fair Information Practices. Consent is one of eight. We have to work with the entire set.

We have to be thinking about an environment in which on the one hand does give people the capability of expressing choice and making that expression of choice computational and follow the data in the same way provenance follows the data. We also have to have a system in which people understand what is going to happen with their data even if they do nothing. That is a core part of Fair Information Practices. I won’t say we are going to be tacking back.

We are going to be going back to basics in terms of driving that message through. There are eight parts of this process and our roadmap from a privacy perspective in particular has to account for all of those. We have 320 million Americans. They have widely varying abilities to understand the basics of their insurance let alone the complexities of the forms you have to fill out when you go to the doctor’s office.

I have a doctor’s appointment today. I was looking at the forms and thought don’t put me in front of bad forms. We have to think about this fair information practice and how to build a system that accounts for all of them. That is partly us as healthcare stakeholders agreeing on what is a fair practice.

What do the rules presently allow under HIPAA? We have permitted access, use and disclosure. How far does that take us towards the interoperability roadmap, the rule system we already have. Then going to the DS4P and the data segmentation, one of the things that you guys will learn as we get into those findings is when we have a stable, consistent environment for rules the computers can do a really good job with those ones and zeros.

If the rules environment varies in an overly complicated way, the Rubik’s cube of rules is too big for us to be a system efficiently. We have to think about all of the trade-offs and the complexity of our rules environment and peoples’ rights and how we preserve peoples’ rights while at the same time figuring out a way to have our rules be able to be adjudicated by computers instead of pieces of paper.

I told Karen in an interview if you have everything interoperable and people are still giving you pieces of paper you haven’t solved your problem.

MR. SCANLON: Other questions?

DR. MAYS: First, I want to thank you for describing your background. It is very exciting to know the range of things that you have done and what that brings to us. That was very helpful. You are not in any kind of box now. I was really fascinated by the webinar that you have coming up where you are going to talk about this issue of potential red-lining.

I am interested because often when we discuss EHRs with racial and ethnic minorities they don’t want to do because it may change their treatment, the various perceptions of what might happen. Are you doing the webinar out of an anticipatory response? Is it that you are beginning to find that that could be the case?

MS. SAVAGE: Just to be clear, we have invited people to tell us what they as experts think on this. This is not an opportunity for internal staff of Health and Human Services to listen as opposed to talking. We very intentionally picked experts in a wide variety of ways including people who worked specifically with organizations serving the health needs of disadvantaged populations.

I will say that part of this comes from my own personal background being in Northern California for 20 years. There is a pretty big difference when the community rises up to empower themselves with information than when people try to get it for them in a non-trusted environment. We have to really look at that historical behavior. We have to take advantage of the wisdom that the experience of the communities brings to us.

There will also be academic people talking about the power of big data, cloud computing. It is quite a diverse group. I don’t want you to think that it is the only topic on the list, but it is an important topic that we intentionally included. Is that helpful?

MR. SCANLON: Thank you, Lucia.

MS. SAVAGEL: Jon and I are now running late for our next meeting, so we are going to get out of here. I look forward to talking with you guys next time.

MR. SCANLON: Thank you again. Why don’t we take a 10 minute break?

(Brief recess)

MR. SCANLON: I think we have everyone back from the break. We will return to the placing on the agenda. We are going to turn it over to Walter. Walter, do you want to take us into the ACA Review Committee?

Agenda Item: Standards – ACA – Review committee on Data Standards, Charge and Expectations

DR. SUAREZ: Hello, Raj. We are just about to get started. Can you hear me okay? Great.

Okay, thank you. This is Walter Suarez. I am the co-chair of the Standards Subcommittee with Ob, who is unfortunately unable to join us by phone this morning. Then also next to me is Terri, who is staff for the Subcommittee. What we wanted to do is spend a few minutes here on the new role that the Standards Sub-Committee is undertaking. We have put together a set of slides that we included in the EBook that cover several other topics besides this particular topic.

I am going to skip some of the slides. I am going to start on slide number five for those that are on the phone as here in the room. What we wanted to describe through this initial set of slides is really the progressive evolution, the National Committee and then the Standards Subcommittee within the National Committee and the work that has been done over the last year and a half or two since we started this theme of convergence and working more closely together.

In this slide, number five, what you see are really the three subcommittees that we have had in the National Committee before a year ago. A couple of years we had another subcommittee called the Quality Subcommittee. We have transitioned from that. We have continued to work through the three major topics, Standard, Population, and Privacy. Quality certainly is embedded across all of them too.

Then in addition to that we have the new Data Access and Use Workgroup that was formed to advise the Secretary on the health data initiative that the Secretary was undertaking. That became part of the National Committee. Those are the four groups. We certainly report back directly to the Secretary. We work on the right-hand side in this big box you see.

We work with several organizations and several HHS agencies and other FACAs including the Health IT Policy Committee and other population and public health FACAs. Certainly with industry across the board there is representation of industry from consumers to providers and health lens, clearinghouse, public health researchers, public programs policymakers and others.

This is a picture of the National Committee and trying to emphasize as we move into the next slide in some of the evolutionary progress and process that we have gone through. This next slide number six really tries to highlight the trend that we have seen over the past year and half of convergence, really seeing a lot more overlapping.

These four bubblers are becoming closer and closer to each other where there is a lot more overlap, just between two, but across the entire NCVHS organization. This is sort of the convergence concept.

Within that framework of convergence, the Standards Subcommittee has just actually received a new assignment that we discussed at the last meeting in September. Next tries to describe a picture of a new assignment.

As you all know the Affordable Care Act included provision that the Secretary would create a review committee to evaluate the status of the implementation of adopted standards and see if they are still meeting the business needs and are responsive to the industry needs or if they need to be modified somehow or updated or changed.

The National Committee was designed by the Secretary in September to function as the ACA Review Committee. The National Committee assigned that responsibility from an operational perspective to the Standards Subcommittee. The Standards Subcommittee has two primary roles.

One is the smaller bubble inside the Review Committee functions, which relate to transactions and HIPAA transactions and administrative transactions. The Standards identifies Operating Rule that has been adopted in regulation. These are reviewing what is in place already. That is the review committee. They are reviewing what is in place and evaluating how those things that are in place are still meeting the business needs of the industry.

The other Standards Subcommittee responsibilities include other standards that work including these three areas at least: Number one is new transactions, so transactions, both administrative and other types of transactions. Then the standards – identifiers and operating rules that are needed for those new transactions.

A good example of a new transaction that has not yet been adopted would be attachments, for example, one topic that we have been working on. Acknowledgement is another transaction, first report of injury, or those kinds of new transactions that haven’t been adopted yet for implementation.

Another major topic that the Standards Subcommittee has been focusing on is population health and public health standards. These are the electronic messaging standards using public health and population health messaging.

Then the third is other standard-related topics including other topics that we have dealt with like virtual cars, the concept of the E-Health Roadmap, and the next generation of transactions that would be needed in order to support health reform and transparency and some other topics that we will be talking about. That is a picture of how the subcommittee work is now evolving in this expanded role that we have.

Now I am going to skip to slide 10 to talk more specifically about the Review Committee. Slide number nine is things we are going to be talking about this afternoon and then reporting back to the National Committee tomorrow.

With respect to the Review Committee, we have now a formal charter that has been approved by the National Committee. Now it is actually posted on our new website. For those that have not seen our new website, we now have a beautiful new website. We have the Review Committee Charter now in the website describing several pieces.

I am not going to go through in detail all of these pieces that you have in the document that we approved in September. I am just going to highlight a few of the things that are important. There is a statutory background that defines in the statute what the responsibilities of the review committee are. Generally, we talked about primarily reviewing standards and transactions having been adopted and evaluating whether they need to be changed or updated or modified and recommend those changes to the Secretary.

The chart of the Review Committee in this next slide is to do that. What this particular slide in this part of the document is describing is what I just described in the picture. We have this new expanded function. The new function is with respect to the review committee it is focusing on existing transactions. We have also this other responsibility of looking at new healthcare transactions and looking at public health and population health standards and other things.

This next slide, slide number 12 highlights this point that I was making with respect to the membership, the consensus, the Subcommittee on Standards would be providing the core membership for the Review Committee. Then all of the other members of the full National Committee will be members and will able to participate of course and join the Standard Subcommittee.

Then slide 13 talks a little bit about the process. It is very important to point out that we have been doing this for some time now, every year, we have a hearing usually in June when we convene testifiers to talk about how things are going with different transactions. We don’t do it in the structured way that the Review Committee is going to be doing it.

We don’t cover all of the transactions. We select some of those that are at some point in time critical to review. Then we bring testifiers. We have done some of that. What we are now going to be doing is we are going to structure that in a formal way. In June of every year at least, at least this point, how it looks, we will be convening a formal hearing and then we are going to call the Review Committee Hearing now.

It is going to be focusing on the various transactions. We will show a little picture of the various transactions that we will be covering. In addition, if needed, we will convene additional hearings. We will convene additional. Most of the work is going to be done just the way we have been doing it, conference calls through meetings of the Subcommittee on Standards.

From time to time we might convene a workgroup or some other task group, time-limited, purpose-specific task group to focus on a specific question about a specific transaction for example or standard. We will continue to operate in many ways the same that we have been doing it. It is going to be a little more formal and structure.

In the Review Committee Hearing, which will be least biannually –- at this point we have been doing it every year -– we will hearing the status of existing transactions. We will plan to hold that in the second quarter in June of the year.

Then all of these hearings will be consistent with our current hearing policy and the practices that we have where we would be issuing a public announcement, developing an agenda and topics to be covered, establishing a set of questions to be addressed by testifiers, identifying and inviting a cross-section of industry representatives to provide oral testimony during the hearing, but also involving the industry at large to provide written testimony.

Then we will allow during the hearing public input. With all of the hearings now, we plan to continue doing this and making this available on the webcast as well.

At the hearing, this is an example of the kinds of questions will be looking to post to the testifier. We will be asking the current status of implementation of HIPAA named transactions and their corresponding standards and operating rules going and the degree to which current standards, codes and identifier operating rules will continue to fulfill the business needs of the industry.

The degree to which the operating rules result in standards and the entire spectrum resulting in any discrepancies, ineffectiveness or inefficiencies in implementation with transaction, which causes conflicting or unanticipated negative impact. Any ability or limitation of the standard or operating rule to meet new or emerging business needs?

As the industry continues to evolve and new industry expectations occur we need to keep an eye on the new and emerging changes in the industry and how the standards and operating rules are fairing with those changes and whether changes in current standards and operating rules for a particular transaction are needed.

We have an array of actors and organizations that are going to be critical to be part of these hearings our DSM, the Designated Standard Maintenance organizations, the SDO, the Data Content Committees or DCCs, the Operating Rule Authoring Entities or OREAs.

All of them are going to be part of the hearing along with a cross-section of representation from industry organizations, healthcare organizations, health plan providers, clearinghouses and others.

Then slide 16, after the hearing, we will then provide recommendations to the Secretary on the need to update specific standards or make any adjustments or changes. We expect that the letters will follow the same kind of structure that we have using our current letters of recommendation to the Secretary.

Now, this slide 17 shows the spectrum, on this slide we capture the entire spectrum of all of the transactions. During our Standards Subcommittee, I was actually posed how many people know the two transactions we have not yet addressed from the 1996 HIPAA Law. We didn’t really know. There were two actually. One is the last two on this table.

Attachments were something named in the HIPAA law in 1996. The other one is something called first report of injury. It is a worker’s comp transaction that occurs when a person is injured and it is related to work. Within 24 or 48 hours, depending on state regulations there is a report that needs to be filed. That is called a first report of injury.

There is actually a transaction that already exists. A standard already exists. The electronic standard allows that transaction to happen. We haven’t done work on that. At some point in early 2000, we looked at this particular transaction, but did not recommend the option of a standard.

At any case, you can see all of the transactions in the rows. Now you see in the columns the four or five major components that we are going to be looking at for each of the transactions. The standard itself, this is an X12 standard or the X12N standard or the NCPDP standards.

For example, for the health plan premium payment the standard is the X12N820. That is the actual standard, if you will, the implementation specification. There is also the code sets. There are two types of code sets. There is something called external medical code set. There is external non-medical code sets. Yet, there is even a third one, an internal code set that is used inside the transaction itself.

You can see examples like ICD-9 and ICD-10 are code sets. They have been have been named in HIPAA under the Affordable Care Act Review Committee expectations we need to look at this as well.

Identifiers are the other major class of things that are used in these transactions. We have the four core identifiers, NPI, PID, the payer ID and plan ID and other identifiers that could come.

Then the operating rules are the last major category of activity. There are some general operating rules that apply across all of the transactions. Then there are transaction-specific operating rules. As you know in the bottom of this screen, this is not intended to be a complete and full picture with all of the details and trimmings.

We were trying to capture quickly a few examples of the things that represent the scope of the work of the review committee. This is not an exhaustive, complete full list. There are a number of other things not in this table that we will be capturing. That lays out the scope of work of the Review Committee.

We started then thinking as a Subcommittee that there needs to be some important guiding principles for implementing the work of the Review Committee. We developed a few points about this. Certainly it is very important to ensure that the Review Committee Work aligns with the vision and the work of NCVHS, not just the standards of the committee but across the board.

We are in the line of optimizing the governance and operations of the subcommittees and the workgroups leveraging common guiding principles that we as a national committee develop. We are aligning and making sure that the review committee work is as consistent with those guiding principles.

Transformative change in healthcare is providing the new convergence opportunity and need and certainly some changes. That is part of what we will see as we work through the Review Committee. There is growing and evolving adoption and use of clinical and administrative standards and transactions to achieve the triple aim.

We didn’t even talk about here the other stream of data that Jim mentioned earlier, the surveys, so that we have the clinical data, the administrative data and the survey data, all of them converging. Healthcare delivery reform certainly has been also a major force with all of its elements and then behind them there are all of these standards that are happening and exchange of data between and across all of the elements of the new care delivery reform organizations, ACOs and PCMH organizations. So there are all of these elements.

We certainly wanted to highlight on slide 19 the guiding principles that we are working on and that we will be using, NCHVS converging guiding principles including the six guiding principles that we have. It was very helpful for us as a subcommittee to go back to the original, back two years ago when we came up with these guiding principles for NCVHS to go and look at them again.

So focus on the patient and the consumer, harmonize policies and regulations, demonstrate flexibility and agility to embrace effective change, balance short and long-term evolution of administrative changes, demonstrative disparity of means to execute and adopt required changes and ensure usefulness of data and effective stewardship. Those were six core NCVHS guiding principles.

In addition to that with respect to effectiveness and efficiency, we have these additional five or so effectively aligned with or enable the triple aim, improve healthcare-related infrastructure, incorporate if applicable privacy, security and confidentiality. Now, this one can drop the “if applicable” because it always applies really. It has measurable impact and serves as enabling capability for direction on strategic shifts.

A very important of this work that we have now in the review committee is going to be the evaluation criteria. These are all elements that we will be using in identifying and determining the evaluation criteria for determining and assessing whether as we ask in the original question whether the transaction standard or identifier or operating rule still meets the need of the industry.

There needs to be some evaluation criteria. Are we still meeting the need with the standard or is the standard not meeting it because of some specific lack of data that is needed with all of the changes, or is there a need for a different transaction all together.

Lastly, in slide 20, assessing and gauging success and outcomes. We understand that there are not currently a set of commonly used measures to evaluate the effectiveness of any given transaction or standard operating rule. We have very limited experience with evaluating in a formal way whether a transaction meets any of the industry. There was a lot of work done at the granular level, but at a higher level I think we don’t have a lot of measures and metrics.

So we have the opportunity to establish a framework for evaluating and developing a baseline measure for existing standards and operating rules. That is going to be the work that the Subcommittee is going to undertake over the next six months in preparation of our first hearing in June of next year.

The potential framework that we are looking at could include three or four elements, establish evaluation criteria to assess effectiveness and efficiency of the adopted standards and operating rules. Review and establish outcomes for each of the standards and operating rules or each of the transactions, establishing and formalizing methods to assess in the industry through partnerships with private sectors organizations and national surveys like the kinds that Wheaties has been doing over the years to evaluate and understand the status of implementation and understand whether the industry feels the standards still meet the business needs and establishing some empirical review of industry’s adoption and effective use of the standards.

So over the next several months we will be developing and working with the Subcommittee on establishing this evaluation framework. The Subcommittee will be able to use these two areas of alignment to frame and orchestrate the Review Committee activities and then the Review Committee operations activities will be revised and refined as we move along with the implementation of this work.

Our proposal as one of the work items for the Subcommittee on Standards, our proposal with respect to the Review Committee is to convene the first hearing of the Review Committee in June of next year. This will focus on evaluating the state of implementation of the HIPAA main transactions. It would be expected to be a two-day hearing actually and it is most likely to be scheduled for June. I know we changed our schedule of the June meeting from June to May.

Now we as a National Committee are meeting on May 27 and 28 I believe. We believe that this hearing is going to have to be set separately because the timing and the meeting base are probably not going to allow us to really do a May meeting. That week that we are meeting is actually the week of Memorial Day. Monday is a holiday. We are meeting on Wednesday and Thursday of the National Committee. It leaves us two bookend days. It is not going to help us to do this.

We are looking at probably convening a second event of the National Committee in this case the Review Committee a two day hearing in June. We plan to organize the sessions around the transactions. This will be truly the first time we are going to take the entire spectrum of the transactions of the HIPAA 1996 law and review them.

We are going to have a conversation about coordination of benefits and eligibility and enrollment and premium payment and each of those transactions and highlight the core elements in each transaction and how things are really evolving and whether there needs to be changes. We understand and we know that there are some transactions that are implemented every day almost 100 percent of the time electronically using the standard like healthcare claims and claim payment.

We know that there are some transactions that are not implemented for many reasons as much as one would have expected. For example, prior authorization is a healthcare transaction that has not yet really been implemented to the level of what claims and claim payment are. We plan to organize it that way. The sessions will include a balanced cross-section representation of industry. We plan to work over the next couple months on planning and organizing this hearing to give it shape.

We expect that we will be inviting a lot of usual suspects that we have in our hearings. We will also expect to invite a lot of other people that we want to make sure we bring in, for example, long-term care, behavioral health and other sectors of our healthcare industry that we don’t have a chance to hear that often. We want to really bring them as well.

All right, that is basically what we want to talk to you about with respect to the Affordable Care Act Review Committee. Again, we have several more slides on the deck that we will be talking about later this afternoon as the Standard Subcommittee meets and convenes the full committee meeting on the Standard Side. We wanted to introduce this discussion here on the Affordable Care Act Review Committee and have some more discussion from the committee. Thank you.

MS. MTUI: From Jim Walker, does ISO or another SDO have general guidelines for measuring the effectiveness of standards or operating rules.

DR. SUAREZ: Great question, Jim. Yes, indeed. I think we are going to be looking for those kinds of guidance and even standards for measuring effectiveness and efficiency of the standards themselves. Yes, I think ISO is a good example of a standard of an organization that has developed some standards. We will be looking at those along with other sources for evaluating this.

I know the standard development organizations themselves and even the operating rule authoring entity organization have defined some criteria to evaluate this. We are going to be working on those as well. Great question, Jim. Thanks.

DR. COHEN: Walter, I know the focus of the work is going to be looking at transactional standards. I would like to go back to the fundamental purpose of the ACA, which is in my understanding to give people access to medical care to improve the health of individuals and the nation.

To the extent that collecting data will allow us to generate the information that might help us evaluate ultimately the impact of ACA on population, my plea is to keep our eyes on the ultimate prize even though the focus needs to be on getting the nuts and bolts right with respect to transactions.

What is the content of the data that we are collecting and transmitting that will help us understand individual health outcomes and be able to aggregate to population health outcomes? Does it make any difference now that folks are covered through ACA?

DR. SUAREZ: Great point. Absolutely, that is one of our overall National Committee principles. It is to look at the benefit of any of what we do. In the standard world it is not just whether you meet the business need of a specifically achieving the transaction of a healthcare claim or an eligibility, but beyond that as you point, Richard, really within the context of the Affordable Care Act, how much it helps achieve the ultimate goals of the Affordable Care Act. We will bring that into the evaluation criteria as well. I think that is part of what we intend to do.

We understand that the provisions of the Affordable Care Act itself are fairly specific. This is actually almost verbatim. I am on slide 10. In the charter we attach the actual language. The Review Committee as provided in the Affordable Care Act is to conduct hearings, to evaluate it up to standards, provide recommendations, no less than biannually. Then ensure coordination in appropriate development and recommendations with other FACAs including the Office of the National Coordinator.

Within this spectrum of work, I think it gives us the opportunity to look not just at the specific business need of a transaction, but beyond that to the larger benefit of the Affordable Care Act. Thank you for that point.

DR. MAYS: I just wanted to get a sense of – and again this is my ignorance of the word standards to see if what I am thinking about can also come under this. That is one of the issues in terms of the Affordable Care Act. Right now, everybody is running around trying to figure out what metrics we should be focusing on. For me, the question would be is that something that we can be talking about.

Then the second thing I think would be good for the committee to do in terms of kind of an alignment activity is for all of the subcommittees and the workgroup to talk with you about some of the things that we think should go in. You raised behavioral health. You raised different thing.

It would be great for us to have some planning time to tell you what we think some of those issues are to make sure that your perspective on them kind of represents the issues as they come from us. Then you could translate it into what a standard kind of issue is. I want to make sure that we have time to have that discussion with you as you all plan going forward.

DR. SUAREZ: Great point. Absolutely, I think the interest that we have as a subcommittee is to work as I was showing in the earlier slides with the convergence theme, really working more closely with the other subcommittees to ensure that the interests and some of the topics that we might not have seen within the Standard Subcommittee, but the Privacy or the Population Health or the Data Access Workgroup, are valuable and can be translated into some of the work that we do in this particular hearing.

Even though we are really going to be evaluating some technical work on the side of the transactions themselves, don’t limit the evaluation to the technical side, but look at the larger set of the issues that might be valuable to really look from the perspective of the other subcommittee. On your first point, at the intro of the meeting today Jim was talking about some of the major initiatives the department is looking on.

Certainly, health reform is a topic that we as a national committee, not through the work of the Standards Committee, but more as a National Committee, can look and ensure that the work that we do is really meeting the goals of the Affordable Care Act overall. What kind of metrics can looked into to evaluate the Affordable Care Act, not just from the perspective of the standards or the technical transactions, but elevate that discussion into a much larger domain, again, just focusing on the transactions themselves.

I think on your first question it is more a topic for the entire National Committee and how much we as a National Committee want to participate in this dialogue of measuring the effectiveness and efficiencies of the Affordable Care provisions. It is not just the standards side or this particular.

MR. SCANLON: And I would interject that is what I view as a convergence initiative exactly. Much of what we have been able to measure so far in terms of enrollment through ACA, which, remember is a very small part of the overall insurance coverage. That has come from administrative data. That has come from enrollment data and the exchanges and payment. Again, I think that is for the full committee to look at how do these three various streams help us.

Further, we have in our planning to evaluate the impact of ACA. We set up a tracking system at HHS that focuses on 10 domains which probably are worth revisiting. What would think the impact would be of the Affordable Care Act on these various domains? What would the metrics be? We have a website now. We are updating it. That would be something that we could discuss in the full committee as well. We have learned a lot now through probably additional measures and metrics and some things we would change.

It is everything from the administrative side of insurance coverage and the various measures through the affordability measures, through access measures, through public health, through clinical preventative services and so on. There are probably additional areas now. That I see as a nice way to look at convergence, administrative data, EHR data and research surveillance data as well.

MS. KLOSS: I think everybody shares the realization that this is really a daunting undertaking. We will need the opportunity to go up to the 30,000th level. I think your suggestion on starting with the department’s evaluation criteria is a really good way to start. I think we will just get so varied.

Bringing back the wisdom of our former member, Bill Scanlon, who always said that we need to find a way to translate this evaluation to how it is reducing the cost burden, particularly of the administrative transactions. I think that may be a sweet spot and it may argue in favor of a real directed discussion by the whole committee with Len, with an economic view to how we might measure. I guess I would support Vickie’s suggestions that we have a structured high level discussion about how we would evaluate this at the next meeting.

MR. SCANLON: Could I ask one while looking into the future, Walter. We talk about interoperability and standards and so on, and we seem to have created a fair amount of interoperability on the administrative data side.

DR. SUAREZ: Yes, we have a ways to go in some parts. Yes, indeed, I think nowadays there is a lot more efficiency through the electronic transactions that have been adopted. We started with 4010 back in 2003 and 4010 wasn’t a perfect standard because it had the duality of the pre-HIPAA to have to deal with. People had many flavors. With 5010, the flavors have been reduced, but there are still several flavors out there.

I think you are right. I think we are achieving a degree of interoperability. We want to continue that journey towards achieving better interoperability I think.

MR. SCANLON: Yet, on the clinical side, we are just trying to get the door open a little bit more. What size is your administrative data or EHR data or is there some strategy –- we talked about this previously –- that is a hybrid which uses the administrative data as the base and looks at adding clinical data? Or are we going to the EHR and nothing in-between. The claims attachment would have been one.

DR. SUAREZ: I was just going to say that the attachment is certainly an example of where the two worlds will converge. In many respects it is still going to happen that we will have some administrative processes happening and then transactions to support those administrative processes will still happen.

I think in the new world of health reform and payment reform, advanced data analytics expectations and population health management the reality is that a lot more of the data that recites to the NIHR is going to be expected to come to the payment side, not just to simply do the traditional payment process, but to do it differently.

Now we are looking at outcome-based more than event-based. I think we expect to see a lot more of that data flowing that comes from the EHR and even beyond the EHR from other sources that come through the pipes in the exchange of information between providers and payers.

We are seeing the challenges as an industry of the exchange between providers and providers with Meaningful Use and how we advanced the option of electronic health records. A lot of people have adopted ultimately electronic health records. The next challenge of exchanging data is not a natural process as someone was saying.

The exchanging of data in the clinical realm between providers and their electronic health records changed systems is not an easy process. I think we are as we see administrative and clinical and then survey and research data converging more and more. I think we have an opportunity to find some sweet spots to try to pursue a lot more integration and harmonization across those multiple sources.

DR. STEAD: First, a point of clarification and then a common on this last exchange. I want to be sure that I am parsing it right. The review committee is focused on evaluation of the existing transaction standards. The full committee is where we would really think through broadly what we need to do to help HHS and the country both evaluate and improve if the Affordable Care Act.

DR. SUAREZ: You are absolutely right, Bill. One small element to go back to Bruce’s point, even as we look only through the Review Committee at the administrative transactions, the goal is not just to look at the administrative transactions in a vacuum, but actually tied to the Affordable Care Act ultimately and some of the goals.

DR. STEAD: But then play back to the other set of questions you are talking about. That is right in the space of the community data engagement and the framework project. The administrative data and the clinical data flowing through the healthcare system are a small fragment of what we need to improve health.

The trick is not to overload those transaction and record-keeping capabilities, but to appropriately relate them to the others. That is really what at least I am hoping the framework will help us do. I have skimmed the JASON Report since Jon told us it was online, at least the front-end of it. It really is smack in the space. We all need to read it quickly.

MR. SCANLON: That is exactly it. I think the administrative data, much of it, and the clinical data is the healthcare system data. There is a whole other set of determinants and correlates and so on of health and population and prevention that are really not in that realm. I think we view that as part of the convergence as well.

MS. JACKSON: Could I make a follow-up note? It never ceases to amaze me how this committee and how this group of individuals takes on work with glee and say bring it on more and more. Linda was indicating the size of the topic is quite amazing. Where populations is going with its three streams, this continues to show the need to make sure we are of one voice, one committee, one group as you are dealing with a lot of these very intricate, complex areas.

What we will do as the year starts is make sure people know what is going on. It is not like standards. It is careening off onto its own again where used to be in pillars and that is there thing. We are all reading things together with the JASON Report. In the meetings and conference calls, we will make sure that people are aware so that we can keep that going and connected.

MR. SCANLON: Any other questions for Walter?

MS. JACKSON: A follow-upon that, you had something about the February meeting, Walter. That sounds like you will probably have another update. We will have another time period in February to provide where you are heading for the June meeting.

DR. SUAREZ: Absolutely, we will bring up updates on the work in February. We will talk later this afternoon at 2:45 on the larger standard subcommittee agenda and the work plan as is on the schedule. We will be talking about what we plan to do in February. Then in June you heard about WEDI and then we will talk about the rest of the year as well. That is really what we wanted to bring up here as sort of a review of the Review Committee.

I think it is very exciting new work. It is really incredibly timely. It is truly for the national media recognition from the Secretary to be designating the National Committee to act as a Review Committee, as a testimony of the work that has been done in these areas. I will turn it back to Jim.

MR. SCANLON: I don’t see Bob Kaplan.

MS. JACKSON: Bob is stuck in traffic. We are hoping that he can make it within the next 15 to 20 minutes. We are seeing if he is going to do this in time to actually be here or not. We can continue.

MR. SCANLON: Let me spend a couple of minutes if you think Bob is coming. What I did want to discuss was that in terms of new members, I have a couple of things. The Secretary is in the final stages of naming two new members. We will now accelerate the naming of additional members for the spring term.

The kind of people we are looking at, you all know the kinds of expertise that are specified in the NCVHS Charter and Statutes. It is pretty broad and very well thought out array. We are generally looking for folks that can wear more than one hat. Like many of you, you do that as well.

Among the first new members, I don’t want to name them yet because anything could go wrong with personnel areas. I think it is our hope that we will have the two new members to join us at the February meeting. We will also work through what could be as many as five members or reappointments and so on for the new group as well.

I managed to talk myself into Bob getting here. I will ask you to send me if any of you have ideas for new members. Send me your thoughts. I know I have gotten some great recommendations from a number of you. In the context of our discussion this morning, if there are ideas you have about who would be interested and who could serve our areas, all three or four areas, everything from population health to data access and use, the standards the ERHs, the privacy and confidentiality. Shoot me and email and we would be happy to put them in the hopper and work it through.

Let’s turn now to Bob. Hey, Bob. Welcome, Dr. Bob Kaplan who is the Chief Science Officer at AHRQ, formerly of NIH. Bob is going to brief us on some of the evaluation of ACA or some of the information with new directions even broader than that at the new agency. Bob, we welcome you.

Agenda Item: AHRQ Statistical Brief on the Impact of ACA Implementation

DR. KAPLAN: Thank you so much. It is a pleasure to be here. It is a pleasure to be back with the committee. I do have to say speaking of directions; I just had about over a two hour car ride from AHRQ to here. I think I set a record so that the George Washington Parkway had a sinkhole. The traffic just stopped. Then my GPS kept sending me in circles. Anyway, you don’t know how happy I am to be here. I am running a little bit late.

Why don’t I jump right into this? We had talked about giving you a little bit of an update of some of things that are going on at AHRQ. I set this up to be a broad range of things. I will rush through because we are running late. Hopefully we will have some time to talk about things.

It is a pleasure to be back with the committee. I was the NIH representative to this committee. Now I am going to be the AHRQ representative. It is just a pleasure because I enjoyed it. I wanted to begin with the AHRQ mission statement. The reason I am doing this is because our mission statement has changed. Some of the theme today is that AHRQ is looking a little bit different than it did a few years back. I want to explain why.

Our mission is to produce evidence to make healthcare safer, higher quality, more accessible, equitable, affordable, and to work with HHS and other partners to make sure that evidence is understood and used. It is the understood and used part of it that is becoming a core part of our mission.

When Rick Kronick left ASPE and came over to AHRQ, he wanted to develop a set of clear priorities for AHRQ. Our four priorities are to produce evidence to improve healthcare quality. The second one is produce evidence to make healthcare safer. The third is to produce evidence to increase access to healthcare. The fourth one is to produce evidence to improve healthcare affordability, efficiency and cost transparency. The common theme is to produce evidence. We are an evidence-producing agency.

The second part of it is that we just have these basic things that we are trying to do, make healthcare higher quality, make it safer, to improve access. There is an equity component to what we do. Then there is an efficiency, transparency and component to it. Those are a few things.

For those of you that are less familiar with AHRQ, these are a few things that you might recognize as AHRQ activities. We run the evidence-based practice centers. There are 11 of them. They were just re-competed. In fact, if you have ideas for what the evidence-based centers should be looking at, there is an open call on the website now to suggest areas that you might want to look at.

AHRQ staffs the US Preventative Services Taskforce, so the Taskforce is independent, but we provide the basic services for that. As the Chief Science Officer it has been great for me because we really like working for the taskforce. They are really smart people. They deal with very complicated things. They just did breast cancer screening which will be out in the spring and aspirin and cardiovascular risk factor management. They make different choices and when they make these decisions it is the taskforce it is not really us. We get to be involved in the discussions, but they get to take responsible.

I am going to mention the MEPS Survey briefly today. Then we have all of these other programs like management of possible acquired infections, which I will mention just briefly. Our budget is about $476 million dollars per year. It seems like a big budget coming from NIH where our budget was close to $31 billion dollars per year it was smaller. We have about $170 million dollars in grant activity and then a lot of grant activity.

It is set up a little bit different than what I was used to at the NIH. We spend basically all of the money on research. We do it different ways. Less of it is in investigator initiated grants, although we are working on that new configuration. A big part of what we spend is in PCOR Patient-centered Outcomes Research which I will mention in just a bit.

I just wanted to set this up with how AHRQ is pivoting from what it used to do. I think a lot of people thought of AHRQ as an agency that did comparative effectiveness research. This is an example of comparative effectiveness research that was funded under the RRA era. This is a study that came out in the New England Journal in the summer that had to do with epidural injections of corticosteroids for people who had spinal stenosis.

A couple million of these injections per year are actually quite costly. In this particular randomized trial, people were randomly assigned to Lidocaine alone or Lidocaine plus steroid. It turns out looking at patient-reported outcomes over the course of six months it didn’t make any difference at all.

This was a very interesting study because it affects a lot of people, certainly a profit center for people in anesthesiology and orthopedic surgery. It was not very persuasive evidence that this is having a big effect. Of course AHRQ was funding a lot of studies like this.

The point I wanted to make is that we are getting out of this business. We are not excited to get out of this business, but we are getting out of this business because with the establishment of the Patient-centered Outcomes Institute or PCORI most of the comparative effectiveness work has moved to PCORI.

What we are pivoting to is patient-centered outcomes research that primarily emphasizes dissemination and implementation. A brief premier on this — I actually didn’t know this before I came to AHRQ.

The Patient-centered Outcomes Research Trust Fund is funded by fees associated with health insurance plans. They are going up to about $2.00 per insured person. Everybody thinks of this as PCORI money. Actually the PCOR Trust Fund funds PCORI. So 80 percent of the PCOR Trust Fund goes to establish PCORI. Sixteen percent of it comes to AHRQ and then 4 percent goes to Jim. We share it.

We all are working together in this space. Part of the challenge for us is to work together as good collaborative partners, but also to set up what we do distinctly from one another.

To give you a sense of it, at AHRQ, this year it is about $106 million dollars. We were actually hoping it would be a little bit more than that. There was difficulty in collecting money from some of the people that signed up for health insurance. It is a substantial amount of money, substantial portion of our book of business.

What we have gotten interested in as many of you have been interested in this problem of this long delay between when knowledge becomes known and when it gets implemented in practice. I see Larry nodding his head back there. He is one of the leaders in this area.

It has been suggested that it takes about 17 years to turn about 14 percent of original research into patient care benefit. We are doing a variety of things that some of you may know. Some of you may be applicants for some of these.

One of the areas we have become interested in is in dissemination and implementation of practices which we know are evidence-based. One of them that have attracted a lot of attention is the Million Hearts Campaign, the ABCS, aspirin, blood pressure control, cholesterol control and smoking cessation.

The reason for this is when you look at the evidence-based reviews that the evidence-based practice centers do and you look at all of the things that are done in medicine and preventive medicine, there is very persuasive evidence that intervention on cardiovascular risk factors does make a difference in terms of cardiovascular mortality and all-cost mortality. It seems like something we should do.

If you look at how well we are doing, we are doing not as well as we should. For example, if you look at the number of people who have high blood pressure, only about eight in 10 people who have high blood pressure are aware that they have high blood pressure.

Among those only about 70 to 80 percent have their blood pressure controlled. Even though we have fairly good evidence that almost anybody can have their blood pressure controlled. It may take three drugs to get there, but laboratory studies and other studies show that blood pressure actually can be controlled in most people.

Only about seven to eight in 10 are treated. Among those, only about half of them are controlled. When you multiply it all out it may be only a quarter or so or little bit more than 25 percent of people who could benefit from this intervention actually get the benefit. On the other hand we know that some organizations do this really well. Kaiser Permanente is one that I did some work with when I was in California. Kaiser actually do quite well.

They use their electronic health record. If you have high blood pressure at Kaiser, they bug you. They get you in. The blood pressure control rates in Kaiser are substantially higher than they are at least in California where we studied it.

We know that in small practices we do somewhat worse. AHRQ had a competition this last summer for small practices to try to do what the big practices are doing, the Kaisers and the bigger players. Those grants had been reviewed and we expect awards to be made fairly soon. We spent a substantial amount of money, about $40 million dollars on this effort this year.

Another thing that we are doing, this competition that is going on now, applicants has been received. They will go to review in early January. We put aside about $10 million dollars for some Centers of Excellence on systems performance. We were very interested in high performing systems and the magic formula that makes some systems perform better than other systems. Again, those grants are going out to review. We are very pleased with the responses that we got.

I am going to mention three things today. I am going to do this quickly so we can ask questions and go to lunch. Three issues that I personally have been pretty interested in. I have to say these are not areas that I am very much of an expert in. I am new at AHRQ and am kind of learning what they do. I just want to mention three things that I thought were intriguing.

To mention how they have been stimulated by stuff that goes on here. I wanted to thank Vickie and Bill for getting me to think about this first thing. This has to do with harmonization of psychosocial issues, in this case the electronic health record. I actually got interested and familiar with this when I was a member of the committee representing NIH.

Vickie held a series of hearings that looked at how we harmonize the way we collect basic demographic information, information on income and education and race and so forth. It made me feel this was an extremely important opportunity that we are missing. At the same time we had the opportunity when I was at NIH to sponsor a study that the National Academies did on harmonization of psychosocial components of the electronic health record.

I want to say this is not an easy task. There are so many things that you could ask. You have to identify the things that you are going to ask about, the domains. Once you do that then you have to figure out exactly what you want to ask, the specific questions. If we could do this, this could have a big impact on the way medicine is practiced. You will get actionable information in the electronic health record.

What was most important for me is this could set off a whole new generation of research. If we actually had information in a harmonized, standardized way, and we could create databases, this could really be a revolution in the way we do things. We have Bill and Nancy Adler to chair this committee. They did a two-component report. One component came out in April. The other came out about two weeks ago.

This is sort of the basic overview of what they came up. They suggest that there are domains. They actually identified the domains. It was an all-star committee. I was really pleased with the way they put this committee together. They had sophisticated epidemiologists really in evidence-based way of looking at this. What are the questions that affect health outcome and then specifically how do you do it?

In the question/answer period if I get hard questions, it is great because Bill and Vickie are here to answer them. I do think this is a very important step forward. We are hoping that this is a very high impact report. As our Chief Science Officer, there is one little suggestion that AHRQ could do something, and we are going to try to do it.

I wanted to mention MEPS. I don’t know how many of you are familiar with MEPS. Chris and Jim are in the Data Council. MEPS are a big component of what AHRQ does. We spend about $60 million dollars per year on MEPS. MEPS is the Medical Expenditure Panel Survey has different components. It has the household component which branches off of the National Health Interview Survey.

There is a medical component and a medical provider component and then there also is insurance claims verification component. It involves about 1400 households, national sample and considers expenditures and deals with the distribution of expenditures and sources of payment. It also deals with demographic issues, family structure and so forth.

It tracks insurance status of the US population. With regard to what is going on with the Affordable Care Act, this provides vital information that helps us assess effects of un-insurance, changes in insurance status over the course of time, how entering the insurance pool affects peoples’ use of healthcare and so forth. I think the potential of MEPS is even greater than it has been in the past.

I always like to have at least one data slide. Steve Cohen who runs MEPS gave me this slide, which you can stare at forever. We have to go to lunch soon. It is a very interesting slide. It suggests that if you look down here about 1 percent of the US population accounts for about 21 percent of our expenditures. If you are in that top 1 percent of the population in expenditures, you spend about $87,000.00 per year on healthcare.

Then when you get to the top five percent collectively, it counts for about 70 percent or so of all expenditures are based on that top 5 percent, including the 1 percent. It is about $40,000.00 per year of healthcare expenditure on 5 percent of the people. Then all you healthy people at the other end, the top 50 percent of the distribution actually spends very little on healthcare.

Understanding the relationship between population characteristics and expenditures I think is very important. You have the handout. I really like this slides because it provides a lot of information. Before we wrap-up I will very quickly mention the healthcare cost and utilization project or HCUP. This is not a simple database. It is a family of databases and research tools and so forth. It has been growing over the last few years. It is just a collection of information about healthcare utilization and expenditures in the United States.

Different components of it include different parts. About 97 percent of community hospital and patient stays are actually captured in this system. We have about 47 states participating. Unscheduled care, the emergency room people don’t talk about emergency rooms when they talk about unscheduled care.

There are about 120 million visits per year for unscheduled care. I was really intrigued what we know remarkably little about. It is captured in the ambulatory surgery database and other components of HCUP that are publicly available.

Just briefly, these are the different components of HCUP and the participants. There are about 47 states that participate in the inpatient database. The state emergency department database, about 31 states. State ambulatory surgery database, 32 states and so forth. These are the types of things that people are doing with HCUP, readmissions visits, expected payers, medical treatment variations, hospital characteristics and so forth.

I am not a tremendous expert on this myself. I am sort of learning the richness of what is available. There are tools that are available like hcup.net that are interactive tools that allow you put the data down and use them. They are relatively easy to use and so forth.

How do I conclude all of this? I just wanted to say that AHRQ is a federal research agency. By the way, most of my life I was supported by AHRQ. It used to be the National Center for Health Services Research when I was on the studies section. Then it was of course AHCPR and now AHRQ.

When you work at the NIH, everybody knows the NIH. The President was there today. When you work at UCLA, everybody knows what UCLA is. I am surprised when I go around and talk a lot of people doesn’t know what AHRQ is. Even a lot of people in the Federal Government and the OSTP Committee on Science ask if AHRQ is federal. AHRQ is a federal agency.

We are devoting much more of our attention now to dissemination and implementation science. As we make this transition with our partnership with PCORI, you will see that much more of what we are doing is dissemination and implementation science. We are a major data provider with HCUP, MEPS and several other data services that we provide. It is a major component of what we do.

Look for us to reengage in methodological research. Rick Kronick is very interested in it. I am very interested in it. For the activities that the committee is involved with, we hope to be able to be a good partner. I hope that was fast enough. I am happy to answer any questions that you have. Bruce had a tent card up. Actually, I just started and he got it up.

DR. STEAD: I won’t ask any data questions. Part of it is just I am very excited that you are back joining us in your new role. I am very excited about AHRQ’s new mission because it is certainly consistent with where we are moving in the Population Health Subcommittee. I hope you can either be here tomorrow morning to listen to the discussion about the Roundtable or call in.

What we heard consistently from the community is they don’t really need more data. They need to be able to understand the data that they have better. The information needs to be actionable. This seems to be exactly in the direction hat AHRQ is moving. We have talked about data literacy, and we will talk about it more tomorrow, both from the perspective of communities and also from the perspective of data providers.

I think all of the time and energy that the federal government has spent generating data very little of those resources have gone to understanding how to do it in a way that really truly benefits folks in communities. I think the niche that AHRQ is moving towards is an incredible priority for the feds in the health sector in general. I am really excited about that.

One question, though, I noticed, and I don’t know whether it was embedded in the mission, the focus is really on healthcare. I didn’t really see a linkage between research on healthcare and looking at the impact on population health.

DR. KAPLAN: Let me do second part first and then we can go back and do the first part. Since I have been there, it was an interesting experience for me personally when I was at NIH. I had been in the School of Public Health. I understood population health. The years I spent at NIH really changed me. I really looked at things differently. I really internalized population health.

Then what happened is I went to an agency that really is about healthcare. This is really a challenging issue. If you go around AHRQ, most of the people at AHRQ is a combination of social scientists and physicians who have been to public health school. They really are believers in population health. Yet, they are not doing as much in this area.

We are talking more and more about this now. If we really are going to have an impact on the health status of the country how much of it can you really do with healthcare? One of the things we are intrigued by is all of these different estimates of how much of health outcome is healthcare and how much is behavior and how much is social factors and so forth.

I am intrigued by trying to reengage in those different estimates and to unify them. I hear that. We are talking about it. I hope we are able to focus more attention on it. The first part of your question — who knows what, will ever happen. I hope that what you will see is that we engage much more on this issue of how information is used from the community and patient perspective.

Although AHRQ has been engaged in dissemination and implementation for a very longtime a lot of what they were doing was very important. I personally didn’t think it was getting at the core of the issues. For example, they spent a lot of time on creating nice brochures to hand out. Maybe that is an exaggeration.

They printed out a lot of materials. They handed out a lot of stuff. The sponsored continuing education courses for physicians and so forth, recently trying to stand back from that some. How are we going to do this? Given that we are small with a limited budget, how do we figure out what we want to invest in, in disseminating? So we are looking at these basic criteria.

What is the population impact? How many people are affected by this condition? What is the evidence that if we did something differently that it would make a difference so there is an evidence-base for what we do? What is the difference between what is being done now and where are we now and where could we be?

It turns out we keep coming back to these issues where it is really about the interface between the healthcare system and people. I will give you one good example. There is a big issue on government, stewardship for the use of antibiotics. PCAST, the President’s Council on Science and Technology had a report that came out in September.

A lot of people say we have to go tell physicians that they need to be better stewards of antibiotics or give them the message that they are over-prescribing. You can ask the physicians in the room. From the day you went to medical school this gets drilled into your head. It isn’t really so much getting the word out to practicing doctors. They know this.

It is actually dealing with that interface between the provider and the patient. The patient comes in with expectations. There is a really intriguing study that we looked at, looking at antibiotic prescriptions for upper respiratory infections. You look at them as a function of the hour of the day. When people get tired in the afternoon, they actually prescribe more.

There are little nudges that you might be able to do. Also, it has to do with getting at this interface. It was a really a great study. A guy at USC named Jason Doctor, a very smart young guy has done this work where he gets physicians to sign a letter saying that they are going to be better stewards of antibiotics.

Then they blow the letter up and put it in the waiting rooms. When they do that, interestingly, antibiotic prescribing actually goes down quite significantly. Again, it isn’t really the traditional let’s give them the facts. It is a little bit more getting at these issues. We are looking for ideas.

DR. MAYS: As usual, thank you for coming. It is great to have you at AHRQ. Many of us know what AHRQ and all of the different iterations of its name were. One of the things that you put up I am very excited about. We were talking about it. It is the look for AHRQ to engage in methodological research. When Jim did his update it was so clear that there are so many issues that are really about methodological research.

I pointed out that both NIH as well as AHRQ was doing less of it. If you are coming back to it, I think it is exciting. My hope is that there will be some opportunity for you to hear several of the things. Some of it is in past reports. Then some of it are things that are going on in the department now that really could use this looking at methodological research.

DR. KAPLAN: It is funny, before I got into the terrible traffic jam today, this is just an example of the types of things that we have been funding and looking at. AHRQ has actually been funding some registry. With PCORI we have a big thing that we just funded on uterine fibroids. Uterine fibroids are a big problem. No one quite knows the depth of it.

It is not an easy topic for randomized clinical trials. We are launching this. We talked today to two pediatricians. You guys my know them. Chris Forest is from Children’s Hospital of Philadelphia, and Peter Margolis from Cincinnati Children’s. These guys are doing this work on learning healthcare system. Peter has this big project on managing kids with serious digestive disorders.

I think it is very intriguing work. If you look at the way we have always done things, it is all about a new molecule. Somebody develops a new molecule and then it works its way through and then finally gets to be a phase III randomized clinical trial. It gets a license. Then 17 years later it gets used.

They are engaging the learning healthcare system with a lot of engagement with patients and providers. There is rapid cycle feedback. What is quite intriguing is if you look at the remission rate for the people that are involved in their studies, it is almost 80 percent. To give you some context, it was about 50 percent or so in 2007.

By the way it is like a third of the kids in the country that have Crohn’s disease or inflammatory bowel disease. It is not a small number of kids. What they are doing I think is quite impressive. What I think is more impressive is they are developing methodologies that are alternatives to RCTs. I have been kind of pushing, serving on the PCORI Methodology Committee.

One of the ideas I have really been pushing is how can use observational data to provide alternatives to RCTs? If you look at what these guys are doing, they are able to use their systems and they are able to get the same results as RCTs, which is actually impressive.

The problem with it is that they already know the results of the RCTs before they do their analysis. If you already know the results of it, it may be easier to get through the result. What I was telling them was there are a ton of trials that are ongoing and they are registered in clinicaltrials.gov. Those trials are going to report out. They are double-blinded. Nobody knows what is going to happen.

You can actually use data in electronic health records to create modeling exercises where you can predict the results of those trials. That is a real test of whether or not you can use observational data to replace RCTs. If you can get to that stage like what Peter was saying this morning. They got the same results as big RCTs with one analyst and they did it in three months or something, where the cost of an RCT is quite substantial.

It is the idea of bigger, better and cheaper could be a reality. We also have a varied interest in Promise. We are funding components of Promise.

DR. SCANLON: Other questions for Bob? Thank you. It is good to have you associated with us again. Thank you. I think we are going to break for lunch and reconvene at 1:30.

(Whereupon, a luncheon recess was taken.)

AFTERNOON SESSION

Agenda Item: CDC Update on Surveillance Systems

MR. SCANLON: We are very pleased to have Chesley Richards here today to brief us on CDC initiatives in surveillance and the CDC surveillance strategy. Chesley is the head of the Office of Surveillance, Epidemiology and Laboratory Services. I think Chesley, the NCHS is still in your portfolio.

DR. RICHARDS: I’ll explain it. I am still confused by it. Thanks, Jim. I really appreciate the opportunity to speak to the committee especially in the coveted slot after lunch. I will do my best to try to not be boring.

I have a few slides that I would like to go through to explain what we are trying to do. I am really looking forward to the Q&A and the interchange back and forth. This is a CDC-centric strategy. That is what we needed to address first and we had the most control of. We did it in consultation with a wide variety of partners. There is where the great ideas are coming from. Hopefully from you we can get some even better ideas about things that we should tackle.

Let me explain my two titles. I have two. One is vertical and one is horizontal. As Jim was saying, I am the Director of the Office of Public Health Scientific Services. That has two centers at CDC, the National Center for Health Statistics here in Hyattsville and then in Atlanta the Center for Surveillance, Epidemiology and Lab Services.

That Center has a number of the iconic brands at CDC. There is the EIS Program, the MMWR, and The Taskforce for Community Preventative Services, some of our large surveillance systems, and a number of other workforce efforts on informatics.

Also, there is the CLIA Program that we do in conjunction with CMS. It has a lot of components. I think all of you are well aware of the great contributions and value here at NCHS. One of the best things about my job is that I get to work with Charlie Rothwell who I on paper am supervising, but somehow it feels like he is my boss. Those of you who have worked with Charlie understand what I am saying.

The second thing is I have a horizontal title so I am a Deputy Director at the Agency. There are five Deputy Directors at the Agency. What that means is I need to think about for the whole agency and not just my operational responsibility on the issues that I have under my umbrella which include the scientific disciplines related to public health, epidemiology, surveillance, informatics, the lab quality pieces we do and then scientific workforce.

What I wanted to do in the time I have is talk a little bit about the strategy and talk about components of the strategy that I think are relevant particularly for this meeting. Then I will end up sort of where I think we are going. What are the challenges?

Many of you work in public health or interact with public health so you are as aware of this as I am. At CDC, we have over 120 siloed surveillance activities. Some are IT platforms. Some are funding programs that go out to state and local health departments. Some are a combination of those two things. Tom Friedan, our director, reminds me that silos can work and they produce good data for that particular condition.

This is not to say that all silos are necessarily bad. What we are losing in silos is the interconnections, the inter-dependencies and the efficiencies that we can’t realize because of these siloed systems. What the state and local health departments tell us is that you are killing us. We have got too many systems, too many requirements. We can’t staff them. You have got to do something.

It also means that when technology advances we are pretty slow to adopt and implement. We don’t have the right workforce either at CDC around informatics in surveillance in the right place at the right time. That is even truer out in the field in the states and locals.

We have also had challenges in being effective and trying to address the emerging health information policy issues around electronic health records, Meaningful Use and interoperability. What are the opportunities?

I think we can move from where in public health we collect a lot of data manually. We pre-define or re-define what we are going to collect. We are used to that model. As many of you know there is a huge amount of data that is just sitting there in the healthcare system that we haven’t defined, but we can leverage and we can understand health.

That is a tremendous opportunity head of us. Improving interoperability is on all of our agendas, novel partnerships, doing more with the healthcare sector and with non-health sectors around issues that impact on public health.

Then we are moving into a revolutionary phase in terms of the visualization and the analysis of data. For us how do we communicate that data out in a way that really stimulates public health action? I think that the vision that we have with the strategy and for the efforts around the strategy are really to get to a point where we have more efficient systems that put the right data information in the right hands at the right time in the right format to take effective public health action.

As we went through the process, this was a charge given to me by Dr. Frieden about a month after I started last fall. We had 90 days to come up with a strategy. We did the outside consultation as well as the work internally. We settled on four general issues to address in the strategy.

First, improving the availability and timeliness of surveillance data to CDC programs for state and local partners and other stakeholders to advance effective use of information technology, electronic health records for sure, but to begin thinking about mobile technologies and cloud computing. To identify and amend or retire ineffective or unnecessarily redundant CDC surveillance systems, everybody at CDC in a leadership position applauded that until we started talking to them about their particular systems.

Then finally maximizing the effectiveness of the resources we have. A word on the resources: We have over 120 systems. It is very hard to sort of get a dollar figure for that. The best I could come up with is about $400 million dollars. I think that is conservative. Agency assets are being devoted to surveillance.

If you think about it, if you had a check for $400 million dollars what could you do with that versus the way we do it now? I think there is something that can be gained by being more efficient. The schematic really sort of lays out the way data for CDC traditionally flows which is from our sources which are out in the state and local jurisdictions flowing from laboratories, clinicians, offices, some patient reported data.

That can come in a whole variety of formats and does. There is everything from electronic messaging to paper and sometimes in the same health department it is coming in, in different forms. It is being routed for us for the most part through health departments where some of that data then flows to CDC. If you look at this bottom line down here in the black the four initiatives I am going to talk about next are really designed to hit pressure points in those two areas.

Electronic lab reporting, electronic death registration and reporting, and syndromic surveillance are really about improving the data flow from the sources to the health departments and then notifiable disease modernization initiative is about improving that data flow to CDC.

Now doing the left-hand of the screen, the ELR, EDR and syndromic surveillance to the health departments we are also going to improve the flow to CDC. It is specifically focused on that area.

Syndromic surveillance: How many of you are familiar with syndromic surveillance? Most of you. After the 911 and the Anthrax attacks, CDC got a lot of money for something called BioSense. The idea was that we would develop a national system for syndromic surveillance.

For the first several years of that system it was a federal system where hospitals report directly to the CDC. That produced nice reports at CDC’s level, but you can imagine that infuriated the state and locals because they were out of the loop. That had to get rectified and it did a few years ago.

The problem we have is it flipped completely so that we get very little use at the federal level or has been getting very little use at the federal level, but states and locals have more control of the data and are able to use it. We have had good success stories with both models, but what we need to move to is a model that has both perspectives. As part of the strategy over the next 18 months that is what we are doing.

We currently have almost 2000 facilities report. You can see from the map that is not really generalizable. It is very concentrated in certain jurisdictions. One of the initiatives we have in the strategy is to really get more representatives across the country.

In order to do that it has to be useful. I think we showed with the potential for a MERS epidemic along with all of the other infections that potentially can become epidemics that we have been able to work with the jurisdictions who are reporting to create value for them in terms of the analytic tools and the other things that are happening in the system to again get more groups coming on. I think that has been good.

There are a number of issues that we are addressing specifically in this system. Again, it is aimed at using really good data that can be used and aggregated with a national level. Really good data and tools can be used at a local level.

Data quality: So this data is coming from EHRs, from chief complaint fields in EHRs in emergency departments and some other sources, some lab reporting. You can imagine that data quality is a real issue. We have got projects underway to really understand the data quality and improve it.

This also is related to how we message. There are efforts on the messaging guide, getting standards-based messaging. The analytics platforms, the state and locals are submitting the data from their hospitals they are submitting the data, really need better analytic tools at the local level for this. That means deploying SAS, ESSENCE, and other tools in a cloud-based environment so that they can use that.

Creating something that hasn’t really existed before that I think will be even better, which is having a real community of practice with all of the groups that are doing Syndromic surveillance as part of this system to understand how lessons learned in one jurisdiction can be applied to other jurisdictions.

Electronic death reporting is a second initiative. Some of you are well aware of the work here that has been led by Charlie Rothwell, Delton Atkinson, and others at NCHS. The goal here is to really improve the proportion of records that move to NCHS. Our performance metric is interesting.

It is not about being able to report electronically. That is the vehicle. The metric is can we get a death record in the hands of a state public health official within a day of death. Can we get that record at the NCHS within 10 days?

Now, under their leadership at NCHS in 2011, about 11 percent of all deaths in the country were meeting that metric of getting NCHS within 10 days. It is up to 28 percent already. We have been very fortunate with support from the department, from other agencies, from CDC efforts to be able to get funds out to the states to really push this.

I think this is one if we can get more rapid reporting in an electronic format on death as a model potentially for other vitals, I think it gives us tools to be able to do things like this is a map of the states. Some of the states are really up over 80 percent in terms of that metric. Others have a little further to go.

If we can do that kind of work and get it to NCHS in a more rapid form, those death records suddenly become something we can use for surveillance in a way that hasn’t been done before. This is a good example.

You may be aware that every season we have flu there is a mortality surveillance system that occurs in 122 cities. It is called the 122 City Influenza Mortality System except it is only in 117 cities now because it is so onerous in terms of the data collection and submission.

That is a system that is over time breaking down. If you look at these curves they are almost identical, meaning that is a system that either probably not this flu season, but next system we can probably stop and rely on our vital statistics reporting systems because of the improved functionality in the reporting systems and vital statistics.

The other benefit is we will have a lot more data in terms of representation outside of the 122 cities that are part of the system. This model is also being looked at for a variety of other things that CDC Agency and NIH are investing around rare vaccine preventable disease mortality surveillance.

We need that surveillance, but because they are rare setting up a siloed system is really not where you want to put your assets. If we can use those vital statistics systems it allows us to use those resources to actually address some of the problems.

Respiratory syncytial virus mortality surveillance, suicide surveillance, a project that they are doing with NIH and then the pneumonia and Influenza mortality surveillance that I have already mentioned.

On electronic lab reporting this has been already a success story in the sense that for a number of conditions lab reports have to flow from clinical laboratories to health departments as part of the reporting requirements. That can come in a paper form or it can come electronically. We have seen over the last several years a dramatic growth in the number that is electronic. We are moving toward meeting a target by next year of 80 percent of all lab reports that come to health departments being electronic lab reports.

That then becomes an electronic piece that can be part of notifiable diseases and make that even better. I will talk about that in just a moment. It can also be leveraged for other things where electronic lab reporting is necessary.

This gives you an idea with the dark brown states being those states where over 75 percent of the lab reports are electronic. You can see a number of states are hitting the mark for our performance metric already. Then we are working with other states to get there.

Finally, our National Notifiable Disease Surveillance System Modernization Initiative: How many of you are familiar with notifiable disease reporting in the country? Most of you. There are required notifiable diseases within states.

Clinicians are required to report to their health departments. That is over 100 different conditions if you look at all states that are required. A subset of that, about 80 to 90 conditions, gets reported up to CDC through a voluntary effort and agreement with CDC.

The Modernization Initiative is about taking what is a system-based on 1980s software for the vast majority of our reports and putting it into a contemporary system that is really based on HL7 messages. To do that, we need message mapping guides and a bunch of stuff. If you look at the left bar, that is the frightening bar. I will show you the actual numbers in just a minute.

Green means that you are using 1980s software. Blue means you are using 2014 software. You see where we have to go. We are committed to doing it and reaching those targets.

This is the system that we have to work with. On the left side of your screen, you will see that there are a number of ways that notifiable disease reports come to a health department. They get integrated and then they are messaged to CDC in three different formats, HL7 in a very few jurisdictions, needs-based system which was the software system at CDC that was created in the late 1990s and then nets which was the software system that was created in the late 1980s.

Then it goes through a whole system here of getting transformed. The process before I came and before our leadership came was to take everything that came in and convert it back to the format that came in the 1980s. If you look at the software message, the nets message, it has got about this much content from the 1980s software. If you look at the needs-based system you have a few more variables, so you have about this much content. If you look at the HL7, it is about that much content.

We are taking messages in those fewer jurisdictions that gives us that much stuff and dumb it down to this. We are in the process of changing that process. It is one where things will flow in an HL7 contemporary message. We will standardize. They will go into a system that then can be accessed by programs.

In that process of taking messages and dumbing them down, what happened was that many CDC programs that made some investments in states to get HL7 messaging from the states then had to turn around and do a second ask from the states because they could not get the actual message that they sent from us. It is our own internal problem to fix.

This gives you the actual number. So we get about 2.4 million notifiable disease reports each year, 2.2 million are in that 1980s software. In the work that we are doing with message mapping guides and other things we are on track in the next 18 months to get this in terms of our performance metric up over 85 percent.

The reason we can get it up over 85 percent in terms of HL7 messages, if you look at those, there are about six different message mapping guides over six to 10 conditions. If we can get those implemented in the states, it will take us up over 90 percent over the message volume coming in that way and really set the stage for transforming the whole system.

Those are four initiatives that all have 18 month deliverables that are real. We are making progress towards those. In addition to that work, we also as part of the surveillance strategy wanted to address tools and policies. In this slide there are three sets of activities that we have done around innovation.

One of the things that CDC and other federal agencies and other organizations are you gets pockets of innovation all over your organization. In our organization they were disjointed, not connected and not informing one another. People failed on things, but we never learned anything about it. When they succeeded on things the other programs that could leverage that didn’t know about it.

What we created is a CDC Health Information Innovation Consortium, the CHIIC. In the CHIIC, we have people participating and learning about the various things that are happening. I think being able to share that information helps us. There are three investments that we have made.

One on the left side of your screen is the Surveillance Strategy Innovation Project Award. Earlier in the year in doing this, I found a small amount of money, about $250,000.00. I said can’t we have small projects. I talked to several people around CDCs in some of the states. They said sometimes they can’t move ahead on innovation because they can’t afford a $50,000.00 analyst or contract, or something like that. It is a small amount of money. We created this small grant program.

It is internal. It is competitive, but with a very stream-downed competition and a rapid award. We were at the end of the budget year for a small amount of money, and a lot of people told me nobody will apply. It is crazy. We had enough for five. We got 33 applications. When we looked through the 33, they were all good. We found money for four more, so we funded nine. We have got nine projects now moving ahead and people are learning about them and really innovating. I think it is going to have value.

The second thing is improving our CDC surveillance by developing an integrated portal where we can have visibility on all of the various surveillance systems in the agency and then how they in terms of the data systems interact with one another.

If you came to CDC and you asked the question how many systems have as one of the data standards that they use for ICD-9, we need that information because we have to make a transition to ICD-10. We didn’t have a clean way to do that.

Now we have a visualization tool that you can see the 30 or 40 programs that use ICD-9 and you can see how they are connected. You can begin to think strategically about how you implement new standards.

The third thing was to begin with ONC a vendor form where we could begin to bring vendors in a systematic way with our programs in a systematic way. We can say what we really need in terms of products are these things. They can tell us in a more systematic way what they have got.

When I took over this job, I would get a call virtually every day from outside vendor who had the latest and greatest thing that he just had to tell me, but then I would find out that he or she has also had the same meeting with 10 other people at CDC. This is a way to do that in a much more systematic way without breaking any contracting rules or any of that.

Finally, on policies, when I came in last fall, we did not have a seat on the HIT Policy Committee. Thanks to Karen DeSalvo, now we as a federal agency, are an ex officio, and I really thank her for the support on that. We had a report to congress tied to our budget that we submitted. It talked about some of the work we are doing. That has been transmitted. We will be briefing on that.

Then we created a CDC Surveillance Leadership Board. Many of you may now some of these people, but you don’t know them all. These are senior leaders from the agency. This is the first time we brought them together and said you all have an ownership stake in surveillance. We need to do this in an integrated way.

Some of the things we are addressing are data standards, funding opportunities and the use of data platforms versus solid systems. When you talk to states about all of the plethora of systems they have, in actuality the reason they have so many different systems often is because that is the way we at CDC give them money. We put restrictions on how they can use that money across systems to really invest in platforms.

We have got to think without getting in trouble with congress and the advocates who have interest in seeing the money that they have been able to appropriate to us go for particular things without violating those rules. We can figure out ways that we can make more strategic investments in platforms.

I am going to finish with that slide I showed earlier in terms of the vision, efficient systems that put the right data and information in the right hands at the right time, in the right format to take effective public health action. Then I want you to look over to the right to see words that really talk about the domains we are talking about here, efficiency and quality in terms of the systems, access. It doesn’t help us to us to have really efficient systems.

The people who need the data can’t get access to it. We have that all over at the right time six months later than what you needed to actually take action is not helpful. We need to have data that is much more timely and timely in a way that is necessary for the public health action.

Timeliness is different for an Anthrax outbreak than it might be for a cancer cluster issue that has to be addressed. It needs to be timeliness that is relevant to the particular issue that you are addressing in the right format. That speaks to the analysis, the ability to take the data and analyze it in a format and visualize it in a format that really helps you take action.

Finally, supporting those decisions that public health practitioners have to make based on the data they have been given. That is what I have. I really appreciate the opportunity. I hope that we can have a dialogue. Thank you.

MS. JACKSON: We know that you took special time out of your schedule to join us and had other things planned today, to come in and be a part of this, and talk about timely and accessible. We really do appreciate it. We have got cards up already. Bruce, why don’t you get started around the table?

DR. COHEN: Thank you, Dr. Richardson that was great. I told you before that I am a vital statistics geek. I wanted to talk to you a little bit about vital statistics. I totally agree with you that Charlie and all of NCHS do a tremendous job with very limited resources around revitalizing our vital statistics system.

Unfortunately we don’t have a vital statistics system. We have 57 vital statistics jurisdictions that operate independently through just an arcane set of byzantine state and jurisdictional regulations that control vital statistics. For instances, your slide on rapid reporting of mortality data, it is the state regulations that essentially inhibit the ability to report more quickly.

When you talk about CDC initiatives and strategic investments, I know the electronic birth systems and the electronic death systems, which were developed 15 to 20 years ago, are on the verge of being outdated and updated in many jurisdictions. Strategically, I think one of the errors that was made initially was all of the jurisdictions developed their own platforms.

There was no federal leadership to develop a common platform that could then be modified in all jurisdictions to provide consistent quality and standards for reporting. What happened was six or seven different vendors got into the game and competed against each other.

The cross walks didn’t exist and chaos essentially reigned. I think it really dramatically increased inefficiencies and dramatically increased costs. It led to essentially the lack of standardized quality rapidly developed and deployed systems throughout the country.

Your goal of making the data actionable in terms of electronic reporting of deaths and births rapidly would be greatly enhanced for a federal initiative to develop common platforms. My past affiliation with National Association of Public Health Statistics and Information Systems, states would love more direction and guidance from the feds to standardize the development of platforms for transmission of all vital events, births, deaths and fetal deaths, which are rapidly emerging as another important system.

As NCHS is taking leadership around disseminating provisional data, I think states are also vitally interested in supporting these efforts and would like more direction from CDC, from NCHS and the feds about how we could all be reporting and disseminating data. Again, there is a hodge-podge or regulations at the state level that slowed down the reporting of data. I think everyone is really committed for appropriate surveillance to generate provisional data much more rapidly.

My plea would be for CDC to pay more attention to develop common standards across all jurisdictions and to work with NCHS, but also work directly with the jurisdictions. There are some models within a lot of the vital statistics jurisdictions that are really very forward thinking that would serve as a wonderful basis for some of the innovate projects that you are trying to develop.

DR. RICHARDS: That is terrific. Thank you much.

DR. MAYS: Thank you for coming. I am glad we outrank New York. I am glad you here. I want to talk about mortality data. First, even through Charlie Rothwell isn’t here, I want to applaud when he linked the mortality data to the NHIS data. It made a big difference. Many of us have now generated papers using that data.

There are a couple of other issues. One is in terms of the mortality data, one of the things there has been concern about is how some of the death certificates get filled out in terms of race and ethnicity. Could we not have some kind of training particularly for people at funeral homes and some of the other places where that is done? I think it is what Bruce is saying. There needs to be some leadership to really organize that.

The other issue is the suicide data. My plea is as desperate as his plea in terms of the suicide data. In the National Violent Death Reporting System, one of the things is that it only has 32 states in it. I had to explain recently to a congressional staffer about that data because they are trying to make some answers around Ferguson. They wanted to have this discussion about data and what they could do. They were just stumped.

Finally, I said you have to go talked to CDC. Don’t kill the messenger. I am here to just explain the data. Again, we need this data. We need this data both in terms of being able to deal with suicides in this country. What has happened is the same situation that Bruce is talking about. California has its own. Other groups have their own.

It makes it very hard for us as public health people to be able to look at very broad trends and be able to come up with prevention and interventions that are really critical. When I had this call about the Ferguson stuff it just dawned on me. Part of the injustice that is going on right now is the inability on a national level to be able to really talk about violent deaths by guns.

I wrote a paper about some of the mental health stuff and I talked about what the problems were. I hadn’t realized it until they were really trying to prepare something and realize that the federal government can only give them like 32 states. Everything else would be cobbled together. They can’t even move fast enough in order to get what they wanted.

The notion of leadership around asking states to come together or mandating operability in some kind of way as well as accessibility to the data –- that is the other thing. For them to try and get all of that data it was going to take too long. They are trying to make this statement that is based on 32 states.

Those states weren’t always the states with some of the worst problems. That really made me understand why sometimes we can’t answer very critical questions because it is cobbled together. I know we are doing as well as we can. I think given now that I see the seriousness of the problems; I really kind of knocked the wind out of me, not being able to help them better in terms of figuring out a strategy.

MS. JACKSON: I am glad you are on board to hear this. Bill and then we will go around this side.

DR. STEAD: Let me also thank you for being here and applaud you for doing things that will clearly improve the existing system. I appreciate hearing your thoughts on a couple of dimensions that didn’t come out today.

One is what kind of surveillance we need or are planning to develop around emergent, non-recognized problems. What is the relationship between the kind of efforts that you envisioned CDC doing and things such as the FDA’s Mini-Sentinel program, et cetera.

A second dimension is as you think about national and local presentation are you taking local, for example, down to the level of the individual hospital or provider. Does a health hospital or health system see all of the people that they are responsible for that died yesterday at the same time that public health are trying to see it? We are trying to see it on a national perspective. Those are just two different kinds of dimensions that I don’t know are part of the plan.

DR. RICHARDS: I appreciate that very much. Let me say a couple of things about the plan. Then I will address specifically these issues.

When I was given this charge last fall, one of the things that became readily apparent in discussions with people who had been down this road before was that a lot of people came into a job similar as mine and then exited having not accomplished what they set out to do over the last 20 years at CDC.

A lot of grand ideas, a lot of really good ideas in, but in terms of the implementation they were too far removed from delivering on something to be sustained. We can talk a long time about the pros and cons of that.

I had to make a strategic decision coming in. If I tried to do this and address everything that we know we need to address for the future, I may not be able to survive in our current environment. What we chose to do was what we considered to be the low-hanging fruits of really improving the systems that we’ve got.

Having said that to me the bigger challenge, but the more interesting challenge is what surveillance looks like in the future. We have got some initiatives, but I don’t think that we have done enough not was the plan as it was set out earlier this year designed to be the end-all, be-all forever.

There are going to have to be refreshments in the coming year that bring in partners and really have this discussion about the future and some of the common elements of the future.

One is -– I alluded to it before -– in public health, we have a tradition of defining the data that we collect around what we think we are going to need. What that leads to in many cases a lot of good data about a condition, but it also leads to thinks in notifiable diseases we have data on 62 variables on a particular condition. We use probably 10 of those variables. The states just say they are not going to put any other stuff because nobody ever uses them.

I think with this tradition we have got to migrate, not to throw it completely away because there are going to be situations, maybe in emerging diseases in particular where we need to go out and do primary data collection. We have got to learn how to use the data that is already there.

What that brings us into is immediate is where is data that is relevant to public health issues? It is in the healthcare system. That is one place it is. We have embarked on trying to stimulate novel relationships with PCORI for example, in discussions with Joe Selby and Rich Platt about how a system being built in PCORI and the PCORnet system of systems. It is really designed for patient outcomes research. How can we use that for surveillance for public health needs? We have had some preliminary discussions about how to do that.

We have had discussions with vendors who control either the products that collect data or even in some cases large amounts of data about relationships. CMS: We have a relationship where we are getting much more CMS data and working more closely the CMS innovation center to really leverage what they are trying to do from a payment standpoint and a new model standpoint and think about the data there they are collecting and what other data could be there.

Discussions with the Mini-Sentinel about systems that are really designed -– if you look at Mini-Sentinel it is really built on work that was funded by CDC around vaccine safety. Leveraging those techniques of looking at distributed data queries and analyses in systems where there are repositories I think that are going to be another one.

My point is I think we have a number of baby steps toward leveraging that broader world of health data that is in healthcare entities. In insurance, we haven’t even talked about it, but that may be another one.

I think when you look at the models around ACO and primary care medical homes they are more population-based. So the data systems that are going to eventually support those payment models are going to be more analogous to what we are used to in public health. I think there is a synergy there that we ought to be leveraging.

The other interesting thing we have had some work -– and I think the more exciting work on this is happening in large cities. If you look at New York, you look at Chicago, you look at LA. It is around what are the data systems that exist outside of health that impact on housing data, air pollution data. We have worked with some, but have we really leveraged it in way. All of those other sectors need to be leveraged.

Again, in cities, if you look at cities there are some exciting things happening in New York and other large cities, but not so much at the states. There is no reason it couldn’t. We could do some work at the national level. I think for CDCs role in particular, I do think we have the opportunity in working with large national holders of data that have locally relevant data to be the broker to help get access to that data and then make it available to the local jurisdictions who really act on it.

I had an interesting conversation with Executive Board of National Association of City and Community Health Office. After about an hour discussion, I said if CDC were to be able to broker a relationship with CMS to get national access to data and be able to create a way for you to look at what is locally relevant to you would you see that as a threat or an advantage. To a person, they said we want you to do something like that.

When I think about what the future needs to be, I think we need to be taking advantage of those existing sources of data and then the resources we put into primary data collection ought to be targeted for where the gaps are and where we need to more deeply or we need to know things that we are not going to pick up in those systems. If you ask me what the future is that is sort of what it looks like.

We also have efforts working with AASHTO and a range of public health partners on a community platform, the cloud-based computing environment where people can have their lockers and put their data. I think all of that sounds great, but if you don’t do that in a standards way with interoperability you really haven’t gained a whole lot. We are doing something similar internally to have a CDC platform.

Those are some of the things I think we could be doing for the future.

DR. SUAREZ: Thanks so much for that presentation. I am very fortunate to be part of BioSense and BioSense Governance Group, as well as the one that you just mentioned, which I was going to ask you about, public health community platform, cloud-based application.

I think the experience that we have in the private market with cloud technology is very valuable and demonstrative of the community that can be brought to public health. Local public health would not have not necessarily recreate or invest in technology that they can grab from the cloud. I am very excited about all of these changes.

The one thing I wanted to ask you about is we always talk about the importance of bidirectional communication. Throughout the presentation a lot of the concepts were really from providers to CDC or providers to public health. More so now than ever I think we are interested. This is speaking for more of the private organization in finding ways in which we can also receive that and receive that actionable information in a timely fashion.

It is almost like the way I describe it generally is the ability for a physician at a point of care while seeing a patient to receive environmental information. It is sort of like the weather information that comes into play to allow the provider not just to see the individual and the individual’s condition, but all of the other public health and environmental health factors that would be valuable in improving the health and the wellness of that person.

I wanted to ask you if there are any efforts around that concept of developing better tools and resources to provide that information to the partners, if you will, both in terms of local public health, but also in terms of healthcare organizations or healthcare providers?

DR. RICHARDS: Absolutely. It plays out in a variety of different ways. Having that bidirectional capability in the systems that I talked about, particularly in Syndromic surveillance, if data is coming from your practice, your hospital, your ER, having a way to compare that data with what is going on around you is really important.

There is certainly an interest in being able to do that and linking it to other tools, environmental data sources that would be relevant to whatever thing you are dealing with. I think there is that. I think there are also more subtle things. There is a lot of work in pockets around the agency to really leverage decision support in EHRs. We already do that with immunizations in terms of the immunization registries and having decision support linked to ACIP guidelines.

We could develop our own tools, but one of the paths that was decided on at CDC was to do a standards-based document that vendors could then use to incorporate the latest ACIP in a real-time way, ACIP recommendations and decisions support. I think there is a lot CDC can do around that.

If you look at what happened most recently with Ebola, for example, I think we all know it wasn’t the EHR that created the problem with the patient who died. We all know that EHRs didn’t function in the way that they could have either stopped the problem from happening or given the clinicians the best information.

CDC was actively involved with ONC and with vendors to think about how they can rectify some of this. That was a response from emergent situation. I think it has created a greater dialogue about how do we design EHRs in a way so that they have got real-time information supporting their decision support. I think there are efforts to do that. It has relevance also to data collection.

I think there are spill-off benefits from that standpoint. I think we are very aware of those particular challenges.

MS. GOSS: This has been a really exciting conversation for me. It has been at the crux of a number of issues that I have watched within my own state. I have heard the pains to which you speak from providers from state agencies, et cetera. I am glad we are having the conversation about interoperability. I really see that it also links with a lot of the standards of committee work and the larger committee work on NCVHS.

We know that a lot of the efforts that we have right now are not necessarily technology efforts. They are also people dynamics in the process and all of us being on the same page and working towards a common goal. It is clear from a CDC perspective that you are creating that common vision.

It sounds like in small ways you are starting to create pockets within the work within CDC that will start to infuse that vision and more of the cultural approach to collaboration and leveraging technology and data outward to the states. Can you speak a little bit more about what might be coming down the pike from a state’s perspective and how we will see that bubble down to a local community perspective? It is really about the whole continuum getting on the same page.

DR. RICHARDS: A couple of things I would say about that. Some of the most exciting work around any of the surveillance topics I mentioned or other surveillance topics that you could bring up happens in the state and locals. When you look at what some of the cities are doing around data integration and standards-based approaches and leveraging all kinds of data it is really exciting. It is the same with some of the states.

I think one thing in setting up some of the structure we have is to be able to learn from that to be able to have the kind of forms where we can actually share more. We hear this from states who aren’t having some of the successes. They want to know who you get some of this stuff done.

So creating those forms with our partners, with AASHTO and CST and NACCHO and NAPSIS and other partners, creating those forms where that can happen is one thing.

The second thing I alluded to and I think we discussed before was to be really serious. It was on the surveillance literature board slide that I showed you. Some of the challenges that states have is not that they don’t necessarily know what to do at the state level or city level.

They want to invest in a platform that is really state of the art. They want to do things in a more bidirectional way with their local jurisdictions. When we at CDC send them 30 different funding lines and then put prohibitions to merge funding to buy that $2 million dollar platform it is not helping.

Again, without getting in trouble with congress or with advocates, we have got to create a way for funds to be directed in a way to make the kind of investments at a state information technology standpoint that will really give them the state of the art platforms. I think there are ways to do that.

If you get funding for HIV, for example, if you can take a portion of your funding and invest in a common platform, proportionate to what HIV is in that platform, that seems like a pretty reasonable thing to do. I think we can do more of that and explore new ways to have funding bundled in a way that they can make these kinds of investments.

We also hear a lot about training that it is great to have a platform. It is great to have this, but we can’t hire people from the information technology field. They are too expensive. If we get them we can’t keep them. We have got some really smart public health staff that are really committed. They are happy with the level they are getting paid. They are going to be here.

If we had a good way to train them and give them some of the skills –- not the full range of information technology skills –- but some of the skills that would make them more effective that would be great. If you don’t have the ability and the funding they get to be able to dedicate part of your funding to that training opportunity you have got a problem. There are things that we can explore there in terms of new opportunities for training.

Also there is leveraging other assets from other partners that are in the information technology field. It has been interesting to have some of the discussions with some large health systems. They are willing because they see a value in the community investment.

They are willing to leverage some of their assets to help a health department really address population health. It is going to affect your bottom line as a business, but it is also going to be a benefit to the overall community even if they don’t get care in their particular system. Those are some of the ideas that we are exploring.

MS. JACKSON: Was anyone online before we open up some more? Linda?

MS. KLOSS: I actually have a late breaking question that was prompted by your most recent comments. How is this work being informed by surveillance work in other countries as you look outside of the US for some best practices or emerging best practices?

DR. RICHARDS: It is being informed by the work in other countries. You might not predict which countries in actuality. Some of the most interesting challenges and work are happening in Africa right now with Ebola in terms of how do you in a real-time way without a lot of resources get the data that you need in a format so that it not only serves the purpose of that village, but it informs what the CDC director is going to tell the President.

How do you do that in a few hours and know that it is accurate and know it is nothing that can be acted on. There are interesting things that we have learned with some of the tools that CDC would normally use both domestically and internationally.

They are cumbersome. They are clunky. They don’t give you that kind of real-time feel. The thing about an event like the horrible Ebola epidemic that we are dealing with is that it attracts a lot of really interesting partners around the world. Those systems are helping educate us on the things that we need to do better. That is one sort of real example.

In addition to that we have relationships with a number of countries, obviously. We have people from CDC who are placed in about 60 or 70 countries around the world. We have regular relations with other countries. We are learning from that. I think some of these real-time lessons we are learning in Africa and other places are really helping us re-think some of the paradigms we have here.

DR. SUAREZ: Just a quick follow-up. I was thinking the number of richer countries that have centralized health systems across the north in Canada or in Europe and Germany or France, where in some cases they have perhaps a more centralized and more ubiquitous EHR system for example. It seems like this is still an evolving area as well in those country.

The way I understand it, this is not something that even in countries that have a lot more centralized health systems and certainly the ability to really gather public health information, not through a lot of the unique structures that we have in this country. It Is not something that has advanced at the point that we are behind or anything like that.

DR. RICHARDS: At least from my perspective, it is interesting. I think you are right. There are countries that have a national healthcare system and centralized data systems. They actually can’t do some of the things that you might think they could. We still can learn a lot from those systems.

I would say in our country we also have a great diversity. We have New York City where Tom Frieden was before. Their health department is very involved in the healthcare system and doing exciting things around colorectal cancer screening and cardiovascular disease prevention and all kinds of stuff that are very integrated with healthcare systems.

We have other jurisdictions in the country that don’t even talk to the healthcare systems. We have to be able to deal with that diversity. As much as I would like to say we have a federal platform that is going to fix everything, I don’t think in reality that is possible, especially in the current political environment. What do we do?

What we do is try to move people toward more standards, toward more interoperability. We try to demonstrate best practices. We try to show where innovations are really making an impact. We try to do this with an eye toward what are the financial assets that a jurisdiction is going to have to be able to do any of this?

Providing a $10 million dollar solution for a jurisdiction when they have only got a very little bit of money is not going to be helpful. I think we have to balance some of those things.

MS. JACKSON: Is there anyone on the phone who has a question or a comment?

DR. BURKE: How much post-marketing surveillance are we doing around medications due to the market when they are out of the clinical trial and into the generalized population? Questions about how much post-marketing surveillance we are doing on drugs once they exit clinical trials in general use with other comorbidities.

DR. RICHARDS: That is a very good question. It is very important. It is primarily under the purview of FDA working with a number of other health partners and government partners. I think the primary efforts have been centered on what was mentioned before the mini-sentinel system which really can do that type of surveillance, or at least that is the idea around 150 million people.

There is a lot of synergy between that system, the CDC system around vaccine safety, the Vaccine Safety Data Link and the PCORnet that is part of PCOR. There are these large systems that I think are going to give us more tools to do that kind of work.

MS. JACKSON: We will have public comment right before adjourn plenary, but if you could stay with us. What I had in the few minutes before we adjourn is just a little stop break to look at strategic plans for NCVHS. This might be a great segue to the letter that I sent out to the full committee.

This was from the joint public health informatics taskforce on requesting improvement in public health surveillance systems. It couldn’t have been a better placement. Where there any comments about that? Then we can follow that up in the next session.

DR. SUAREZ: Sure, I can probably give some background on the letter for those that might not know it. The Joint Public Health Informatics Staff or JPHIT is a collaboration across multiple state, local and federal public health organizations including AASHTO, the Association of State and Territory Health Officers and NACCHO, one that Chesley mentioned is local, city and county offices as well as APHL, the public health laboratory association, CSTE, the state epidemiologists. There are several other organizations.

JPHIT has been working over the past four or five years on the importance of brining out information technology related issues to public health and serving as a forum really for a lot of the work that is being done nationally on adoption of standards for public health including Meaningful Use Program, electronic health record certification program, as well as other activities around standardization of public health data.

I happen to be a member of the board of JPHIT representing the former Public Health Data Standards Consortium. The discussion at JPHIT was that really the epidemic really offered an opportunity to highlight the importance of outbreak management and early warning systems if you will and improving the effectiveness of those systems, particularly the role of health IT in advancing those systems.

The letter was drafted and actually submitted to the Health IT Policy Committee, the Health IT Standards Committee and the National Committee in the interest of primarily raising the importance of this issue and the opportunity to have actions around through the National Committee convenings on an activity on this topic. That is what the letter from JPHIT is.

The recommendation is to consider organizing some sort of a hearing or activity that would allow the testimony of different organizations to be brought forward with respect to the role of health IT in this outbreak management capability and electronic public health surveillance systems. That is the background of this letter. I think it was very timely. I think it is very timely to discuss it here.

MS. JACKSON: Dr. Richards is on board as well, the importance of everyone knowing and being on board when communicating. We appreciate you being here.

DR. SCOHEN: Dr. Richards, did you get a copy of the JPHIT letter? I was just curious about your thoughts were on it.

DR. RICHRDS: Yes, I have seen it. We appreciate JPHIT highlighting some of the issues and communicating that to the various FACAs. I think that is positive. I think I would stop there.

DR. COHEN: I was a little surprised. I saw the list of folks that it got sent to. Targeting us as the primary FACA organization to deal with this, this seems more like an issue that would be focused at CDC.

I was wondering if we were to consider working in this area, I would strongly recommend that it would be in partnership with CDC and a variety of designees who seem to have more expertise quite frankly in developing surveillance systems than CVHS does right now, although our strengths are in health IT, I think substantively CDCs strengths certainly are in developing and evaluating surveillance systems, particularly for infectious disease.

MS. JACKSON: This is for information. When letters like this come to the office, they usually go to one of the subcommittees. That is the usual level of conduit. It was felt that the issues were so prevalent and so prominent that we were having surveillance on the discussion for plenary, we sent it out to the full. We can discuss that later. This was not a sense of obligating or putting on a docket, but really for information that is the timeliness of real-time that is so important. We wanted to be a part of that.

DR. RICHARDS: I think what I would say from a CDC perspective I would characterize it as an incredibly good working relationship with all of the organizations that constitute JPHIT. I think all of those organizations and CDC and public health in general are aware of the issues that are raised there. I think part of opening this up is to bring other partners in to the discussion in a way that hasn’t necessarily been as effective. I don’t know, Walter, if that is fair.

DR. SUAREZ: Absolutely. I do want to express a couple of points. Number one, I mentioned this letter was actually sent first to Health IT Policy Committee and the Health IT Standards Committees, those two committees and then also to NCVHS as a request for consideration more than anything of a potential opportunity to gather some feedback and provide advice to CDC to the Department of Health and Human Services. It was a lengthy set of discussions with the full JPHIT. JPHIT includes CDC.

It includes all of the organizations that I mentioned. There is about 12 national public health organizations, NAPSIS is there to, NADO another new affiliated organization. Everybody thought it would be a good idea to raise a series of issues and points and request that if it would be helpful to convene something like that to provide some discussion or open opportunity and then advise the department on actions. Not just the Department, potentially even congress, farther up. That was sort of the intent.

It wasn’t really more than that. I think it was a very timely opportunity given the seriousness of the global crisis that we are now facing and are facing. That was the intent, to really pursue this through the FACAs, not to go around CDC. Actually CDC is part of JPHIT. It is in very good partnership with all of the organizations with CDC, with some of the private sector representatives that are in JPHIT. That is the main thing.

MS. JACKSON: So it is good the subcommittees and everyone has that information. We had a question from someone in the audience. We can have a quick public comment. Introduce yourself.

DR. DEWAYNES: I am Dr. Michael DeWaynes, Chief Public Health Officer for the American Optometric Association. I appreciate your comments. I appreciated the fact that you brought up the silos. Walter over here mentioned the environmental components to disease, which are extremely important. We are seeing that more and more each day.

One of the silos at CDC seems to be ATSDR. I was wondering if there is any way that you could somehow overlay those datasets at ATSDR to some of your datasets and whether that is something that has been discussed. Thanks.

DR. RICHARDS: It hasn’t been explicitly discussed, but that is a terrific idea. So folks understand the relationship, ATSDR is a separate agency from CDC. The CDC Director is also the administrator for ATSDR. Within CDC the Director of the National Center for Environmental Health also plays a similar role, but they are distinctly different. I think taking that extra step and figuring out how there is data integration would actually be a nice addition. Thank you for that.

DR. STEAD: I am aware that there is a lot of activity around both the response to Ebola and this question that has been surfaced within the IOM. The IOM is engaged not as a leader but as a part of a lot of this activity. It seems to me that what we would do is it would be looked at, at the subcommittee level.

The first thing we would do would be to get our hands around what is actually in place. Is anything extra needed or not? There may well be plenty in place. I don’t know if that is a population health subcommittee question, a standards subcommittee question or some amalgamation of the two since it needs to be handled at the subcommittee level. You can figure that out and let us know. Thank you.

DR. KAPLAN: I had a question for Dr. Richardson that is not related to the letter but related to your presentation. It has to do with you mentioned training. I am curious about where you guys are going with that. When we look at the Learning Healthcare System, for example, where are the people going to come from that are going to lead this? Are there physicians that understand information science or information sciences like healthcare and population health? When you talk about training are you thinking about degree programs or short-term training?

DR. RICHARDS: That is a terrific question. I think we don’t grant degrees and we are not funding people to grant degrees. Having said that, a number of schools in public health, along with a number of other professional schools, are including tracks around health informatics or even degrees on health informatics.

I think our focus on training around health informatics in particular at CDC, has traditionally been to have a fellowship program on public health informatics where we have a number of trainees. They do a two year fellowship and then they have been employed both within the agency and in public health and then other sectors.

I think our investments will continue there, but if we are going to do new investments it is probably not with that model. It is going to be more along the lines of the training in place model. It gets at for our particular partners that we work in public health and especially in institutional public health. What I mean by that is state health departments and local health departments. They can’t hire somebody who comes out as a bonafide hotshot informaticist because they can’t afford them. If they can get them in the door. after about a year or two, they get hired by the billion dollar health system down the road. But they do have dedicated public health people who are very smart and who are very committed. They know a lot about epidemiology and they know a lot about public health.

What they need is training in place to give them the tools to be able to leverage informatics in a way that can help them get their job done. If you think about the scale of investment and the output for training one two year fellow, we can probably train 20 public health practitioners to have enough informatics savvy to be able to get their job done.

I think that is where we are going to put more emphasis going forward. Hopefully that addresses the question.

MS. JACKSON: One more final follow-up.

DR. COHEN: Bob, I thank you for bringing that up. That highlights one of the messages we have been hearing clearly from communities around technical support. It is the fact that we have generated lots of data, but communities don’t know how to use the information that we provided. I would love for us to be actively involved with you, Dr. Richards as we move forward thinking about strategies for HHS to provide ubiquitous technical support at the community level.

We talked about the agricultural extension service model. We have talked about data concierges. We have talked about strengthening regional HHS Office abilities to provide support at the community level. It is clear that we have done a much better job of being able to generate data than be able to help communities use the information that we create. This is going to be one of the focuses of our next year’s work.

DR. RICHARDS: If I can respond, I think that is a terrific investment. I think the other thing from the Affordable Care Act that has some legs in this area is the requirements from the IRS around community health needs assessment. The idea if you take that to full implementation, the idea is that communities can come together with a range of partners, one of whom is a public health department. The other partners may include not only the healthcare system but people like the nonprofits and the United Ways, to be able to say together what is the health of our community and where are our investments going to make the most bang for the buck to improve health? If we can leverage the variety of partners in a community who have in many cases the informatics skills and leverage that asset, that would be a tremendous boom for a lot of communities.

DR. KAPLAN: Just a quick response. There was a really interesting model that Rick Brown, before he died, actually had a – I used to call it evidence based advocacy. He did a great job of bringing people in from the community and teaching them how to use the California Health Interview Survey. They were actually very early in developing these tools. (microphone issues)

We are getting to the point where there are a lot of online tools that people can use for a variety of different datasets. I think it is an important step for a lot of groups.

MS. JACKSON: On that note, it was great to realize the importance of the nexus point of communication and talking to each other. That was one of the points you made in some of your slides, Bob, and the same thing. You see how important it was for you to be here. I hope that comes across. As you can tell, we will continue to be in touch. We are going to adjourn the plenary and in three minutes. Yes.

DR. COHEN: Right before we adjourn the plenary, I want to call everyone’s attention to the definition of community and this wonderful poster that will follow us wherever we go. We might tweak the definition of community, but it all goes back pretty much in every meeting, we end up talking about what we mean by community. It is there in black and white and fuschia and blue and green for us all to see. I want to thank Tammara, and the staff at NCHS, for putting together that poster for us all.

MS. JACKSON: Thanks so much. We will have to get that on the website. We will adjourn plenary now. As Jim mentioned, as far as the subcommittee sections, we will start with Standards and then follow by Privacy. Tomorrow morning we will start with Populations. Plenary will begin tomorrow again at 9:15. Thank you.

(Whereupon, the Plenary Session adjourned at 2:50 p.m.)