[This Transcript is Unedited]


Meeting of:
National Committee on Vital and Health Statistics

November 29, 2016

National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782

Proceedings by:
CASET Associates, Ltd.



Agenda Item: Call to Order and Review Agenda and Layout for the Two Days

DR. STEAD: We will start with our introductions of the committee members, including whether you have conflicts or not. Would you like to lead us off, Nick?

DR. COUSSOULE: I am Nick Coussoule with Blue Cross Blue Shield of Tennessee. I co-chair the Standards Committee, member of the Executive Committee. I have no conflicts.

DR. GOSS: Alix Goss with Imprado. I am a co-chair with Nick of the Review Committee and the Standards Committee. I have no conflicts.

DR. PHILLIPS: Bob Phillips, American Board of Family Medicine, member of the Population Health Committee and Executive Committee, no conflicts.

DR. STEAD: Bill Stead, chair of the Committee from Vanderbilt University, no conflicts.

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

MS. LOVE: Denise Love, National Association of Health Data Organizations, APCD Council, Population Health and Standards Subcommittee, no conflicts.

DR. RIPPEN: Helga Rippen, member of the Full Committee and the Population Subcommittee, Privacy Subcommittee and the Data Working Group. I am from Allergy and I have no conflicts.

MR. LANDEN: Rich Landen, member of the Full Committee, Standards Subcommittee and Review Committee. No conflicts.

DR. CORNELIUS: Llewellen Cornelius, University of Georgia, member of the Full Committee and the Population Health Subcommittee, no conflicts.

DR. STEAD: Vickie, would you read yourself in please.

DR. MAYS: Vickie Mays, University of California Los Angeles. I am a member of the Full Committee, Pop. I have no conflicts. I do the working group.

DR. STEAD: Bruce and Dave, could you introduce yourselves?

DR. COHEN: Bruce Cohen, Massachusetts Department of Public Health, member of the Full Committee, co-chair of Population Health Subcommittee, no conflicts.

DR. STEAD: Are you on, Dave?

PARTICIPANT: He is on the webcast.

DR. STEAD: Rebecca then.

MS. HINES: Rebecca Hines, executive secretary with CDC and NCHS.

DR. STEAD: Can we pass the mike for staff?

MS. SQUIRE: Marietta Squire, NCHS, staff to the committee.

MS. BRETT: Kate Brett, NCHS, staff to the Pop Health.

MR. DECARLO: Michael DeCarlo, Blue Cross Blue Shield Association.

MS. KOCHER: Gail Kocher, Blue Cross Blue Shield Association.

MS. DEUTSCH: Terri Deutsch, lead staff to the Standards Subcommittee and the Review Committee.

MS. JACKSON: Debbie Jackson, National Center Health Statistics, committee staff.

MS. JONES: Katherine Jones, NCHS, staff to the committee.

MR. RODE: Dan Rode, education and consulting and also representing the Electronic Health Network Accreditation Committee.

MR. WHITE: John White. Interested bystander from the Office of the National Coordinator for Health IT.

DR. STEAD: Anybody else on the phone?

DR. HUNTER: Good morning. Mildred Hunter, regional coordinator, Office of Minority Health, US Department of Health and Human Services Region Five.

DR. STEAD: Welcome everybody. This is our first chance to be in the new space and my first meeting as chair. I thought I would make a few personal comments to start the day. Personally, I am humbled to have the opportunity to serve you and the country. Over the next couple of days, we are going to work together and identify how to best use our time and our resources. We need to find the right mix and sequence of vision development and work yielding recommendations that are important in the near term.

We then need to tune the scope of each effort that we are electing to do for maximum input within the available committee and staff bandwidth.

We are at a time of transition and times of transition create great uncertainty, but they are matched by a great opportunity for leadership. The National Committee has enjoyed bipartisan support for over six decades. By wrapping our heads around the best path forward from what we know today, we will create the contextual awareness we need to be able to respond appropriately to whatever challenges and requests come down the pike going forward as the new administration gets its feet on the ground.

Rebecca and I are committed to creating a comfortable work environment for the committee. We want to work together to minimize undue stress. By way of example, I plan to serve as chair of the committee and as a member of the Review Committee. I do not plan to be a member of the subcommittees. In part, it protects my bandwidth. In part, it protects the autonomy of the subcommittees.

As chair, I stand ready to participate in any of the activities of the subcommittee of the work group as you ask. But the lens I will bring to that is how to help you think about how to bring the Full Committee along so that we are all comfortable with final recommendations as they move forward. That is the lens I hope to bring to our work.

With that brief background, unless there are questions, I will review with you how we are planning to use the next couple of days. We are going to start with a series of short visioning blocks, starting with the legislative must-haves such as the 12th Report to Congress and such as administrative simplification and then working through a series of vision development activities that we have been working together to build scoping activities.

As we do this, Rebecca and the team have helped us set up a white wall. It is a portable version of what I am used to in my design center at home where we have space for each of the quarters in 2017 and then a space for 2018 and over here is 2019 and beyond. The key is just to begin to post post-its, which are on the tables there. Any of us can grab one and write them at any time and just begin to post them in either quarters and hopefully in related horizontal what I call swim lanes as we think through how to do our work.

As we go through the visioning blocks, we are going to need to have the discipline to contain the discussion to the 30 minutes for each block. We are not trying to do the work of answering the questions or figuring out what we would want to recommend in that block. We are really trying to make sure that we understand the scoping statements that were in our books and are also in front of you in this hand out, understand them, refine them, tune them a bit and get key steps where they might land up here.

Again, as we go through it, we are going to need to keep a careful lens to scope and bandwidth. ASPE has given us some constraints which will increase the importance of us keeping an eye on scope. We have basically been instructed that in fiscal ’18, we want to plan on only three face-to-face committee meetings, which means that our November 2017 meeting will be some form of virtual or tele-meeting. This gives us an opportunity to think carefully about how we want to use our bandwidth during the time that we are together in the face-to-face meetings and what we want to do through tele-meetings or virtual forums.

And the last block on today’s agenda of the 4:30 to 5:30 block is really about committee process and structure. That is when we will get into that. We spend the bulk of the day going through the scoping statements, putting things up on the wall. We then have a block in the 3:00 to 4:30 time where we will shift things around on the wall because if this is like any other planning effort, we will discover that things land far too close to the left. Our job is going to be to spread them out a bit so that we are really doing the most important things in the first part and we have an idea of what the most important critical path is.

We then go home and we sleep on it. Because one thing I have learned about design is that which is muddy and frustrating in the course of the day somehow seems clearer the next morning. As we have done with the scoping documents, we do not need to get this right today. We just get it up there. We will come in in the morning. We will review it briefly because we will have additional agency members here in the morning to see where we are. We will briefly review it and get their feedback and input. We are not asking them for updates from their departments. We are actually asking them for feedback on where we are in the planning process. That will get us some input.

Then we will take some time to work the things that are in flight from our previous meeting around de-identification, around the all-payer claims database and around the pop health measurement framework. And then as we move into the afternoon, we will revisit the plan and really tag the things that are most important and identify what pieces each of the subcommittees of the work group will do as we move forward. That is the way we have laid it out. I am glad to take questions or suggestions for changing that approach.

Dave, are you on the line now? We will let Dave introduce himself whenever we work out the connection.

Do you want to add anything, Rebecca? Are we good to role?

MS. HINES: We are good to roll.

DR. STEAD: That gets us ready to roll with five minutes to spare. Legislative mandates and must-haves. Linda, do you want to walk us through the approach to the 12th Report to Congress:

Committee Visioning

Agenda Item: Legislative Mandates and Must-Haves

Agenda Item: 12th Report to Congress

MS. KLOSS: We are already ahead of – we will keep it to 30 minutes. There is a scoping document on the 12th Report to Congress on HIPAA. As you see, the scoping team includes Bob Phillips and Nick Coussoule and myself. I will lead off, but Nick and Bob, please help me after I do the initial framing.

This is a nearly annual report that has been completed because the law requires that an annual report to Congress be prepared to cover the following, but not limited to the following four topics: the state of compliance and cooperation in implementing standards, including barriers, the extent to which entities are meeting security and related standards, whether the federal and state governments are receiving the information needed to carry out their responsibilities and the status of adherence to time tables as laid out in the law. Those are quite specific subjects written as we know into law 20 years ago.

The most recent reports to Congress, the 11th report and the 10th report were included in our eBook. I came on to this committee at the time of the 10th report. It was presented for review at the first meeting. As you saw, that was an ED page report and a lot to digest. That particular report was as lengthy as it was because it was the tenth report and an anniversary of sorts or felt to be an anniversary and designed to be a more comprehensive report.

In preparing the scoping document, I actually went back and looked at nine, eight, seven, six, and five. And what I saw was that these reports were more of a letter format in the early years and quite succinct in terms of relating what had transpired since the last report. It was that tenth report that we grew to be more comprehensive and in some ways, follow that model in the 11th report.

I think as we consider the project plan for the 12th report, we can – I think we should feel that it does not necessarily need to be the next iteration of the 11th report I guess what my conclusion would be from having looked at earlier reports. We have some discretion as long as we are addressing the points required in the law. How we frame it I think is up to the committee and hopefully we will get some clarification on that.

What we did add here is – in previous reports, we have – all of the reports have started out with an overview primer of what this law covers and previous milestones and considerations for the future.

But our main focus will be to look at what has transpired from January 2014 to December 2016. We have a two-year frame to provide a status report about. Our out of scope is that we will not make new recommendations in territories that are not covered by the requirements or out of scope in the time table. At least that is our recommendation.

Let me stop there in terms of the description. If there are any comments, questions. Nick, Bob, what would you add to that?

MR. COUSSOULE: I think one of the bigger questions really is – we will talk about this with several is the scoping question. Are we interested in providing a more broad comprehensive report or getting more focused with specific topics and recommendations and how does the report structure and work effort frame up to do that. We will have that discussion in a couple of different topics today. But I think the scoping is going to be a challenge.

MS. KLOSS: Our project plan considerations I think at this meeting would be to develop a consensus on what points do we need to make. What do we need to report and what do we want? How do we want to frame that in consideration that we have a new 115th Congress and our timing will be to —

MR. COUSSOULE: To Bill’s point earlier in the half an hour today or the time we have today and later to talk about this, we will not get into that level of detail, but I think it is something we need to work through how we are going to get to that point.

DR. STEAD: Actually, on this one, I would like us to try to see if we can answer this because from my perch, this is actually a three-year report, the three years that are in the time window that you said. We will have a new Congress.

There has been a lot of water under the dam in that three-year period. I think our job is actually to come up a level and to say what are the most important things to communicate to the new Congress about where we are relative to the bullets on this list.

And based on what we have already done, I do not think that this isn’t about what we are going – we are in parallel with this doing many things about what we think need to be done next like beyond HIPAA, like the predictability roadmap and other pieces. Those will be in the 13th Report to Congress, which we may elect to try to get done more at two years than three. I think to get back on a two-year cycle would probably be a good idea if we can take it up a level so that it is more of a writing task. It is this committee saying these are the most important things to put in then. And then it is more of a writing task than if you will a visioning or design task.

Because what we are trying to do is make what we have done approachable and to I think have hooks to the detail that are in the excellent letters and reports that we have already done because we can make something that is readable. Those things do not go to Congress. They go to the secretary and to the data council and wherever they then redirect them. That would be my view of how we might both make the scope of this work manageable while getting something out quickly enough that it is helpful to the new Congress and then freeing up our bandwidth to do the things that will be in the detail. It is a possible way to frame it.

MS. GOSS: Thank you. It seems to me that if I translate what I just heard you say was let’s take the time or the opportunity in this report to really showcase the substantive work that we have done and I think somebody already did some of the homework on page 194 and 195 of the eBook that outlines – those extended pages. Thank you, Rebecca. But the two pages that I was looking at, 194 and 195, seemed to be broken down by the work products that we have done. That to me is easy enough to point to. We could put links in those.

But I was not really clear if you were wanting this committee to tease out a couple key concepts from each one of them and then weave a story together or if you were thinking that we were going to do a recap of this is the great stuff we have done. Here is a vision of where we think we need to go that pulls it all together.

Linda, you have some thoughts on that.

MS. KLOSS: I think that we need — and I would like to key off on Nick’s comment because I think if we could identify the three or four messages that we want to deliver to Congress in this letter, if we could do that today then the rest will kind of fall into place. It is unique opportunity. We have just acknowledged the 20-year anniversary of this law. I see that as how this letter somehow starts. In some way of framing what it has meant to the health care industry to be addressing formally the administrative simplification of health care. What we have done to advance that in this three-year period and what at least the key challenges are in the coming period. I think if we could do those three things in a straightforward fashion that might be helpful to a new Congress who I think our hope would be that there is consistency in advancing administrative simplification.

MS. HINES: Linda, just to summarize. Deliver three to four key messages to Congress, but starting off with noting the impact of the 20th anniversary of HIPAA to deliver the three messages and what are the key challenges moving forward.

MS. KLOSS: And recapping the advancements that have been made over the three years. There have been a lot of standards enacted.

MS. GOSS: And we want to tout those resources because they really can be very helpful to the industry as well.

DR. STEAD: Let me make one comment and then take it to Rich. I think that, one, I want to thank Debbie because she has done the yeoman effort of creating these pages in the eAgenda book. And my hope and I think what she has done lets that be possible is in essence that gives us appendices. We can decide if there are tables in the report or if there are appendices, but that work is essentially done. That is a nice way of summarizing things so that the report itself can focus in the areas that I hear and in the way I hear Linda doing. I think that is a nice way to do a bit of both. Making sure that everything is readily accessible and linkable in one place with text that I think Linda’s statements are perfect.

MR. LANDEN: Thank you. I agree with where we are going. Maybe a lot simpler than the previous two reports, staying high level, talking about what we set out to do three years ago, what successes we have had, what the status is with the rest of it, then maybe a little bit of how the world has changed around us and then some teasers as far as what is on our plate for the coming year. And then as Alix said, lots of links to the specific reports we have already filed without summarizing them within the body of the new report.

DR. STEAD: Let’s see if we can identify maybe the top three or four items because I think – I sense real consensus around the basic approach to this letter. One point that Linda is saying is the 20th anniversary of HIPAA and how HIPAA has advanced the industry.

MS. KLOSS: And maybe one step back. The importance of administrative simplification in defining that because HIPAA has a specific way of looking at defining that. I think we have to frame that for somebody who may not be familiar with all the ins and outs that is this combination of standards and advancing technology and underpinnings of privacy and security.

MS. GOSS: I think that is a very nice broad picture to paint and I think a few of the key successes we have had. But I think that we have to speak early on to the evolution of technology, the administrative simplification meeting, clinical world, some of those landscape dynamics that go back to Rich’s point.

DR. RIPPEN: And again, the nuance of any economic benefit I think would be an important thing to consider somehow weaving in if possible.

With regards to the potential changes and the views and desires moving forward, the question is what is the value.

MS. GOSS: Why are we doing administration.

DR. RIPPEN: Exactly. Why is it important and valuable to continue doing it I think is a very important component.

MS. GOSS: I would put that up front.

DR. STEAD: And I was thinking that actually might come in the importance part.

My thought is the ticklers about what we plan to do next and will come off wherever we come out of our road mapping over the next two days. Things like the predictability roadmap are likely to be up there. It seems to me that — I think beyond HIPAA will be up there. I am hoping that will actually give us that block if that is practical.

MS. KLOSS: I think we need to bridge somehow in this letter the more recent or more specific standards mandate that have been laid out in the Affordable Care Act that we have worked on in these three years and link that to HIPAA. This is the report on HIPAA. But the specific tasks that we have been doing came out of the Affordable Care Act. We need to describe that linkage in a pretty clear way. I think we think about the Affordable Care Act and think about insurance dimensions of it, not necessarily these parts of it. I think that is something. Again, with a congressional audience, it is different than if we were writing it for the health care industry who understands it.

MS. LOVE: I like where this is going. I agree. In this 12th report though, do we highlight or was it implied some the gaps that HIPAA does not cover? It will come up later in these conversations over the next two days.

MS. GOSS: It maybe that links with what Linda – sorry to interrupt, but doesn’t it sound like if you are going to look at the ACA with the Review Committee and some of the gaps, that seems like a natural segue to what Linda said.

MS. LOVE: We have huge identifier gaps and others that it does not address, but I still think are important that are outside of HIPAA’s scope today. Do we not cover that in this report? I do not know.

DR. STEAD: I think where we have to be a little careful is we are going to do a lot of work around beyond HIPAA. I think we can put a hook in for beyond HIPAA. But I think as we have talked through and that may have been on the executive committee. The reason we have named it beyond HIPAA instead of HIPAA 3.0 is because we are not thinking it is reasonable to recommend major changes in HIPAA.

What we think is more likely to be feasible is to recommend other things that can be done that work in conjunction with HIPAA to go where we need to go. We may want to telegraph that in a paragraph based on what we do this afternoon. That may be a much more important – as much as the Review Committee – the things we have learned and recommended through the Review Committee clearly need to be one of the central of the three to four things that are on this list. That is clearly going to be one of them. My guess is beyond HIPAA will be one of them two years from now when we write the 13th report. But we need a hook for it. Is that right or not?

MS. LOVE: I agree. I think that would cover it. I wanted those gaps to be mentioned. I think the committee’s importance in the next two years should be elevated because those gaps will become beyond HIPAA more important. I think including that I agree with.

MS. KLOSS: I think the Review Committee’s work becomes a central summary of those gaps. That falls within our time span.

DR. STEAD: From my perch, the important thing from the Review Committee is that if we double down on end-to-end implementation of the transactions that are most implemented, that will really drive the value and then open up the ability to do the next piece. We have to figure out what is the – we have given the reasonably short letter in a long report. We have to figure out. What is the sound bite that we really want to communicate from the Review Committee that would be most helpful? Otherwise it ends up being too long to really connect. I may be wrong. I am really thinking about is this is an opportunity to connect.

MS. LOVE: I completely agree.

DR. RIPPEN: I guess I just wanted to loop back to the ACA comment. It is one thing to just mention if we were required to do certain work as part of it. I think it is really the question of what is the value of what was done as opposed to focusing on the connection with it because again I think that people are going to be reflecting on what is health care in the future. And really what we are trying to do is we are not political, but really just thinking about what is in our charge and what are the benefits of the work that we are doing. I would recommend that that be really the focus as opposed to any one act.

DR. STEAD: Let me make sure I am hearing you. You are advocating for making clear the importance of what NCVHS is doing. As I read the previous letters, some of them spend a fair amount of time on that. Others were more focused on what administrative simp was doing or what the – that is an interesting balance. Is that what you were talking about?

DR. RIPPEN: There is a requirement of what the report is to include. That is the focus. If we bring in other pieces because again it is an opportunity to again going back to what are the future activities and where are the gaps. The gaps based on what perspective and how does it all fit in as opposed to focusing on other acts. Again, we need to highlight what we think is important in total as it relates to health information technology and standards and things like that and the health care sector. I am just saying that be cognizant of other acts and other legislative things that may just be a herring and again what is the focus of the letter. That is all.

DR. STEAD: We will need to know if Debbie’s summary on 192 and 193 were an attempt to take what had been in the 11th report and to augment it for the subsequent legislation. But we will need to know if that needs to be augmented in some way.

DR. CORNELIUS: One way to frame this is if we are going back to the old school organization and financing and care sort of like if you are thinking on one side on the financing in terms of reimbursement, insurance, and providers, why this activity is needed down the road irrespective of whatever legislation. The same thing on the provider side in terms of doctors and hospitals. We are emphasizing over the 20-year cycle. This has been important down those domains and they are going to remain to be important especially with the spin-off of technology. That allows us to keep our feet on the ground without tying it to whatever kind of legislation issue.

DR. MAYS: Great minds think alike. I was going to say something very similar. I think part of what is important in going forward is making connections in ways in which we know this very well, but it may be that people who are going to be looking at this do not understand the value. I think the value is important. I think we are kind of ahead how we look at it. I was just going to say. It is almost like we may need to go back to basics in terms of how health care is structured and what the meanings are because you really need to think about as people look at this in terms of within the next administration. It will be with very different eyes, I think. We have to cover our basics and then in covering the basics, make sure that what we are giving them a sense of is the importance of what we are doing to help understand the connections and the importance of the topic itself.

I think the new piece moving forward is to tie in because I understand that this is going to be a big piece going forward is the health technology piece. That is where some of the E economy stuff is going to come. That is where it is thought that cost savings are going to come. We want to make sure regardless of how little that we have done that we instead see that as one of the forward thinking activities that I think is going to be discussed more in the future.

DR. STEAD: I sense pretty comfortable consensus about what we are trying to do around scope and some of the key points. Maybe we think a little bit about timing and how we actually do the work. Do you want to pick back up, Linda?

MS. KLOSS: It was suggested that we begin by looking at the list of what we have accomplished from 14 to 16 and we are ahead of the game, but having pulled that together. Thank you very much, Debbie. And looking at what our target might be would be committee action on this report in April 2017 and doing that by called conference call rather than waiting to the June meeting because it is important to get this letter into congressional hands probably end of first quarter. That may be as soon as we can accomplish it. I think that is an assumption that we should discuss because everything else is driven by that.

DR. STEAD: If we take this as largely an identification of key points and a writing task, not as – this is a communication task. It is not a new design task. Then what we would need to do is have some process where building on this discussion today we had some period in which period could almost submit I would think the key points they would like to see in this almost in a bullet form, not a long piece, but a way that lets us be somewhat systematic and how we harness people’s thoughts to the degree they have time to do that. We might want to do that over the next few weeks.

Then my thought is that Rebecca and I might work with Debbie and other members of the staff to pull out the key pieces around those points and get it into some rough form. Have you had a chance to find out if we could get writing support?

MS. HINES: We can get writing support. We just have to confirm with the writer whether the writer is interested in the project.

DR. STEAD: Outstanding. Can I say anything about that?

MS. HINES: If you want to, but I have not asked her. But we do have the resources to give the writer all of this information and to basically weave together.

DR. STEAD: My sense is that given this approach if we can persuade Susan Kanaan to contract to write this that would be the best way to get it in a form that was easy for people to understand. Susan is just unbelievably talented at doing that. I think we have shown with what Debbie has done that we can pull the building blocks together because a lot of this is not in Susan’s space. She cannot be creating things, but she can take what we assemble and turn it into something that I think is smooth and connects. If we do that then my goal would be for us to have that in a form that the Full Committee had in advance of the February meeting and that we then in the February meeting took a block of time to clarify, capture any additional editing material. Susan is very good in working in that way. She could then take that and make those changes after the February meeting and serve it up for us to take action on an April call. I am seeing lots of nodding heads and no concern.

MS. GOSS: It seems to me that there is a strong desire on this first one pager to get this artifact developed and in the hands of Congress. As much as I do not want to say this, I am going to say it. Do you want to wait until April? Don’t you really want to call the question as quickly as you can out of February and get this in their hands or has the ship sailed? We have a lot of other one pagers to think about from a timing perspective so maybe we do not nail it all down. We get the best game we can and we reconcile later. I have seen us do this dance before. There is only so much bandwidth. We are going to have to reprioritize I think at the end of all of this. But I think generally it is a good plan. I just wonder if you want to try to tighten it up.

MS. HINES: May I say something? The answer is nice thought, good thought, reasonable and it depends. If we can pull all the building blocks together and the writer agrees and has time and can get maybe by the February meeting. We do not have two months of iteration to do. It depends.

MS. GOSS: I think I was just trying get at just how critical we thought this was to get done and in the hands of Congress sooner than later because April seems too late. That is really my underpinning.

DR. STEAD: My own nickel is if April is too late then the process may not be – the things that are going to happen almost immediately with the new Congress – I think it is very hard for this kind of a deliverable body to influence. I think that is going to take place. It will shape what we do. I think for us to take the time to make sure we get the clearest message is more important than getting it out in January. If it can get out in February, awesome. I am trying to make it as simple a task as we can. I want us to take the time to be meaningful. The first question will be when we come out of this meeting is do each of us have the time to jot down the key points we brought in over the next two to three weeks.

MS. GOSS: I think it is a great placeholder for us to balance. We need to get through the rest of the stuff.

DR. STEAD: To model our process and other people can do this. This is not a chair task. Let’s put a few things on the board. Let’s say we are going to use blue for action. Nick is trying to help us get some taxonomy. Then what we are basically saying is that – I think we want to post it. Let’s put the blue action on 12th report at the beginning of Q2, which would be April.

DR. CORNELIUS: Maybe you want to share for the folks on the phone those pretty little charts that are on the wall.

DR. STEAD: What we are doing is making post-its and we are beginning to sequence them on a butcher board simulation of white walls that are taped on the walls. Then let’s put midway in Q1 Full Committee review and revision of the 12th report. If you put that in the middle of Q1. And then we know in advance of that we are basically saying I saw comfort with two weeks after this week that we will have gotten key points. In that process, Rebecca will work with Katherine to see if we can work out with a contract for Susan Kanaan to do the writing while Debbie and all of us pull the information out of our previous reports. Is that a game plan for the moment? Let’s move to item two.

MS. HINES: Quick lunch note. The important topic of food. If you have not turned in your form and your money, please do so in the next ten minutes in order to have food delivered. Janine, I believe it is $8. Staff will come around and pick up your form and your money.

MS. LOVE: I am thinking of the first hundred days and all the changes and the need for the report to get there and get there right. Are there two stages? I was thinking if I am new to Congress and all of these things are hitting me, does NCVHS have a messaging of that we are here and what we do and more of a marketing and I do not want to call it marketing. But if I am coming on, do I need to know that there is this committee there that has been there for 70 years, not all of us serving that long, but we are the go to people for this, this and this or does that happen elsewhere. How do they know we exist? What is the orientation to that?

MS. HINES: I defer to the long-standing senior support staff who have that information. I do not know that I am aware of any activity that we actively do from the agency standpoint. ASPE, who is not in the room today, as far as I can tell, would be able to answer exactly what that might consist of.

DR. STEAD: Maybe that is a question. That is an issue that we raise in the morning when we –

MS. HINES: Because that would sort of grease the skids for the report. I do not know.

MS. GOSS: They may know who we are based on the 21st Century Cures aspect.

DR. STEAD: We are mentioned in that. If everybody will be patient with me, I would like to move us to the predictability roadmap so we stay on schedule. We are a couple of minutes behind.

Agenda Item: Predictability Roadmap for Standards

MS. GOSS: Is that my cue? Denise and Rich, please chime in. I am going to go ahead and set up what is on page 20 of your E book, the predictability roadmap. Some of you may recall our extensive discussion on this topic at various points including last June. I think it was really nicely summarized on what is page 7 of the last report to Congress or page 93 of your E book. When it says the health care industry has expressed to NCVHS the need to develop a strategic plan and a roadmap for adopting and implementing standards and operating rules in a coordinated, sequential, timely, efficient, and cost-effective manner. NCVHS has heard from the industry representatives that is experiencing implementation fatigue with uncoordinated, misaligned competing priorities. Consequently, NCVHS will evaluate and prioritize the opportunities presented by each statutorily required initiative for its potential to effect changes that result in cost and process benefits.

That extract that I just read is really a capstone to what the predictability roadmap is about. It is about a framework for a more efficient development, testing, adoption, and implementation of the HIPAA transactions and operating rules. We are only at this point considering transactions and operating rules. Anything else would be out of scope. That was based upon our deliberations this past June that we wanted to take a stab at a predictable roadmap for upgrading transactions, implementation specifications and operating rules and see what we learned from that process before it may be tackling some of the others such as code sets, identifiers, privacy and security.

The thought process was to establish a baseline of existing processes across the applicable organizations. The standards development organizations we are talking about are X12, NCPDP, HL7, the operating rule authoring entity, CAQH CORE, the designated standards maintenance organizations, which oversee technically the change requests for HIPAA transaction implementation specifications and their related code sets. The work group for electronic data interchange has a role as an advisor to HHS under HIPAA and then our role in NCVHS and then ultimately what happens. If you think about somebody makes a request, a business change or a technical change to implementation guide or operating rule, they go through the necessary organization or submit a change request. That then bubbles through a process that results in a new version that then would come to the DSMO for recommendations to us along with some WEDI work and then we would do our vetting. And then we would make a recommendation to HHS, which then kicks off the federal rule making process.

What we wanted to do is figure out where we had opportunities to improve the process. This is not a new body of work. There was work that was done after the initial implementation of HIPAA 4010 that appeared to have been upgraded during the 5010, an NCPDP D.0 upgrade. We have some reference points, but we need to bolster those because we do not have as succinct documentation, maybe a CAQH CORE perspective balanced into some of those earlier works simply because operating rules were not in existence when that work was done in the 2003 to 2009 timeframe.

If we were to establish a foundation of processes that we could then put together in one big picture, bring together the applicable entities and some workshops to produce a set of recommendations that we could get feedback on and then make those recommendations to HHS or the SDOs to implement to garner efficiency. Ultimately, the goal is letting business and providers, payers, public health all plan – know when the upgrades are going to come and make them more manageable so that they can better manage their resources and incur more reasonable costs.

The thought would be that we would establish those baselines in the first quarter of 2017. We would have a workshop in quarter two. We would distribute and post the options in late quarter two. We would look to the next one pager. Thank you, Nick. And then we would have a hearing and then we would synthesize that feedback from the hearing in Q3 and Q4 and then we would make recommendations in Q4.

I think it is important to understand that this body of work could have an interplay with the anticipated upgrade for the 5010 and D.0 versions in the sense of we are expecting a DSMO change request in mid to late 2017. Ultimately, if we are going to request an upgrade, it would be nice to give content to HHS and CMS, National Standards Group that they might be able to include as a part of an NPRM process. There is some interdependency potential. But from a clean perspective, we really just want to take a deep dive into how do we make the process work better and how do we educate people on where to play so that they can then start to manage their resources more effectively.

Denise and Rich, do you want to add anything to that?

MR. LANDEN: Since you invited us, yes. I think you described it quite well. I think HIPAA, as we mentioned earlier, it is the 20th anniversary. It should be a steady state. It should be predictable. HIPAA defines the covered entity. We know that we are talking about payers and providers. Basically, it is a bidirectional communication. It should be more predictable than it has been for the past 20 years. It should be mature enough. We have had enough experience. We should be able to enhance the predictability and the more rational application of resources. We also need to be cognizant that all of the players in this, the covered entities including the clearinghouses, which I did mention. They are all working in the larger world where there are other things going on like value-based programs and the encouragement from CMS innovation center and others that the private sector align more closely with alternative payment models and that changes the needs of the communications system beyond HIPAA. While we have a specific target in here that is HIPAA focused, it also has to work in the larger context so that resources overall can be available when needed and not have to – and the workflow has to be balanced over the one, two, three, four, five-year cycle, whatever it turns out to be.

MS. GOSS: Thank you for those remarks because I think it is important for me to note that I forgot that we anticipate the inclusion of the Office of National Coordinator in these discussions because we want to think about this from a larger – the clinical and administrative simplifications, the impacts on the providers, payers, clearinghouses. They are trying to juggle all these. We do not want to do it in a vacuum. We need to be thinking about electronic health records

MR. LANDEN: The other thing I will mention is even though we are focusing on the communication systems, it is basically to benefit the patient and from our perspective at NCVHS when we talk about patient, we are really talking more on a population health basis than we are individual health care, but that is fundamentally where the real value is despite our focus at a different level.

MS. KLOSS: I had a scope clarification question. Does this roadmap stop when the recommendation goes to CMS and HHS for rule making? Or are we going to address the actual implementation in some way? I think we need to clarify or at least offer some recommendations on how it gets put in place. That came out when we had previous hearings about predictability, the process of when a rule gets promulgated and the two years after. Can there be a vision piece here that does more than say now it has gone into the rule making or the sausage machine? But really to have the impact, it needs to be fully implemented.

MS. GOSS: I think I did not call it out specifically in my narrative about how the pieces fit together. When we started working on this framework thinking starting with Ob and Walter and Harry and I a year ago, we did have implementation in there and the words there, but I think we are missing a piece to this, Linda, that you are calling out. It is not just about how do we get from I have a business need that needs to translate into an implementation guide change and then a regulatory adoption process, but it is the two years or whatever, the 6 months, 18 months after that. I am thinking about all that we did in ICD-10 or HHS did to kind of elevate that, help with implementation, the WEDI efforts with implementation. That is what you are talking about. The nuts and bolts after the rules have been promulgated and we all have to get to business to make it work.

MS. KLOSS: And ideally, if you have a predictable roadmap and you know what is coming and you are able to allocate resources rationally then maybe it does not need to take two years or three years or five years for something to become an effective date. Or maybe there are variable effective dates depending on what it is. I just think we are locked into this process that is helpful to covered entities because these things come at them and it is nice to know you have two years. If we really truly have a roadmap then we should be looking at how we accelerate adoption and full implementation if we are going to move the needle I guess.

MS. LOVE: I think that is a big part of the problem to follow off of that. We will talk a bit about this tomorrow. The alternative payment models and all-payer claims databases are moving quicker than HIPAA. Is it through the workshop and other means that will address those gaps because that is some of the collision that we are having between the payer response and the state reporting needs? There is this chasm so to speak that cannot wait two or three years for the HIPAA process. It is not waiting two or three years. I have some ideas how to address it and I will talk about that tomorrow. But would that be addressed through the workshop discussion of how to speed up that implementation?

MS. GOSS: I think we need to have some more discussion around the implementation aspects because honestly I felt like it was going to be a monumental lift to get the SDO, operating rule, DSMO, NCVHS, WEDI and then the regulatory process to find its opportunities for predictability. I think it makes sense to try to look at the implementation predictability and efficiency options. I think that we need to look at that in the whole process here, but I do not think it is called out well enough in the scoping document.

MR. LANDEN: And if I can jump in and help respond to that. Part of this is not for us to say, but for us to learn during the hearings that are part of this what are the industry needs. What is the value of a two-year cycle as opposed to the value of a three-year cycle with the tradeoff being deployment of resources? Where is the value? Is it a better value on the whole to do a three-year or a four-year cycle or a one-year or two-year cycle? The answer to that needs to come from the industry and based on their priorities. We have to get that education before we can really get to answer that question about is it better to be more agile or nimble or is there no real value in that to the people that have implement it.

DR. RIPPEN: I think keeping with the narrow scope is important because it allows us to assess what different components of the HIPAA standards and the requirements would take what length of time or effort. If it is a data standard by itself versus a transaction standard versus who needs to be involved because different players tough different needs. If we can actually have an assessment of what is an approach for different things then as we step back and have to deal with things that lay outside of HIPAA, there is a framework that might be leveraged beyond it if we do it well and that can be expanded beyond. There are a lot of pieces that are not necessarily HIPAA, but we can maybe leverage it as a way of thinking about it. I do not know if that made sense. Again, it is the process and how does one approach it from a reasonable standard.

DR. STEAD: From my perch, I appreciate the attempt to limit scope and I like the way you have tried to limit it. It still seems bigger than a bread box. I am just wondering how we really get it done. My gut is although I appreciate the importance and the things that need answers.

MS. GOSS: Keep in mind. Some of the base work was already done.

DR. STEAD: If I put back on what we have done with pop health and this may all be crazy. It would seem to me the baseline of existing processes is the analog to an environmental scan. With the environmental scan, we did that work by having a consultant that really knew it, work with the subcommittee, and pull it together and do it. It was the subcommittee’s environmental scan, but we were not doing the environmental scan around things like existing processes with a hearing or with something that got individuals to submit. We were somehow less trying to synthesize it, which is a very staff intensive process.

One question is is there a way to get the baseline done in a way that lets us bring that in and then have the hearing targeted around some of the kind of questions that I guess Rich raised around what does the industry want to – what are the improvements that the industry wants to flag as the key design objectives that would drive the process. My guess is somehow that gets spread out. We need the baseline. We need to know what are the design objectives from different industry perspectives. Given those design objectives, what are the alternative processes that might meet those design objectives? I can see recommendations coming out along the way. But if we are really going to get at the heart of what you are trying to do, which is the ability to forecast and rationally direct resources and to accelerate the capability of the industry to implement, that is a C change.

MS. GOSS: Keep in mind in 2006 a body of work was presented to this very committee by Margaret Weiker, Lynne Gilbertson and myself that was updated in 2009. Part of the processes, the baseline already exists. Analysis was done in early 2016 to take those 2006 and 2009 process modification white papers that were developed by three of the SDOs with input of the DSMOs and translate that into something that was spreadsheet workable. What we are missing is the operating – one, somebody to validate the analysis work that we did. Two, the operating rule equivalent version of their process and I just have not had time to talk to Gwen. I think I saw Denise walk in so she might be able to help us. And then it is the regulatory process. Denise and I had a brief conversation about that as well as Sean over the summer that we need to get that process. It is putting together some of the building blocks.

The idea was let’s get a small workshop together to roll up the sleeves to identify the different recommendations that we thought were viable in today’s world across the various pieces, the development, the adoption, the implementation and then use that as a body of work to have a hearing to get the industry feedback.

DR. STEAD: That unpacks this very helpfully for me.

MS. GOSS: It is still a big lift. But I think that we have at least some good starting point to that lift. I do think that we need some very strong support to get us there through either administrative or actually analytic work and documentation program management kind of work support.

DR. STEAD: I am hearing consensus around purpose and scope. We can add a few little comments. There are some edits that have come along that we can do. I am hearing that. And what I am hearing you say is the gating factor is whether we can get –- you are basically saying an update of the baseline in Q1. We need to get that up on our board if we can. That would be whatever we are using for committee work. It is not blue. It may be yellow.

And we need to know what the staffing requirements are because if we cannot identify those requirements then this slides out. We have to have the discipline of saying this is what we want to do. We have narrowed the scope. You think you have a lot of the pre-work, but you need support.

MS. GOSS: We are missing some. We have a lot of – I think we need an opportunity to get the people that are going to sit in the workshop to have a pre-call, to actually get them on a conference call, walk through everything, make sure everyone has the homework that they need to read and then narrow the scope down for the actual workshop. And then hold the workshop so that we can actually come up with a specific —

DR. STEAD: And doesn’t that say that Q2 is too early for the workshop under virtually any circumstance? I know why you want to do it.

MS. GOSS: I am happy to push this out. I think that there are some other factors here. I am torn with wanting to get something of substance with industry feedback before we get that DSMO change request for the HIPAA upgrade. But I also realize that this is a part of our review committee stuff.

DR. STEAD: My gut says the workshop realistically if you really want to prepare for it is Q3. In Q1, you are going to be head down trying to get this baseline work done, which will give you – and make your connection to the operating rules, get the same thing around those, which is necessary work for you to really refine who you want at the workshop and then the workshop could be in Q3 and maybe we would have then your distribution and post set of options in late Q3. That may become – we will need to see, but that is all contingent on us getting the right – maybe there is a way you can make some notes of what is the support you need to pull off the Q1 yellow tag because that is going to turn out to be gating. If we can get that then we can begin to think about whether it is doable or not. We can get Rebecca, Katherine and others to help us look at it. Does that make sense? It would add a quarter to everything in essence. It would put an extra quarter in. For the moment, is that good?

MS. GOSS: I like it.

DR. STEAD: Is the rest of the committee good? We are still on track.

MS. HINES: It is break time.

DR. STEAD: It is unbelievable that we are on our break on time. Congratulations to each of you. Thank you. We will regroup at 10:45.


DR. STEAD: We are now ready for the administrative simplification if Nick wants to carry us away.

Agenda Item: Legislative Mandates and Must-Haves

Agenda Item: Status of Administrative Simplification

MR. COUSSOULE: Thanks Bill. I will get us started. This is really a combination of a couple of different things in regards to the status of administrative simplification. The first is that NCVHS as the designated review committee is required to do things by statute. If we look at the description – take a step backwards.

When we talk about the topic of administrative simplification status, it is both a question of how are we doing with what is already in place and adopted as well as potentially what might need to be done differently going forward. The two different topics, as you see down in the description below that get that is first is the review committee. There is a statutory obligation in the review committee that is carved out to authorize – to establish NCVHS as the review committee. As that review committee, we are required to conduct hearings – biannually to evaluate and review the adopted standards and operating rules. We are required to provide recommendations to the secretary not less than biannually, every two years. For updating and improving the standards and operating rules, to recommend a single set of rules per transaction standard, and maintain the goal of creating as much as uniformity as possible in the implementation and then to ensure that the coordination as appropriate and developing recommendations with the electronic health records technology working with the Office of National Coordinator for HIT.

There are a couple of different things in regards to the Review Committee to talk about. One is certain things are explicitly out of scope of the work of the Review Committee by a statute, which is any new health care administrative transactions for which standard operating rules have not yet been adopted. If we were strictly focusing on just a Review Committee, it is really a look at what has been implemented and how successful has it been and then what might need to be done differently. And also anything outside of HIPAA is specifically not the purview of the Review Committee directly as well as any privacy, security or transport standards associated with that. If we strictly look again at the Review Committee, it would go back to the points I brought up a little bit earlier.

The first hearing was actually conducted in June a year and a half ago in 2015 with the industry feedback being gathered in regards to the state of implementation for all the HIPAA name transactions. I was not part of the committee at the time. Those of you who were part of it were there. You can certainly get into a whole lot more detail about the content of the committee. But there were a very large number of testifiers and a large number of topics going through lots of detail. I have read through a lot of it. I cannot say I have read through every single presentation, but I have read through a lot of it. Those of you who were there would know this better than I.

But there was a letter that was sent in February outlining some specific recommendations to HHS in February 2016 and then a detailed report outlining a broader set of findings and recommendations for consideration not just by the secretary, but by the health care industry, the standard development organizations, the operating rule authorizing entity and that was submitted in October.

The question becomes for 2017, there is a requirement to conduct another review committee hearing and then subsequently provide recommendations back to the status.

There is a second piece to the administrative simplification, which is specifically in statute involves the ACA 10109 requirements. That really talks more about things that are not included under HIPAA that might be beneficial from an industry standpoint to address in regards to the administrative simplification.

NCVHS has a mandate to solicit input on whether there could be greater uniformity in regards to those activities, not just within the HIPAA-covered entities, but in more generally the ecosystem as well as what other transactions should be considered for adoptions such that the standards and operating rules would improve the operation of the health care system in its entirety and reduce administrative cost. That is more of what I would call a little more of a forward looking activity as far as what does not exist or does not exist in standards or an adopted standard yet, not necessarily what is not being considered anywhere, but what has not been adopted into standards and not covered by HIPAA regulations.

When we look at both of those things, the considerations for the project plan or what we might want to think about going forward – I think the biggest question is to gain a consensus on the scope of the hearings. As I said earlier, the initial review committee covered all the HIPAA-named transactions and made recommendations to a very broad swath of players across the health care ecosystem. Determining which components and standards warrant review and update including the code set identifier opportunities is an interesting question.

In the span of – since we issued the report really relatively recently, quite recently as a matter of fact in regards to the more generalized report, what would we want to cover in the next set of hearings to be meaningful from what has changed in the industry perspective, what kind of information might we want to get to opine on a going forward basis?

Some of the areas – Bill actually hinted at this a little bit earlier. Do we try to focus on areas where there has been significant adoption to really try to push that forward even faster and drive more value generations to the value extraction part of that or do we try to focus on ones that have not had as much take up, but they may be perceived greater value benefit even from the results of the Review Committee meeting that we conducted relatively recently or the meeting in the subsequent report that is conducted?

Some of the recommended focus areas that I would like to set out for consideration, which basically have a perceived long-term value of limited existing take up and some amount of blocks to implementation in reducing efficiency would be the prior authorization transaction, which was a large topic of conversation at the last committee hearing. It is specifically including the use of attachments and also the implications for EHRs. We have not at least in my time here have not spend as much time talking about the EHR side of the implementation and what that means in regards to the administrative simplification transactions.

A second recommended focus area would be the issue of clean claims and the implications for consisting editing rules, again, trying to take some noise out of the system as far as the back and forth of what do I need to submit and how do I submit. And a lot of the noise that does not add any value in the system, but really gets into the payment questions and validity of claims.

And then third are the audited enforcement rules. Are there recommendations or changes we could make into that space that would help drive industry-wide adoption? What kind of feedback could we get in regards to that and how that might have changed? A lot of information in regarding enforcement actions and questions. Is there a part of the environment that we could help solicit some input and gather some feedback to make changes to the audit process and enforcement rules such that it would ideally help with the implementation not in regards to creating a punishment scenario, but in regards to creating an incentive scenario for adoption to increase and subsequently drive value. Again, if there is no value being driven, pushing adoption does not really help. But if we could try to structure those things together in regards to what the audit enforcement rules might be to help guide and drive that value for all payers in the industry.

And then the question would be to gain consensus in my mind on the focus of the hearings to leverage that scope. How much would we target a broader industry review like was conducted in the hearing back a year and a half ago versus how much might we look forward to talking about things that may not be included in the scope of a Review Committee, but would be covering things like the ACA 109 hearings.

I know there is an interesting question. I will toss this up because the question has come up in our previous discussions. Are those two in fact related enough together would be the same kind of participants and the same topics or should they really be done separately? I think it is an interesting question. But it also gets into a scoping and how much can you undertake at one time and how much can you leverage feedback from the same kinds of players so the same kinds of participants at the same time.

With that said, I think it is a pretty straightforward structure as far as setting up the objectives of the hearings, conducting the hearings, writing the letters. That is a very normal process for us. But the question is the scoping question. How might we do that?

DR. STEAD: Alix or Linda, do you want to add? Would you introduce yourself to the group since you have been able to join us?

MS. GREEN: Certainly. Good morning everyone. My name is Denesecia Green with the Centers for Medicare and Medicaid Services. I have been at CMS for about 18 years now. I have had the wonderful privilege of working with many of you around the table and I am looking forward to meeting the folks that I have not. Most recently, I have worked on ICD-10 and implementing that across the nation along with many of your industry partners. Also, we have a very dedicated group back at the office in Baltimore, our headquarters. They are listening in. We have our staff lead here as well, Terry. We are just very thankful to have you all really focused around the issues that we are very interested in and getting some traction going for this year and beyond. Thank you very much for your service to this committee. We will be very intently listening to your recommendations. Thank you.

DR. RIPPEN: I think the question that you raised as it relates to combining the two activities might be actually interesting in a sense that you could break it up to two days where there is so much overlap with regards to the challenges as it relates to some of the implementation and adoption. That might actually be insightful for the process overall. I agree that there will be a challenge with balancing on how much do you need. But there is so many dependencies on each other that I think it would be really powerful if you could somehow join them together and have maybe a build.

DR. STEAD: I must admit that I am swinging back and forth a bit as I listen to this conversation. I have just recommended moving the predictability roadmap workshop or hearing or whatever it is into Q3. We can jiggle that. That is the nice thing about post-its. But I did that because it seemed like we had a fair amount of pre-work to get ready.

I think an interesting question, which I had not considered is can we identify a sufficiently limited scope for the 2017 Review Committee, given the report we just issued, which was broad that would allow us to have a relatively focused hearing for the Review Committee in Q2. This is your general list moving post-its around. That would all depend on us identifying maybe today or tomorrow an impactful narrow scope for a hearing to move the Review Committee ball in line with its charter while recognizing that the related work like the predictability roadmap is going to take longer and could then come along after it. Just a thought.

MS. GOSS: Could I offer some practical counter perspectives in the sense of when I hear Q2, which I think we can set a scope and we really did talk about trying to narrow down the Review Committee work, realizing that some of this roadmap work is tied to the Review Committee as well as our prior committee efforts. Q2 says to me February.

DR. STEAD: This is Q2 calendar. Q2 to me for the Review Committee means a hearing may be tied to our June meeting. That might work.

MR. COUSSOULE: It would be two years from the last Review Committee.

DR. STEAD: It would be two years. I am also trying to pay attention to another thing, which is that my understanding is our budget allows for four hearings in federal 2017, which ends in September. One thing as we work our Ouija board, which you may like better than post-its. One of the things we are going to work out is what is the best use of those four pieces also, one of which I think needs to be the Review Committee. I will be quiet. We have a tent up from Helga and then one from Rich.

DR. RIPPEN: Just to kind of continue because the other option is because yours is a workshop, which is going to be potentially a workshop, the big question that the hearing can actually inform or refine. Depending on how you want to do it.

MS. GOSS: What I was envisioning was that we would actually have a workshop that would give specific recommendations that we then took to a hearing to get the larger feedback from the industry as opposed to a smaller working group set of participants.

DR. RIPPEN: As opposed to saying a working group to provide a hearing to provide some guidance that then you would have a working —

MS. GOSS: I feel like to some degree we already have received guidance as the Full Committee over iterative years.

MS. KLOSS: On the predictability?

MS. GOSS: I think that is what everybody is trying to weave in here.

DR. STEAD: From a scoping point of view, I am just raising the possibility. We need to know what the possibilities for a narrow scope review committee would be. I do not think I have yet heard those.

And then I am thinking that the predictability roadmap, which will work through and be recommendations in Q1 now of 2018, I believe. Everything has moved. Truth be known is all this work. That is going to feed set up of the 2019 Review Committee. This is not a one and done process.

We also have the possibility of figuring out how to weave in some of the other important blockers, which Nick mentioned, which are not appropriate to the Review Committee. To the degree we narrow what we do with the Review Committee, we open up bandwidth. It is just a thought.

MR. LANDEN: I am thinking about all the – we have three or four different reports. We have a number of initiatives or projects we are doing. The content of all of those or a lot of those overlap. I am struggling with what is our approach. Do we have fewer individual workshops, meetings, hearings and given our budget limitations and scope the nice and narrow and easier to manage? Or do we have a smaller number of large scoped initiatives? And then it would be up to us to structure those so that we can in the end tease out what information belongs to which of the projects and reports that we are doing, which is more difficult to manage, but it condenses the time and certainly minimizes the travel burden on those who will be doing the testifying or participation of the hearings because in many cases, they will be the same across the different topics.

MS. HINES: One more question for you, Alix, to add to Rich’s. The workshop you were outlining under the predictability roadmap. My sense is that was going to be a smaller, leaner discussion. Is that a correct understanding or were you thinking that would be a larger gathering?

MS. GOSS: I suspect you are questioning that from an NCVHS attendee or you are talking about – when you look at the potential attendee list, we are talking – let’s just say we elect two representatives, X12, NCPDP, HL7, CAQH CORE – we have to have somebody from the DSMO. We have to have somebody from WEDI. Suspicion is we probably want somebody from NACHO because of the overlap with EFT. We need us and of course CMS NSG. We were hoping that possibly we might be able to have NCVHS host a meeting, but use a Baltimore security boulevard area location to actually have the meeting to maybe potentially get – to support more federal participants listening in and thoughts and those kinds of things.

MS. HINES: That is perfect. What you have outlined to me is a small gathering of maybe 30 people. If you take – for X12, HL7, CAQH CORE, NCPDP, WEDI, ONC, DSMO, NACHO, CMS staff and whoever from this group, 30, 35, that is not a huge pop health 90 to 110 workshop. That is basically a relatively small well-informed group of people that you hope to come out the other end of with a set of draft ideas that could be put out for public review and tomato throwing. To me, that is very different than a two-day hearing. I am just trying to get my head around it.

MS. GOSS: I am going to build on this. Yes, it is a workshop that leads to needing to have a hearing, which we could tie with Review Committee. But keep in mind that this administrative simplification outline really encapsulates one of our statutory obligations, which is ACA 10109, which gets at the clean claims and audit enforcement. Editing of claims rules is one topic. The other one with audit and enforcement is the other topic that I believe is of interest to CMS and is tied back to the ACA 10109.

To your question earlier, Bill, if we wanted to just do one very narrow scope as it relates to Review Committee, we had talked about that end-to-end workflow and standards perspective related to the prior authorization.

DR. STEAD: Again, just to make sure I am tracking context, this workshop is the predictability roadmap, which right now we have posted in Q3. I am hearing that there are two other things we need to do. A Review Committee hearing, which might be limited to end-to-end prior auth as a case. Isn’t that what you said?

But then I am also thinking of a hearing around the blockers that are in ACA 10109. I am hearing three. A workshop and two hearings. Am I wrong?

MR. COUSSOULE: I think that is a correct. There is a third hearing also that would be after the workshop.

MS. GOSS: Back to Rich’s point, can we move the puzzle pieces around?

DR. STEAD: There is the predictability roadmap hearing. Is it in federal 2018? If we do Q3 for the workshop —

MS. HINES: It is the last quarter of the fiscal 17.

DR. STEAD: That is Q3. That is the workshop. You are talking about with the predictability roadmap a hearing after that.

MS. HINES: Didn’t you say you wanted a hearing after public comment on the predictability roadmap?

MS. GOSS: Yes, but I have always been envisioning that we could double dip, but I do not know if we can.

DR. STEAD: I understand that we may double dip, but that is further out than the Review Committee.

MS. GOSS: I am trying to process what the Review Committee hearing date. That would be Q3.

DR. STEAD: No, I am advocating for June as the Review Committee with a narrow focus.

MS. GOSS: I think that there are numerous pros and cons no matter which way we go. I feel like I am okay with it either way. I feel like I cannot really have an opinion about this until I see all of the one pagers work out to see if —

DR. STEAD: Let’s just for the moment just to make – because I like things up where I can see them. Let’s put a Review Committee hearing and we can tentatively pencil in end-to-end prior auth as the case we would work. You can change that. It is just an example to help us understand the magnitude of what we are talking about. If that can go at the end of Q2 and that would be another orange one. Blue is action. This is designed as we go.

Let’s assume we do the workshop in Q3 for predictability roadmap. Would the hearing for predictability roadmap then be in Q4 2017 or would it be in Q1 of 2018? Just put it up somewhere. This is the predictability roadmap hearing.

MS. KLOSS: My anxiety is don’t we have to narrow in on what the focus of the Review Committee is before we sequence.

DR. STEAD: We certainly will before we come out of this afternoon or tomorrow afternoon. I am simply trying to get a draft up here and I have taken Alix’s straw person just to say it is going to be narrow scope. Does anybody advocate for the Review Committee being broad scope? Do we have a convinced consensus? We may not know what the narrow scope ought to be, but do we have a consensus that given the fact the last one was broad and our report was very recent that the biggest gain now would be a narrow deep dive? If we know that then June is feasible, not in concrete. And we need to then iterate what that narrow scope in fact is.

MR. COUSSOULE: One question I would have is – what I am not sure would be good to do and the question is are we then setting ourselves up for a regular more narrow discussion. I think that would be problematic.

DR. STEAD: We are not doing anything but trying to sequence our work. My gut is – I am just trying to think out two years. If we build on the last one with a narrow one, we then really work through the predictability roadmap stuff and that is big. That is not little. That will all be done. We are going to have these other things you are talking about done. That will let us maybe take a broader view on Review Committee 2019. It is a matter of how we sequence rate and pace. I do not have an emotional dog. I am just trying to help you think through rate and pace.

MR. COUSSOULE: That is where my head was at too. I would concur with that strategy.

MS. GOSS: I am hearing Terry’s words in my head, which says we still have an ACA 10109. The thought process could be that we just collate those topics with one of the other hearings.

DR. STEAD: The other thing we need to put up there if we can figure out how to handle it is what I am calling the blockers. You had picked specific items.

MS. GOSS: This came out of some discussions about how to —

DR. STEAD: Prior off claim aims. We might pick the prior off. We might knock off with the Review Committee. Or is it a different piece?

MS. GOSS: I am right with you.

DR. STEAD: Then the other hearing and these may come together or not, right now, would be around clean claims and audit enforcement.

MS. GOSS: Yes.

DR. STEAD: And that would address your ACA 10109. I am slowly learning the numbers. Then we need an orange thing for clean claims and audit.

PARTICIPANT: Workshop or hearing?

DR. STEAD: Hearing. And given where this – where do you want it up there? You will be able to move it around. Put it up there so it is just up where we could play with it.

MS. GOSS: We are on the clean claims and the audit enforcement because I am still trying to process your question about where was there a hearing on the predictability roadmap whether that was Q4 or 2018 Q1. You have now two questions —

DR. STEAD: Right now, we have it out there in Q4.

MS. GOSS: Let’s leave it there.

DR. STEAD: It is probably going to have to move out.

MS. HINES: Where do you want the first cut —

MS. KLOSS: Would it be too big a lift to Rich’s point, to do a prior auth to do a two-day or a day and a half hearing and knock off both of those in one hearing?

DR. STEAD: — Review Committee and those two together?

MS. KLOSS: To roll those three into the Review Committee including 10109 as a two day.

MS. HINES: Alix, if you look behind you, the way that looked now is the RC hearing with the narrow scope on prior auth and the hearing on clean claims and audit enforcement — the green are hearings. What they are proposing is that the Review Committee hearing with the narrow scope on prior auth be paired up with the hearing on clean claims and audit enforcement.

DR. STEAD: Let’s leave it there for the moment. We will see what is workable. Can we move from this one pager because we are four minutes over?

Bruce, are you on the phone? Would you like to take the stage with next generation vital statistics?

Agenda Item: Committee Visioning – 2017 and Beyond

Agenda Item: Next Generation Vital Statistics

DR. COHEN: First of all, I really need to acknowledge the terrific teamwork. We have had a wonderful planning team. Dave Ross has been our inspiration and visionary. We have had really good feedback from NCHS colleagues and vitals, Michelle and Dalton, in particular.

The purpose of this effort is really to build the case and reestablish the value proposition for vitals in the US. I think this would be particular valuable in the broader sense for the new administration as well as a broader audience, not only in HHS, but a lot of executive offices and agencies that rely on vital statistics in many kinds of ways.

We really want to get back to the notion of how vital statistics are foundational public health data as well as I think the significance and importance of vital statistics as the key elements for identity establishment and verification.

I think folks do not realize that right now vitals are an interlocking system of 57 independent jurisdictions governed by a variety of jurisdictional statutes and needs. Some of the records are open. Some of the records are closed. But the system is very complex. Essentially, we need to tighten this up. There is need for core support and unified development to build a strong, secure, effective national system for vital statistics. Our vision is to get all of the important players together to address really the reestablishing and raising the awareness of vital – foundational not only for public health, but a variety of other purposes. Get the different perspectives on the current status of the system and develop recommendations about where we could go from here to make the system more secure and more useful from the national perspective as well as from the research perspective and the use of the data from a variety of other needs.

This would involve I think extensive input from a variety of key federal agencies as well as research and private sector partners who rely on vital statistics information. Those really describe thanks to Susan Queen, another great input into this conversation – the middle of the description.

Our goal will be to target hearings. I think Q3 would be the earliest possible time to have those and then prepare a report and recommendations based on those hearings.

I will stop there and turn it over to other folks in the room who were involved in the planning and add their suggestions and thoughts.

DR. STEAD: Dave, are you on?

DR. ROSS: Bill, this is Dave. I am on.

DR. STEAD: I know you have been hanging through communication challenges. Would you like to add and introduce yourself and speak to your no conflicts and then add?

DR. ROSS: This is Dave Ross. I am president and CEO of the Taskforce for Global Health, affiliated with Emory University. I have no conflicts.

To just follow on what Bruce said about the vitals, I think it is really critical that we explain the argument or the case that there be a national unified capability. This idea of 57 jurisdictions operating under their independent rules I think made wonderfully good sense in Colonial America. The importance of vital statistics data to inform so many different parts of public health and overall population health really means we have to create some national capability. That is going to take an argument that has to be well thought through. I think the idea of the hearing the committee has developed, the subcommittee has developed is really essential. I agree with Bruce – Q3 is about as reasonable a time for them to happen as possible.

That is my only comment at this point.

DR. STEAD: Delton, do you want to introduce yourself and weigh in?

DR. ATKINSON: I am Delton Atkinson. I am the director of the Division of Vital Statistics here at the National Center for Health Statistics and have been the director now for the last three to four years, working on many of the problems that we are talking about here today.

CAPT. BRETT: I am Kate Brett at NCHS. I am working as the lead staff. I do not have any major comments at this point.

DR. MAYS: I just want to say that I think in terms of this project, it is really critical given that the way the states are sometimes handling some of the changes they want and what some of the data collection is and the background that unifying this to some extent would make a big difference in terms of the kinds of analyses that people could do.

But I want to also ask about a couple of other things and whether or not they are under consideration in this. One is marriage whether or not at all marriage statistics can be considered in this. And the other would be and I brought this up before about the – we have the same problem in terms of the national violent death system. It does impact seriously some of the mortality issues. I just want to get a sense of whether or not those are on the table to be included as well.

DR. COHEN: I have several responses. I think nuptiality statistics, marriage and divorce statistics are collected so idiosyncratically within the jurisdictions. I think we need to separate that out and think about whether we want to have a national system or develop better standards for local and state data collection. I think there is enough meat just for births, deaths, and fetals, to be the phase one of our focus on vital statistics. And then if we want to go on from there, I think there might be possibilities to deal with marriage and divorce statistics, which are important for a variety of other social reasons.

The NVDRS – when we talk about death data and the use of death data, I think when we get into those discussions that will certainly be part when we think about early detection and monitoring of opioids, of Zika, of violent related deaths. I think this will come into play as part of the discussion of building a more effective, rapid response mortality surveillance system. Right now, as Dalton can talk about much better than I, NCHS is moving towards making death data more available more rapidly. There are lots of other applications that would benefit by raising the bar on the data collection around death. I think that will be part of the discussion.

MS. LOVE: Hi, Bruce. Thanks for briefing this. On the workshop, you mentioned under number three linkage of vital records data. What aspect of linkage because that is a pretty big deal involved in itself. At the NAHDO meeting just a few weeks ago, this is one area where payers, stakes, and providers all agreed. We need a common NPI methodology, not a number, but a methodology so that even the industry can follow their populations, but also not to respond to 51 different state NPI methodologies. Is that a part of it or what part of linkage do you see in this workshop to be addressed?

DR. COHEN: I think – we move forward and lay out the scope. We will get more into those kinds of specifics. But certainly with the development of EHRs as well as other administrative databases, the interaction of vital statistics systems, which had been fairly independent from all of these other developments, the interplay and coordination if not the specific linkage needs to be explored for purposes of efficiency and just obvious use of the data in more robust fashion. NVDRS is an example of linking deaths to other local data systems. Many states routinely link as you know case mix data and maybe APCD data with vitals. And certainly some states are beginning to use EHRs as inputs into their vital systems. I do not know whether this is a separate topic or whether it will be integrated in our entire discussion, but certainly it is an important one to consider.

MS. LOVE: Especially from a scope standpoint, you could get mired down and lose the focus of the larger issue of vital records. I just wanted to call that out.

MS. KLOSS: I also think that is a core element of the interoperability roadmap. We can look to what is being done there.

DR. STEAD: It is my understanding that what we are trying to get in this workshop would be the vision. It would not be how to implement the vision. I read your document as scoping this at the level of vision. If it is at the level of vision, not how we actually implement the vision. Once we have the vision then maybe our 2018 roadmap might include something around where we can help most in framing how to implement a piece of the vision, but that would be a sequential process. Am I hearing you right, Bruce?

DR. COHEN: I think that is the great perspective, Bill. We need to lay the foundation first. I am sure a lot of these issues will be touched upon, but to give them their full due would be too much to do in I think the initial workshop or hearing. But this might be the first of sequential activities related to us working in vital statistics in the longer term sense. I think you are absolutely right.

DR. STEAD: Because the linkage piece was one that I advocated to be there. My mental model is imagine that an individual, and this would take some of the things you wanted, could authenticate to their birth record and direct that it be used to establish their electronic health record with a new provider. None of this would be some massive database. All of this would be under individual control in ways that are absolutely compatible with the current HIPAA work. Maybe that is not a good piece of the vision, but if it is, something like that could be part of the vision without us actually having to work out the implementation.

I think the other piece that is really important to have as part of that vision from my part is at the end of the day, this is going to turn out to be a national security issue. I think that we want to keep that on the radar screen. That will be helpful.

DR. PHILLIPS: Bruce, this is Bob. I wanted to weigh in. In August in the New England Journal, there was an interesting article by Tom Lee called Coming Back from the Dead about a patient who was erroneously labeled as having deceased and how that made it into the national death index because that was linked to his bank and to his Social Security. Everything was on hold. That propagation error was a problem, but so was the recovery from it. That is not quite what this is focused on, but I think there is an issue there that errors in our vital statistics can propagate in ways we do not expect because of the way they are interlinked now and that we may need to actually look at that as an issue as well.

DR. COHEN: As both you, Bob, and Bill just touched upon, the use of vital statistics as basic reader documents to establish identity and to de-establish identity is really growing. Fraudulent use both of birth certificates and death certificates is a real potential problem.

I know a lot of – at the annual vitals meetings, one of the best attended sessions is the Homeland Security session where they talk about emerging trends and the use of these data and how to tighten up the systems. There has been talk and recommendations of certification of vital systems to meet standards that will increase the confidence in the provision of both birth and death certificate data.

You have identified I think a new problem emerging from the rapid events of technology that I do not think the vitals community has really dealt with yet that will need to be dealt with.

MS. GOSS: Bob, I think you make a really great point as an example of real world impact, but I also think that there is a tie in with this conversation to the vocabulary’s discussion later. It is not only that we have the book ends of birth and death records, but it is the quality of the data along the way in how we use our vocabulary to how we codify things, how we share things to our overarching data analytics to get to precision medicine. To Nick’s point earlier, everything is interwoven here. I would be really curious when we get to that one pager of vocabularies and semantics, the implications there if there – it is not just identifiers to Denise’s point. It is all about the people and how are we going to actually use the data to make it better for the citizens.

DR. STEAD: To get into post-it mode before we run out of time, what I heard is that you are thinking of the visioning hearing is maybe occurring in Q3. Is that correct, Bruce?


DR. STEAD: We will post it there. We clearly are going to have to do a little left shift before all of this is done – excuse me – right shift before all of this is done.

Bruce, before we lose you, would you like to say a few words about the future of surveys since you are not going to be on when Bob leads that block after lunch?

DR. COHEN: Thanks for the opportunity here to tee up the postprandial discussion. A lot of the topics that we talk about, Alex, the vocabulary issues, data standards, a lot of the activities that we have been talking about around monitoring health and communities and general public health research, issues regarding survey data collection and survey data use end up being an integral part of those kinds of activities.

As recent events have shown, there is an enormous focus on the quality of survey data. We want to explore the future of health surveys and several particular areas. Some of the issues around survey methods and how we can make sure we can feel that the health surveys we do accurately represent health issues and trends that are generalizable. And in a lot of our work around community health, we cannot use administrative records to populate all of the cells we want to. But the federal government has enormous knowledge and survey expertise. We want to see how they can better support community efforts.

And the third prong of the stool is really wanting to make sure that the data that are collected by health surveys are available for policy and for research. And the description describes at the bottom of page, first page and top of the second page some specific ideas to be considered in these three buckets. I am sorry I cannot be with you the rest of the day. I am looking forward to hearing about how this discussion goes.

DR. STEAD: Thank you, Bruce. Take care of yourself and your family. Our thoughts are with you. Thank you for joining us.

DR. COHEN: Thank you all very much.

DR. STEAD: I think we have reached lunch a couple of minutes ahead of time. My thought if it is okay with people maybe we will take a half hour of this and pick up our lunches and begin to eat and catch up on our email, et cetera.

I would like to then maybe in the second half hour loop back to this idea of the scope of the Review Committee because I think we have left that hanging. That seems to me the biggest thing we have not – we do not yet have anywhere close to a finger on. I would suggest if it is good with people that we use the working part of our lunch to focus on that and see if we can get a little further before we move into the afternoon so we do not have too many loose ends. I am seeing nodding heads. We will take about a half hour to do various things we need to do and then we will convene around quarter after. Thank you all.

(Lunch Break)


DR. STEAD: Let’s reconvene for the rest of our working lunch, if we may. What we want to do is see if we can wrap our heads around alternative narrow scopes for the 2017 Review Committee hearing. We had one alternative put on the table, which was to do a deep dive into end-to-end support for prior authorization, if my memory is serving me right.

You put that draft on the table, I believe. Do you want to add any color commentary around that, or do we want to see what other suggestions people may have?

MR. COUSSOULE: No, not a whole lot of color commentary. That came up during the hearings as an item certainly with opportunity but not a whole lot of traction at this point in time.

DR. STEAD: What a hearing might do would be to get input on how to reduce blocks and barriers to implementation, or what?

MS. GOSS: The prior authorization implementation guide has been seen as not meeting industry needs, yet, it is — We have heard testimony that a lot of the shortcomings are actually capable of being addressed within the implementation guidance transaction set. So, one of the things that emerged in some of our vetting discussions that led to the one-pager was that we seemed to have a lack of understanding about the transaction from beginning to end, how it fits into the larger set of transaction sets, and what were really the things that needed to be addressed or changed to enable the 278 to get some traction — 278 is the prior authorization transaction.

The thought process was if we looked at a 278 transaction from beginning to end, we may be able to figure out how to modify either the implementation specification or maybe more so really address the educational needs around the usage of it. Some groups like WEDI may be already tackling some of this, so there may be some leg work that we can leverage.

But I know Linda was a proponent of the end-to-end on the 278, and since she has just returned she may have some commentary on that idea for the Review Committee as well.

MS. KLOSS: It certainly keeps coming out as a particular point of pain in testimony, and I think there would be a fair amount of support for exploration for how to smooth that process out.

MS. GOSS: And I think it also provides a nice opportunity to look at the concept of attachments and clinical data in the intersection of administrative simplification with quality payment programs, meaningful use, whatever acronym you want to pick today, but it’s really about how do you get the necessary clinical information with prior authorization to justify the referral or the treatment that’s necessary.

DR. STEAD: Is that adequately stated for people to know what that alternative is?

MS. GOSS: I am not sure what alternative you mean.

DR. STEAD: I’m hearing this as one alternative, one option for the scope of the 2017 Review Committee hearing.

MS. GOSS: Do you have another option you would like to propose?

DR. STEAD: I don’t. My sense was that this didn’t resonate with everybody around the table and that —

MS. GOSS: I read some of the hesitation as being putting ACA 10109 enforcement and clean claim edits with the Review Committee — that was what we perceived as sort of people trying to parse these things out. So I’m offering this to see if anybody else wants to chime in and see what their confusion or hesitancy was on the Review Committee.

DR. RIPPEN: My comment was really more around the simplification and then, also, the kind of timeline, the roadmap, predictability roadmap — that it was just a question of if you’re having a hearing how do you do more with less.

MR. COUSSOULE: I think there is an obligation to try to get some amount of statistical information in regards to usage. That would need to be part of it as well, just kind of a two-year update on what the penetration rate is for the different standards or the different utilization rates, et cetera. I think that would be necessary and could bring some more background context. Where there has been progress made in a number of areas over the last couple of years, here’s where we see it and here’s where we don’t, and then delve into one topic more specifically.

I do think it would be worthwhile getting some of that as well.

MS. KLOSS: I completely agree. I think that would be very useful on a lot of things on the roadmap, if you had some metrics that were guiding. But where would that come from? Do we have those kinds of adoption statistics?

MS. GOSS: We got some — not the roadmap.

Let’s go back to the Review Committee topic. There was some commentary offered, especially by MGMA and there was a number of overlapping coordination with AMA, AHA, MGMA that gave us a number of statistics, and I think we were trying to narrow down the diverse numerous aspects in the Review Committee hearing. We really had the results of the eight core recommendations to the Secretary in February, and then the 60-plus page full report in October got approved. And I think we felt a little overwhelmed by what was really going to be of value in the next review committee and didn’t want to try to open it up again. So, what was the biggest pain point, and that’s what led us to 278.

DR. STEAD: Let me see if I’m parsing Nick’s suggestion correctly. My recollection is that many pieces of the testimony contained indications of rate of use. One thing we could do is request submission, not oral testimony but put out a request for reports of rates of use. And we could start with the people who gave us testimony the last round because they had a process through which they polled members and organizations to provide that. And that could maybe be a candidate for something.

Those of us that were very generalist and participate in this area thought that it would be good if that could become more systematic. You would think if this whole thing were really running well, rate of use would be an automatic byproduct of what we were doing. But we’re not there yet.

MS. KLOSS: That’s why I jumped to the metrics for the predictability. I just thought that could perhaps be one of the goals.

MR. COUSSOULE: We are trying to get, over a reasonable length of time, into a value proposition. I think getting regular feedback on utilization statistics, even though it’s not perfect, gives you directional information on a regular basis.

DR. RIPPEN: I would also say what the challenges are and the barriers are if the utilization isn’t moving. It goes back to what’s the issue. Is it because we’re not timing it right or because the implementation guidance is wrong? Whatever it is.

DR. STEAD: I think that is one of the places we have some challenge at breadth because at breadth, we got pretty consistent feedback about what the key barriers were, and our recommendations about those are sufficiently recent that people haven’t really had much time to do something.

So the idea of updating the statistics — but maybe we wait until the 29 —

MS. GOSS: But one of the things that I’ve been interested in better understanding is, of the universe of specific recommendations and additional observations in the RC report, if CMS has any particular areas that they would like us to focus on. So, Danisha, I guess I’m really pointing to you. From your unified regulatory agenda perspective and the workload you have, is there anything in that report that really is bubbling up beyond — you know, maybe we haven’t talked about yet?

MS. GREEN: I think you all have hit on some of the major things that I have heard in industry conversations. Definitely, prior auth has been one that has been out there. It can be useful. The question is how do we make it useful, how do we make it of value.

And I’ve heard education as a major key. There are a few people out there who may not understand how to utilize the standard, may not understand how to utilize the operating rules — thinking of small providers and how do we get them engaged and involved in utilizing the standards as well.

But I think you all have hit on some of the major things under the Review Committee and CVHS recommendations. I have seen attachments, I’ve seen audits. Certainly I’ve seen a call for more robust enforcement and compliance across the board. I think we are aligned.

DR. STEAD: Thank you. Do people resonate with the idea that we would, one, figure out a way to request an update on statistics about rate of implementation and use?

MS. GOSS: I don’t know what scope you’re looking at. Are you just talking about 278 or are you talking about the whole suite?

MR. COUSSOULE: To me it’s the whole suite. I think we need to get regular about trying to get that information.

DR. STEAD: That would be, in essence, a very targeted request for an update on rate of use, not the broad sweep, not with explanations; just an update on the statistics. Then we do the deep dive into 278.

MS. GREEN: If I could just add something here, certainly any data that you all have on utilization would be helpful for us. We’re out there scanning what’s available. We have certainly taken in some of the data that’s out there, but if you all come across testimony, additional data that would help support why something is not working or is working effectively, we would take that under consideration.

DR. STEAD: You’re looking a little puzzled, Rich. You’re good? Okay. So, do we accept that as the draft scope? And with that draft scope, we assume we would request input and the statistics. We would get that. That would not be the focus of the hearing itself. That would be input that would come to us.

The hearing would be focused around 278. Does June still seem like that would work?


DR. STEAD: We will take that as a draft.

MS. GOSS: And I would suggest that if we want to ask for the statistics in advance, that we really need to figure — There’s a separate timing there and I don’t know when you want to get to that one, because I think you want to be able to have them have enough lead time to go out to get it and then submit it so that we can then digest it before we get to the June meeting.

DR. STEAD: I think that the request for the statistical data should go out at the beginning of Q1.

MS. KLOSS: And it’s in the form of a request for information, which isn’t something that we’ve necessarily done, at least in my tenure.

MS. GOSS: But I think it’s a nice opportunity to kind of morph our process. It says we know you are going to do this work anyway; why don’t we go ahead and start that process so that in May we’ll have a little more time to reflect on their stats as it relates maybe — or their testimony for the 278.

MR. COUSSOULE: The last information we have will be two years old by that point in time.

MS. KLOSS: And we will at least know where there are gaps —

MR. COUSSOULE: If there is any significant progress or not.

DR. STEAD: If we are going to try to get that out in Q1, do we need to accompany that with a statement of how we propose to use the hearing, so we’re giving people the context? This is what the Review Committee is going to do this year. You’ve got these two pieces.

MS. GOSS: I think it is great. It’s all about predictability, planning and people being able to step up and meet our requests. And if we don’t put the plan out there, they can’t do that.

MS. KLOSS: Then you can add the link to the report that was submitted — reiterate that once again.

MS. GOSS: You’ve got a lot of people shaking their heads behind you; that’s why I’m smiling at you.


DR. STEAD: So, standards as the point for the Review Committee. We would need to figure out how to support you in drafting that.

MS. GOSS: Is this an RFI? Is that what you’re saying?

DR. STEAD: Well, it’s two things. It’s a description of what the Review Committee process is going to be for 2017 and a request for information to update our statistics on rate of use. The last review committee tried to scrub the word adoption for things that had to do with rate of use and replace it with implementation.

MS. KLOSS: And it didn’t work for me.

MS. GREEN: I just have one more suggestion for the committee to think through. As you all are getting those data in, also look at it from the sort of use case scenarios, because how they’re using the 278 is important as well as the standard itself. Not just as important.

DR. STEAD: Would it be possible for us to get some scan or summary of the information that you are already receiving on rate of use?

MS. GREEN: I will certainly take a look at what we have and share —

DR. STEAD: That would be a wonderful input. If we know what’s already available in your wheelhouse, then we wouldn’t have to be dual requesting that.

MS. GREEN: I don’t think we have the full data that you all are looking for. We have more testimony from various industry groups, and then we may have — I don’t know if the healthcare efficiency index does address it, but it’s at a high level. I don’t want to speak for that group. But I do think we need a deeper dive on the data, and we will certainly share anything that we have with you.

DR. STEAD: If we could get a summary of what —

MS. GOSS: I am a little confused. Wouldn’t we just start with the information that was reported, provided to us in testimony in 2015 and ask them to update that for us to be able to start benchmarking?

MR. COUSSOULE: I think that is what we said, but I think Bill is just asking if you have some other information.

MS. HINES: I do recall that was in the first hearing that I sat in on before joining this club and I remember them saying we only had 10 days, and we had a 45 percent response rate, so I’m not sure I would use that as the definitive baseline. I remember being so impressed that they put out this informal survey and they pulled together some slides, but I don’t think it was —

MR. COUSSOULE: I think it would be a source of where they were trying to get the information from. If we reached out to the same folks they might have more complete information, so that’s certainly a starting point. If there are additional ones here, I think that’s useful as well.

DR. STEAD: I’m just showing my ignorance here. I don’t know the degree to which CMS has data that we did not obtain as part of that process. I don’t know the degree to which our hearing process got —

MS. GREEN: I think it is worth everyone taking a look at what we have, collectively, and then going from there.

MS. GOSS: I think we need to talk to WEDI.

MS. GREEN: Yes, absolutely.

MS. GOSS: See whether MGMA has anything, if CMS has anything, WEDI has anything, and then what we’ve got in our RC report.

MS. KLOSS: And whether they want to update what they gave you. MGMA may want to do another survey.

MS. HINES: More turnaround time.

DR. STEAD: If we could get this out in January, then give them until end of March — what is a reasonable response time? Is it end of April?

MS. GOSS: I think that’s a really hard question for me to answer because I haven’t asked the industry — I haven’t done MGMA’s process, so maybe there’s somebody in the audience who might have a sense of this. But I would think that we have to make a request to the entity, they have to develop something to put it out, they need to then get it out, give it some time, get it back — end of March might be just barely enough.

DR. STEAD: Let’s then target getting it out in early January and asking for the request back end of April.

MS. GOSS: Because we want good solid information is the point, and we want them to invest in a process that we can repeat. That may be the other part of our message.

DR. STEAD: That would be a neat part of the language, to actually begin to make this a repeatable process.

Okay. We can move on to beyond our working lunch to reconvene to discuss the future surveys more deeply than we could in Bruce’s brief remarks. First, Josh, do you want to introduce yourself?

DR. ROSENTHAL: Sure. Josh Rosenthal with the Data Access and Use Group.

Agenda Item: Future of Health Surveys

DR. ROSENTHAL: I appreciated Bruce’s willingness to at least cover the first phase of this next scoping document on future health surveys. As he said, this really addresses three potential areas for us to consider. One is around technical issues around survey methods and response rates. The second is around getting other federal knowledge and survey expertise into this space to talk about how to do the community surveys better. And the third was around access and ease of use, particularly for research and policy purposes. That is almost an assessing phase.

The second phase, in building on that information, is are there new technology-enabled sampling techniques. We heard in the last meeting from NAMSS about a meaningful use opportunity that had tens of thousands of physicians willing to submit data from the EHRs to NAMSS as a way to supplement the way it collects its information. So it’s really starting to look at some new opportunities.

And Vickie brought up the issue, in creating this, about scientifically constructed samples that might help when our current larger samples have lots of noise-to-signal ratio, and how we might use those to achieve better robustness and scale.

We’re kind of in the early phase of this. It’s not clear whether we’re discussing a workshop or hearings or a series of projects, so we really could use some input on how to approach this, much less how we frame it into Bill’s wall frame. I would say out of scope, because it really helped some boundaries, is that we’re not talking about specific design and content issues for the national community surveys. We are really just talking about how to make the information they collect better and more useful. We could really use your help.

Further down in the document about key inputs, in that first phasing there’s a real opportunity to look across our federal stakeholders and other federal resources around this to get a clearer idea of how big a problem this is. That might help us figure out whether we need to move on into actual development of new recommendations.

I think I’ll stop there because we don’t even have scoping or a timeline attached to this one.

MS. HINES: I think there is some due diligence needed here because, for instance, we know that there’s a federal committee on statistical methodology that just had a charter pulled together, just formed specifically to look at the low response rate issue. So this is not an HHS-specific problem; it’s a government-wide survey conundrum with all of the shifts and things in the world — technology and phone use, lack of land line use, and people’s unwillingness to participate in surveys and so forth.

So, if you are sincere about moving forward on this, I think the first thing to do is find out what’s already underway, because my sense is there’s quite a bit.

DR. MAYS: I think there are a variety of issues that also fall into this. The little bit I remember is that that committee really is looking at the rates of participation and what kinds of things we need to do to be able to increase that.

But the other thing that we often talked about that we should be thinking about here is the linkages of the survey, the coverage. One of the critical issues for us is — if Susan Queen was around or on the line or somewhere, I could get her to comment about this. It’s very hard, for example, to get a document to tell you, like in terms of heart disease, how is it covered, who is covered, and who is not. So I think when we think about the future surveys we’re also talking about creating them in ways in which we have the adequate coverage for most Americans.

I think we also are talking about all of the privacy and confidentiality issues that come with linkages. Some work we were doing around data access and use was looking at some potential linkages between HRQ, NCHS, and I think there was a third one but I can’t remember what that was. So there really are several things beyond just survey rates that are in our interest to think about.

DR. RIPPEN: I know this is a bigger issue than just HHS. I think non-response rates are important. My question is more, if we step back and say what’s the role of the committee, there’s a question of are we in the business of making recommendations about methodologies and strategies for improving survey response rates. Again, going back to the scoping question, ultimately, what is our role in this big issue? Is it technical expertise? Do we bring the experts in? Or are we talking about the importance and the concern of not having a response rate, highlighting the issue, or also identifying alternative methodologies or alternatives to how we do it, in addition to the linkages?

So, again, it goes back to scoping because there are a lot of different buckets and they all have significant implications, and I don’t know what the right answer is.

DR. STEAD: I read a few things last night on the airplane that I had earmarked. One was the charge to the new federal task force, and it’s focused on how do we calculate non-response rate during the course of a survey so that we can adaptively correct the sample to have a representative result at the end. It is a statistical methods effort. It’s very important, and that is not in most of our wheelhouses, certainly not in mine.

We also received a couple of articles and editorials that described successful efforts to link the statistical NHANES sample to administrative datasets such as HUD to, for example, calculate the difference in rate of lead poisoning in people who were in assisted housing from those that were not, and showing that housing assistance was improving, or appeared to be improving; whereas, 20 years ago the reverse was true.

So these are examples of things that are underway and fit into Rebecca’s suggestion that there needs to be a good environmental scan of some ilk.

As I read the scoping document, the parts that I don’t believe are underway are thinking through how we make the data more usable for communities on the one hand, and how we actually help the communities use methods that have been developed by the federal government to let them fill in the gaps as appropriate in a statistically valid way. I don’t think anybody is really sitting down and saying, in 2017 or 2020, or whenever it is, what is going to be the best way to construct a meaningful statistical sample of the American population. That’s sort of the next generation component that’s a little bit like next-generation guidance.

So my sense is that is where it would parse out. Does that compute? Given that, do people have a gut reaction to where this sits in our priority, in terms of the sequencing? I think that latter question, the vision — well, I think both how we help communities and the vision piece are work that it would be very helpful if it could be done. My sense is there are enough moving parts, and I’m noticing that 2017 is getting pretty full. I guess the question I would put on the table is should we consider parking this for 2018 or beyond.

A second thing we could do is figure out is there a way we could do the kind of environmental scan that Rebecca was mentioning within our bandwidth. But let’s have some committee discussion about where it’s sequenced.

DR. MAYS: There are a couple of other pieces. I’m going to be Bruce; I’m going to try and channel Bruce.

One of the things that we haven’t talked enough about is the fact that there is an organization that does the development of these state surveys, and part of what he has looked towards NCHS or the federal government to do is to help mount more and more state surveys.

For example, California has the California Health Interview Survey; they helped New York to do a New York NHANES. If you want communities to really get better at this, what you really want is not just reliance on the federal data, but you want technical assistance to help them to do this for themselves.

California does wonderful stuff because we have a survey that’s for the whole state. I do a piggyback on it which is the state’s mental health data. There are so many ways that having your own state survey is important. So I think we want to put that as part of this scope.

The other thing he has talked about is this issue of the development of expertise and statistics for small populations and small areas. That’s something that I don’t think we should put so far on the back burner because there may be opportunities as the federal institutions get shaved, such as NIH, et cetera, whereas they may decide to put money in NSF — if all these things are there and well funded.

So the issue of having statistics that allow you to figure out — it goes with what that other committee is doing — actually figure out what is the true rate for if you only collect like three American Indians and you’re trying to figure out how to adequately weight them. Having statistics that guide you on doing that for rare and hard-to-reach and unusual populations would really be very useful. And then some of these area type statistics as well.

Bruce, wherever you are, I hope I channeled you.

DR. RIPPEN: If you go back and look at what Pop Health’s focus was with regards to what kind of data, what level of granularity and how do we make it more valuable to communities and geographic communities or other communities, and then you start talking about the tools to analyze it, right, because we were talking about statistical tools, and now we’re expanding it to say, okay, what about surveys. What’s the suite of survey tools with the guidance as far as how do you use — what survey methodology, because, again, that’s a very specific kind of expertise.

That’s a very different kind of flavor as one strategy as far as enabling those at the local, regional that may have a need to.

What I don’t know is if there’s also a need for the balance as far as when is it and why is it important to do a national. Again, it goes back to what’s the message. One is more support and kind of methodology and here is your toolbox. The other is when do you make a difference between when it’s up to the state versus when it might be important. Just things to consider.

DR. STEAD: Another alternative in terms of how we handle our critical path, which we’re going to do a little more of when we get to this afternoon on the Pick List, is to identify targeted updates that we actually want to bring in to the full committee meeting to help us evolve our thinking around what we do next. It’s, again, a middle ground between parking something and holding hearings or workshops. Lee?

DR. CORNELIUS: Just to add to the discussions, the piece about technical assistance relating to data quality — I see that as very important. While we’re talking about the idea towards connecting to either administrative records or electronic health records, we have to sort out the purposes of that data; that is to say, the clinical purposes, as opposed to for survey research. So the piece about technical assistance really, first, at the federal level across all the statistical agencies.

If this is the direction we’re going to move in terms of dealing with non-response rates, we still have to handle how do you make sure that the data that you’re going to pull together is going to be of such quality in terms of missingness and how it’s reported and so on that it’s going to stand on its own. And then it moves down to the community level.

So I don’t think we want to assume that just because we have this data and we have something in terms of non-response and so on and so forth that pulling the data forward is going to solve it, because garbage in-garbage out.

DR. PHILLIPS: My comment is more about timing. I wonder if there’s an opportunity to work with this new group that has been convened to actually hold a joint workshop or a joint hearing where part of it is focused on response rates and non-response rates and how to handle them, and part of it is on the issues that are more of interest to us that are around that, so that that group can hear both conversations and we can hear theirs. I wonder if there’s an opportunity for us to do that jointly.

MS. HINES: I did reach out to them and haven’t heard back. Not on that specific request but just could they come meet with us at the February meeting, and would that be the right time, and can we plug in. That’s a very specific example of how we could actually work together with them, so I will follow up again.

DR. MAYS: Just so you know, on December 12th — and since you’re local you might want to go — they are actually having I don’t know if it’s a workshop or hearing, but what’s scheduled to discuss that day is data, data management, data issues. I think they are wrapping up some time in February or so. It’s December 12th.

DR. STEAD: I’ve heard several potential expansions or additional detail that could be put into the scoping document. My sense is we would then be left with two options. One would be, in essence, a broad visioning activity of some ilk, analogous to what we’re saying we want to do around next-generation guidance — not into the implementation, but what is the big vision.

The other alternative is to figure out, of the items that are in the current document or that you have mentioned as additions, is there one of those items, or are there two of those items which we would like to focus in on, and maybe we do that by having some update at a full committee meeting. And the non-response group — hearing from them is one. To have a chance to hear from them and have a dialogue with them about — that’s one that would be a targeted thing that wouldn’t take a full hearing.

What is the next most important thing? You could use that same kind of approach to getting input from one or more states around what they had or needed in a way that — I’m just trying to look at is there something short of a hearing, since my sense is we’re full of hearings, that would move the ball. It would help me to sort of have a straw person.

One option is high level vision. Another option would be targeted updates at the full committee meetings that move our thinking forward on a couple of things. Another would be try to figure out how to have a focused workshop or hearing on one thing. Those are, in essence, roughly the three approaches we can take.

Just a quick show of hands. Who would favor starting with vision? Okay, one.

Who would favor starting with picking one topic and having a dedicated workshop or hearing? One.

Who would favor doing targeted updates that move our thinking while some of this work is taken on? Three.

We don’t have a landslide.

DR. MAYS: You didn’t allow us to give you other examples. I wouldn’t say there’s a lot of energy around it. I think it’s more a combination of things, and starting with some due diligence for us to get some updates on some of these things, not as the full committee but for Pop to go do that.

Second, it would be what are the things that we should move first on because they have opportunity. There are two committees, the statistical committee and the evidence-based one, that are going to come in with recommendations.

MR. COUSSOULE: Do you view this as separate from the Population Health or a part of Population Health?

DR. STEAD: I think the idea that this could be worked first at Population Health is a good one.

(General agreement)

MS. KLOSS: I would just say that one of the early things we might do here is retitle this topic. To me, it says we’re going to start with vision. So, if we’re going to do an environmental scan — health survey challenges or something like that. That might be a little more descriptive.

MS. HINES: As the Co-Chair of Pop Health, what is your thought?

DR. PHILLIPS: I appreciate the suggestion. I’m not sure if it catches the breadth. I do like having it come under Population Health, though.

DR. STEAD: My sense is what we’re doing is returning this item to Pop Health. We already are hoping to get an update from the Evidence-Based Policy Commission. If we can get an update on non-response — let’s make those a couple of things we’re going to try to feed into the full committee, and let Pop Health work this another round.

DR. RIPPEN: One of the things that may be important to include in the activities for Pop Health is kind of trying to get a sense of the demand, because if the assertion is the question of local and regional wants it and how to leverage the surveys that are created at a national level and distributed, it would be good to have a sense of do people really want it or not.

DR. CORNELIUS: It’s like the Field of Dreams; if you build it they will come.

DR. RIPPEN: We’ve said that about a lot of technology.


DR. CORNELIUS: But this affects what we do.

DR. RIPPEN: I’m a proponent, but it’s nice to say that there’s a demand out there.

DR. CORNELIUS: Induced or not.


DR. STEAD: My sense is we are all good with that outcome, so Bob and Bruce will pick it up with Pop Health. Which paves the way to HealthData.gov.

Agenda Item: HealthData.gov – The Next Generation

DR. MAYS: Could members introduce themselves, that are online?

DR. STEAD: If any members of the workgroup are online, would you please introduce yourself? Josh is here with us.

DR. SORACE: Jim Sorace.

DR. FRANCIS: Leslie Francis.

DR. DAVIS: Damon Davis.

DR. HUNTER: Good afternoon. Mildred Hunter.

PARTICIPANT: Mr. Savage from LNC is on.

DR. MAYS: Okay. We will get started. There are two handouts that you’ve got that I just want to point you to. One is called Introduction to HealthData.gov, and the other is a set of slides that we will talk through. They give you some examples that we want to share with you.

I realize there’s a background piece that has to make sense to understand why we have been asked to do what we do. Last time I presented, one of the things I talked about was the open data movement, and that was back in about 2009 and the administration really was trying to, both for the sake of E-economy as well as making government more open and transparent, really promote this issue of open data.

At the point of that, we also had Todd Parks, and he was the chief technology officer, and part of what Todd Parks was very interested in was making sure that data was getting out the door, that it was being used. Part of what he did was he designed something then that was called the Community Health Data Initiative, and that was really designed to encourage innovative use of our healthcare data, and that’s what is now known as Datapalooza. Historically, Datapalooza actually came through HHS.

Also what Parks believed was that by designing HealthData.gov what was going to happen was that it really was designed to support the public health goals of HHS, but, at the same time, a very important aim for him was also to make sure that we would be able to capitalize on business opportunities in the area of M-health and E-health. So, from a background perspective, HealthData.gov had a very important role to play, and it was predominantly healthcare for innovation and on the public health side in terms of data being accessible and usable.

The other piece that goes into this is that part of what was designed under Todd that is also what’s known as the Idea Lab, which I will ask Damon to tell you what it’s about. The Idea Lab was a design of Todd’s to bring in innovation. It was the home for HealthData.gov as well as Data.gov, if I’m not mistaken, and the reason that the workgroup was created was to actually be a consultant to the Idea Lab.

In our early history, we started around 2012, and at that point Justine was the Chair, and much of the activity for the couple years that Justine ran it was to be a consultant to Todd, Damon and others, even though there is also the Office of the National Coordinator in other areas. It was mainly for HHS because they didn’t have the right set of people, so it was for us to kind of bounce off of that.

We have gone through several iterations of that model where, in 2014, we had a letter that went to the Secretary, which is actually described, about use, usability, et cetera that we gave them some advice then and it’s still relevant today in terms of needing to take that advice. But we moved away within the last year to not necessarily being a one-off all the time but instead to come up with very specific projects that would come from Damon.

So let me ask Damon to just describe very briefly the Idea Lab, and then I will come back and describe the request that has come to us from HHS, and then ask Jim to give you a little bit of background about that.

MR. DAVIS: The Idea Lab is an innovation office within the Department of Health and Human Services that is positioned in the Office of the Secretary with a focus on trying to deliver government services in a better, more efficient, cost-effective way. The idea behind the Idea Lab is to promote innovation, design, entrepreneurship and action amongst our colleagues in HHS, and we try to bring in entrepreneurs and residents and external knowledge holders to help us and contribute to solving problems within the Department.

One of the things we like to do here is to incubate new and creative ideas and then disseminate them out to the remainder of the Department or help them to grow and flourish in the places where those ideas have originated.

I hope that is helpful for you. I’m not sure, Vickie, what else you wanted me to cover there.

DR. MAYS: That is exactly it, to kind of give a sense of what it is that you do so people get a sense of what it is that we should be doing. In this transition, one of the things that his office has been very involved in is maintaining and really innovating as much as possible HealthData.gov.

Jim Sorace, can you talk a little bit about what went on in terms of HealthData.gov and the National Library of Medicine?

DR. SORACE: I think Damon and the group have been searching for a permanent home for HealthData.gov, and they have looked at a number of places. The first one, which I think was very logical, was to see if NLM wanted to take it over. Basically, that was evaluated by NLM and they decided not to.

Damon, you’re a little more up on what has happened since then, but I think you’re also looking at the Chief Information Officer’s office here at Health and Human Services, and I presume that is not finalized or may not be going through yet. Am I wrong about that?

MR. DAVIS: You are correct. We’ve got a couple different options that we’re considering, none of which has really truly materialized, so you could think of us as being in discussions with a couple different groups. So stay tuned.

DR. SORACE: It is logical that HealthData.gov should be moved to a permanent home. In the meantime, I’m helping to keep the lights on and some of the wheels turning as best I can during the transition.

That is where the website and database itself stands.

DR. MAYS: As you can tell, a lot of resources and energy went into the building of HealthData.gov. And one of the things is Damon and Suzanne before they leave would like to make sure that it has a home and that what we think about is how do we talk about HealthData.gov in terms of its value, its potential innovation to address many of the issues that we’re facing on the public health and healthcare side.

What we have been asked to do by HHS is very specifically to come up with a report for the next administration — so we’re looking at really trying to get this done in February — and in that report, talk about what would the next iteration of HealthData.gov be. In our discussions, what we have done is we’ve talked about two really important components that we have identified that we want to kind of lead this report with, and then you’ll see the more general things which is part of what we want to get input on.

One is to remember that even in the open data, health data is a value; it’s E-economy, and that was a big push. If you remember what Todd did, he wanted to see HealthData.gov really support the growth in healthcare for M-health and E-health.

On the other side, it also is to help in terms of public health. Often you will hear — and Jim I think represents this very well — is HHS being able to utilize its own data better, and is HHS able to even link its own data to be able to come up with the kind of information that it needs. It is not unusual for HHS to have contractors often come in and utilize some of this data in order to be able to get an answer to a question. So, thinking about ways in which HealthData.gov could be more functional as well as supporting E-economy would be useful.

The other thing that we talked about is value. What is this unique resource? What is the value that’s attached to it, and what are some of the things that it can do that have not actually been thought about and promoted? That’s one of the other things.

I am going to ask Helga to talk a little bit about some of the E-economy issues and why we would be putting those forth, and then have Josh talk about some of the value of ways in which we are not aware of that quite often HealthData.gov is used, and that we think is a real selling point for why this valuable resource should remain.

DR. RIPPEN: Just to put into context again and reinforce what Vickie said, if this is about the value and importance of the whole initiative and finding a home, then a big part of that is making the case as far as why should anyone care. As administrations come and go and as you look at budgets and whether or not you’re going to fund something, you’re going to have to make a decision about that.

It has been very clear, based on my limited interactions with others in the field and also the business sector, that an important component of this is the notion of other people using it. Datapalooza is actually an excellent example where they have demonstrated actual real life use of the data to actually do a lot of really interesting things, and actually have spun off a lot of companies and entrepreneurs that have leveraged the data. In addition, too, internally within the Department being able to access data that they might have been able to access but maybe not as easily.

So, one of the components of this would be to really highlight the reason why this is valuable and why something like Data.gov is an important thing not only internally for the government but externally for entrepreneurs and others.

I think Joshua has real life examples as far as how this data is being used.

DR. MAYS: We have a set of slides. Again, a lot of these are the non-HHS uses that I think if you were to suddenly have this disappear it would make it much more difficult for some of the entrepreneurs. And you would be surprised — you probably use some of this data at times.

DR. ROSENTHAL: I’m probably fairly close to this on a number of fronts. One, I’m on the steering committee for Health Datapalooza, so for the past couple of years I’ve been responsible for running around and seeing who nationally is using this, from technologists to delivery, payers and providers to E-health and E-mobile, so we’ve looked at thousands of companies that are using this.

In my day job, I’m actually an entrepreneur, Ernst & Young entrepreneur of the year, and we use this to manage $850 billion in 48 states with 100 million patients and members looking at this concept of low value care. Specifically, $.30 of every $1.00 goes to just outright waste, and these releases from Part B, D and A are incredibly helpful in being able to identify that. So we do that with Ivy League academic medical centers to publicly traded companies to little, tiny ACOs. There’s a component in the business-to-business around this that’s often overlooked.

Finally, I actually teach and have lectured and do workshops on how to use government data at Harvard for the past five years literally where they are using this HHS data and particularly HealthData.gov. For a variety of reasons I don’t want to get too technical about it. Technically, you can interact with data without having to go to HealthData.gov. It’s a lot more difficult for a host of reasons, particularly when you’re dealing with people who aren’t experienced healthcare researchers or don’t have PhDs after their names.

With that, I can just walk you through a couple samples. This is what I do in my day job where we have 97 percent of doctors ranked around their ability to move to pay-for-value versus fee-for-service, so we’re getting rid of that $850 billion of waste, which tends to be very important both for providers and for payers.

We built that product using HealthData.gov. This is Ivy League academic medical systems, publicly traded companies. And the beauty of public data that way is it’s not – obviously, it’s public by nature so I can see my competition. I can see people who aren’t in my network. I can see names that are named and not de-identified, so that accelerates competition and accelerates a very important market dynamic.

One of the things we do is we work with — especially in the teaching capabilities — other — Health Datapalooza has had an international tract for the past three years very specifically working with NHS, Israel, France, et cetera, and they’re using this next-generation computer science for a variety of reasons based on public data, so there are things we can think about from there.

The thing I would say is the beauty of health data, one way to think about it is in terms of an ecosystem. What most researchers and most people in the room are probably familiar with is an enclave approach. That’s where I go in, I get credentialed, I have an application — last year there were two of them accepted perhaps, et cetera. Most of the users of health data are not going to enclaves; they’re not only not going to enclaves, they’re not going to destination sites.

In my day job, we partnered with U.S. News and World Reports and we have tens of millions of Americans using this for AAA and to make decisions around which hospitals and which doctors, but you never see any of that. That data has gone out into the ecosystem where it’s being used. So, moving up from enclaves to destination sites. Most data is interacted with at meta-sites or repositories, of which HealthData.gov is an example, or data browsers. This would be like Google public data. HHS data is out there; hundreds of millions of uses around that.

Pure play technology folks who don’t have healthcare backgrounds are starting to do some incredibly interesting work around here, one of which would be ReadWriteWeb, where they just put up HHS data in a browser. Todd was great, but one of his axioms was he wanted coders and entrepreneurs to have to have coding skills and statistical skills. Putting it up in a data browser allows people to — out of 500,000 entries — people were looking at comorbidities for diabetes — and it was a 15-year old girl who won the thing — just to give you an example. Lowering the bar to interacting with health and human services data. And that was, of course, not accounted for in any samples of destination sites.

And then all the way up into other delivery mechanisms. There’s U.S. News, ProPublica and Yelp and Charlie and those sorts of folks. The point I’d like to say is that when you think about it, our group is dedicated to extending the use and access, and HealthData.gov occupies an incredibly meaningful spot in this scenario, literally allowing students to be able to use the data, entrepreneurs to be able to use it for product development, and folks from outside healthcare backgrounds in a meaningful way.

These are just other examples of what I mean by what is a data browser. You go there and you don’t have to code anything, and you literally see your data visualized and can do analysis in a graphical interface-driven environment. So I don’t need coding skills, I don’t need data skills; I’m interacting with data without any of that. It opens it to people from different backgrounds.

DR. MAYS: One of the interesting things about this is that HHS typically does not know this because it’s not built into the system to be able to capture this. For example, a very simple recommendation that we will make is that they be able to better understand how their data is being used and where it’s being used to understand its value. We will present information that actually talks about — there are companies that develop to do this.

But Damon and Jim are often asking the workgroup members can you tell us how our data is being used, so there’s great value in the data but it hasn’t been captured. There are certain things that could be done to actually deliver this information about its value.

What we have been asked to do is to write a letter particularly to the Secretary and talk about HealthData.gov and its value and, at the same time, offer those high-level recommendations. We are not going to get down into the weeds, but high-level recommendations about what are some of the ways in which changes could occur for HealthData.gov that would make it have more value. And there are lots of different things. This is the work that the workgroup has done over time in terms of trying to say, well, if we did social tagging, or if we did — There are lots of things that we have recommended that we think would actually help with access and use.

I think what we want to do at this point — and I will make sure if anybody online wants to comment that they can. But I think what we want to do at this point is to get some feedback from you all around the direction we want to go in with this, any ideas that you have, and to make sure that we’re in the timeframe of when we’re going to do this. We think we can do this by February.

What we have given you is an outline of the kind of report we would like to write, so we’re looking at about a 10-page report, a letter to the Secretary and a 10-page report. In his 10-page report, under No. 3, how HealthData.gov can reach its greatest potential, is where we would make recommendations.

But before that, we would start off with its background, talking about its size, why it’s a unique resource, the value of it, which would be things like this and identifying that kind of data. Then, what the current state is, because it is currently — we have a contract. We even have ideas in terms of contract of things that can be done for the various people who deposit their data there to kind of bring it into compliance over time. And then something about who the users are and who the potential users could be.

Let me just see if there’s anybody online that wants to make any comments before we move on.

DR. FRANCIS: Just to say that I’m willing to help with the report.

DR. MAYS: We always like to hear that. Jim, any comments from you?

DR. SORACE: Just to echo the fact that value-based care and purchasing is going to be around for quite a while. If you look at MACRA and other legislation that was recently passed and was bipartisan, I think we have to make a case that by providing this data, numerous other people go out and use it and turn it into useful products that can actually make healthcare delivery more efficient and of higher quality.

DR. MAYS: Sounds good. Comments?

DR. STEAD: Let me try to put a point on this and invoke some energy from the committee. The workgroup, at the request of Damon and HHS, is taking this task on as a fairly rapid cycle effort. The letter will come from the full committee, so we need to work out how we need to engage with the workgroup to mine their insight and expertise but, at the same time, bring us along so that we’re comfortable with the final recommendations.

This would be, depending on how it plays out, either the first letter that would reach the new Secretary or it would happen about the same time as the report to Congress.

We’re going to try, in both of these cases, to have drafts in a form that we would have a block of time in day one of the February meeting so that we could work through the draft. And we would be in a position to take action on day two if we didn’t need subsequent edits or, as with the report to Congress, if it needs subsequent edits, they could take place in advance of our April teleconference to take action.

So we’re thinking about this in that kind of timeframe, which basically means this meeting is the time we have to make sure that the scoping document, which in this case is actually fleshed out by an outline so it’s a lot more detailed than a scoping document, that that fits and provide some input.

With that, Denise and then Helga.

MS. LOVE: There may not be an answer, but I remember the Data Web, and we paralleled the meta-databases and data browser to query the national datasets but then we made it scalable down to the state level. I’m sitting on two or three requests right here of users that you talk about that have mined Medicare data quite a bit but they hit a limit because most the care paid for in the states are moms and babies who weren’t on Medicare. So I get multiple requests from the national users on how to do similar things that you did with the Medicare data beyond Medicare data.

So, would this in the future dovetail in the ecosystem of the state databases that are coming on, and even other public health databases?

DR. ROSENTHAL: It’s funny you mention that. I think that’s one of the most significantly specific opportunities where the state PUF files are beautiful and no one is touching them in a meaningful way right now.

MS. LOVE: It is very difficult but I think it could be more cohesive, so I’m just challenging the committee a little bit to, as they develop these wonderful tools and resources, really think hard about how to pull in key data from what’s out there right now in the states. What is a PUF file?

DR. ROSENTHAL: Public utility file.

DR. MAYS: We’re talking about the kinds of things that we would be suggesting, not actually the details of how to do it, but this would be a suggestion.

MS. LOVE: With a model to pull in not just federal but to start with the federal but pull in auxiliary datasets over time.

DR. ROSENTHAL: Absolutely. And that’s part of beauty of — I mean, HealthData.gov being that meta-site, over the past year they have taken specific steps around that. You can now click a tag and see is it in a JSON file. You can click a tag and say what’s the geography; is it county for Medicare; is it PUMA; is it zip plus four; is it Census tract, et cetera.

So they’re starting to do THAT, and that’s a huge piece of the specific work which I am under strict orders not to get too technical but is literally around that metadata piece of it, which is something we’ve been dreaming about since day one. Technically, any time you build something, you have an ERD there, you have an entity relationship diagram. you could publish that easy-peasy and that would save massive effort.

So yes, that’s exactly what we want to be doing.

DR. STEAD: Are you suggesting and agreeing — I’m hearing agreement in this exchange, so will that be an additional item under No. 3, how HDG can hit the full potential, or do you feel it’s already covered?

DR. ROSENTHAL: I think it’s included. If you look through in detail, there are already examples of that at HealthData.gov. It’s one of the beautiful examples of it but is not complete by any stretch and it is only a very first cut at it, but it’s very good and very powerful and I personally think it’s included.

DR. MAYS: Yes, it’s there. I think what I am hearing is that we should focus on the issue of scalability to some extent. So it’s not that the “to do this” isn’t there, but I think the emphasis, which I appreciate hearing, is more about scalability as the high-level issue as opposed to here are some of the things we think you should do. So we do have it that way, but scalability I think would be great because it connects this exactly the way you’re asking.

DR. STEAD: Linda?

DR. RIPPEN: It goes back to scope and focus, because with regard to making the case and then one of the many things that you’re making a recommendation about — because there’s a whole list. There was a whole thing about scalability and then the metatags — how do you do the standards. There’s the question of data quality. It’s a lot.

So, again, going back to the comfort level of the group and is this the moon shot, or is it what’s in the scope of the first versus what is recommended second — you know, how much to put in or not.

And perhaps maybe, Vickie, it’s something to think about with regards to — we can sketch out what we have and then we can cut, or we can just — what would people be comfortable with? Remember, there are implications of cost also if you want to make the data more usable.

DR. STEAD: Can I make a comment on that before we go on? From my perch, if you look at how we handled a lot of things lately, meaning the minimum necessary, de-identification, I think it’s helpful if we can have a few recommendations that are actionable in the near term. It’s fine, then, to include a section on future directions to provide the hook, but if you could try to parse it that way I think you would make it more approachable for the committee as a whole and more actionable for the Secretary. Is that fair?

DR. MAYS: That’s good. I agree.

MS. KLOSS: One assumption is that our overarching goal is to have the Secretary understand that this is a resource that exists that could be leveraged for a variety of future purposes. I think that’s kind of an important message, and I would make it as black and white as possible.

MR. DAVIS: I want to underscore that last point because I think it speaks to the critical value of the platform. The idea that we’re trying to figure out how to sew together a healthcare system that acknowledges the importance of social services, research, electronic health record utilization, surveillance, every one of these things, into a really, really smart and knowledgeable healthcare system with the help of entrepreneurs and innovators out there is of critical value. And I think it really needs to be said with more passion, because HealthData.gov really does truly provide a one-stop shop for any ability to understand where the breadth of information across this entirely huge department comes from.

I would love for us to be really emphatic about the importance of the data itself as well as this platform for its discovery and the interconnectivity of those data and information.

MS. KLOSS: And if it didn’t exist it would have to be built. The second thing that strikes me is how far it has come in a short time. The first letter that this workgroup — In 2014, we were really at kind of rudimentary things about basics and documentation and usability, and just to see where we are today — I think I would underscore the amount of learning that has occurred to move it this far this fast.

But I can certainly see that this is a fast track letter.

MR. COUSSOULE: Is any of what you are undertaking trying to get into the quality of the data itself or really just an organization of the accessibility to the data?

DR. MAYS: I think we are talking more about how the data can improve quality as opposed to the quality of the data, so we were trying to stay away from getting down into that. We have talked about.

MR. COUSSOULE: The reason I bring that up is I think that’s a rattle. It would be so complicated that I don’t think we would be able to manage it. I just wanted to make sure I understand how you scope it.

DR. MAYS: The other thing is that we’re going to also be looking at what the Evidence-Based Policy Committee is doing, because it will have that meeting on the 12th. To the extent that we can see some parallels or the extent to which even getting the pick-up of their recommendations, ours coming along as very similar or the same I think will be useful. So we’ll see. We are also looking at that.

DR. STEAD: Vickie and Josh and Damon and others on the phone, I think you have got our support and guidance, so let’s move.

We are now going to move to Beyond HIPAA, Linda and Bob.

Agenda Item: Beyond HIPAA

MS. KLOSS: We are both jumping in in the absence of Barbara Evans who is our third member of our scoping team.

This topic has morphed from what we were once talking about as the future of privacy that then became enlarged in scope to, well, it’s not just privacy; it’s the future of all HIPAA, and then it became HIPAA 3.0, and then it morphed to Beyond HIPAA for the reasons that Bill led off with this morning, that we really aren’t suggesting that there be a replacement to the current HIPAA law. We are looking more at the territory outside of HIPAA.

When you look at the description of this, it is certainly a visioning task, but it’s exploring the issues, including the governance mechanisms, that picks up where HIPAA really leaves off. And in B, we have outlined those that we have come up against in various work we’ve done across really all the subcommittees and all the tasks — big data and analytics, cybersecurity, balancing individual privacy and the socially beneficial data access issues, recurring calls for individual ownership of data, population and community health initiatives, personalized medicine, personal health technology, standards and changing technology and data landscape — all of which are vexing problems and kind of operate outside the core design of HIPAA.

It’s kind of visioning, but what we envisioned as the output would be policy guidance regarding perhaps a framework of principles, not unlike what we did in the guiding principles for privacy and confidentiality and security as it relates to community health data, our guiding principles letter, but a little broader in scope.

Ways to advance consistent privacy policy across federal agencies and states, standards, levers, and even not excluding legislative mechanisms such as fines for unauthorized used or misuse of health information. You will see some of these themes come up tomorrow when we talk about de-identification because a lot of these kinds of issues came up in that discussion. What happens if one re-identifies de-identified data? It’s outside of HIPAA and if it gets re-identified there’s no mechanism to either fine or put limits on that. I think this is contained in a narrow way in the de-identification issue, and this broadens it.

As we thought about how to approach this, the closest we could come was to give you an either/or. We could hold one or more hearings with testimony on some issues, so, that long list of issues we could cluster them and have a hearing or two or a couple days back to back. We could do more of a roundtable, a larger meeting, more participatory kind of discussion about the issues rather than hearing testimony. And I don’t know that we’re far enough along to know which is the better mechanism.

But we would see this resulting in a report, and I keep thinking it’s maybe like some of the reports that were done on data stewardship or another committee report that has had some tenure. It has had some shelf life. And a letter of specific recommendations to HHS that would come out of that which would be more short-term in action.

We would learn from the private sector and have to involve certainly private sector but also a range of federal agencies, academics and technologists. And we thought that there probably are some standards and best practice approaches even from other countries that should be looked at, certainly ISO standards or other kinds of standards that might be relevant.

What we put out of scope for now is specific recommendations to revise HIPAA. That is not our goal. Our goal is to look at all of these issues that are floating out there in the ecosystem that so often we have to kind of make it up as we go along how to deal with them.

I think that’s it. Bob, what do you have?

DR. PHILLIPS: I think that’s really helpful. The appendix that’s kind of stuck on is an example of the quality payment programs as both a potential lever for data but also as an exemplar of what’s beyond HIPAA, the idea that the social environmental determinants of health now are being used in public health and are being proposed as a way to adjust payments under the quality payment programs. That was not even under consideration when HIPAA came out and yet some of the data are going to be collected about individuals and some of it will be attached to them based on where they live, so it’s unclear how to deal with that in this context. But there are a lot of other things in the quality payment program that are beyond HIPAA that this doesn’t even touch.

DR. SAVAGE: This is Lucia. Can I make a comment? Thank you.

I think that one of the challenges we have because of the alternative payment models is a pretty significant need to connect social services agencies and traditional healthcare. I think that helping traditional social service agencies and healthcare organizations figure out how to do that consistent with the fair information practices could be potentially really helpful.

There are environments where there hasn’t been a lot of dialogue. The underlying rules that apply — social services agencies have different — they have a different nature than the way we recognize HIPAA, and we’re sort of familiar with it in the traditional healthcare system. We want people who are disclosing out of the traditional healthcare system to feel secure that they are not absorbing liability by doing what’s right for the patient. You guys have talked to me about that a lot and we have heard that.

At the same time, we want social services agencies, particularly private organizations under grants from government, to really understand that there’s a lot of human dignity attached to this information and that treating it casually is not a good idea.

So I think that helping navigate how to connect all those different things like different philosophies, different legal backgrounds, different technical capabilities and connecting them to the output of improving the health of the community and the patient and maintaining the patient’s dignity would be something that would be really helpful.

MS. KLOSS: Thank you. That’s a clearer statement of purpose than what we have written here. Thank you.

DR. RIPPEN: Yes, and it’s narrow. There are a lot of topics here that may be associated but it depends on how you spin it. So I can see this as being a very challenging set of topics to cover. Then you have HIPAA in there, too, as the title.

The other thing that you may want to consider as we go through this is you can do big data — big data is anything that has more than one side and has a lot of data types==of you want to have a broader approach as far as what are things that you have to think about when you use big data. And then, to specify — it’s one thing if it’s to inform action specific to a person versus is it an action specific to a community or a set of individuals as a community. Those are very different because one is identifiable and one is de-identifiable. There is a third as far as just the use of big data, as business and for other purposes.

So you may want to think about how you bucket it, because each one may have a different nuance associated with it and it may become important to think about.

MS. KLOSS: So your recommendation would be to perhaps re-aim so it’s not — and then clump it or look at narrower groups.

DR. RIPPEN: Yes, because if there are information practices, if you’re linking about an individual, that’s a theory you could put under big data as identifiable actions for a person, so what are the fair practices. Versus if you’re aggregating for population level health, because there are different nuances associated with that. Then you do have to worry about — right now, the (indiscernible) was saying how they are not going to allow targeting based on ethnicity, so what are the implications in healthcare. Those are just examples of the potential issues.

I would say you may want to consider retitling it. What you rename it depends on the focus, and the structure depends, again, on what the focus is, because I just see it’s a lot of stuff.

DR. STEAD: Let me suggest an alternative. My sense is that this is as big as the 2002 vision for health statistics for the next period of time, which, in many ways, has established a conceptual frame of how to deal with the change in scope and scale and the convergence.

It seems to me if we could figure out how to develop such a document by, say, the end of 2018 — this is really big. I don’t know how we’re going to play out when we get to our afternoon thing, but this is definitely work that has to be done first by the committee a whole. We are not going to assemble this from the subcommittees, I don’t believe. That is, I guess, a key question. One thing we could do with something this big is ask one or more subcommittees to go work on it. My sense is this is work we may need to do as a committee.

But I can also imagine us carving out half a day in each of our meetings for the next year and a half to actually bring in pieces of this and to work this while we develop this kind of a vision statement, because the vision statement doesn’t actually have to reflect periods. It can, in fact, be, given the change in landscape this is how big it really looks. And we would want that vision to be broad enough to accommodate the kind of changes we’re talking about here. It just takes many more levers.

Then I imagine we would then spawn an endless series of hearings that would outlive any of us, that would work individual levers down a level. That’s one way for us maybe to think about this. I’m just sort of positing how to maybe make it work, so I’ll just put that out as an alternative. Then this statement could actually stay in pretty much as it is. But we would be getting testimony as part of our standing meetings almost until we got a rough draft of what we were talking about. Just a possible approach.

MS. KLOSS: I do believe this is the issue that at least over the last two years has occupied most of the time of the Privacy Subcommittee. One way or the other, it always comes back to the things where we don’t have guidance or regulations.

DR. STEAD: And we can think through, once we deal with de-ID, in addition to working this as a whole — the predictability roadmap will play into it. Everything is going to play into it, so we may want to identify the next more focused area that privacy and confidentiality would want to work, that would feed the broader discussion. And we may want to figure out when does population or the intersection of population and standards have the bandwidth to begin to do something around quality payment programs. The question around leakage of social services and healthcare is another potential targeted piece

What I’m thinking we might do is work on two very different planes — a high plane as a committee of the whole with key topics as different subcommittees can work them along the way as we try to move to what, in many ways, would be — this would be as bold a statement and vision as the original HIPAA language was, not around HIPAA but around — It would really be working the first bullet as the committee as a whole.

MS. KLOSS: If Barbara were here she would be describing the challenges in the genomics data area as a particularly burning challenge, in addition to certainly the big data.

MS. BERNSTEIN: When Bill was talking about making the sort of grand plan and then when we get that done in 2018 or so, whenever that is, picking off the specific individual topics, I was going to raise my imaginary card to play devil’s advocate and say but isn’t that what we’re sort of doing now, or what we still need to do.

What this committee still needs to do now is review the current topics that are challenging the Department and kind of pick from that array whatever is the most pressing that the Department finds that the committee can provide advice on in a timely and useful way. The committee sort of has to come in at the right time for the advice. If it’s too late then it’s not useful. If it’s too early we’re not ready to do anything about it — that sort of thing. And we can usually figure out what those topics are, and from the choices that we have, the committee I think has made over the years very good choices about what those topics are.

So then when you amended and said wait, maybe we should have these two planes, I was like, yes, that’s something more like what we need to do. I don’t think we can wait until 2018 to continue to provide the kinds of specific topic areas. There’s a long list that the Department needs advice on, and I would be concerned if we were going to push those off.

DR. STEAD: We have Alix and Bob and Rich.

MS. GOSS: One of the things that struck me as I was reading this one-pager and Beyond HIPAA was that it was really taking up where the vision aspects of the report to Congress left off. So, building on a couple of your prior comments, it does seem to me that we need to know the hot topic priority issues of our next secretary, so we need a little time on that.

I think we have, as Bill noted, some overlapping work with the other one-pagers that we’re vetting, but I do think there’s an opportunity to have a roundtable or a workshop — I don’t know which color sticky it is. But we have a laundry list of stuff that we know are hot topics, but maybe we need to get outside of just some of our initial thinking and a detailed heads down on the topic, and have a roundtable — as I know Rich has been interested in sort of promoting during his time on the committee — on let’s really push the envelope and think really far out.

Maybe we need to do a combination of things is what I was going to suggest.

DR. STEAD: In 2019 we’ve got the next report to Congress that reflects what we did in 2017 and 2018, and I like the idea of having a framework of principles and guiding principles. I like the idea of having that done before the end of 2018 so it is, in fact, part of the Report to Congress for 2019. That’s big. And I think that would be really nice. I like the idea of identifying the most critical tasks that we want to try to slot in here for hearings in the interim, and I like the idea of an innovation roundtable.

Obviously, we’re going to have to go on a diet at some point tonight or tomorrow around how we sequence these things out, which is where I think — I’m really beginning to see a dramatic change in how we use our full committee, or now limited full committee meetings to move this agenda because we’re basically working with three full face-to-face meetings and four hearings, roundtables or workshops. That’s the bandwidth that we’re being allotted, at least for the moment.

MS. GOSS: And there may be other organizations that are doing similar things that we could then — You know, if somebody else is already having the CIO roundtable sort of discussion, then maybe what we do is have them give us sort of a synthesis and we do more of an exercise of taking multiple things and trying — you know. We’re also testing ourselves on whether we’re on point with our thinking, and we need that critical feedback before we develop any of those principles.

MS. SAVAGE: I think you’ve kind of hit a nail on the head. At ONC we take our title, our name of our office, very seriously, but I think as you go into the realm of what’s coming down the pike in innovation, it would really be beneficial for everyone to coordinate not only with NIH, who has a clear work plan for precision medicine, but also with ONC who is obviously forging ahead with the openly engineered API and the app-based ecosystem for moving the data in whatever volume those tools make it available.

So I just think this is a great opportunity to coordinate. I, of course, will be here. I leave in January, but John White will be our acting national coordinator and I know you know him well. And Anthony will be joining you tomorrow, so you have two great people to continue on with in that coordinating capacity.

DR. PHILLIPS: I like how this has shaped up. I struggled with how big a bite this was, but I think to have a full committee vision statement and at least what our vision is, is a great calling card and invitation to bring people either to roundtables or to bring other advisory committees into our sphere and us into theirs and then to let us hone that down into the subcommittees for the particulars that we think we are most responsible for but in the meantime gives us a vehicle for having the conversations about where the levers are or where the landscape is uncovered by HIPAA that I think we need right now. So I think this is a very good strategy.

MS. KLOSS: Also, when we have the articulation of those principles it will just inform all the work. It won’t just help the Secretary; it will help the committee.

DR. STEAD: Rich?

MR. LANDEN: Where to begin? Like others, I recognize how huge the scope is. It is also spot on. So, how we divvy it up and attack it is going to be a wonderful challenge. I like the idea of the two planes that you referenced. We’ve got to be working on both. As I look at some of the bullets here, those fit clearly in with some of the other initiatives, projects, workshops, reports we have identified. But I think so much has changed since HIPAA.

When HPIAA was first envisioned a couple years before the bill was passed, we didn’t have EHRs. Most of the billing systems were stand-alone mainframe-based. We have come a long way. We have two generations of ACO programs, patient-centered medical homes. We’ve got the meaningful use, three generations of that. We’ve got the ONC certification program. We’ve got the experience of MACRA and MPS, the new CMS final rule. And early this month, like what Lucia just referenced, CMS announced that the quality reporting, which also was not around back in the HIPAA adoption days. MACRA and MIPS, unlike meaningful use, is going to be going to an API model. That API model that CMS announced is essentially a proprietary CMS standard, something that was anathema to HIPAA policy which said standards should be adopted by SDOs. So, in a sense, CMS has turned full circle now, for better or worse.

So there are a lot of issues here, a lot of policy issues, a lot of learning that we need to apply to an environment that’s very, very different than what HIPAA did. So I am really excited about all these bullets and challenges and looking forward to divvying it up and getting it done.

MS. GOSS: To that point, Rich, are there a number of guiding principle references that we could actually have somebody find and put together? I remember there were the 10 guiding principles we had under HIPAA. Could we put them all together and use that as maybe a focal point for us as a committee to kind of nail that down? Because I think it’s a matter of attention and energy at this point, not necessarily —

DR. STEAD: And we’re going to have to pay attention to timing. There are some very good and, I think, still current guiding principles in the 11th Report to Congress, so there is good work that was done in the 11th Report to Congress that we can use to help guide us.

MS. KLOSS: And we have the guiding principles for community health data use that we developed. And, at the time, Leslie Francis had done kind of a comprehensive review of things — remember all the published guiding principles, HIPS and others — so I know I can dig that out. And I’m sure you have that in abundance, Maya.

We’re not starting from whole cloth.

DR. STEAD: I guess I’m beginning to see a lot of things we’re going to have to get done between now and February and then February to April. I see a lot of work rolling into Q2 and Q3. My sense is maybe starting with the June meeting, if not the February meeting, we need to see — we’re going to want to begin to carve out time for us to work this topic initially as a full committee and begin to bring in key viewpoints.

And then it seems to me we basically want to begin to, in essence, make this maybe the big ticket or one of two big tickets for 2018, because there’s a lot of energy here. Hopefully, we’ll go into 2018 without needing to do a review committee. The review committee will be 2019.

We’re going to have to begin to get some of your sequence here.

MS. GOSS: I think we have vocabularies left —

DR. STEAD: We’ll need to figure out how to tease these apart and we’ll be able to keep working on that when we get into the sequencing block after vocabulary. With that, say a last word.

MR. LANDEN: I just wanted to piggy-back on a comment earlier that we don’t need to do all this work itself. Part of the pre-work that can be done using staff resources might be to see what other groups or agencies have done work in whatever areas we’re going to bite off so that we can leverage that work rather than repeating or reinventing it.

DR. STEAD: Good point.

MS. HINES: Let’s talk to Lucia before she departs.

MS. SAVAGE: I’ll leave the plan information with the 14 people remaining in the office so you’ll have great resources there.

DR. STEAD: And then we’re going to have to loop back and figure out — maybe we can do this as we work through the bullet list later — what is off our Pick List and which of these — how do we end up with the right smaller task for privacy and confidentiality. We’ll need to come back to that a little bit like we had to come back to scope or review committee, to the task.

But let’s move on to terminology.

Agenda Item: Terminology and Vocabulary

MS. KLOSS: Well, I’m glad we got the big one out of the way and that we have such a simple subject. Bill and I are the scoping team for the health terminologies and vocabularies, and, as you noted on the write-up, we’re seeking additional co-conspirators on this topic.

This flows out of the fact that one of our really important charges is to study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information and report to the Secretary recommendations and legislative proposals for such standards in electronic exchange with the emphasis here on data standards for medical record information.

In recent years, since I have been on the committee, we’ve carried out this charge principally by supporting the adoption of ICD-10 and making recommendations on issues pretty much related to implementation. But we have not stepped back to look at the larger issue of vocabularies and health terminologies with ICD-10 CM and ICD-10 PCS as certainly important systems but not the only systems that our health system relies on.

There is also the issue that NCHS is the U.S. center for ICD work, and work is underway on ICD-11. The latest estimates are that it would go to the World Health Assembly in May — I think now it’s really 2018 but probably that’s not even realistic. But it’s not 30 years away; it’s some years away for adoption in the U.S. But it is part of the ecosystem of terminologies and vocabularies. So, we have an issue of an advancing system.

We have a current issue of just having been through adoption with I think still some questions about what the accuracy of — we went through a pretty smooth transition, but I don’t think we fully know what the accuracy and data quality issues are. I certainly hear some anecdotal evidence of some concerns about accuracy.

This is part of an ecosystem, and I brought this topic forward because I testified before this committee in 2004 because AHIMA and AMIA had done a joint task force to look at the state of health terminologies and vocabularies, and it was quite a comprehensive study. We delineated the full number of them and the issues and made some recommendations.

At that time, NCVHS did not take this forward, so I’m bringing this topic back because I think the issue is not only the vocabulary and terminology systems but this whole mosaic — how we develop them, distribute them, promulgate them, maintain them, and whether the U.S. system is robust enough for the importance of all this to the effectiveness of our electronic health information world.

The major components, then, would be the landscape of the current terminology and vocabulary mosaic, specifically, some key questions around alignment between ICD and SNOMED, approaches to support iterative addition of concepts and a roadmap to ICD-11. And, in order to do this project, we would certainly need to work with federal agencies — NCHS, CMS, ASPE, National Library of Medicine, ONC — and private sector stakeholders — the health plans, American Hospital Association, American Medical Association, AHIMA, AMIA, HIMS, others — and certainly the developers and SDOs.

I see this as a pretty central issue in our whole standards and data advisory role, and it seems like it’s the right time to do it. I’m not sure that we could have stepped back to look at this while we were in the process of thinking about ICD-10, but we certainly can do better as we go forward on adoption of vocabularies and terminologies.

My committee tenure is over in 2018, so this is my last shot to get this agenda item before the committee while I’m a member of the committee, so I am suggesting that we begin this in late 2017 and continue through 2018 with a report to the Secretary on how the U.S. needs to organize and resource these important issues.

DR. STEAD: I joined Linda as a co-conspirator because nature abhors a vacuum, and I think this is a little bit analogous to the predictability roadmap for the standards as moving forward with. In essence, I see the question as how do we get to a world in which standard terminologies can be continuously extended and we end up in a world where we’re not having these major version changes.

I know that the National Library, for example, has a fair amount of the infrastructure to do this in the way they have handled working with the VA and others — RxNorm and UMLS. UMLS has the advantage that it’s not a standard terminology; it is in fact a way of bringing together several thousand vocabularies in a way where the linkages between them actually have much more information and content than any of the standard vocabularies themselves. So that was a key difference in how Don tackled that many moons ago.

We need to figure out how to move in that kind of direction, and I think this is one of those cases where other countries may give us a guide that we may, in fact, want to leap frog on. In my day job, as we have really matched up genotype data with deep clinical phenotype out of the HER, we’re recognizing relationships between otherwise unassociated diseases, so the important classifier is actually going to be something that is not caught in the evolving terminologies.

So there is likely to be a shift between adding evermore granularity to something like what I still think of largely as an administrative coding scheme, even if it’s done for clinical purposes, and how we actually tag people and records with fine-grained phenotypes. That would be beyond this.

I think the first step here is how do we move to a more continuous evolution and maintenance. I think that’s what we’re really talking about here, understanding that over a period of time the fundamental organizational principle of today’s classifiers is probably going to prove biologically unsound, and what will we do when we hit that. But that’s a bridge too far for what we’re talking about here.

MS. GOSS: I had two points. You have covered one, Bill, thank you. I see the analogy there.

But I also see the predictability roadmap as secondary to really getting at what are the core issues with the data quality, because we are banking on robust analytics that are dependent upon data capture, data normalization and usability.

When I went to AHIMA this year I walked away with a very deep appreciation and, to some degree, horrified by the ICD-10 coding concerns that I was hearing. And when I think about how we want to use that data to help with all kinds of things like value-based purchasing, precision medicine, et cetera, this topic jumped in importance to me above some of the other things that I have had on my wish list during my tenure. There’s a lot being banked on the quality of the data and there’s a huge concern — forget just upgrading the code sets. It’s how are people using it and what does it mean downstream.

DR. MAYS: This, to me, is like a really critical issue, so I’m glad that you want to bring it to the table, and there are some pieces that I want to unpack. You started the issue of the concerns that people have about coding, and I’m trying to figure out if some of what we’re struggling with in terms of quality of data is one of these inter-professional issues and how it is that different groups are understanding the same thing if people are using some of this in different ways.

I think bringing in this examination of the inter-professional issues might be important around the vocabulary, because I think that’s where things are really falling apart. I sit on a List Serve in psychology where there’s all this stuff that gets discussed about coding and people are saying I use it this way but the physicians use it that way, and it’s frightening to me, because I try and do research with this data and I’m watching this List Serve and then I just go, I don’t want to do that project because I know the quality of what’s in there is really bad. Then I have heard some similar things in terms of nursing, so this is really important to think about the inter-professional issues here.

The second thing — and some of this is also for later because later I want to talk about bringing the National Library of Medicine to our table. There is a request for information from them. They’re doing a strategic plan right now and they want to know where they should go, and they’re asking for responses by January 9th. I’m happy to send it to you if you want it.

But we should think about being in that agenda a little more in terms of, at the end of the day, several of the things we’ve talked about but this in particular because they are actually asking about dealing with the role of National Library of Medicine in advancing data science, open science. They’re going on about a lot of this stuff so I think that’s — if you all can decide whether or not you might, either as individuals or the group, want to respond to that.

DR. PHILLIPS: I actually testified to this committee eight years ago about this issue, about the fact that ICD-10, much less 11, really doesn’t serve the needs of primary care, although I get lectures every Wednesdays when I’m in clinic about how I need to code certain things certain ways because it determines our payment, but as a data infrastructure it has no service to my environment.

Whereas, the way the Dutch do it, it can be turned into a Framingham construct for each clinic to tell them the probability of someone developing downstream disease from current day symptoms which is based on episodes of care coding in ICPC. I have actually published some studies off of their data where I could make those connections of probabilistic modeling of future disease. That’s the kind of data I need in my environment.

And there are cross-walks between ICPC and ICD-10 that actually can guide me to do higher quality coding in ICD-10 but starting from my coding classification that actually has value in my environment where I’m invested in actually capturing the data correctly.

So we are at a time and a date and age where you don’t have to be wedded to a particular coding classification if it’s not what fits your environment, but it doesn’t mean that you can’t service a greater coding environment if there are good cross-walks.

MS. KLOSS: That’s right, and there are other classification systems that we haven’t used routinely in the U.S. that have potential value if we could find a way to make it easy to use them — behind the scenes.

MR. LANDEN: Crosswalks are good when they’re one-for-one matching or they’re unidirectional. When they get to be bi-directional and not one-for-one, it brings in more challenges.

Other challenges — I didn’t see any reference to natural language processing in here which might be worthy of consideration. But the thing I really want to include in the discussion is the policy emphasis on inclusion of patients, the patient engagement and the current capabilities of the EHRs and the regulatory requirements under meaningful use Stage 3 2015 certifications to be able to import into the EHR data supplied directly from patients.

At the same time, the new certification standards allow the export of core vocabularies to any API the patient wishes, so we have now in the equation, or soon will have, a lot of patient-selected APIs that may or may not use the same vocabularies and they get clearly out of the realm of inter-professional discussion of coding. We are now talking about direct patient engagement and there’s no way that there are going to be professional coders and there’s no way they are going to adhere to any agreed-upon coding schemes.

DR. STEAD: Given the richness of this conversation, Linda drafted, relative to this discussion, a narrow scope which had three basic pieces — how do we advance alignment of ICD and SNOMED, approaches that let us get to a more iterative edition, and the roadmap to ICD-11 adoption.

Is the committee interested in trying to take a step toward that limited scope in 2018 as a platform to let us then discuss other aspects of the problem downstream?

MS. GOSS: Did you mean fiscal year 2018, or do you mean calendar year 2018?

DR. STEAD: I don’t see any way this is going to fit — I think we can do ground work, but I’m seeing a pretty full calendar 2017, and Linda I think put this — If we’re going to get the things done that we’ve currently got penciled in for 2017, and if we’re going to really gear up for a major vision statement on Beyond HIPAA in 2018, I think this might fit as some pre-work followed by a roundtable or workshop at the scope Linda said here in 2018. I can sort of see how that works together in sequence, as that would be after we had the standards predictability roadmap.

If we want to make this bigger than that, then we could in fact have a visioning session in 2018, I believe, but if we do that, we’re not going to get down at this detail. And my sense is there actually may be an opportunity for near-term steps around the narrow scope that might begin to move it on. That’s why I’m sort of parsing it that way, but I’m not prescribing that.

We’ve got Vickie, Helga and Rich.

DR. RIPPEN: I think it’s wise to scope it as you do want to get something done, so I think narrow scope is good. I think, as long as we can do narrow scope but allow for broader discussion in hearings to set up the, well, what is it not addressing, so you get two for one, you get the sort-term but you’ve already collected testimony that might be broader.

DR. MAYS: She said what I was going to say.

MR. LANDEN: For the three bullets in the scope, the first one I’ve got a question around the advance alignment between ICD and SNOMED. That is a known issue; it has been a while that we have known about it. So my question is what resources does NCVHS have to bring that others don’t, or are there other groups that are already working on that or could work on that. To me, that’s more of an implementation thing than a policy issue.

If there are things we can contribute, absolutely yes, but my impression is policy has already been established and it should be better integrated. So I just question what’s the relative value of applying our resources to that. If there’s something we can do, let’s go for it. If not, let’s do things that others can’t.

For the other two bullets, both of those fit beautifully in with the predictability roadmap concept, so I’m very supportive of those.

DR. STEAD: I probably was the one who inserted ICD and SNOMED into it and I did that after a conversation with Betsy Humphries. Betsy thinks the time is right that the capacity of the organizations that are involved and the way they’re working together is moving in the right direction, and, therefore, might be some opportunity to make advanced progress.

Our job would be to ask this question as part of a hearing or whatever, and if the answer is nothing else needs to be done, fine. If not, then clearly that gets at this relationship between the natively clinical languages and the more administrative piece. Eventually, we’re going to have to get at this. Do you keep adding granularity to ICD-10 or 11, which is going to continue to decrease — It will increase the potential of precision while decreasing the accuracy of coding until it’s all somehow done by the environment for us, whereas, SNOMED is natively designed to be something that works clinically.

MS. KLOSS: There is another dimension to that, and that is as these two co-exist in the healthcare delivery system, the adoption — we understand theoretically the linkage, but the actual adoption of SNOMED in the ways that we understand it is still remarkably limited. I think it’s just because of the way the two systems co-exist.

I think one of the values of shining a light on this is to reiterate why vocabularies and classifications exist for different purposes and how they inter-relate and what the value is. There just is enough work that has been done, but if you go to the health systems, how many are really using SNOMED for any practical day-to-day purposes. Not. And that’s disappointing because we thought that would just kind of bubble up naturally. So I think there’s the adoption piece, not just the policy piece.

I had one other practical thought. It could be that we could find time toward the end of 2017 to get a briefing on the design of ICD-11, which does create that more straight line roadmap from classification to SNOMED, and I think to understand how that’s structured and what that’s going to do could help prepare us for a launch in 2018.

DR. STEAD: And let’s put something else in 2018.

MR. COUSSOULE: I have a more generalized question. Does this naturally fall under the purview of the Review Committee?

MS. KLOSS: It certainly is a code —

MR. COUSSOULE: If that is the case, how do we lay that out into the roadmap and the Review Committee at the same time?

DR. STEAD: I don’t actually see this as falling under the Review Committee but that may mean that I misinterpret the Review Committee. I think the Review Committee is about whether people are succeeding in implementing and whether we’re getting value and what the barriers to that are.

Much like the predictability roadmap, I see this as about the approach in infrastructure to maintain and evolve the terminologies and code sets, which, if we can get to where it’s less episodic, will make something that is more implementable, so it will play back into the Review Committee. But I think, just like the predictability roadmap, it touches but I think it’s different. But you all may know better than I do.

MS. GOSS: I think Nick brings up a good point. When you look at what we’re chartered to do within the Review Committee, our first foray into a Review Committee hearing was very much limited to transactions and operating rules, and the charter for the Review Committee squarely puts code sets and identifiers in the mix and we really didn’t take a gander at that in the first one.

However, I also think that there’s a further distinction in all of this in that there are code sets that are used with implementation specifications or exchanges of data that are administratively based as opposed to some of these larger clinical vocabulary challenges. HIPAA doesn’t adopt code sets in and of itself within the regulations, but then, by extension when they adopt implementation specifications for transactions, they also are adopting code sets that way.

So, one of the other things we need to keep in mind is that the designated standards maintenance organization, or DSMO, is made up of SDOs and data content committees, so there’s a number of different paths this takes. I recognize the distinction of the predictability roadmap being an item that came out of our Review Committee hearing but I’m really concerned that we need to get back to these vocabularies and code sets because so much is being based on it.

DR. STEAD: Then maybe issues of coding quality and use of the code sets would fit into the Review Committee for 2019 if we had some of this work done out of our way in 2018. But this work is really more around maintenance and support and evolution of the code systems themselves, which will enhance implementation but it’s not implementation. That’s the way I’m parsing it.

MS. GOSS: I wasn’t sure I was tracking you with the end of that, which is part of what was in review versus what wasn’t review. That’s where I got lost. I’m not sure how you would change this health terminologies and vocabularies issue. I did track that this could be some groundwork towards having a more focused 2019 Review Committee hearing on it, but then I got lost.

DR. STEAD: I think the roadmap to IC adoption could — well, that could be.

MS. KLOSS: Because that will be a named code set. I think the distinction is that there are certain code sets that are HIPAA-named, and those clearly fit in the Review Committee and the roadmap. The vocabulary and terminologies issue includes those but it’s broader. I think it’s wise to keep it separate and study it and figure out where we go with it, realizing that the named code sets fit squarely in the Review Committee.

MS. GREEN: I just have a quick clarifying question. Are you talking about maintenance of the code set or just looking at greater accuracy with the code set? Or are you looking at aligning various code sets and terminology?

MS. KLOSS: All of the above.

MS. GREEN: Okay. I asked the question because there is a vehicle, a public vehicle, for maintenance of the code set right now where any industry partner can submit use cases for maintenance, corrections, you name it. So I’m just interested in what you want to scope this particular recommendation as.

MS. KLOSS: I don’t know what the recommendation would look like. It just occurs to me that as we move to an increasingly electronic healthcare system, the idea that we do a once-a-year big change is perhaps not taking full advantage of the kind of vocabulary and classification technology that exists that could be updating sets even more frequently.

We do it a certain way that was designed for the ICD-9 world, and we updated the classification system but we haven’t really stepped back to look at the delivery system for the classifications. I don’t know that we would have done anything different for ICD-10, but certainly, looking down the road at new iterations — There’s wonderful vocabulary server technology now. It’s just a different technology world that I don’t think we’re fully deploying for maintenance, dissemination or within health systems and health plans how we manage these systems.

MS. GREEN: Thanks for the clarification.

DR. STEAD: With that, we will bring this block to closure. We are five minutes over so we will regroup at five after.

(Brief recess)

Agenda Item: Assembling Initial 2017 NCVHS Workplan — Chair and Full Committee

DR. STEAD: We now have two blocks of work to do. The first is our – is to look at the work plan as it has evolved and put on the intermediate steps and so forth that aren’t there, decide if we need to move some things out, and decide, as we look at this pick list at the bottom of you – the bottom third of your handout – Marietta has been nice enough to bring it up on the screen – are items that are of interest to us that were not – we didn’t turn into big scoping items, but we thought we would plug in the most important ones, wherever they fit.

Let’s sort of walk back through what we have got over here. The degree to which people are going to want to stay at their tables versus huddle around the Post-its – me, I tend to be a huddler around white walls. That may not be appropriate for the national committee.

Rebecca has developed the following key, which will become a permanent part of our process going forward. This color, which is some cross between green and blue is – turquoise – is an action step with recommendations. The yellowish green is a hearing. Orange is a workshop or roundtable. Pink is input to the fall committee. The big yellow is an intermediate step. She has now added months so we can begin to try to sequence work by months and remember to the degree things cannot fit here, we have the opportunity to move them to 2019 and beyond, which is where the 13th report to congress is currently living.

DR. MAYS: On the work group, we had a series of things that we had asked about plugging into the subcommittees. They are not on that list. I just want to make sure they don’t get orphaned or made a foster child.

DR. STEAD: So we will need to keep that in front of us as we work through this. We have a fair amount of time to work through this. As an incentive to the degree we have developed consensus, if we can get done, we can move into the committee process block, which I think is actually going to take a certain amount of work. I don’t think any of us would mind if we actually got out of here before 5:30. Let’s work this as reasonably as we can.

Let me just walk through it first. I think that is probably the best way to – we are saying that in January, we are going to have outreach to the evidence-based policy commission that would presumably lead to input to the committee at either the February meeting or the June meeting or somewhere in between by webinar, depending on how we elect to make it work.

PARTICIPANT: Is there a focus?

DR. STEAD: We actually want a report on where – on what their recommendations are beginning to shape up as. In the conversation we had, it is – February would be the earliest; June the latest. We just need to see where it would fall. It would feed into several of our discussion topics.

In December, which isn’t up here, but Rebecca is not going to forget it so it might be worth just pasting on the wall, in December, we are going to get input from the full committee on key points for the report to congress.

MS. HINES: Should they send those to me?

DR. STEAD: They should send those to you. That sounds like a wonderful plan.

Then in late January, we are going to issue a request for utilization statistics as a RFI, related to the review committee. We will be – I am trying to think what is the best way. Is the best way to walk this through by item or by month? Stay like I’m doing.

We will have the full committee review of the report, on the 12th report to congress. We get the input from the evidence-based committee. We have the full committee review of the healthdata.gov –

MS. HINES: We need to set up an executive subcommittee call in mid to late January.

DR. STEAD: I want an executive subcommittee call in December. I want an executive subcommittee call in January. I can’t believe at the rate in which we are trying to do, we shouldn’t just go on and set up executive subcommittee calls every month at least from now through June. Then they will be in the calendar. We will know what they are. Let’s just have – I think we need them monthly. Maybe sometimes we will need them more.

It is not the work group – healthdata.gov. So, full committee review of healthdata.gov draft is in February.

MS. HINES: We also have in February full committee review of the DID letter.

DR. STEAD: Correct. Well, we are hoping to have action – we want action on the DID letter. We want action on version four of the measurement framework and the workshop report from pop health. Let’s put an action – do we want to have full committee review of APCD in February? This is – let’s put an intermediate step in February of full committee review of APC draft.


DR. STEAD: Action on the APC letter. Is it okay to let that wait until June? Do you want to try to pull it – this is all –

PARTICIPANT: We can do a conference call.

DR. STEAD: We are going to do the 12th report to congress if we don’t nail it in February. We are going to do the healthdata.gov if we don’t nail it in February. We could put this in that stage and tomorrow, we can move it out. We are going to revisit this whole plan tomorrow afternoon.

PARTICIPANT: I am good with that.

DR. STEAD: Then we have healthdata.gov letter and report. For the moment, let’s just put that all in one comment. We can let it go forward or back as we see where we are. We are doing the intermediate steps here that could allow stuff to be pulled forward if it is done. Fine. We will adapt.

DR. PHILLIPS: The commission that has been created to look at health survey response rates and methodologies, when do you want to get feedback from them?

DR. STEAD: Do we want that to come here or is that going to go to PopHealth?

MS. HINES: And I would say since they just got started and the holidays are upon us, there may not be much there in February, but I can ask Kate to follow-up on their timeframe.

PARTICIPANT: It should go to PopHealth.

DR. STEAD: We need a way – our scheme doesn’t have how we are going to handle the things that are being worked at this juncture just at the subcommittee level. Because, in essence, I think that PopHealth is going to incorporate whatever they want to do within PopHealth on the future of health surveys into a PopHealth workplan, using some of the bandwidth that is not consumed at this level.

MS. HINES: Do you want to start using the lower ones for subcommittee stuff?

DR. STEAD: Let’s do that.

MS. HINES: We can swap out – we need a clean sheet here.

DR. STEAD: This is a very aggressive plan.

DR. CORNELIUS: Yes, I would say so, even from over here – I’m just saying.

DR. STEAD: Let’s keep trucking. Once we get it down, we can adapt it. This is the nice thing about Post-its.

May, we have utilization due in from industry for the review committee. We’ve got PopHealth Future. Get input from – so can that now go – you have just put that down here.

MS. HINES: The EBPC is different. The question is does EBPC go to the PopHealth or to the full committee?

DR. STEAD: My sense is the full committee would like to hear a report from the evidence-based policy committee. Am I reading the group right? Okay. Everybody is saying – right. We will see where that lands. We will let the statistics be here.

DR. MAYS: Is that presentation for February?

DR. STEAD: Donation to the government. Can they buy us white walls?

Then June, review committee hearing, narrow scope, which is going to be prior – is going to be prior off plus updated use statistics. We are also talking about a hearing for clean claims, an audit. Right now, they are both the review committee hearing – right now, both of those are together in roughly June. Is that sort of, this afternoon, still an okay place? We are getting the utilization data –

MS. HINES: Right, are we going to feed that into the June meeting?

DR. STEAD: Yes. Okay. Good.

MS. GOSS: I have a question as it relates to the Beyond HIPAA. We are going to be addressing it or working on it at each of the meetings. I don’t know how you want to capture that. It is not like nothing happens until end of 2017.

MS. KLOSS: I was kind of thinking that maybe the Beyond HIPAA consideration for February falls in line with DID. Then we frame a topic for consideration at the June meeting.

DR. STEAD: I love it. What Linda suggested is that we view finalization of – or close to finalization on DID in February as the work – as work toward Beyond HIPAA. We double count it.

MS. KLOSS: And then we pick up a topic –

DR. STEAD: Then what we will want is in June, a Beyond HIPAA topic – Beyond HIPAA update. We got to identify what the topics are. We are going to want them at the June full committee meeting.

PARTICIPANT: Did we want to frame it first at that meeting in June?

DR. STEAD: Let’s hold that. I am not smart enough to know the answer to that – to even have an instinct on it.

Let’s go on and put a topic for that in June and again in September. My guess is framing it may be – a first cut at framing it may be closer to September.

PARTICIPANT: Picking up on Linda’s theme, you could almost double dip with the predictability roadmap on the Beyond HIPAA part as well, maybe.

DR. STEAD: That’s an interesting point. Let’s think about is De-ID the detailed plane item for Beyond HIPAA? What I am trying to get at is De-ID/predictability roadmap are what we were talking about as detailed early actionable steps that we would be doing at one plane while we were working the vision at a second plane. If we have bandwidth, it would be probably useful to have one item each time that we are working at the detail – at the lower – whatever the right word is – at the detailed plane, while maybe getting one piece of input on the higher level vision, if we have bandwidth.

Where are we? We are in – anything we are missing on June?

PARTICIPANT: Right now, we are missing all the steps getting us to those things.

DR. STEAD: We are going to have to build out – we want to put another – let’s put some more intermediate steps back – if we get the request for information out by the end of January, will that include a framing of how we are going to use the review committee hearing? I think that request for information will be more helpful if we can – if we could, in fact, communicate.

MS. GOSS: That is going to take a lot of time and energy between now – December/January – to actually have the subcommittee, review committee focused on doing that. I think we are at that point where we do need to – we have decided how big the breadbox is. Now, we can get into the next set of processes, which is working with staff to develop the detailed questions, figure out the invites, what artifacts have to be developed. I think we would have to have enough energy between – we have a couple things in parallel in December that would have to happen to support anything going out in February.

MS. HINES: Can we back up a sec? For just the RFI, nothing else, we would need a paragraph, a page that says – you just need a paragraph or a page along with the request for exactly what utilization statistics – it could be a two-page/three-page document that just says here are the utilization statistics we need and this is why we need them. This is our plan for the review committee, period, and then do a RFI. While that is out, then we cook all of this other stuff, like all of the tasks you were talking about. If we can just spend the next six weeks –

MS. GOSS: I think you introduce a risk by doing it that way because you haven’t thought through the whole thing as least at a high level, but I think you can do it. I would also look for staff to give us some guidance from what this means to their end of the workload.

DR. STEAD: Can you write a short statement of what you need from staff to achieve this? That might be the best way to –

MS. GOSS: I think, honestly, we have to kind of – I think that every subcommittee needs to think about what this workplan looks like and define their subtasks and support needs. I think we all have to –

DR. STEAD: Okay. So maybe we are trying to go too deep for this afternoon. That is good. Okay. Then we are thinking of a July or maybe July to August predictability roadmap workshop.


DR. MAYS: I love it. Why not?

DR. STEAD: Next generation vitals hearing, we are targeting August to September. Predictability Roadmap summary – where do you get a review committee – where do we want to think that – if we have the review committee in June, where do we want to think about positioning the review committee report? So, you are thinking the workshop summary will be easy to do.

MS. GOSS: There are a lot of interdependencies, which we don’t always control those interdependencies. I think we can take a best stab at it.

MR. COUSSOULE: I think, given the scope won’t be nearly as large as the last one, ideally, drafting up the documents won’t take quite the same amount of time. It is going to take some amount of staff and committee time to go through that.

MS. KLOSS: We plan to get the approval done in 2017.

MR. COUSSOULE: If we want the approval done in December, then we need the review done the meeting before then – either at the meeting or at least through some review process.

DR. STEAD: So review committee draft summary or theme, some high-level input to begin to split people up. Then a review committee action out toward the end of the year, probably telephonically or whatever.

MS. KLOSS: I think there might be an opportunity to plug in – you might be able to plug in in third quarter, some work by Privacy on principles framework, to start looking at the Beyond HIPAA.

DR. STEAD: Would Privacy take a cut at that without it being limited to Privacy? So, the Principles framework, what Privacy would be doing is beginning to work governance principles, but recognizing that it would be – those principles would apply beyond Privacy.

MS. KLOSS: Right. Q3.

MS. HINES: It seems like the subcommittees need some work time to start –

DR. STEAD: Yes. Now, in – so terminology and vocab toward the end of 2018 – sometime in 2018, but probably the latter half of it.

MS. HINES: Put anything in subcommittee – put it below.

PARTICIPANT: The hearing is everybody?

PARTICIPANT: Yes, but the tasks leading up to it –

DR. STEAD: I think that is a good way to parse it, putting the hearings up above, tasks leading up to it down below.



DR. MAYS: Use the mics. Later we won’t have any minutes.

PARTICIPANT: We are just trying to decode the color schemes and put stuff into subcommittee stuff.

DR. MAYS: We still would like that in the minutes.

(Comment off mic)

DR. STEAD: The bottoms are just quarterly work by subcommittee or workgroup. We need to add – so for 2018, we have the terminology and vocabulary deliverable. We need a – we want a Beyond HIPAA vision – needs to be –

MS. KLOSS: Do you think there would be an opportunity to work on that at the last meeting of 2017? If we were going to have a hearing, we would need to figure out what the hearing goals were, who and what by the end of 2017. I was just thinking that the Beyond HIPAA – oh, yes, we got it.

DR. STEAD: Let’s have a Beyond HIPAA –

MS. KLOSS: It is up there. Something roundtable –

DR. STEAD: This is an innovation roundtable.

MS. KLOSS: That is probably not December, is it?

DR. STEAD: That is what it is up there. Let’s put Beyond HIPAA policy framework toward the end of 2018. So I guess you were thinking Privacy would outline Principles –

MS. KLOSS: And we would have some full committee discussion on that before the end of the year.

DR. STEAD: I think it would be ideal if we could have full committee discussion of the privacy principles at the September meeting.

MS. KLOSS: Then we could figure out –

DR. STEAD: So the subcommittee would be setting us up. That would help us really lay out a more detailed workplan from here down. We are getting the rough lay of the land. We can then figure out how to use our briefing time as we carve this out. Is that beginning to feel good to people as a rough framing?

MS. KLOSS: The discomfort I have is just that crunch between now and the early part of the year. I just know how long this de-identification letter is going to take.

DR. STEAD: We may discover we have to decompress this.

MS. GOSS: I think the other thing is as subcommittees, we need to go back and think about what work we have to do to kind of come at this from the other angle to validate that this is even realistic. For me, it is looking like it is coming together okay, but it is still that –

DR. STEAD: The mental model I would have is this is letting us try to see how to coordinate across efforts. You will sleep on it tonight. We will have a chance to diddle it again tomorrow after the lunch. We will then be able to diddle it at each executive committee call going forward. This will be – like the scoping documents, this will be an evolving draft. It will be our current view of what can happen. Everybody should feel very comfortable surfacing the need to change or refine as we go along. That is fine. We are not being locked into something. We are trying to get the contextual awareness to know how to make decisions.

MS. HINES: Would resurrecting the old table that had a column by cue be helpful? And then knowing that each time we open it up, we are going to have a new version and have it be a working, flexible, things get moved forward as they go. That way, this can then all be in one document.

DR. STEAD: I think we will want – wherever we come out of tomorrow with, we will want to represent that back into the spreadsheet. If we have time to do it while we are here, fine. If not, we will do it afterwards.

MS. HINES: Then my second thought would be for each of the co-chairs to look at these dates. At Vicky and I were talking about, the healthdata.gov, set your milestones and work backwards. If there is not enough time – maybe in the next 15 hours, think about, okay, well, if we have this thing up there on April, first month of second quarter, and then you work backwards and there is no way to get it done by then, then tomorrow, we move it forward.

MS. KLOSS: I think if we are successful in getting the action items that we have for February done, then the rest of this is going to flow. I just think we have this bolus of work. I feel a real sense of urgency getting that de-ID. That hearing was months ago. I also know what it is going to take.

DR. STEAD: That also needs to be a caution as we look at how many things we bundle in here. Part of that is we did an awful lot within a very short number of weeks during the summer.

Let’s look at one more lens on this before we try to begin to look at layering in some of the other things to the degree we want to. We have got – we are authorized to have four hearings or workshops between now and here. Right now, we’ve got next gen vitals – that is one – predictability, two, RC hearing, three, and clean claims and audit, four. Right now –

MS. GOSS: Can I ask a question? Are hearings equivalent to workshops, in that hearings are typically very – you know, there is lots of audiovisual equipment. It is public access. As opposed to working sessions. Is it the same cost?

MS. HINES: As long as basically the infrastructure you see here is needed, whether 75 people show up like they did for last year’s review committee, or whether ten people show up, it is the same equipment. It is really on the staff and all of the prep work that leads up. What you see here basically has a fixed cost, the transcripts, the WebEx, the staff, the mics, and all of that. Really, the cost is in the staff time. A meeting is more or less a meeting.

The only other exception to that is if we get kicked out of our space and have to go to a hotel, which has become awfully common since I have been onboard, which apparently wasn’t so common before. That adds a whole other cost. We are funded through Q3, which is the last quarter of the federal fiscal. We are fine through there. After that, not sure.

DR. STEAD: I made the call working with Rebecca to have this meeting here this time rather than to risk being moved. Whenever we are in Humphries, that risk is there. No matter what we are committee to, it is simply a risk of the space.

MS. HINES: I will say that Marietta has reserved Humphrey for February, June, and September, and this room. There is no more construction. Basically, we will either be at Humphrey unless we get bumped, and then we will be here if we get bumped. We know we don’t have any hotel costs for meeting space between now and the end of the year, which means we definitely, I think, have money for four one-day or three one-day and one two-day or however – we will have to look at it, but, yes, that is kind of how Katherine has projected the budget.

DR. STEAD: So this plan fits with that and whatever we do here around action items will need to be in some form virtual. Or an innovation roundtable and a predictability roadmap would actually be two of our four hearings for the next fiscal year, if, in fact, that works out. We may not – we will have to pay attention to that.

(Comment off mic)

DR. STEAD: Right now, the committee members are already scheduled for February, June, and September. My guess is we want to leave those alone for the current year. We can think about whether we want to jiggle spacing if we can finish this part and get the committee process.

Given this, then we need to take a look at whether we want to – we have covered commission on evidence-based policymaking. Do we want to try to get input at one of our committee meetings on analytic impact of ICD 10? Do we want to leave that be and make it part of the vocabulary piece?

MS. KLOSS: Could we bring it into the December hearing? Could we do a two-part – what did we learn from 10 and where are we going with 11?

DR. STEAD: You are talking briefing on ICD-11. Is that – do we want to have a briefing on ICD-10 coding issues here?

MS. GOSS: I think it falls naturally in the Review Committee. If you are going to do statistics, you could – is it really a Review Committee extra topic? It is a code set. Is there a way to sort of – we are trying to find a way to overlap.

MS. LOVE: The analytic issues are more the statistical trend, longitudinal, population health.

MS. GOSS: Valid.

DR. STEAD: Who would be providing the input?

MS. LOVE: AHRQ. At the NAHDO in October, we had the Agency for Healthcare Research and Quality and UC Davis, Patrick Ramano, do the analytic impact and their findings, looking at dual coded datasets and some of the quality measures that are coming out of that and the comparability ratios that haven’t been fully developed that they did for the Death Index many years ago.

DR. STEAD: Want to bring that as an input into February?

MS. LOVE: It could be shovel ready, I suppose, if you want to just be debriefed on it.

DR. STEAD: It is analytic impact of ICD-10. Let’s just, for the moment, put it up there as pink in February. We can jiggle it around.

MR. COUSSOULE: In regards to that, has there even been enough runway for there to be good information yet?

MS. LOVE: I think we have some early findings that we found. I can share the slides. There are some definite – I think on the injury and some of the other codes – I mean, we have some preliminary information. It just depends how much you want. We can present what Patrick Ramano and his work.

DR. STEAD: Everybody look at the Pick List because I want us to keep moving. The question is which are the most important – I mean, I think we can tell we are going to be busy. The question is which are the most important topics? My own nickel is preparation for social security from healthcare identifier might, in fact, be –

DR. CORNELIUS: You know, we could have done this point four quicker if we had a little check sheet and we all just went around and pick our top three, rather than round robin this for 15 minutes.

DR. STEAD: That is fine.

MS. HINES: They are all lettered. Top three.

DR. STEAD: Should we do this by e-mail and sequence it up afterward. No? Okay. Do this however you think will work best.

MS. HINES: Vicki has requested you now go to page 29 of the e-agenda book, which is page two of healthdata.gov. On the opposite side of your sheet of paper, there is integration of workgroup activities into subcommittees or future plans. Pick your top whatever and put that on the back side. Make sure you not that this is from the workgroup so I will know which list –

DR. STEAD: Rebecca says she can count these in real time.

MS. HINES: Give them to me when you have got them.

(pause to list preferences)

MS. HINES: For the Pick List you have 5 Ds, 4 Hs, and 4 As, top winners by far. That would be the first one, Commission on Evidence-based Policymaking, Preparation for Removal of – okay – and H, which is Recommendations on Improving the Patient Authorization Process. If you want to go to the next level, it would be I. If you want a fourth one – for the workgroup, the big winner was F, far and away. That horse got around a length ahead, whatever F is.

DR. STEAD: Guidance on best practice for access and use.

MS. HINES: B got five, Data Use and Service Agreements for Wearables and m-Health. A got four, Impact of Changes on Privacy – Security on Data Access.

DR. STEAD: Let’s try to land this airplane. So, preparation for removal of SSN – when do we want to do that? We’ve got the EBM commission. We’ve got – did people not check analytic impact of ICD-10 because they knew it was already up there? Does that mean that comes off? So, analytic impact of ICD-10 is coming off. Everybody in agreement with that?

MS. GOSS: Is it going anywhere or just going in the trashcan?

DR. STEAD: Then let’s pull Social Security Number to February.

MS. HINES: Is this input or what is it?

DR. STEAD: Input to the committee. We have already got the Commission. We don’t know where it will land. How are we going to go about obtaining input on recommendations on improving the patient off process?

MS. KLOSS: That topic came up in the minimum use letter, if you recall.

DR. STEAD: Is that something that Privacy could work?

MS. KLOSS: That is where it falls, as does the – guidance on best practice for access and use, which is certainly related, at least in part, to authorization.

DR. STEAD: So, do we want that coded as an input coming to Privacy?

MS. HINES: Or full committee.

DR. STEAD: You want to get input at the full committee and then work it within Privacy?

MS. KLOSS: I really think we can work it within Privacy and then frame it –

DR. STEAD: That can flow – that might flow into Beyond HIPAA and lord knows what.

MS. KLOSS: It might.

DR. STEAD: Okay, so that is the first list. Where’s Vicki’s list? Guidance on Best Practice for Access and Use. Unpack that.

DR. MAYS: We started off with a document. We have parts of it that actually talk about what best practices are. I think this then becomes the detailed things not – that we were talking about earlier where we started talking about meta-data, data stewardship, tagging, the kinds of things that we aren’t going to put in the report.

DR. STEAD: I am just trying to understand how we frame it in terms of a workplan. I am not hearing –

MS. KLOSS: I actually think this is a Beyond HIPAA topic in the context of healthdata.gov.

DR. MAYS: Can you explain it?

MS. KLOSS: Because it came out of healthdata.gov. This is issues of access and use of data that has been released to healthdata.gov. It is Beyond HIPAA.

DR. STEAD: It is a Beyond HIPAA topic. So then where do we put that?

MS. KLOSS: We have a blank briefing – we have an open briefing topic, where we didn’t specify the topic. Is that in June? Right there. We didn’t specify a topic.

DR. STEAD: Input on best practices for access and use – let’s put access and use. So, we have landed that.

MS. KLOSS: I mean we may decide there is something more compelling and we flip it, but we have actually –

DR. STEAD: Okay, data use and service agreements for wearables and mHealth.

DR. MAYS: I was going to say I think it is Beyond HIPAA.

DR. STEAD: That is another Beyond HIPAA. In essence –

DR. MAYS: I think we should do the access and use because the AMA just started off with the –

DR. STEAD: That is another good Beyond HIPAA.

PARTICIPANT: Could you say that into the mic?

DR. MAYS: What I was saying is I think we should do the wearables later because I think that the first one is probably more critical. I think the second one, we may have more information because the AMA just took it on just recently. I don’t know exactly where they are going to go with it, but they are very concerned about it.

DR. STEAD: Maybe put it in the 2018 stuff. Or late?

DR. MAYS: I think late or else we may be irrelevant. I think late in 2017.

PARTICIPANT: I think some other work has been done on that by OCRN – CDT. We should look at that.

DR. STEAD: Put it here. Okay. I think this is enough – the goal here is to get an initial draft and have us all sort of mull it overnight and see how it morphs as we work through things in the morning.

MS. HINES: Before we do that, I just want to point out a couple things. For February, we have no hearing or roundtable or workshop. For June, we have two, although we have talked about putting them together as maybe a two-dayer. Is that what you are thinking?

MS. GOSS: I think we intended that there was a logical co-location. I don’t know that I can warrant two days, but maybe from a rule of thumb guesstimation, maybe Terri has a gut reaction. We were talking the review committee hearing topic for the 278 and the ACA 10109. Do we need two full days do you think or can we do it in a day? Survey says one.

MS. HINES: One day. Okay. Then we have Next Gen Vitals. Delton really likes this timing because he will have some work from Miter ready that totally feeds into this. Then we have the Predictability Roadmap. Basically, we have one day or a day and a half and a day and a day, unless the Next Gen ends up being a day and a half. That is good, actually, for our fiscal year. 2017 – we are –

PARTICIPANT: Didn’t you miss the – what about the workshop?

DR. STEAD: It is hard for me to believe that –

MS. HINES: The orange and the green added together tells us the total number of separate –

DR. STEAD: It is hard for me to believe that we are not going to need a day for the Review Committee and a day for the clean claims. My guess is that will be two. If it is one and a half, fine.

PARTICIPANT: Why not just plan for the worst-case scenario?

MS. HINES: It is miraculous, but you have all managed to give us the right number of something separate from a full committee meeting, which is let’s say conservatively, two days, three days, four days, and we have hit there. Congratulations. We have not signed up for more than what we can do.

DR. STEAD: Let’s then sit back down and shift into the conversation about committee process.

(Transition back to table.)

Committee Meetings: Process, Structure and Format — Chair and Full Committee

MS. KLOSS: I guess I have to look at what she has been working on. The guidance on patient access is out. The question is – I don’t know what the question is.

DR. MAYS: The question is there have been some policy changes about linkages of datasets that have made the datasets now be behind secure data centers, which has decreased access. The implication is that the census has procedures in which they are able to make it more widely available. It doesn’t seem to be happening within HHS.

MS. GREEN: Just one quick question. Have we included 7030 in – a hearing for 7030 in here anywhere?

MR. COUSSOULE: Every time we talk about that, we punt it out waiting for where it is going to fit in the schedule.

MS. GOSS: It is going to pop up, but realistically, it would pop up in next federal fiscal year funding related to hearing. I don’t think there is concern about it because we are anticipating it is past third quarter of calendar year 2017, when we will likely get the change request. It has to not only finish out through the standards bodies, it has to go through DISMO and then come to us. We are aware of NCPDP’s X12 timeline. NCPDP may be ahead of X12. Gail, am I on solid ground with the timeline for third quarter or later for X12? Thank you.

DR. STEAD: What I am going to do is take the liberty of moving us forward to the committee process structure and format in continuing to hope to maybe get us out of here at five. I think I will start by just putting some thoughts on the table that, frankly, are new since we drafted this agenda because in many ways, they flow out of the direction we have received from ASPE to reduce the number of face to face committee meetings and some conversations we have been having about how to best mainstream the kind of input that we have been getting from the workgroup.

To back up and just sort of think it through, if we want to maximally utilize our time, some things that we might consider – one would be to shift from using face to face committee time for department updates and work out a schedule of webinar department updates that would occur over the course of the year. We could work out the rate and pace that we needed them in. These would not be targeted to things we are trying to do. These would be the various pieces of the department updating us on what they have been doing, which is a very important input, but it is not clear to me that we need to do it face to face now that we are taking a quarter reduction in our face to face time. That is one possibility.

That would then have our input from the – the input from the department that we would do in these meetings would be targeted to the task that we are working on together. We would hopefully end up with more time where we were working with customers, if you will, around topics of mutual interest, but less time on general updates to keep the committee aware of what is going on.

MS. HINES: Can I just ask a question to echo that from Katherine and Jeannine and whoever else? Since there is no chance, based on life with Doodles, that we would get 100 percent participation from committee members, can these be recorded so that if four committee members miss one of these updates, they would be able to go back and listen to them?

DR. STEAD: That was my thought.

MS. HINES: Would they need a federal register notice? Just some things to put out there, some information we are going to need in order to make that happen.

DR. STEAD: What I am trying to do is open people’s heads up about how we think about how to maximally – get maximum impact from what will now be more limited time together and how we leverage other ways of getting other input. That is one thought, which would roughly free up close to half a day.

Another thought is that we are – once we live through this sprint to February, one piece of which involves the workgroup, we would pause the workgroup in its current instantiation and over the next several weeks, get input from the workgroup about how we could best connect to get expert input on a – the right topics of our mainstream committee workplan so that – and subcommittee workplan so that we were – mainstreaming is the best way I can think about it. The kind of expertise that the workgroup has been bringing to bear is now important to almost everything we are doing. Beginning to think about it as integral, organic, and figure out how we would manage that. We don’t yet know how we would manage it. Vickie is going to help with conversations to help get us guidance. That would be another way to do it. As we have done – as we are doing at this meeting, that would then let us work into the afternoon of the second day.

If we are going to do that, I recognize sort of when people tend to depart a bit. Therefore, we brought the second day to closure this time at 3:15 or so. People are out by 3:30 to make it easier for people to get home that night. Frankly, I think that is part of maybe having us have a livable life, given what we are all doing. We could elect to let it go until five, but my own bias would be we should bring it together –

MS. GOSS: And also, think about how many meetings in the future are going to have additional meeting days attached to them before workshops and hearings. I am applauding the three o’clock.

DR. STEAD: I am seeing lots of nods. In essence, those two moves would give us back essentially face to face, most of the time that we are losing.

As we do that, I would at least advocate – I, at least, like when we are able to work the way we have done here. This has been a real working session. We did a lot of pre-work, which lots of people paid lots of prices to get done. I would think that we might, as we think about how to do this – we talked a bit about this with the Beyond HIPAA work – we might want to carve out a half a day where we were actually working in a pretty focused way around one of the topics. We don’t have to do that. We can experiment with it. I just want to put out on the table that we can elect to jiggle how we use the time to let us get as much work done while we are here as practical.

I think the other thing that we really have struggled with is this business of when we have a full discussion and then we need time on the fly to finish something. That is when we sort of went back to try the parallel subcommittee blocks at the last meeting to – they weren’t committee meeting blocks. We only did two of them. We didn’t do one for each one. But we tried to give us some time to work in parallel. We can do that or we can use – we can, in essence, say we are going to have – if we are only going to have three full committee meetings, maybe we have a telephonic meeting. It doesn’t have to be a day and a half. We may have a telephonic meeting where we might take actions, et cetera, between it. What that would do is mean we would have a chance to do the discussion and we wouldn’t have to close action on the second day. We can. When the changes are small enough to let us close action without people having to work all night, we can close action. When not, we can fall back on telephone pieces.

Those are thoughts I just wanted to put out for people to think about and get feedback about. The other thing I think we want to figure out how to do – I think Rebecca felt we would maybe work on this again after this meeting – I think all of us felt that it was very effective when we had what were then called liaisons that were key stakeholder/customer reps that were consistently at the table with us, involved with the discussion, and helped us stay aligned. We have to work through the – what is appropriate and not appropriate and how we make that happen from a point of view of the FACA regulations. I think we will – Rebecca will try to work on that say between now and February.

MS. HINES: There was a difference of understanding. The FACA office that oversees this FACA is in CDC Atlanta. They said no problem, we just need to revise your charter. When I mentioned this to ASPE, they said we can’t revise the charter. I just need to find out where the pain point is and get different people on the phone to have this discussion at the same time, rather than me having separate conversations and getting completely different answers.

DR. MAYS: Can we talk about which ones we think are important to have at the table?

MS. HINES: Sure.

DR. MAYS: I have a list.

MS. HINES: Do you just want to read it out?

DR. MAYS: Sure.

MS. GOSS: Can we clarify liaisons are for just information sharing and like philosophical alignment? There is no – we tend to have a lot of people assigned to subcommittees that it is very unclear what they do or why they are there. I am trying to figure out if I am on the same page as to when we talk about liaisons, what we are really expecting of them.

DR. STEAD: I think it would be helpful if we could identify some number of key connection points that we would work out the regulatory pieces and we would gain agreement with those agencies, for lack of a better word, that it was worth them having somebody here –

MS. GOSS: This is just strategic alignment. That is what I wanted to clarify. It is information sharing and alignment only. There is no work from them. There is no support of the committees’ efforts.

DR. STEAD: This is distinct from staffing the work. I am talking about contextual awareness in the work we are doing. At the same time, we have to work out the match between whatever of this we are going to actually execute on and the staffing to get it done. I see those as two separate pieces.

Do you want to share your list, Vickie?

DR. MAYS: I just want to add one thing. Sometimes those – I don’t want to use the wrong word, but those people sitting at the table of the full committee are often people who then take the issue and can take it the next step sometimes. It has been very useful to have them because they can actually make a change as it applies to their agency.

I have NIH. I have AHRQ. I have NCHS, even though I know we have them, but it means sitting full-time. I have ONC. I have NLM.


DR. MAYS: I just didn’t have them because I assumed they were – they have been coming.

MS. GOSS: I would add OCR.

DR. RIPPEN: We are talking about government only, right?


DR. RIPPEN: I would say if we can, VA, DOD, potentially OPM, depends. Member health benefits, it is a different view. DOJ potentially if you are doing the fraud. Again, you can keep on expanding. Again, it depends on the scope and how often there are going to be overlaps or it is worth their time.

DR. STEAD: I think we could figure out which of these would actually want to be liaisons with the subcommittee and which would be – would want to be liaisons with the full committee. It would depend –

DR. RIPPEN: Then if there are any specific to an issue – because again vital statistics, obviously social security. Again, depending on what does it need.

DR. MAYS: Can I just ask, when you say liaison to the committee, usually they then have a different role. It is like a staff person and they have to give part of their time and they are doing work. I think we should just make sure that we are clear. Usually, the staff versus the full committee is different.

DR. STEAD: What I am talking about are people – if you play back the time Mike Fitzmaurice spent with the committee over decades, Bob Kaplan, these were –

DR. MAYS: Those were full committee. Those were to the full committee.

DR. STEAD: Right. I think getting the right liaison – I don’t know what the word is. I want people at the table that can engage in the conversation. I don’t want a dozen of them, but we probably want five or six that work with us enough that they actually want to, as we do, stay at the table enough to get into each of our heads and we actually sort of know how to understand each other and how to work. I think getting some number of connections like that re-established would be worth its weight in gold.

In parallel, we have got to get the right alignment around staffing. In both cases, it really means – we are all busy. Each person and their manager or supervisor or whatever you want to call them, needs to recognize and agree that their work with this committee is the best way to get certain parts of their day job done. If we don’t manage our pick list of what we are doing up here with that end in mind and if we don’t work out those agreements, then it is not a win-win and it will not work. It will only work when we can get that kind of alignment. We will need it whether we are asking them to be here and really engaged in the conversation or whether we are asking them to drive the work as lead staff or whatever.

MR. LANDEN: I would just add the CMS Innovation Center to one of our candidate liaisons.

MS. HINES: Got it.

DR. STEAD: I did a big download of possibilities and then we got into ways we could get input. Do we want – let’s go around and –

MS. HINES: Do you want to summarize those? I am not sure I have it. For everyone’s benefit – yes, I got a nod. So, the first thing is to free up time, have the classic HHS updates provided by webinar in between the full meetings. That is one option.

DR. STEAD: And recorded and work out what is the right periodicity for both the agencies and us. It is not just something people have to do. It actually relates to what – in many ways, it relates to what they think the frequency at which it is best to update us would be. We will then continue to request input and updates related to our various workplans, but they will be more targeted. A little bit like we are asking for the feedback tomorrow when we have asked for the engagement.

MS. HINES: The other way to free up time is to take action on items by phone in between meetings if they are presented and there is a lot of just polishing to be done afterwards, rather than bringing it back the second day. The third thing is carving out a half day at meetings to work in a focused way around one of the topics. Another is integrating workgroup members into full committee deliberations, tasks, processes, and then this liaison concept. That is everything I’ve got. Does that cover it?

MS. KLOSS: Mainstreaming the workgroup?

MS. HINES: That is a good way of saying it. Thank you, Linda.

DR. STEAD: Debbie, you have a lot of scar tissue. Does this make sense? Are we going to put the cart in the ditch?

MS. JACKSON: It sounds great. Considering so many of you have come on like in the transition of when we did have – were able to use the term liaison so you saw how that worked and the value of that and hearing what the agency representatives are bringing to you as well as what you are bringing back to them. From the structure of this meeting, this is a perfect launch to how you really want to brand and organize what you are getting from people and how because the value of what the agencies are hearing today and what they are bringing tomorrow really shows a cross of respect of their time and effort. I am very pleased with that. We are just working on terminology and focus and commitment, considering this new day of the time element that we have and transition of people. So, thank you. I think that will work.

MR. COUSSOULE: I like the idea of the presentations being made by the other groups being ideally done through webinar or recorded. The one thing, obviously, you lose is it is one way at that point in time. Certainly, if it is a webinar, you can have some interaction, but otherwise it is recorded. I think it needs to be – we would need to put some detail around what we actually want to have covered, what they want to share, and make sure that is synchronized as well. I think it does need to make sure we ideally create some value both ways. I think that is a great way to save some time. When we do have the day long hearings, we can be much more focused on a specific topic and not a more generalized history of what happened over the last –

DR. STEAD: And for clarity, I would hope that as many of us as reasonably could would connect and, therefore, we would, in fact, have two-way conversation.

MR. COUSSOULE: I think that would be really important. I would hate for it to just be a data dump. I think you lose something in there. I am also recognizing the logistics of 18 people. Sometimes it will be challenging. I think that is a really good idea.

I don’t know enough about the liaison process to frankly weigh in on that one and whether that has worked or not. I think the idea of making sure our interests are aligned and getting that kind of regular feedback and cadence, instead of walking in, hearing something, not realizing, by the way, we have talked about this for six months and here is where it has come and why, I think that provides value all around. If we could make that work, I would be real hesitant to do that with 20 people. I think it would get very unwieldy. I think we would have to pick and choose the ones that really mattered and then build some relationships. I think that structurally can work, but I would be much more focused on picking the right ones that matter the most and not getting a broad swath. You could conceivably leave somebody out, but I think it would be a better option to leave certain people out than to not get the right folks and the right level of input and engagement.

DR. STEAD: And if we can work out the legal issues, let’s start adding – we know we have interest from the bridge around the National Center and the Board of Scientific Counselors. Let’s start adding where we have alignment and interest and build out as we go. We don’t need to – it would be – John White was very effective in that way also. While he is – if he would be able to do that in his new – his acting role would make that impossible, but be that as it may.

MS. GOSS: I think that we need to get the updates before we get into this environment – I think is something he already touched upon. I also think by recording them and putting them on the website, you are actually helping the industry get better timely updates. It might be a better, broader service than we were maybe thinking initially.

I also think that we need to be mindful of the fact that we are not fully staffed – sorry, we are not at full capacity of the committee members. We have at least three coming onboard. Hopefully, that is in process and will happen in this calendar year. If not, who knows when we might get to full committee. I think we have to – even though I have just started my second term of four years, I remember what it is like to try to jump into the rhythm of the group and then figure out what every meeting – you feel like a rookie for your first four years.

I think that we need to be mindful of how this conversation translates to the members, either the orientation or having some way to level set all of us and refocus us. We do all have our paying day jobs and our personalize, we hope. We need to be concerned as well, on how much stuff we are going to add between meetings. There is a tremendous amount of work that goes on and priorities seem to – we all have priorities. I am just trying to figure out what this workload is going to mean between meetings if we are also going to try to put other things in advance of the meetings, webinar attendance, et cetera. We probably need to think through how those all sync together from an efficiency perspective.

DR. PHILLIPS: I don’t think I have any more people to add to the list. I think that that liaison with the Board of Scientific Counselors at NCHS is really important. Is there – does that also serve ASPE or is there an equivalent at ASPE?

MS. HINES: The history is that this committee actually used to encompass the Board of Scientific Counselors. Can you imagine having to do all of that work and this work? What happened, I think once the new mandates came onboard with HIPAA, is the Board of Scientific Counselors was carved out. It is so specific to the Center. It is very specific to NCHS. That is the how we ended up with two FACAs. This one just had way more than one FACA could bite off and chew.

It does speak to why they need to be talking to each other. Once again, our charter, meaning the NCVHS charter right now, doesn’t have language that allows for that, apparently. The question is just bureaucratically, how do we overcome that?

DR. PHILLIPS: I think the web-based updates, for all the reasons that have been mentioned, can be very helpful. I also am concerned that may lose some of the value of the face to face conversation around content and around input.

DR. STEAD: I think what we want to make sure is that we have the right face to face conversations. Whenever there is something that arises that we think wants to be a conversation more than we can have for the webcast, we promote it to one of our blocks at these meetings. We will need to – we almost will need a list of committee practices that, as a tickler, we look at so that each of us – so that each of us helps the committee as a whole.

MS. HINES: It makes perfect sense.

DR. STEAD: So you don’t have anything else you want to add?

MS. HINES: No. I think what you are saying is the face to face would be very targeted to what we are working on, whereas, these general updates would be more what does the committee need to be aware of.

DR. STEAD: I find the updates extraordinarily valuable. I get Alex’s concern about time away also. I just think with six days together or five days together a year –

MS. GOSS: Yes, but it is not that. It may be six days publicly together, but it is – we are all meeting – you know, we are talking about executive committee meetings every month. We have gone to trying to get the subcommittees together every other week to try to advance some of this work. It is becoming guaranteed one full day a week, at least from my perspective, of what I either have to read, comment on, think about, advance, coordinate on. That is a lot.

MS. HINES: That is where the staff support comes in and contractor help. I have been most closely involved with PopHealth. I would say, yes, Bob and Bruce and previously Bill were certainly thinking about it, but Kate, myself, Gibb, Susan, Monti, other people have foot a lot of that bill. We really were using the co-chairs as the brains and the vision.

DR. STEAD: I lived before and after. There was a period of time when we were doing all of that work, largely – the addition of you and Kate and Gibb, in addition to Susan, was a remarkable –

PARTICIPANT: It was a lot of help.

DR. STEAD: It was a remarkable amount of help. We have to figure out how to get those same kind of focuses around the rest. It is not like – there is no way one staff person can do this. It takes a team.

MS. GOSS: I guess from my perspective, you know realistically, we are two committees. We are the Standards Subcommittee and the Review Committee.

DR. STEAD: As we ponder this, we need to pay attention – as we sleep on it, are we being too aggressive in the workplan?

MS. HINES: And then the other thing to your point, we are down four members. With any luck, at least one of the new members could step up. Do we need to look at splitting the co-chair personship of the Standards and Review Committee so that that workload shifts or add a third? In the spirit of Bill’s thinking outside the box, we don’t have to keep everything the same. I will advocate for that fourth open spot, which there isn’t a memo in process for, to be a standard person. If you look at the map, I don’t know – I can’t say what will happen because ASPE has to put that forward. I see it, myself, day to day, that that is where we lost two big horses. We lost two members, who are gone now, who did a lot of that heavy lift and you guys are feeling it.

MS. KLOSS: I’m feeling it, too.

MS. HINES: Hopefully, one of the new appointees will pan out.

MS. KLOSS: We need to look at staff support, too. Most of the committee members are doing the writing. I do think it is just wise to keep experimenting. I think we should try everything on the list. If it is not working, we can try something else. I think it is great to – I like the flexibility.

MS. HINES: I really want to invite us all to consider that document, which will become a single document, as something that can be changed on a dime. Just imagine each one of the items is a Post-it. We can shift it forward rather than stressing out.

MS. KLOSS: We probably need to organize it in a way that we can look at it chronologically, but also by project.

MS. HINES: I got the idea for the colors from Walter. I don’t know if you remember, but he color-coded the action items, the workshops, the roundtables. We could do the same thing.

MS. KLOSS: But we need to do it by project.

DR. STEAD: It would actually be advocating for a review committee row.

MS. KLOSS: Right.

MS. HINES: Yes. If we need a Beyond HIPAA row –

MS. KLOSS: We do. That is what I am saying. I think each project needs it row.

MS. HINES: Can we take one minute for my sanity and define the rows right now? I am going to be doing this thing up as soon as I possibly can after we are done. It used to be the rows were subcommittees. We have a PopHealth, Standards, Privacy, and Working Group. What are the rows now?

DR. STEAD: I think we want some rows that are project-related.

MS. GOSS: I think that there is a lead – a subcommittee that may be helping to shepherd it forward, but I think the crux of it is still projects.

DR. STEAD: If we get rows around projects, we can also have rows for the subcommittee for things that don’t fit in the projects.

MS. KLOSS: Just look down the agenda. 12th report to congress. Predictability roadmap.

DR. STEAD: The row would be Report to Congress because we have already got the 13th out there. Predictability Roadmap for Standards. I think we should say review committee hearing –

MS. GOSS: If you are going to do that, you also have to do ACA 10109. They may be co-located, but they are statutorily separate.

DR. STEAD: Do you want two rows?

MS. GOSS: I want two rows.

DR. STEAD: Good. Next Generation Vitals. We don’t need Future of Health Surveys because that is now down under PopHealth.

MS. HINES: Is PopHealth one?

DR. STEAD: Each subcommittee will have one for things that don’t fit up in the big projects.

MS. KLOSS: That may move up. I think it would be wise to keep a full list of projects before us, even though we have delegated that project to a subcommittee for a time because it shouldn’t stay there.

DR. STEAD: Okay, so all the rows will be equal. Healthdata.gov, the next generation, Beyond HIPAA, terminology/vocabulary, de-ID, APCD, measurement framework.

PARTICIPANT: Do you want to say them all over again and make sure we have them all?

MS. HINES: The review committee hearing, ACA10109, report to congress, predictability roadmap for standards, next gen vitals, beyond HIPAA, healthdata.gov, terminology and vocabulary, de-ID, APCD, and PopHealth measurement framework and workshop report.

DR. STEAD: Do we then want a row for full committee – whatever the pinks, full committee updates?

MS. HINES: I will put that first.


DR. STEAD: That would be in the full committee update row at this juncture. If after we hear that, we want to turn it into a project –

MS. HINES: So what else goes under full committee updates? SSM?

PARTICIPANT: Some of those pinks really were project related though.

DR. STEAD: The evidence-based policy commission. You are going into the – they are the pink things up here.

MS. HINES: And they will just be laid out by quarter. If they are too ambitious, we move.

DR. STEAD: Were you done Linda? Denise?

MS. LOVE: My day job is calling. I kind of missed out on important information. I just wanted to say that especially with the administration change, I think in person dialogue and updates will be even more important than they have been in the past to get to know each other. I would hate to see that part of it go. Not only do I find it useful, but I think it helps with the personal connection, at least initially. That is just my two cents.

DR. MAYS: The liaisons – I’ve pushed for this for a while because I think that they are critical. One of the things I really want to discuss is the NCHS one. We really need the person here full-time. I am wondering like when you talk about the BSC person – it is like when we had Ed Sondik here, we didn’t need the BSC person. Ed could cover everything. Getting someone like Susan Queen or someone that is at a level where they can answer a lot of issues, as well as make commitments and do things I think is really important. I just want to kind of push on that one.

I think that the liaisons from some of the other agencies – I just want to make sure we are going to go to the right level. Like at NIH, when we had Bob – usually, Francis Collins appoints the person and they are from OBSSR. That is the one that cuts across all of the agencies, as opposed to a single one. I just want to make sure we are thinking about it. I agree with what Nick is saying. We don’t want 20 of them. I think we want the ones who really can help carry the water and give us advice so we are aligning very well.

The other thing is – Rebecca, I don’t quite know what to do about this because it really comes down to this issue of – I want to talk just a little bit about being able to do these things using technology and thinking about project management things – I know it always says, well, we can’t use this, but I am just wondering if the committee makes recommendations around how to use technology – that is what our workgroup does, but ways in which we can officially communicate, ways in which – even in our own materials. We put everything up in PDFs. We would tell you that we are trying to tell HHS not to do that. Having some ideas about software that can be used because I think if we don’t get it, it really is – we are not going to be able to work the way that we are talking about.

MS. HINES: You are hitting against security.

DR. MAYS: I am asking whether or not it is at all useful. I know this is what they are saying to you. I am asking the question of whether or not the committee can make a request for a recommendation and see if it can be considered. There are differences, maybe, in terms of when we are in this building versus being in the Humphrey building. I just think we actually need to be able to work a little differently. Can we actually do that and see whether or not there is any dispensation that can be made?

MS. HINES: My honest answer is probably not, but we certainly – I already started to have that conversation based on previous conversations. We have very tight parameters under which we are required to operate, as you probably know. We can’t even get Smart Sheet, which would like resolve 90 percent of our organizational problems. I put in a request one more time.

The point is I am happy to continue having the dialogue. So far, the answer I have gotten is you are a FACA. You can’t take resources from outside groups. It has to be government managed and operated, period, end of story. As I am going to be going to our FACA overseers to talk about the liaisons, I will see what I can do. Obviously, Katherine will as well in negotiating our new contract.

DR. MAYS: And whether or not in between the meetings, if we are working as a smaller group, we may be able to function differently. That would be the other thing I would want to –

MS. HINES: Don’t know.

DR. MAYS: That is why I am saying I am asking for a lot of like let’s check each of these things out so if we are working on something and we all want to do something in terms of meeting, then we can. That is different than the full committee acting as the FACA.

(Comment off mic)

DR. RIPPEN: I have nothing really to add. I think everyone has made some really great points. I think we can probably move forward.

MR. LANDEN: Overall, I am pretty comfortable with all of the suggestions. For the routine updates, I suggest we have those relatively – within a week or two before the face to face meeting so, number one, they are fresh in our mind. Number two, if any thing comes up, they are still in time to invite the liaison or representative to the meeting. I guess that is it.

DR. CORNELIUS: I like the idea of the updates in advance of the meetings. The other thing I would really amplify is it really helps for me to know in advance when we have these two-day meetings that we are scheduling a meeting before/after. Once I get to playing my schedule game, it is hard for me to back-in to change everything around.

MS. HINES: That is going to be partially looked at tomorrow. If we do make changes, obviously, the schedule will change. I will tell you Marietta has booked space at Humphrey and here on the day before and the day after throughout his fiscal year because we are trying to be prepared, ourselves. Obviously, it may not be feasible for you to book the day before and the day after every single meeting, but there is what we have done to at least get ourselves some space booked.

DR. STEAD: To play on that, if, as we come through this tomorrow, this is beginning to seem real to people or some part of it is, then for us to begin to agree on when those dates are going to be so that we go on and lock that in. All of us have that problem.

MS. HINES: I would love to ask CMS whether you could check out having the work – the workshop for the predictability roadmap onsite in Baltimore. That way you would have better attendance by the people at CMS, who have obviously, a lot of interest in that discussion. If that is something you could find out for us, that would be super.

MS. GREEN: Sure, we will take a look at that.

DR. STEAD: Did you want to add anything?

MS. GREEN: I just thought it has been a very productive conversation today. I am looking at the board and it is shaping up. I think it is a full plate for everybody, including myself. I am just very excited to see what comes from this. I thought very thoughtful discussions, very strategic. I see the planning – a lot of planning going into this. I think the work on the front end helps with the back end a little bit in laying all of this out, budget, resources, an all of that. That you for the opportunity to participate.

DR. STEAD: Do we have any public comment based on what you have been listening to?

Agenda Item: Public Comment

MR. RODE: I wasn’t sure you were going to do this this afternoon. I am glad you are. My name is Dan Rode. I am an independent educator and consultant. The comments that I want to make have nothing to do with the EHNAC group that I mentioned before.

I just have a couple of things. There is tons you could say, but very short. I am very concerned that this committee would put off at least the letter to congress explaining the impact of the ACA sections that you are involved with. It is no secret that there is a move to change the ACA as an agenda item. I think people need to understand the impact of the operating rules, the impact of some of the other rules that you are going to be involved with this year. We worked very hard to get those because they did not come out when we originally did the HIPAA legislation. I think there has been a success story in what the committee has done in working through CORE. I think at least a short letter explaining the importance of these so that as the discussion in congress begins on the ACA and it is probably one of the first ones that will begin, that there is at least some understanding of don’t throw all the babies out with the bathwater. That is my first comment.

My second comment is with regard to the HIPAA rules, transactions especially, and the whole process that is involved. I hope that as you look at this, we don’t look at how do we change internal processes that already exist, but look a little broader.

Some of the things, again, that were in the original HIPAA did not anticipate that it would take seven years to make a change in the standards that we use and the processes we use. There was quite a bit of discussion, again, on the ACA rule as we were looking at the sections already discussed of other changes that could be made that would emphasize the industry input into the Standards groups. This group would be looking more as a reflective group, post-Standard and not rewriting the standard, itself, or going back and forth between standards groups. We estimated and ICD proved us even further wrong, but we did estimate at the time the average change on some of these is seven years. We can’t continue, as has already been discussed, to have seven year changes in these kinds of processes. They don’t keep up with the technology or the needs for CMS or other payers in other groups. I am really worried about that and hope you will expand that discussion.

My last, which kind of gets to some of what you have just finished talking about, is for some of us to follow this whole process and not be a part of the committee is very difficult. I hope you will consider looking at your meetings and your phone meetings and others similar to the way that the policy and standards committees for the ONC look at those so that they are available to the public in a listen-only mode on the phone, that there is material that we can look at to understand what you are discussing, rather than listening to page numbers, and just open the process a little bit up. It is very helpful to us. It gives us a sense of when we should or should not make public comment.

I thank you for listening to me. Have a nice dinner.

DR. STEAD: Thank you. Other comments? Well, then do I hear a motion to adjourn? Thank you all. We will adjourn and meet up for dinner tonight. Tomorrow morning, we start at 8:30.

(Whereupon, the meeting adjourned.)