[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

Meeting of
Subcommittee on Standards

November 14, 2013

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

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
caset@caset.net

P R O C E E D I N G S (8:03 p.m.)

Agenda Item: Welcome

MR. SOONTHORNSIMA: Why don’t we get started? I am Ob Soonthornsima, co-chair of the Subcommittee on Standards. I have no conflict.

MS. KLOSS: Linda Kloss, member of the full committee, member of the Subcommittee, no conflicts.

MS. GOSS: Good morning, Alix Goss, Pennsylvania Health IT coordinator, program director for Pennsylvania e-health partnership authority. I’m a member the full committee, a member of the Standards Subcommittee, and I have no conflicts.

DR. CHANDERRAJ: Raj Chanderraj, practicing physician, member of the Subcommittee, no conflicts.

DR. SCANLON: Bill Scanlon, National Health Policy Forum, member of the Subcommittee and the full committee, no conflicts.

DR. FRANCIS: Leslie Francis, University of Utah, co-chair of Privacy, Confidentiality, and Security, and member of the full committee, and no conflicts.

(Introductions around the room.)

MR. SOONTHORNSIMA: Thank you everybody for being here this morning, bright and early, especially after a great celebration last night. We all didn’t get back to our hotel until 11:00, but we had a wonderful time. Debbie isn’t here, but I wanted to acknowledge Debbie and staff, for putting together a fantastic event for Marjorie last night. Without any further ado, we’re expecting Walter to call in. Good morning, Walter. Would you declare your presence please?

DR. SUAREZ: This is Walter Suarez. I’m a member of the national committee, co-chair of the Standards Subcommittee, and no conflicts.

MS. WILLIAMSON: Hi, this is Michelle Williamson. I’m on the phone, staff to the Subcommittee.

MR. SOONTHORNSIMA: Good morning to both of you, wonderful to have you. Are you able to see the screen, Walter?

MS. WILLIAMSON: They haven’t been displayed yet. They have one for today, but I don’t know if it will start for this or just for the full committee.

MR. SOONTHORNSIMA: Walter, we do have an agenda, would you like to walk us through the agenda you sent last night, and I have the slides up from the original deck?

DR. SUAREZ: First of all, my apologies for having to miss the meeting yesterday and certainly the celebration last night. I think the original agenda that we had, we were going to talk about several things, but my understanding from Ob’s– the discussions yesterday from the committee was that there were some changes to the original agenda that we submitted and published. My understanding right now is that we’re going to be talking about first the 2014 areas of work, and you all should have received a slide deck earlier this week with the full set of documents that I think we’re going to review.

First we’re going to start with the 2014 areas of work, then we’re going to spend some time on the e-health roadmap and do some follow up and refinement and talk about the next steps with respect to the roadmap and the e-health addition. Then we’re going to spend some time reviewing the population health roundtable.

I assume that this came out from yesterday’s discussion, and I’m not quite yet familiar with that part, but I will let Ob lead that, and then we’re going to talk about the sub-committee plans in terms of our meeting schedule between December and February. February is our next full committee meeting, and our plans between now and February, and then finish up with an open opportunity for public comment.

MR. SOONTHORNSIMA: Thank you, Walter. Why don’t we jump right– if you have the slide deck in front of you, Walter, that would be on page 43 or 44 now. That will cover the 2014 Subcommittee agenda section.

DR. SUAREZ: Yes, exactly. So the first slide after the cover is the– I’m not sure the order of the slides since we sent different decks, but in any case, the first slide after the cover slide is a quick summary, a quick review of the Affordable Care Act and defines a deadline for some administrative certification activities coming. You all have seen this slide before, so I won’t spend too much time on it, but just to have in mind some of the operational and regular requirements that we have and activities.

I think out of this as two or three main things that we expect to see coming up next year would be a plan of implementation of ICD-10, the data renumeration of health plans with the health plan ID, the release of regulations related to the claim attachment standards, and then any operating rules for the remaining transactions and those are listed in the slides, the remaining transactions for which operating rules are to be named, including claims, enrollment, premium payment, pre-authorization, and claim attachments.

I think those are the main things that I think will be coming out next year in terms of our HIPAA administrative certification related activities. There’s also of course some experiences that have been occurring with respect to the health insurance exchanges and the administrative transactions, particularly the enrollment transactions. I think it’s going to be important to continue to monitor the impact that these enrollment transaction– the issues and challenges and impact of this is having and will have in the enrollment processes.

Then on this page at the bottom, NCHS and the Affordable Care Act Review Committee, so there is an ongoing discussion with CMS regarding that, and I think we’ll be continuing the discussion and bringing those up in terms of potential venues and ways to proceed to the subcommittee as we have them ready.

MR. SOONTHORNSIMA: Walter, I do have a question, or really a comment, with regards to health care reform health insurance exchanges. I don’t think we’re doing anything at all with that. We simply are observing, but no action, no activity, not tasks, for our team or staff to do, correct?

DR. SUAREZ: At this point, there is no activity directly related for us. As you mentioned, it’s primarily monitoring, but certainly with the relationship of these transactions to the operating rules for enrollment and the current experience with enrollment transactions, there might be some expectations, and we will talk about it as we go through the various topics and activities.

There might be some expectations and interest among the members of the Standards Subcommittee to hear about what’s going on or what’s happening. This is certainly an area that we see very much related to the areas that we’ve been working on, but right now there aren’t any concrete activities for this year. Again, next year, we have something on the schedule for next year.

Maybe we can go to the next slide, which is the areas of work for 2014. What we did was divide this into into the quarterly activities and then three main concepts. One is what are the topics that we will be covering, and then what are the possible hearings or roundtables or workshops, kinds of gatherings, meetings that we could consider? And then the letters and reports and papers that we could be expected to produce.

With respect to quarter one, the topic, the main topics that we have are listed there. The first one is something that we been briefed to, and that is the NCPDP, the National Council on Prescription Drug Programs, prior authorization transactions. We heard testimony regarding this. We made some recommendations, and we are going to be hearing some follow-up from NCPDP and the DSMOs later this year, or early next year, so that’s something to have in the schedule.

The second topic is operating rules for the remaining transactions. So we would want to hear about the status of those. The third topic is, as I mentioned, the administrative transactions in health reform, particularly the issues with the 834, the enrollment transaction. The fourth topic is the review of the findings from the reports that are coming out related to administrative simplification and the future of the administrative processes in healthcare.

The 2013 WEDI Report is expected to be released toward the end of the year, I think early part of December, and then the Institute of Medicine is working also on a report on the future of administrative simplification. Those two will be topics that we would want to review and see how they relate to and potentially can be leveraged for the work we’re doing next year.

Then the conversations related to the ACA Review Committee and our role and potential engagement of the National Committee Standards Subcommittee in this process, that’s something also for quarter one.

Then the possibility that the health plan compliance certification regulation would be out. My understanding is at this point that regulation is in the OMB process of review. They’re going through their 90 day review process. They could release the rules before, for publication, before the 90 days. I believe the 90 days are completed in the later part of January, by the end of January, but they could release the ruling, and the rules could be published before the 90 day process, so that’s another element that we have commented on and we want to keep an eye on. Those are the main topics that we have for quarter one.

Potential hearings, I think certainly we can plan for a potential hearing on the operating rules for the remaining transactions. We would like to hear about any development in status and possible recommendations of any operating rules for any of these remaining transactions. That would be something to do in the area around the February meeting. That’s one of the topics.

Along the way, we can include also the topic of health reform and the issues with enrollment transactions. Then also the Affordable Care Act review committee process, we can include that. Those would be potentially the kind of hearings we would be considering.

The other one is the collaboration with the Population Health and a possible second hearing or roundtable, and we’ll talk about it more later on in this meeting. Those are two possible roundtables or hearing activities.

Then in terms of letters, I think the letter on public health data standards hearing would be one thing to develop between now and February, the completion of the HIPAA report coverage will be another report complete. Then any finalization of the review committee proposal.

Let me stop there and see if there are any comments or questions about this first quarter activity?

MS. GOSS: I want to suggest that maybe our topics for Q1 need to now include some of the work that was agreed upon yesterday for a systems approach to measurement and analysis. At least some of the team members will be participating in that overarching activity. I’m not sure if you want to put it in here.

MR. SOONTHORNSIMA: Let’s go ahead and put it in here. How would you want to say that?

MS. GOSS: I am not exactly sure which one I got signed up for yesterday.

DR. SUAREZ: It sounds like there were things that were proposed as new activities to sign up.

MR. SOONTHORNSIMA: Is it a framework for across the subcommittee, right?

MS. GOSS: I am not sure that I would put it under hearings, roundtables, and workshops. It’s more of a topic that we want to start to merge through weekly conference calls.

MS. KLOSS: Just put, participate in framework development project.

DR. SUAREZ: Participate in framework development project, is what I heard. I would understand the cross subcommittee activities.

PARTICIPANT: That is correct.

MS. GOSS: In a nutshell, there was a new methodology put forth for really achieving the convergence, leveraging a data continuum framework, methods framework, community focused convergence case studies and solution sets.

DR. SUAREZ: Okay, that would be great. Thank you.

MS. WILLIAMSON: Just a point of clarification, I want to understand as far as the letter, you mentioned a letter possibly on public health data standards between now and February. You have also mentioned the possible subsequent hearing in collaboration with Population Health and the Privacy, Confidentiality, and Security Subcommittee. Are you proposing that there may be one letter based on the Standards feedback, and if Populations and Privacy decide on a second letter that would be a separate letter altogether?

DR. SUAREZ: I would say yes because I think it’s not clear yet necessarily, I don’t know if that has been decided, whether Population Health will be even having a second hearing in the first quarter or a roundtable or some other activity, and whether that will happen in this first quarter of 2014, or later in the year.

I think we should work towards developing a letter with observations and possible recommendations out of this first hearing or the hearings that we had earlier week. Then if there is such activity organized under the direction of the Population Health and any partnership with our subcommittee, we can certainly do a follow-up letter, a second letter after that.

MR. SOONTHORNSIMA: Later on this morning we’ll be talking about what we heard from the public health hearing the other day. At that point we can determine whether the letter is necessary, whether we gathered enough information.

MS. WILLIAMSON: Okay, thank you.

DR. SUAREZ: Any other comments?

MR. SOONTHORNSIMA: Okay, we’ll move on to the next slide.

DR. SUAREZ: All right so quarter two, I think here the topics are more– I think one of the overarching themes for 2014 is really the continuation and conclusion really, I hope, of the work that we have been doing with respect to e-health vision and roadmap.

I think in quarter two, we would devote the time to continue that discussion. That would be one of the leading topics there. Meaningful use and administrative transactions would be a possible second topic depending on whether we see meaningful use three regulations, or at least final recommendations from the policy committee be issued. That’s something we want to, in the interest of our convergence with respect to Standards we want to keep an eye on.

Certainly claim attachment regulations, if they are out, we would be interested in reviewing and understanding. And then activities related to the review committee would be also part of what we would be expected to be doing in quarter two.

In terms of hearings, in June we regularly have what I’ve been calling the annual hearing on the status of standards implementations. We regularly in June hear from the industry about how things are going with the implementation of standards.

In this case we will be hearing about the regular standards implementation process, as well as the implementation of operating rules, the preparation for the renumeration process for plan ID, ICD-10 will be just on the verge, and there are number of conversations and questions about how would ICD-10 PM and PPS adoption affect the exchange of claims and administration transactions in the worker’s comp arena as well as P and C, property and casualty, since they are not properly related to adoption of ICD 10. So it’s concerning how much people are going to be having to handle still to coding standards and the walk between them.

Then in terms of letters, if there are any letters coming from any hearings that we would have in quarter one would be there for quarter two and for our June meeting of the National Committee.

Any actions potentially, any recommendations related to the transactions and health insurance exchanges would come in that quarter as well.

Then our review committee work plan continues, and then possibly the development of a roundtable paper in terms of the outcomes from the roundtable discussion that we had in September. That would be one other product.

MR. SOONTHORNSIMA: One comment from Linda.

MS. KLOSS: Do we want to consider doing the status check on ICD-10 earlier than June next year? It seems to me that whatever we might learn in June is too late. Might we want to push that up to February?

DR. SUAREZ: I think that would be a really good idea, too, absolutely.

MR. SOONTHORNSIMA: I am going to move that back to– thank you, Linda– quarter one for February hearing. The only comment I would make for the February 19th hearing, I would take out the health reform, health insurance exchange, at this point. It will be too soon, too early, too much activity is going on, and replace that with ICD-10.

MS. GOSS: While you’re on that slide, I think we also need to link my last comment, participate in the framework development initiative, with the roadmap, because I see that those two activities are all interrelated. I noticed on the next slide for Q2 we labeled it as “e-health vision roadmap”, and I think they’re all tied up together, or do we want to separate them?

DR. SUAREZ: Which one?

MR. SOONTHORNSIMA: E-Health roadmap.

MS. KLOSS: As I was thinking about it, I think we should proceed with the roadmap focused on our Standards tasks and just march along with that, and then see at what point they come together. I think we’ll lose ground if we wait.

MS. GOSS: I agree with that. We want to copy over the Q1 work and participate to Q2.

MR. SOONTHORNSIMA: Any other comments?

DR. SUAREZ: Just one point, Ob, I think the suggested taking out the administrative– well, at least the health insurance exchange portion in Q1?

MR. SOONTHORNSIMA: That is correct. For the February 19th hearing, include ICD-10 status review. That’s the only replacement.

DR. SUAREZ: I would say add it instead of replacing it, mostly because they continue being concerned about what’s going on with that. If we are going to do anything about it, it would have to be at that time. My sense is by Q2 this would be a non-issue at that point, hopefully. Maybe if we’re stilling having issues with that at that point.

Why don’t we do this? Why don’t we keep it tentatively there in Q1, and we can revisit as we get closer to the February timeframe of the hearing, we can revisit whether we need to still follow that topic or not?

DR. W. SCANLON: I am not sure what our role is in this at all. To be quite honest, you can think of the exchanges as a broker’s office. Why do we distinguish them from others? They need to be compliant with the regulations that are out there, and if they’re not, that maybe is an issue, but that’s a compliance issue. That’s not something we would normally deal with. I think staying out of this– the agenda is so crammed already that we need to think about priorities.

MR. SOONTHORNSIMA: We tend to agree with that, especially if it’s too early on and if they’re not changing any of the 834, 820, at this point, they are still too new. We can observe, continue to observe and then we decide later on in the year if we’d like.

DR. FRANCIS: I want to make sure the insights of Tuesday don’t get lost in this. Some of what I envision is the idea that whatever emerges from the public health data in terms of a letter, it might almost be a roadmap kind of letter about where there are issues, where things should be built in. One of the obvious places that was raised was the whole linkage to meaningful use.

There was a slide up yesterday that I think Linda had, that was the map one with what would go where, and I really liked that slide and am remembering the blanks that were at the bottom and the discussion of — that’s it right there.

The whole question of those blanks and when they might get filled in for population and public health. We didn’t hear anything about personal health, but I would really like to see as the Standards plan goes that that bottom dimension doesn’t get lost.

MR. SOONTHORNSIMA: Can we come back to that in our next topic?

DR. FRANCIS: I know, how to not have it get lost is the next topic but while this is all being–

DR. SUAREZ: I’m hoping we didn’t lose that. My sense is we have more than enough. In fact we had quite a number of very important observations and even beginning to formulate in my own mind, and then heard others as well, recommendations. So my sense is that we would have a letter on the public health data standards hearing by that time. I think your point is emphasizing that also in my mind.

MR. SOONTHORNSIMA: We are running a little bit over time, but this is good discussion.

DR. SUAREZ: We only have one more slide I think. So quarters three and four, basically of course at this point it’s more general directions, not very concrete and specific as the topics in Q1.

In Q3 and 4, what we’re looking at is finalizing and I hope completing our discussions and development of the e-health mission and roadmap. Of course, we will have ICD-10 PM and PPS implementation right in there, and so we’ll be monitoring what’s going on with respect to that implementation.

Then again, possibly depending on– and I kept in here the review committee line because there’s– every period there’s going to potentially some work items related to the review committee.

There is again in here some convergence work with Population Health, Populations Health and Standards, and we should have added there Privacy, of course. Then the ACID enumeration will be happening at that point, so we will also be monitoring that. There is no concrete, specific activities related to that, as the implementation will begin, the enumeration process will begin.

Possible hearings again, a possible follow up of the hearing on public health data standards, depending again on the work plan of the Population Health Subcommittee. Now targeting certain topics, and this is something out of the hearing that we had on Tuesday, where there are some areas where we can take a deeper dive to talk about the standards being used in public health.

Then a possible third roundtable on e-health vision and the standards road map, as part of our completion of the discussion where I could envision getting everybody together and presenting and having a conversation about that finalize e-health vision and roadmap. Then letters and reports, any letters coming out of our June hearing, and then the finalizing of vision and roadmaps could be another one.

MR. SOONTHORNSIMA: Comments? Okay, thank you.

DR. SUAREZ: That’s the work plan I think that we have, and it’s a busy schedule, particularly the first two quarters where we have more detail. Things always evolve and new items might come up that we might need to address, and some items might not be– like for example the health reform part, we might not necessarily be engaged so we can drop some of those as we go along.

MR. SOONTHORNSIMA: Very good. I think Marjorie you joined us, would you announce yourself please?

MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the Committee, and thank you to the Subcommittee for the prodigious amount of work that you do.

MR. SOONTHORNSIMA: Thank you for joining us this morning, especially after such a fantastic night. I’m sure you didn’t get home until very, very late.

MS. GREENBERG: I was a little late because I stayed up reading my memory book, and then I was looking at it again this morning. So thank you to all of you who were there. It was a very special evening. We missed you, Walter.

DR. SUAREZ: I was there in spirit.

MS. GREENBERG: You definitely were. Everyone went around to say when they’d first met me, and you and I go way back.

MR. SOONTHORNSIMA: Alright, we’re going to move onto the next topic, e-health roadmap follow up and refinement. Yesterday we had some really good feedback from the national committee. Maybe we can start talking about adjusting or refining our concept here? There were two key points, if I recall correctly, and my colleagues please correct me if I’m wrong. One is under the guiding principles I believe Michael suggested that we separate out some of the vision statements from guiding principles, because when you read them some of the key points were coming across as vision statements and not guiding principles. We can do that very briefly.

The other suggestion was around– and by the way, we don’t have to word-smith this right now, but just go line by line and identify which one is a vision sort of statement and which ones are guiding principles, truly guiding principles. The next suggestion was maybe our roadmap, and this probably will require some more discussion, our roadmap should really focus on the standards, things like admin simplification, meaningful use, implementation, and public health, but try not to go beyond that because that’s beyond the scope of our committee. Those were the two comments that I heard yesterday. Were there any other thoughts and comments that you heard or would like to include in our discussion this morning?

With that said, let’s jump right in. I’m only going to time box this one for maybe five minutes, just going down the guiding principles versus the– we should spend at least 15 minutes on the roadmap scope considering the discussion we had yesterday with the population health. Walter, you can turn to page– this probably would be page 34.

DR. SUAREZ: I am there, the first slide of the two guiding principles slides.

MR. SOONTHORNSIMA: Do you want to go down the list one by one? Let’s just do that on the first slide. eHealth policies facilitate the evolutional, practical, and pragmatic changes. Is that a vision? That’s a vision. The next one, let’s go down the list, is that a vision or is that– eHealth facilitates, same thing, right? Transformative change, that’s a vision right, because it’s sort of related to the first? Major changes are optimized and aligned to minimize administrative burden — Raj?

DR. CHANDERRAJ: The sub items, the bullet points are supposed to be not the vision but the– the main heading is okay, but the bullet points should be taken out of the vision. Actors, stakeholders defines, impacts, anticipated and articulated. The second bullet is conflicting and competing policies identified, reconciled–

MR. SOONTHORNSIMA: Those are guiding principles?

DR. CHANDERRAJ: They should not be in the vision statement, I think.

MR. SOONTHORNSIMA: I totally agree. That’s part of the guiding principle.

PARTICIPANT: Do you not think that that is a principle – the main point?

MR. SOONTHORNSIMA: The sub-bullets are the main point, but we can refine it.

DR. SUAREZ: In many respects I totally agree. I think some of these feel more like visionary, some of these feel more like principles. In general even the first two would be, I agree, those are more vision than principles. They can also be rephrased to extract a principle that could be valuable for our — and at the end, how are we going to apply these principles is whenever we are faced with evaluating and recommending a standard.

I think the first one even could be converted into a principle, too, which is a valuable one in the sense that the action, the recommended standards, whatever action we’re going to take, should facilitate an evolutionary and practical and pragmatic change. Even though that right now reads as visionary, I think it could be converted as a principle or reframed as principle.

Right now, I agree. I think those two first ones are more vision statements. I don’t want to lose them from the principle side which they are valuable, too.

DR. W. SCANLON: Is it appropriate to comment on content here? I guess the third one, the major changes are optimized. I find that– I guess there’s an issue of priorities. I would say, optimized and aligned to maximize desired outcomes while minimizing administrative burden in industry. We really need to be focused on the goals.

MR. SOONTHORNSIMA: Thank you, I will do that. Next one?

MS. KLOSS: I think that aligns very well with the roadmap process. I would call that a principle – the stakeholders.

DR. SUAREZ: May I suggest one thing? This one is a bit repetitive of the first two bullets in the previous one. I would suggest making this a third sub-bullet, erasing where it says, clearly defined stakeholders, and keeping, clearly defined opportunities and risks, because I think that is the other element that is not stated in the previous one. I would just say a third sub-bullet that reads, opportunities and risks are clearly articulated.

MR. SOONTHORNSIMA: Yep, we’ll wordsmith later, but that’s now a third sub bullet point, clearly define opportunities, risks.

MS. KLOSS: Could we remove actors from the first bullet? That seems a little glib.

MR. SOONTHORNSIMA: Alright, next, we made that the third sub-bullet point. Let’s move onto eHealth changes, deploy practical and pragmatic approaches focusing on administrative and political process to achieve Triple Aim.

MS. KLOSS: Part of that is vision. The last part is vision.

MR. SOONTHORNSIMA: Is this repetitive, too, the first part?

DR. SUAREZ: I think it is repetitive to the very first bullet.

MR. SOONTHORNSIMA: We will wordsmith this later. So focusing on administrative and political processes to achieve Triple Aim, that would be the vision, right? The beginning of that, eHealth changes deploy practical, pragmatic approaches to mitigate implementation, adoption, that’s clearly repetitive, so I’m taking that out, good?

DR. SUAREZ: I agree.

MR. SOONTHORNSIMA: Done. eHealth changes are optimally defined to achieve greater good for the whole, recognizing also, however, that changes may not be possible for every entity. Is that more of a principle?

MS. GREENBERG: It may not be optimal–

MR. SOONTHORNSIMA: What we mean when we try to put this– and we’re not doing a good job here– what we meant when we put this together is that not everybody will make that change. It’s impossible for every change– to expect absolutely every entity to adopt. We just have to–

DR. CHANDERRAJ: That may be a principle rather than a vision.

MR. SOONTHORNSIMA: You’re not sure what I meant. For example– let me pick an easier one– you might have a situation where small practices, retiring physicians are absolutely not going to go down this path. They’re not going to adopt electronic health records. They’re not going to x, y, z. At what point do you let that go and move onto the bigger– focusing on the majority?

MS. GREENBERG: On some of the standards, it isn’t really an option for them not to, right?

MR. SOONTHORNSIMA: But there’s a possibility in some of the implementations– I’m not talking about–

MS. GREENBERG: This is a long discussion I’m sure, but something like electronic health records, if they really are– have the evidence– and I don’t think all the evidence is in yet, but if the evidence really demonstrates that they really do improve the quality, the continuity, and even the efficiency of care, then it seems like there’s got to be some solution for– you don’t want the two cities on the hill, because that will affect population health in areas of the country. It seems you’d need to think in terms of some kind of cooperative, collaborative consortium, some type of approach that will bring the benefits of eHealth really to everybody, whether they get their care in a small practice or in a rural place, et cetera.

MR. SOONTHORNSIMA: The concern here is how far do you go? How long– we create this drag. We’re talking about implementation tail. It impacts the next set of initiatives and implementations, and you’re still waiting for people to adopt. At what point do you say if you don’t come along you’re not part of this and just move on?

MS. KLOSS: Is that our job to worry about?

MR. SOONTHORNSIMA: I believe it is for the next set of rules, initiatives that are hanging on these post-implementation or delays, but I think at some point as a committee we need to acknowledge this is not for everybody, and those people who are not coming along just–

DR. W. SCANLON: I think there are two ways to look at this. I’m concerned that our history here, and it goes back to administrative simplification, is that we have been too tolerant of variation, and therefore we haven’t achieved it. That’s what that seems to be– playing to that. There’s also another principle, which is that you shouldn’t let the perfect be the enemy of the good, which means that you’re going to move forward.

There’s also– there’s a context here. Regulation is one thing. This is the only way you’re going to practice– if that’s the regulation, then you need to think about what are the consequences. Maybe some people just have to stop because it’s not appropriate, but it’s not clear that we’re only talking about regulation. We’re talking about, in some respects, setting out a model that we’re also expecting the marketplace to respond to. That’s voluntary.

People can decide that they’re going to sell yesterday’s product, or try to cell yesterday’s product and nobody’s going to buy it, that’s fine. Let the market work. This is a worrisome principle because it does harken to that past even though I am a big believer in the perfect not being the enemy of the good.

DR. FRANCIS: Another point to be sure we don’t lose sight of is what was raised yesterday by the discussion from OCR about the security people not having done risk assessments. Somebody can have eHealth but be doing it really, really badly. One of the things I think that there’s a real role for this committee in is looking at those gaps.

MR. SOONTHORNSIMA: To your point, I think that is what Bill was articulating. Certain things are legislated, and it’s about compliance, so you’re not going to let that go, but others are much more voluntary more–

MS. GOSS: Maybe it’s a higher level principle we want to get at, which is trying to influence the culture and the approach to how we do this as opposed to balancing the various comments here and some of the words we’ve heard.

DR. W. SCANLON: Going to that OCR example, that is about a regulation where you’re qualifying for a payment, which is voluntary. You do not have to accept the money. The issue is– it’s very different. Basically the courts have said that participating in Medicare is voluntary. You don’t have to do it, so therefore the regulation standards are different than if we were to say everybody in the country is going to do “x”. That’s a very different kind of regulation.

MR. SOONTHORNSIMA: So do you think we need to keep this here? Maybe we need to word it differently?

MS. GOSS: I think it doesn’t hit the reflection of the comments we’re hearing. It doesn’t take it from a proactive what we’re going to do principle perspective.

MR. SOONTHORNSIMA: I agree. Does it support the second bullet point that says eHealth policies facilitate transformative changes? We clearly define current and future states. What will be embraced, what will be abandoned? That sort of says–

DR. CHANDERRAJ: I think if you split the last sentence, the eHealth changes are optimally defined by geographic group, put it as a part of the vision in the first thing and the last part, recognize the changes may not be as– put it as a bullet point as a guiding principle on its own.

MR. SOONTHORNSIMA: I’m not sure that achieves what we just talked about.

DR. CHANDERRAJ: eHealth facilitates the elevation of practical and pragmatic changes in industry–

MR. SOONTHORNSIMA: In the interest of time, do we still feel that point is still needed, that we just have to craft a better message? There’s a reason there. All these changes aren’t for everybody. We have to acknowledge that. We’re not going to change the whole– we don’t want the–

DR. SUAREZ: Is that a principle to evaluate standards or is that a mission? In my mind, I’m trying to really find a–

MR. SOONTHORNSIMA: I think if we leave it there, it needs to be a principle, because the vision is you want a grander thing–

DR. SUAREZ: That’s why I’m suggesting maybe this is more a vision, because I’m trying to make these principles more, by using the first bullet, more pragmatic and practical. This one I’m not sure how I can make it pragmatic and practical. In my mind this is more of a vision statement.

MR. SOONTHORNSIMA: Do we want to keep that last point that this is not– changes may not be for everybody? We don’t need that at all? That means we don’t want any straggler to drag the industry behind. Take it out?

DR. W. SCANLON: I think the issue is not so much the straggler the industry– slowing the industry, it’s the issue do we tolerate the straggler? Do we allow them to continue to be in practice? That’s the ultimate question. If you think about it in terms of licensing, we’ve got CME requirements. If I chose not to do the CME requirements, I don’t get my license renewed.

DR. CHANDERRAJ: The point is participating in the eHealth, is it delivering good healthcare? That’s the point we’re focusing on. If you’re not participating in the eHealth care, not taking the bonuses, what is being provided is appropriate care but not participating in the process, that’s all.

DR. SCANLON: I am thinking I wouldn’t have such a rigid rule. What’s vague about this here is that it seems like we don’t know what the consequences of not being possible for every entity should be. Should it be that they just don’t participate and they don’t get the advantages of it–

MS. GOSS: You play or you get left behind. That’s the principle.

DR. SUAREZ: The word possible is not necessarily the best. In my sense there are some changes that may not be needed for every entity. That’s one dimension. The other one is this one that is saying that there might be changes that may not be possible. Needed is different than possible. Here possible gives the impression that even though the change might be needed, it might not be possible for some entities to achieve it because of whatever condition they are.

MR. SOONTHORNSIMA: Embraced, needed, certainly not possible.

DR. SCANLON: I think embraced reflects the reality of what may happen. Needed is a strong word, because that’s saying I’m giving you absolution that you didn’t need to do that. Possible is another judgement issue, but “embrace” is just the reality. Some people just didn’t do it.

MS. GREENBERG: We leave unstated what the consequences are. That’s sort of out of our scope. Embraced I think– yeah.

MR. SOONTHORNSIMA: So that is really a principle. We can take out the first part because again that’s part of practical and pragmatic, right? eHealth changes are optimally defined and achieve greater good for the whole– we don’t need to say that anymore.

DR. SUAREZ: We’re moving it more to the vision. We’re taking it out of the principles and moving it to the vision– that’s the first step.

MR. SOONTHORNSIMA: We already did that.

MS. GREENBERG: Isn’t the first one part of the vision, too? I see, you put “vision” there.

MR. SOONTHORNSIMA: That’s why this is repetitive, the first part is repetitive. Now we’re basically saying as a principle that changes may not be embraced by every entity. That’s just a principle, and leave it at that. If we don’t like the wording, we’ll change it later. I’m trying to time box this conversation. Linda, you didn’t like it?

MS. KLOSS: I am just thinking about our role as an advisory committee. I think the purpose of doing a roadmap is to clarify, improve the process, facilitate adoption, and I think that’s what we’re doing. I think the issue of the straggler is less our concern.

MR. SOONTHORNSIMA: It’s not, but we spent a lot of time talking about. That’s my point.

DR. SUAREZ: I think I agree with Linda in the sense that how does this become a principle? What’s the effect of this principle? The reality is not everybody embraces– so what? What is the principle we’re really trying to say?

MS. KLOSS: We spent time talking about it from a what barriers are there that we can suggest remediation for? We do it from an enabling perspective not from a tough love–

MS. GREENBERG: It is not really a principle. It’s a finding. It’s not part of the vision, and it isn’t really a principle either.

DR. FRANCIS: It’s monitoring and suggesting ameliorative measures.

DR. W. SCANLON: The way it’s worded now, changes may not be embraced. It’s certainly just factual. The issue would be or principle could be that changes need not be embraced by everybody because basically don’t let that stop you– the principle is for the greater good that you do it. I think we do hear– we spend a lot of time hearing about this is too burdensome, and the issue is well, how prevalent is that burden? Should that be the factor that says, no we can’t do this.

DR. FRANCIS: Isn’t the principle that the role of this committee is to monitor and suggest ameliorative measures, which is not necessarily at all coercive? I’m thinking education, help, all kinds of things.

DR. CHANDERRAJ: All these tools that you’re enabling people to join may not still be– from a principles stand point a practitioner may decide not to do that. In those situations, we’re saying it is okay, but you don’t qualify for the incentives or whatever monies to participate.

DR. W. SCANLON: That is one particular example, but I think we also play a role in terms of advising the secretary on regulation. I think the issue or what’s underlying our recommendation generally should be some type of cost-benefit analysis. These are the benefits, and we recognize there are costs, but we find the trade-off reasonable and therefore we’re saying– this is the role of regulation. We’re going to force this to happen, but they have to have a reasonable basis in terms of the gains. That’s I think what we’re about.

MS. GREENBERG: The principle it seems is really that barriers to adoption will be thoughtfully explored and identified, and to the extent possible addressed. That’s really the principle.

DR. SUAREZ: I really like that, what Marjorie just said. I think that is really aligned with the three sub-bullets, under the third bullet there, particularly the third bullet where we say opportunities, risks, and maybe we can even say barriers are clearly articulated.

MR. SOONTHORNSIMA: You are ahead of me. That’s exactly where we put it. We put another bullet point– again, we’ll word-smith later– barriers will be explored, addressed, to the extent possible.

MS. GREENBERG: That’s something you can act on.

MR. SOONTHORNSIMA: The other point will be remain, changes designed for the greater good may not be embraced by everybody. That’s a principle.

DR. SUAREZ: Changes may not be possible for every– are we doing that? I thought we were dropping completely that last bullet.

MR. SOONTHORNSIMA: Changes may not embraced or need not be embraced by every entity.

DR. CHANDERRAJ: For the greater good can be taken out and you can word-smith it later and put it in as part of the vision statement.

MR. SOONTHORNSIMA: I think the greater good– Linda, go ahead.

MS. KLOSS: I like the greater good. I think that’s part of the measure because when the rubber hits the road, is this going to move the industry towards the vision?

DR. CHANDERRAJ: It would be part of the vision I’m saying. It should be included in part one.

MR. SOONTHORNSIMA: I am going to move on. Let’s go to the next one. eHealth changes facilitate and enable capabilities that empower consumers with actionable information in engaging healthcare; improve providers’ delivery, quality, and outcomes; optimize costs– next. eHealth transformation establishes and articulates a roadmap of short term and long term changes.

MS. GREENBERG: In the top one, can you say something about population health? Power of consumers, improve providers– and then improve patient safety, improve or something population health.

DR. CHANDERRAJ: I think you making the vision too big, and with the bullet points also it takes away the main message from the vision. I think this is expanding it a lot.

MS. KLOSS: I think we should take these four or five vision statements and reshape them into one or two, because they are redundant.

MS. GOSS: I would think that we would take it in the staggered approach to defining it.

MR. SOONTHORNSIMA: This one is a little bit more specific because you are targeting different stakeholders, the providers, the consumers, the patients, very specifically, and now what we just added is really a separate point, enabling public health, right Marjorie? It’s not really consumer providers, it’s really more of public health, which is a bigger, separate vision. Is that what I’m hearing?

MS. GREENBERG: It is sort of what we were talking about yesterday, but it’s in that continuum. It’s different. I think doesn’t it belong under there?

MR. SOONTHORNSIMA: The only point here is because– it might belong under data. I don’t know. The reason why it might be separate because the main bullet point is really focusing on providers and patients.

MS. GREENBERG: But see, that is the problem. If it’s just a healthcare model–

MR. SOONTHORNSIMA: That is why we’re separating public health. Your point is well-taken. That’s why I’m–

DR. SUAREZ: You’re adding a bullet under improve patient safety or population health? Is that what you’re doing, adding another bullet under improve patient safety, saying something like enhances public health and population health?

MS. GREENBERG: That is what I’m saying. It should be– we don’t want that dichotomy between healthcare and–

MS. GOSS: I think we need to do this iteratively in the sense of let’s just take the fodder we have so far, put it into a vision or a principle one and then go back and iterate on it separately because we’re trying to do too many things at once and not really getting through any of these efficiently.

MR. SOONTHORNSIMA: You are right. We’re not going to word-smith right now, but we’ve got one major point is population health, and we’re on board with that. We’ll come back and word-smith it later. Let’s go to our next one, eHealth transformation establishes and articulates a roadmap, short term and long term, principle, yes? You have to have– the point here is that we have to keep the roadmap alive and well.

MS. KLOSS: It suggests to me that we are not looking at each change in isolation.

MR. SOONTHORNSIMA: So Walter and Michelle, we just added a bullet for population health enhances or enables population health. That’s a vision. Let’s go to the next one–

MS. KLOSS: I think what we might want to do on that previous one on the roadmap is align it to the roadmap so that we’re considering both the policy and regulation be implementation issues and evaluation, are measures of success. I think that’s the breakthrough here.

MS. GOSS: I heard two parts there. One was to make this set of work linked to the larger committee’s effort, and then two, the measurement aspect. Is that what you were trying to call out?

MS. KLOSS: When we make a recommendation for something that’s going to be a regulation, we need to think about the roll out implications and the measures of success at the front end.

MR. SOONTHORNSIMA: That is why we said optimize and achieve benefits iteratively.

MS. GOSS: She’s more specific, and I think she’s right that we need to make it–

MR. SOONTHORNSIMA: But is that not covered in the previous slide, that stakeholders define. I’m sorry, the first one, clearly defined concepts, objectives, and measurable results.

MS. GOSS: I am hearing there are two parts here. It’s one thing to put it in the visions. It’s another thing to have specific principles if you’re going to do it.

MS. KLOSS: Have it be a principle that we’re evaluating–

DR. SUAREZ: My sense is that this bullet that I’m reading, eHealth transformation establishes an articulated roadmap, I think that is not really a principle for purposes of evaluating standards. The principle will be eHealth changes our plot in a roadmap of short-term, long-term changes. That’s the principle. eHealth changes are appropriately plotted, placed, inserted, incorporated into the roadmap of short-term and long-term changes. That to me is more the principle. This statement reads more like an overall vision of the larger roadmap that we’re developing.

MR. SOONTHORNSIMA: We will come back and word-smith this. Is that the concept?

MS. KLOSS: Yes, and then to add to what Walter said, that process of plotting considers not only the standard itself but its implementation and evaluation of impact, because if you remember on that roadmap we had three blocks, the development of the requirement, the implementation path, and the evaluation.

MR. SOONTHORNSIMA: Okay, quality and value evaluated.

DR. CHANDERRAJ: Doesn’t that duplicate the fourth one, allow for course correction?

MR. SOONTHORNSIMA: I am not sure it does. I think that’s a result of if you do this well, that’s the next thing you do. If you anticipate, evaluate, then you course correct as appropriate when you see some advances in technology or process or even policies. We worked this one to death, so let’s move on. Keep in mind, testing is assumed. It’s in the map itself. If you look at the map, when we’re talking about effective–

MS. KLOSS: We have to define those a little better.

MR. SOONTHORNSIMA: In the roadmap– I hate to use the word “assumed”, but it is methodically laid out. That’s why you roadmap these things so that we allow time for effective testing to your point. If you want to put it here, we’re fine. Otherwise it becomes an implementation guide.

MS. KLOSS: Just drop it in parentheses so we don’t forget it. I think that’s a really good point.

MR. SOONTHORNSIMA: Okay so this is still principle. Let’s go to the next one. eHealth facilitates effective, purposeful data exchanges and uses that to empower and inform healthcare and public health objectives. That’s what we talked about earlier. Is that enough because we already talked about public health in here, or would you like to expand it, Marjorie? Instead of a having a separate bullet that’s already included, public health is already included there, population health.

MS. GREENBERG: I still want a bullet under improve patient safety that’s improves population health, but I won’t beat it. I just want those together.

DR. SUAREZ: I agree with that. I think it should be under improve patient safety.

MS. GREENBERG: Just another bullet now, like you had it originally and not capabilities, health, and then this other one down here is fine.

MR. SOONTHORNSIMA: Okay, that is a vision. Last one, eHealth uses effective data management and stewardship practices to gain stakeholder confidence and trust. Done. That was a quick five minutes. So there was a conversation– thank you very much, that was very productive for us to do. Let’s talk about the scope, and this is a much bigger topic. We’re not going to edit this. It’s a contextual conversation. Do we want to limit the mentions or components of our roadmap? For example, ACA, administrative simplification, population health, and then HIT. This is really the meaningful use adoption. Let me restate the items.

MS. GOSS: Are you asking whether or not the left side options are the right ones–

MR. SOONTHORNSIMA: That’s right, the scope of our roadmap, should they include those four?

MS. KLOSS: I think one of the things we talked a little bit offline yesterday about is that we could begin the development of this roadmap with the administrative simplification block and use that to test the mechanisms and do that because that reflects the core work. Then when that gets more fully developed and we see that this is working, then move to the other blocks and where it’s important, engage other stakeholders in developing with us those other blocks.

DR. SUAREZ: The scope in my mind is health IT standards and health IT standards in poorer domains, administrative, clinical, public health, and personal health, consumer health, so health IT standards around those four areas. Now, the sources of the requirements are going to be a variety, and you listed a few of them, so HIPAA, ACA, HITECH, FDA regulations, there are a number of different sources that are to be plotted in the roadmap, but the scope really should be defined as health IT standards in those four domains, administrative, clinical, population health, and consumer, personal health.

MR. SOONTHORNSIMA: So let me restate that, so HIT standards as a key– the scope of the HIT standards include admin simplification, public health–

DR. SUAREZ: No, it is administrative, clinical, population health, and personal health. In other words, administrative means the administrative processes and transactions. Clinical means the clinical messaging and exchanges. Public health is the public health standards, and personal health means the personal health records and requirements around health information exchanges with consumers.

MR. SOONTHORNSIMA: I agree with you. The question I have is I can see clinical, administrative, and public health, but personal, that’s the one that I’m challenged–

MS. KLOSS: I think that is a future area that–

MR. SOONTHORNSIMA: Yeah, we can grey that out as a possibility, but there’s nothing there for us to tangibly work on right now.

DR. SUAREZ: Remember the roadmap is not– all the things that are going to be plotted in the roadmap are not things that we are all the time responsible for and the only ones responsible for, but there are standards for accessing and disclosing health information to consumers. –

MR. SOONTHORNSIMA: I don’t disagree. That’s why we want to gray that one out.

DR. SUAREZ: They’re kind of standard requirements, because really the scope is health IT standards, but really what that’s plotting is the requirements for implementing those standards. That’s what is plotted in the roadmap, and the requirements come from the various sources, HIPAA, Affordable Care Act, HITECH, and in those requirements health IT standards flow through those four domains.

Now, health IT standards are factorizing four general categories, which are messaging, vocabulary, terminology, transport and security, but that’s a different way of categorizing standards. I’m just talking about what gets plotted in the roadmap would be the health IT standards requirements of these four areas.

MR. SOONTHORNSIMA: Agreed. Walter, one question we heard yesterday is, who the audience is. Is it the Secretary? Is it our subcommittee? Is it our national committee, the industry? That was Justine’s question, a very good question, because that’s how we would frame the scope of how we would use this roadmap. I’ll pause right there.

DR. FRANCIS: So one of the things that came up yesterday in the discussion of accounting for disclosures, this was a point made by Linda, is that as we roadmap, issues like audit capability and whatever kind of information to consumers about access should be included in the roadmap, but Linda’s suggestion was further down the line. I just want to point out that it’s not clear to me that personal health is broad enough in scope.

I think it ought to be something like consumer-facing issues that includes a variety of ways that consumers might be contacted, want to interact, everything from access to records, communication with providers, and I’m not saying it’s something that gets filled in early on there, but I think that the idea of standards with respect to consumer-facing issues is the way that ought to be framed.

MS. KLOSS: I think that is a good suggestion, and an example of a potential convergence is privacy was thinking about let’s study some emerging issues for example, patient-generated data, which is becoming certainly much more of an issue with regard to management of content in electronic health records. If we did something like that through privacy then we begin to identify issues that then could– that we could think through from a standards perspective.

DR. SUAREZ: I thought we agreed with that. The term we used, personal health, was to try to capture exactly what Leslie just said, that is all the standards to used by the system to interact with the patient and the consumer, specific consumer engagement, health information technology standards are consumer facing, all those are the ones that I would think…

MS. KLOSS: The electronics on your refrigerator–

MS. GOSS: Looking at the environmental issues if you make it consumer-facing, it gives you a huge bucket–

MR. SOONTHORNSIMA: Okay, so we have it. This is the scope, health IT standards, clinical administrative, public health, consumer, patient–

MS. KLOSS: Are we going to call it the health IT standards roadmap instead of eHealth?

MR. SOONTHORNSIMA: That is another point. eHealth could convey–

MS. GOSS: Do we have agreement on HIT versus eHealth in response to yesterday’s conversation?

MR. SOONTHORNSIMA: I like the HIT standards better. Thank you for that suggestion. What do you think Walter, Michelle? The issue is eHealth and again, Justine raised this concern yesterday. It was a very good point. It seems to be all encompassing. We might actually– there’s so many eHealth roadmaps out there. This is specific to NCVHS within the context of these standards that we just outlined. It’s not meant to be usurping anybody’s or all inclusive. Instead of calling it eHealth, perhaps call it HIT standards– I’m sorry, HIT standards roadmap.

MS. KLOSS: The only issue I have is that to call it technology is limiting because, again, we’re advising on information policy, and I would like not to use “HIT”. Health data, or health information standards.

MS. GREENBERG: Because if you get into content–

MS. KLOSS: We’ve got to focus on how we handle information.

MR. SOONTHORNSIMA: If it is technology as a means– that’s right.

MS. WILLIAMSON: Health information standards?

MS. KLOSS: Health information standards roadmap.

DR. SUAREZ: What about vision? Is that health information standards vision, or is it the eHealth vision?

MR. SOONTHORNSIMA: Not eHealth.

MS. GREENBERG: No, I think health information standards vision, which drives the roadmap.

MS. KLOSS: This is great. Now I’m excited.

MR. SOONTHORNSIMA: Let’s stop while Linda is excited. Thank you. We will not have time, unfortunately, to go over our observations from the public health hearing two days ago. Walter, we have five minutes– let’s talk about do we open up the floor? Do we want to talk briefly about our plans for December through February.

DR. SUAREZ: Yes, just one minute to say that I think what we need to do is plan for what would be the winter 2014 conference calls period. My suggestion is at least we plan to have one conference call in December and then two in January, one in the early part of January and one in the late part of January, and then one more in February before the full committee meets, so four conference calls about an hour and a half each. What we’ll do is work with Maria to send out possible plans and all that for the subcommittee.

MS. GOSS: Walter, some of us may be running into conflicts to support the larger framework conversation that emerged from yesterday, so there may be some need for reconciling meeting dates and availability considering–

DR. SUAREZ: What we’ll do is make sure that Debbie and Maria are working together in terms of scheduling the various follow up conference calls. We’ll try to make sure that we don’t hit the same date and time for–

MR. SOONTHORNSIMA: We are going to use our time very wisely. We’re going to time box our conversations in these calls as we tried to do, make sure the calls are very productive, but you’re right, we need to balance our efforts with the other subcommittee’s crosscutting work, particularly around that framework. Very good. Thank you very much. Now, it’s time for public comments, if any. Hearing none, Mr. Chairman is here. Thank you, Walter.

DR. SUAREZ: Thank you for the meeting. I think this was very productive, and we’ll look forward to working with everyone over the winter.

MR. SOONTHORNSIMA: Thank you very much Walter. Thank you Michelle.

(Subcommittee adjourned at 9:28 a.m.)