[This Transcript is Unedited]



September 26, 2007

Crown Plaza Hotel
8777 Georgia Avenue
Silver Spring, Maryland

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 180
Fairfax, Virginia 22030
(703) 352-0091

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

DR. CARR: I’m Justine Carr, Chair of the Quality Work Group.


DR. CARR: Our agenda today is item number one is to take another look at the letter. Susan made some revisions and we want to see if that’s okay. I would say step two is to think about what is the next step in terms of having done this piece of work where do we go from here. Item three will be to look at the update of the May 2004 NCVHS Quality Workgroup Report and what’s happened since 2004, so lets see, before we get into the changes, any additional thoughts about the letter and the discussion yesterday?

MS. MCCALL: The only comment was that we had not explicitly surfaced an intent which was to have us become merged with what could be coming out of the AHIC Quality Workgroup and that is probably a good thing if it in fact is still our intent to talk about the what’s, the why’s, the how’s.

DR. CARR: The logistics are in the hands of Jim Scanlon and Simon Cohn. I think perhaps it is errant to say is there synchrony between what is in the letter – the letter representing the current state of public reporting and the AHIC Quality Workgroup putting together the future state of quality reporting and are there any disconnects or synchrony’s or things that are in here that ought to not be in here?

MS. GRANT: With regards to the current state, I think, obviously based on the testimony that you received it sort of covers where things are right now. As some of you may be aware, AHIC Quality Workgroup sort of put forth their first set of recommendations to the Secretary back in March. Some of those are still in the process of being implemented, not everything was finished sort of this past six months so it will go into next fiscal year. So the next set of recommendations we have been working on all summer and now we are just starting to sort of finalize the topics and then we will draft the language. Initially they were supposed to go to the Secretary in November but we sort of felt like that was rushing things because it really would not be enough time for the Workgroup to sort of work through them so the idea is that the next set of AHIC Quality Workgroup recommendations would go to the AHIC in January and sort of the focus of this next set is around that future state and longitudinal sort of data management and data analysis and what is really needed to take us from where we are today to the point where we can do that. So some of the topics that have been tossed around have been this notion of a minimum data set, patient matching, incentives, so that is sort of where the Workgroup is now in terms of agreeing on the topics that they want to advance and drafting the language. So in terms of where this letter is in line with where the Workgroup is I think that this document really focuses on — where as the AHIC Quality Workgroup is focused on how HIT can enable measurement, so I think they are actually sort of complimentary. So I don’t – I have be very honest, I had a couple of other projects to work on last night so I have not really compared this in detail to where that document is but –

MS. MCCALL: But I’ve been reading that and I assuming that very much should influence what we’re doing. And the reason I bring that up is there was a comment made yesterday afternoon about the chemical level of action-ability here and we had, in anticipation of being able to find a way to merge these streams to create a double helix, I think that because we were anticipating that we kind of slowed up on getting really specific and yet if we weren’t going to do that then I would suggest that our path is in fact to become that specific so that in the letter we can recommend –

DR. CARR: That’s a perfect segue way actually, I think maybe what we could do is just talk about the changes we made based on the feedback yesterday and then get to the recommendations and think about is it actionable language and who might be the actor. Because we don’t have infrastructure printing and copying here, we’ve done a bit of a mix and match. In your packet you have the letter as it appeared yesterday, and Susan has distributed our handiwork from the computer workstation out here where we made revisions to page one and to page four really, but we’ve added page four and five so you have all of the recommendations. Let me just say, as you can see we were stressing the ink supply of the thing. Susan do you want to just take us through the changes that were on page 1?

MS. KANAAN: Yes, We removed ‘hospital’ from the title, and we added a sentence under “scope and purpose” about the generalizability of the themes beyond which is consistent with taking hospital out of the title.

DR. CARR: Will you read that please?

KANAAN: Yes. “Although the hearing testifiers reported on hospital data, the Quality Workgroup was attuned to themes that are generalizable to quality measurement in an array of settings.” Then there was another point which folks wanted made which we made in a fairly straightforward way when there is once again a reference to the hearing we said ‘quality measurement falls under the treatment payment operations roles permitted by the HIPAA privacy rule.”

DR. WM. SCANLON: Why is it they wanted this?

DR. CARR: Well Leslie was the one who raised that given all of the attention to secondary use that this stands out, it seems to her, is this permissible use and what’s the evidence that this is permissible use? Maybe we are not altogether clear as to what we meant here.

DR. WM. SCANLON: The term measurement is a much broader term. It is sweeping.

MS. GRANT: To the extent that this is relevant, I think that some of questions and comments that I have spoken to Kelly about regarding what was in the NCVHS secondary uses document was sort of making this kind of statement and sort of laying out there what is or what is not from a quality perspective –sort of quality proven activities measurement reporting what is or is not allowed and permissible under PPO, so I think this is helpful and it is clear, whether or not it falls in the right place but I can tell you that this is certainly something we were hoping would come out of NCHS.

DR. CARR: Yes, and I think we heard that but I think it is sort of a disclaimer-that is how I view it when we are talking about this kind of measurement, its part of PPO and its not going beyond that.

MS. KANAAN: Is there a more graceful way? I’m not – what’s the big point we are trying to make here?

MS. MS. MCCALL: I’m still confused as to the main point. The language and its placement seems awkward and I cant decide if what I am reacting to is its placement in the wording or its concept as being appropriate in what we are trying to cover.

MS. KANAAN: What would be another way of saying this?

DR. CARR: I think the expectation is, and if you were presenting this kind of information based on individually identifiable data that its either covered under an IRB, in other words there is authorization through an IRB or through treatment payment operations.

MS. MCCALL: What we may want to do, if that is what we are trying to say, is go ahead under scope and purpose and create another paragraph short but sweet that essentially acknowledges there is another very important theme and that we would just like – its almost like a for the record – but just to be clear.

DR. CARR: Well the only thing I would say is that given that secondary use – where the workgroup has taken up, I wouldn’t want to go too far out on a statement from NCVHS saying this is what we think because I think there will be more thinking in that other document.

MS. MCCALL: No, Not just what we think but because it is emerging as a very important topic, its important that we acknowledge that quality measurement falls under the dot, dot, dot.

Dr. WM. SCANLON: Part of our testimony was about the age of data which is not operations, in fact it’s a research database, I mean one of the best examples in terms of merging administrative and clinical data. S I just think our concern about quality is much broader than operations.

DR. GREEN: So is it your suggestion to take that on?


DR. CARR: And what would you say?

Dr. WM. SCANLON: Nothing, we should talk with Leslie about what she really is looking for because I think this –

MS. KANAAN: The way I heard the reference to PPO and it was almost like that was a-

MS. MCCALL: You’re absolutely right the age update does not fall under that, and I think its out of scope for this to take that on – it wasn’t addressed in the testimony and we’re not prepared to respond.

DR. WM. SCANLON: I think this is more of an issue to the secondary uses and the boundaries here, for me, I feel most uncomfortable about it – what’s the boundary between operations and research? Where does quality fit because you try to influence quality in both areas and the question is how different are the rules for these two different activities – operations and research –and are they appropriately different?

DR. GREEN: I’d like to flag that.

DR. CARR: I would too. That came up and that really struck a cord with me yesterday.

DR. GREEN: That deemed a social unresolved issue. That would be worth taking up in its own right.

DR. WM. SCANLON: We’re going to get to the recommendations about the research and the common rules when we get back upstairs and I was going to because this is what has been bothering me-

DR. GREEN: From day one?

DR. WM. SCANLON: Well I didn’t know enough on day one to be bothered but somewhere along the course of this, its kind of been my issue – wait a minute, I can come up with a binding operations and use it in that context and then suddenly the same finding is not acceptable to be one to be released under research and then there were certain other things –

MS. MCCALL: I didn’t anticipate because I didn’t know what I didn’t know.

DR. WM. SCANLON: Right, and the Mayo testimony was that they would stop someone who hadn’t anticipated and who had not anticipated and who had not sought permission.

DR. GREEN: I’m quite interested in this also for entirely different reasons and in the spirit for sort of staking out the territory for future discussions – let me sort of use a little hyperbole – there is no difference between research and quality improvement therefore the attempts to distinguish them into clean buckets on which we can base national policy is futile. There are some difference in terms of use and that sort of stuff but when you get to intellectual issues this falls apart and we could burn a lot of calories as a nation and as a committee by trying to create a structure that starts with distinction and then sets up a different rule sets.

MS. MCCALL: I’ll take us back to some testimony that we heard from Brent James and he talked about a continuum building a system. He started by building a system that could only measure accountability and hold people accountable that you essentially painted yourself into a corner and yet if you actually started by building a system that was built to discover knowledge then you could work your way to the other end and that’s what we’re talking about.

DR. CARR: Although he has the chapter here in these Hastings report that I am carrying with me everywhere, about separating out – first let me acknowledge I think you are right, this might be a very good topic that we could work, I mean we would have to work quickly to feed into the secondary use report that’s not called secondary use but I think they would welcome our input of vetting this a little bit deeper. One thing that I’ve seen in a couple of the reports and heard from Mayo is that how you draw the line from one to the other is less of a focus than that you have a structure that oversees the initiative, what you are looking at, how you are doing your analysis and that appeals to me because it covers the risk of inappropriate or inexperienced, or unsophisticated use of the data and not meant to be an obstacle but to elevate the hard work that goes into it to make sure that you don’t have a flawed or incomplete data.

DR. WM. SCANLON: I’m not sure that I will ultimately be in this position, but my one sentence is its an issue of potentially upgrading the standards by what happens on the operations side to make that much less open ended and make it more comparable to the standards that we have on the research side, to some extent you don’t want your risky things or bad things done but now the two buckets for me are operations and research, that’s where the legal distinction comes in and its kind of what it takes to get you into this operation side and some respects get you a certain amount of license that you don’t have on the research side and I think we have to ask ourselves is that right? Is that the way we want this to be?

DR. GREEN: I agree with both of your comments and want to call attention to I think that we as a workgroup need to pay very careful attention to the evolution of the letter that we’re going to be dealing with upstairs around this idea of data stewardship because its possible that there is a convergence point out there somewhere where the ideas of data stewardship and these issues we are talking about now can come together in a constructive way.

DR. CARR: I really think this would be a tremendous asset if we could try to pull together framework of thinking about it and it will bring stewardship to quality measurement and it will create some structure so that it doesn’t feel like the fast track and the rigorous track comparing quality and science.

DR. GREEN: I’d like to ask an operational question here – is your role, and I apologize I’ve forgotten your name from CMS – Bonner – I’m wondering in this line of thinking how we secure interactive participation by CMS and the —

MS. GRANT: Just so I can clarify my role, that might be helpful. Booz Allen supports AHIC Quality Workgroup and as part of that contract, Kelly Cronan asked that I support the NCVHS secondary uses effort but at the same time there had been dialogue between the AHIC Quality Workgroup and this Quality Workgroup, and since I’m here already and I have knowledge of that workgroup that’s sort of why I’m here. In terms of logistics or in terms of how – Justine I think you mentioned that its up to Simon in terms of how we merge –

DR. CARR: Of how the letters go together – we need to get back to how we structure the language on that, I think that will happen. I think Carolyn wants it to happen, everyone wants it to happen, so I am not using my energies to figure out the navigation of who speaks to whom – I’m sure they know all that – I think we will be able to get it there, I’m sort of more focused on the content. Bud, did you want to say something?

MR. KAMBIC: In the hearings, did anybody from CMS testify? Hospital compare, I assume.

DR. CARR: We heard Mark Wynn talk about the premier projects.

MR. KAMBIC: There are lots of different things going on that I’m struck I don’t see CMS mention.

MS. MCCALL: There are actually some attachments that will summarize all of the different –

DR. CARR: Yes, let me give you the summaries.

MR. KAMBIC: I think it is important that the QI/QA program $400 million dollars per year, its probably the principal government program for healthcare quality improvement across all settings and its ongoing, there a lot of – I mean looking at it now as you – IOM did a long report on it and ASPE’s looking at it, the Senate is looking at it

DR. CARR: I’m sorry, looking at –

MR. KAMBIC: Looking at the QA/QI programs so there’s lots of interest in how to use the infusion of government money to actually affect what you’re talking about here. One of your points that I actually very much agree with is with the question of the oversight – the leadership can implement the quality improvement in any organization and we have a couple of programs just starting to begin to look at those issues now in fact the night scope of work contract which will begin in about a year there are leadership assessment tools that the QI are supposed to take to hospitals and look at how these C Suite and the board are actually involved in quality improvement, because if you just have sort of work flow and e-health and so on and there’s no interest at the top and the community perception that the hospital’s doing it which the leadership would take the lead in doing the public relations if there is not this type of involvement, I don’t think you’re going to get the metrics passed the sixty days DR. CARR: We heard that very, very loudly in our afternoon testimony. Let me just speak first to the CMS representation, we looked for a spectrum of types of things so where we could have spent the entire day on the CMS things we really wanted a kind of sampler of things and in the afternoon we heard from a number of places that talked about the effectiveness of their public reporting and what a catalyst it was to organizing the institution, the providers, one or more said its not really about the consumers, its about organizing the providers and the administrative leadership and as we outlined in the letter, the elements that appear critical to have an effective public reporting program and leadership from top down was very much a part of that so we agree with what –

DR. GREEN: We need to get back to the letter. I realize – Debbie, maybe you can help us where – I am very interested in as the quality workgroup moves forward, being very careful to engage and involve AHIC and its successor organizations, and CMS in this discussion if at all possible.

MS. JACKSON: Eyes and ears and people attending the meeting I thought the AHIC meeting as well and I know there is a lot of very loud concern about what’s going on with the successor and the framework of all of that.

DR. GREEN: As an example, CMS ended yesterday at five o’clock was the end of a response period that CMS set up as the successor to OASIS, the data set and document for all of the information that people in long term care are going to skilled nursing home in and out and all that sort of stuff, and when I checked into that they had two comments for the comment period that changes 23 or 24 of the dataset items. When you look at the dataset items its almost like the EHR that you would want for this population of patients to get to longitudinal care, to do the patient linkage over time to track the quality of their care – I mean questions like, did they get any better – I mean horrible questions to ask I mean, did anybody get any better out of this? Or at least you ask did they at least not get worse? I mean this is the dataset that would permit that sort of assessment and it is as if its not implying.

DR. WM. SCANLON: Well, but when did you check because there is the history of comments —

DR. GREEN: September 24th not, 25th, so there may have been –

DR. CARR: Let me just part that comment there for the moment, and get back to the letter – Mary Beth thank you and I’m sorry we forgot to tell you that we were going to start a bit earlier to get on the letter –

SPEAKER: Mary Beth why are you late?

DR. CARR: Yes, two comments – one was even though we only heard about hospital the sense was our recommendations were generalizable so we are taking ‘hospital’ out of the title and adding the sentence ‘although the hearing testifiers reported on hospital data the Quality Workgroup was attuned to the themes that are generalizable, the quality measurement in an array of settings to cover that.

There was one request by Leslie, who is a lawyer, to address the fact that quality measurement where it stood in relation to PPO or to HIPAA and actually as we thought about it I thought – oh, great, it was all PPO but as Bill pointed it we heard about the age cup data which doesn’t fall under PPO so I think our consensus is we’re not going to go there even though Leslie asked that we address it. That the secondary use group is taking it up and I think it would detract and distract to try to address it in this setting but we’ll see what the committee says.

So I think most of you have the changes on the recommendations on page four so under recommendations we have added a sentence – NCVHS recommends that the department initiate and/or accelerate actions as outlined in the recommendations below. The question came up yesterday to whom is this directed and what can they do. So Susan and Marjorie took a look at this; a couple of other things we wanted to make sure we acknowledged HITSP, the work of HITSP and AQA and so as you see added on recommendation two – working with HITSP support the standardization of specifications as begun with NQF. Under number three, working with HITSP and AQA to find a course set of measures; and recommendation five we are going to reference – presumably will pass – the standards and security letter today that supports moving forward with ICD-10.

MS. KANAAN: Justine, excuse me for interrupting but I wonder if we should have said specifically what the letter was about – it was about the 5010. Do you think we should add that or is it enough just to refer to the letter?

DR. CARR: Let’s look in the secondary use thing because we refer to letters there and whatever we do there we should do here. Let’s take a look at that.

Number seven we say ‘provide and encourage the provision of incentive supervisors’. I’m not quite comfortable with this yet because I’m not quite sure who is doing the encouraging, providing, and accelerating and I think that’s where we are stuck a little bit – but if this were a letter to the Secretary – let’s do some scenarios – if this were a letter to the Secretary what would be the language that would appropriate on these recommendations?

PARTICIPANT: I’m sorry, say that again?

DR. CARR: We’ve written this sort of as what we think ought to happen – the generic universe, these are motherhood apple pie kind of things, how do we make these actions items so if they were to go to the Secretary that something could be done? And let me just say that the caveat is a lot of it is underway. I think the things that are-

MS. FARQUAHR: I think part of that is too with regard to the seven provide incentives, you can put something like Federal Government should encourage incentives and maybe State players can do that too because some of them are starting to do the paper performance.

DR. CARR: So does that mean they pay or do they ask payers to pay?

MS. FARQUHAR: The Federal Government is paying right now. CMS is doing the paper performance and I know for a fact Maryland is in the process of doing something too so and several others are doing that so you might want to say Government, local or whatever, something to that effect.

DR. CARR: So Bob, in terms of CMS or something like that would this fit – I know Paul Tang is a strong supporter of this, that as we are trying to encourage adoption and there are a lot of financial challenges early on but if there were incentives it would perhaps accelerate.

MS. MCCALL: Do we need to say something about continuing to encourage because it sounds like it is already –. Would we then say acknowledge those parties who are doing that work already, do we need to say continue to encourage and expand?

DR. WM. SCANLON: There is an issue in terms of this, this isn’t only reporting, this is not pay for performance but there is an issue with reporting in things like state of authority. Right now we have hospitals, physicians – there isn’t a statutory provision that – where there is a change in the Medicare payment if you don’t report quality information and –

PARTICIPANT: What about –

DR. WM. SCANLON: No, there is a physician initiative too – physician quality reporting initiative.

MR. KAMBIC: With hospitals its actually in effect, with physicians I think there is still a question –

DR. WM. SCANLON: I think its an issue that if you don’t report you don’t get paid a bonus.

MR. KAMBIC: That’s a physician quality reporting initiative.

DR. WM. SCANLON: Right, so they’ve got time limits so there is an issue of —

MR. KAMBIC: That is because physicians are participating in that so it doesn’t apply across the board. I think we need to be clear. Almost all the hospitals are in the hospital quality monitoring.

DR. WM. SCANLON: Right, they all

MR. KAMBIC: But for physicians, its sort of a voluntary system.

DR. WM. SCANLON: Hospitals are voluntary, too.

(Simultaneous comments.)

DR. WM. SCANLON: oHThe physicians we don’t know yet but the assumption is that the money is so small for many practices, they are not going to – but the bigger point is these are not within the problems of CMS necessarily, it would be hard to think about how do they change the payment system without the statutory authority to do so? Right now there is pending an issue of whether they are going to convert the paper reporting on the hospital side to a pay performance and there is a report to that effect that is in the department that has to go to Congress and it has to be legislated, it can’t be done just by regulation. I think that would be – there has been some imaginative use of demonstration authority.

DR. CARR: We have the demonstration, we talk about the premiere demonstration project we have here.

DR. WM. SCANLON: There has been imaginative use of demonstration authority which is causing some people concerns about whether or not the demonstration authority is being exceeded and whether we are making statutory changes without going –.

MR. KAMBIC: I could agree with that.

DR. WM. SCANLON: So we are not proposing that’s the vehicle here, there is the issue in terms of incentives. Medicare is obviously a great potential vehicle but its going to take Congressional authority. In our secondary uses report I remember writing words saying, “seek legislation”.

SPEAKER: Seek legislation for?-

DR. WM. SCANLON: To do something I can’t remember what.

(Simultaneous comments.)

DR. WM. SCANLON: Seek privacy of legislation. This would be ane issue that they would have to seek legislation to do incentives.

DR. CARR: So how do we feel about this first of all? Do we feel that is the message we want to send?

DR. WM. SCANLON: Just to give a bit of background, the idea of reporting for quality is regarded in the Congress as an intermediate step to pay to performance and it was if they wanted to do something but didn’t feel ready to pay for performance and so they did pay for reported. When I say they didn’t feel ready there is also the issue of what kind of resistance you’re going to get as soon as you put an incentive team in place and a reporting meant that virtually all hospitals are participating in and all will be getting the same reward. You move to the premier situation and you start dead winners and losers.

DR. CARR: Well, I think the issue they are saying, paid for reporting elements from your electronic health record?

DR. WM. SCANLON: The issue is that the pay performance proponents may feel that its undermining them at least that’s how-

MS. FARQUHAR: Its gone too far, is that what you are saying?

SPEAKER: No, I hear pay doing less – that’s the issue.

MS. MCCALL: I would support something that – here is the problem that I see is that you have to know before you can incent, so to me reporting is necessary but not sufficient. So but you have to do it, you have to get it under control, you have to develop some insights into what actually has an impact, and then we are in a position to actually wrap incentives around that, to try to encourage or discourage different things but right now it is one big lump and so I would support putting something in that acknowledges and ultimate link that report is not the be all, end all, but I also don’t want us to undermine the fact this is an absolutely critical step – that without it you cant jump immediately to incentives because then you are just incenting whatever you walk by and see good, but without that kind of rigor of having spent a lot of time trying to understand it.

DR. GREEN: I realize the details are important but our heading is our key message, our position is that we now know our infrastructures necessary for this are frail, fragile, and nonexistent and that 7A, 8A and 8B are some specific things that –. Isn’t our real messages that you have to build this infrastructure for quality reporting before you can do things like pay for performance, and I feel like we are sort of losing that key point.

DR. WM. SCANLON: But that he same time there is some potential argument that we’ve already managed to get this reporting because in addition to the hospitals we’ve got the health plans that are submitting their heedis statement and what we’ve done in both of those cases is we’ve set out a requirement saying we want you to give us this data and they’ve found a way – whether they are coming from an electronic record or what – we don’t know, and in some respects we don’t care, and that’s kind of where we are today, but the issue for the future is how can we enrich the data that we get in a way that’s not so burdensome that the plans –

DR. CARR: I mean we do care about the burdens.

DR. WM. SCANLON: The providers are going to – might be a strong resistant force.

MR. KAMBIC: I think this is a critical point and we’ve discussed this a lot up at CMS, the question is do you want to gather quality information from what you’re calling the National Health Information Infrastructure or are you going to have the clinical data and the claims data all mixed up and moving over the web or are we going to have as we have now – independent silos collecting hospital quality on hospital care, nursing home quality on nursing home compare which is entered independently of the record by some data entry person somewhere so adding an extra step. I think the vision for the future is to grab the data out of the networks and I think I have not been involved enough to be able to read the letter to see if that’s clear but you might make those points – make a distinction between quality data gathered and, to me this is going to take years – yesterday somebody mentioned 2013, this is going to take 25 years before we actually get a functioning EHR and I’m actually pushing my horizon up. But in the mean time I think we don’t want these quality silos comparing nursing home compare and you may eventually have a physician compare somehow or other with this quality reporting initiative, but I think it’s important to make those distinctions.

DR. CARR: I think that what we heard and what we talk about in the report is that there is this hybrid currently, that there is administrative data, there is administrative data enhanced by clinical lab present non emission kinds of elements, and there are also nursing measures about safety and that we’re getting it but the burden of getting it is quite high and because its all the different ways you’ve said – someone does a chart review and enters it, maybe sometimes it’s a byproduct of electronic health record so we say here is the hybrid state and we’re going to be there for awhile so what do we want to do about that? So there are a couple of things, given that everybody is not going to have an electronic health record for a while, can we enhance our utilization of the administrative data and do risk adjustment to do more fair comparisons and better understanding, and then can we promote reporting of what you have because that organizes places. Then looking ahead we think about building electronic health records so that the data becomes a byproduct of the work.

MS. MCCALL: Lets go back to recommendation seven because I think this is how we got here. Which is do we need to get more specific – does it lack specificity if this is going to be a letter and kind of on the who, that was one issue, and the second was do we need to say something that makes a link to pay for performance?

DR. CARR: I think the point that I heard was true, we heard about the one pay for performance thing and the absence of risk adjustment was a consideration that they had and they felt that it penalized them severely so I don’t we are in a place to make a recommendation about pay for performance, I think we are here saying here is the current state, what’s good and what needs work and I think our recommendation should be how do we make the current state more usable.

MS. MCCALL: Maybe the way to do that, we already say it at the end of the sentence of proven utility and what we heard testimony on is that part of that utility is in support of pay for performance as well as a whole host of other things. So, I think that somehow we, if you incent reporting, then somehow you undermine incentives for performance, I’m not willing to buy that, I think one begets the other or can, and I think we’ve said it here but we haven’t been specific, utility across an array –

DR. CARR: SO what would you recommend, what would you say?

MS. MCCALL: That’s a proven utility across an array of uses. It’s a proven value.

DR. CARR: Clinical data of proven value across an array of uses. Does that get to what you’re talking about Bill?

DR. GREEN: When we start using language like that given the very small list.

DR. WM. SCANLON: Well it holds down the burden of reporting.

DR. CARR: Provides and encourages provision of incentives to providers and health plans for reporting quality measures to include additional clinical data of proven value across an array of settings.

I think we are saying two things here.

DR. STEINWACHS: When you look at the background that builds up to this the justifications for incentives are to offset cost or to get behavior change or to encourage EHR?

DR. CARR: To encourage because what we are saying –

DR. STEINWACHS: The only reason I am saying anything is you lead in with EHRs and the burden of collecting and then there are others who would argue that part of this is the behavior change issue – independent from all those things and I think it would be useful if there is a message you want to give to talk to – and it doesn’t have to be imbedded in the recommendation, it may be in the context that leads into –

DR. CARR: This blends two thing, one is that we heard the addition selected clinical elements can enhance administrative data and the second is those clinical elements may well come from electronic health record and therefore it promotes electronic health record.

DR. STEINWACHS: Is there anything that can be said that if you do it through electronic health record and they get more reliable and better quality because abstracting can induce errors – I mean abstracting does increase error rate.

MS. FARQUHAR: And so does putting it from the nurses point of view, I can’t speak for physicians who never make mistakes –

DR. STEINWACHS: I think there is a general sort of thing that incentives are useful and you could get agreement on but you as a way of background some might argue that some of those might be directed at some of the pieces to help the system change process otherwise a lot of places will just continue abstracting, why do it differently?

MS. GRANT: Justine, this sentence included additional clinical data, is it only clinical data that is going to come from a EHR versus supplementing it with lab data or pharmacy data?

DR. CARR: I think what we heard its really both, I mean this is a hybrid as I retrace version three through seven of the letter followed by versions 14 A thru Z, this comes about from this Paul Tang in here pushing electronic health records but also is the remarkable refinement we heard of administrative data. Its appealing because as we are relying on administrative now and for the near term, we want to make it better so clinical elements, whether they are abstracted or electronic, still will make the data better. So it is saying two things.

MS. GRANT: I just wanted to make sure that are we just saying the clinical data that comes from EHR or is it sort of electronic data regardless.

(Simultaneous comments.)

DR. CARR: And I think we have as one of the research things how do you –one of the research agendas is – one research thing is accuracy, number six, accuracy and validity including risk adjustment of administrative data by the addition of clinical elements. That’s a research project. Then down here under performance measurement we talk about other research which is the core measures, the prioritization of target areas, modification of measures to align with evidence costs, benefit of measurement, and criteria for retiring. Somewhere in here, Mary Beth, I thought we had research about how do you – you may have an electronic health record and you may have administrative data but how do you make those go together to generate a report? Did we talk about that? Early on I thought you said Ann Alex Hauser had –

MS. FARQUAHR: Ann Alex Hauser and AHRQ has several initiatives, they put out an RFP to do just that to encourage the sates to gather the data elements, now how they are going to do that is kind of like the wild west – they are still playing with it.

DR. CARR: So I think we have to think about how macro and micro we want to go and I think we don’t want to go so micro that we get ourselves tied up.

MS. MCCALL: And that to me to go micro is one of the values of linking to the AHIC Quality report because that’s a lot about the technical how and we started here saying if this were a letter to the Secretary how do we add specificity? And yet if its not going to be – do we know the answer to that because I feel like we have two paths to it?

DR. CARR: It is, according to Mike Fitzmaurice in a unified way but you raise an interesting point because maybe because this is a conduit going through AHIC Quality Workgroup who is working on the electronic health record, maybe the message is as you get electronic that’s good, in the beginning you will have lab data work with the administrative data because that’s the hybrid world and if you can find a way to link your initial albumin with your initial coronary artery bypass graph you will then be able to do risk adjusted outcomes. So maybe that’s really – are we saying that clearly enough? Do we agree that might be one of the things we want to say, because Carolyn was a lot about what is the current state in this hybrid world and the fact that she wants it linked to that, there should be some crosswalk of why is this important in relation to that. So as we look at that – first, any comments about that? Great, we all agree – lets look at this. Just kidding.

DR. WM. SCANLON: I don’t think seven is clear enough in terms of trying to encourage EHRs because we in some respects can do different thing by saying, okay, give us these measures, and we can do it – think of the ultimate incentive being you don’t get to participate in the program unless you provide the data. I mean forget about payment – yes/no you’re in the program or you’re not and to a degree that’s what happened with the health program. There is not a provision to pay them extra when they give data that is a condition of participation and this has actually been talked about in other contexts, particularly MEDPACK about how do we encourage EHRs, while we require the providers to or the plans to do something that would be so onerous that without an EHR they are going to go run and get one. That’s essentially been considered as a tactic as opposed to saying we are going to build into your payment an allowance for EHR.

DR. GREEN: Do we deal with that in number nine or do we deal with that in number seven?

DR. WM. SCANLON: It is unclear what seven is going to do in terms of infrastructure.

DR. CARR: So what we want to say is we’ve heard about the burden of data collection and we heard

DR.WM.SCANLON: We’re dealing with the two, right?

DR. CARR: Two?

DR.WM.SCANLON: We want to standardize.

DR. CARR: It’s a theme –

DR. WM. SCANLON: So the issue of burden was five people are asking me for this measure and five people are –

DR. CARR: You’re right, and we’ve addressed that but if you think about again about performance measurement reporting infrastructure there is two parts of it; do I have what I need and how hard is it to get what I need? So do I have what I need? Now we’re hearing to do good reporting it is good to have some clinical elements, and where are they? And then the question is how do I get them? I can still do chart abstraction so we could take everything Ann Alex Hauser presented and do that today, you know get the albumen and whatever the other things were and put that with the data and we would have better data and if we could get that electronically we could have better data in shorter time with less resource expenditure.

DR. WM. SCANLON: But what Ann presented also was in the context of a very incremental step relative to where we are today because for DRGs we already have to know about diagnosis and so present on admissions is kind of a tweak, its not a new abstraction and then secondly the lab data are potentially the furthest along short of having an EHR but still being automated, and we have precedent, we have AETNA gets us lab data, at least they used to before they bought US Healthcare, they used to have lab data on every one of their beneficiaries every time a lab test was done. The thing is those were not big leads and we’re talking about in some respects trying to encourage big leads in terms of capacity.

MS. MCCALL: I think what we are trying to encourage is fly wheel effect because I don’t think there is going to be any one magic moment

DR. STEINWACHS: You are going to have the spontaneous fall in love with my reporting system.

MS. MCCALL: No, but I think its because doing precisely the things you are talking about whether it seems like a tweak to use diagnosis or the labs that are there that by continually pushing on that flywheel that we can get to the things that are today are these leaps – and yet there are two ways to cross a cow – one jump or two.


MS. MCCALL: I guess we’re just not going to be able to do that.

DR. STEINWACHS: Let me try one idea out on you just on the recommendations, it might be worth as you take this to AHIC having a little end summary paragraph that brings the key threads back together but it seems to me if I am listening to you correctly this morning, there is a series of burden factors that the Secretary could more immediately address and you’ve got that spread across here, some of them they deal with single set of standard measures, single definition, and those in concept are more immediate. Then there is a series of infrastructure issues that don’t stop – you don’t need infrastructure to do this reporting basically, you can go to the charts, you can pull claims, but it recognizes that the system is at different levels-some very fundamental, some intermediate, some with the idea.

To me some of the messages here, you’ve heard about some places that are doing exciting things on the cutting edge and making a difference and so to me the message is if you want the whole health system to look like these places on the cutting edge, we not only need to address the burden factors which come up most frequently, we need to help accelerate the infrastructure, otherwise you don’t have the flexibility or capacity for doing this in a meaningful, ongoing way.

DR. CARR: That’s a beautiful thing. You were on vacation, we didn’t hear from you.

DR. STEINWACHS: See being on vacation has its merits. I cleaned out the brain cells, wiped out the memory banks starting again,

DR. CARR: Susan, so it would be under recommendations, it would be just before –

DR. STEINWACHS: I would just put a little end summary that says two things – we’ve found a variety of burdens or barriers that could be addressed and the other is infrastructure is key to the long term development.

MS. MCCALL: I like how you separated them out – there are burden factors, things that can be done in the shorter term and then there are infrastructure barriers that are deeper and they have to do with flexibility and capacity. Today there are some delightful writing that talks about artifacts as some handcrafted things. Right now we have artifactural quality but we are not able to machine them out. We need to go from kind of the hunter/gatherer to the machine age and that’s what we’ve been trying to do. We have seen evidence of these exquisite artifacts; they are beautiful, but not able to be done by everybody.

DR. GREEN: You said there are two things? One of your observations that gives I think bite to the recommendations is the statement that we saw examples of success.

DR. FITZMAURICE: And that’s what drives the exhibition to reality.

DR. GREEN: We were tantalized by what – I can still see that guy from Tennessee talking.

DR. STEINWACHS: Larry, we’ll get you your pills.

MS. MCCALL: We are working with Ben by the way, just so you know, Ben Yendel who is actually from Louisville, Kentucky, and the work that they are pursuing, if you think of data as a giant “T” where he has narrow but deep data, then we actually cross it, we pay for about 30 percent of the beds, Humana does, we are going to link the data and try to answer the question – you have perfect quality here, did it matter and so we will see if we get anywhere.

DR. WM. SCANLON: Staring a long time makes you think of different things. I would suggest dropping seven and moving three and four under performance measurement infrastructure and modifying three to include a reference to the EHRs because when we talk about a course set of data elements, we are talking about EHRs, if I understand this right we are trying to create things that are easily retrievable and convertible into quality measures as opposed to having to –

DR. GREEN: Can you say that one more time?

DR. WM. SCANLON: Drop seven and put three and four under performance measurement reporting infrastructure.

DR. CARR: And change three.

DR. WM. SCANLON: This is about trying to make the EHR a tool which allows quality measurement to be much more robust.

Define a core set of data elements to be included in EHRs for assessing quality of care. Four sort of follows on that which is to ensure the HER includes support for capture and import quality measures. We are trying to change the nature of EHRS and that means part of the infrastructure.

MS. GRANT: With regards to number three, and HITSP and AQA and the core data elements, there was a meeting at the NQF on Monday for the Health Information Technology Expert Panel that Paul chairs, and sort of within that meeting there was discussion of three project initiatives that are going on with regards to sort of defining these core data elements and they are trying to figure out how to pull them all together. The high top is supposed to be defining the core data elements. There is an AMA, NCQA collaborative that is all doing a little bit of this, then there is also the quality use case as well. So I don’t know how specific for number three, I am not sure where the reference to AQA is coming from because the core data elements are actually being defined by higher top and sort of the same collaborative and then they are supposed to go to, although I think there is confusion in terms of what HITSP’s actually doing, but they are supposed to go to HITSP then say here are the data amounts/elements, what are the standards that are needed – for the language for number three working with HITSP and AQA we may just need to clarify that.

MS. MCCALL: And then it goes to CCHIT for some –

MS. GRANT: And it will go to CCHIT, I have the timeline, but it would go to them next spring and then eventually the certification for an EHR would be like July 2009, I have the timeline.

DR. WM. SCANLON: I would agree, I guess my concern in looking at these references to organization was given how much shifting goes on, given what we heard about the budget yesterday and the AHIC transition, its kind of like what’s going to be here in 2009?

DR. CARR: Exactly, and I think to that if we say NCVHS recommends the department initiate and or accelerate actions it recognizes that these actions are under way without assigning them to particular organizations.

MS. KANAAN: So do you want to take out all the references to — even number two as well?

DR. CARR: Yes, we probably want to do that. I think what I would like to do is get to the summary statement that Don suggested because I think we want to get that and then want to rearrange these recommendations to kind of punch out what we are trying to say. Then I think we can go back and say do we have the right verb, is this a secretarial verb or a committee verb?

DR. WM. SCANLON: Still think we should take out organizations in question four whether we should start with ‘work with’ or ‘ensure that’.

DR. CARR: Right, so I think that we absolutely need to get our language right. The first thing we want to do is improve the conceptual thing we have here and then get the language right. In terms of the do you want to just dictate, let’s start with what you were saying Don, and let us see how it goes.

DR. STEINWACHS: The best part of what I said was “In summary, these hearings and the experience of different organizations demonstrated the potential and public reporting and its impact on quality.”

MS. MCCALL: I would in there add in there something about we saw examples that demonstrated that potential.

DR. CARR: And supported examples — that supported the –

MS. KANAAN: How about the hearing offered examples or presented examples of ?

DR. CARR: So what’s the sentence that you that you have so far Susan?

MS. KANAAN: The summary of the hearing presented examples of the potential of public reporting and its impact on quality.

DR. CARR: The hearing demonstrated testifiers-

DR. GREEN: I would say very succinct straightforward on the basis of testimony we concluded that there is progress and great promise in this area. Something like that. Much more can happen but we actually saw concrete progress that should get people in gear to do public reporting, get the data right, get the infrastructure in place and keep going.

MS. MCCALL: Then we can say what we also saw, and still exists are tremendous burdens as well as infrastructure barriers to make these examples–

DR. GREEN: These are going to be widespread —

DR. MCCALL: To make these examples of success and progress uniformly.

MS. GRANT: To the extent of your point about the examples, the requirements analysis are sort of the background document that the Quality Workgroup has been pulling together to set up these next set of recommendations details out two case studies – one is Geiserger(?) and one is Inner Mountain – as sort of exemplifying these are where we would like everyone to be so if its helpful to share that language with you, I don’t know if it would be worthwhile to sort of include some examples of what you mean by –

DR. CARR: I think we want to stay with what we heard and then the linkage to the AHIC will be besides this, so I think we want to stay with the testimony; what I have is “in summary on the basis of the testimony we concluded that there is both progress and promise in public reporting and quality improvement”. In quality public reporting?

DR. WM. SCANLON: Use public reporting or quality improvement – they know what you are talking about.

DR. CARR: “In using quality reporting for quality improvement.” “We also saw the continued existence of barriers to what an infrastructure –“

MS. MCCALL: What I said was, we also saw examples that we still have tremendous burdens as well as infrastructure barriers. There are a variety of burdens, but yes that would be included and that a number of burdens and infrastructure barriers still exist to making what we saw in those examples much more ubiquitous.

MR. KAMBIC: Institution specific as Don said. In other words, the provider has to spend extra time, resources, money on providing this silo quality data infrastructure issues are sort of endemic or pervasive – they are related to the National Health Information Infrastructure, the RIOS standard and so on, things that we could be concerned with on a national basis. So I think dividing into those two separate baskets is useful.

DR. CARR: So we also saw institution specific burdens and endemic infrastructure barriers, is that right?

DR. WM. SCANLON: I think in the summary sentence getting that detail where we haven’t set this up is going to –

MS. MCCALL: I liked what you talked about in terms of burdens and infrastructure barriers and the way that what I heard you say is the burdens are things that are some of them in the here and now, things that you can do around single sets of measures, and things like that regardless of the infrastructure can make life a heck of a lot easier.

DR. CARR: I like what we just heard, I think its consistent, institution specific burdens in data collections and then endemic sort of broad scale infrastructure barriers in transition – in the absence of electronic – I don’t know what we want to say.

DR. STEINWACHS: Well the infrastructure in both system wide and institution, it cuts across.

DR. GREEN: I like that its infrastructure burdens at the local and national levels.

MS. MCCALL: I would even say not national but kind of systemic and system wide.

DR. CARR: And systemic infrastructure burdens, institutions specific burdens and systemic – institution specific burdens and systemic infrastructure burdens.

MR. KAMBIC: Look, I am good at wordsmithing, I can do this next week if you will allow me, I mean can volunteer for this kind of stuff.

DR. CARR: The only is that we want to get this passed today by the Committee. We are going to get your input that we get this all done, we’ve got plenty of time – 15 minutes, we haven’t even got to the rest of this but I think this is important, I think we are very close.

DR. GREEN: I think we are close enough that we should consent as a Workgroup to adding the summary paragraph before the recommendations that this is set up the way Don said, and make the moves that Bill suggested and call it a day.

MR. KAMBIC: And everything was subject to the executive committee word smith.

DR. CARR: That’s true, so actually we will be having the opportunity to get your input. So Susan for today then we are going to need to have something to project to the Committee on what the changes are so it would be that summary which goes just above the recommendations, then under the recommendations “NCVHS recommends that the department initiate and/or accelerate actions outlined below”. Then under the recommendations we move data quality from number three and four goes down under performance measurement and we delete recommendation seven, and then we leave the rest. Is that correct?

We are ambitious here, but what do we want to do next? We were discussing in the beginning whether the Quality Workgroup ought to take on giving more input on this secondary use issue over quality versus research, I think that would –

MS. KANAAN: Sorry, just clarify one thing – do you want to remove the references to HITSP, AQA, etc. and how about NQF?

DR. CARR: Yes.

DR. WM. SCANLON: Well, the one NQF reference where we use it as an illustration as NQF has begun, that one is okay.

SPEAKER: I would like to see that left in there. Its not implying a usage.

MS. FARQUHAR: I have one issue to with the public reporting thing here, it says about promoting public reporting of quality as standardized format, state of the art and state of the science isn’t there yet, I would word smith it to the point where its like provide guidance or promote guidelines that can lead to standardization of reporting based on evidence, or something to that effect because we are just not there yet.

MS. KANAAN: What number is that?

SPEAKERS: First one.

DR. CARR: Isn’t that entailed in what it means to promote or are you-

MS. FARQUHAR: I don’t like the term standardized format too good.

DR. CARR: Consistent format?

MS. FARQUHAR: Something like that. Consistent format based on evidence – something like that. Based on the current state of the evidence.

DR. CARR: So would we want to suggest that we spend more time on behalf of the Secondary Use Workgroup on this issue between quality and research. If we were to offer that we would have a kind of accelerated timeline because they are looking to wrap things up by the October. On the other hand I think that we’ve got a lot of thinking and if we could get on a conference call, do some reading, some exploring some different models, and again this Hastings report has some very interesting ideas and models and then come forward with something. I think for the report, we don’t want to be prescriptive and my thinking is that we are going to want to say that there has to be oversight that ensures the integrity, validity and utility of quality reporting similar to how research is conducted, that there are principles and they are followed. We don’t have to say what they are or how they are but that they are.

DR. WM. SCANLON: For me its services in terms of operational activities that relate to quality because its so similar to research but I think the issue is whether there needs to be requirements for operations that are similar to requirements for research. Lets say for some reason this activity would not be called quality; results in the same problem and do you want that happen.

I was thinking the workgroup would take this on but for longer term. I was thinking we may get into the Secondary Uses Report to a point where we leave a question unanswered but we identify the question and we talk about that the Committee is committed to looking at that question and answer it in the future. There are two issues-one is timing, this whole process has been very compressed, and the second issue is that even if you take the collective wisdom of this Committee we don’t necessarily have enough to come to an answer and that we would benefit from bringing in additional people. We would hold hearings and we would try to – I don’t know if at the end of that day we would have a definitive answer either but this is a pretty thorny issue.

MS. MCCALL: This is actually one the more I think, not the only, but one of the most important things that I think we can do as we start to thinking about all these enhanced uses.

DR. GREEN: Would you be comfortable having that thorny issue really important that, can we get that conclusion into the October report as part of the setup? It is so important that this requires further –

DR. WM. SCANLON: I think the October report has been written and we are trying to answer all the questions, and I think at this point it doesn’t, and then what do you do?

DR. CARR: But Kelly had some good suggestions on the last call and speaking yesterday, which is to say that the report is not going to answer all the questions but its going to tee up the issues and some of the solutions are going to be use the examples for opt-in and opt-out, look the Massey Health Initiative where they can compare how it works in the community for this, hold hearings on operations to get a broader understanding of this spectrum of ways people do it. I really think that is where the October report will be helpful is to say here is the issue and here is a next step and this would be a great next step for that.

MS. GRANT: I think that will be helpful in terms of something Jim said yesterday, and actually a bunch of people said yesterday, in terms of having language in there that may stop research, operations, or activities that are already going that you certainly don’t want to create any more ambiguity that is already out there. At least if you say based on the testimony we already heard, these are the critical issues in the industry and we are going to tackle them this way or that way, and to your point Justine, research and quality and sort of that line – what is the line – between when you go from quality over to research and I don’t know if that can be sort of defined.

DR. STEINWACHS: The other part is what is the oversight on quality improvement in any position, at any time, do anything in the name of quality improvement and how does the organization of the system responsible for some oversight of risk and benefits?

DR. GREEN: I think we should be very careful not to presume that the oversight for research is working. Where I’m headed, this is a real problem and its not just related to quality — that’s what the Hastings report says in my view, but and Joan’s house of Internal Medicine article really lays out there this sucker is close to broken, the IRB process is disrespected, we go to places where people refer to is as the Office for the Prevention of Research, and this is serious – the research side is in trouble too. We have an opportunity to harmonize this in some way that kicks it upstairs in someway –

DR. CARR: Take the ‘harm’ out of harmonize.

DR. GREEN: Lets do this, lets make sure we get through this.

MS. GRANT: Can I ask a clarifying question? I’ve heard the term ‘quality improvement measurement reporting’ sort of thrown around and wanted to find out if there was a way to sort of get clarity whether we are talking operations and what is covered or allowed? When we say quality improvements are we lumping under measurement reporting under that, are they three distinct functions and maybe quality improvement is allowed under operations but reporting and measurement – so I just want to make sure when we are using those terms we may want to clarify we are talking improvement or not talking measurement reporting in this case.

DR. CARR: We can’t answer it today but I think that is the way we could structure it. How do you decide on quality improvement activities? What are the quality measurements?

DR. WM. SCANLON: And I think that is a key and its kind of at this point, if there was enforcement that was vigorous and something was challenged you would have the lawyer in there arguing wait a minute, I did it Okay, I was subject to those rules, I was subject to these rules, and you could have a lawyer on the other side doing exactly the opposite. Its classic confusion.

DR. CARR: Just as we depart, there has been very nice work done looking at the 2004 report and updating where we are today. I feel that we haven’t had a chance to do it justice although I would like Marjorie kind of to be a part of this as she is the thread of continuity, so I would just like to bring it to your attention and I think what we will do, we will talk to Marjorie and think about setting up the next hearing and as part of the hearing we will have time for the Workgroup to meet and discuss this as well.

MS. JACKSON: Michelle Williamson attends a lot of the various meetings on HL7 and seems very attuned to what is going on and she is updating this.

DR. CARR: Right, and having her there as well would be very helpful. Thanks.

(Whereupon, the Workgroup on Quality adjourned.)