[This transcript is unedited]
Embassy Row Hotel
2015 Massachusetts Avenue, Northwest
Washington, DC
DR. CARR: Good morning. Welcome to Day 2 of the September meeting of the National Committee of Vital and Health Statistics. I am Justine Carr, Stewart Health Care System Chief Medical Officer, Chair of the Committee and no conflict.
MS. GREENBERG: Good morning. Marjorie Greenberg, from the National Center for Health Statistics, CDC, and Executive Secretary to the Committee.
MS. MILAM: Sally Milam, West Virginia Health Care Authority, member of the full Committee, Populations and Privacy, no conflicts.
MS. KLOSS: Linda Kloss, member of the full Committee and the Quality Subcommittee, no conflicts.
DR. NICHOLS: Len Nichols, George Mason University, full Committee, Quality Subcommittee, Population Subcommittee, no conflicts.
DR. COHEN: Bruce Cohen, Massachusetts Department of Public Health, Full Committee, Population Health Subcommittee, no conflicts.
DR. SUAREZ: Walter Suarez, Kaiser Permanente, member of the Committee, on several subcommittees. And no conflicts.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, Member of the Full Committee and the Standards Committee and Quality Committee, no conflicts.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, Liaison to the full Committee, Staff to the Subcommittee on Standards and on Quality.
MS. SOONTHORNSIMA: Ob Soonthornsima, member of the Standards Committee and full Committee, no conflicts.
DR. HORNBROOK: Mark Hornbrook, Kaiser Permanente, member of the full Committee and the Population Subcommittee, no conflicts.
DR. BURKE: Jack Burke, Harvard Pilgrim Healthcare, member of the Privacy Committee and the full Committee, no conflicts.
DR. MAYS: Vickie Mays, University of California Los Angeles, Member of the full Committee and member of the Subcommittee on Populations and Privacy.
DR. MIDDLETON: Blackford Middleton, Partners Health Care, Harvard Medical School, member of the full Committee, co-Chair of the Quality Subcommittee and member of the Population Subcommittee, no conflicts.
DR. CHANDERRAJ: Raj Chanderraj, practicing physician, member of the full Committee and member of the Standards Committee.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the full Committee, co-Chair of the Quality and member of the Privacy Committee.
DR. FRANCIS: Leslie Francis, University of Utah Law and Philosophy, Member of the full Committee and co, I hope, Chair of the Privacy Subcommittee, member of the Populations Committee, and I have no conflicts.
(Introductions around the room)
DR. CARR: A couple of announcements; first, I'm happy to announce that Linda Kloss has graciously agreed to assume the role of Co-Chair to the Privacy Subcommittee. I think that Linda has done significant work both through AHIMA and very knowledgeable in the area, and will be a nice partner for Leslie, so thank you, Linda.
Second, I want to remind folks that we hold, is it one Friday a month, from 3:30 to 5:00, the third Friday of the month, please put on your calendar a hold for 3:30 to 5 p.m. We don't often need it, but we keep it in place so we don't have to do so much searching for times for calls, Eastern time. Just put that as a standing hold and if we're not using it, fine, but at least we'll have it there.
Also, I want to acknowledge a number of folks. Karen Trudel has been our liaison for CMS, and she's now moving into a different role at CMS and will not be our liaison, but we want to thank her for her diligent efforts and insights and support of the Committee. We welcome, as her successor, Robert Tagalicod, who is now Director of eHealth Standards and Services, together with Lorraine, who's Deputy Director of OESS. So we're really fortunate to be working with all of you, yes.
MS. GREENBERG: And we'll prepare a letter for Karen.
DR. CARR: Great. I want to also acknowledge a number of awards that just keep rolling in to the Committee; Marjorie is going to be the recipient of the NAHDO Elliot Stone Award for Excellence in Health Data Leadership. And as we all know, that's very well deserved, so Marjorie, congratulations. Some of us, as we discussed yesterday, will be at that meeting.
I also want to acknowledge not only is the Committee being recognized for leadership in technology by WEDI, but so is Lorraine, and extremely well-deserved, so congratulations on that.
A couple of other little housekeeping things: I'd like to just get a clear accounting of who is on which subcommittee, so we'll have Linda joining the Executive Subcommittee as a Co-Chair, and then as the Subcommittee on Standards, I have Walter, Judy, myself, Raj, Bill Scanlon, Ob, Jim Walker. Did I miss anybody? Is there anybody else who's on Standards? Okay.
Next, on to Privacy. So Leslie and Linda, Jack Burke, Sally, Walter and Paul Tang. Did I miss anybody else on Privacy? Vickie – okay.
Then moving onto Population Health. I have Larry Green, Sally, Jack, Bruce Cone, Mark Hornbrook, Vickie, Blackford, Len Nichols and Walter, on Population, and Leslie. Anybody else? No.
On Quality I have Blackford and Paul as Co-Chairs, then Larry Green, Linda, Len, Bill Scanlon and Judy. Anybody else? Bruce, excellent. Mark Hornbrook.
Terrific. And then finally, when we spoke yesterday about the report to Congress, I asked a couple of members to help put fresh eyes, read the report and pull out the key points that we would want to put in an Executive Summary introduction to Congress. So as we saw, the report is incredibly detailed and rich, but we want to get a very compelling headline in the first three paragraphs. So Ob has agreed to coordinate input, and Raj and Mark, Leslie and Linda, have agreed to give input to that, so what I would like you to do is go through that and find the salient points and let's put them together. Ob, you'll then draft a kind of Executive Summary and then work with Judy and Walter in terms of how that fits.
MS. SOONTHORNSIMA: Can you repeat the members again?
DR. CARR: It's Linda and Leslie and Mark and Raj. The timing would be over the course of the next week.
So on the plane, on the way home, take out those yellow markers and we'll get them, so that will be terrific, thanks very much.
At this point, turn it over to Walter and Judy and Lorraine.
Agenda Item: Standards Letters – ACTION
DR. SUAREZ: We're going to bring back to you the three letters of recommendations related to the administrative simplification provisions. The first one is acknowledgments; this was the letter that we presented to you yesterday, recommending the adoption of a standard for acknowledgments instead of operating rules and requesting that this get moved fast in the regulatory process. So the only change that we heard – two changes that we heard that were recommended – the first one is, and I'm highlighting here the actual recommendations of the letter, so the set of recommendations we didn't change; adopting the ASC X12, TA-1, 999 and 277 CA acknowledgment of transaction, the standard transaction, and defining it as is noted in this section.
The second one is adopting the ASC X12 standard and corresponding implementation guide, and then the third one is where the first change occurs – define the conditions under which each of the acknowledgment transactions will be expected to be used, and we said, on the second one, the ASC X12, the ASC X12 999 implementation acknowledgment should be required as a response to all HIPAA transactions, is what we had, and it was recommended to change to all ASC X12 transactions, regardless of the submitter of the transaction. That will be more consistent with the current practice and the fact that if we say all HIPAA transactions, they will apply to pharmacy and other sectors that do not do this, other transactions like the pharmacy transactions that do not use 999. That was the first change.
And then the second change was on recommendation 1.8, where we had originally considered excluding real-time transactions from the requirement of using the acknowledgment standard, but as we heard, there are some instances where industry trading partners doing real-time transactions do use the acknowledgment, so the recommendation was to have a statement that says that if those entities choose to do the acknowledgment transaction on real-time transactions, then they should be required to use the standard adopted. So that's what we're trying to say here, "Require the use of the recommended acknowledgment standard for entities that choose to use electronic acknowledgments in connection with real-time transactions."
So this is not forcing everybody that is doing real-time transactions to do acknowledgments; that's very important to state. This is not forcing everyone that is doing real-time transactions to use acknowledgments, this is requiring that those that choose to do electronic acknowledgments when conducting real-time transactions, to use the adopted standard.
Any comments or questions? I don't know if Justine, you want to take each of the letters and move for approval?
DR. CARR: Yes, why don't we do it one at a time, so we can entertain a motion?
DR. SUAREZ: I'll move to get approval.
DR. CARR: To accept the letter as amended, and I think I saw Mark second. Any further discussion? All in favor? Any opposed? Abstain? Passed. Thank you very much. Next.
DR. SUAREZ: The next one is the letter on ICD-10 and 5010 before the hearing about the current status of ICD-10 and 5010. There were two changes that were considered; one was changing in the recommendations; so in the recommendations related to Medicaid, we noted that HHS, to establish, communicate and enforce a deadline, but there were concerns about the word "enforce", so we agreed to modify it to adhere. That was the main change. And it didn't change any of the other elements.
DR. FITZMAURICE: Could I suggest maybe adding a "to" to that adhere to, a deadline?
DR. CARR: Walter, any other discussion, any other information?
DR. SUAREZ: Yes, there's another change that we talked about during our subcommittee. We have become aware of a situation that occurred because of having the standards be named in different regulations. So, the HIPAA regulations name 4010 as a version when everybody's using 4010, and now everybody is going to move to 5010 because HIPAA regulations call for the move to it.
Well it happened that the e-prescribing regulations that were adopted in 2005, and then in 2008, actually codified there as well that, when conducting remittance advices electronically, that entities are required to use the ASC X12 835, version 4010. And they codify that in the regulation of e-prescribing, and that was never updated, and so we are faced with, on January 1, adopting 5010 and starting implementing 5010, and then, for transaction-related e-prescribing, the rules still say 4010. So there is already work being done; CMS is on top of it, and moving quickly to try to adjust that rule on e-prescribing, to make sure that it says 5010 instead of 4010, but we thought it would be helpful to emphasize that point in our letter, and so we added this following statement:
"NCVHS has become aware that current e-prescribing regulations require the use of an ASC X12 and 835 version 4010 standard, and that this has not been updated to conform with the requirement to use the new version 5010. So the recommendation is HHS should expedite the process for modifying the e-prescribing regulations to conform with the national requirement to move to the 5010 version for all administrative transactions naming the regulations, so that by January 1, 2012, the industry does not have to use two different versions of the standard for the same transaction."
DR. CARR: Is there anywhere else that this could be? That's a great point.
MS. DOO: Not that we know of. There's just that one inconsistency because of the timing of the regulation.
DR. WARREN: There is some concern from NCPDP that this is not true -
MS. GILBERTSON: It's just a clarification. It's not to move to the 5010 version; the e-prescribing regulations name the Telecommunications Standard 51 and the X12 standard 4010s. So it would be - the 5010 version is just only one piece of the request; so it's the national requirement to move to the new version, or however you want to say it, it's not just X12 5010. And CMS is well aware of all this, it's just I want it to be clear that it's just not 5010.
DR. SUAREZ: Clear that it's not eliminated, good point, thank you. The national requirement to move the name for the X12 standard naming that regulation to the 5010 version.
MS. GILBERTSON: Perhaps it's just easier to say, to move to the named standards in the regulation, and that's both NCPDP and X12.
DR. CARR: Okay, Walter, anything else? Do I hear a motion to approve? Judy moves, Sally seconds. Any discussion?
MS. MILAM: Isn't that standard plural?
DR. CARR: Are we ready to – Walter?
DR. SUAREZ: I will edit it to make sure that it reads correctly, I just don't want to -
DR. CARR: Lynn can look at it, yes, we don't have to watch you type. All in favor? Any opposed? Any abstentions? Unanimous. Thank you very much. Do you have something else for us?
DR. SUAREZ: One more. We have a letter with observations on the standards and operating rules, maintenance process. We reviewed it with the Committee yesterday. There were no changes recommended, so we're requesting approval of that letter as well. So I move to have the Committee approve the letter on observations on the standards and operating rules maintenance process.
DR. CARR: What tab was that in? Four. Okay. And we did review this –
DR. SUAREZ: We reviewed it yesterday. It's a letter with observations on the – we note – there's no recommendations, and we note in the letter at the end that we are going to be holding hearings later this year to continue the discussion and to develop recommendations.
DR. CARR: We were asked to render these observations?
DR. SUAREZ: In the Affordable Care Act, we are asked to review periodically, actually, the process and the adoption of the standards, and so this is our first step, really, in that process.
DR. CARR: So did I hear a motion to approve? Walter, and second, Judy. Any discussion? All in favor? Aye. Any opposed? None. Any abstentions? None. Unanimously passed, excellent, thank you.
MS. GREENBERG: The next item on the ANPRM, on the response to the ANPRM, are you going to address that next?
DR. SUAREZ: Yes, thank you. Well this is not a Standards Subcommittee activity, really, it's more – this is not coming from the Standards Subcommittee. This is a Committee activity.
DR. CARR: Let me just make a clarification; our agenda says that at 11:30 – we're ahead of ourselves - So what we want to do now is talk about the draft letter on metadata in response to the ANPRM from ONC.
DR. WARREN: We've deferred the discussion on the primer until the November meeting. So we have time.
DR. CARR: Although we could preview – depending on how long this discussion goes. So what would be helpful, I think, with regard to the letter, is just a little overview of what the ANPRM is asking for, why we're responding and what is the basis for our response. Is it based on previous work of the committee, previous letters, previous hearings or discussions? Just want to be clear on how the voice of the Committee is being represented and that it is uniformly the voice of the Committee.
DR. SUAREZ: I'll take it. I offered to help this – one of the Committee calls, I think it was the Executive Committee call, we thought it was going to be very important to provide some comments on this ANPRM, and -
MS. GREENBERG: I think it was actually during the open call in which we approved the letter on the PCAST report, and acknowledged that during that process of our writing that letter, there's now been an ANPRM -
DR. CARR: So everybody has a copy at their desk. Do we have a copy we could put up on the screen?
DR. SUAREZ: So the background, to answer your point, Justine, the background first and then we'll talk about the source of the comments and how we organize these comments. The ANPRM basically is about metadata standards, and it follows pretty much as a next step of activities and actions from the PCAST report. The PCAST report calls for the use of metadata, and the Policy Committee identified, as well as the Standards Committee identified, a series of areas where this metadata could begin to be tested. The Standards Committee, the HIT Standards Committee, also made a few other comments regarding the steps, and we're citing a few of them here.
The rule itself, the Advance Notice of Proposed Rule, included a description of the whole process that PCAST report, the recommendations on the PCAST report regarding the metadata, the recommendations from the Policy Committee and the response from the Policy Committee to the PCAST report, then the work that the HIT standards committee metadata power team did during the summer; during the summer, the Standards Committee created one of the power teams and was focusing on metadata, and that was to look at what can be done with respect to adopting standards for metadata used, along the lines of the recommendations of, again, the PCAST report as well as the Policy Committee.
So the proposed rule, and it's at the bottom of the first page, focuses on three categories of metadata. Patient identity, and it describes the minimum necessary data required to uniquely select the patient from a population with a guaranteed degree of accuracy, that's a first use case. The second one is provenance; the minimum data element required to document the history, origin and modifications of the data, which the metadata is about, and then the third is privacy, the minimum data to document and transmit the data type, sensitivity and patient privacy preferences about the sharing of his or her information. So those were the three areas that are consistent with the recommendation for the Policy Committee and the Standards Committee, of areas that should be the focus of this initial proposed rule.
On the second page, we state at the top of the page that a few other summary items, that the ANPRM is also considering the adoption of these standards in support of Stage 2 of the meaningful use program, and establishing certification criteria for EHRs to be capable of applying the metadata standards for stage 2. So it's not only defining what are the standards, the proposed rule, for these three areas, but also recommending, or looking at recommending, adoption of this to be used in connection with the Stage 2 of meaningful use. And to use it in the certification of electronic health records.
So those are two aspects of this ANPRM that are important. Further define the standard and then recommend to move it into Stage 2 and adopt it in certification. The ANPRM argues that this metadata tagging capability may also be applied to other directed transfers of health information, and looking forward, the health care industry could gradually develop innovative ways to repurpose this capability, to be applied to specialized sections to meet future policy and organizational objectives.
So this is sort of a summary of some of the key points of the ANPRM. So we start with some statements. Now to answer to your second question, Justine, most of, if not all of, what we say in this letter tracks back to the main document that we used, which is the PCAST report letter of recommendations, observations and recommendations. So that is the main source of most of these comments. The second point that is important to keep in mind is, we're not making recommendations in this letter. We're staying away from the word, even, recommendations. We're making observations and providing our perspectives on this. We can edit it – Page three has the word? I missed it. Okay. So it's important to avoid that and turn that into observations.
DR. TANG: It says do not -
DR. CARR: The way it's written, it says do not incorporate, do not adopt – the recommendations, there's four, on top of page three, and they're written in language that looks like recommendations.
DR. TANG: And they're not bad ones.
DR. SUAREZ: It's important to note, when this was being drafted, the recommendations, I wrote them, basically, and we discussed them, basically, as conceptual recommendations. This wasn't to be the actual wording of the recommendations; we just never got to update the wording itself, but we can talk about that.
DR. FRANCIS: Since these are comments, we don't need to have the recommendation form, we can make comments that reach conclusions, but this isn't a letter addressed to the Secretary, and that's why we typically have the bulleted -
MS. GREENBERG: So can we call them conclusions instead of recommendations?
DR. COHEN: Why can't we call them recommendations?
DR. FRANCIS: We can. It's just often not done that way in comments on -
DR. CARR: Let's get the concept down; what are we saying, why are we saying it, and then we'll decide.
DR. SUAREZ: I'm still kind of on Page 2, but I realize that when I say we're not making recommendations, I see recommendations; I made a mistake there, so I'm sorry for that. We'll talk about that.
MS. GREENBERG: We should note that these comments are due tomorrow.
DR. SUAREZ: At the end of day tomorrow.
MS. GREENBERG: There's no opportunity to leave this meeting and finalize the letter, we've really got to redo it today.
DR. SUAREZ: That is if we want to submit these comments as comments to ONC in response to the ANPRM. We, as a Committee that reports directly to the Secretary, we can have recommendations next week if we wanted to –
MS. GREENBERG: You can make recommendations any time you want -
DR. CARR: But I think that we want to redeem ourselves in terms of our capacity to adhere to timely timelines, and therefore I'd like to see us get a letter out in response today.
DR. SUAREZ: So getting to the comments, we organized the comments into two areas, basically; one is the overall regulatory approach, and then we had a separate area for scope priority and recommended standards. Those are the two areas in which we organized the comments and the recommendations. So the first area, the overall regulatory approach.
We stated we believe the adoption of a series of standards for metadata tagging via formal regulations is premature, and contrary to the process of first testing and demonstrating how such standards, and the technical assumptions that go along with them, will actually work.
DR. CARR: Because this is us all together for the first time, are we in agreement with that statement? Okay. Next sentence.
DR. SUAREZ: We are concerned that the proposed standards, while they might be appropriate in content, are not mature enough to: 1. Be formally adopted as new national standards; and 2. Be required to be implemented as part of the meaningful use program.
DR. CARR: Okay. Any objections to that? No. Three –
DR. SUAREZ: In this regard, we strongly agree with the conclusions reached by the HIT Standards Committee, that the overall metadata tagging technology approach, and, specifically, the standards to be used, be thoroughly tested and evaluated prior to proposing these standards for adoption through regulation. This is actually a quote from the regulations – the Standards Committee made that statement.
DR. CARR: And we're saying we agree with that. Any objections?
DR. SUAREZ: The ANPRM only mentions once, and in a very brief passing form, ONC's intent to "seek pilot testing of the metadata standard to gain insights into any implementation level challenges that may exist". This goes against the concept of adopting, by regulation, new standards that have not been fully vetted, thoroughly tested and widely accepted by the industry with at least some implementation demonstration already underway.
DR. CARR: Any comments?
MS. GREENBERG: I think this is a double negative; it needs to be "this goes against the concept of not adopting by regulation…" new standards that have not been fully vetted.
DR. TANG: This goes against the concept – the concept is to -
MS. GREENBERG: Or you could say, if you don't want to be too negative, negative, negative, this goes against the concept of adopting, by regulation, new standards that have been fully vetted, thoroughly tested -
DR. CARR: I think stating it in the positive, this goes against the concept of adopting, by regulation, new standards – or maybe it's by only adopting -
MS. GREENBERG: Sometimes things are adopted that haven't been fully vetted, thoroughly tested and widely accepted by the industry. So I don't think we should – this can't be an absolute.
DR. CARR: This goes against the concept -
MS. GREENBERG: Of adopting, by regulation, new standards that have been fully vetted, thoroughly tested and widely accepted by the industry with at least some implementation and demonstrations already underway.
DR. TANG: But that's not exactly saying, they don't seek to adopt everything that is – but you would not want to adopt something before it is tested, that's the point -
MS. GREENBERG: I think this is a little bit too – I'd say this goes against the concept of fully testing and vetting new standards before they are adopted by regulations.
DR. TANG: Maybe what we're shooting for is the spirit or intent. So in order to avoid unintended consequences, you would not want to adopt things that are completely new without first testing it. So that gives the – why would you want to test something? When you're promulgating widespread regulation, you would not want to adopt new approaches, or new technologies, before testing it.
DR. CARR: Is it a concept or is it a practice? This goes against the practice of first testing and vetting proposed standards before adopting by regulation.
DR. TANG: It's going against their intent; I think that was – so they would not intend to adopt new technology without testing. It's not a concept.
MS. GREENBERG: This is contrary to the practice of -
DR. CARR: The practice. It goes against the practice of first testing and vetting before proposing a regulation.
MS. GREENBERG: New standards; before adopting new standards.
DR. SUAREZ: How about this: This is contrary to the practice of adopting by regulation new standards that have been fully vetted, thoroughly tested and widely accepted.
DR. CARR: I think it gets confusing, because really, the practice is that you test and then you adopt, so I would put it that way, this goes against the practice, this is contrary to the practice of first testing and vetting new standards before adopting by regulation. And that shortens it.
DR. SUAREZ: Then we say we also concur with the concerns expressed by many commenters to the PCAST report regarding the timing of adoption of these recommendations, in the midst of meaningful use stage 1, preparation for meaningful use stage 2, implementation, regional health information exchanges, the transition to ICD-10 process, the implementation of new HIPAA standards and operating rules and the move toward new forms of health care delivery and financing under the Affordable Care Act – the industry would not be in a position to incorporate, test, implement and carry on with the many policy, legal and liability implications that the use of metadata tagging will bring about.
DR. CARR: So are we really in a position to say "will not be in a position" or "may not be in a position" or "would find it challenging to"?
DR. TANG: One of the concerns of implementing – I'm trying to get the word – one of the concerns in the industry of implementing a large number of initiatives at the same time is their inability to do that successfully. And your concept is, do you really want to add yet another unproven, or not yet tested, technology to that mix? That kind of an approach.
DR. CHANDERRAJ: I think the word is challenging --.
DR. TANG: Or actually risk. So the point we're having is, it's risky to do all this stuff and do we want to add on to that?
DR. CARR: So maybe we begin with "implementation of – would pose a challenge and a risk"
DR. SUAREZ: In the midst of implementing -
MS. GREENBERG: Can you tell me where you are?
DR. CARR: Recommendations. There's actually a very long sentence, first sentence, we also concur, the next is in the midst.
DR. TANG: One of the main concerns expressed by many commenters to the PCAST report is the timing of the document's recommendations. Then you say – the concern revolves around -
DR. CARR: How about incorporating, testing and implementing these – what are we calling them, this -
DR. SUAREZ: I think what Paul was talking about was implemented and proven, or untested -
DR. TANG: Not yet tested.
DR. CARR: Even if they were tested, it would be a challenge.
DR. TANG: That's correct. We're just trying to say, we have a number of initiatives, a number of deadlines, coming up that are already CMS programs, and that has been challenging to the industry and creates a certain amount of risk to patient care. In that context, we would not want to add yet to be tested new technology to that mix. Something like that.
DR. CARR: So introducing untested new standards – introducing yet to be tested new standards in the midst of ongoing initiatives, including meaningful use, et cetera, would pose -
DR. TANG: Additional risk.
DR. CARR: Why don't we say, introducing yet to be tested standards poses a significant risk due to the competing agenda of ongoing –
DR. TANG: That's where I think you made the sentence – I mean, that's how the sentence got so long, too many things in the sentence. So set up, people are busy doing some very important things with a deadline. We shouldn't add new -
DR. CHANDERRAJ: How about breaking that sentence into two parts, rather than the second line that says "in the midst of meaningful use, the industry is already involved in implementation of meaningful use, preparation for meaningful use" and break that sentence at the Affordable Care Act, and then start another sentence?
DR. CARR: Industry and providers are currently focused on a number of time-sensitive initiatives, so industry and providers are currently focused on a number of time-sensitive initiatives. And then we say introducing yet -
MS. GREENBERG: Do you want to mention which these are?
DR. CARR: Yes, as they are, including, there you go, and take out in the midst. Including those, and then go down to code sets, operating rules, health care delivery finance under Affordable Care Act. Period -
DR. TANG: I might take out implementation of regional health information change, because that's not falling on the providers.
DR. CARR: Industry and providers. Okay, take out implementation of regional health information change -
DR. SUAREZ: No need to pile up everything -
DR. CARR: Transition to ICD-10, new HIPAA standards, operating rules and the move toward new forms of health care delivery and financing under the Affordable Care Act.
DR. SUAREZ: I would also – the transition to 5010, D.0 and ICD-10 causes -
MS. GREENBERG: We are taking out preparation for meaningful use Stage 2. What are we taking out?
DR. SUAREZ: Implementation of –
DR. CARR: Regional health information exchanges.
DR. SUAREZ: Regional health information exchanges, that one.
DR. CARR: But I would put implementation of 5010, D.0 -
DR. SUAREZ: Implementation of 5010 and D.0 and the transition to ICD-10 – and 3.0 -
DR. CARR: And then period after Affordable Care Act. Marjorie, if you don't quite have it, I think we can come back and get to it. So the next sentence then would say introducing a yet-untested new standard would pose significant challenge and risk.
DR. HORNBROOK: Question for clarification; I thought metadata tags were universal. Computers and programs attach metadata tags to any packet of data that's transmitted and operated on; it needs to know where it goes in the memory, it needs to know where it came from, it needs to know what it's sending, Oracle puts on metadata tags, SAS puts on metadata tags, I thought this regulation, then, was meant to regulate a practice that's already ongoing, not instigate a new practice. Am I wrong, am I misunderstanding things?
DR. WARREN: If you look at the tags that are in CDA documents, they tell you specifically where to go look, so if you have two independent bodies adding meta tags, they could add metatags that address the same thing differently, so then you wouldn't be able to match them up and aggregate them, and that's what we're trying to get out. There's nobody out there that is harmonizing metatags.
DR. HORNBROOK: Do we want to slow down on this regulation?
DR. NICHOLS: Can I jump in here, because I just feel like – I'm clearly the least knowledgeable human being about what this is about, but I just want to ask, what are we afraid of? And what happens to the meaningful use tool if we pile on and say enough already, don't do this? Are we – what are we afraid of, what am I missing?
DR. WARREN: Starting over. We have standardized terminologies, we're working on standardized data elements, if we go to metatags we'll throw all that out and go to metatags, and start over with trying to agree which ones are the metatags everybody will use. And that's very simple.
DR. SUAREZ: And then the biggest concern is this, to be blunt. You don't regulate something that you don't know what it is. You don't create regulations on something that is untested or yet to be tested or is something that conceptually could work but we don't know; nobody has done any of what is said in the regulations at this point in health care.
DR. NICHOLS: So this is a gross overreach of what -
DR. SUAREZ: What we're saying in the first paragraph – we believe that this is premature, to start with regulations on something that is not yet even implemented in health care at all. That's the main point, really. Two years from now, when the industry, when we have CDAs moving, actually flowing, and when we see that this can be now tested to see if we tag a CDA with the provenance and with the patient identity and with privacy, even, then we can look for the establishment of some regulations to ensure that everybody uses the same, and does it the same way. But in the midst of starting to do messaging with CDA, trying to force untested or yet to be tested methods to tag, it will unravel into something we don't even know. So that's the concern.
DR. BURKE: I think it's better said later on in the letter, what our fear would be is the technology is driving the policy rather than the normal course of events, that's the fear.
MS. KLOSS: To Mark's point, on page 2, the second paragraph, I was a little uneasy about, because metadata tagging is standard information practice, to call it a promising new technology. I think this is really an application of a technology rather than a new technology; it's standardizing a certain set of tag specifications for this use case – am I correct?
DR. TANG: So could we call it a new approach or even new architecture for exchange of information? Architecture – because it has such far-reaching implications on the current -
DR. CARR: What line are you talking about, what page two?
DR. SUAREZ: Page two, second paragraph.
DR. CARR: "We believe that the metadata approach to document and tag certain characteristics of the data being exchanged is a promising aspect –"
DR. SUAREZ: New implication of a technology –
DR. FRANCIS: Just take out new.
DR. SUAREZ: The new implication of the technology in health care.
DR. CARR: You could just say, has the potential to – take out is a promising new technology that – we don't give it a name, we just say to document and tag certain characteristics of the data being exchanged has the potential to increase – so just take out is a promising new technology that.
MS. KLOSS: Because I think, as a Committee, we look at this as something down the road that's very aligned with our vision of information integrity and standardization and interoperability, but this rush to apply it to a certain document –
DR. CARR: To be clear then, there are metadata tags that could be proprietary and are not aligned, and our concern is the lack of alignment will lead to chaos down the road, so where do we need to be saying that?
MS. GREENBERG: Do you want to say we also believe in standardized metadata tagging, to increase the interoperability -
DR. CARR: Yes, that's a good one. We believe that standardized metadata -
DR. TANG: Correct. And then we could follow that down with we currently do not have standard metatags; it's a cart-horse kind of problem.
DR. CARR: So the second paragraph will say, we believe that a standardized, a standardized metadata approach to document tag – that has the potential to increase the reliability, dependability and trustworthiness of health information exchange electronically. Then we go on to say we also believe that metadata tagging can increase the interoperability of health information exchanges by including metadata descriptions about the data being exchanged. And the next paragraph, it says however, but really the however is currently, there is no standardization. There are metadata tags, but they are not standardized.
DR. TANG: There are tags being used the way that they're proposing, so I almost would lump it in one sentence by saying, although metadata tags could plot, there are currently no – this approach is not in current use and there are no standard metadata tags.
DR. CARR: So where does that go, before this first or second sentence?
DR. TANG: You said, metadata tags could be useful.
DR. CARR: What he's saying is, in the first sentence to say although, begin with although – what?
DR. TANG: Use of standardized metadata tags could improve the interoperability of data exchange, this approach is not in current use, and there are no standard metadata tags. So there's two points to that. Therefore, the approach of pilot testing this approach is very reasonable. And then we come up with the -
DR. CARR: She's working on the introductory paragraph too – are you talking about the specific – where are you in the document? Okay, so you start it by saying although this approach is not in current use and there are no standards for metadata tags?
DR. TANG: Start with the good thing. Although use of standardized metadata tagging can improve interoperable data exchange –
MS. KLOSS: Marjorie, if you look at the last sentence, it has the language that he wants after although. Look at the last sentence of that paragraph; that has the language that he wants to move up.
DR. CARR: So that allows us to frame the challenge early on in the discussion. So while Paul wordsmiths that, could we bring our attention back to the top of page three, and with that framing – Linda?
MS. KLOSS: Can I raise one other framing question? I'm second to you in terms of being the dumbest person at the table on this. But in the ideal, wouldn't we argue for metadata tagging at the data element level and not at the document level? Isn't this approach one that would need redo?
DR. SUAREZ: This approach doesn't prevent the next step, which is going from document to data. It does not, it just starts with document level. You can tag and you can start tagging at the document level; later, when things are more mature, you can begin tagging at the data element level, but there are questions still about the appropriateness of tagging at the data element level for certain things without appropriate context. That's part of the argument we make.
DR. CARR: We'll see what the wordsmithing is on the paragraph on the top of page three. Next question, for us to keep moving this along, is – we have four recommendations. So let's look at those and say do we agree, and then let's entertain whether we call them considerations or recommendations.
DR. SUAREZ: If anything, the standards should be adopted only for testing and demonstration projects, and in reality, you don't need to adopt standards in regulations to do testing and demonstration.
DR. CARR: So is adopt the right word?
DR. SUAREZ: No. I think it's recommend the use of standards for testing and -
DR. CARR: Test standards in demonstration projects.
DR. SUAREZ: Test standards.
DR. CARR: Test draft standards in demonstration projects.
DR. SUAREZ: Perfect, yes.
DR. CARR: Next one. Include in the NPRM the parameters, metrics and outcomes for pilots and demonstration projects. Reasonable. Any objection there?
DR. FRANCIS: I'm not entirely clear what that means. Would that mean we would be saying by rule that demonstration projects need to – it doesn't make sense.
DR. SUAREZ: One position, which is the first one, test the recommended standard or the draft standards in demonstration projects, pushes the question to are we saying withhold completely this NPRM, because there's no reason to do it, you need to test first, and then just not reference the second one; the second bullet would be define parameters, metrics and outcomes for pilots and demonstration projects.
DR. CARR: Articulate the performance expected from the pilots.
MS. KLOSS: Those two could be combined into one bullet.
DR. CARR: We are just doing a concept, we are on the recommendations at the top of page three, but we're kind of doing concept first and then we'll get the language. So do we want to combine them?
DR. SUAREZ: The question whether the first bullet should actually be more explicit to say do not move forward with the publishing of an NPRM. That's the first question, because if we go that fast, then -
DR. CARR: Do not move forward – how do you want to say it, Walter? But that is what we've been saying, right? Do not move forward with this?
PARTICIPANT: You're advocating a delay?
DR. SUAREZ: We would be advocating for withholding – that might be the – withhold the -
MS. GREENBERG: - NPRM until the standards have been tested -
DR. TANG: There are two approaches. One is to convert this NPRM into one that is proposing standards, or proposing to develop standards. That might be more of a positive way to say stop. So what we were building up is – our rationale is, it is promising but new and untested, and we have lack of standards, therefore it would be premature to create a final rule around this. However, it would not be premature to propose to develop standards. So do you think – hey, we're working on standards with metatags, do you think that's a good idea; then you get feedback and then you go do something.
DR. COHEN: So we should say focus the NPRM on testing these standards – developing and testing these standards, before -
DR. TANG: Then it's no longer a rule.
DR. SUAREZ: But you don't need an NPRM for that.
DR. CARR: Are we saying instead of putting standards in an NPRM?-
DR. TANG: We are probably saying what you said before, which is the activity to be undertaken is to test out a new technology, which requires standards, and we really aren't saying to put in place an architecture that this ANPRM proposed to do. So that is consistent with what you said, which is -
DR. CARR: Test draft standards and demonstration projects; before issuing?
DR. TANG: We just need to find a better way to say it.
DR. CHANDERRAJ: How about saying the proposed development of standards, testing and then implementing it?
MS. KLOSS: That doesn't speak to the NPRM.
DR. CARR: Let's get our concepts down. I'm cognizant of the time; we are going to get this done today. So the concept is, test draft standards in demonstration projects before issuing an NPRM. We'll come back to how we are going to say that. Then we go onto the third bullet, do not incorporate into meaningful use stage two.
DR. COHEN: I never saw that in the ANPRM, so I don't think it's an issue.
DR. SUAREZ: It is the objective of the ANPRM.
DR. COHEN: To incorporate into stage two?
DR. SUAREZ: And to create certification criteria. It is actually explicitly stated in the NPRM to do that.
DR. CARR: So our points are: Do not incorporate into meaningful use stage two and do not create certification -
MS. GREENBERG: Do not incorporate what? Metadata tagging?
DR. FITZMAURICE: Mandatory.
DR. CHANDERRAJ: Three and four can be combined into one, right?
DR. CARR: So we want to say do not incorporate metadata tagging into meaningful use stage two?
DR. FITZMAURICE: Justine, might I suggest to incorporate mandatory metadata tagging? Because it might allow for the possibility.
DR. CARR: Do not incorporate mandatory metadata tagging into meaningful use stage two.
MS. GREENBERG: Is this parenthetical here?
DR. CARR: No, we don't need that, do we?
DR. TANG: I think we're just trying to say what does this mean, it says don't create a measurement –
DR. SUAREZ: No, we don't need the parens.
DR. CARR: And then do not create certification criteria for EHRs based on the proposed standards until they have been thoroughly tested, demonstrated and evaluated. So we still want to say that, we may want to say it a little bit -
DR. TANG: Otherwise it gets put in; that would cause the industry –
DR. SUAREZ: So the second part is the scope; priority areas and recommended standards. This is a little longer because there are three priority areas. We can review at the end, there's only one recommendation, but there are some things in that -
DR. CARR: Let's start with the end recommendation, to see if we agree with that, and then we can get back to the understanding. So the end recommendation says, emphasize the need for ONC to first explore the feasibility of such a system through pilot and demonstration projects and develop a policy framework, including governance, privacy and security, before considering adopting and requiring the use of privacy metadata tagging standards.
Now is there overlap with what we just were saying?
DR. TANG: We're in a different - one they were talking about the whole architecture and metadata tags, and now they also put a statement about use of this in controlling the accessibility, the privacy of data. And we're making a separate comment.
DR. CARR: The first one was about the architecture?
DR. TANG: The second one was about the use of this architecture as a -
DR. CARR: I think that's helpful in getting how we might say this a little differently, to align with how the first recommendation reads.
DR. TANG: We're trying to make a separate policy statement in the second one, I think.
DR. COHEN: So Walter, was this last recommendation intended just for the privacy?
DR. SUAREZ: This recommendation is in the context of the privacy metadata tagging only, because that's where -
DR. COHEN: But there weren't similar recommendations around identity and provenance.
DR. SUAREZ: No, we didn't include any specific recommendations on the patient identity and provenance; we made observations, for the most part.
DR. COHEN: So to me it seems like either there should be one for each, or this should be a general recommendation that covers all three.
DR. SUAREZ: That's why it might be helpful first to go through those and then decide what recommendations. So we're going back to page 3, scope. I'm going to read very quickly here.
The ANPRM specifically states that the media scope is the association of metadata with a summary of care record, or more precisely, the instance where the patient obtains a summary of care record from health care providers, electronic health record, or requests that the summary of care record be transmitted to the personal health record. That's specifically the use case that they are trying to address with these proposed rules.
MS. KLOSS: Did anyone else question – we probably don't want to go there, but – it seemed like a limited, a not greatly used use case. Would that even be a good test of this? We'd do a lot of work, and then have a use case that is specifically limited to patient-requested summaries, when we know that's not a huge – there's not a huge demand. So I don't know if we care to, but if we're going to say test it, we may want to raise the use case question.
DR. CARR: We have recommendations admixed with background here, and I think it's important for us, in our fifteen minutes that remain, to say what is it that we want to recommend with regard to these provenance areas.
DR. TANG: Maybe one of the reasons that privacy is being called up is that it is – we have written specifically on this issue and had specific recommendations about the scope, all in segmentation. And so this is inconsistent with that, and we want to provide information for why we think it is premature to go to this level of granularity.
DR. CARR: So should we really focus on privacy and our comment, and then we can add there, if we have other recommendations on these other two. I just think the way it's set up, it sets an expectation of a recommendation, and then there isn't one.
DR. FRANCIS: Justine, I actually think it makes sense to read all the way through, because there's an unclarity in the ANPRM which this calls out, which is whether it's really meant to be at the document level, and I think you have to have that to understand what comes later.
DR. CARR: But again, I think at this juncture, before we get into the wordsmithing, I'm looking for the concept; what is it that we are trying, what, for the most knowledgeable among us about this, what are the two or three things that we feel we need to say? So something we need to say is that you need to be clear about whether what you're proposing is metatagging at the document level for a certain use case, or metatagging at the data element level, and the ANPRM doesn't make that clear the way a lot of people read it.
DR. TANG: But we have already indication, since they have the data segmentation, I don't know whether it's called –
DR. SUAREZ: Data segmentation.
DR. TANG: Is it in ANPRM as well?
DR. SUAREZ: No, standards and interpretability initiative.
DR. TANG: So we have that juxtaposition that says hey, there is intent somewhere to go directly to the data, so we need to make clear what our previous conclusion was, in recommendations.
DR. FRANCIS: But that suggests distinguishing at the beginning, as we're starting out on this, that a scope question is, is this about document or data element? That's all. I don't want to derail us, but I think it makes sense to read all the way through to decide whether we want to move this.
MS. GREENBERG: So what I was saying was, after stating what the scope seems to be, that I moved up this paragraph, if I'm hearing Leslie correct, and I agree with her, in any event, that there's some confusion whether this is, the focus is, at the document level, or the granular data level, and then we actually say here, and I don't know if you want that as a recommendation, but we say here, we strongly recommend clarification of this point, in, I would say, any proposed rule.
DR. CARR: And then do we draw upon our previous -
MS. GREENBERG: We further recommend that any proposed regulations must at this time be clear and unambiguous about applying only to document level tagging, as we do not believe data element tagging is appropriate and mature enough. I don't know if we need this statement here?
DR. CARR: I think we need to shorten this letter so that we only say what we need them to hear. We don't have time to do all the background.
DR. TANG: Then let's just do the positive. We understand that there's an interest in using data tags in the privacy domain, and this is our recommendation.
DR. WARREN: I think the last two sentences that Marjorie read were recommendations, and were phrased that way. Let's call them out right where they are, put them on bullets.
DR. CARR: So there is interest in using metadata tagging in privacy -
DR. TANG: To control privacy. And we've written on this subject, we recommend the following.
DR. CARR: We have written on this in our letter of last week -
DR. WARREN: There is a second one there, Marjorie, a second we recommend. See at the end of the line? That we further recommend, the end of the line you're on?
DR. CARR: Okay, there's an interest in using metadata tagging to control privacy. We have written on this in our previous letter to the Secretary in August. We recommend – and just go to that and take out all the background so that we don't -
DR. TANG: Instead of saying there is an interest, the ANPRM proposes to – because there's more than an interest.
DR. CARR: Yes, ANPRM proposes to use metadata tagging for privacy.
DR. FRANCIS: What's happening to the comments about the overall syntax and format standard that came before, and about patient identity and provenance?
DR. SUAREZ: We haven't gotten to that. We're still on page three.
DR. CARR: We are just going to take this letter as far as we can, so the more efficient and focused we can be, the more we'll include in the letter. The letter has got to get done by 11:35 and a half.
The ANPRM proposes to use metadata tagging for privacy. We have written on this in our letter to the Secretary in August of whatever. We recommend – what?
DR. WARREN: The recommendations are in that paragraph, so if Marjorie -
DR. CARR: So see privacy metadata standard. So what that says; do we want to just put all of that in? First, we believe that lack of policy framework, okay – second paragraph, we are concerned with the inclusion of patient identifiers. We also believe that the use of privacy could create significant liability. We are concerned that the ANPRM makes a number of technical and operational assumptions. So all of those paragraphs stay in?
MS. MILAM: Justine, I've got a question. We refer to patient preferences being represented in the metatags, but I'm not finding that in the ANPRM.
DR. CARR: What paragraph is that in?
MS. MILAM: It's in the privacy metadata standard recommendation, it's page 5, second paragraph.
MS. GREENBERG: I'm trying to move all the privacy stuff up, is that what you want to do?
MS. MILAM: The sentence begins the fact that patients may be able to set their privacy preferences, and entities will use metadata tags to attach such preferences to specific documents, does not establish a legal requirement on the receivers, but when I look at the privacy section in the ANPRM, it seems to be speaking of a policy pointer and then content metadata, so there's either a disconnect or I'm not following how it fits together, because I haven't worked with metadata tags, so I just raised the issue.
DR. SUAREZ: That's one of the areas that's not clear. The expectation is that the metadata will allow the consumer to declare privacy preferences, and that that will be one of the elements of the metadata tag, to convey those privacy preferences.
MS. KLOSS: To convey and communicate patient preferences, parens, permissions or limits.
DR. SUAREZ: Privacy metadata.
DR. CARR: I'm concerned that we're jumping around in the letter and that Marjorie's not with us.
DR. SUAREZ: Let me just suggest one thing; if we can go back to page 4 and talk briefly about the overall syntax and format, and see if we want to keep it or limit it. Then we can go to the next one, keep it or eliminate it. That will be helpful.
MS. GREENBERG: Let me just tell you what I've done here. Starting here. First under two. The first paragraph stays the same. Then I moved up the fact that this confusion, created two recommendations here – this confusion needs to be clarified, and furthermore, it should be clarified in the direction of it being at the summary care record level, and then go into what our concerns are about the adoption of metadata standards for tagging at the element level.
DR. CARR: So just to be clear, Marjorie has totally reorganized the letter based on comments that she heard.
DR. SUAREZ: So you moved all the privacy up front.
MS. GREENBERG: I moved all that up front. Because that seemed to be that drew on the last letter, et cetera.
DR. CARR: Let's not touch any more on the letter for the time being. Let's hold on the edits. Walter, why don't you read the section you were proposing to read, from page four?
DR. SUAREZ: Yes, the overall syntax. The ANPRM recommends a proposed of an option of the XML syntax and format in the HL7 CDA header. This seems to be the conclusion of the Standards Committee as well. The statement that we make, while we generally agree with this approach, it is consistent with the recommendations of the Standard Committee, we are concerned that the standard will only be applicable to the specific use case, the summary of care record, and that it might not be extendable to other adopted message standards, such as those using administrative transactions and other health information exchanges that do not use an HL7 structure. It will be important that the proposed rule, or any future rule, clarify the scope and the limitations of the recommended syntax and format standard. So this is a specific point about the syntax and format, that it be recommended to all the tags, whether it's for patient identity, for provenance, for privacy.
MS. GREENBERG: I don't think this has really been discussed by the Committee before. This Committee.
DR. CARR: Is it something that is so obvious that everybody knows? Or is it something –
DR. SUAREZ: We're not recommending; we're raising a concern. We're not making a recommendation, we're raising a concern that the standard might not be applicable to other areas.
DR. WARREN: So in the administrative standards, they don't use HL7 transmission?
DR. SUAREZ: We don't do that, no. Exactly, that's what we're stating.
DR. WARREN: So no one's talked about taking the meta, the tags, and moving them into the administrative transactions, so if you've got tags in one and not in the other – that's your intent, Walter?
DR. SUAREZ: Yes, the concept is that if they are driving this down through the adoption of an HL7, they use syntax for the metadata tag. What happens to messages that are not formatted in HL7 format?
DR. CARR: Marjorie is raising the point that we don't want to speak about things that we haven't spoken about before. Harmonization, or something along those lines, that the scope ensures parity or something like that.
DR. FRANCIS: I think that it's really important to bear in mind that these are comments, these are not recommendations to the Secretary, and so if they're comments, we can agree on an observation; all we're doing is flagging it for somebody to think about.
DR. CARR: That's what I'm saying. If it's a fact, that is a fact, then we just say we observe that there is a disconnect, because – whatever, something like that. So how is it phrased?
DR. SUAREZ: It's page four, the third paragraph – we are concerned that these standards will not be applicable to other areas, basically, and only applicable to the use case. So that's a concern. We're not making this as a recommendation. I don't know if anybody is not concerned about that.
MS. KLOSS: If I understood it, I'm sure I would be.
DR. CARR: However its stated, this is fine. Let's go on to priority areas and recommendations.
DR. SUAREZ: So basically, we divide this into three areas. The first one, and this, by the way, is not in the order it was presented; the first one was provenance, the second one was patient identity and the third one was privacy.
MS. GREENBERG: In the meantime I already moved privacy up.
DR. SUAREZ: So, patient identity metadata standards. Again, while we agree with the overall value that patient identity metadata would provide to a data payload such as a summary care record, we're concerned about the accessibility and use of this metadata beyond the main purpose of providing basic information about the subject of the data being tagged. In the ANPRM, the description of the expert analysis done on this topic shows that the patient identity metadata includes the necessary data required to uniquely select a patient from a population with a guaranteed degree of accuracy.
MS. KLOSS: That word guaranteed popped out in the ANPRM. What does that mean?
DR. SUAREZ: With a high degree, high level.
MS. KLOSS: It's probabilistic, though, is it not?
DR. CARR: Well it's their words, not ours.
DR. SUAREZ: It's their words, and they're just stating that the expectation is that that metadata will help with a certain guaranteed degree.
DR. CARR: I think they mean designated.
DR. SUAREZ: This does not seem to reflect the main purpose of this metadata (document and confirm that the data tag is about a specific patient), but rather the second theory, possible use, search and select data about individuals from a population using the identity in the metadata.
We believe ONC needs to rectify the main purpose for which patient identity metadata is being tagged to a summary of care record, and separate and explicitly constrain the use of such metadata for secondary purposes, such as search and selection of patients.
So in other words, what they said is, the patient identity metadata will then be used to do search and selection, and the query health initiative is about that, sending out queries and pulling out data, potentially using this patient metadata. In reality, the primary purpose of patient identity metadata is that when I send data as a provider to another provider, that other provider receives that and confirms that the data that they're about to see is about the patient that the metadata says. That's the main purpose of metadata at patient identity level. A secondary use of it is in this population level gathering of data. So it seems like they're making the secondary use the primary purpose of the metadata. And we're kind of hoping that they will rectify that.
DR. CARR: So we're saying that we think they need to restate the purpose, right?
DR. SUAREZ: We say rectify, but yes, restate.
DR. CARR: Restate the purpose for which patient identity metadata is being tagged to a summary care record.
PARTICIPANT: How about refocus instead of restate?
DR. COHEN: I guess from my perspective, I can interpret the word "select" to mean a variety of different things. You could interpret it broadly to focus; they want to select somebody to make sure it's the right person when it's transmitted, rather than interpreting select in the way you are interpreting it, as culling out one individual from among records.
So I wasn't as troubled – this is just my interpretation of the wording in the advance notice. I didn't distinguish between the intent of their select and what we feel the primary purpose of the rule, which is to make sure you get the right person.
DR. CARR: And also, it's a function, and it will be applied in many ways, and it could be applied to identify a population, but with the proper guidance or governance or oversight, right?
MS. GREENBERG: I'm a little concerned that you might be explicitly constrained. You might be saying things here about the uses of data for secondary purposes that really goes beyond -
DR. CARR: I think that it gets back to our thing about having policies guiding this powerful function, and I think, I wouldn't try to – I mean, the functionality, once it exists, will be used, and I think the focus needs to be on having policies that guide, and governance, whatever.
DR. FRANCIS: Could I suggest wording? When you get down to "We believe ONC needs to, instead of rectify, clarify, the main purpose for which patient identity metadata is being tagged to a summary of care record, and separate and explicitly govern by policy the use of such metadata for secondary purposes.
The only thing I would say is that it's – once this functionality exists, there may be very many other worthy goals that we use it for that are not – so to clarify the primary purpose is, I think, the time limited. I think the key thing is that when you use this functionality, you're guided by policy.
DR. FRANCIS: We're just saying that it needs to be guided by, before you do.
DR. CARR: I'm just saying, it may not be that this is – it may be today, this is a primary use, but tomorrow there may be other uses, so I don't think we should make them say this is the primary use. I think what we want to make them say is that use of this function must be guided by policies governing privacy and confidentiality. What do you think, Walter?
DR. SUAREZ: I think that's fine. The point was really what is the main purpose of patient identity metadata? And there's different purposes. The primary, like I said, is to identify the data that I'm sending to another provider, the provider that is receiving it, to identify that it is the right person. But the analysis and the approach seems to be more about using the patient identity metadata tagging to do population-based analysis. Which is secondary.
MS. SOONTHORNSIMA: Have they stated some example of use cases? Any examples of use cases or any specific use cases that –
DR. SUAREZ: No.
MS. SOONTHORNSIMA: Perhaps that's part of the recommendation, or an observation; be very explicit that before you make any regulations, you would want to be guided by, besides policy, but some specific use cases.
DR. SUAREZ: They need to define the policy for using patient identity, the purpose, and -
MS. SOONTHORNSIMA: That way it's very specific in terms of a framework, anyway, so we're not getting - in terms of the language of the -
DR. WARREN: Does that kind of stuff actually go into an advance notice of rulemaking – the use cases and stuff, because that's what you're asking.
MS. SOONTHORNSIMA: That's what I'm asking, yes.
DR. SUAREZ: Not use cases, but more the purpose, so that the policy and the purpose is really what it's about. Now that's the first paragraph, patient identity. The next paragraph is about the data elements, and we can comment on this or not comment, I guess. We just state that we agree, at the bottom of page four, we agree with the data elements identified for inclusion in the recommended metadata standard, and then we just make a few comments about some of the elements, so on the main element, we do not see the added value of capturing a prefix, but this is perhaps too much -
DR. CARR: I think so, it's too granular, let's drop that and let's try to stay at the higher policy level.
MS. GREENBERG: So what are you keeping? Are you just keeping a statement about – all I kept here was that this functionality of patient identity metadata standards needs to be guided by privacy and confidentiality policies for different use cases.
DR. SUAREZ: Different purposes, for specified purposes. I mean, it's not so much for different use cases, but for specified purposes.
MS. GREENBERG: For specified purposes.
DR. SUAREZ: Yes, I think that's all we need to say.
DR. CARR: I think that's right. All right, provenance.
DR. SUAREZ: Provenance metadata. This is basically, of the three metadata areas, provenance, in our view, represents the area that offers the most promising short-term applicability of the proposed new approach. We agree with the data elements identified for inclusion in the recommended metadata standard for provenance, being a tagged data element, identifier, time stamp, actor, actress, affiliation and birth certificate. We are concerned, however, that het purpose and applicability of the tagged data element identifier is not clearly stated and explained in the ANPRM.
We believe that in defining the provenance metadata standard elements, it would be best to decouple them from any particular security architecture so that the metadata truly relates to and reflects the property of the data itself rather than the security characteristics. And this was a specific question they had about should the security, the digital certificate information, be encoded and embedded in the provenance, or should they decouple provenance from security. And so the recommendation is – but again, this might be getting too much into detail that we really don't need to. I think in the provenance, my only recommendation would be that this is truly one area where people are looking for this type of tagging, that it is one area that they should immediately try to test and develop the standards.
MS. KLOSS: I would support that.
DR. SUAREZ: And then not get into the details of it.
DR. CARR: I would say less is more.
DR. SUAREZ: And then we get into the full privacy metadata standard. So here we have several strong concerns regarding the adoption of metadata standards for tagging a summary of care record document with privacy information, and ultimately, establishment of the meaningful use requirements. Most of these concerns have already been discussed in detail in our August 26 letter on PCAST. We would like to emphasize a few points in this letter, and this is where all these other statements come from.
DR. TANG: So to pare them, we might suggest getting rid of paragraph 3 and 4 – page six. Just paring this down. Number 3 is the liability, and I was talking with Leslie, I'm not sure – it may be a distraction. Number 4 we already talked about as far as the untested stuff. We could just try to get it down.
DR. SUAREZ: Absolutely. Simple.
DR. TANG: I don't know about the next one. It's a little bit wordy, it may be a good point, we could either reduce the words or get rid of it, because it's not –
MS. KLOSS: Are you talking about the one that says – the current metadata standard?
DR. TANG: It's just long. And it seems like you'd have to do a lot of explaining.
DR. CARR: What about five; I mean lastly.
MS. KLOSS: Well for example, on referencing the policy pointer. Standard assumes the existence of a privacy policy repository or registry. That did seem like an important point to underscore, as being ahead of the -
DR. SUAREZ: Paragraph 4 contains some critical elements.
DR. CARR: Let's read it – this one, the content metadata standard as described in the ANPRM –
MS. GREENBERG: Is this still about privacy?
DR. CARR: Yes, privacy. We are concerned that the ANPRM makes –
MS. GREENBERG: Go up one paragraph.
MS. KLOSS: No; the second sentence in that paragraph; for example, the policy pointer standard assumes the existence of a privacy policy repository or registry to which the metadata would point, and that's not in existence. I think it's an important point.
DR. SUAREZ: That's an important point.
MS. KLOSS: It's an example of why more development and testing is needed.
DR. COHEN: - the previous sentence.
DR. CARR: Leave that one back in.
DR. TANG: Actually we say first, we believe the lack of a framework for how privacy metadata would be expected to use, just put that right after that sentence. So that takes care of one paragraph.
DR. SUAREZ: The last one on that page six is kind of a general – it seems clear that the proposed method relies heavily on theoretical concepts and assumptions and little or no actual implementation or even testing of the entire project is available.
DR. TANG: So maybe instead of velocity that's just the concluding thing right before we go to our recommendation. So we haven't dealt with the content metadata standard paragraph. It's sort of interesting; it says if you're supposed to include all the organizational stuff in the metadata, that's a lot of stuff.
DR. SUAREZ: Conceptually, you have to imagine, there's a document of a patient in California, and now you have to tag the Federal law, and let's just say to simplify it, it's not about behavioral health, but you have to tag Federal, HIPAA privacy laws that affect that document's privacy, and then -
DR. TANG: So it's initially, this paragraph, just because it says – this is a simple idea, but wow, I don't know how you would include all that stuff and how would you use it? How would the machine understand; oh, California, let's do – it's not – the concept is simple but the execution will be very challenging, and that's, again, why you need to do the testing. So maybe that paragraph is useful for that.
DR. CARR: So leave that in. So I think – my only other question is, the way we have framed recommendations, this final recommendation doesn't really capture what we're recommending in the other paragraphs. So do we not have recommendations and just have it be a narrative of here are our thoughts, or do we -
DR. SUAREZ: We can just say, in conclusion, it would be premature to move forward with the adoption of standards for metadata tagging via regulations.
DR. COHEN: Take out the heading recommendation.
DR. CARR: I think that's right. That we -
MS. GREENBERG: In conclusion, we believe we want to emphasize -
MS. KLOSS: I had a concept that I thought this conclusion might benefit from; something to the effect that the feasibility in testing and a solution upon which future development can build, because once we determine that this is a viable and useful path, then we need to think more broadly about how it extends beyond this one use case, and looks beyond – on which future development can build.
DR. CARR: We have ten more minutes; it looks pretty good.
DR. COHEN: You need to take out the word privacy -
DR. CARR: 11:30 to 12:00 there was supposed to be discussion of the primer; we took that off the thing. So I guess -
DR. COHEN: Do you want to address Linda's comment? Do you want to add anything to that paragraph?
MS. KLOSS: Maybe change the word system to approach? Pilot and demonstration projects and develop a policy and technology, or policy and standards framework on which future development can be built? Or, and if feasible, develop -
DR. SUAREZ: Yes, before develop; if feasible, before the word develop in that first line on page six.
MS. GREENBERG: If feasible? Why are we putting if feasible there? Oh, first explore the feasibility of such an approach through pilot and demonstration projects, and if feasible -
DR. COHEN: Why don't you put a period after projects and then start a new sentence; if feasible -
MS. GREENBERG: If proven feasible, is that what you're trying to say? Otherwise it sounds – develop a policy framework if it's feasible to develop the policy framework. I think you have to say if proven feasible. If the approach is proven feasible, then –
DR. CARR: Then develop a policy framework.
DR. FRANCIS: Actually, could I try a different way of doing that? To say, the need for ONC to first explore the feasibility through pilot and demonstration projects to inform development of a policy framework.
MS. GREENBERG: Except I thought we'd been saying develop the policy framework first. But can you really not do that?
DR. FRANCIS: That's actually why I said this is pilot testing to inform development of a –
MS. GREENBERG: Because either way you need some policy here.
DR. SUAREZ: In the concluding paragraph, which is NCVHS acknowledges the work and at the same time – believe that the nation cannot afford, we use the word "untested" and I think Paul had pointed out, it would better to say "yet to be tested". New, yet to be tested, standard.
MS. SOONTHORNSIMA: Marjorie, going back to the previous paragraph, to inform development of a policy framework, including governance, purpose/use cases. Is purpose enough?
MS. GREENBERG: You want to put purpose there?
MR. SOONTHORNSIMA: You think purpose is broad enough – but in order to come up with a policy framework, I assume that you have to have some specific use cases are down in the weeds, so to speak, but high level enough; is purpose broad enough to include all the possible use cases?
DR. WARREN: No, I would add use cases. Purpose, to me, is a pretty narrow, succinct statement.
MR. SOONTHORNSIMA: So in that case we want to use "use cases".
MS. GREENBERG: Instead of purpose, you want use cases?
DR. WARREN: Maybe purpose slash use cases. I think that would be better, even though some of us don't like slashes.
MR. SOONTHORNSIMA: That is what I had before.
DR. WARREN: Okay, I think that would be better.
MS. GREENBERG: Even though some of us don't like slashes.
DR. CARR: I think that we have the concepts captured there. I would like to just reserve the right to do a little formatting, or whatever, and so with that, would someone like to make a motion about this letter?
Bruce moves us to adopt, Vickie seconds. Any discussion? All in favor? Any opposed? Any abstentions?
(Whereupon a luncheon recess was taken at 12:00 p.m.)
DR. CARR: Could everybody please take their seats. I'm going to just move to the next item on the agenda and then we'll go back to it when he gets here.
The one question we had, the electronic funds transfer that's in our books, is there anything we were supposed to do with that, or is that just informational?
DR. WARREN: No, that's informational. First time the Committee sees it, we went over it this morning with our committee, so that they are aware of all the things, because we have to look at the operating rules. This is our first time to do this, so we wanted to be sure everybody knew of where we were on the process, in case we're missing something they can holler at us before we're done.
DR. CARR: We'll start with Standards – this is just a report out of where we are. We have Quality, we have Standards. I'm looking for Privacy and Populations. Why don't we start with Judy, if you could give us your report out.
Agenda Item: Committee Report outs
DR. WARREN: Walter's not back yet, but I think it's pretty straightforward. Our Committee met this morning and we went over basically what we're doing with the EFT and ERA. We're really coming in with now it's time for us to actually review the operating rules that have been submitted, and then to make a recommendation to the Secretary for that. So in tab 7, we've given you our best analysis of those rules. We met with the Subcommittee this morning. The subcommittee will have a couple of calls in which we will do the final review of those rules and draft a letter, and then our intent is to have a meeting with the Executive Subcommittee some time, probably the end of October, to put that letter forward to them, and then that letter will come to this Committee in November for approval.
That's one of these that again, I can't say this too many times. As we go through, this is our first operating rule that we're reviewing, so as you see the products that we start sending out to you, really think about that and help us out, because we are starting a process that's new to the Committee.
We also went over the agenda for our hearing in November, which will follow this Committee in the afternoon, and then the second Friday. This is to begin the next round of looking at operating rules. Also to begin the work that we were tasked with in ACA of doing some collaboration with the two HIT committees, odd work to come to some harmonization of looking at standards.
We didn't talk about it this morning, we are going to be following up with the HIPAA document and Ob is taking the lead on drafting of comments and stuff like that. When he and his team are done, that will be shared with Walter and I, and so we're hoping to bring the final HIPAA letter for approval in November, so those will be at least two things that we know will be coming through.
DR. CARR: You've done a great job. Any questions for Judy? Hearing none, let's move to Quality.
DR. MIDDLETON: Well, we had a great meeting with new members, welcomed Linda and Len, Bruce. Jim Walker couldn't make it this morning. Basically had two activities. We reviewed the Quality Committee work with Matt's help, from 2008. We then took a look forward, thinking about, from where we are now, given community health data, initiative activities, given the health benefits exchange activities, given ongoing EHR/PHR adoption, how can we build upon the rich legacy and really deliver some concrete recommendations -
DR. CARR: You're speaking about the former co-Chairs and Chairs?
DR. MIDDLETON: Yes. And I guess the basic thought is, we're going to flesh out a couple of things. One is sort of a picture that integrates the various policy initiatives relevant to the NCVHS, and use that road map of the policy activities and HBE, Health Benefits Exchange, and HIT, and others, to try to identify the opportunity points for really inserting guidance or suggesting guidance. We think there's an intersection between the HIE, HBE, PHR and EHR activities that's relevant to Community Health Data Initiative activities now and what to offer some guidance, what can be done concretely, to help shape the Community Health Data Initiative activities and meet the needs of national priorities and GEMs 10 priorities as well.
So that's a quick recap. We plan to have hearings possibly as early as December, possibly in February, and we're focusing that topic still a little bit further, but anticipate a letter of recommendation from the Committee to the full Committee for consideration, probably in the early Spring, late Winter time frame. What did I miss, Matt and Paul?
DR. TANG: So we also looked at a new sort of a construct; we call it the Lifecycle of Health Conditions or Health Management, thinking that in the current medical model, it starts when you get sick, that's the only thing you need us for. In the future medical model, there's all kinds of things that can affect your health, and it can include non-medical things like the social determinants of health. So could we track someone as they go? And you could think of, let's say obesity; it didn't start that way, but there may be early signals, like what happens in grade school, et cetera, and it doesn't end with what happens in the doctor's office, it can go on with what's the outcome.
So we think of the whole entire lifecycle of an individual's health. We can take signals from all over the place, pre, during and after. And so could we have a measurement system that could track that? Both at the individual level, for individual health partnerships, and at the community population level.
Another aspect is, we talked about this earlier, as a result of our Meaningful Measures workshop, which is, meaningful to whom? And we wanted to make it from the consumer's perspective. And a consumer can't relate to risk-adjusted, all information taken out of measures, but really it should be stratified instead, so they can identify where they are, who they are, what group of health risk are they in, and who does the best job at managing that? So a number of these ideas came from our new members, Len and Bruce, and so we thank them for that.
And the final thing is, it's in some way, it's a recapitulation of our Meaningful Measure letter. It's just – that was written in early 2009, before both HITECH and ACA. So after both of them, it's far more relevant, and perhaps that's one of our entrees into saying hey, look, here's the new world, here are the new needs. Quality measures just didn't have the relevance they do today. And here's what we think it would take, here's the roadmap, or at least a strategic direction they're going. So we're hoping to get that – so Blackford mentioned late winter, early spring, and Justine's new way of trying to be timely as a way of being relevant. We're going to try, even though it's due next month. We're trying to at least come not too late to –- in a time when it can have an influence on regs.
DR. CARR: Did you want to say anything about what Bruce had brought up about informing, like health literacy in a way, for consumers who get this information and what they do with it?
DR. TANG: So Bruce mentioned, I won't say specific health issue, but people have questions about their health. Right now, they go to Google. But wouldn't it be nice if you could identify yourself in these reports and these organizations who concentrate on people like me, not me, people who have, it could be a test they're considering, it could be the result of their test they've just gotten. How do you go the places which would be most pertinent to you, whether it's health education or treatment? So that's part of the before, during and after. It just expands the accessibility of the health information and health advise tremendously.
DR. CARR: So you're having a hearing in the winter, what is that on?
DR. TANG: In some sense, it's going along this life cycle, and what are the challenges, and probably some of these enlightened and inspirational committees we heard from would be input. So whereas we previously focused on what's your story, we might take much more of a data-centric view in terms of what's the data and knowledge that could be made available, the relevant data and knowledge that could be made available, to help you improve your health? It's a bit of a different spin than hey, what are you doing with community health data? And it's that kind of a thing.
DR. MIDDLETON: The only other thing I would add is perhaps at the same time, we could consider how to fold in not only community perspective and details upon their data, as they're making community health assessments, but think about what data are relevant to the individual consumer for a real consumer point of view on his or her own sampling of health issues. Some of those data obviously may intersect with community health data in behavioral, environmental and social.
DR. TANG: This could be input to both Community Health Data Initiative, because they're sort of unleashing liberating the data, but not necessarily spending a lot of time worrying about how it's used, how it's consumed, and also to the whole meaningful use program, where we're trying to get more data captured, but what's the data most relevant to the consumer? So those are a couple of areas, but I'm sure it also influences, let's say ACOs, and Len was educating us on what's required for the insurance exchange. The same quality measure for them to be evaluated is required, and they're having to do this on their own, because there isn't a national standard. It's trying to get ahead of things where if we don't want 50 different system measures, we'd better provide one for them, at least select for them.
DR. CARR: So at the November meeting, what would you see as the activity -
DR. TANG: Probably an update on our scheduled December hearing, where our objectives will be panelists and what are the questions we're going to ask them?
DR. CARR: With regards to Jim's ten priority measures, is there anything planned for that in the near term?
DR. TANG: I think it's just keeping those in mind. We probably won't get to the health insurance coverage, as just an example of one domain. We may focus more on the prevention side. There were some preventions domains he had. We're missing an important point. You know, the new Million Hearts campaign that CMS just started; that could be something we could piggyback on and focus the measurements and the premeasurements, in a sense. Measurements about pre-condition and post-condition follow-up from an outcome point of view.
So we can take that, we can apply it to this high priority that HHS has decided, and figure out how do you measure the pre- and try to intervene at the pre-time, and how do you assess outcomes at the post-time? That's pretty new from a quality measurement point of view, and that would be useful from a PCO kind of design.
DR. CARR: I think that is very very cool, and you put a lot of ideas out, and I think that each of them could take about a year to do, but I think the idea of looking at the -- . So in November I know you're not here in November, but Blackford will give us an update and you'll have sort of a more specific plan around that. And then I think interfacing with the Community Data Initiative is great, to sort of see the intersections and let people know in the event that they might want to attend as well. So very exciting.
DR. WARREN: Do you have dates for the December meeting?
DR. CARR: It's January, I think.
DR. TANG: It's December, right Matt? It's the first week of December.
DR. WARREN: Do you have dates?
DR. TANG: We're looking at the first week, the 5th through 9th time frame. We're trying, obviously, to go ahead of the holidays, because then there's another five-week down time, that's if we can start to set up the questions to answer and the people.
DR. CARR: Very very exciting. So I expect our speaker momentarily, but we could move forward. I think it was Leslie reporting out on everybody else? Is she here?
MS. JACKSON: We think for the population's privacy, just administratively, that the Full Committee was invited, and we built it and you all came. It was one of the first times, not the only time, but we've had a precedent of that, where the Committees realized that the confluence of everybody was important, so rather than have concurrent break outs, we had the one full break out, and just about everybody was there.
Susan provided information on the Community Health Information Project that is going just full steam. We were wondering about the whole -- so much in there, and then wondered about the timing, but it really worked out, we didn't want to – we wanted to take advantage of what was in the report as is, even though there were concerns about it being so broad. So Sally did set up a time frame and schedule that Paul and Blackford will get me suggestions as soon as possible.
DR. CARR: They already did, actually.
MS. JACKSON: Electronically, and I'll pick those up first thing tomorrow, and Susan will revise and report; based on the discussion and the recommendations, we're looking at mid-October to have a revised report, isn't that right, Susan? You can come to the mike as well. And the Joint Populations Privacy Call in that mid-October range, so that the momentum that was established today will continue, all in efforts to have a report in time for review at the Executive Subcommittee in early November, so that everything will be reviewed in time for the November meeting.
DR. TANG: You said something about Blackford and me; what are we supposed to do?
DR. CARR: I think both of you already did.
MS. JACKSON: Yes, that you did yesterday; I haven't picked up – everything that's happening in real time.
DR. CARR: So we'll see at the November meeting, we will have a report then, this report as it is, and then we'll make a decision about whether a letter would follow at the next meeting.
MS. JACKSON: Yes, and that's to capture the amazing amount of work that's already in there, realizing that there's always a series of more to come.
DR. MAYS: In terms of the going forth, we talked about, I think, several things. The one that I will raise is the social determinants; I'm trying to remember without my notes; social determinants, LGBT and there's one other – SES. I'm willing to take a lead on that, because I have a lot of the stuff, having done the same thing about the collection of data for that on the IOM Committee that just finished, in terms of Healthy People, 20/20, leading health indicators.
DR. CARR: Say a little bit more about that; I know it's come up a couple of times, that meeting. So what you're saying is that a direction for the Populations Committee is to address LGBT and SES, and so what would that be, what's the activity?
DR. MAYS: Here's my understanding, is in 4302, there is a series of issues that they're looking for advice on standardization. This is going through the Data Council, as well as, I think, some other aspects of HHS. And I know ASPE is involved, because Susan Queen's working on it. So there has been the request for the race advisory, on race, disability and primary language. The next set that are coming up, which are considered secondary, or it's better to say considered not required, but requested, will be social determinants, LGBT and SES. And SES, the discussion has been to look at indicators. I think the two big issues, and we had a long discussion at IOM about this, is the issue of indicators and linkages; those are the two thing you want in terms of being able to do that.
So my understanding of what we would do is just like they requested a comment on race – they're going to request comments on SES, LGBT and I was less clear about what the request was going to be in terms of social determinants, so I have to get that clear.
DR. CARR: And who's requesting?
DR. MAYS: When the race came out before, it came out from - wasn't that the Data Council that was asking for it? Because I think that's why Jim brought it up.
MS. GREENBERG: - Secretary for Planning and Evaluation. So I don't remember exactly who the request came from, but it's part of the ACA, and they're starting with standards for surveys, and so they have an internal work group, but by the time the request was published, it had like a month; really there wasn't time for the Committee to weigh in, and at that time, Jim suggested that there were some new issues coming along, and they were actually mentioned, I think, in what was published, but - I guess I wasn't clear, I know it's SES and the LGBT –
DR. MAYS: That's what I said – I was less clear, he said it, kind of this last time. Before I thought it was just the two, so that's something that I was going to talk with the staff to get clarity on, because he went through items so fast –
MS. GREENBERG: - social determinants; they're starting to work on that, so the Committee wants to get ahead of it so that they would have something to contribute when the -
DR. CARR: So this would be to hold hearings to get input? What would the input -
DR. MAYS: Again, I think we have to find a time line. And I think the second thing that I would have to do is to find out if there's any material that we've already done that would give us a foundation to stand on as opposed to starting anew.
DR. CARR: I don't think that, at least with LGBT, in the last seven years that I've been here, there hasn't been anything, and SES. So again, is it going to be a – I'm hearing a couple of different things. You're saying there's new work, you're saying the Data Council was looking for something. How does this come together, because we have a couple of models; some are we get an ANPRM, we come together, we draw on our all things and we sit together and talk about it. Some are we're having a hearing, we're going to put something together. I'm trying to understand where in the continuum, and where the expertise comes from. You obviously are, and the IOM has already spoken on this, so why NCVHS, that's sort of rhetorical, and how, because I don't know that we have -
MS. GREENBERG: I thought the way we left it was you wanted me to talk with Jim to find out what their time frame is and what opportunities there might be for the Committee to contribute in a timely way on these things. So would a hearing be useful? I do know that on the LGBT, the Department is holding these listening sessions, and I'm not frankly sure that there's that much more for the Committee to do in that area right now; I think you should get a briefing on it, and we can certainly have Virginia Cain, at a minimum, brief the Population Health Subcommittee, because the next steps, having these listening sessions, and then they're going to pilot some questions in the health interview survey. On that. On the SES, it might be more open-ended, because there are several different – it could be occupation, it could be education, what have you. So I think we have to find out what could be useful.
DR. COHEN: When you talk to Jim, it was incredibly provocative that they're developing these domains. To the extent that the Committee can contribute, operationalizing these domains, particularly with respect to data available for population health, and create standards for the collection of those data related not only to population health but to quality data, I think would be a nice perspective for us to move forward with, so I think when you do talk to Jim, you could find out more about that, that might be useful for the Population Health Committee.
DR. CARR: I think it would be excellent to have a briefing in November, is that possible?
MS. GREENBERG: You could on both, but that might be a little late. I don't know what the timeline is for his work group. I think the same process in which they came up with the other – and of course they drew on all sorts of already-recommended things, but I think they are establishing that work group now on SES, so November might be a little late, although it's the first time the Committee is meeting. I'll check with Jim, and maybe we could have a little conference call with him, a few members of Population Health.
DR. CARR: So at the end of this, however it works out, I want to understand. We can be a part of the conversation if we have something to say, that is. This has not been a topic that's been -
MS. GREENBERG: I've made recommendations, not in LGBT, but on the socioeconomic status, 20 years ago this Committee made recommendations.
DR. CARR: Exactly, I just want to line that up, or if it's a new focus, where we would have hearings, I like Bruce's idea of tying it into work that we're already doing. I think that, again, there are so many aspects to it that we want to make sure that we build on what we already have so that we can continue to enhance the work products that we have.
MS. GREENBERG: And I suggested that if there were a hearing, the Standards Subcommittee should also be involved, and then someone mentioned the Quality Subcommittee; I don't know. So again, it could be. And then there are privacy issues.
DR. CARR: So there will be some conversation and we'll hear what the plan is with that. All right, anything else on populations? Hearing none, we'll hold on Privacy and we will welcome our speaker.
Agenda Item: DHHS Report on Eliminating Health Disparities
DR. GRAHAM: Thank you. I think Jim might have given you a preview of what we're doing, based on your discussions here. So I'm going to touch on that a little bit, and hopefully can clarify terms of some of the questions you had in terms of our timeline, or on our data collections standards, because that is moving fast.
So my name is Garth Graham, and I'm the Director of the Office of Minority Health, the Department of Health and Human Services. When I was asked to give you a briefing on our Department's action plan, strategic plan, if you will, around health disparities, that we released in April of this year, this led to a subsequent series of activities. One big focus of the plan is data, and like I said, I gleaned from what you were talking about that Jim preceded me in talking about some of our data plan, which is good, so I'll kind of give you an update on that as we move forward.
So the kind of onus that came about in terms of developing a disparities plan was twofold; one, after some discussions with our Secretary, she wanted to have a strategic plan that focused on activities and actions, and many of those born out of the Affordable Care Act, but certainly some components of which might not have been included in the Affordable Care Act, but included things that we, as a Department, can and should be doing.
There are a lot of other plans that have been developed over the last year and a half. We have been involved in all of these plans, so there's been a lot of synergy in terms of plan-making, one of the most significant of which has been the national HIV/AIDS strategy, which has served to kind of focus a target along the Department's spending.
Our plan is twofold; I should say the disparities plan is twofold. It's a lot about focused spending and activities, but it also touches on just increased coordination in terms of priority areas. So before I get into that, just kind of background in terms of one of the other plans that we're also significantly involved in, and are also co-leading one, the disparities aspect of it; the national prevention strategy. It was released on June 16 of this year, as a by-product of the National Prevention Council, chaired by the Surgeon General, but more importantly allowed the aspects of dealing with social determinants of health by the representation of seventeen Federal departments and Cabinet secretaries across the board. One of the components of this plan, if you can jump to the bottom of this next slide, is elimination of health disparities. The other areas also deal with health disparities in a contextual manner, but really this is one of the focus areas, and what we try to do, or what we'll do with what I'm going to present to you later on, is show some synergy between a lot of these public – these plans are made very public, and what they do, like I said before, is kind of set a road map in terms of priorities.
You'll notice, as I go through, I'm going to skip through a lot of – trying to get to some of the pertinent areas that I believe you are particularly interested, and touch on much in terms of we're going to be doing our own data, and the data standards. Now we developed the standards, I think Jim spoke to you about today, through the Data Council, our office, Agency for Health Care Research and Quality and CMS, so you'll see me kind of jettison through some of the other slides to spend some time talking about that topic area, because I think that's the most interest to you.
Let me skip to the next slide. What we released on April 8 were two plans. One was a national stakeholder strategy and the other one was the HHS Action Plan. The national stakeholder strategy was the combination of a series of meetings that our department had held with health disparities groups over a two-year time period, and basically started with regional meetings, then national meetings; we had people vote on national priorities, and they came up with five specific overarching goals.
The whole idea was to have a series of activities that stakeholders developed and brought in, along with priorities from the stakeholder world in general, so this included folks in the private sector, housing, education and a number of different areas to define some of those priorities, so to clarify for you, on April 8 we released two plans. One was a stakeholder plan and the other was an HHS plan that basically documented where HHS would be going, at least over the next two years, and we define that in fiscal years.
So we released stakeholder strategy on December 4 at the same time. Then we also released the HHS Action Plan, the Secretary's action plan, that was really developed as a departmental-wide response that the stakeholders wanted to see, with some specific priorities that our Secretary wanted in terms of overarching Secretarial priorities. The momentum for this certainly was building on the Affordable Care Act, but a lot of it was activities outside of the Affordable Care Act.
So the plan was organized in five general areas that are reflective of the Secretary's priority areas, so the Secretary, about a year ago, articulated her priorities for the Department in five specific areas, and we aligned the disparities plan with those generic priority areas, as well as she wanted some overarching priorities for senior leadership at HHS in terms of Secretarial priorities. So a lot of jargon, but suffice it to say, big picture, the Secretary wanted to see some things that are important for her, but she also wanted other activities to be aligned with things that are broader in the department in terms of departmental priorities.
So here are the overarching Secretarial priorities. One was heightening the impact of our HHS policies, programs and resources. Basically, what this meant was looking at what we're spending around disparities, looking at what we're not spending in disparities, having better alignment of resources in terms of what we're directly spending on disparities, and areas where we're not spending those monies that are targeting disparities, wonder if we should be doing that, and how do we heighten the issue of disparities among HHS broadly? Also to look at things such as health disparities impact statements across all our grants. So an example of that would be, quite frankly, if you had a non-disparities-related grant program, understanding what impact that grant program has on disparities, and understanding how we can align some of our grant infrastructure with that.
The second issue was increasing the availability and quality and use of data. You all have been in tune to a lot of these things; certainly, Todd Park has been leading with the Open Government Initiative from the HHS side, but certainly building more on the Affordable Care Act and what we're going to be doing with some of the new standards there.
The third issue was measuring and incentivizing better health care quality, so we're looking at all the money we're going to be spending with the Affordable Care Act, with the Centers for Medicare and Medicaid Services, with things like the Innovation Center, as well as other things that Rick and those guys are leading over there, and understanding, how do we start to incentivize quality in general?
And then last was to, on a biannual basis, review and report on whether we are making any progress, whether all the stuff we're doing is really working, and be able to monitor and measure that and report it publicly. These were the other goal areas that I'm going to touch on.
So one generic goal area was transforming health care and really, within this generic goal area, the main action steps had to do with – these are just a snapshot of some of what was here, but I'll tell you about some that are not here; had to do with mainly the implementation of the Affordable Care Act and how would we implement the Affordable Care Act to emphasize issues around improving access to care? So a lot of it has to do with certainly expanding insurance coverage through Medicaid and things that you've heard about before, but we also wanted to delve more into how do we utilize health information technology, electronic health records, and mix that into everything that we're discussing around health insurance exchanges, new service delivery sites, et cetera. I also wanted to certainly highlight some of the Affordable Care Act provisions, and more importantly, target with specific outreach mechanisms how some of the preventative services that were talked about in the Affordable Care Act, and how do we target minority communities who are most in need of that?
So let me just take a step here and tell you where we're going with health IT in general. We've been working pretty closely with – we started working with David when David Blumenthal was the National Coordinator, and continued to work pretty well with Farzad, on how do we target specific health IT strategies to reduce disparities. We've actually posted, for public comment, some things that we're planning on doing; it actually just went for public comment two weeks ago. That's our bottom post there, in terms of some of the things that ONC will be doing with HRSA, OMH as well as other parts of HHS, to utilize health IT to reduce disparities.
One of the things we noticed, to lead up to the next slide, is that quite frankly, is if you look at the expenditures in the health IT world, government spends a certain perspective, but a larger perspective is really the private sector. So how do we engage private sector folks in a variety of different ways? We started doing that, and over the last month, have announced some local private sector initiatives; one with a Medplus Quest Diagnostics to donate the license for electronic health workers, including equipment and training. We are partnering up with AT&T and just announced last week some mobile health technology that AT&T is going to be donating to work with diabetes educators to allow patients to manage their own diabetes and information about their own diabetes via mobile cell phones, via Smart Phones, actually. All of these are just different examples of how we, in the past month, are working with the private sector, quite frankly because that is where a lot of the onus of expenditures are.
These are some other action steps that we are doing in terms of the plan. I want to skip to the next slide because this contains some of the key things that we are doing. One is, we are really emphasizing the issue of community health workers and promotores. Promotores are community health workers who work mainly in Latino communities who have specific skills and things that we believe are a side of the realm of just how the Federal government normally interacts. We, as a government, sometimes can't reach people that well, but we know that community health workers and promotores in communities are able to do that, so we have been working with a number of folks, including agencies outside of the Department of Health and Human Services, to highlight and support those folks.
We are also redoing our class standards. Many of you are familiar with those. Some of you might not be, but it's a series of cultural and linguistically appropriate services and standards that HHS just had moved forward ten years ago, and we are redoing that as part of this activity.
There is also an emphasis on translation services, so we are working with this issue of certifying interpreters, and what does a certification of interpreters mean. Medicaid is also moving forward on, as many of you know through CHPRA, there are some activities to increase the matching rate that states have in getting aloft to provide translation services and use that as an incentive.
So I'm going to move quickly through some of these, and you can stop me with clearing your throat or a hand signal or something if I'm moving too fast.
Here it just gives you some examples of some population-specific health interventions that are ongoing, many of which are part of the plan, some of which are outside of that. Many of you are familiar with the Community Transformation grants. There's some wording in there that specifically targets minority communities, and the recently launched Million Hearts campaign, that has disparities, and the wording of our plan, as we're developing a plan, we're able to influence some of the way of the Million Hearts initiative. If you're not familiar with the Million Hearts initiative, it's an initiative that was launched by CMS and CDC to basically reduce the burden and incidence of coronary artery disease, cardiovascular disease at large by modifying risk factors in primary prevention, but certainly affecting secondary prevention as well. It's basically to save a million hearts over the next couple of years.
I'm going to briefly mention this here; we're going to go into more detail, this issue of collecting more data. It sounds like Jim has given you a preview of what we're doing here, so this was supported by the Affordable Care Act, but as we're developing this plan, we went outside of the onus of the Affordable Care Act, in terms of some specific data activities, and I'm going to skip over going through that detail now, because it's the last set of slides, that really open up for discussion. I'll talk to you about where we're at with that.
Now another thing that we're doing that's a part of the plan has to do with what was previously known as Comparative Effectiveness Research, but has now come to be known as Patient-Centered Outcomes Research. Whatever the issue, whatever the terminology, we have been developing a series of activities in terms of disparities and minority-related CER. We've started a grant program over at the National Institutes of Health. We've also had some funds coming from our office, and we'll hopefully begin some work with the Patient-Centered Outcome Research Institute, the quary that has been set up by the Affordable Care Act, and had some funds to deal with issues around advancing CER.
So going back to data. The thing is, Jim talked a little bit about what we're going to be doing with data, so section 4302 required that HHS establish data collection standards for five specific demographic categories: race, ethnicity, sex, primary language and disability status. The law said that this must be developed within two years, built from the OMB standards, and that the data be used for analysis and results, and it was prodding the Department to really move on this issue of data.
So in implementing this, we co-led an effort that was nicely supported by Jim and the HHS Data Council, to develop a multi-pronged approach to move forward on the implementation of this particular provision. As we were doing this, we also realized that this provided an opportunity, though not explicitly stated in the law; the law did give the Secretary the ability to develop standards for other areas as well.
So we developed a progression plan for collecting LGBT data, primarily on the National Health Interview Survey, but also allowing other agencies to start doing that. I heard you mention a little bit about the IOM report and some of the things that had been co-occurring there. Granted, when we started this process, we did have the benefit of the IOM report, having already been out, but we also faced some realities that IOM did which is called a budget, and so honesty and the reality of developing a plan, saying that we will do this and then being able to execute it in a time of fiscal challenges, so what we really decided to focus on there was to start – this is now, I'm talking about LGBT data, we have this focus on developing some standards for the National Health Interview Survey, that will get some broad data.
We ended up having a series of listening sessions. We had three listening sessions, and I heard somebody mention before, we're actually not having a whole bunch more listening sessions on certain of the topics that we're talking about. I'll tell you what we have planned.
We had initially three listening sessions, the public health community, minority communities and with LGBT communities, to get input from stakeholders on how we go about doing that. And we also realized that though these standards, as articulated by the law, should apply to all Federal health programs, we knew that from a financial perspective, we could only start with the population health survey data, and then work with ONC and other folks in terms of looking at what they're planning on doing around health information technology, et cetera.
So we put this up for public comment on July first and had it opened up until August 1, a month, and really, the public comment was supposed to be targeted around race and ethnicity and primary disability status. We got a lot of comments about the LGBT area, which we had announced at the same time, but weren't actually soliciting comments on that. We received a total of 466 public comments, and for the most part the comments were generically positive. Certainly we know that a lot of folks had challenges with the law and things that the Affordable Care Act was promulgating, and received some comments around those lines there.
So here's how we broke things down. This might be a duplicate of what Jim did, if he did this earlier – wish I knew he was coming, then I would have coordinated better with his slides, but the proposed standards are in terms of for race, white, black, as you can see here, African-American, Asian, American Indian or Alaskan native – I'm breaking this down into a number of different subsegments – Asian, Indian, Chinese, Filipino, Japanese, Korean, Vietnamese and other Asian. Native Hawaiians, I'm breaking this down into two major, native Hawaiian and other Pacific Islander groups, and then having the option for other Pacific Islanders. Backing up to Hispanic or Latino, Mexican, Mexican-American or Chicano, Puerto Rican, Cuban, and then another blank area for other Hispanic or other Latino origin.
This was a description of the process that we did with the work group we were chairing and kid of what we were planning on doing, and our plan is to, having gotten the public comments, we're in the process now of finalizing these, and I think that's the matter that Jim spoke to you about. And the final standards will be, hopefully very soon, this fall.
The LGBT timeline is different, so the timeline for race, ethnicity, primary language, as dictated by the law, necessitates that we be done with that by the fall of this year, for surveys and other kinds of programmatic activities being next year. The progression plan for LGB and then LGBT is going to take longer, particularly because we did start a listening session activity with transgender researchers to start getting more input on the T part of LGBT. So that might have been what you heard about in terms of ongoing listening sessions. That will be the T part of it. We're not necessarily doing any more listening sessions on the LGB portion, but we're certainly going to be doing some more meetings on the T part of it. We had our first meeting two weeks ago. It was basically half the meeting that was led by Jim's boss, Sherry Glied, with a number of us that put input in that together.
So that gives you a snapshot of where we're going data-wise, and hopefully, I think, what we're trying to figure out is 1. How do we make sure that we do this correctly the first time, particularly on the language part of this – I'm sorry, did I tell you about the language standard? There's also standards for disability, and that we'll be completing as part of this overall process, and language, which Jim might have spoke to you about, trying to distinguish between spoken language and preferred language that is used in medical settings. So all of that part of it will be completed this fall.
So the last line really is about how is HHS going to be able to do all these things that we're putting forward in this plan, and what's our whole thing, so the law has created additional minority health infrastructure, in particular agencies, and we've created this strengthened infrastructure to deal with minority health and health disparities issues. We're going to be working to streamline a lot of our grant processes, and as mentioned before, reporting back on a biannual basis in terms of the progress that we've made overall.
So this October will be the six-month period since the release of the plan, and our Secretary sent out a note to all her agency heads about three months ago, having folks develop these six-month rolling plans that will be evaluated to make sure that we're making progress, and we're going to use that to put that all together in one plan.
So overall, the HHS Action Plan was developed as a response to this national stakeholders series of meetings. It built on health equity provisions from the Affordable Care Act. It was the first ever plan that HHS has ever had. It was not meant to be just something set in stone; it's meant to be fluid. We'll certainly revise this as we revise our progress on a biannual basis.
With a new office of minority health infrastructure in various agencies, as well as the solidification of those minority health infrastructures, we think we have more players on board to be able to execute this. Certainly, we are in the throngs of moving forward and finalizing on our data activities, as you probably heard from Jim earlier, so there's a lot going on. A lot has been supported by the Affordable Care Act, but we've gone outside of the Affordable Care Act to deliver on a lot of things that we thought we should do right now.
If you have any questions about anything –
DR. CARR: I'd like to just put out the first question. Of the top three disparities that are among the many that we are addressing, where are we today, and where do we think these many plans will bring us, and by what date?
DR. GRAHAM: You know, certainly you can slice disparities a lot of different ways; you can slice it by specific diseases in terms of you're looking at cancer, diabetes, heart disease, et cetera, but if there's one thing, if I could take a quote from Ted Kennedy – if there's one disparity that affects all of these that is the most overarching, certainly disparities in access to care. So disparities in access to care impacts all these different numbers. If I was going to articulate this, I would say that's a number one disparity priority. And where we are, if you use the various measurements of access to care, is we are, prior to, I would say, the most recent AHRQ report, maybe about a year ago, we saw that access to care, for the most part, was staying the same for some communities, getting worse for some communities, depending on what measure you were looking at.
Certainly the rate of uninsurance was not getting any better. In fact, if you look at the minority communities that make up the bulk of the uninsured, over half of the uninsured are made up of people in minority communities; you see a worsening in that number and you saw a worsening, especially, for Hispanic communities. So I would say that in terms of looking at the number one priority, which I would say is access, because access affects all the other disease entities, we have seen some a persistence of health disparities.
Now I'll tell you that one of the things that we learned from a recent exercise in terms of how to eliminate a disparity, has to do with disparity around vaccination. So the CDC just published some data, final data last week, showing where we are with flu and annual vaccinations, and for the first time, we've actually eliminated the disparities in vaccination rates for minority children, though the disparities for adults in vaccination rates still stay the same.
Two years ago we did a similar thing, like you saw we're doing here. We did that for flu. We did a big coordinating thing for FLU and vaccines and I think it's worked, quite frankly, and it does show that its issue of coordinating resources, targeting resources and pulling in partners can work in general, and I would say for its biggest disparity, which has to do with access to care. That's what we're trying to get at now, and I think that's a big part of not just ACA but a part of what we're trying to do here.
DR. CARR: Other questions? Leslie?
DR. FRANCIS: This is a question about data and data protection. We're currently involved, the Populations and the Privacy Subcommittee of this committee, we're currently involved in a project that's looking at some of the things that communities are doing to use all kinds of data to improve community health, and one of the questions that's coming up in that is how are communities – what sorts of strategies are communities using to make sure that people can trust that their data will not be misused. I also noted in the Advance Notice of Proposed Rulemaking for Research, a question about whether certain kinds of protections, say for the secondary use of health information and research, whether there might be particular issues with respect to certain communities and the use of their information. And so I'm asking this as an interactionist question; are there things we could do to help you with respect to the question of getting better and better data and putting that data to better and better use? Are there things we could do with respect to data protection initiatives, privacy, confidentiality, and the like, that would help?
DR. GRAHAM: And actually, I feel like as if – I had one big ASK for this group, and I feel like you stole my ASK, because it was going to be along those lines, but you articulated it better, which makes me refine by ASK mid-stream, to re-ask what I was going to ask.
And so here's what I would say. I would say that – I would ask your question two-fold. I would say that one of the challenges that we face with data collection in the generic community and you'll see some of this in a health affairs article that is going to hopefully be published in the next couple of weeks, is certainly the perception and understanding of what we're trying to do with data, influences how people are approaching this. And whether we are adequately protecting their information, as part of either the collection process or the reporting process, is a major concern for folks outside of – a major concern for the average person who is just hearing us talk data, data, data.
And so I would say that we need a lot of help, particularly when it comes to minority communities, in understanding how we articulate some of those protections, as well as figuring out what are some of the best protections for some of the newer kinds of research activities that we're employing, particularly as we move into this issue of CBPR, Community-Based Participatory Research, more, and particularly as we move forward with Comparative Effectiveness Research more and that community engagement model. Simplifying this, to answer your question, I don't have a good answer to your question, because I was going to ask you to help us with those kinds of answers, in that I think we need better explanation to communities of what we're doing with their data and how important their data is, and certainly I think a part of that is certainly understanding how we protect their data better.
I think one of the things we learned from the public comment period around Section 4302 is a lot of people think we are going to – not a lot of people, let me back this up – one thing that we learned is that there are some misperceptions about these data collection improvement efforts and what they're intended to do, and what they will do, and I think there's a lot of misperceptions around privacy, especially about race ethnicity data; not a lot of that embedded in fact, per se, but I think a lot of that embedded in just public perception of that.
DR. FRANCIS: That's great, that's just the answer I was hoping for.
DR. GRAHAM: And with my ASK, it builds on that, my more detailed ASK.
DR. CARR: I believe we have Walter, Bruce, Mike, Vickie and Marjorie.
DR. SUAREZ: Walter Suarez. I'm very pleased to hear about the plan; I'm a member of the National Health IT Disparities effort, and this is very exciting. On the lines of what Leslie was asking, actually, one of the interesting elements on privacy is this famous, under HIPAA, Notice of Privacy Practice, that entities have to provide their patients. I actually worked on translating the Notice of Privacy Practice from English to Spanish in a number of places, and found how amazing some of the translations of those turn things around in a way that actually, the entities that are giving those to the patients don't even realize. Things like the way they explain data will be used turns out to be totally the opposite of what it is supposed to say, and they don't even realize that they are telling that to the consumers, but the person that is delivering it, of course, doesn't necessarily speak Spanish. So I think improvements in the education, as you point out, and in the communication to non-English speaking minorities on how health information is to be used and the privacy rights and expectations, it's going to be very valuable.
The other aspect I guess I wanted to touch on was the extent to which some of these standards are going to be sort of pushed, or moved, not pushed, moved into the standards that we are using to capture data through electronic health records; of course, under the current Meaningful Use program, they have incorporated, and we were very pleased to see that, of course, incorporating information around race and ethnicity and language preferences and things like that, and they reference in those regulations the specific standards, but as this new section 4302 defines the newer standard, or the newer categories of breaking race and ethnicity, how will that be incorporated back into the requirements?
DR. GRAHAM: So part of the challenge with this, to answer your last question first, but I do want to talk about your other question, because it also goes back into the more detailed component of this ASK, so HITECH helped put in place a lot of the meaningful use issues and a lot of the Standards Committee and all those processes had already started before this work got underway. So one of the challenges that we face, in terms of phasing this in, is recognizing that this wasn't a planned, staggered process per se, and I think the Standards Committee, they were doing a good thing. Based on the information they had at that time.
And so they moved forward and those things are moved forward, so we've been talking with ONC about just that, how do we recognize the good work that has been done but incorporate this eventually? Basically, what we've decided to do is to genuinely do a staggered approach, so to the extent, because this even hasn't been finalized yet, so that's a challenge; it's like two trains that need to meet and what we're going to try to do is to force them to meet down the line, but understand the practicality is, those two trains can't meet right away, because that other process was underway in a well meaningful process, underway well before.
Let me go back to your last issue about the translation issue so that people understand how important this is, not just in terms of Health Information Technology, but if you look at some of the issues that have come up in translation just for informed consent processes, right, so when people are doing clinical trials, if you also look at the widest gap in last year's National Health Care Disparities Report for Hispanic populations, was the ability, I'm going to paraphrase this, basically the gap in whether parents thought that their provider was communicating well to them about their child. That was the largest disparity gap in terms of all the various disparity measures, or especially in terms of a proxy quality measure.
So how concerning is that – the thing that's getting worse is you don't know if your doctor is understanding what you're saying to them about your child, and then vice versa. So these language issues, and then you overlay on that just the dramatic growth rate in terms of the very plethora of languages that are being spoken in any urban community, and certainly the growth rate in the Hispanic community, you understand just how quickly we have to move on these language access issues, and why we targeted Medicaid as a particular incentivization structure to help promote language issues.
I guess another issue is that a lot of people think, well, I speak English so that's fine for me, but it really isn't. Because these population dynamics affect health care everywhere, and affect the way everything is happening, and if you look at the data, that's just where things are going. So quite frankly, I think this is one of the key most important challenges. It's going to be hard, because obviously, we're trying to deal with these challenges in a time of other fiscal challenges, but I believe what we're trying to do with incentivization of language access, particularly in Medicaid, is particularly important.
DR. SUAREZ: Thank you so much for your amazing leadership on these issues.
DR. CARR: Bruce?
DR. COHEN: I've got an ask for you. I'll do half an ask. I'm from the State Health Department in Massachusetts, and we've gone beyond the OMB regs with respect to collecting race and ethnicity data, and this has to do with our experience, that I think is a key issue that hasn't been addressed by OMH and by other Federal agencies, and it's essentially the encounter that collects race and ethnicity information, we found that the real key to making this a constructive, rather than an adversarial encounter, is training. And my ask is, for regardless of the standards developed, is OMH dedicating resources, and is all of HHS dedicating resources, for training of those who are responsible for collecting the data? Initially, I know, the primary focus is on health surveys, but the reality is, and as we discussed, this will all trickle down to all health surveillance data sets, it will be incorporated into electronic health records, and we went out into communities, the people least able to collect this information are the registration clerks in hospitals, and a lot of the front line people in community organizations, because they aren't instructed about why they're collecting it, how they're collecting it and how to respond to reasonable concerns of clients and consumers.
DR. GRAHAM: I'll say, on a practical level, certainly the OMH budget, neither has the HHS budget, for those of you who will soon see the 2012 budget, have not dramatically increased. So there is not necessarily a huge infusion of new cash to do a lot of this training. So part of what we're trying to do is to move this out very slowly and then be able to utilize a lot of our local networks for this training.
Now we have learned a lot from Massachusetts, especially with Howard Colby being involved at the helm of this. We have learned so much. I've read so much about Massachusetts; it's just served to educate me even better. And I'll tell you that there is an additional component which goes back to the privacy issue in Massachusetts that I think also came up, and I think that the best answer I can say is we're going to move slowly on this, certainly we're going to continue to move things on a staggered fashion. We're going to try and incorporate training as much as possible, realizing the realities of our budget climate, and I think also, what we did learn from Massachusetts, and what we are learning, especially from our public comment period, is how do you do this bidirectional communication from folks in an efficient way so people don't think that you are trying to come in there and ask them about their race to use that in a nefarious manner or something along those lines. So this is not a simple, easy topic.
And it is not going to necessarily be a simple, easy thing. But to go, I think I'm running out of time, so can I end with my last ask?
DR. CARR: From our side, you're not running out of time. Because you started at 1:20, we'll give you your full time.
DR. GRAHAM: I think we need a lot of input and thought from you all on this issue of both privacy, in terms of how we continue to protect, but privacy in terms of generic communication, and that latter part, for me, is what struck me the most in terms of what we were trying to do. I'm just going to plead ignorance and assume that most people thought that we were using this for the better good of the rest of the world, but I'll tell you there are certainly a lot of misconceptions about the privacy issues around data, and certainly, once you get into some of the more sensitive issues, and even when you get into more sensitive issues, like sexual orientation and things along those lines, you trigger all kinds of different emotional privacy challenges. But the flip side of it is, we do need to collect this data to better define the problem, so I think – I'm not sure Jim talked to you on this earlier – I think one of the things we would certainly want to come back and hear from you and engage in dialogue with you, is communicating to communities about how important this is, particular minority communities.
I'm not sure if my uncle understands how important this is. I'm not sure my own family understands how important this is. Even in that realm, I'm not sure I've communicated it that well. So then take, for instance, a lay person on the street whose program wants to collect data on race and ethnicity and sexual orientation – this triggers all kinds of dynamics. So I think the issue of privacy is, I think, of paramount importance in terms of being able to use some collective wisdom to help chart our path forward.
DR. CARR: We have a couple other folks; happy to put you on, Walter, after the others. Mike?
DR. FITZMAURICE: Let me join the applause for all the action and activity that you're doing; I think that's great. A couple of questions. Are your categories mutually exclusive; that is, if you add them up will you get 100 percent of the population, or is there some double counting because some people can be more than one?
DR. GRAHAM: I guess if we're just thinking not on a disability or language, if we're just sticking with race and ethnicity, I guess theoretically it would be mutually exclusive. There are some challenges with that, of course, in the mixed race category, and that's part of our ongoing discussions. We tried to mirror as much as possible the American Community Survey and the sense of dynamics there, as well as the calls for restrictions, because one of the things, as Dr. Cohen pointed out, that we view, we know it's going to trickle down, so we know that whatever we do might impact a state that might not be ready for this, so we are trying to do that, but one of the challenges will be to that level of mutual exclusivity and how do we incorporate the mixed dynamics of our culture?
DR. FITZMAURICE: You're saying they're in line with OMB, they roll up into the OMB categories, correct?
DR. GRAHAM: Yes, exactly.
DR. FITZMAURICE: Did the Committee look at the levels of evidence needed; for example, if somebody is taking in people for a program, they can use their own eyeball, they can use the person's last name, they can ask the person, what do you consider yourself to be? Is there –
DR. GRAHAM: Yes, I think there was some discussions about that in terms of the overall scientific validity of the self-report, or the co-self report, if you're there and somebody's asking you, what are you reporting. And I think there's always some challenges in there. There's always some challenges with the issue of surname data, although there's some good data that show that actually it works in terms of identifying folks, we just decided that, so I think there was a lot of discussion around that, but I think the decision was to continue to go with the self-report aspect.
DR. FITZMAURICE: I think essentially it's not so much a matter of the scientific validity of which category a person falls into, but are they really deprived of access? Are they really getting a different quality of care? And being able to discern that in scientific studies.
DR. CARR: I have Vickie, then Len, Marjorie, Paul, Walter, and we'll close. So Vickie, you're up next.
DR. MAYS: Thanks, Garth, for your presentation. A couple of questions, because I'm trying to ensure I have some clarity about what's done and what's the agenda that is left to do. In looking at your slide, I guess what I understand is that you got LGBT comments within the race/ethnicity request?
DR. GRAHAM: No.
DR. MAYS: So those came in through the listening sessions?
DR. GRAHAM: Maybe I should have explained that better. The law basically dictated the five areas; race, ethnicity, primary language, disability status and sex. It also gave the Secretary the ability to designate or develop standards for additional areas. What the law did say was that we needed to develop the five basically by this fall for it to kick in by next year. It did not say and it didn't really put any strict time lines on the other areas.
Now I think, as Jim pointed out to you, age and socioeconomic status, along with LGB and then LGBT, are the other areas that we're kind of proposing over time. So to be very clear on the LGB portion, we did not believe that there was enough data ready to propose a definitive LGB or LGBT standard by this fall, by what we're supposed to do. And that had to do with some challenges that the – and I think Virginia can articulate it better when she comes to talk to you. But certainly, as they were doing the National Health Interview Survey, some pretesting they had done on LGB questions had shown some challenges there, so what we wanted to do was to say to the community, we want to develop an LGB standard. We want to develop activities to improve data collection for LGB and LGBT populations. It's not ready now, but we're going to outline a plan to get there that includes some funding for the NCHS to do some more testing, and that‘s where they are in, and that's what Jim talked to you a little bit about today.
So that's a separate but related train, but the train on the five standards, race, ethnicity, sex, primary language and disability status, that train has left the building and arriving where it's supposed to arrive this fall, and the LGB train has left the building and will take a longer time to arrive where it's supposed to be.
DR. MAYS: Let me make some comments, because like you reading Massachusetts, I suggest reading California, because we have a lot of data on this, and I know that there is some testing that's going on. I wish Susan Queen was here, because she could also talk a little bit more about that; this particular issue.
DR. GRAHAM: Susan Queen from ASPE?
DR. MAYS: Yes.
DR. GRAHAM: Susan has been involved in –
DR. MAYS: Exactly, that's what I'm saying. I think she could tell you how much data there really is on that, and it's a scientific issue, because it's actually been in the surveys off and on for –
DR. GRAHAM: We discussed that at length, and stuff with the CHIS and what's been going on there –
DR. MAYS: It's not the CHIS, it's actually we have the Williams Institute, there are several other data sources. Some of us have been publishing several years on the data that actually comes from some of the HHS surveys. But let me ask my other questions then.
The TI, there's listening sessions, I agree, I think that that's going to take much longer. One of these I'm looking at is the proposed standard in line with OMB. When you have proposed data standards for race, you have then the Asian category, and then you have native Hawaiians or other Pacific Islanders. In the past we'd actually had Asians, native Hawaiians and other Pacific Islanders, and I know that Inoue was very instrumental in making sure that native Hawaiians actually were pulled out and had their separate count because they have a set of very unique issues in terms of those who were in Hawaii, those on the mainland, et cetera.
In this, it's actually being – unless I don't understand it correctly, it seems that that's being back-ended to what we used to –
DR. GRAHAM: No, it's not. It's pulled out. So it's Asian standards, then we have the native Hawaiian standards. It might be just how it's presented there.
DR. MAYS: Yes, because it says native Hawaiian or – Okay.
DR. GRAHAM: Definitely did not want to do that.
DR. MAYS: It's a little different on the slide.
DR. GRAHAM: It might have been just the way that my slides are –
DR. CARR: Okay, Len?
DR. NICHOLS: Well thanks for a great talk, and Lord knows, Godspeed. It raises three questions from me, one of which picks up on Mike's.
I was struck, in the public comments, what I would have guessed, and that is a lot of guessing, a lot of recommendation, of a multiracial category, and yet the decision was made not to have one.
DR. GRAHAM: I can't say this –- the standards aren't final. I mean, that was the original proposed standards, these are the comments. So I'm just saying that we haven't – the final –
DR. NICHOLS: So this slide is not what you're recommending?
DR. GRAHAM: Those slides are what was put out for public comment and in the comments you see what was received in response to those public comments.
DR. NICHOLS: Okay. So the final decision has not been made yet –
DR. GRAHAM: No; I was saying, that's a train that's going to be arriving this fall.
DR. NICHOLS: So where I'm headed is, have we changed enough, even with what you put out for comment, that we're going to have to go back and redo baselines to really have a sense of how to measure changing disparities –
DR. GRAHAM: You're saying has the makeup of the –
DR. NICHOLS: I guess the advantage of rolling up to OMB is you can always go back to the old Latino, whatever.
DR. GRAHAM: This gets into an interesting issue. And it goes into basically the bang for the buck. So how much have things really changed? So though we know that, for example, there are more – I use myself, for example, knowing that there are more Caribbean Americans here, is it worthwhile asking a question about Caribbean Americans because I know that in New York City they have got a ton of Jamaicans, and answer to that, basically, is from a fiscal perspective, no. So though there might be areas where you would like to see further development and further expansion, it's not entirely clear whether there is just enough population dynamics there, even though it's changed over years, to be able to adequately say we are going to say everybody should do this, and you know that states are going to adopt doing that, and so I guess what I'm saying is, I think we actually still have, just in terms of percentages of people in the United States, it still does really roll back up, because things, though they've changed, a lot of the drivers have been changes in the Hispanic community in terms of major population demographics, changes in Asian-American community in terms of the fastest-growing community, and though the mixed community has grown relative to where they've been the question is still whether that end number is still just as much as the others, if that makes sense. So a lot of the questions we got, the mix of black may change, but we still want to know if black is different from white.
DR. GRAHAM: Exactly. Because a lot of the mixes, and we got a lot of questions, especially when we did the release, a lot of people were well, you should do more Caribbean-Americans, you should do more X Americans, and though, like I said, I would have liked to have said yes, we will, it just wasn't that practical benefit in terms of making that the baseline standard.
Now surveys can go deeper, and if you're doing a survey in some place where there is so much more diversity, then you can go deeper, but I'm not sure if adding on Caribbean-American across the board will be helpful to the folks in – I don't want to be disparaging to any state, but just the place where the density might not be higher. Does that make sense?
DR. NICHOLS: It does, although I would point out that to an interviewer's point of view, it would be very easy to recognize by the lilt in your voice, we do love that. That is easy to pick.
But the last question is on this question of T. What is the a priori guess about the percentage of the population that is T? And the reason I ask the question is simply, I remember in the health insurance world, where I used to spend a lot of my time, a lot of focus on this issue of have you been denied an insurance offer? And we asked the question over and over again, and in the population at large, it's like less than 1 percent, couldn't pick it up, HRQ dropped the question after a while.
So I just – I don't mean to imply in any way T's aren't worth study, because there's lots of clinical implications, et cetera, but maybe the survey apparatus is not the one to get to them, and maybe –
DR. GRAHAM: Well that's why we're having these, a lot of these discussions. Because if I was going to pay devil's advocate, a lot of folks might say well, you haven't asked about how many T's are out there, so you don't really know. So it is certainly at the national level, breaking new ground, so we are trying to hear from as many experts as possible, because we don't know what we don't know, and I think that the criticism of what we don't know on the T end is – it feels like we don't know what we don't know, so we need to do something to understand what we don't know. So basically what we're doing now with these listening sessions is just hearing from people who have been knee-deep in this, to figure out what we do know and what we don't know.
DR. CARR: Okay, so we have Marjorie, then Paul, then Walter. Marjorie?
MS. GREENBERG: One quick clarification; in the race/ethnicity, people – at least in what you put out, you are recommending a person can report more than one.
DR. GRAHAM: Certainly I think we might, going back to that earlier question, certainly we're trying to have things roll up to some degree into the prior OMB categories, but we're not banning anyone from being able to self-report –
MS. GREENBERG: But the OMB standard now requires – you have to be able to give the person an opportunity –
DR. GRAHAM: That's the tail part of my answer. You have the opportunity to do –
MS. GREENBERG: That's a different issue than having a category called multiracial. So it's consistent with the OMB guidance that you can report more than one? That was not my question, that just came up in this last discussion. My question was, and you may have heard us talking about this when you came in, it's my understanding the next issue, in addition to LGBT, we've talked about that, is the socioeconomic status? Do you know what the timeline is for that? Because that's an area that –
DR. GRAHAM: We are hoping that the Data Council and those folks will be able to complete that in about a six-month timeline period, starting soon. So unless, and I'm hoping I didn't put Jim on the spot, because he might have said a year; if he said a year, go with what he said.
But if not, I think the plan is to actually tackle that next. So we're finishing up this, and kind of putting this out there, and the plan is to tackle that, because it is part of what we are recommending eventually, we just didn't have a standard right now.
DR. CARR: Paul?
DR. TANG: Thanks Garth, for an incredible report and work. I just want to make sure, for meaningful use, that we're getting aligned with you. I think I heard what you said is, when we first came out with stage one, that was before the IOM, so we did what we did at the time; are you – we're headed for the IOM granularity in stage three. Is that aligned with you or not? Because you made a comment about what's nice, but what's feasible.
DR. GRAHAM: That's just in terms of all of these different categories.
DR. TANG: Yes. That's this work and the meaningful – we want, actually, all the work to be –- I want to make sure I understand what your –
DR. GRAHAM: I guess what I'm saying is I'm not sure we could ever deliver on the level of granularity that the IOM recommended in a practical context. I am not saying that it's not needed, I'm saying that particularly, even in areas like electronic health records, and trying to balance the workload, that when IOM data people come to present to us, actually, and I think actually presented to us twice, I think part of the challenge, I'm speaking for myself here as the person involved in all of this, is it certainly is good thinking, certainly very much scientifically based, but once you get into the practicalities of going beyond a certain level of granularity, you get into some financial challenges, both at the Federal and local level, that make that challenging to do on a practical level.
So I think that it's good for the IOM to recommend it. I think it's harder for us to say you know what, Minnesota; you should be doing all of this, or you know what, - because it gets into just fiscal challenges.
DR. TANG: But if we require the ability to store this information, using those granular codes, in the EHR, is that a good thing? It sound like, by what you said, it might be a good thing for you; first of all, you're not making the ask, because you guys had this –
DR. GRAHAM: That's a good question, actually.
DR. COHEN: We're requiring hospitals now to report not only five broad race groups, but thirty-two detailed ethnicity groups. So they're collecting those data; it's only one more data field with thirty-two responses. So the answer is, how you use it analytically, but the actual task of data collection, if people are trained, is not that difficult –
DR. TANG: I think it goes back to training – can't remember which of you to ask, but it's training, one, how to do it, how to do it appropriately, but also how to do it accurately. Because otherwise we're going to really mess things up.
So you would not have an objection if this data were to magically populate –
DR. GRAHAM: No, I would not have an objection. From my personal standpoint. I wouldn't have an objection; there's just a lot of practical challenges.
DR. CARR: And Walter, last question.
DR. SUAREZ: This is more a comment than anything, but on the privacy side, going back to that comment, on the part that you mentioned about educating the community, the different audience, about this in a culturally appropriate way, OCR, the Office for Civil Rights, is responsible, and is now developing and maybe it's already starting to implement, a national campaign to educate people, just in general the community, about the benefits of electronic health records and particularly the aspects related to privacy and security, so I don't know – there is a connection, of course, between that national campaign and elements of that campaign to be directed to minority communities –
DR. GRAHAM: It's a good point, actually, and you know, the leadership at OSA just recently changed and they have a new dynamic leader, so I think it's something we can explore. Those actually are good points, so thank you for bringing that up.
DR. CARR: Well thank you for that very stimulating presentation and the great work. I appreciate it very much.
Agenda Item: Committee Report Outs (Continued)
Okay, we have one and a half report outs to do. Leslie tells me that she had some additional information on the population, so you take us through that.
DR. FRANCIS: First of all, I apologize that I stepped out just when I wasn't supposed to. This is what Sallie left me from Populations. I don't know if she left the same thing for Debbie or not – you have that? This piece, from Sallie? Then the Populations is taken care of. Privacy is working with Populations on the CHIP report. Privacy also, as a one-person band, I sent around my effort to clip out various thoughts that people had had over the last four years of next steps and what had been accomplished, and so on, and now that in the Chair role, we are once again a happy duet, the Committee is, that is, and also Linda and I are, we will be talking over the next week or so about the ANPRM. I will be getting in touch with people about some areas; I know several people have volunteered, and we'll have a draft of that out.
We'll be talking about further contributions to the CHIP report, and will be speaking to next steps with respect, I think particularly, to what we just heard. So that's what I have to report out, and I'll ask Linda if she wants to add anything.
DR. CARR: Walter? Judy did the report out on Standards.
DR. SUAREZ: She did?
DR. CARR: I'm sorry, because we had the window of time, Judy reported on Standards, and Debbie reported on Population. Paul and Blackford did Quality and now we've heard from Privacy.
DR. SUAREZ: If I may just, one second comment – during the Standards Subcommittee, we mentioned this, but it's worth mentioning to the entire committee – in November, and she mentioned it, I'm sure, Judy did, we're going to have three hearings, one on claim attachments, one on Section 10109 of the Affordable Care Act that deals with some future areas for standardization, and then one hearing on the standards and operating rules maintenance process and trying to find ways to improve that process.
So those are three hearings that we're going to have in November, but the important point I want to make is –
PARTICIPANT: On the same day?
DR. SUAREZ: No, there's going to be November 17 from 1:30 to 5:00; the afternoon of our Full Committee second day meeting. So the second day of November 17, the Full Committee will probably need to adjourn around 12:30, and then at 1:30 we're going to do the afternoon hearing on claim attachments, and then on Friday morning we're going to do the hearing on the Section 10109, which deals with Workers' Compensation, with claim edits, standardization, things like that. And in the afternoon on Friday the 18th, we will be doing the third hearing, which is on the improvement of the standards and operating rules maintenance process.
But what I wanted to mention is, this is all part of the Affordable Care Act request for NCVHS to provide input on these new areas, but the Affordable Care Act also calls for the Health IT Policy Committee and so Paul, this is mentioning for you the Health IT Policy Committee and the Health IT Standards Committee, to provide feedback as well, so we're going to be inviting members of the HIT Policy Committee and members of the HIT Standards Committee to join those hearings and so just wanted to bring it up as an information item.
DR. CARR: So just to recap, that means that some folks will be coming in for the NAHDO lunch, right? For that panel, that's Tuesday. The meeting is Wednesday and Thursday. Thursday afternoon is Standards claims, and then Friday is operating rules and the 10109.
Busy, busy week.
MS. JACKSON: Following up on that, thanks for putting that in the official record. We will be planning the November agenda to adjourn accordingly, and this is the shortest period between meetings that we have, between September and November; this is essentially October, as it were, -- need to get a lot of the action items, the items that I have for action so far are the Community Health Information Data Report, the HIPAA report will be in action, and then the EFT Operating Rules. And then you would let me know if there are any briefings that you would want, but the Executive Subcommittee will be very busy with these materials coming in by November 1, essentially, for all these actions.
DR. CARR: Is there anybody that we want to have a briefing from then at that meeting?
MS. GREENBERG: You mentioned on the LGBT and the SES. It sounds like somebody said the six months –
DR. MAYS: Let's see, what's frustrating is to have one and then you don't have time to talk. If we're going to join at 12:30, that's a really short time to talk about all this stuff. I'd like to --, because I think there's some other – I want to make sure that if we do it, that one, we have time to propose the questions that we want them to talk about, and then that we have time to talk about what that means. So I think we need to look at the agenda, and then let's you and I and whoever else have a discussion with Jim so that there's greater clarity, because there are also other people involved who are really leading this train.
DR. CARR: And I think also if you want to include the Co-Chairs –
DR. SUAREZ: Just for clarification, the full Committee needs a full day and a half, so we have a full day on Wednesday and a half day Thursday, so it's not just a half day Thursday, the full Committee, we do have a full day of Wednesday.
DR. MAYS: I thought we usually end around three, so we're ending around –
DR. SUAREZ: On Thursday.
DR. CARR: On the other hand, that week, I don't see how we can put any more in that week.
All right, Leslie?
DR. FRANCIS: Two second question, I was just trying to check a calendar. Do we know what day the last Friday in October is?
DR. SUAREZ: Last Friday?
DR. FRANCIS: The 28th. That's after – our last Friday of the month is our regularly scheduled –
MS. GREENBERG: No, the third Friday. – Set up October the 21st to approve -
DR. FRANCIS: So make sure – on the ANPRM.
MS. GREENBERG: You will need that set aside time on the 21st.
DR. FRANCIS: So I'm just reminding people.
DR. CARR: Debbie could you send out or make sure that everybody gets it on their calendar officially?
DR. SUAREZ: And then we need to set up a meeting of the Executive Committee in early November to review all the things that are going to come back to the full Committee.
MS. GREENBERG: We had also talked about something more extensive with the Executive Subcommittee, but we'll have to talk about that off-line.
And last night people were even talking about the value of having like a one-day, obviously not in November, but kind of retreat, in a sense, of the full Committee, to really – because we're always –
DR. CARR: All right, so let's put that on the agenda for November. But I don't see that we can fit anything more.
MS. GREENBERG: Not in November, no.
DR. CARR: Okay, is there anything else? Now we really are adjourned, so thank you everyone.
DR. SUAREZ: Thank you.
(Whereupon, the meeting adjourned at 3:00 p.m.)