[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

September 28, 2016

Courtyard Marriott
Congressional/Monument Room
1325 2nd Street, NE
Washington, D.C.

Table of Contents

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

Agenda Item: Call to Order, Review Agenda

DR. SUAREZ: Good morning everyone, and welcome to the National Committee on Vital and Health Statistics meeting. My name is Walter Suarez and I am the Chair of the National Committee and I welcome you all to this meeting. We have a very packed agenda for the next couple of days and we have a number of important announcements and messages, so we’re going to go ahead and start right away. We are going to go around and introduce ourselves, the company you are with and the group you are in within the National Committee, and whether you have a conflict.

I am, again, Walter Suarez. I am with Kaiser Permanente, Chair of the National Committee, and I don’t have any conflicts.

DR. MAYS: Vickie Mays, University of California, Los Angeles. I’m a member of the committee and I am on Pop and Privacy and the review, and the Workgroup, and I don’t have any conflicts.

MS. KLOSS: Linda Kloss, Kloss Strategic Advisors. I’m a member of the full committee, Co-Chair of the Privacy, Confidentiality and Security Subcommittee, member of the Standards Subcommittee, and I have no conflicts.

MR. COUSSOLE: I am Nick Coussoule with Blue Cross/Blue Shield of Tennessee. I’m Co-Chair of the Standards Subcommittee and a member of the Privacy Subcommittee and I have no conflicts.

DR. PHILIPS: Bob Phillips, Vice President for Research and Policy, American Board of Family Medicine. I’m a member of the full committee, Population and Health Subcommittee and Privacy and Security Subcommittee. No conflicts.

MS. LOVE: Denise Love, National Association of Health Data Organizations, an all-payer claims database council learning collaborative. I’m a member of the full committee. I am a part-time member of the Standards and Population Subcommittees; no conflicts.

MR. LANDEN: Rich Landen, Harris QuadraMed, member of the Standards Subcommittee and the Review Committee, no conflicts.

DR. RIPPEN: Helga Rippen, Allergy, member of the full committee, the Privacy, the Population Health and also the Data Workgroup, and I have no conflicts.

DR. ROSS: Dave Ross, President and CEO of the Task Force for Global Health and also on faculty at Emery University, on the Pop Health Subcommittee, and I have no conflicts.

DR. CORNELIUS: Good morning. I am Llewellyn Cornelius, a faculty member at the University of Georgia, member of the full committee and Population Health Subcommittee. I have no conflicts.

DR. O’GRADY: I am Michael O’Grady. I’m with the University of Chicago NORC at the University of Chicago and O’Grady Health Policy. I’m a member of the full committee and the Population Subcommittee. No conflict.

MS. EVANS: I am Barbara Evans. I am a law professor at the University of Houston Law Center. I’m a member of the full committee and I’m Co-Chair of the Privacy, Confidentiality and Security Subcommittee, and I have no conflicts.

MS. GOSS: Good morning. I am Alix Goss. I will be joining Imprado, which is a consultancy division of DynaVet Solutions. I am the Co-Chair of the Subcommittee for Standards and the Review Committee, and I have no conflicts.

DR. COHEN: Good morning, I am Bruce Cohen, Massachusetts Department of Public Health, member of the full committee, Co-Chair of Population Health, no conflicts.

DR. STEAD: Good morning, I am Bill Stead, Vanderbilt University Medical Center. I’m a member of the full committee, Co-Chair of Pop Health and a member of the Review Committee. No conflicts.

DR. SUAREZ: Is there anybody on the phone that’s a member? Okay. According to the rules, we go to ex officio members and liaison representatives.

MR. SCANLON: I am Jim Scanlon; I’m Deputy Assistant Secretary for Planning and Evaluation at HHS, and I am the Staff Director for the full committee. After years of therapy, I still have conflicts.

(Laughter)

MS. HINES: Good morning. I’m Rebecca Hines, Executive Secretary and designated federal official, and I’m with the National Center for Health Statistics.

DR. SUZAREZ: Other members or ex officio or liaison representatives? Anyone on the phone?

(No response)

Okay, we will go through the room.

(Introductions from audience)

Agenda Item: Committee Updates

DR. SUAREZ: Okay, I think that is it. We can formally confirm that we do have a quorum to proceed, with over 10 members.

You all have copies of the Agenda. We are going to start with some committee updates. I’ll say a couple quick words and then turn it over to a couple of the committee members that have, over the last two or so months, interacted externally from the National Committee with others that we would like to hear about.

Very briefly, probably the most significant event that happened between the last meeting and this one was on August 21st when we celebrated the 20th Anniversary of the signage of the HIPAA legislation in 1996. There was a special ceremony actually held at the Department of Health and Human Services. I was able to attend along with a lot of friendly and very dear friends and colleagues that represented other departments back in those days when HIPAA was being developed and then when the rulemaking process started. So I just want to acknowledge that and remember that 20 years ago, we got a major new charge as a national committee.

I know there are a couple other members who want to express a few thoughts on an activity that happened. I think, Rich, you have some things to report and I believe Bob also.

MR. LANDEN: Thank you, Walter. I was honored to represent the NCVHS and give a presentation to a group called the National Plan Automation Group. This happened last week just north of Charleston, South Carolina. The NPAG group is a group of EDI professionals of the Blue Cross/Blue Shield plans from across the country, about 50 in attendance. Mainly, the audience was EDI professionals with the Blue plans that are dealing with the HIPAA name transactions and also have provider relations responsibility in the area of data exchange.

I presented to them what we have been doing, gave them an overview of NCVHS, talked about the recent reports, talked about what’s on the Agenda, so I hope many of them are listening in to the Webcast this morning. Then I also laid out the work plan for next year, specifically talking about the Review Committee and — we don’t know the schedule, but the Review Committee has finished its biennial report and will make a decision soon about when we get into the next biennial review report.

I challenged the group a little bit to think about where they wanted to be 10 years down the road and to start thinking about the input that they will be giving to the Review Committee process next year. Our systems are based on rather old business processes and the world has changed a lot around us in terms of what is the role of the health plan, what is the data flow, what are the business operations requirements. Are we still processing claims like we did back with Cobalt-based mainframes, which essentially was the state-of-the-art when the foundational work was done with the X12 837 and those transactions, even though it has been upgraded several times since then? So the thought is where do we need to be 10 years from now and how do they prep to give us the information in our next Review Committee hearing series.

That was it. It was very well received. Lots of good conversation at the end, and, as many of you who have presented know, you don’t always get good conversation. People listen, take copious notes and you don’t get feedback, but this was some good feedback, and I am looking forward to hearing some thoughtful input into our processes next year during the public hearings.

DR. SUAREZ: Thanks, Rich. Bob, do you want to say a few words?

DR. PHILLIPS: Sure. I had the honor of serving as your liaison at the National Center for Health Statistics Board of Scientific Counselors, their own federal advisory committee, and just a few things I wanted to highlight.

The first is that the Census Bureau is considering merging the race and ethnicity categories in the Census, so, not making them distinct categories but bringing them together, and making some other alignment issues. It has NCHS concerned and questioning about do they immediately harmonize with Census or do they continue to bridge their structure within the NHIS with what the Census is trying to do.

Mark Flotow, who is in the audience today, is a member of the Board of Scientific Counselors, and I encourage you to talk with him at the breaks and afterwards, but he reminded me very thoughtfully that what Charlie said at the meeting was that we’re trying to do as little harm as possible in making this change.

The National Health Interview Survey is actually going through a fairly significant overhaul at this time, with the goal of reducing some of the core data collection efforts around the family section, around injury, disability and mental health. They’re seeing a pretty big decline in response rates, so the goal is to try and make it smaller and shorter so that they get better data collection.

There is a sponsored content in NHIS. NCI has been one of the folks who have kind of paid to play to have questions loaded in, so the sponsored content may grow a little bit even as they reduce the total size.

There was a discussion about the Commission on Evidence-Based Policymaking, and some invitation for NCVHS to weigh in on this group, specifically around their efforts. There’s some tension around data protection versus access. The tension really is to liberate all data versus some secured process for data access such as research data centers.

The second tension is about the role of the Commission around the support of internal government evaluation, capacity versus external stakeholder research and evaluation capacity. It was pointed out that economists make up the largest block of the Commission members and they’re mostly interested in the external use, so we may want to pay attention to the evolution of that conversation to weigh in on what we think it should be trying to achieve.

One of the other announcements made was that NCHS, AHRQ and SAMHSA are launching a joint research data center in 2017. They’re bringing all their data under one roof, which is exciting because it means you can access and link to more datasets. It raises a little bit of concern for me because it brings some of the data in protected that are now public, like MEPS and some of the ACS data, so the accessibility of those previously public datasets may be something that we want to discuss.

Then there was really good news around national mortality data, that the state uptake of the standardized electronic reporting system is nearly complete, which means you’re starting to see a real rapid output of mortality data. What used to take 18 months to two years is now down to around nine months, so at least for that collection of vital health statistics data, access is increasing.

Again, Dr. Mark Flotow is in the audience, and I encourage you to talk with him at the break or afterwards. Thanks again for letting me serve in this capacity.

DR. SUAREZ: Thanks, Bob, for taking that role.

I want to make an acknowledgement and then I’ll turn it to Bruce. I want to acknowledge and congratulate Dave Ross and the Task Force for Global Health for being the recipient of the Hilton Humanitarian Award this year. I think it’s an incredible honor, and it’s truly an honor to have you, Dave, here among us. I don’t know if you want to say a couple of words about it.

DR. ROSS: Thanks, Walter. Of course, we are thrilled. It’s always nice to have somebody recognize your work. For our organization, it’s really a recognition of 32 years of work started by Dr. Bill Faghy that has just continued, and we’re really fortunate to be able to have the kind of partners that we have. I am unable to be here tomorrow because I have to go to New York for the Hilton prize ceremony event, which is nice.

I think what I am most proud of is that our organization basically builds partnerships. When we get credited for treating hundreds of millions of people every year for tropical diseases, the reality is that is the work of many, many partners, and it’s difficult in fact to accept an award for one entity when really the credit belongs to many, many people over many, many years. So, for us, it’s really just an acknowledgement of all those people’s hard work for a long time. It’s really a wonderful thing to have happen, so thanks for pointing it out.

DR. SUAREZ: Congratulations again.

(Applause)

DR COHEN: I just wanted to follow up on one item that Bob mentioned. The Census folks were here to talk to us about potential changes in race/ethnicity, and since a variety of our population health activities and the data workgroup activities deal with equity-related issues, I’m wondering if we could get perhaps a more recent update at our next meeting so that we can begin to think about how it fits into some of our planning strategies.

MR. SCANLON: If I could interrupt, Rashita on my staff, is our liaison to the OMB workgroup. When I get to my update I’ll tell you a little bit more, because OMB is asking for our comments on these various things before they make any decision. I’ll update you.

DR. COHEN: Do you think it would be appropriate for us to submit comments?

MR. SCANLON: I don’t think you have time as a committee to do it, but these are public comments so individuals can write in. That’s meant for public comment. Then we have a more direct way to provide comments to OMB. I’ll update you on that when I give the update.

DR. SUAREZ: Michael?

DR. O’GRADY: Jim, this may fall into “I’ll cover it in the update.” But about this Commission, about evidence-based policy, that does seem that it could have a large effect on federal data policy and, at a minimum, do we know who they are? You mentioned that they tend to be economist-heavy, which is okay with some of us, but —

(Laughter)

DR. O’GRADY: We’ve seen this before where a group is all actuaries and they stumble because they don’t take into account non-actuarial — all economists if they stumble are all statisticians and they stumble. Were you going to talk about that group? Okay.

MR. SCANLON: We will talk about it. There’s a way to provide input there as well.

DR. MAYS: I just want to follow up on something that Bob brought up because I think it’s really important for us to think about whether or not either the data access group or the privacy group needs to look at it, and that is there has been this movement towards pushing more of the data into the secure data centers. It used to be that MEPS and NIHS could be connected outside; no big problem.

I think we need to look at — especially for us, on access — I think we need to think about looking at whether or not privacy, confidentiality and security is being interpreted in a way in which it gives us the maximum ability to use the data. I mean, we all want to protect; we all are worried about mash-up in terms of social media with some of the data, but there is this question that has been floating around in other places about this. So I want to put that on our agenda at some point for us to talk about it.

I think the other thing is the NHIS, to not do health, and what people will say right away when NHIS is not doing it is that SAMHSA is doing it. Well, we do integrated care now, so we don’t want mental health over here by itself; we want mental health within the context of a health data system. And as far as I know, the SAMHSA data and the NHIS cannot be merged in ways in which you can take advantage of it.

These are some significant, potentially lost opportunities that the committee I think should think about talking about in terms of either recommendation or some kind of action.

DR. SUAREZ: Thank you, Vickie. Thanks for bringing that up. Any other committee member comments or updates that anybody wants to bring up? Hearing none, we are going to move to our updates from the Department. Jim.

Agenda Item: Updates from the Departments

ASPE

MR. SCANLON: Good morning everyone. A couple of things, and I’ll try to keep it a little short. On the personnel front, I’m very happy to report that the Secretary has reappointed three of our current members, Bill Stead, Alix Goss and Lee Cornelius. I’m hoping they will accept their reappointments.

(Applause)

You won’t get a signing bonus, but —

(Laughter)

On the minus side, Ob has found that his new job is consuming all of his work time. He hasn’t been able to be at our meetings for quite a while so he has resigned. He stepped down from the committee. We are very thankful to Ob as well, but, so, plus three, minus one.

And now that we have the reappointments straightened out I think we have three vacancies that — well, our first priority had to be get the reappointments. If that didn’t work, then we had a lot more vacancies. So we’ll be looking at putting new member recommendations to the Secretary shortly. A number of you have sent recommendations to us. If you have any others, if you could do it by the end of next week please send them to us. Then we’re going to have to work it through the process.

At HHS, I think you all know we have a new Acting Assistant Secretary for Planning and Evaluation, my boss, Katy Martin. She was at OMB previously. She was at Academy Health previously, and she was a counselor to the Secretary for the healthcare financing and services area. She’s very capable and she has that view of the importance of data and evidence in policymaking.

And I think you all know Joel Cohen has taken Steve Cohen’s place, so he’s Director of the Center for Financing, Access and Cost. And some of you may know at SAMHSA — we mentioned this previously — Daryl Kade. She is the Director of the Center for Behavioral Health Statistics and Quality, which is the SAMHSA statistical unit as well.

Let me say a couple things now. Obviously, on the budget we are nearing very close to the end of the fiscal year. We’re all hoping that, by Friday midnight, a continuing resolution will pass. The picture for 2017 still looks a little bit cloudy. And then, of course, for 2018 there will be an entirely new administration to prepare a budget in a fairly short time.

Let me catch the committee up on a few of the things that were mentioned. The Commission on Evidence-Based Policymaking, remember, was established in a statute by Senator Murray and Congressman Ryan, and the focus is to be able to use administrative data and survey data better to support evaluation and decision-making and policy-making. Anecdotes are fine, but they also have to have evidence, too.

They have to finish up their work with recommendations by pretty much a year from now, and the recommendations can be legislative; they can be directed at the Executive Branch; they could be at agencies; they can do any of that. The panel itself is about 15 members. Three were named by the President and three were named in the Senate, the majority and minority leaders, and then similarly in the House.

We know many of the people on the group. A former ASPE member, Sherry Glied, is on the group. Catherine Abraham who was head of BLS for a while, an economist at the University of Maryland — she is on the group as well. Bob Groves, who was the Census Director, is now at Georgetown and he is on the group as well. Several privacy advocates or privacy experts are on the group. It’s chaired by Catherine Abraham and Ron Haskins, who brings in the social and human services area as well.

They have had two meetings. They spent their last meeting discussing this issue of — They’re looking at what are the barriers to sharing access to administrative data. And they’re looking at survey data as well. They’re looking at how can you link surveys with administrative data to get often fuller or additional information. So they’re still in that information-gathering stage.

They released a request for comments or information which I will send to the committee members via email about some of these ideas. They asked a series of questions and they’re looking for advice. I don’t think we have time to pull together a committee response, but I think if the committee members individually want to weigh in, that would be helpful.

MS. LOVE: When are the comments due?

MR. SCANLON: I am forgetting, but we still have plenty of time.

And then HHS, we actually had the Research and Policy Director of the Commission come over to our data council meeting last week and talk about how they were moving forward, what areas they were probably going to look at and how we could have input to them. We offered — I think we observed the same situation — other than Sherry Glied, there didn’t seem to be much of a health or human services focus. It looks like, as we discussed a moment ago, a lot of the members are from the economics group, and I think that’s where the impetus started in terms of poverty data and things like that. We’ll have to see where they’re heading.

One of their charges is to recommend, if possible, a federal platform for putting all this information, or making this information available in a suitable and confidential and secure manner. So we don’t quite know what that would be. It could be a federated approach; it could be anything. These ideas have come up before. It’s not like they’re easy to do. If they were, they would have been done already.

They’re looking at administrative data, number one, but they’re look at the surveys as well. They’ll try to see — and, again, this is more how to get access to the data, how to be able to share data, how to make it more accessible. I think they’re looking at the laws and the privacy and confidentiality rules and regulations and practices, which I think they believe are one of the issues that prevent sharing even between NCHS and AHRQ, for example, because the Census doesn’t share its establishment data that much. There may be a way to just work this a little better.

At any rate, we’ll send out to the committee members, Walter, the request for information from the Commission and you can see the kinds of things they’re looking at. Again, as Mike said, you never know how these work out. These are very difficult problems, but at least we have very capable folks on the Commission. Again, this is not privacy or access; this is you have to find a way to do both. So that’s on the Commission.

I wanted to say just a quick update on the Affordable Care Act. The open enrollment period 4 opens in November. We have been monitoring ACA. You’ll remember the strategy is surveys to look at insurance coverage and access, the administrative data, the Marketplace enrollment data and so on. And there are special studies periodically to sort of look at where we are.

We published, through our early release program at the National Center for Health Statistics, the first quarter’s health insurance coverage data from the National Health Interview Survey. Basically, the uninsured rate is down 8.6 percent. This is all ages, and this is probably the lowest we have seen it since we began measuring it in the survey probably even before Medicare, in the 1960s. At least in that sense coverage is improving, and we’ll get the release relating to the second quarter of this current calendar year probably in December.

I wanted to say a couple of words about — but I think Bob did a nice job — the research data center consolidation is underway, or at least it’s going into the stages where several of our agencies — AHRQ, NCHS, part of the National Institutes of Health and others and SAMHSA — we’re doing this carefully, just to make sure this works out before you make a big leap. But the idea here is to put the survey data into what is the current NCHS research data center environment, and then researchers and others would be able to access the data through any of the research data centers.

For example, we have one at the Humphrey Building. We have an NCHS research data center there. No one ever sees the identifiable information in these research data centers. You put together your request for tabulations and what analysis you would like to do and submit it, and then you get it back. No one walks away with identifiable information. That’s the approach there.

But I do think there are public use files for the HIS and other surveys that I’m not sure will be in there or that they need to be in there because they are public use and they don’t have to go through that process. These are basically de-identified and so on.

We’ll have to figure all this out. That should continue as it is. There should be a way to put that in one place or at least easily locatable. You have to be somewhat of an aficionado to even know what and where some of this is. At any rate, the plans for the research data center are proceeding.

The survey responses came up in the discussion of the Health Interview Survey. All the federal agencies that conduct surveys are experiencing some declines in their response rates, and it’s understandable. Some of them are still fairly high; others, the trend clearly is downward. When you think about what occurs in society, it’s not a mystery as to why, with cell phones, land lines and interviews, how hard it is to do personal interviews and so on.

There are some surveys that are being done on the Web. Some of them are good; some of them it’s not clear what they represent. They have very low response rates, and it’s not clear that you even meet the basic assumption for statistical inference with some of these.

At any rate, the HHS data council sponsored a workshop where we brought all the experts in and all the federal agencies on surveys and how we were doing. We have a nice report, sort of an environmental up-to-date scan on where the various surveys are and we included the response rates. I can share that with the committee. If the committee is interested, we can give you a briefing on this overall.

And then we thought, well, we could see what’s occurring. What could we begin to do about it? It’s very tough to reverse the trend, I think everybody agrees. That is going to continue as a general rule, but there are ways to look at it. What you’re worried about, obviously, is, number one, do you meet the threshold assumptions for statistical inference to begin with. And number two, should we be looking at response. To what extent do these lower response rates bias the results so that you’re not getting what you think you are; you’re getting a population that doesn’t represent that fuller population, and when you make estimates and conclusions, you may be missing it by a lot?

This happens in the Web surveys a lot. And we found this with the Health Interview Survey where we knew what we had in the Health Interview Survey where you literally send interviewers out to knock on people’s doors, which is kind of the gold standard, versus what you got for the same estimates in a Web survey, and you’re really missing a lot of the lower income population and other populations that are largely invisible on these Web surveys. So you have to be a little careful.

And the Web surveys, even the ones that are designed as a probability sample, some of them are quite good but others have like a 9 percent response rate. I’m not sure what you can do with that other than it gives you maybe qualitative information, and I’m not sure what you make of it.

So, one way of proceeding we thought was to, on a broad federal basis, do some work on how we measure response bias now — there are ways to test this. Do you really want to put your money into adding new respondents whom you already have plenty of, or do you want to put your money into adding respondents that are from the less-represented groups? So there are strategies you can employ. It’s not necessarily the intuitive way you would do it, you know, let’s just get more respondents.

So we have asked the Federal Committee on Statistical Methodology, which is the interagency group here, to put together a working group from all the federal agencies and to conduct some — probably it’s going to take more than a year to do some work in this area and see if they can give us some guidance. We might even end up with better ways or more sensitive ways of measuring response rates and response bias, so we’ll be doing that as well. That’s just starting, but we have a nice state-of-the-art paper that we had one of our contractors do for the data council.

Just two more quick things. Even before the Commission was established, as I mentioned earlier, we at HHS had been working on guidance for our agencies to align some of the questions and the data on some of our major surveys; not everything, but in four areas. One is health insurance measurement, which Mike has labored on for a long time trying to do that. Secondly, tobacco use, because of a lot of the initiatives now on tobacco control. Substance abuse and mental health, which we really thought needed to be brought together where we are and can we agree on measures and recommend measures and data sources to use. Those are tough areas, as you know. Mental health is not an easy area for measurement. And, finally, sexual orientation and gender identity.

We have four expert workgroups under the data council working on this. The idea was to look at the portfolio surveys now and look at how we’re asking these questions and can we identify consensus on what are the best ways, what is the best estimate of insurance coverage to us. Instead of developing one-off questions, what is the best question we would recommend people use to measure health insurance coverage? It depends on what the question is exactly. We did that the same for the other three areas as well.

We have developed some draft guidance. I think it has gone through HHS clearance and hopefully the Secretary will be signing this any day now and then will issue it to our agencies. So it’s guidance. Once you say you have to do it this way you enter into another regulatory role, and it’s hard to do that. This is really guidance to our internal agencies, and we’re quite serious about this, particularly for health insurance. We can’t have surveys making up one-off questions because they don’t like the question or the researchers think they have to do it differently. Here, we’re trying to get some alignment.

It worked out pretty well. I think we have some good questions now. I think agencies have already begun to incorporate these modifications, and I think everybody is agreeing that these are the data we want to use when people ask about health insurance or substance abuse or mental health prevalence measures and so on.

On the mental health side, it was a little harder, but I think we got agreement that there were some measures that agencies, if they are going to collect mental health data, whether it’s diagnostic or symptoms — there are better measures than others that people should consider first, and I think people are already looking at those for when they do the next round of their survey. So I’m hoping I will be able to report next time that we have done this and sent it around and people are implementing it now.

One other thing on administrative data, I think we have all heard. We sort of know what the surveys are, and we have a portfolio and we understand what’s there. On the administrative data, it has been much harder to get a handle on what the holdings are, other than the obvious ones like Medicare claims data. How do you get it? What value is it, what’s the quality and so on? How do you make it more accessible?

The data council has formed a working group with all of our agencies and with Census and others to take a look at this and see if we can provide some guidance to our agencies about what to consider in terms of administrative data — you know, you can’t turn an administrative data operation into a new national center for health statistics or something like it, so it has to be proportional to the value and the demand.

But, clearly, I think people think there’s a way. It shouldn’t be a one-off, start from scratch every time somebody asks about community health center data or something else. There should be a way of thinking about this — standards, a certain level of infrastructure proportional to the interest, and so on, so that there are ways to do this that don’t cause you to have to start from scratch every time you do this.

Hopefully, in a little while we’ll have some guidance about how to do that as well, and it will relate to the Commission’s findings as well.

Let me stop there, Walter.

Dr. SUAREZ: Thank you. We have four people lined up for questions. I’ll take a quick prerogative to ask a short question.

On the legislative front, one of the most significant legislative initiatives is 21st Century Cures. Many of you know it’s a legislative initiative, a package that includes many, many different aspects of advancing NIH funding of FDA regulation modifications to accelerate access to new treatments. Do you have any thoughts or perspectives on where you see that going, or any comments?

MR. SCANLON: Again, you don’t want to bet on the legislative process or any particular outcome, but I think there is a lot of bipartisan interest in providing access to genomic data and related data like that, which has been hard, and it raises privacy concerns as well.

Number one, in many ways, it’s sort of a big data issue because this is big data in science about how you even manage it and pull it together and make it available for research, and then protecting the confidentiality of the persons who provide this kind of information.

There are a lot of activities now. I think for the Precision Medicine Initiative, for example, that will be a cohort of 100,000 — is that right?

DR. SUAREZ: A million.

MR. SCANLON: A million followed over time. Again, there are privacy and confidentiality safeguards already, but that will be one application because that presumably will include medical care data, surveyor interview data as well as genomic data. But there’s a lot of interest in this, and I think we’ll clearly see some changes and some movement ahead there.

In addition, as you all know, we have been working on the common rule for the human subject’s protection that governs HHS and 17 other agencies. It covers pretty much all the research programs and human subjects research at all the federal agencies.

The goal there is to not create barriers unless there is a risk, and, if there is a risk, make it a risk-based approach only if there are risks. Sometimes the risk is privacy; other times the risk is physical or psychological. But to more or less modulate the approach and the regulation to the risk itself. So that will also I think help. The idea is to kind of pull all these things together in that direction, Walter, to sort of reinforce each other.

But clearly there’s a lot of interest and there will be a lot of activity there. It’s a bipartisan kind of initiative.

DR. SUAREZ: Thank you. We have Alix, Vickie, Nick and Mike.

MS. GOSS: Thank you, Walter. Jim, I appreciate your bringing today’s good news about the reappointments and the paperwork to make that easier. I am sad to hear Ob has resigned but certainly recognize why and know that he has had a tremendous influence here, and if we need him all we have to do is pick up the phone and he’ll do what he can to help us.

As you look for new member recommendations, I think I heard you say that there are three vacancies plus Ob’s, so it’s four? Or with Ob? Okay. So it’s two vacancies.

MS. HINES: Alix, the vacancies are Ob, Sallie Milam, and then Walter is leaving us.

MS. GOSS: Are there particular categories that we are lacking in that you are looking to bolster, as we all put our brain trust hats on and try to figure out to help? Quite frankly, from my perspective, we need to fill those vacancies like yesterday because we have so much work in the pipeline, and the sooner we get staffed fully with members and also ensure that we have designated staff to support the committees, the better off we’ll be in accomplishing our mission.

MR. SCANLON: Well, I think Standards, with Ob leaving, I think that kind of leaves us — and with Walter as well — we clearly have a gap there. I am open on the other two. I think we’re looking for sort of the best athlete kind of concept, you know, the person who has more than one area of expertise and can help us generally.

I think some of you have already sent us nominations, and if you have other ideas now — we can have a clearer picture of how many we’re going to have.

My worry, honestly, was that we wouldn’t get the reappointments and then we would have six and that would be a much tougher place to start. Now, I think we’ve got a good foundation. But if you have them, shoot your recommendation to Rebecca or me and we’ll pull them all together.

MS. GOSS: Do you want the CV?

MS. HINES: Yes. If you have it, send it. If you don’t have it, send the name and we’ll let you know whether we want it.

DR. SUAREZ: Vickie?

DR. MAYS: Thanks for the update. There’s a lot of stuff, but I’m just going to ask about two or three things.

One is the Commission. There are a lot of things going on with the data access and use group that have some relevance to their work, so I’m wondering if we should talk to them or they should talk to us, or if there’s some exchange so that, one, we can make sure that the work we’re doing is considered or that we consider the direction they’re going in terms of some of the guidance that we want to offer.

MR. SCANLON: We are all trying to find ways to provide input there. Take a look at the request for information. and I’ll send it around. That will give us a hint. We don’t really know yet where they’re going to focus further other than they’re looking at privacy and confidentiality and how that interacts with access and so on.

We have offered the auspices of HHS experts, and certainly I can offer the committee members as well, for input into that. They meet about every month. They’ve got a lot of ground to cover; they’re still at the general information policy, statistical policy, level. But if there’s some way — We offered at the data council meeting to help them and they could come to us, and I would include the committee if there’s some way we could help, and any products that we have although I don’t think they are at that point yet.

The committee staff should be — and this is a commission, so there’s full-time staff, and they should be pulling together what they think is the relevant research and background. But I think they’re still kind of sorting out what should they really focus on other than what the statute said.

Take a look at the request for information first and that will tell you what they’re looking at. And if we have material from the committee or they need experts to talk to the Commission, we could use the committee’s auspices and HHS to help with that.

DR. MAYS: Okay. My other question has to do with the alignment activities. Were those sent out for comment? It’s all internal?

MR. SCANLON: It is internal, yes.

DR. MAYS: What is the process if there’s comment about it? I know some changes that got made by NHIS around sexual orientation and gender identity people didn’t like, and so I —

MR. SCANLON: Remember, this is an alignment; this is not research. This is can we align the questions we’re currently asking. We’ll do a briefing for the committee.

To be honest, we’re not really looking for — we’re looking for people to do some basic alignment. Maybe at another round we can think of things where research is needed, but the focus now is turning to administrative data, which is a little different. As you know, you don’t have as many degrees of freedom with administrative data. You sort of have to take — It’s secondary to running the program, so we can’t just keep adding questions or changing questions. Every keystroke costs a lot there.

I forgot to mention the race/ethnicity initiative. OMB and Census are looking at are there changes they should make in the OMB — number one, in the decennial census, but OMB is looking at should they consider revisions to the policy standard that has been in effect since first 1977 and then revised them in 1997. They’re looking at different ways and they’re going to test different ways, and we’re offering a cognitive limb, a survey limb, to help with those as well. But others need to be tested.

They are also thinking of adding another category to the five. It has already been publicized, a Middle Eastern-North African category. Again, when you add a category, as you all know, it affects all the other categories as well, and do people understand it. So a lot of work needs to be done.

I think in about a week or so, OMB is planning to issue a request for comments on those proposals, so we will shoot those to you. I don’t know how long the comment reaction period will be but we’ll send those to the committee.

Again, the comment period may be 30 or 60 days. It’s hard for the committee to deliberate. But I think individually folks could see where they’re heading and they really are looking for advice about how to do this.

So those are two requests for information that we’ll send around to everybody.

DR. SUAREZ: Okay. Nick?

MR. COUSSOULE: Just one general question. We have talked a couple of times now about the challenge of getting the survey data and response rates, et cetera. When does that become a problem and how does that manifest itself so that if we start thinking about what we’re looking at over time in regards to what we need to be doing, how do you — ?

MR. SCANLON: This is the whole issue of trends. Again, this is sort of overall data strategy. Administrative data you get from claims, you get from program records and so on, and you get from the financial reports, and that tells you about what you’re doing in a very specific population or very specific program. You often don’t know what the denominator is for that. But that’s very helpful. And there’s a whole environment of how you analyze that and trends and so on.

Surveys were — I wouldn’t say invented, but the benefit of surveys and research is that you standardize through the research process and interviews the questions that you can ask everybody, and it could be programs, but usually it’s surveys of household populations. The Health Interview Survey is probably up near 50,000 households in the United States.

The questions are standardized, and in many cases they have been validated to indicate the data against some criterion. We do this every year or so. So not only do you take a snapshot of that particular time, but you also want to see is health insurance coverage getting better or worse, is access to care getting better or worse, are preventive services being used more or not, or prevalence of various conditions — disability and impairments, are they increasing or not, are expenditures going up or down? So it’s good to be able to do that.

So you always have this issue of I have trend information and it depends on good response rates and good analysis and standardization versus you need to change that question; there’s a better question to ask. Several of our surveys have done this — when you start changing questions or even samples, you may be introducing an interruption in that time series and you can’t compare it to what you did previously. So that’s always a consideration.

When we ask people to align towards another question, they have to do it in a way that won’t break the trend. Or, on the hand, the trend, it may not have been very good data anyway so maybe you want to keep it up. So this will be a question for the Health Interview Survey. There may be trend changes there. When agencies change, they redesign their sample. This issue comes up as well, and there are ways to bridge that and see that as well.

But the claim and response rates — it has been obvious for quite a while now. Even Census, the Census interviewers can show you the badge, and many of their surveys are required by law — they still have problems. And our Health Interview Survey is actually Census interviewers, so they benefit from the aura of the requirement of the Census.

But it’s a balance between changing, maintaining time trends and adding new questions. And when the response rates go down you really have to evaluate how much — so now I’m seeing a change in an important measure; is that because I’m missing 30 percent of the people who should be here, or is it because there’s a real change, or is it because I made a change? This all goes into the discussion.

DR. SUAREZ: Okay. Mike?

DR O’GRADY: I just want to bring up about the Commission, and I have to say I’m a little concerned. If you look back on this Commission — because parts of it have been kind of bubbling up — the Commission, as a result, we have seen in a couple of different policy areas that this Murray-Ryan combination has worked fairly well to actually move bipartisan policy in a very tough environment.

What we have also seen is the kind of policy context of these discussions that seemed to trigger this idea of do we need a commission was the idea of anti-poverty. For any of you who have been involved in these sorts of legislative things, there’s an incubation period — let’s use health reform as an example.

You saw it during the Clinton Administration, big ugly fight, didn’t work. Congress basically said we have banking to work on, we have environment — we can’t keep fighting this one out forever. Lay it aside, let it rest, do more thinking, do more research, whatever. Ten, fifteen years later, it bubbles back to the top; the problems have gotten worse and worse. Congress takes it back up again.

So, at least in the press reports, which are not — I don’t think anybody is going to accuse the media of being detailed, analytic and legislative thinkers in this area, but this idea that anti-poverty is moving back to the forefront. There are both Republican and Democratic proposals. They both suffer tremendously from lack of data and lack of analysis.

My own research — I had to bring up that literature — much of it is either very dated, very backward-looking, tells you about in the Clinton plan in 1995 what worked and what didn’t, which is good but kind of not enough for policymakers to think about what provisions you would want moving forward. Much of it is very much in that school of somebody got tenure but it didn’t really inform. You know. Beautiful methodology that reports their final results in log form. Most congressmen don’t bring up the analog tables and kind of take —

So I understood from my own work why Murray and Ryan would go, are we going to do what we just did with health reform where we weigh into a very important area and we’re flying blind? The same issues you talked about — do we really know how many uninsured there are? Do we really know what groups they are? Do we really know how long they have been uninsured?

My read of this was very much how would those very practical and sophisticated policymakers from both parties be able to design policy and not be told by CBO we just don’t have the data, or, there’s no research that has been done on the secondary health effects of changing income levels, or it’s not trusted because it’s an academic who keeps talking about non-significant results because he really wanted the result to be that there was an effect. So it’s one of those kind of areas, so I understand fully.

As we know from other work, our measures of poverty are still a little ancient. It’s not important whether these guys succeed or not, other than this is — if Murray and Ryan are successful and this does rise to the top and there are proposals, and these guys spend their time on privacy and confidentiality — which I’m not reading as what the initial charter was — then it’s all going to fall on you. We know it will fall on HHS, it will fall on ASPE, it will fall on ACS. And you were around during the last, you know, Clinton welfare reform thing. There will be a lot of pressure to answer a lot of questions, and there will be that terribly pit of the stomach upset trying to tell some senior policymaker we don’t know. We spent all this money on research and we have a lot of tenure, but we don’t have a lot of answers to policy questions.

I’m not saying tell them what are you thinking, guys? Have you talked to the congressional people who created you to find out what they would really like at the end of the year? I don’t know. That’s their business.

But if Murray and Ryan are right and successful, you guys are going to get it. It would be nice if these guys could help that. But my whole read of why they wanted to do this in the first place was to feed into things like better CBO cost estimates. We went through with the last two major health ones where the CBO was saying one thing and the Office of the Actuary was saying something different, so legislation grinds to a halt while they fight out their methodological differences. That doesn’t go over very well.

In thinking about this, if those two are successful, there’s some very good work that should be coming. But if these guys aren’t successful at thinking about how you turn the battleship so that you really have a body of literature both in the data and in the analysis that really will say here are the three different things you could do moving into the future. You know, earned income tax credit does X. Childcare tax credit does Y. If that analytic work isn’t ready for prime time by the time the political stuff is ready to use it, it’s going to fall on you guys.

MR. SCANLON: Of course. And you never know everything anyway. Even when we did experiments, we’re still using the Rand health insurance experiment for a lot of the parameters.

DR. O’GRADY: Right.

MR. SCANLON: But I think it started out with that focus, Mike, it could turn into a Christmas tree — you never know — where everybody has a different thing to raise.

I think the second meeting focused on — what they’re trying to look at what are the considerations.

DR. O’GRADY: Other than Sherry, is there anybody who has kind of a natural policy-making background?

MR. SCANLON: Catherin Abraham I think from BLS, and —

DR. O’GRADY: But BLS doesn’t make policy. That’s like saying Census. Census is great, but nobody asked Census to put together the next Medicare bill.

MR. SCANLON: No. And Census is carrying a lot of the water here, I think. They kind of put the staff in Census and so on.

MS. HINES: I think they were given $10 million to put together a platform.

MR. SCANLON: Yes. They have a lot of money. But again, you’re right. Census doesn’t make policy. They’ll have most of the income data and so on.

But again, take a look at the questions. They’ll do what they want to do, but we like to give them the best information.

DR. O’GRADY: That would be my only reason for bringing it up in this. We’re not here to kind of guide them, but we are here to sort of advise HHS, and my notion would be, if this incubation continues, there will be work for you guys and a lot of it coming down the road within a few years.

MR. SCANNLON: We do it anyway. Yes.

DR. SUAREZ: Thanks, Mike, really good questions. Denise?

MS. LOVE: I think my questions are along the Commission lines also, like Michael’s, but a little less complex and a little more shallow. It’s a rookie question and I’m going to lower expectation because it’s not so deep.

Of course, I come from a state focus and I heard they’re going to recommend platform. And then I think, are we back to trickle-down data policy, because what the feds do —

(Laughter and general discussion)

My rookie question is can we work with that committee or monitor — I don’t want to be negative but if they came up, say, with a bad idea that the data, we’re going to be locked down in an enclave in a tight platform.

MR. SCANLON: It’s just a concept. They could be smart about it or they could be traditional.

MS. LOVE: Okay. I guess the rookie question is not what they’re going to do but how can we have input as a committee.

MR. SCANLON: That is one of the questions that you’ll see in the request for information.

MS. LOVE: That’s going to be critical because it does trickle down, good and bad ideas.

MS. HINES: And we will look at what the request for comments looks like and if there is any ability for us to do a joint, we can. If not, we’ll just suggest that all of you individually send in —

MR. SCANLON: Yes. We’ll use the committee here, too. If they do ask — so far they have heard from federal agencies and some privacy folks — not all of them are necessarily privacy experts, so how do they get their information? One is the expertise they bring. Second is what expectations do they understand their job to be. Then, it’s gathering information. I hope the staff does a good job there. And there I think we have to kind of get them to know a bit about the health area. It’s always a double-edged sword with that.

And then it’s what experts can they bring in, testimony or otherwise, to help them.

MS. LOVE: I think of the data systems as an ecosystem, and sometimes the states and what goes on is just absent in some of these conversations and it really does have implications.

MR. SCANNLON: Yes. That’s true. Sorry I took so much time.

DR. SAREZ: This is one of the things we always want to do, is have enough time for this type of update. We’ll be able to catch up on the time along the day.

We’re going to go to Shana from CMS. Shana, welcome to the committee.

Agenda Item: CMS

MS. OLSHAN: Thank you. It’s my pleasure to join you once again to provide you with the CMS update. I decided to do it a little differently and have some slides for you this time with pictures to share with you.

In June when I was here, I told you about how we were updating the administrative simplification pages of the CMS website to make them more user-friendly and to help provide one-stop shopping for users for information on administrative simplification. I am happy to say that on June 23rd we did it. The website went live and we believe that the site will enhance our agency’s ability to respond to this committee’s recommendations on enhancing stakeholder education.

The approved website features new pages and revised content, and it’s designed to improve ease of use and ensure consistency in the interpretation and implementation of the transaction standards code sets, identifiers and operating rules.

Here is the landing page. Once you are on this page, you can easily access all the other pages as well. To get to this one, we have a shortened URL. It is go.cms.gov/AdminSimp, and I have that on a later slide. Once you are on this page you can access other areas. You can either click on the highlighted text, what we have in blue on the main part of the page, to get to the other pages, and also there are some choices on the left hand side. It says HIPAA and ACA right now.

Because of the way the CMS website is set up, we have some limitations on what we can do. One thing you cannot see on this slide, unfortunately, is at the bottom there’s also a section called Related Links, and that will get you to the other sections as well that we have on administrative simplification pages to get you where you need to go.

I thought it might be helpful to give you a couple examples of some of the enhancements we have that really have been of interest to users so far. This first one is our new and updated covered entity guidance tool, and it helps users determine if they are a HIPAA-covered entity and, therefore, subject to the administrative simplification requirements.

We had a tool on the other site, but this one is easier to use and it’s a lot prettier as well. Like with the older version, you can also access this particular tool from the office’s web page. We get a lot of hits from that page as well.

The next one I wanted to highlight is one I use a lot. I’m a regular user of this particular timeline, and it shows the 20-year history of the key administrative simplification laws and regulations. From this, you can link directly to the statute or to the regulation in question. It’s actually much longer than what you see on this page, but at least it’s a starting point. And having just celebrated the 20th anniversary, there is still quite a bit to do with this.

So far, we have received positive feedback from the industry. These changes are just the first of what we hope will be many improvements to the website. We plan to continue to enhance these pages to improve the customer experience and to provide educational materials about this subject matter to the healthcare industry. I encourage you to go visit this website at go.cms.gov/AdminSimp and explore the pages. We welcome feedback and suggestions for the website. I have the URL up here on the slide that I just gave you, and if you have any comments or questions about it, please send them to the email we have on the page. Hopefully, having the URL here and the address will help you.

I also indicated in June that we were about to deploy an improved tool to receive complaints about compliance with the administrative simplification requirements. That upgraded system also went live. It’s the Administrative Simplification Enforcement and Testing Tool. We like to call it ASETT. It went live on June 20th. This side has enhanced security and improved user interface, user-friendly navigation capability, and is much more intuitive than the site that preceded it, the system we had before it.

With this tool, individuals can submit complaints about entities that they believe are not in compliance with one or more of the administrative simplification standards or operating rules. CMS validates and investigates the complaints that we receive and we work to bring the filed-against entity into compliance if we do substantiate the non-compliance.

ASETT is not a system to file the HIPAA privacy or security complaints. We do still get a lot of those complaints in this system. Those need to be submitted to the Office of Civil Rights, and if we receive them we will redirect the user to the appropriate place to submit them.

Like most CMS systems that collect protected health information, ASETT now requires users to be identity-proofed in order to access the system. It also uses multifactor authentication each time a user logs on. We have received complaints about adding these requirements, but they are necessary to ensure the safety and privacy of the information and are an enterprise-wide security solution we have at CMS.

Despite this, it is still possible to submit an anonymous complaint. Anonymous means that it’s anonymous to the filed-against entity, not to CMS. CMS will know who filed the complaint, but CMS will never share that information with the filed-against entity.

ASETT also provides registered users the ability to test transactions for compliance with the standards. Users do not need to file a complaint in order to test the transaction; you just have to upload your transaction file and run the test, and you will receive a report indicating any errors that may be found on that transaction.

You can find more information about ASETT on the CMS website. In addition to being able to access ASETT from our general administrative simplification web pages, you can access it directly at the URL that I have on this slide.

Finally, if you explore it or you have any more questions about the tool or suggestions, you can send them to a different email box we have, at hipaacomplaint@cms.hhs.gov.

We are also actively reviewing the NCVHS attachments recommendation that you sent to the Secretary in early July, and as part of our review process and in accordance with statute, we consulted with the Workgroup on Electronic Data Interchange, WEDI, and posed questions on attachments at a special forum they held in Chicago on August 9th. Overall, there was tremendous support for the recommendations included in the committee’s letter. The WEDI session provided CMS with more details that are assisting us as we’re developing the regulation and attachments, so stay tuned. There should be more.

I know at the last full committee meeting, Dr. Pierre Young spoke with you about the agency’s efforts at implementing the Medicare Incentive Program Advanced Payment Models, or MIP’s APM, and other provisions of the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA as we all like to call it. We now collectively refer to these provisions as the Quality Payment Program; you may hear it as QPP as well.

Earlier this month, our Acting Administrator, Andy Slavitt, published a blog on the CMS website that provides an update on the Quality Payment Program, and I wanted to highlight some of the information he included in that blog post.

CMS received feedback on its April 27th proposal for implementing the Quality Payment Program both in writing and as CMS talked with thousands of physicians and other clinicians across the country. Universally, the clinician community, not surprisingly, wants a system that begins and ends with what’s right for the patient.

CMS heard from physicians and other clinicians how technology can help with patient care and how excessive reporting can distract from patient care; how new programs like Medical Homes can be encouraged; and the unique issues facing small and rural non-hospital based physicians. So these areas and many other comments the CMS received will be addressed when CMS releases its final rule on this subject by November 1st. Hopefully, you will see that pretty soon.

In recognition of the wide diversity of physician practices, CMS intends for the Quality Payment Program to allow physicians to pick their pace of participation for the first performance period that begins January 1st of next year. During 2017, eligible physicians and other clinicians will have multiple options for participation. I tried to summarize them on this slide. Choosing one of these options ensures that they will not receive a negative payment adjustment in 2019.

The first option for physicians and other clinicians is just to test the Quality Payment Program. Under this option, as long as some data is submitted to the Quality Payment Program, including data from after January 1st, 2017, a negative payment adjustment will be avoided. So you just have to submit something.

The second option is to participate for part of the calendar year. Participants may choose to submit Quality Payment Program information for a reduced number of days. This means that the first performance period could begin later than January 1st of 2017 and the practice could still qualify for a small, positive payment adjustment.

For those practices that are ready to go come January 1st of next year, they may choose the third option, which is to submit Quality Payment Program information for a full calendar year. For those that do it, that means the first performance period would begin January 1st and participants could qualify for a modest positive payment adjustment.

Instead of reporting quality data and other information, the law allows participation in this program by joining an advanced alternative payment model such as Medicare Shared Savings Track 2 or 3, in 2017, and this is the fourth option. If participants see enough of their Medicare payments or Medicare patients through an advanced alternative payment model in 2017, then they would qualify for a 5 percent incentive payment in 2019.

However, providers choose to participate in 2017, CMS will have resources available to assist them and walk them through what needs to be done.

Another exciting announcement that CMS made earlier this month relates to work done to reduce hospital admissions. To address the problem of avoidable readmissions, the Affordable Care Act created the Hospital Readmissions Reduction Program which adjusts payments for hospitals with higher than expected 30-day readmission rates for targeted clinical conditions such as heart attacks, heart failure and pneumonia.

CMS has also undertaken other major quality improvement initiatives such as the Partnership for Patients, which aimed to make hospital care safer and improve the quality of care for individuals as they move from one healthcare setting to another. The data show that these efforts are working.

Between 2010 and 2015, readmission rates fell by 8 percent nationally. On September 13th, CMS released new data showing how these improvements are helping Medicare patients across all 50 states and the District of Columbia. The data show that since 2010, all states but one, have seen Medicare 30-day readmission rates fall. In 43 states, readmission rates fell by more than 5 percent, and in 11 states, readmission rates fell by more than 10 percent.

Across states, Medicare beneficiaries avoided approximately 100,000 readmissions in 2015 alone compared to if readmission rates had stayed the same and stayed constant at the 2010 levels. This means that Medicare beneficiaries collectively avoided 100,000 unnecessary return trips to the hospital.

CMS has received lots of interest in its activities regarding replacing the current health insurance claim number, which has the social security number embedded in it, with a Medicare beneficiary identifier. Just yesterday, the Centers of Medicare and Medicaid Services updated its web landing pages for this initiative and messaging to key stakeholders as part of its efforts to remove social security numbers from all Medicare cards by April 2019, as required by MACRA.

These updates offer healthcare providers, industry and others information on the new Medicare beneficiary identifier that will replace the social security number-based information on the new Medicare cards for Medicare transactions like billing, eligibility status and claim status. Included in this information is the format of the new 11-position alphanumeric identifier, and I did bring one hard copy of that if anyone is interested in looking at it.

You can find information about this initiative at another website here — www.cms.gov/medicare/ssnri/index.html. Hopefully, now if you just do a search on the CMS website it will come up, but it just went live yesterday afternoon.

Finally, given that this is your last meeting, Dr. Suarez, I wanted to take this opportunity to publicly thank you for your commitment to the committee, to the healthcare community and to patients. We will miss working with you in your role here with NCVHS. Good luck in your new opportunities, and I know that our paths are likely to cross in the future.

DR. SUAREZ: I’m sure they will. Thank you, Shana.

Before we go to questions to Shana, I want to ask Elise Anthony who is from ONC and on the phone and who has a hard stop to say a few remarks and provide us with her update. Then we will come back to questions for Shana.

Elise, are you on the phone?

Agenda Item: ONC

MS. ANTHONY: I am. Thank you so much. I appreciate that. Unfortunately, I do have a presentation that I have to give a little bit later but I want to take some time and give an update on some of ONC’s activities. We have actually had some exciting releases on Monday, in fact. Let me start with some of the more ongoing activities we have been doing and then I’ll transition over to those.

First, we’ve been doing a lot of work to update our model Privacy Notice. This is an initiative that we had, and I believe I referenced it at the last meeting, and in the past it was based on PHRs, personal health records. As health IT innovation has continued and health information is taken in a number of different ways, whether it’s a fitness tracker or a remote monitoring device or from a patient over to a provider, we wanted to make sure there was an opportunity for patients to be aware of how their information is being used.

What we did in the past is we had basically a form which the developer of the technology could answer, and that would develop a privacy notice that could then be shared with the patient. So, in light of the new technologies such as health apps, et cetera, we wanted to make sure that that model privacy notice has been updated.

We essentially call it the NPM 2.0. We are working on that now and had the pleasure of working with our fellow advisory committees to take a look at that. The workgroup just took a look at this yesterday and will be working to incorporate what comes out of our federal advisory committee into the final model privacy notice that we are working on. So keep a look out for that.

Our team continues to work on public health areas including Zika response, engaging with the CDC, for example, to look at the clinical guidance that they have released and help to translate that, as it were, into an algorithm that can be used by systems to move through information within an EHR, so, being able to capture where a patient may have been, are they pregnant, are they not and so forth. Obviously, those questions are helpful to the Zika response. We are pleased to help to move that along especially considering the impact that Zika can have and has had so far.

In addition, we have our 2015 edition which was released early last year, and we are working now to continue to implement it, and that, of course, is our certification criteria. That includes a number of different health IT standards and functionality that we believe are crucial to health information exchange and care delivery. That is our latest edition.

We have on our website an entire page that focuses on the 2015 edition including what we call the CCGs. Those are certification companion guides. For any of the certification criteria we have, we have almost like a one-stop shop where someone can take a look at what we are requiring, whether it’s functionality or standards, the testing requirements and any FAQs, or frequently asked questions, that might exist related to that particular criteria. Just in terms of providing a resource I wanted to make sure I noted that.

I want to spend most of my time focusing on the releases that we did earlier this week, and we are really excited about these. I think, as part of supporting the care continuum environment, a lot of that has to do with supporting providers and supporting the information that providers need to have so that they can make decisions and have a better understanding of the impact of health information technology and the opportunities of health information technology.

On Monday, we released our Health IT Playbook, and this builds on the Patient Engagement Playbook that was released earlier this year. The Health IT Playbook is a more complete resource. You can actually locate it on our website at healthIT.gov/playbook. If you go there, you see that it’s set up as a search window. We want to make this easily accessible for providers who are providing care every day and need an easy way to access information for a particular issue they may have.

Whether it’s understanding our certification program — you could type in, for example, the requirements that CMS sets out in their EHR incentive program as they relate to health information technology. You can type in information related to PGHD. Each of those search terms would bring up resources that ONC has developed or has worked to develop or resources from across the federal landscape to your particular issue or interest.

The goal there is to identify and share some of the leading practices and successes including success stories about how health information technology is being used to provide care and to improve the care continuum. It also helps to hopefully resolve key issues and challenges that providers might experience. If you’re wondering what certified health IT is and how our certification program is set up to support you, information can be found there through that initial search window.

Also important to note is our goal was to make the information accessible. Whereas we do draft regulations, obviously, to support certification criteria, we wanted to make sure that the resources that were on the playbook were something that could be digested in an easier way than the traditional regulatory form. You’ll also find videos on there; you’ll find Infographics, different mechanisms to help make sure the information can be used quickly and efficiently by the providers and across the stakeholder continuum.

The second thing I want to focus on is what we release in addition to the playbook, and this also goes to the concept of provider support. That’s our EHR Contract Guide. We call it EHR Contract Untangled: Selecting Wisely, Negotiating Terms and Understanding the Fine Print. And this is actually built on an earlier contract guide that we did in 2013. This one is much more substantive in terms of the type of information that we provide, and I think that’s indicative of how information technology is being used as part of the care continuum.

So, why do we have the Contract Guide? The goal of the Contract Guide is to ensure that providers and other purchasers of health information technology have an understanding of the resource of what health IT can provide and that their understanding of what the health information technology that they’re considering purchasing will do, and that there is communication between the vendor, the health information technology vendor, and the purchaser — the provider, for example — in terms of what that technology will do and how it will operate.

We think that communication and solidifying that communication in the contract can help inform health information technology use across the continuum, but can also ensure that what providers think they’re purchasing is, in fact, what they are purchasing. And I think that is something we have heard as well. That goes to things like interoperability — the ability, for example, of a provider to have access and control over the information they are inputting into the EHR, for example.

The Contract Guide helps a provider understand fine print, includes example contractors — and we think this is important because while this is definitely not a legal resource and this is not meant to provide legal advice, the goal of this is to help providers and other users of health IT understand the landscape of legal questions that they can ask or questions they can ask generally about health IT as they are developing these contracts.

What we have heard is that there have been a lot of standard form contracts, and that’s pretty much a contract that is presented to the provider and the provider signs it. Whereas, negotiating and discussing with a vendor what you need the technology to do to support your particular practice produces a better relationship, we think, on all sides across the stakeholder environment. And that’s part of the reason why we developed the guide.

How is it set up? The guide is set up in two sections. Part A is about planning, so it’s things like what are the types of EHR products and service models — cloud versus in-practice installation. It allows you to research and compare different products and vendor type; identifies and prioritizes technical and operational requirements that you might want to consider as a purchaser; helps you to understand the certification and regulatory requirements that you might want to consider in setting up your contracts.

For example, if you’re reporting under the EHR Incentive Program as a hospital or an individual professional, what are the things that you want your technology to be able to support so that you can successfully attest? Those are conversations that we want to encourage you to have with the vendor and that you consider as part of putting together that legal document that supports that relationship, and also, procurement strategy, planning and resourcing. So that’s Part A.

Part B gets down to the nitty-gritty in terms of the contracts. It’s things that you can consider. Again, I want to emphasize that this is not legal advice but really is a resource to start the conversation of a potential purchaser with their vendor and with their internal team, whether it’s their compliance officials, whether it’s their particular attorney, questions that you can ask about and learn about so that the contract that you end up putting together is really indicative of what you want to see to support your practice, your hospital and the services you provide to patients.

Part B focuses on the negotiations and the contracting phase of acquiring an EHR. It includes strategies and recommendations for negotiating best practices and addresses the practical issues that are important to providers. For example, how the data moves, data portability. If I’m switching my EHR provider or my EHR vendor, then does the information that’s included in my first EHR, do I have control of that so I can then move it over to the new EHR? So those are switching issues that we have heard about from stakeholders and we wanted to include and highlight in this document.

Other areas that are included in Part B — there’s a discussion of safety and security, and we note that it’s a shared responsibility in our minds. That means that an EHR contract should assign appropriate roles and responsibilities for both the provider and the vendor and should ensure that providers are not unreasonably prevented from reporting and discussing patient safety, security and other issues integral to the care they provide to patients.

What type of safety questions? Things such as ongoing maintenance, upgrades, performance monitoring and optimization, internal controls and processes for software and upgrades, investigation and collaboration in response to EHR technology-related injuries or unsafe conditions, transparency about problems, and even training and education of users.

Likewise, security. A Security Assessment Questionnaire, which is something that ONC does provide. A security risk assessment which can be helpful to providers. An independent security audit; provider information regarding a security program, the encryption methodology and secure data destruction; and even compliance with applicable state laws and federal laws that can be considered in the development of a contract. So it’s quite substantive in terms of the areas it covers.

Other areas we have noted are system performance, and we include a section on that. As I noted, we included a section on data rights and managing and safeguarding EHR data. That includes responding to emergencies, facilitating patient access, preventing data access from being blocked. This is also part of an ongoing effort at ONC, recognizing that in order for health information exchange to benefit care so that information is at the right place at the right time in the right way to support the patient, information should flow. Part of that is making sure that the contract addresses the issues that the provider needs to address regarding that patient, so we want to encourage that communication between the vendor and the provider.

We also included a section related to interoperability and the integration of technology, as well as sections related to intellectual property issues and managing the risks and the liability associated with the performance of an EHR.

And then we also included a section on dispute resolution. What should dispute resolution look like for you? Continuity of service during a potential dispute as well as litigation versus arbitration. Again, I noted switching EHRs, which is a key component I think as well for the Contract Guide.

Ultimately, we hope the Contract Guide elicits and encourages conversation and supports the needs of users of EHRs, as well as enables vendors to have a better understanding of what the providers need as part of the care delivery that they provide.

With that, let me stop and see if there are any questions.

DR. SUAREZ: Thank you so much, Elise. An incredible amount of work and I know there’s even more that we hopefully will hear more of during the privacy session. Bruce, you have a question?

DR. COHEN: Thanks. I just wondered if there was any update around implementation of ICD10, particularly around state Medicaid agencies and how they are faring.

MS. ANTHONY: I don’t have information on that per se. I think CMS might have a little bit more information in terms of implementation of the ICD10 component of it. But it’s something that I can reach out to my counterparts to see if we can provide something back to you.

DR. SUAREZ: Thank you. I think Janet will probably be able to answer that. Any questions for ONC?

I do have a quick question and I don’t know if you might be able to address it. It’s a specific question about public health and EHRs and it deals with the adoption of standards for NAMCS, the National Ambulatory Medical Care Survey, and the use of standards to report that.

I know there were some issues with the standards named in the regulations. Any updates or any thoughts about how the standard name would be adjusted or appropriately addressed? This is particularly because the standard that was named in the 2015 edition is an earlier version of the standard that is actually finalized and currently to be used, and that will be able to be used by EHR vendors.

I don’t know if you have any comments.

MS. ANTHONY: I think this is something that we have heard about. Let me coordinate with our public health team and see if I can get back to you with a more specific answer related to how that’s being addressed.

DR. SUAREZ: That would be great. Thank you.

MS. ANTHONY: Thank you so much for the opportunity to present. I know my colleague, Lucia Savage, will also be presenting on privacy tomorrow. We really appreciate the relationship here and hopefully this information is helpful to the team.

DR. SUAREZ: Very helpful, Elise. Thank you, and thanks for joining us this morning.

Now we are going back to questions. I know the first question was about ICD10.

MS. OLSHAN: I have a question back to you to make sure I understand your question. Is it about how they implemented ICD10 generally, or what’s happening with the next round of updates that are happening October 1st?

DR. COHEN: Great, now I have two questions.

MS. OLSHAN: I have an answer to the first, but I don’t have an answer to the second. The first one, we monitored all of the state Medicaid agencies very closely the first several months of the implementation of ICD10 and they all were doing really well. There were maybe little glitches here and there, but they were resolved very quickly. So far, it seems like it has been a success across all of the state Medicaid agencies.

I’m assuming that the answer to the second question is that things will go just fine, but I do not know the answer.

Dr. SUAREZ: I can mention a couple of things about that. I attended actually the ICD10 coordination and maintenance committee. There are two big important things that are going to happen October 1st, in about five days. One is — and Shana, you can correct me if I’m wrong, but so far, with respect to the implementation of ICD10, CMS has used a sort of discretionary perspective in terms of enforcing the use of the ICD10 in claims.

MS. OLSHAN: I will have to correct you on that, but continue.

DR. SUAREZ: I might be using the wrong word, but the message basically was starting October 1st it’s going to be very strictly followed in terms of the requirement to use ICD10. Of course, ICD10 was required and has been required to be used as of October 1st of last year, but this sort of more flexible approach is ending. Of course, the fortunate thing is that we have seen, at least in our industry as well, as a payer and as a provider, we have seen very little issue with the use of ICD10.

The other big thing is all the frozen codes that have been accumulated over the last four years because of not implementing ICD10 will be released. There are about 3500 codes that will be required to begin to be used October 1st of this year. There’s probably not a lot of significant concern about many of them because, as I see them, they are part of larger groups of conditions that are not necessarily spread across the entire spectrum of services in health care; they are more concentrated for certain specialties. So I think that is going to be expected not to produce major concerns

MS. OLSHAN: I just want to modify that a little bit. You’re correct that Medicare, when they implemented ICD10, did institute what we call flexibilities regarding the implementation, but, unfortunately, those flexibilities have been interpreted more broadly than they actually were. The flexibilities pertain to two areas specifically.

One was in the selection of a claim for audit of whatever sort. A claim would not be audited solely on the specificity of the ICD10 code, assuming that the code that was selected was in the right, what we called, family of codes, basically the three-digit family. So, if the claim was for a service provided to a patient with diabetes, the diagnosis code wasn’t congestive heart failure; it had to be a diabetes code. That’s a pretty extreme example but I think it illustrates the point.

And if a claim had been selected for audit, for whatever reason, the claim then might not be subsequently denied solely because of the specificity of the code as long as it was in the same family of codes. That was the first flexibility.

The second flexibility had to do with the program year 2015 quality reporting, to help with some flexibility on that because the change was happening during the reporting year. Those were the flexibilities.

We had a long list of clarifying FAQs on the CMS website which continue to be there, where we said repeatedly that Medicare did not change any of its editing. You still have to have a valid code on the claim, and all of the edits in place for national coverage determinations and local coverage determinations were remaining in place and there were no changes.

The change, come October 1st, is actually pretty straightforward; it just has to do with we will return to auditing when it regards specificity of ICD coding, to whatever it was prior to October 1st of 2015. Hopefully, it should look the same to everybody, to the majority of providers out there.

We did add another set of questions to the FAQ document specifically talking about the end of the flexibilities. There are about 10 FAQs that we added because we got questions along the lines of are you going to phase it out; what’s going to happen. The answer is no, we are not phasing it out. Come Saturday, you need to do what you should have been doing all along, and there is no flexibility when it comes to the auditing anymore.

DR. SUAREZ: Thanks for that clarification. It’s very helpful.

MS. LOVE: I commend you for all the work and the smooth transition. It’s remarkable, the work that CMS has done, and that transition reflects that work.

But now — and, Shana, thank you for helping us — we are elevating the discussion at the NADO meeting because we are seeing the analytic impact. One of the things we’ll be talking about is, you know, the ICD10 matrix and the ICD9 matrix.

One example that was brought forth to me was, if you fell into a body of water and drowned, it was drowning in I9, but now it’s falling and drowning in I10. Drowning in I9 and falls and drowning in I10. So that matrix we’re going to talk about.

And then the hospital discharge databases, the trends are just — The outpatient procedures apparently are just escalating in the data, which is somewhat expected, I think, beyond the bilateral and more specificity. So we’re trying to understand from the analytic standpoint and I would imagine throughout the administrative datasets.

DR. SUAREZ: Maybe you can provide an update.

MS. LOVE: Yes. We’ll have Patrick, Romano and AHRQ and CMS at the meeting and we would provide an update, because I think we’re just seeing now some analytic concerns.

DR. SUAREZ: Thank you. I have two questions I need to ask. One of them is about health plan compliant certification. I don’t know if you have anything.

MS. OLSHAN: I have no updates.

DR. SUAREZ: The other one is about Medicare, social security number replacement ID. We are, as an organization, starting to look at this and the impact that it will have in our organization, and it’s quite significant, the way we’re starting to see it, the number of systems that will be affected.

I started to think about, from an NCVHS perspective, some of the opportunities, and one of them was perhaps recommending that the committee consider holding some sort of a hearing in 2017 to help bring some of the perspectives from the industry. I think that’s one suggestion that you will see potentially coming, the possibility of convening, as part of maybe other hearings or something like that, this possibility of convening and inviting perspectives.

And the other one certainly is that organizations like WEDI would be interested in looking at a way to help industry understand the impact that this will have. I think it’s going to be a significant change.

MS. OLSHAN: It’s interesting you mentioned WEDI because at the attachments forum we had in August, the attachments were Day 1. The half-day of Day 2 was about this initiative to remove the social security number and to replace the current health insurance claim number with the Medicare beneficiary identifier. So there was a presentation there as part of CMS’ broader education campaign.

I will let the people who are leading this program know about your suggestion about coming before this committee to educate. Educating communities has been a really important part of the work they have been doing, and if you go look at what they have put on the website so far — it went up yesterday so I just glanced at it — they have a section for providers, a section for health and drug plans, partners and employees and for states, and there is some information in there. It’s still minimal but it’s something I think they plan to develop more and more. And there is a way for people to submit comments as well.

As I mentioned in my remarks, included in there is an example of what the format of the new identifier will look like, so I think that will also be helpful to many of the partners. As I said, for those of you who are interested, I have a copy of it with me here and you can pass it around or photocopy it, but I suggest going to the website and looking at it.

DR. SUAREZ: One last comment I wanted to make, and this connects with the standards. I was actually earlier this week at the X12 meeting and we talked a little bit about this. Where does this number go into the claim, and in all the other transactions? This is a new number, a new code —

MS. OLSHAN: It’s a subscriber number.

DR. SUAREZ: I just wanted to mention that. From the X12 perspective, it looks like — and I’m not speaking on behalf of X12; just translating some of the sense and message — it looks like this is going to be manageable and doable even though they are right now finalizing comments on the 7030 version of the new standard. But if this comes to be implemented before the adoption of 7030, then they are certainly looking at explaining and describing how this could be incorporated into the current transactions, the 5010 version of the transaction.

MS. OLSHAN: There should be no difficulty at all in doing it because it’s the same size as the current HICKEN, and it’s alphanumeric just the way the current HICKEN is.

MS. GOSS: The reality is it has to have a valid qualifier that exists in the base standard or else it’s not going to work. That I don’t know. Has anyone checked?

DR. SUAREZ: We talked about it and it looks like the current system will support that. I’m glad to be able to say that.

Rich?

MR. LANDEN: Shana, I did a quick search for that website and it’s not coming up. Could you repeat the website?

MS. OLSHAN: Sure. It is cms.gov/medicare/ssnri/index.html.

DR. SUAREZ: One quick comment from Ms. Phelps.

MS. PHELPS: Ruth Ann Phelps, Veterans Affairs. I have serious concerns about the admin simplification enforcement website. Its new iteration is asking for your birth date and SSN. That’s a little curious when CMS is in an SSN reduction mode.

As a manager in VA, I cannot require employees to put their personal birth date and SSN in an order to make a complaint, so, for VA, we’re going to have to find another way to make complaints. Given that it’s supposed to be anonymous, and we are probably the highest user of anybody making complaints, other people are afraid to make complaints because of retaliation from the payers, and this has a further chilling effect. And personal reassurance that it won’t be shared with anybody is really not compelling.

When you have to give up your birth date and SSN in order to make a complaint, I think that defeats the purpose.

MS. OLSHAN: We understand that complaint completely. It is because of the CMS enterprise identity management system that is on many, many CMS applications, not just ASETT. It’s the tool that is available to us to use. These are the requirements of the system for anyone that potentially could be getting protected health information.

We fully understand and appreciate your concern. We have received this complaint a lot. We tried to get permission not to put this on our system and we failed in that effort. We are continuing to explore what other mechanisms may be available in the future but, right now, that is the tool. That’s all we have available to us.

MS. PHELPS: I understand we have that two-factor identification and I’m sure it’s across all federal agencies. But the one-off person who is in the community, doesn’t want to give himself up, there really needs to be another way for them to communicate, even if it’s just a letter to the Secretary of HHS. There needs to be another way for people who don’t want to use that particular mode.

MS. OLSHAN: There is. People can still submit paper complaints.

DR. SUAREZ: Okay. Thank you, Shana, for coming, and thank you for all the work on ICD10. It certainly was a major project, and now we’re launching the next one.

We are going to take a ten-minute break and come back at 11:10 and start again.

(Break)

DR. SUAREZ: Just to ask if there is anyone on the phone. We now follow very strict committee rules. We have to re-confirm anyone on the phone. Anyone on the phone?

MS. HUNTER: Yes. Mildred Hunter. Good morning.

MR. LINCOLN: Mike Lincoln from V.A.

DR. SUAREZ: Good. Let’s go ahead and start.

MR. SCANLON: We have three reappointments announced earlier today. Walter will be finishing up, as you know. We have been fortunate enough to have Walter for two terms, eight years, and his term expires in October. So we wanted to honor you now, Walter. The Secretary has written a nice letter of appreciation for you. There’s no cash or funding, but you have our undying appreciation and a certificate of appreciation.

I think we are going to ask, if you are willing, even when your term is over here, if you are willing to continue with us on the Workgroup on Data Access and Use. We will give you an invitation if you would like that.

The Secretary has written a letter. “Dear Dr. Suarez, it gives me great pleasure to award you this Certificate of Appreciation for your eight years of leadership and service to the Department of Health and Human Services National Committee on Vital and Health Statistics as a member and as Chairperson. The committee is one of the oldest and most prestigious advisory groups serving HHS, and its recommendations have helped shape health data standards, health statistics, privacy, health information and public health for our nation. Your knowledge, expertise, experience and leadership have contributed greatly to the excellent work of the committee.

“We wish to commend you particularly for the time, leadership and counsel you provided as the Chairperson of the full committee and the Executive Committee as well as Co-Chairman of the Subcommittee on Standards, and as a member of the Population Health and Privacy and Security Subcommittees.

“We are proud to have had the opportunity to associate with you. Again, if the occasion arises, we would like to feel free to call upon you for further advice and assistance. Sincerely, Sylvia Burwell.”

We will get a nicer award for you. The Certificate is awarded to Walter Suarez “for dedicated leadership, outstanding service and major contributions to the advancement of health data standards and national health information policy as the Chairperson of the National Committee on Vital and Health Statistics, as Co-Chairman of the Standards Subcommittee, as Chairman of the Executive Committee and a member of the Population Health, Privacy and Security Subcomittees.” And I think we already have you on the Workgroup on Data Access. “June 1st, 2008 through October 15, 2016.”

So thank you again, Walter. We really appreciate all your service.

(Applause)

DR. SUAREZ: That’s very nice. Thank you.

MR. SCANLON: We, of course, have a succession plan, so go ahead and say your thing.

(Laughter)

DR. SUAREZ: October 1st coincides with the fiscal year, and I was looking for any provisions in the continuing resolution —

(Laughter)

It has been the greatest honor. I think I have to say I migrated to this country about 30 years ago. I’m originally from Colombia. Ever since I came, I have worked in public health, in health information in HIPAA, in all these areas, and the biggest honor really by far, professionally and personally, has been my affiliation with the National Committee.

I started coming to the committee even before I joint testified in some instances back in the early 2000s, and ever since, I felt this is an incredible group and incredible organization and incredible opportunity to advance and to help the country in a very unique way. Ever since I joined, I have been blessed and honored working with all of you and with all the people who were on the committee before. I had incredible mentors who introduced me to all the aspects and elements of the National Committee.

I am honored also to have worked with the staff of the committee along the years with all the different staff members who have supported us. Without their work, of course, as you all have said, all our committee work wouldn’t be possible. It has been a true honor. I couldn’t be happier to see the National Committee the way it is and where it is.

I’ll have some more parting thoughts and remarks tomorrow when we talk about the work plan of the National Committee and some ideas. I think we are at yet another one of these moments, on the verge of a new, really transformative time for the healthcare system, and the role of the National Committee in helping the industry move forward is going to be very, very critical.

I have been able to very closely work with the industry in many ways as part of my role in the National Committee. I can assure you without any reservation that the work and responsibilities of the National Committee are taken so hard and so at heart by the industry, and they really see the National Committee as the place to come. That type of a role of facilitator and convener and interaction and interface with the private sector has been critical.

So, for all the years that I have been involved and engaged with the committee and for all the time that I have spent with you all, I really thank you. I wish you all the best in the coming years with your involvement in the National Committee. I have seen personally how dedicated each of you is in conference calls on Sunday afternoons, believe it or not, and all sorts of odd times of the day. It is really testimony to the commitment and the belief that you have about the value and the role that this committee plays in the nation’s healthcare system. So thank you again for that. I really appreciate it.

I look forward to interacting with you in many different ways. At some point, maybe I will be on the other side of this table. I certainly look forward to continuing to watch the work that the National Committee will be doing in the coming years. It’s very, very important. So thank you again so much.

(Applause)

MR. SCANLON: Thank you, Walter.

HHS never makes a move without a succession plan, so the Secretary has also asked Bill to step in as Chair after Walter’s term expires. I think, in a moment of weakness, he has agreed, and I got him to sign papers.

(Laughter)

Bill, we’ll pass the baton probably tomorrow. Again, we appreciate all your work.

When I think of the 20th Anniversary of HIPAA, I think of actually a previous Chair of this committee who said, well, they’ll never pass that Kennedy-Kassebaum law, and sure enough, it was January when the law was passed. The committee was given a major role in both the privacy, policy development and the administrator simplification policy development. Walter was there and contributed both from the industry side and then the NCVHS side. So the fact that the world didn’t come to an end when we passed it but we’re at ICD10 and we’re moving along and we have made a lot of progress — it’s really a reflection of the nice work the committee did and the leadership.

Bill, do you want to say your thoughts?

DR. STEAD: Just thank you, and it will be a pleasure to serve you and help try to keep going in the good directions we have been going.

(Applause)

DR. SUAREZ: Okay. We are going to go to our ACA Review Committee, so I’m going to turn things over to Alix and Nick for their report.

Agenda Item: Discussion on Report from the ACA Review Committee for Action

MS. GOSS: I think Nick and I are actually going to turn it over to Terri, who has been instrumental in pulling together an extensive set of feedback from the industry and deserves tremendous credit and accolades for her perseverance, discipline, writing and being able to pull all this stuff together because it was a very large and intense several days of hearings. So we thought it would make sense for Terri to walk us through the rest.

MS. DEUTSCH: This is a tough act to follow. I’m going to be presenting the Review Committee report on behalf of the Standards Subcommittee, and I’m going to start with just an overview.

You have all heard this in previous meetings where we talk about the Review Committee, and it’s Section 1104 of the Patient Protection and Affordable Care Act, or ACA, that authorized the Secretary to establish a Review Committee to conduct hearings no less than biennially to evaluate and review the adopted standards and operating rules and to provide recommendations to the Secretary no less than biennially.

The Secretary appointed NCVHS as the Review Committee, and NCVHS delegated it to the Standards Subcommittee. So this is the result of our very first hearing that we had in June 2015.

The first hearing was to gather feedback from the industry, from the HIPAA-mandated transactions, and the committee reviewed the standards and the operating rules where they apply to the different transactions. There were four that were not, at that time, adopted. Those are listed up there. They are the health plan enrollment/disenrollment and premium payment, claim status, health plan eligibility, benefits inquiry and response, prior authorization, healthcare claim or equivalent encounter information, electronic fund transfer and electronic remittance advice and coordination of benefits.

Over the two-day period, NCVHS listened to 75 testimonies and reviewed over 100 written testimonies. The testimony, both oral and written, represented healthcare providers, health plans, vendors, clearinghouses, professional and trade organizations and associations, public programs, standard development organizations, operating rule-authoring entities and consultants. So this report represents the first Review Committee report which summarizes the findings from the hearings and the recommendations.

I want to note that there was a separate letter sent to the Secretary on February 29th, 2016, which contained a summary of findings and recommendations for HHS. Those are indicated in the report with an asterisk. The letter itself is in the Appendix if you want to see that again.

The report contains an Executive Summary and background information; the actual Review Committee hearing including its intent and structure; evaluation criteria that were used to evaluate the standards and operating rules; the general findings and recommendations, and we listed what those were. Then there were transaction-specific findings and recommendations. The general findings and recommendations meant that it applied to almost all, if not all, of the transactions. Then there were the specific ones that only applied to the specific transactions.

There’s a small Conclusion and then the Appendix, which has the panelist questions, which were questions each of the panelists was asked to respond to; the names of those who testified both orally and the organizations that they represented; and the written testimony contributors. We also had several public contributors that provided input. There’s the February 16 letter to the Secretary, and then there’s a summary of all the recommendations, and that’s at the end and I will go through that very briefly at the end of this report.

We can start with the Executive Summary, and what I’m going to do is go through each section and ask if there are any comments before we proceed on to the next section. There are a couple of edits that were done and I will highlight those to you. They are not in your document.

If we start on the Executive Summary, it’s page 4, and in your E book it’s page 26. Does anybody have any comments on anything in the Executive Summary?

If we go now to the Background on page 11, or 33 in your E book, much of what is in this is the same content that we had in the February letter. Are there any comments on the Background section?

If we go to General Findings and Recommendations, it starts on page 16, or 38 in your book. Any comments on that? The sections are here — the definition of the HIPAA-covered entity, which was in the February letter; broadening education was also in the February letter; ensuring consistency, and that was also taken from the February letter except for Recommendation 3.2. That’s new, and that’s on page 21 or 43 in your E book. Enforcement or compliance, or enforcing compliance, starts on page 21, and all of this is also from the letter except for Recommendation 4.2. That’s on page 22. That’s new.

Acknowledgements section was taken directly from the February letter. Predictability, which starts on page 24, is taken from the February letter except for Recommendation 6.1.1.1, and that’s new.

The Evolving Healthcare is on page 25 or 47 in your E book, and that is all new.

If there are no comments on that, we can move on to the Specific Findings and Recommendations that start on page 26, or 48 in the E book. Enrollment, there is one correction that was done on Recommendation 8.1. We had a public comment that asked for a little bit of clarification of the wording. It does not change the content of it and doesn’t change any of the recommendations. Unless somebody wants me to read them out loud, we can go ahead.

MS. GOSS: Terri, I think you are okay. I think it’s great that we got a few suggestions from the industry that shows they saw that we posted the Review Committee report and that they took the time to give us a few things just to help make sure our intent was clear.

MS. DEUTSCH: The next one is the Health Plan Eligibility, Benefits, Inquiry and Response on page 28, or page 50 of the E book. Prior Authorization is on page 35 or 57, and there was a public comment. We made a slight modification of the last sentence on page 35 to describe the NCPDP script.

We can go on to page 40, which is the Healthcare Claim or Equivalent Encounter Information. NCPDP asked us to put a paragraph that explains about their version D-O, so there is an additional paragraph after the first paragraph on page 40. Again, it doesn’t change any of the recommendations.

Also, they requested to have the addition of an issue, which was added on page 43, having to do with using one of the fields to designate the prescription drug amount, so that is still pending being adopted. So that sentence was added. Again, it doesn’t change the recommendations.

Page 67 is Coordination of Benefits. Claim Status is on page 48 or 70 in your book. EFT-ERA is on page 53 or 75 in your book.

And that concludes the report. I just wanted to bring everyone’s attention to the summary that I was talking about. That’s on page 85 or 107 in your book. That takes all of the main recommendations — some of the recommendations go down quite a few degrees, and all of those degrees are not listed here. It indicates which entity the recommendation had been directed towards. When it talks about expanding the definition of covered entity, that was HHS.

Some of them are just one entity-specific; some of them are multiple. These are all highlighted, so if anyone wants to do a quick check on what recommendations addressed them or did not address them or a way of keeping track of them, it’s something that NCVHS can keep track of. Are there any comments? Thank you.

MR. SCANLON: Were there any comments that we did not adopt or use?

MS. DEUTSCH: No. There were none that were rejected.

DR. SUAREZ: Just to remind people, the draft of this document had been circulated a number of times among the subcommittee, the Executive Committee and the full committee actually over the last month and a half, I believe. For sure, the full committee has had the opportunity to review this for a good month. I think we got some minor comments maybe?

MS. DESUTSCH: Nothing. Not one comment.

DR. SUAREZ: But from the industry. We even posted this report on the website and we received some comments.

MS. DEUTSCH: Yes.

MS. GOSS: I think the silence we’re hearing today is a level of support that we have received because we have taken the time to try to get everybody’s feedback early on. It’s an extensive report, much longer than our normal report lengths, and I’m happy to see that our approach to the process has worked to make today sort of more productive and enables us to really focus the last couple of weeks on the industry feedback we received.

MR. COUSSOLE: I think, Walter, you hinted that we probably should have walked through that before, but the sequence of events up to this point has been significant review with lots of different parties involved, including around this table. This is not a kind of one iteration and let’s provide some feedback; this is probably eight or nine steps down that path to that review including a public posting of this for comment.

MS. DEUTSCH: Right. And I want to mention that I did indicate that it was the Standards Subcommittee that was the review committee; however, for that first hearing, Vickie and Bill were part of the review committee, that were not part of the Standards Subcommittee.

MS. GOSS: And they are welcome back next year.

(Laughter)

DR SUAREZ: Yes, Vickie?

MS. MAYS: One of the things I want to say is that I really appreciate the process you put in place because some of us are playing catch-up to understand it. There were a lot of points rather than we kind of crash and burn and then it’s frustrating. So I think it’s something for all of us to think about using. It made it so much easier, and you were so available in terms of whenever we had questions. So I appreciated it.

MS. GOSS: I am so glad to hear that because one of the things the subcommittee has discussed is the need to create a review committee hearing playbook so that we don’t have to reinvent the wheel since we have to do this every two years. You know, the process, the questions.

There’s an awesome table that Terri referenced that will help us on track and be more efficient as we evolve over the next number of years, and potentially the players at this table will change but that playbook will enable us to have a good, dare I say, roadmap for a review committee hearing.

MS. DEUTSCH: One of the things that is very important is that this is really a dynamic document and it’s not something that was produced and gets sent and put on the shelf. There’s a lot of valuable information in here about directions that can be looked at, so it really would be important to look at this in a different perspective about what other things can be done to make the adoption of these transactions better or how NCVHS can then provide guidance or additional hearings or direction so that they can get better, because there is a great deal of information.

MS. KLOSS: I think one of the important breakthroughs was how to organize this mountain of material and to differentiate the general from the specific recommendations. I think once the group got its arms around that, it really worked. And I think the specific recommendations and the general recommendations will inform not only future review committee work but future hearings by the Standards Subcommittee on routine standards updates. It will be a reference.

MS. GOSS: And to that point, Linda, I think it also helps the Standards Subcommittee think about HIPAA 3.0 — that’s part of some of the things that we want to talk about, but I think that intersects then with privacy 3.0 and public health 3.0. And I think, as we look to the HIPAA report, 12th report to Congress, we usually do a vision section, and that’s a process that the full committee goes through. So I think the timing is really nice, how it’s all coming together.

DR. SUAREZ: Yes, and I am leaving the committee at the most important moment. I’m so sorry to not be able to engage.

MS. GOSS: We know you will be available for public comment.

DR. SUAREZ: I will be there.

You just basically summarized indeed what the future is about our work as a committee and how important this document is as a staging point for the next iteration of HIPAA.

MS. GOSS: This afternoon, the subcommittee will be talking more about our work plans — and I do mean roadmap in this case — and our predictability roadmap regarding standards development, promulgation and implementation is a critical thing for us to take a look at now, as well as what is the vision 10 years out and how do these pieces fit together that we’ve learned. So it’s going to be an exciting six months.

DR. SUAREZ: I want to just highlight this particular table that Terri mentioned at the very end which summarizes all the recommendations and identifies the audience, if you will.

I think we are speaking as a committee not just to the Secretary in terms of recommendations, which is our primary audience, but really extending this to the full industry. I think this is something that I expect the industry, through all their different groups and associations, will be taking in and beginning to really look into and consider some of this. I expect that the National Committee will be getting back into this, as Linda mentioned, into the future as follow-ups — you know, how are we doing with some of these recommendations. So I was very pleased with this.

This is probably one of the very first times that we as a National Committee take this type of extensive action of recommending not just to the Secretary certain things, but very specifically speaking to the industry in order for this journey of HIPAA administration modification to continue and to go to the next stage.

MS. GOSS: It might seem appropriate then for you to lead us in a discussion and vote to approve.

DR SUAREZ: I will be very pleased. As you have heard, this has gone through several reviews. This has been formally brought in front of the full committee for action. We will, as always, certainly, adjust some of the formatting, the cover, all these elements that we always do in the background once we get an approval, formatting it as a formal final report with the official cover, and probably making sure that any minor editorial changes are done.

But given that, let me ask if there is any more committee feedback on the report itself, any comments or additional feedback.

(No response)

DR. SUAREZ: We are going to entertain a motion to approve the report as submitted with the additional minor changes that Terri covered.

MS. GOSS: I will make that motion.

DR. ROSS: Second.

DR. SUAREZ: Any further questions, discussion or comments about the report and the motion specifically? Hearing none, everybody in favor say aye.

(Chorus of Ayes)

(None opposed, no abstentions.)

DR. SUAREZ: Motion adopted. Thank you very much again for incredible work. The work that you just did in this report is a reflection of all the work that you have done for the committee over the last several years, so we really appreciate that. And thanks to Alix and Nick for facilitating and for leading this work as well.

MS. GOSS: And a shout-out to Ob for his role early on and yours. You have been instrumental in a lot of this.

DR. SUAREZ: Thank you.

We are going to move to our next item, which is the letter for action on minimum necessary, so I’m going to turn things over to Linda and Barbara and Maya.

Agenda Item: Discussion on Letter for Action on Minimum Necessary

MS. KLOSS: We are not going to use the slide deck. We’re going to take advantage of the fact that you all have a copy of the letter in front of you and also as distributed in the book. As Terri did so well, I will also cross-reference pages as we go through.

On behalf of the Subcommittee on Privacy, Confidentiality and Security and my Co-Chair, Barbara Evans, members of the committee, just to remind you, are Vickie Mays, Walter Suarez, Bob Phillips, Nick Coussoule and Helga Rippen. We have our invaluable lead staff, Maya Bernstein and, of course, our other agency staff who have participated in what has been a pretty intensive process. This hearing was just held on June 17th, so we thought we would try our best to bring this forward, in part because the Office of Civil Rights is eager to have our letter.

As you will recall, we held a hearing on de-identification on May 24th and 25th and held this hearing June 17th and then made the decision to reverse our subcommittee work on preparing a letter, again, because OCR is eager for this particular feedback. We will be turning our attention to DID immediately following this work.

Again, thank you all for your work on this. Of course, I also want to thank all the industry experts who prepared and delivered testimony for the hearing on June 17th.

We took the action, not unlike the Review Committee, of circulating drafts, even early messy drafts, to the full committee just because we thought that they may have some educational value if you weren’t involved in the hearing, just to bring you up to speed on the issue and its many nuances, so you got this along with the subcommittee as we churned through it this summer.

As we have done with other letters, we will walk through the sections and ask for comments and questions and also really acknowledge that now, for this time, we will ignore typos. I found a few of them in reviewing this over the last 48 hours again, but we won’t worry about that; that will be part of the final editorial.

For those who weren’t part of the subcommittee, I want to thank the individuals who provided comment to us through this. Bill did, Alix did and others, so thank you very much for reading it and tracking with us.

One of the last changes we made was to pull forward into the Executive Summary all ten of the recommendations without the elucidating dialogue behind them that comes later in the letter. Are there any comments or questions — there may be things that just aren’t clear yet — on page 1? It’s just our usual setup, who we are and —

MS. HINES: I have a critical edit, which is it was June 16th, because I will never forget June 17th. That was a different hearing.

MS. KLOSS: She’s right. I just looked it up.

MR. SCANLON: When we refer to things like poorly understood, that’s what we heard — poorly implemented or sort of lack of compliance is kind of a legal term. Is there another way to — I don’t think we investigated compliance. Can we say, instead of poorly implemented, variably or inconsistently? I don’t want to suggest implementation legal problems if we didn’t really look at that in particular, right? Just another word.

MS. KLOSS: Okay. We were again playing back the uneven implementation that we heard from those who provided testimony.

MS. EVANS: Uneven?

MR. SCANLON: Yes.

MS. KLOSS: That’s better. The judgment, thank you.

We began the Executive Summary by just saying that — We reiterated the importance of this, and we did that because, while it has been part of the law and been updated several times, the guidance has not been updated for a long time, so we were just reiterating that it wasn’t updated because it wasn’t important. We put that forth early and outlined the reasons why it remains a vital part.

And then we moved into covering 10 recommendations. As is true in all of this, we unearthed some issues that we thought were certainly grist for additional study, but we chose to move those into an appendix and discuss them as issues that, if we were to weigh in on, would require further investigation. So we kept the 10 recommendations of things that we felt were near term, doable and important to be addressed by HHS.

Page 2 begins the recap of the recommendations. Are there any comments on Recommendations 1 through 7 on page 3?

MR. SCANLON: These apply when it sounds like what can be done for guidance or education or training.

MS. KLOSS: Correct.

MR. SCANLON: Not new legislation, right?

MS. KLOSS: Correct. The thrust of the recommendations is they are near-term actions that HHS can take, and we believe that is what we heard the industry say is needed now.

If you’ll notice on number 5, we even made a recommendation that HHS make no change to the current exception to the minimum necessary standard for treatment. Later in the letter, we explain it actually was a point on which we got testimony suggesting that a change would be valuable. So we were kind of explicit, and we were trying not to leave gaps.

Page 3 in the letter, or page 116 in your book, comments, questions? So you agree that these are a good, solid 10 recommendations that are actionable near term and, if they were taken, would be helpful.

MS. GOSS: I agree. I did not attend the minimum necessary hearing but I have lived in this world on a day-to-day basis, so when I read the letter I was thoroughly impressed with how easy it was to read, the topics it got into, the substance of what it was trying to do, and I really provide my kudos.

MS. KLOSS: The next section takes us through what does the standard say and what do the implementation specifications say, and how have they been updated over the years. Beginning on line 183, we replay what we learned about state of implementation, the uneven implementation and the issues that we heard about through testimony.

Then we moved right into short-term priorities and recommendations, acknowledging that there were other substantive issues that we chose not to try to tackle at this time or really felt that we would need more study in order to tackle them. As we referenced that, we said that NCVHS could consider further work on this as part of our overall strategic plan, so I don’t think we necessarily committed. We know that we always have to juggle priorities, but these are areas that we think could use more work but we may choose as a committee to do something else that is more compelling.

DR. PHILLIPS: I think that’s a really important point in that the pace and turnaround of the letter is geared towards creating some sort-term actions that can be done relatively straightforward. There are enough other things in here that, if we tried to really get into depth in that, it could take another year before any material recommendations or actions could be taken. So I think separating those two is a really important point.

MS. KLOSS: And then we substantiated each of the recommendations in more detail on pages 7 through the end of the letter.

Let me make a note on Appendix A. I want to acknowledge the extraordinary work of my Co-Chair, Barbara Evans, on Appendix A. I think that’s the clearest way of summarizing how this stuff really is laid out in the letter, and I know she worked hard to pull all that in. We had it initially in the body of the letter but we thought it made it too long and took us in some directions on topics that we didn’t intend to discuss.

But we thought it was so valuable, and, like the review report, we know that this letter is going to get broad reading by people who are dealing with these issues so we thought that leaving this in was really educational, and we hope that way of relating the tiers of privacy protections will be useful to HHS, also, as it updates guidance materials. That really is new work that I think is a substantial contribution to our understanding of the tiers of privacy protection.

DR. PHILLIPS: Thanks, Barbara and Linda, this is a really great resource and reference for a lot of stuff. I think public activities for covered entities was dealt with very well. There will be implications I think for non-covered entities or mixed entities with regard to research that I don’t think are necessarily in the purview of this letter but really need to be considered moving forward. So I hope we can get to that space, too, because it really affects non-covered entities and mixed entities as well.

MS. KLOSS: Barbara, do you want to comment on that?

MS. EVANS: Yes. I think we have noted, of course, that the use of waivers under 64-5-12 is subject to minimum necessary, so that does affect research. We particularly highlighted in Appendix B as it relates to one important area of research, genomics, and we felt that the issues were such that it was just too much to try to resolve them in this letter. As was just said, it’s an important thing but we would need to weigh the future work against other priorities before the committee, so we did flag it as an important area but did not try to completely resolve it now, lest the analysis be too rushed. It’s an important issue that needs perhaps more input.

MS. RIPPEN: Just building on that, because I think it was a pretty robust discussion. And I think, perhaps if we step back from a committee perspective, not just minimum necessary, but we mentioned changes in the common rule; there is the component of if I’m a healthcare system I can do analytics for improvement.

I think it’s the whole question as far as how does the landscape and all the rules associated with it and all the different players really come together or not. I think it’s probably broader than the minimum use, and I think we should reflect on what’s the best way to flag these issues, be it genomics, be it analytics for a learning healthcare system versus all these other things.

So I do hope that from a broader viewpoint we can maybe pull those pieces together as opposed to just linking them into only one component. So, again, great work. Again, that summary is pretty amazing, Barbara.

MS. KLOSS: Vickie?

DR. MAYS: Hopefully I’m not jumping ahead, but Barbara started talking about things that were in Appendix B. Each one of them kind of ends with what you’re going to do going forward, and I was just a little concerned as to, either way, if you know you’re going to do it, then fine. But if we don’t, then we have to have a way to come back to the public and say, we did consider this and we probably are not going to do it.

For example, it sounds like you’re definitely doing the technology. The technology one is 660 — consider useful follow-up hearings and study that could assist. It says it intends to consider. It sounds pretty much like you’re really going to do some work.

DR. KLOSS: I don’t think that was our intent. We will modify that, probably to the kind of language we used in 705 where we said, going forward, the NCVHS will consider how it might assist the department to study these issues, but without committing, because I think we do want to balance — It’s on the list of things to be considered.

DR. MAYS: Yes. I think a couple of them —

DR. KLOSS: Yes. We need to farm down. I think we have Bob next.

DR. PHILLIPS: Thanks to reacting to so many of the comments that were given back on this. I really do think it’s nice and succinct. I like the appendices.

One of the things I want to highlight is that we heard some fairly impassioned testimony about the fairly ineffective authorization process that patients have. I know that is somewhat tangential to minimum necessary, so thanks for handling that. I see it mostly in Appendix A under the explanation of the four tiers of protection. I just want to thank you for including that.

Just as a related story, I had some friends whose freshman in college was admitted to the ER for depression and the hospital refused to communicate with the family for 24 hours about where he was or his status under the protection of HIPAA, which was just detrimental. So we still need to clarify that, but this is not the place.

MS. KLOSS: We did have some robust discussion about the need for the subcommittee to revisit authorization, as foundational as that seems, because we did hear that.

MS. EVANS: We also mentioned it at line 467 under our recommendation 7; we actually mentioned that there, too, the last paragraph, that we agree it’s an important issue but it isn’t, strictly speaking, a minimum necessary issue.

MR. SCANLON: I might just mention that a related regulation, the common rule, is nearing completion as a final rule, and one of their goals was an attempt to harmonize HIPAA for research. and HIPAA privacy requirements — with IRB. We’ll see how that turns out.

MS. KLOSS: Denise?

MS. LOVE: I think I answered my own question, but what came up in the hearing was future data mining for policy research, but that then is punted into the future.

MS. KLOSS: Again, we didn’t hear enough in testimony.

MS. LOVE: Right. Because we want that flexibility, and then the public health exception is still, by law — but sometimes we get caught with what is oversight, even if it’s by law. If it’s not in a public health department but in a quasi-public agency, that’s tripping us up a little bit.

DR. EVANS: There are issues there that do need to be looked at.

On this issue that Vickie raised, in that Appendix B, why don’t we just lay out here are the future issues and then at the end have a single thing that says we will figure out what to do.

MS. KLOSS: Good idea. And we did say that actually in the body of the letter in referencing Appendix B. I think we probably said it the way we intended to say it, as topics for future consideration in the body of the letter. The first one didn’t get edited to soften that, but we’ll make that change. Bill?

DR. SNEAD: I want to also congratulate you on the way you have handled the split. As we look at how we tune the wording, if you go through the edits this afternoon, I would also down-regulate 723.

I think what’s critical here is that the unevenness, which is a gentle statement, of the process and procedure in provider entities around minimum necessary is so great that the key here is not to put anything into this that could distract HHS into thinking something else needs to be answered before we get this guidance out, because if we can get this guidance out, it will take 18 months minimum to work across the industry and raise the level of people doing what we already know how to do. If we can quickly get that moving, then we’ll have time to step back and work some of these other issues, and then we’ll be able to introduce them from a higher playing field.

So I just think we want to be very careful as you make the final read lens. I don’t want any word in here to allow somebody to say, yes, we’ll come back to this after we answer X.

MS. KLOSS: We did add one recommendation that we haven’t used before, and that was that the draft guidance be put forward for public comment before it’s finalized. That isn’t a recommendation I recall having seen before.

But we did that in some ways because of the recent experience that the industry has had with the patient access guidance that came out of OCR recently and has had tremendous impact on operations, and it caught everybody by surprise. We thought, instead, that it would be wise for OCR and guidance like this, which does really change how people do their day jobs, to use a teaching moment by releasing draft guidance for some comment.

Everybody okay with that?

MS. GOSS: Yes. It actually seems more of today’s approach to partnerships and collaboration.

MR. LANDEN: I am very much supportive of that. I have seen in the past several years, guidances come out where the language was different from the intent or the expertise of the group that promulgated the guidance and did not take into account all the sectors of the industry that the guidance impacted so there were gaps and omissions, and what worked well for a known group or hospital did not work so well for a small practice — to pull out a hypothetical.

So I think that recommendation is very, very beneficial and invaluable to the industry.

MS. KLOSS: I think the key take-away is to keep the additional issues as future issues but not imply any timeline on them, and we will make that change.

Do you want to see that change before this is approved, or do you consider that editorial?

DR. COHEN: I think it’s a technical editorial correction that we don’t need to review.

MS. GOSS: I agree. I’m hearing that you’re maybe in the same place the Review Committee is, which is you may be ready to ask for approval.

DR. SUAREZ: I see a lot of nodding that people are agreeing with that, so I think we are probably ready to take action, then, on this letter. Again, thank you, Linda and Barbara and Maya, for all the incredible work.

Let me ask if there are any additional questions or comments before we go to a vote. Anything else?

MR. SCANLON: Can I ask one? To what extent has OCR been — are they familiar with the content of what we’re signing here?

MS. KLOSS: They have seen each draft as part of the agency liaison —

MS. BERNSTEIN: Rachel has participated as a representative. To the extent that the whole office — Rachel certainly has been involved, which we really appreciated. Her expertise and her participation in this has really been invaluable to understand —

MR. SCANLON: And they asked for it.

MS. KLOSS: And I do believe the way we handled the complex other issues is the way they wanted us to handle it. They wanted us to keep this to recommendations that could be acted on.

DR. SUAREZ: Let’s hear a motion to approve the letter with the recommendations and with the additional minor technical edits that we will make.

MR. COUSSOULE: So moved.

DR. SUAREZ: Nick moves. Do I have a second?

MR. LANDEN: Second.

DR. SUAREZ: Rich seconds. Any further discussion, comment or questions about this? Hearing none, everybody in favor say aye.

(Chorus of Ayes)

DR. SUAREZ: Anyone opposed?

(No response)

DR. SUAREZ: Any abstentions?

(No response)

DR. SUAREZ: Motion carries. Thank you very much.

(Applause)

Today, certainly, we have taken action and tomorrow, as Rebecca has pointed out, we have a full hour from 9:00 to 10:00. I know that at 10:00 we have Andy joining us by phone. We might use that hour to do some preliminary discussion on the strategy that we were going to have from 1:15 to 2:00, and talk about some of the work plan. And if we end up using all that hour and it’s sufficient, then we’ll be able to have a longer lunch. Maybe the Workgroup on Data Access and Use can begin — I don’t think we can change the Agenda and start time because people join and come in. I expect we will have enough discussion about the work plan and items for 2016 and 2017.

(Administrative discussion)

DR. SUAREZ: Okay. I think we are ready to adjourn for lunch. It’s 12:22. We will come back at 1:30. Thank you.

(Luncheon recess.)

A F T E R N O O N S E S S I O N (1:30 p.m.)

Agenda Item: Developing Recommendation on Claims-based Databases – Follow up to June 17 hearing

DR. SUAREZ: Thank you. We are reconvening now the National Committee. We still do have a full quorum with the members that we have present. I just wanted to declare that. I don’t know if there is any member that has joined us on the phone. If there is anyone else on the phone that wants to — I am sorry, I was not with my mic on. We are reconvening. We have a full quorum. I wanted to ask if there are any members or anyone else on the phone that we need to introduce. Anyone?

MR. LINCOLN: Mike Lincoln from VA.

DR. SUAREZ: Thank you. I am sorry, yes. Anyone else on the phone that wants to introduce themselves? Okay. Rashida, do you want to introduce yourself?

DR. DORSEY: Good afternoon, everyone. This is Rashida Dorsey. I am the director of Division of Data Policy within ASPE. I am Jim Scanlon’s alternate. I will be sitting in for him this afternoon.

DR. SUAREZ: Thank you. We are going to move to our next agenda item, which is the discussion on developing recommendations on claim-based databases, following our June 17 Claim-Based Database hearing this year. For that, I am going to invite Denise to lead us in the first part, and then I will transition and do a little bit of the recommendation.

The purpose, just to open up, is to have a conversation with the National Committee about areas and sort of the directions for recommendations that we want to include in what would be a letter that will be brought back to the full committee hopefully by November.

MS. HINES: Can I make one process statement? So for those who aren’t aware, there was a small sort of self-selected group of members who have been involved since June 17th. For those who aren’t part of that group, I wanted you to be aware that it was Alix, Bruce, Bill, Linda, Vickie, Bob and Helga have been on all of the emails, and have had opportunities to weigh in. So I did want you to know that we sort of formed an ad hoc working group to get to this point. It wasn’t just one or two people

DR. SUAREZ: Indeed, thank you for that. As you recall, this was one of those committee-wide activities. This was something that was part of a larger discussion that involved all the committee groups really, subcommittees. So that’s why we really had me and Denise facilitating the development of some of these. But then, we engage a group of people that volunteered to participate in the smaller group to discuss this and frame this draft. Denise, I am turning things to you now.

MS. LOVE: Thank you, Walter. Thank you for co-chairing the hearing on June 17. Thank you for the subcommittee for providing input. I think I will preface my overview of the letter by saying I am a member of the all-payer claims database council. I just wanted everyone to know where I am coming from.

We put this hearing together on that day to begin, I guess, the journey and the discovery about what is happening with claims-based data. Then after my presentation, talking about where it is going or where the committee is going vis-a-vis claims-based data.

I will go over the executive summary. Well, this is the letter outline. What we did was Rebecca sent tons of materials. We combed those materials, took a stab at a version one with excellent input from the subcommittee. I took another stab at version two is what we will talk about today.

I went back and combed through the testimony. This letter to the secretary we proposed looks like this with an executive summary, of course. The background on claims-based databases, just the landscape. Then we talk about the hearing, what the objectives of the hearing were and what the agenda held.

And then we had a section in the testimony about value and uses. The key challenges that the testifiers brought forth in their testimony, and then committee recommendations. That is sort of the structure for the letter eventually that we will be going over.

The background of the highlights, basically on the background, claims-based databases development are driven by several things, payment reform, transparency, the push in many states for triple aim improvements. The letter goes on to talk about what the characteristics, what are we talking about with claims-based data. The value and benefits to the various stakeholders, how some of the states either aspire to or are actually linking with clinical registry and other public data sources with their all-payer claims data.

Almost every presenter, I think all the presenters, call for a need for standardization. That was something that came out probably the clearest to me in the hearing. Then there was a minor discussion or part of a discussion about structure and architecture. Should we be exploring centralized versus decentralized and federated? But that was just brought up and debated. So we included that in the letter.

The stakeholders that presented represented states developing all-payer claims databases, private sector claims databased initiatives, such as the health care cost institute, Blue Cross Blue Shield. We heard from health plans. We heard from one large employer group, probably not enough employers. But we did hear from two employers. Then federal agencies, CMS, OPM, SAMHSA, ONC and again the APCD Council themselves out of the University of New Hampshire Council.

We recognize that the stakeholders were not the whole universe of potential stakeholders for all-payer claims. At the hearing, we had one day. We acknowledge in the letter that the stakeholders who testified represented those most fully engaged with APCDs at that point in time.

The letter also acknowledges that this is a dynamic not only health care landscape and environment, but the health databases themselves, health care databases, are changing to meet that environment. We really bring out in the letter that this is a snapshot in time. It does not address all future needs and solve all the problems.

It is very dynamic because we have several things happening in the background that are not resolved, such as Department of Labor and its ERISA ruling, and some other public comment periods still open on SAMHSA and a few others.

Some of the findings, and these are for the committee to mull over, is the states are developing these public APCD data products for multiple uses. They are looking at market and coverage patterns. They are looking at care coordination and transitions. They are modeling and looking at cross system comparisons. They are targeting improvement activities, among other things we heard.

The private claims data initiatives are developing similar repositories, as well, for research, market insights and subscriber information needs. HCCI has developed a guru of public site with some pricing information. Players definitely are in the value-based purchasing game and looking at regional benchmarks.

Payers, they are important because they are the source of all of the claims data. They have a big say in how it is collected. They have concerns about the burden, the lack of standards across states. We heard that loud and clear. And how useful the information is. I think that was an important piece of discussion that some in the industry are questioning the utility. We have to be up front about that, the utility of the claims data given, value-based purchasing and alternative payment models.

In light of that, we have to take that into consideration where they are coming from. They had some recommendations from the industry to go to the EHR. But they are two different datasets. In the hearing, we didn’t delve into how that might work, but maybe the committee has some ideas.

So what are the key challenges because there are many? Need for standardization across the states. I inserted in the letter, the draft, and again, are we even going to hand out the draft? We are just taking input. We will do a version three. It will come back to you at a later meeting.

MS. HINES: No. It will actually come back in between meetings. We are hoping to actually have a letter at the November meeting.

MS. LOVE: So we didn’t really want to push a letter through. There is no rush. There is no timeline that has to be met. It needs to have some work.

But I inserted the post-hearing development, we have worked diligently for months, and it seems like longer, 14 states to develop and agree upon a common data layout for core common data elements across state all-payer claims databases. This data layout then was vetted with payers over a course of weeks. I think one of the last calls with the payers might have been this week, just as late as this week.

So we are finalizing this. I think it is finalized or close to finalization by October 2016. This was not addressed in the meeting. It was just alluded to in the meeting. Alix?

MS. GOSS: I just wanted to add on to what you were saying. One of the things I have understood from attending the hearing, as well as the follow-up conversations, is that everybody is mindful of not wanting to reinvent the wheel on how we play well together with the all-payer claims database kind of conversation. I noted on the slide the use of the word, standard common data layout.

I think it is important for people to understand that the work that they have been advancing is about the data content needs, not necessarily a standard for data exchange structure, like we think about the word, standard, when we talk about the standard subcommittee.

I just wanted to kind of make that distinction for folks. I know I have been confused. They may hear some of those words. This is really about getting everybody on the same page as to what is really the basic data that you have to have to support the claims databases. Is that fairly put?

MS. LOVE: I think so. I mean, standard is used interchangeably. I understand. You are the standards person, and I would defer to you. But bear in mind that getting the states to give up data elements that they have already put in rule and collected is a big deal. Getting payers to include data elements that we cut out is a big deal. It has been a remarkable process.

All of that, I must say, has been done with no resources. The states have spent, I don’t even know if it is over hundreds of hours, we will tally. I know my staff and UNH have spent hundreds and hundreds and hundreds of hours getting to this point.

But it is so important. That is why I put post- meeting hearing development because at that hearing, the payers were almost crying out for such a thing to happen. But we couldn’t really taut it because we couldn’t sell it before we knew it could really happen. So we were trying to lay a little low at the meeting. So I added that as kind of a postscript in the draft letter.

DR. PHILLIPS: So common data layout here is specific to the elements, not to the structure? Because layout communicates to me that there is a structure, too.

MS. GOSS: Thank you, Bob. That’s exactly my challenge I am trying — Denise clarified it for me.

MS. LOVE: See, I get confused because there is a sequence and a format, so they can write —

MS. HINES: Right. The payers were actually saying that if they were working with six states, they had to do basically the same thing over again six times because there was no standardized approach.

MS. GOSS: There is a data content approach that they are developing, but there is not a data exchange structure to Bob’s point.

MS. LOVE: Well, because most of the payer systems are flat file.

MS. GOSS: So what we have is a world of the flat files needing to meet with the EDI world. We haven’t matured yet.

MS. LOVE: This is a flat file world that we are dealing with.

MS GOSS: Which is a whole other issue in and of itself considering it is —

MS. LOVE: That is a whole different issue. We have got Legacy systems and flat file. That is where we are at.

DR. STEAD: If practical, it may be important to build an educational appendix a little bit like we had from minimum necessary that would actually help begin to educate about these differences. We are going to need to be able to capture claims for payments, I guess. We are going to need to be able to capture payments in a value-based payment world. Sorting this difference out will be extremely important to be able to bridge that.

MS. LOVE: I think that is reasonable. Alix and I have been going back and forth. I have been educated about terminology, too. We use standards and uniformity interchangeably sometimes. But anyway, we will work on terminology.

MS. HINES: Can we just confirm instead of saying common day layout, should it be common —

MS. GOSS: I think that is up to the APCD Council. They just have to understand that they have created a bit of a question out there in the ecosystem about what do you mean when you say, common data layout? It is exactly where Bob went.

It is just trying to figure out — we have got data content committees today. We have standards development organizations. They all play well together in the land of HIPAA. Okay, maybe that is an exaggeration, but in the land of DSMO, Designated Standards Maintenance Organization. I am just trying to figure out if we have already got this common framework, how do we get the language, so we all understand how it is going to fit moving forward?

MS. LOVE: Outside the letter, though. That term was started, the common data layout was started by a group of states and business entities working on total cost of care methodology. They came up with a guide and called it Common Data Layout. We sort of adopted that. It has become a terminology used by the state. We will have to work on that. I am not saying the title can’t change, but that is where we are at.

MS. GOSS: We can put a translator in there.

MR. COUSSOLE: I have been in the middle of this for six or seven years. If you are not in the middle of the discussion, you come in and you read it one way, it may be totally different than the way the group needs it to read. It really will be important to clarify that, so that there’s no surprises.

DR. COHEN: A good model you might want to look at is the inter-jurisdictional exchange agreements that govern vital statistics. The 57 vital statistics jurisdictions went through this same issue, the semantic issue and practical issue of how to describe having a bunch of folks do the same thing. You might want to look at that.

MS. LOVE: Again, we will work. I think the council, and I am speaking for a lot of people and states, so I could be wrong, aren’t married to any terminology. I think this whole process, we welcome guidance. This is a journey that was started in response.

MS. HINES: You just want a solution, whatever you call it.

MS. LOVE: Yes. The important thing is not what it is called. The important thing is we have laid some foundation for harmonization or uniformity. There are still these information gaps. We heard loud and clear. I think the SAMHSA substance abuse thing came out loud and clear as a crying issue and need. In most states, it is the only source these outpatient data are going to physicians are the only real source of substance abuse data outside the hospitals where very few treatments are inside the hospitals. Even if they are in the site, the hospitals, sometimes it is in a unit that is called an outpatient. We are missing some of those data.

I won’t even take the next two days to talk about ERISA and the Department of Labor unless you want to add another day to the meeting. That is very important, but that is a gap. States are addressing it. We have some information on that.

DR. O’GRADY: Is the Department of Labor doing anything at this time?

MS. LOVE: We thought the rule was we have comments. And part of this common data layout is in response to some of the comments we submitted. The closure period was October 4. I went on the road and it was done. But they extended to December 5. They are in an open comment period, so we can’t really communicate directly with them.

It has been a multi-state effort. We are working with various folks in the state across insurance and EGs.

MS. GOSS: To clarify, you mean APCD council responded, not NCVHS?

MS. LOVE: No, not NCVHS, though I would encourage you to.

DR. COHEN: Workers comp?

MS. LOVE: Workers comp is not included in most states. Neither is VA. OPM and FVHB data.

MS. HINES: Or Medicare

MS. LOVE: Medicare is, but they are getting Medicare. We have a state research request process for states with the APCDs housed in a state agency. Nile Brennon’s been fabulous in working with us to streamline that process. Most states are getting the Medicare data. They get their Medicaid separately through their own state agency, interagency work.

Another unmet sort of information gap is the clinical data. We heard that HIEs and EHRs are important data sources, and may be more important as value-based purchasing comes down the pipe. I think what we are hearing and what we are seeing states do is bring that data in through strategic linkages with those clinical data sources, rather than taking in clinical data directly from a source.

Those are sort of the key challenges that we are finding and that came out in the hearing.

DR. O’GRADY: Can I ask one follow-up? How often do you see states considering using this data for kind of rate filings for their insurers in the regular individual and commercial market?

MS. LOVE: A handful of states, Massachusetts and I think New Hampshire are definitely very insurance-based using it. I can’t tell you. I think if my UNH folks are on the phone, they might have a better handle how many states are using it in that way.

DR. O’GRADY: Is that an advantage or a concern if you are an insurer?

MS. GOSS: Yes.

MR. COUSSOLE: Just commenting from an insurer perspective, the states, at least in Tennessee, to do the rate setting for the Medicaid operation, they already have all the Medicaid data. There isn’t a need —

DR. O’GRADY: I meant more kind of your small group, still regulated by a state insurance commissioner portfolio.

MR. COUSSOLE: Not in the past that I am aware of.

DR. O’GRADY: Okay. I can see this, rather than having to go through that, you just say, just refer to our data in the state’s database.

MS. LOVE: Yes, I think probably Massachusetts is the one to look at for some of the rate review and risk adjustment and those mechanisms and possibly Maryland, as well. They are probably more advanced in that. Many of the states, the conduit is a transparency initiative. Many of the health departments are getting into this to add to the population databases. But the actual rate filings, I would look for models, Maryland and Massachusetts are the ones.

(Operator interruption)

MS. LOVE: Well, I am putting everybody to sleep here. Again, we mentioned, and this comes out in the letter, the subcommittee really pushed to make clear that payment linked to outcomes, we are going to need new kinds of data and more dynamic tools. That is acknowledged.

Then sustainability, and this is a tough one. We don’t know the long-term sustainability. Right now, the states are putting together diversified funding sources. As the data are produced, they develop a constituency who has an interest in either sustaining it or advocating for paid legislation.

DR. ROSS: Sustained how?

MS. LOVE: Either through general appropriations, that is the one tool. We are seeing more states on the Medicaid match for the share of the Medicaid population. It really is a valuable tool for Medicaid, if they see it that way. Fee assessments on industry through insurance, in a couple of states where a percentage of revenues. There are several different conduits, and then data sales.

DR. ROSS: (Off mic)

MS. LOVE: Oh, yes. This is something that came up at the minimum necessary. It comes up and it will come up. In the state work that I do is that legislators who appropriate for these things put into the mix that data sales will offset the cost of the system. We really educate that, first off, you can’t sell data that hasn’t been collected and proven value. You need to have an established data source.

But hospital data has been sold for many years. Absolutely pricing is an art here. The expectation by legislators are that their investment will have some return back to the agency through data sales. I am fine with that. I was in an agency that sold data. As long as the pricing didn’t shut out public health, it didn’t shut out research. For third party use that is packaging say proprietary benchmark database, their prices go higher to either license or to use the data. They are selling it for a lot of money. This is a tough argument.

This gets back to the philosophy that I struggle with. I kind of put it here. As we start building these public databases, if there are to be a public utility, who should pay? The public isn’t going to pay for it directly. They are not going to subscribe to a health cost website online to look up one arthroscopy that they have to have next week. So who does pay?

DR. ROSS: It is sort of like (off mic).

MS. LOVE: Yes, it is.

DR. ROSS: I am bothered by it personally.

MS. LOVE: What agencies are doing is dual track, where they will charge for certain extracts. Actually in hospital data, pricing can be a control. Anybody going fishing for data that has to pay $3000 might not, but for a public health department or a government agency, it may be free. Or for a public website, no cost. I think I have written a paper, too, on pricing. It is troubling in some ways, but it is reality.

Then the sustainability is also alignment to the extent that they can align with high-tech money and Medicaid match. That offsets some of the cost.

MS EVANS: If public utilities are a model, conventional public utilities always have tiers of pricing for residential and commercial. It seems like it would be quite normal to have a tiered pricing structure.

MS. LOVE: Yes. For hospital data, that has been established. I think we see that because they have been around for decades. APCDs are so new. That is why I put this as evolving. The states haven’t been releasing all-payer claims database information as long. It is really new. They have been collecting it and working on collecting. But getting it out the door is still something we are working on. That is another workshop.

DR. RIPPEN: I guess there is a challenge with regards to redundancy and who is the data center within states, too. With the HIEs and their sustainability, there are questions about them charging or figuring out how to do it. There are database costs associated with even research organizations that are doing it at different levels. There is a lot of duplication and charging.

Again, it is kind of an interesting question because even as you look at it, this is about individual. If it is now clinical data, it is individual information. If people are charging, then there is going a question of, wait, you are making money out of my information, just like the cell line question.

I think that this is a bigger question again about there is a need for having the ability to leverage information for a variety of reasons. What are some of the pros and cons about the different approaches? Especially given that there are a lot of reinforcements about information exchange and the value. ONC is providing funding for creating that infrastructure, too. States are doing it at different levels. It is a tough thing. Even CMS, though they don’t charge really to make money, but let’s just say there is a lot of money that you have to pay them to pay for their effort of getting the data. It is a big problem.

MS. LOVE: It is a big problem. I just want to say that I don’t think any state that has linked with clinical data is putting that in their data sales. The data sales I am talking about are the sanitized, scrubbed, de-identified extracts.

DR. RIPPEN: (Off mic)

MS. LOVE: I understand, but they are not selling the research-level data.

MS. GOSS: I think you bring up a good point, which is that it is better for us to start getting our arms around this stuff now because that intersection of the clinical and the claims data has to come. Better to kind of figure out some of the rules of the road.

MS. LOVE: I don’t want to wake up someday and have all the health data in the world locked up and for sale. I think that would be a bad direction.

Recommendations, these are just kind of raw kind of recommendations. We start talking about them and thinking about them. We heard interoperability come up. That is another term that I will probably get schooled on. I kind of say it sheepishly, standardization and interoperability.

Just thinking through what I heard, and again, maybe Walter takes this over because I don’t want to be perceived that I have any conflict of interest because we have worked so hard on this.

MS. HINES: Five days.

DR. SUAREZ: Five days?

MS. HINES: Right, until October?

DR. SUAREZ: Five days until October 1st. Then what happens then?

MS. LOVE: I think I will have him present, don’t you think?

DR. SUAREZ: I can present. I think what Denise very properly was raising was, and she and I talked about it, this set of recommendations come from the consensus in general of the group. I think you will be mentioning —

MS. LOVE: I love it when things are all about me right now. But I will say this, this is not about me. I am going to punt this to Walter because I want something to happen. I want the committee’s help. It is not all about me.

DR. SUAREZ: One point I wanted to make, and you put a lot of effort into this, you have been mentioning what I mean by days and what I think. This is truly the reflection of the discussion of the small group and some feedback from the larger group. Then again, I am not taking away any of the incredible amount of work that you have put into it.

But the other important thing, I think it is very important to say, and she said it already, is the fact that clearly these recommendations are about helping improve the purpose, effectiveness, the standardization of APCDs and claim-based databases. Denise has been, and continues to be, working directly. Her organization and her involvement in the APCD council is very important.

We wanted to make sure that we, as a committee, understand that these recommendations are not necessarily recommendations that would create conflicts the way we see it, the way at least I see it and the way I have been talking with Denise with respect to her ongoing role in the work that her organization does, as well as the APCD council. I wanted to be very open and explicit about that because I think it is very important.

DR. O’GRADY: But she is right. If you went on with these recommendations, you would have to do the standard conflict of interest, declaration, et cetera.

MS. LOVE: Absolutely. These should reflect what we heard at the hearing and what is actually happening on the ground, and not for any other reason.

MS. HINES: Plus committee expertise.

DR. O’GRADY: And we have gained from your expertise in this area as you have moved us up the learning curve. But if there are recommendations, it should come from someone else.

DR. SUAREZ: Thank you. We spent quite a time understanding and identifying what are the main areas that we can present to the secretary of recommendations, that HHS could undertake. We just approved the recommendation, the report from the review committee, that included recommendation not just to HHS, but to the industry at large. In some ways, this might be another place where not only we make specific recommendations to the secretary, but also identify some potential actions that can be undertaken by others in the industry, including states certainly and including the rest of the industry that is involved in collecting, maintaining, reporting, using this data.

We start with the standardization interoperability. That was the probably the biggest interest across the board because of the fact that there is, in many ways, as they say, when you have seen one, you have seen one with respect to APCDs and when it comes to reporting of the data. To point out the common data layout questions.

There is a set of data elements, a list of data elements, and a definition of each of those data elements that is critical to come to a consensus. Then there is a how to package that message in terms of technically creating a message, an electronic message in a structured way, and transported electronically and all that. That is a separate aspect of this.

I think the interest that there is is to have standards on both components, but clearly the starting point is really achieve some level of standardization on the data element, the list of data elements, and what each of the data elements means. So that everybody that is reporting something in a particular field knows that this is consistent with all the other reports. We are not creating 50 different versions of data sets that are not comparable even across them.

The first recommendation is about pursuing requiring, and the question about requiring is, of course, which mechanism to use. Pursuing that HHS and pursue the option of the common data layout and this common data set standard, and use that to provide utilized mechanisms to do it through grants or contracts or Medicaid-matching funds or other things that help push this standardization at the state level forward.

Clearly, you understand that there is no federal law that requires collecting this data. There is no federal standard to submit it, to federally mandate the standard submitted. This is a state activity significantly. We are trying to find mechanisms where HHS can actually foster the adoption of this standard through mechanisms like grant, contracts and things like that.

I will finish this one, and then we will comment on each of these. HHS can support ongoing sustainable mechanisms. It is really important to sustainability of the mechanism of the standard itself on a national learning network for input into the standard. That is another element.

I will finish up the listing, and then we can open up the questions on this particular slide. The third one is provider identifiers and data linkage solution methods. HHS can facilitate the knowledge base that exists about how to handle data linkages using provider identifier matching mechanisms and things like that. Then the last one is leveraging funds from existing initiatives that will again entice, foster, facilitate the adoption of this standard.

Let me stop there. I know there are a number of questions. I will start with Mike.

DR. O’GRADY: I think in general, these are all great. The first one is somewhat at least controversial. If you are putting it in Medicaid-matching funds, you are effectively requiring it given the hundreds of billions of dollars that are involved at that point.

I guess the question is a clarifying question. In terms of the common data layout, the CDL that you have got right now, is this a recommendation to start a process to make sure? I know that there is a version of that now. Is that considered generally accepted? Or is this starting a regulatory process that will have a proposed mechanism kind of perhaps a broader request for information from a broader population of possible people affected by this, like Medicaid agencies and whatnot?

And before you go to a straight, if you want your federal funds, you need to do X, Y and Z. I think this is a good idea. I support it. But I am afraid if it looks like you are forcing it down people’s throats, you are liable to get kind of just an automatic pushback because it is now tied to federal dollars.

MS. GOSS: My thoughts were tied to what Mike is getting at. The Medicaid Matching Funds, I think the inclusion there is really because we heard pretty clearly from ONC and CMS Medicaid during the hearing. Although we heard Walter accurately indicate that these APCD structures and initiatives are really state-driven efforts, and the feds have a limited involvement, what we are finding is that ONC does want a lot of support for this work. We heard their testimony.

Medicaid said, hey, we have 9010 matching funds. They are really incentivizing states to get creative. When you think about the last bullet on here about leveraging funds for existing initiatives, if states really want to be innovative and controlling their costs, for instance, on average 25 percent of the state budget is Medicaid, they need to be thinking holistically about their innovative public health and Medicaid initiatives with their private sector partnerships around HIE et cetera, and cohesively weave all of this together. Medicaid has been willing to come forward and say, there is a part of what you need to do as a state cohesively to move your population health, et cetera.

Part of that goes back to the Medicaid population. We will pay for a portion of it because we think there is good stuff happening in payment reform using this claims data because it is what we have got.

DR. O’GRADY: Federal Medicaid would like this. I am going to guess, and correct me where I am wrong, that in most states, it is not the Medicaid agency that is taking the lead on the all-payers database.

MS. LOVE: It is not.

DR. O’GRADY: This is more of a process concern. This may be perfect, and you may have an open kind of comment period. You end up with the exact same CDL you have got right now. It may be these sort of things.

But we have all heard states talk about federal red tape and all the strings attached, et cetera. It is one thing to ask them, and they say good idea, sure. It is another thing to say, if you would like your state matching funds, you damn well better get in line.

MS. LOVE: Jessica Kahn, who testified, and it is in my notes very clearly, spelled out the pathway for those matching funds and the stipulations. But said she would be concerned about 51 different data warehouses.

DR. O’GRADY: Oh, absolutely. I think on the policy, I think you are on very solid ground. On the process, you don’t want to get ahead of yourself.

DR. SUAREZ: Part of this issue, too, is that most of the states have coded the listing of the data limits in law or in regulation, administrative ruling in the state. There is an untangling of that process to ensure that the adoption of a common layout can happen. But before that can be pursued, there needs to be some push from this type of national consensus as option of this.

MS. LOVE: I am feeling really not good about regulating the CDL. I guess require is the word I am struggling with. Maybe recommend.

DR. SUAREZ: I have to say I am not sure which type of regulatory action —

DR. O’GRADY: It is going to be included in contracts and grants. There is another thing to say we are going to encourage it through start-up funds and that kind of a grant. I have never been a state Medicaid director. Anyone that I have ever talked to seems to be a little prickly about the feds deciding they have got a great new idea, and we have to snap into line. Who made you god, you know, that kind of conversation.

We have seen this repeated in any number of good policies that somehow get somebody’s back up because they feel there is a gun being put to their head. Therefore, it ends up they push back, they push back successfully, and then the good policy never sees the light of day. I think this is good policy. You just have to decide how much of a push you are going to do. What is the right amount of push to make sure it gets done without so much push that you mobilize this whole opposition to what you are trying to do.

MS. LOVE: A little.

DR. SUAREZ: This will be an HHS decision. We can recommend something.

DR. O’GRADY: Right, but are we recommending that they make this mandatory?

MS. GOSS: No.

DR. SUAREZ: Alix.

MS. GOSS: So my point would be that if we want to have data content that is standardized and effectively is the CDL, but we don’t want to be prescriptive about the exchange standard or format, we need to be thinking about what that means to the private sector entities that may want to use some standardized structure like an X12. The CDL really tracked probably with an 837 content.

I am trying to figure out the linkage back to our standards community, and what we should or shouldn’t be doing from a larger ecosystem perspective. I don’t have an answer. I am just looking for some help on that.

DR. SUAREZ: Good point.

DR. ROSS: I agree with what has been said. I think it is important, the way we go about this. I think about it. If it is going to be a standard, that means it is standard because everybody agrees to do it that way. Getting them to agree to do it that way is the process. It is important. But if we are going to ultimately require it, it has to have a standard. We are kind of in the circular discussion.

The second bullet bothers me. HHS can support. Are we saying they should or they can advocate for it? What is that sentence actually meaning? Of course they can support this, but what if they don’t? Are we saying they should?

DR. SUAREZ: I think that should be they should definitely. I think the idea is that in order to create this mechanism of a standard data layout, and the mechanism to maintain this, there needs to be some sustainable process for that standard, particularly the learning network for providing that. It is a mechanism to have HHS consider providing that support. The idea is to allow the standard process and the standard development mechanism to be sustainable.

DR. ROSS: And you think the only way that would happen is if HHS did that?

DR. SUAREZ: No. The expectation is that HHS provides all the support needed without anybody else providing it, too. I think the idea is they join with others.

MS. LOVE: I also think industry should support because the administrative simplification is going to save. But I don’t know how to make that happen. I think it is what Walter said, a blend of efforts.

DR. ROSS: What we are saying actually is that the discussion so far is that, A, we all agree it has to be sustained if it is going to be standard. But we do not have a recommendation on how to do that.

It is somewhat similar to the digital bridge discussion that you will have tomorrow, the same idea. We need a governance. We know we need it.

DR. SUAREZ: We need a facilitated point.

MR. LANDEN: Directionally, everything I am seeing and hearing sounds good. Where we are along the path, it is a good place to be. My immediate reaction at reading these, though, as a first look at this is I don’t have really any good idea of how narrowly or how broadly we are circumscribing this.

To what extent are we talking specifically and exclusively about mechanisms around all-payer claim databases or, like in the fourth bullet, when are we really talking about the larger picture of standards development, the X12HL7. We talk about macro MIPS in the last bullet. I am really fuzzy about how narrow and specific we are, or are we really talking about major changes to other processes outside of APCDs.

DR. SUAREZ: I think this is narrowly focused on APCDs. This is not attempting to change or alter the mechanisms that are in place already and operating for the standardization of administrative process or clinical standards or things like that, that are in place. They are ongoing. They are moving ahead. The gap is in this particular area of standards.

MR. LANDEN: Thanks. But I think when the time comes, we need to be really clear and explicit about drawing this line.

DR. SUAREZ: Good point.

MS. KLOSS: I may not express my concern clearly, but let me try. In some ways, this seems like a narrow topic that is a point in time topic. If I put my National Committee hat on, I am struggling with how does this fit with our expression of a theme of convergence and a broader look at the whole data ecosystem.

I just worry some that any policy statement about how we are going to pay for data — we have got transitions from claims to payment data. We are pretty far down the road now in demonstrating that. Some clinical data is absolutely essential to certain kinds of analyses. The convergence of clinical and payment, I just think we have to be really careful about how we frame this, or we are digging ourselves into a whole that some could step back and say, this is kind of retro.

DR. SUAREZ: Good point. We have several more slides, by the way. This is not the only set of recommendations. We have some more, and then I am sure we are going to be covering the convergence and ecosystem in a minute. Let me take one more comment, Bruce.

DR. COHEN: I just wanted to quickly respond. I think there has always been a huge gap in public surveillance around morbidity data. Some say this is the Holy Grail. Some people think it is not. But the potential to fill gaps about our understanding of morbidity that doesn’t require hospitalization at lower levels potentially could be an enormous benefit for other activities when we look at population health. There are a variety of issues where claims used for public health surveillance and research will fill huge gaps in data that we have available. I think it really fits into and converges with a variety of other themes that we should be concerned with.

DR. SUAREZ: Let me suggest one thing. We are just about at 2:30. We are going to need to move to the next agenda item. We do have tomorrow morning a full block, from 9:00 to 10:00, to allow us to continue discussing this. I am going to ask that we wait until tomorrow.

You started already hearing about this and understanding this. You have the slides about this. We are going to go through the next set of slides. There are not too many more slides about recommendations, but I think we are already capturing exactly what we wanted, which was input on the directions of where we want to go with the recommendations. This is perfectly and exactly the kind of discussion that we wanted to.

Thank you so much. Again, thank you Denise for facilitating this whole discussion. I know there is also some other members that have been listening to the discussion that hopefully they will be able to join tomorrow morning. We will have some feedback from there, too.

All right. We are now going to move to our next agenda item, which is next generation of vital statistics. That is an amazing title. We are not talking about like next generation of people. We are talking about next generation of vital statistics. For that, I am going to turn it to Bruce and to Alix. We have some special invited guests, as well.

Agenda Item: Next Generation Vital Statistics

DR. GOSS: Thanks everyone. We are now going to switch gears and go to the land of public health. As you may have seen in your eBook, there were a number of pages that were included in that to help prep you for today’s session. That background information provided by Delton and a variety of his counterparts or teammates enabled us to paint a picture for you of public health initiatives.

What we would like to do today is leverage that background reading material that we provided and add a little bit to it with some overview from Delton and Michelle Williamson, who I think most of you probably all know, and Bruce to set some context. Then pivot to a braining storming discussion that will help inform our thinking and strategy about where we feel we need to go with public health data standards.

With that set up, I will punt to Bruce to see if he wanted to add anything else.

DR. COHEN: Thanks, Alix. What I am going to do is just do a little background in context. Then I will turn it over to Michelle to add her expertise and then Delton to give some of his summary remarks and some suggestions.

But we want to go rather rapidly through the slides because the focus will be turning it back to Alix to facilitate a discussion as we prepare for hopefully a workshop sometime in the winter dealing with the quality vital statistics data.

So background, the vital statistics system is the oldest and most successful example of intergovernmental data sharing in public health. There are 57 jurisdictions, the 50 states and two cities and five territories. This really is a cooperative system that relies on the interlocking bureaucracies of many jurisdictions. That is good news and bad news.

But it has all been brought together in a national system via the National Center for Health Statistics and the Cooperative Vital Health Statistics Program. This sort of gives a summary of some of the key events in the recent history of vital statistics since 1900. You have to remember, vital statistics started off as a system of baptismal certificates and wills. Vital statistics system really is a legal system at the jurisdiction level. It is the foundation identity documentation for driver’s license, passports, for adjudicating estates when people die and life insurance claims.

Using vital statistics data for public health surveillance is really a secondary purpose from the purview of the states. It is a relatively recent development that we have been fortunately able to capitalize on. I think that is an underlying context that sometimes we forget when we think about the national vital statistics system.

Here are some of the challenges. Yesterday, somebody mentioned, I hope nobody still uses paper and pencil to collect data. We still have folks using DOS-based systems with little computers mainframes to collect vital statistics data. So vital statistics systems are sometimes antiquated. They serve very different purposes across the jurisdictions.

So many people lay their hands on vital records. For birth, it is the mother and sometimes father. It is the birth registration clerk. It is a physician. It is prenatal care records. It is a whole conglomeration of folks. For death records, it is next of kin. It is funeral directors. It is physicians. It is coroners. These systems to generate the basic foundational documents that we use are incredibly complex and varied across jurisdictions.

They are governed by legal requirements that sometimes, from one jurisdiction to another, seem incompatible. It is complex to say the very least.

We have an opportunity to think generatively and constructively, and maybe strategically, about what role we can play focusing on how to improve the quality of the data in this system. Some ideas have to do with offering guidelines to build the next generation of systems. We need to think about how these systems interact with advances in technology and EHRs. Hopefully that is the kind of discussion that we will get to.

We have essentially divided the quality standard world into three buckets for purposes of this discussion, content, transactions and systems development. We will focus primarily on birth and death data, although there are five vital statistics. This is a quiz. There is the natality data, the mortality data and what I call the nuptuality statistics, which are divorce and marriage statistics. The fifth is the fetal record data.

But for the purposes of our discussion today, I think we are going to focus on quality issues around birth and death data, although fetals might come up. I will turn this over to Michelle to sort of address some of these questions. But generally for the content, we are talking about cause of death for mortality death. For the birth data, it is how valid is the information provided on the birth certificate, which comes not from the mother, as well as from the hospital record and sometimes the clinic record.

Transactional data, quality issues, I mentioned all the folks who touch these certificates and the issues that brings on. System development, there are lots of vendors who deal with developing these systems. Can we make any sense out of that approach?

I am going to just turn it over to Michelle to sort of maybe respond to some of these questions.

MS. WILLIAMSON: Thank you. I think I know most of the members. But as I look around with the membership changing, there are a few new faces. I will just introduce myself. I am Michelle Williamson. I work for CDC’s National Center for Health Statistics. I have had the pleasure of working with Delton Atkinson and his group to support the development of standards for vital registration.

I want to pull a few of the questions out to give you some food for thought based on our experience on developing these standards. If you look under the column for content, where does the gold standard quality come from? We have always looked at the medical record as really being the gold standard for getting information, especially the facility information, that medical content, health information that we need about the baby and about the mother.

As we move into the electronic environment, it brings us new concerns about the quality of the information and what are we getting. Are we making sure that we are getting the information that we need for vital records reporting?

The second to point out under content, have EHR vendors and state jurisdictions begun to embrace the existing VR standards? I can tell you it has been a slow, slow, slow process in terms of embracing it. One of the things that we have done in terms of engaging with vendors and others on the standards that have been developed is to do outreach to vendors to say, why don’t you adopt this? Put this in your standard. Make is something that we can start testing and use.

We have been very successful with one big EHR vendor. They actually incorporated these standards into their product. They have the ability to do birth reporting, send information to a state in a state partnership where there has to be that handshake. Obviously, they can’t have a system that can do it and the state not be able to receive it. There has to be that combination of efforts.

But it has been very slow. We have had one vital records systems vendor that has come to the table and has been working with us. Those two partners have helped us to advance a lot of the work for trial implementation activities and to refine the standards and improve them. But we need to make that a bigger scale. We need more adoption.

The other point here is how do EHRs fit into the current status and future of vital records. NCHS has put a lot of effort, a lot of time and resources into the development of standards. We see, and I like to pull from something Delton said at a NAPHS meeting, National Association for Public Health Statistics, an information systems that represents all the vital registrars. When we started the process, he said, we have a hypothesis that we believe that these standards and using EHR systems can help to improve the process. It is still out to determine, but we are committed. We believe in moving forward with this effort.

Just to touch on a couple from the transactional, what standards are being used. I believe there was a link that Delton provided in the material that he gave to the committee to the NCHS website, where we have listed the host of trial implementation standards that have been developed through health level seven in integrating the health care enterprise. So the foundation is there. We have standards that we can use.

What can we do to improve national standards adoption? Just a point here, one of the biggest things that I heard from vendors and others in trying to promote adoption was there are two issues. One, they would say, is it a meaningful use? That is always the first question. And if I said, well, not yet. It is not meaningful use, but would you still consider? They would say, well, where are my customers?

It is a cycle because the customers, when you look at our initiative, it is really the provider. It is at the provider level. How do we incentivize providers, so that they will want to adopt this? Is it even on their radar? Most of them are not looking at their IT investments. I know I worked in a hospital and worked in hospital implementations. We knew nothing about what was happening with public health. When we talked about what we needed to do and what we wanted to advance in our hospital system, it was what we needed from the clinical environment.

There needs to be almost a touch point, a connection, between these hospital associations, the provider level, to understand what is it for them to gain from doing this? The hospitals that have implemented systems that incorporate this product now that can go birth reporting, they just happen to have done it. Maybe they were going to upgrade, but it is not a national initiative. The awareness is not there.

Those are just a few points just from experience in working in the standards development. I will turn it over to Delton.

MR. ATKINSON: Go ahead and do the slides. While they are looking at the slides, I will say a couple of things. Some of the things that have been mentioned before are indeed things that we need to think about in terms of vital statistics. Some of the major initiatives that we are undertaking at this point in vitals, it is all focused on how do we try to improve the timeliness and the quality and the usability of the data. We are not just interested in timeliness and quality just to say we have got better data. But can we use it in different ways to address programmatic and policy concerns?

As was mentioned, we have the 57 jurisdictions. Their abilities vary tremendously, as you will go across. Everything from jurisdictions being very efficient and highly technical in terms of how they process and do their business, to other jurisdictions who are still sending us pieces of paper. We do the key-in and the coding with my staff down in research, Triangle Park, North Carolina.

We are governed by a whole set of different laws. We try to work with states and their various laws in order to try to collect and process and use the data. Some of those laws date back to the early 1900s. They haven’t changed. Some emphasis needs to be, as we move forward, focused on in terms of how do we help states modernize those laws. That is touchy from the standpoint of a federal entity trying to interfere within a state to try to carry out their business.

But we provide a whole set of technical assistance, models and guidelines, the US standards certificates to model law, guidelines for an electronic system. We do a contract with each of the states where we purchase the data from them. Where we put in there standardized data elements that they must report to us.

We talk about procedures for collecting and transmitting data. The last contract, we did something for the first time. We put in there special projects. These would be monies for which we have been able to obtain from any place that we can find them. We go all across the government to track down dollars that we can use to help improve the system.

Funding comes from every place, from the secretary on down to various programs. These are projects for which we provide the monies to states on a competitive basis for them to elevate the vital statistics, not to do the same thing. Then we offer training and instructional materials.

We will open it up for discussion after this, in terms of some of the things that I look at as what is needed in vital statistics. Some of these, we are trying to move ahead on. One is beginning to look at a new vision for vitals. Where should vital statistics be in the next ten years?

When we talk about the capture of medical information associated with a birth certification, that process, that concept actually got started in the 1900s, where we had basically paper processes, and that is the only way that you can do it. Is that the model we need to have over the next ten years? Has technology and medical records and so forth begun to suggest new ways to begin to look at this?

Second, the whole interoperability of vitals in the health and medical systems. As Michelle was mentioning, we have begun to work with national standards on the births and deaths, and the interoperability between these systems and beginning to collect information that way, rather than by pieces of paper, or having a clerk go through the medical records to extract the information to actually put onto the electronic systems.

The third area, medical examiners and coroners. If you think about this group handles somewhere in the neighborhood of 30 to 35 percent of all deaths are coming through them. They are handling basically all of your injuries and events and so forth.

Beginning to work with that set of individuals, and especially if we are beginning to talk about improving the quality of the data. Across this country, we have some states with statewide medical examiner systems. Some are coroners. Some coroners know very little about the causes of death. How do we improve that in the future?

DR. SUAREZ: Can I ask one quick question? From your perspective, how do you see the technical capabilities at the registrars’ offices in terms of receiving electronic messages? I don’t know if you were going to touch on that. As you mentioned, improving the health vital statistics laws and I was thinking with respect to technology, how far down they are.

MR. ATKINSON: It varies tremendously by state. I would say that there is probably a handful of states who are able to do it at this point. We have a special project right now with California on the death side of the picture, where the information that is needed for the death certificate is coming from the medical records. It is being electronically transmitted to the state vital records office. It has been electronically transmitted to us in the same day.

We are now able to code electronically 80 percent of the records within 10 minutes of the time that it hits the CDC firewall. We are now getting that information back to the state. That information is going back to, in this particular case, it is the University of California Davis and their hospital. They have a research interest. Trying to get that flow, a more real-time flow between the transmission, the registration, the coding and back to the state and to the hospital.

The state of Utah is another one that we have done some work with in the state and the Intermountain Healthcare is a part of that. We are beginning to do these special projects, many of which we are funding ourselves to try to demonstrate the feasibility of doing these kinds of activities. We want to be able to obviously take that nationwide.

Beginning to do some things on the birth side of the picture, as well. All of this is governed by the standards. That is the work that Michelle is putting into place. We have to have nationally-approved standards for which not only the states, but the private sectors, are using, such that we speak the same language in terms of this.

MS. WILLIAMSON: Can I make one comment to that point? There are also vital records systems vendors that are specifically taking on this role, so that they can supplement that lack maybe of technology capability at the state level. Some of the vendors are saying, I can do this for you. Then they serve the role as the state representative.

MR. ATKINSON: The other two areas, and then I will turn it back over, is the quality of the vital statistics. That was talked about a little bit earlier, both on the birth certificate side, as well as the death certificate, especially looking at the cause of death. We have just now funded 13 states to begin to wrestle with how you improve the quality of the cause of death. Those states were just funded in September.

When you think about that, how do you begin to incentivize the medical providers to provide the correct information and not provide just what will get through the systems? We have got a study going on in the state of Vermont where the Office of the Chief Medical Examiner is pulling about 700 records. They are going back and looking at the health records and determining what should have been put on the death certificate. We are comparing what actually got put on the death certificate, and then those two things, did it make a difference in the coding of the causes of death? We want to look at those particular differences.

But the goal is not to stop there. Once we understand that better, what do we do about it? How do we make it better? We are never going to improve the quality of the causes of death, the codes that come out unless we can improve the quality of the cause of information that is being entered onto it.

We have put in place a new system called VIEWS. It is Validation Interactive Edits Web Service. We tied that to the state’s electronic death registration systems, such that when a physician or whoever is filling out the cause of death, those literals are picked up and, within ten seconds, is providing information back to that person, whether or not the cause is specific enough, whether it is a rare cause, asking the questions, do you really mean that? Where people have put on abbreviations that you can’t figure out what it means and so forth, so trying to do those things.

The final thing, and let me talk about it, is obviously beginning to look at the basic financing of the vital statistics infrastructure in this country. The statistical components really depend a lot on two things, the sale of certificates and then the selling of the data. Is that a healthy trend? That is where we want our future to be.

We are going to begin to look at some of those. We have entered into a contract with Mitre to enable us to look at some of the economic models that are associated not only with vital statistics, but with our national death index. The one thing that researchers are complaining about bigtime is the fact that they are being charged for the matching of their records against the death records.

Now, how do we get out of the dilemma if the way that we finance this is through the charging of the data? It is an interesting question. I think we have to wrestle with it. Bruce?

DR. COHEN: Let us see if I can go back to the previous slide. Alix is going to lead us in the discussion.

MS. GOSS: I think our goal and objective at this point is having set some framework for this brainstorming conversation. Open it up for questions, comments. What we will do is take your input. Certainly, we have four areas that Delton has thrown out there from what he sees, a need for a vision, interoperability, quality and financing aspects for us to be thinking about. I really appreciate the fact that he gave us some fodder to get going with.

With that said, I see, Dave, you have your card up.

DR. ROSS: First a comment. I want to thank Delton, Michelle and the entire team. I think you have done wonderful work. I have been close enough to it to know how much energy and brilliance and sophisticated thinking they have put into all of this. I really appreciate it. That is one general comment.

The other, of course, is that vitals are really, in my view, core to all public health, population health data. If we can’t get this right, I don’t have a lot of hope. We have to.

This is so vital to the future vision. I think the future vision gets to understanding vitals as part of the health data ecosystem, not really its history. I was glad that Bruce brought up the whole history. The fact of the matter is this is a cottage industry. Every locality runs this little business called the vital records department. The question about what is their technical capacity today, well, it is all over the map because there are these little businesses.

What we haven’t done is get to the sort of the national dialogue about the importance of these data. I am really glad that you are looking at economic models. In my view, I wish we would start to value this as one of the core important national utilities. A dataset so important, it is worth investing in on a national level. So that we are not doing this hand-to-mouth operation.

I used to be very critical of vitals until I got more involved. Then I realized, oh, yes, I see. It is all about how it is financed. Each little group can do what it can do in its locality. I don’t think most citizens understand that. I don’t think most policymakers understand the importance of these data to so many foundational policy decisions.

I think the direction you are headed is great. Anything we can do to be supportive of it, I think we should be supportive of it. I think the progress you have made in timeliness of death reporting is great. I know you are getting a lot of applause from Dr. Frieden and others because you deserve it. But I hope we accelerate this trend.

DR. COHEN: Dave, I wanted to ask you if the National Committee can do a workshop, if we had to choose priorities for focus, I guess that is the question I have. As Delton and Michelle described, there are a lot of opportunities. NCHS is trying to move forward, and so are the jurisdictions. My background is from vitals and jurisdiction. What is the one thing, or the one or two things, where we might be able to make a difference to help move these conversations forward? That is essentially the question I want to ask the group.

MS. GOSS: We are referring to that affectionately as it is a call to arms.

DR. ROSS: I think if a change in financing, to make it more robust vitals, is going to happen, I think the sustainability broadly that issue is the most important. But to get there, there is an educational effort that has to happen. I don’t think many people in policymaking at local levels, states, federal levels have a clue.

We have gotten by well enough with vital statistics supporting a lot of policymaking that it is now invisible. I think we have to really energize to teach many people about why does this matter. If we don’t conquer that, it will not become the kind of vital component of the health data ecosystem that it needs to be in my view.

MS. GOSS: I am going to keep running down the line. I saw cards pop up at various times. I am not sure who was actually next.

DR. RIPPEN: Thank you so much. I know it is kind of what I call the bookends in our lives, the chapters in our lives. I know some of the struggles because even before electronic world, the question of what do people fill in. It is the nuance, right?

As we move forward, again, I know there is a big push from HHS as it relates to interoperability. Meaningful use, well, you know it goes back to timing. But again, I am assuming that you have reached out to ONC as it relates to trying to make sure the standards are put in place. Again, anything that we can do.

But I think there might be a unique opportunity potentially that we may want to explore. One is kind of going back into the broader ecosystem, the HIEs and kind of interoperability and the change. Then the alignment of some of the work that is being sponsored by CDC for infrastructure for the public health departments. It might also even touch upon some of the claims data. The question is if states are building infrastructure, this one could maybe form a basis of an opportunity to demonstrate because it is required.

But going back then to your question with regards to if we do have to focus on things, it could be the alignment of where are we now in EHR standards. To me, this is part of an EHR. Then the question with regards to HIEs or the interoperability, and the implications of that and who the players are. Again, really important work, but I am biased.

MS. WILLIAMSON: One quick comment as it pertains to HIEs, and that is kind of an interesting space. When we started the standards, and we first started talking about how we would implement them, most said, oh, let’s not go into the HIE space. But now, we do have a couple of states. Just this past week, Michigan and Indiana both reached out to us and said, we want to implement those standards. But we have an HIE. How can we explore it? It is coming forward.

DR. RIPPEN: It helps because it saves money. It saves money to the hospital systems to have to support. It doesn’t duplicate infrastructure from the state public health department level. Again, trying to figure out how do you reduce costs.

MS. GOSS: I think to that point, there are some states that have gotten creative with leveraging Medicaid dollars. In Pennsylvania, they did it from a public health gateway perspective. But what we also ran into was the interpretations of the rules of the past, and whether that data could actually come from somebody other than a provider, whether it could come through an HIE, if it had to be a pass-through, it could actually be generated. It was amazing how that conversation spiraled.

We spent over a year, and then had several flashback experiences again in subsequent years. We think that there is a policy aspect that goes back to, if we want to get to the interoperability, we have got to make sure that those outdated policy aspects aren’t precluding it.

DR. RIPPEN: I think the EHR, with regards to who filled it in, right, versus then how does it sent.

DR. COHEN: Thinking about what the gold standard and source of information is for all the items in the vital records is not as straightforward as one would seem. When someone is admitted to a hospital, he can give his name as Jack Johnson, Joe Johnson, Joseph Johnson the Third. I mean, probably the best source of information for name is actually the certificate, rather than the hospital record. There are some fields that probably should be populated from clinical records. There are others that might be populated from other places.

The same thing, I think, in terms of where do these causes of death come from. First of all, most deaths don’t occur in hospitals, point of fact. Where do we look for the gold standard for cause of death information? Zika virus or opioid addiction, how can we confirm quickly and identify the accuracy of death data that we use for the basic surveillance statistics?

DR. RIPPEN: But there is the question of what is it that we can do as it relates to data versus what has always been a challenge with some of these things. Is there anything that we can do to maybe improve it? I guess it is the question of what is it that we are focusing our efforts on doing. We may not be able to solve everything.

MS. GOSS: I am going to move on to Rich.

MR. LANDEN: I have got kind of three sets of comments. First, Michelle, I would love to follow up with you offline about more of the vendor HR developer issues. No, it is not a meaningful use mandate. There are some concerns about —

MS. WILLIAMSON: It is always the first comment I get.

MR. LANDEN: Could this rise to the level of competition with what other potential mandates are there? But the other side of the coin on that is this is not a request I have been hearing from our customers. Would they use it, even if we built it? If we built it, there is obviously cost for that. But there is a lot of room for discussion. I am glad to see what I can.

MS. WILLIAMSON: Rich, just repeated the same that I said that are the two that I get from every vendor. It is not a meaningful use. I don’t have any customers asking for this yet.

MR. LANDEN: If we went out, and we built this functionality into our product, we would get kicked out the door because they have got a list. Our clients have a list of 20 other things they want before they want this.

MS. WILLIAMSON: That is why I said the whole issue of getting this on the radar at the provider level is key.

MR. LANDEN: How does one demonstrate that? That is one thing. Second, I had a personal experience between the last minute and this. I can confirm that the death certificate process is convoluted. It is pretty straightforward, but it was entirely literally fax and sneaker network. The funeral director had to physically get in his car and drive.

Then the third comment is the death certificate itself, when I first looked at the one that was involved here, it was rather a strange instrument. I went onto the CDC website and found the guide for filling out death certificates. I looked at the one in my hand against the guide. Maybe 40 percent of the guide was followed. The diagnosis, the cause of death, the primary contributing appeared nowhere in the clinical record. It was a nursing home, not a hospital. There are some interesting challenges there. I look forward to pursuing the issue.

MS. WILLIAMSON: Can I make one additional comment as far as providers? We did have an interesting discussion, we being my colleague, Hetty Khan and I, received an email from a provider in New York, if I am remembering right. She had done some searching because she was just outright frustrated about having to complete information in the medical record. They had an electronic health record system at her hospital. Then having to do the same for birth reporting on a different system.

She contacted us to say, how can we stop this? And is something moving forward, so that we can just put this in our system? We actually had her come and talk at the NAPSIS meeting. There are providers who are interested and want to see this happen.

MR. ATKINSON: The other thing is we are beginning to get a sense of experimentation among the registrars. To follow up on that particular one, we have in the state of Utah, where they have, with Intermountain, embedded the fields for the cause of death into the electronic medical records. If the person dies in the hospital, a screen automatically comes up.

The physician never gets out of the medical records and enters in the cause of death. And he can toggle back and forth to kind of look up whatever he or she needs. Once he or she finishes, that information is electronically transmitted to the state’s electronic death registration.

Part of this effort is going to have to be continuing to build that sense of willing to look at new ways and new strategies among our registrars in terms of doing some things.

MR. LANDEN: One other quick comment. The Mitre study will be interesting because, in my experience for this particular Ohio County, it was $28.00 per copy. It took four weeks to deliver. We wound up needing 12 copies to file with all the agencies and copies that needed it. Each company wanted their own certified copy.

DR. COHEN: The problem is, as Dave said, these are mom and pop shops. Sometimes they have to support themselves on the revenues they receive for selling certified copies.

MR. ROSS: Most of the time. Isn’t that true?

DR. COHEN: Sometimes the money that they get goes into the general fund of the states. The registries don’t even see that money. It is seen as a profit center for states. It doesn’t even support the vital statistics enterprise in the locality.

MR. ATKINSON: The other thing with that is that we have a growing percentage of the states for which state-appropriated dollars have been taken out. They have been told, you have to live strictly on the receipts that you earn. Which is why there is more coming up with all kinds of strategies to get others to pay for the data. That is the trend that we are getting into.

DR. ROSS: This is why I am arguing. Modernized thinking initiative here. It is like the interstate highway system. At some point, you create uniform national value. We are no longer in the day of just engraving the name into the book of life and the book of death.

DR. COHEN: Timely comment.

DR. ROSS: We are so far past that. But yet, institutionally, we are not. The fact that we make these little operations be this small, independently-financed operation. As long as that can happen, a state government is quite happy because then they don’t have to worry about raising taxes or doing anything else to help support this. They can dismiss it. That way, they almost have no skin in the game. I think that is why we have to elevate this to a different kind of discussion.

MS. WILLIAMSON: I also heard the buzz about concerns with funding at the state level when we talked HIEs. They said, well, wait a minute. If it is going through an HIE, that could impact our funding.

MS. GOSS: I am going to go ahead and move onto Linda.

MS KLOSS: You have given us a lot of good data on both of these systems. I am wondering if one of the things that has to happen is to separate the focus on birth and death. They are very different workflows. They are very different processes and different sponsorship.

Do we maybe take the page out of what we did yesterday and put some effort into doing a good environmental scan to unearth all of the operating problems before a workshop. It seems to me that because most of the birth data capture is in the hospital, it is pretty well controlled. It is kind of closer to the electronic record, if you would. Day-to-day work is done by the same people. Raising that bar might actually be faster, although at the same time, I could argue that the death certificate system is more broken.

But they aren’t the same. And they aren’t going to be the same workflow. So I think we need different paths. The more we muddle them, the more we aren’t going to find the best route through.

DR. MAYS: First, let me just congratulate you all. You have been at this, and each time you come back, we find that you have done something else. Given the budget constraints and everything, I don’t know how you do it. But I have a feeling you have bake sales or something. You are doing really good stuff. Thank you.

DR. ATKINSON: I have a dish pan that I hand out.

DR. MAYS: You gave us your wish list of kind of the areas that you wanted to do. I want to do a wish list, as well. I agree with you about vision. I want to include public access, interoperability I agree with. I want to add education and linkage. Those would be on my big wish list, if we were going to have a meeting.

But the most important part of this, I think, is the vision. Again, it is almost like what Linda is saying. I think we have to think a little differently about some of the pieces of vital statistics. For example, one of the things, and it probably doesn’t technically belong there, but I think it is a part of what needs to be there, and that is the National Violent Death Reporting System. It is like that is a part of the mortality data in many ways. But it gets kind of short shrift. It is over there by itself. Not every state has it.

But given where we are right now in terms of health and the demands that people in Congress and other places keep wanting to know about all these violent deaths, I would like to see that kind of thought about as part of this.

In terms of access, this public access, I have seen the most horrible things happen at the time of death because of the cost of getting death certificates. People have had to contribute. People have had to raise money. Because without the death certificates, there are all these things that are stopped. I mean, I have seen things actually come to a halt because when somebody says, well, for each of these, you need this amount of money. People have no idea. People need to be told, like, you had better save some money. When somebody dies, you don’t get money right away until after you put all this money out. I don’t think the average person really knows that until you really have gone through this death stuff, you have no idea.

I mean, I sat there in one instance. They were filling out the death certificate. It was my first. I was like, no, you have to ask her about the rates. I was like, oh, I have got to shut up and calm down. I was doing statistics instead of realizing. There are so many parts of education that I think have to be done just to kind of make the quality okay.

The other thing that people don’t think about in terms of the death certificate that is turning out to be a big deal is the parent, the father. So there are some states that once you put your name on the birth certificate, unless you can go to court, and I am told some courts will not accept it, you are on the hook for the support. Of course, DNA and all that kind of stuff, it is almost like half of them have to go on these judge shows to pay for those and get it.

But people don’t understand what happens. Some people are like, well, the guy is here. Let’s have him put his name on it. That will be great. Or I love you now, and then later, it is a problem. I knew it wasn’t. There is so much education that would make this system, I think, just be much more palatable that we have to do.

The linkage, you know, it is like my life became great when the mortality data got linked to things. I think we ought to have a vision about what it is that the birth data should and can get linked to. This is where I think privacy really needs to be at the table to figure out do we need some of the rules that we have, in the day and age of what we have, in terms of the ability to think about this vision of there are certain things to de-identify.

Then I think in terms of some of the financing issues, there are states that are very interested because California is trying to do a lot of different things. There are states that are very interested in figuring out whether or not they can start collecting social determinants data and have it as part of the background relative to this.

It is almost like maybe if we present at states with a vision of how collecting some of this other data could serve them economically throughout the life of the person and could be kind of fed into other systems at other points of time. We might actually be able to get some money from them. I can tell you, California is really interested in this. It is being pushed by one of our offices.

Of course, they are really trying to deal with all of these rules that say what you can’t do and who owns this and that. But let’s have a meeting where we actually present a vision of what could be a value added, and then see if we can sell it.

MR. ATKINSON: Vickie, you mentioned one thing that is something I have been struggling with a little bit. That is with the National Violent Death Reporting System. Trying to work with them to think about where relevant information from that system needs to be on the death certificate. How do we create an environment or facilitate an environment at the state level that allows that working together?

Now, if we get the funding, and as I said, my staff and I go after all kinds of funding. We are going after funding to do a project where it is focused on the state vital records office, the Office of the Chief Medical Examiner and one or two other data systems. One of those that we are thinking about is the National Violent Death.

Trying to create an environment where there is the interoperability between those systems such that the information that one system collects can enrich the vitals, the death certificate. That then becomes that permanent source for which become available for statistics and surveillance and research and all of those kinds of things. How do we create the willingness to work together?

It has to also start at the federal level, working and thinking in that way. Right now, that is not the way that it has happened. Everybody is thinking by themselves. That is something that we need to work on.

DR. COHEN: For those of you who are less familiar, the NVDRS is a CDC-funded system. They fund, I think the last time I looked, it was 20-some states to supplement death certificate data with data from the medical examiner’s office, from public safety and from other sources to give a much fuller picture around violent deaths. So that local health essentially can understand better the epidemiology of violent death.

It is an example of using the death certificate as the core element of an expanded data collection system that puts together many state and local databases. For the states that have been fortunate enough to get the grant, it has been really helpful dealing with a lot of the issues around understanding the ideology of violent death.

DR. MAYS: I think the place where there is funding potentially is the Department of Justice. They current are getting so much grief that I know the people working in policing that they are being asked about this. And the issue of the states that don’t even have this or the states where there are a lot of problems, where a lot of these violent deaths are occurring, which is in the south.

I mean, I can connect you. Since you seem to fund raise well with this conversation because I have been really trying to push to make sure all the states will have it. Congress is actually asking for this, so it is a really good time.

DR. SUAREZ: This is so exciting, and again I am so sad I won’t be a part of this. I am so glad really that we are paying attention to this and focusing on this. Vital and health statistics is part of our name, part of our DNA. I am so glad that we are bringing back and beginning to focus even more on this.

I certainly support very much this concept that is being mentioned of a workshop and agree with all the comments that everybody has done. I do want to say a couple of things very quickly. One is I think there is an opportunity. This is almost like the concerns, and Vickie mentioned some of the concerns about cost.

It is almost the same thing as access to health medical records and how much providers and others are charging for that. OCR having to issue guidance about how much you should charge. I think there is an opportunity perhaps to develop some guidance about birth and death access, if you will. And some of the understanding for consumers and providers and others, even for death records, funeral directors, about what should be considered when having to process this type of element.

I would say one of the products that can be generated is some guidance about this. But the other one I wanted to suggest, and this is much more actionable in the next few weeks, is, as you know, and then you mentioned meaningful use and this idea that everybody. I know, Michelle, we all think about the first question that everybody asks is, is this part of meaningful use.

The meaningful use part has, as you all know, two components. One is the metrics, the meaningful use requirements that CMS publishes for providers to meet. They have to do 90 percent of their ordering for labs electronically. They have to do 70 percent of prescription drugs electronically. They set the metrics, and they say they are required.

The other part of meaningful use, and is now beyond meaningful use, is what ONC does which is certifying EHRs for capability, functionality and standards. They published ONC, and I think we heard it, maybe we didn’t actually hear it from ONCs update. But they just published the 2017 advisory on interoperability standards, which basically lists all the 120 plus standards that are being promoted. Do you know how many times the word death was there in terms of death records? Zero. There is no mentioning of the death record. There is no mentioning of the birth record as a standard.

I think there is an opportunity. They mention at the very end. They received some comments about including birth information. I think there is an opportunity to have them clearly identify standards that exist. They are written. They are adopted. They are normative. They are in place in many places. Probably not in this country and other countries. But in any case, I think there is an opportunity to really include those two death and birth sections.

I know we as a committee are not going to comment on it. But I encourage you all to consider commenting on the ISA, the Interoperability Standards Advisory that ONC published. A simple comment suggesting that this be added as an advisory of future standards to be considered for adoption. That was my suggestion.

MS. WILLIAMSON: I would like to comment on that. NCHS, for a number of years, has provided comments on the ISA and the processes. We as a center will provide comments to CDC and CDC as a whole moves it forward. We have written a list of comments always saying, these are the bookends of the record. They should be in the ISA. It has not been adopted. Anyone who is sending comments, if you want to see our comments, we will be happy to send them to you.

DR. SUAREZ: We will do a hash line or whatever they call it, hashtag.

MS. GOSS: Michelle, would you be willing to take a follow-up action to have those comments distributed to the committee.

DR. STEAD: Again, thank you for what you are doing. I like the thread of this conversation. I just would add one dimension to it. All of my scar tissue is that data that isn’t used isn’t right. The trick is to get multiple uses and to particularly get uses of people that might know how to refine the data.

In our own provider world, now that people are really being tied to observe to expected mortality trust you, trust me at Vanderbilt at least, every service lines works every death and goes back and makes sure everything was right in the data trail, and who it is attributed to. We weren’t doing that a year ago.

The quality payment program is a key lever to get death data used. Increasingly, people are going to be attributed populations, whether they are in the hospital or not. So as we build this vision, one of the things I would do is, or maybe even add a bullet into it, of identifying all of the users and the barriers to use, and what we could do to overcome the barriers.

If we capture accurate birth certificates, then that is the logical way to initiate a medical record, not just in the site where the person is born, but in other systems when the hit them. I don’t know when we will be able to comment on it. But I would think the certificate would be a key ingredient to any non-identifier based patient matching.

We might think through.

MS. GOSS: That is not happening today. It is not even a factor in enterprise NPI reconciliation.

DR. STEAD: I understand. All I am trying to do is get us to not just think of this as the chain of vitals, which is terribly important. But to think about it as what are the key uses at each stage. In essence, when somebody gets a new patient, they ought to be able to do a certificate check that would be analogous to an eligibility check. It should work that simply. These are things we ought to think through.

Again, the key part of any kind of outcome piece, if we could actually get the set of uses. I understand for each thing I suggested, there is a barrier. What is the way to overcome that? We really could maybe flip the system around and have perfect vitals as a byproduct of the fact we are all using this data as a key component of our health.

DR. COHEN: A quick add-on to that, Bill. There are universities, researchers developing the systems. I know I am most familiar with the pregnancy to early life. It is called PELL in Massachusetts. They start with the birth certificate. They add hospital discharge. They add the APCD. They add birth defects. They add early intervention program.

They are building a database with the core starting with the birth certificate to essentially crate a life administrative certificate with regard to health outcomes. They are trying to get school records to incorporate into that and build from there. That is a wonderful idea.

MS. GOSS: Helga, I think you had your card up next.

DR. RIPPEN: Again, going back to the value proposition. Again, it goes back to them, this whole thing about how you do sustainability. I think what you do is so core again. We rely on it for everything, births, projections, every sector, deaths. It goes to population.

Kind of building on what Bill had said, it is really important to get it right. Anything that we can do to make sure that the quality is there, and what needs to be there is in there. I will give you an example. I know we talked about the violence piece. But I am a biomedical engineer. There was somebody looking at, well, trauma. What is the cause of trauma? Remember the softball, the kids getting killed? They pushed to actually add some more information about cause of death and blunt force trauma, how do you describe it?

I think instead of just picking the cause de jour, which changes and is very political, which is what you don’t necessarily want to do, think about how robust does it have to be. That is number one.

Number two, going back then to what is a value proposition. Everyone has to fill out, well, there are certain people that have to fill it out as part of their kind of job to do it. Birth records is easier. Death records, it just depends, if you are in the hospital.

So anything that can be used as a service, it saves money. A lot of people, the reason why there usually isn’t a demand is because they have got their own process in place. But if you can say, well, you can demonstrate streamline, it saves you money, that is always an important thing.

The other thing that I had done when I was working at kind of a state level is there is so much need to actually close out a record. I know Bill was alluding to starting a record. But it is just as important to close a record. We were actually linking back to the death certificates to say when someone passed, so that the health care systems knew, which was important because for quality measures and also understanding what happens to patients. It becomes very important.

But then the fourth, which is really important, and that is why it really has to be correct, is for services being provided. We found that there were certain people that may or may not have been dead, or somebody was using their information. We don’t know. We know what happens if you are said that you are dead, and you are not. It is not a pleasant thing. I just saw a 60 Minutes piece on that.

Again, if it is high quality, it provides value to the state because you don’t have pay certain things, benefits and things like that. Health care systems, you get benefit from it. There are a lot of points in the value proposition that, again, as you brainstorm on where the value is, you may want to do it. Again, it is the core pieces.

MS. GOSS: Dave or Rich, not sure who was next.

DR. ROSS: I am just beating the same drum. It is the value proposition drum. Back to the original question that Michelle and Delton asked me, so what is the best thing to do. I would agree with what has been said absolutely. We have got to get the value proposition to all of the different stakeholders really, really refined and enumerated. Only then can you start to talk to the different groups, explain to them why this actually does matter to them.

I am a public health guy. I understand the value of vitals. But that doesn’t mean anything to the medical care delivery community. As has been pointed out, it is not showing up. If you go talk to provider organizations or talk to the CIO within a big hospital system, hey, has anybody been knocking on your door saying you need to refine the system to do this, they are going to say no.

That is not necessarily the statement that it is not needed. It is just a statement that we have not done our job to alleviate with great clarity and specificity the value proposition to each of those major stakeholder groups.

If there is a future hearing, I think getting prepared for that, and then having this committee hold a workshop on validating that and further expressing it, so that then you can start to communicate and educate all those different audiences about why this becomes important. We are not armed with those facts in a way that we can communicate it and when the day. I think that is our starting point.

MS. GOSS: Excellent. Rich.

MR. LANDEN: ONC has come up in several different contexts today in the discussion here, both about their role as meaningful use and the annual interoperability standards advisory. I would like to suggest we consider inviting Dr. Vindell Washington to introduce himself to this group and us introduce ourselves to him maybe at our next meeting or at the February meeting. There seem to be a lot of areas of overlap.

For those of you that don’t know, he replaced Dr. Karen DeSalvo as the national coordinator since our last meeting. Each coordinator has brought a new and slightly different perspective and mission and strategy to the ONC. It would be very advantageous for us, I think, just to share some information about looking forward, especially as we plan our agenda for next year’s review committee hearings and see where our paths are converging and where they are not converging.

MS. GOSS: I love the idea. It has been very insightful to have them come present their perspectives and for us to establish that dialogue. I don’t know that everybody will have the depth of appreciation of the relationship, as Karen DeSalvo did between NCVHS and ONC. But I think it is important to keep that relationship and rapport moving forward.

MR. LANDEN: And we have also talked about the imminent intersection or increasingly intersecting areas between the administrative data and the claims data. ONC has two FACAs that report to it that are charged with the clinical side of the data.

DR. SUAREZ: Just so people know, we did actually try to reach him for this particular meeting. We were hoping in some ways that we were going to be near their location. Unfortunately, it didn’t work out. But certainly I believe and I totally agree. We should try to bring him or invite him to participate, and introduce himself. I know we would want to do it by November rather than February because he might not be around in February.

MS. HINES: I was going to say Jon White.

DR SUAREZ: Jon White has come and talked to us a number of times already. But I think it would be great if we can have the national coordinator by November. We will see. I think we can try to work on that.

MS. GOSS: I think we can put that as an action item to look at. I have been taking notes. I also noticed that we are slated to have some public comment. I wanted to open it up for the audience to see if they had any public comment before we sort of wrapped up and went to break.

MS. HINES: Before we do that, can I just put something out there? There has been a really rich dialogue at so many different levels. The way my brain thinks is I want to see the big picture. What I see discussed here today, and it is missing all of the beautiful detail all of you have raised.

But ultimately, what Delton and Michelle are trying to get us is the best quality data. Then there are all these pieces that lead into it, starting with the funding. Then that supports or doesn’t all the people responsible, and then all these crazy processes that end up at the end of the shoot giving us data.

My question for all of you is where in this process do you, as a committee, feel like you want to weigh in on different pieces of it, on one part of it, on all of it? It seems to me there are so many different layers to this that end up with data that either are or aren’t good quality. From the funding and the education to the stakeholders, all the way up.

DR. ROSS: Rebecca, the argument I am hearing is that until we get the value proposition explicated at the level of pretty finally granular of all the different stakeholders, it is very hard to argue for funding. Nobody knows what you are selling. We have to know what we are selling. People buy what they want as a solution to their problem.

We have to identify who are all those stakeholders, what stake do they have in this. We have got to make that clear.

MS. GOSS: It is not just the value proposition for stakeholders. I think it is critical, but it also has to be blended with where we think a vision is going.

DR. ROSS: That is right. They fit together.

MS. HINES: That is missing the stakeholders and the value proposition. Again, once we add that to this model, if you will, of reality, then where do you, the committee, where do you think you can have meaningful impact? That is really the question.

DR. MAYS: I don’t think we really have to discuss the vision. I think we haven’t even interrogated this well enough. I think what we operating on is what we usually do and a little bit on the edge of what technology has allowed. But we haven’t even pushed what technology can do and linkages and all this other stuff. I think it is the vision of how is this used.

Because right now, it is just used, okay, somebody is born and it is fine. Somebody dies and you need a certificate. But in the world, we haven’t said how vital statistics, other than we have, but the world does not know how it can use vital statistics for a lot of things that I think we haven’t made the case for.

MS. GOSS: What I am proposing is that we need to have some more additional discussion. I appreciate the visual diagram that kind of collected. I think there are a few things we can add.

I wanted to see if there was anything we were missing from the larger public comment perspective. Then I was going to attempt to see if we could maybe get a volunteer group to take this feedback and give us a little bit more of a recommendation on where we need to go. I had some volunteers I might like to propose.

MS. HINES: Bruce has one proposition, which is to have a workshop in 2017. That group would have to work obviously with you to define what the focus of that would be.

DR. COHEN: I think also, we need to pull in the jurisdictions because they are the source of all this information ultimately. They need to be involved in the conversation as we frame how we want to move forward. I agree with Alix and everybody. We need a little more work before we can get to a point where we can lay out, I think, a direction and a productive next step. This was, I think, a very useful start. But we need more input. We are not ready for primetime.

DR. SUAREZ: I think between now and certainly November, the next meeting, there could be additional, if there is time, brainstorming and revisiting this idea as the committee builds the work plan for the coming year.

MS. GOSS: Bruce and I have been really spearheading this along with Rebecca’s support. So I am curious as to who might want to play in that space, Dave. If there are other people who might want to also. He has so much great experience in this. I think it needs a little bit more than just a standards person and pop health person. I am trying to pull other people into this offline brainstorming. I know you are busy. Anybody who would like to be a part of that next conversation.

DR. ROSS: I am very willing.

MS. GOSS: Okay. I have Dave and Helga and Vickie. That is a great working team.

MS. LOVE: A lot of these things, I am very interested in. But I am really shy about over committing the time I don’t have. Is there a way to not immerse, but have intermediate check-ins.

DR. MAYS: — the discussion between now and November.

MS. GOSS: Guys, I am not committing to what date it is going to be. I think we need to step back and look at the totality of the work in front of us and prioritize it. We will figure it out. But I want to know who are the usual suspects that want to at least influence the ground floor thinking that we can then bring back to the full committee and have much more productive conversations by doing that offline work.

MS. LOVE: I am just wondering if the same go-to people who do this incredible work, but if there are ways to vet at small steps before it comes to the committee.

MS. HINES: That is what the small group does.

DR. SUAREZ: Between now and November, there is only just the brainstorming. I think the idea is to have some more brainstorming about this proposal.

MR. ATKINSON: Let me just say to add to this conversation because this has been something that we have thought some time about. There are two things that we are doing that I think can aid this process. Number one, we are having a vision in process with the states. The first meeting, that is going to be a facilitated set of retreats that we are going to have. The first one is going to be December 14th and 15th, I think.

DR. RIPPEN: Can people crash it?

MR. ATKINSON: Yes. Secondly, because we see this as very important and really kind of setting the direction and the future for vitals, I am in the process of putting in place a senior service fellow for vital statistics. That person will report to me and will begin to help me address some of these kinds of issues and thinking through this process. I hope to have that in place by the first part of November and will recruit for a person to be able to work with this.

Again, this is something that we have thought about and we have been serious about how do we move this agenda forward.

DR. ROSS: Is that paper something that would inform the group here?

MS. WILLIAMSON: It is posted on the NCHS website. I can give you the link.

DR. ROSS: Looking at the EHRs and data and where the intersection —

DR. RIPPEN: I don’t know if it would be helpful, but we do pull in people to testify or at least to provide information. Again, depending on what you recommend, it would be nice to have kind of people presenting different viewpoints or kind of experiences from the state levels and the different positions.

MS. GOSS: I think it is really key. I think as a part of the work that does offline brainstorming can do to take the feedback that we have gotten today from the committee, think about what that means in the context of a workshop, what we want to tackle, start to put some meat on those bones.

I think we do have to make sure we have a broad level of stakeholders, which maybe then helps inform some of this value proposition work. It is going to take us a while to get through this. But I think it is important that we do get that next call scheduled while we have got all this.

DR. RIPPEN: We may want to have something in addition to a workshop. I am just saying because a workshop implies a different kind of activity.

DR. COHEN: We are also very fortunate to have in the audience Mark Flotow, how is the past president of NAPSIS and has been involved with this stuff forever, and is the BSC representative. I am sure Mark will have some ideas that we can take back to some of our NAPSIS colleagues. I have got some input from them, as well.

DR. SUAREZ: Thank you so much. I want to thank both Alix and Bruce, as well as Michelle and Delton. I think it is going to be very good and very valuable work.

I think we are going to transition to the public comment in a second. I just wanted to see if there is any final comments from the committee about this topic before we transition. Anything else? There is a public comment in a minute, yes.

Hearing none, we are going to be going to the public comment. Anyone please introduce yourself.

Agenda Item: Public Comment

MR. FLOTOW: Hello, I am Mark Flotow. I am the past president of NAPSIS. This has been a wonderful discussion. There are many wonderful things that I heard and some things I had not thought about before.

I really appreciated David’s epiphany about how valuable vital records are. It sort of points out that, in some ways, the support for vital records is a mile wide and an inch deep, just like it is for the census. We all love it. We all want to use it. There are interesting things about it. But somebody else is supporting that.

The other things that I really liked were what Vickie and Delton talked about in terms of the vision. Having a vision that we can sort of expand our borders and find out what the players are. I also liked what Bill said about flipping the ecosystem. That really sort of got my brain going. As to put emphasis a little bit differently, so it isn’t a mile wide and an inch deep. Again, I find this session was great. I really look forward to hearing about the workshop coming up, too.

DR. SUAREZ: Thank you. Anyone else from the public who wanted to make a statement or any comments? Okay, do we have anyone on the phone? We don’t, okay.

MS. LOVE: I think there were a few that were going to comment on the APCD and will come back tomorrow.

DR. SUAREZ: Yes. At 9:00, we will continue our discussion on the APCD recommendations. With that, I think we are going to proceed. As we all understand now, we are not adjourning as a full committee. We are going to proceed into breakout sessions. We are going to take a break until 4:00 p.m. Then we will transition to the sessions.

(Adjourned Full Committee.)