[This Transcript is Unedited]

Department of Health and Human Services

National Committee on

 Vital and Health Statistics

Full Committee

January 9, 2018

Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201


Welcome – William Stead, MD, Chair

Committee Updates

NCVHS 2018 Work Plan

Beyond HIPAA Environmental Scan – Linda Kloss

Predictability Roadmap – Alix Goss and Nick Coussoule           

CIO Forum Planning – Alexandra Goss, Nick Coussoule

New Medicare Card Project/MBI Follow Up – Full Committee

Foundations for Evidence-Based Policymaking Act of 2017 (HR 4174) – Amanda Cash

NextGen Vitals 2017 – Discussion and Full Committee Approval – Bruce Cohen, Dave Ross

Next Generation Vitals for 2018

HHS Data Access: Approach to Fact-Finding – Robert Phillips


Agenda Item: Welcome

DR. STEAD: Let us come to order if we may and start with introductions of members in the room. Denise, would you like to kick us off. We will go around this way.

MS. LOVE: Denise Love, National Association of Health Data Organizations, member of the Full Committee and member of Population Health and Standards Subcommittee, no conflicts.

MR. LANDEN: Rich Landen, member of the Full Committee, Standards Subcommittee, no conflicts.

DR. CORNELIUS: Lee Cornelius, still at the University of Georgia in spite of last night, member of the Full Committee and Population Health Subcommittee, no conflicts.

MR. ROSS: Dave Ross, Task Force for Global Health, Emory University, member of the Full Committee, member of Population Health Subcommittee.

MR. COUSSOULE: Nick Coussoule, BlueCross BlueShield of Tennessee, co-chair of the Standard Subcommittee, member of the Full Committee and Privacy and Confidentiality, Security Subcommittee, and I have no conflicts.

MS. GOSS: Good morning. Alix Goss with Imprado. I am co-chair of the Standards Subcommittee, a member of the Full Committee and Executive Committee and no conflicts.

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

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

DR. PHILLIPS: Bob Phillips, American Board of Family Medicine, member of the Full Committee, and co-chair of the Population Health Subcommittee, no conflicts.

DR. THORPE: Roland Thorpe, Johns Hopkins University, member of the Full Committee, member of the Population Health Subcommittee. I have no conflicts.

MS. MONSON: Good morning. Jacki Monson, Sutter Health, member of the Full Committee and member of the Subcommittee of Privacy, Confidentiality and Security and no conflicts.

MS. STRICKLAND: Deb Strickland, CONDUENT, member of the Full Committee, the Population Health Subcommittee and the Standards Subcommittee, no conflicts.

DR. STEAD: Member on the phone? Has Vickie been able to call in?

MS. HINES: She has, but there might be an issue on whether she is on the open line.

MR. THOMAS: Sam Thomas, Rose Li and Associates, contractor staff.

MS. HINES: We are doing staff next.

DR. STEAD: Staff.

MS. HINES: Rebecca Hines, executive secretary to the National Committee with the National Center for Health Statistics. I am glad you could all make it today.

MS. SEEGER: Rachel Seeger, Office for Civil Rights, lead staff for Privacy Subcommittee.

MS. JACKSON: Debbie Jackson, National Committee on Vital and Health Statistics, NCHS Committee Staff.

MS. DILLON: Michelle Dillon, RLA contractor staff.

MS. BENNETT: Ruth Bennett, RLA contractor staff.

MS. GEARHART: Chris Gearhart, CMCS.

MS. BEBEE: Suzie Bebee, ASPE.

MS. KANAAN: Susan Kanaan, writer for the committee.

DR. LI: Rose Li, Rose Li and Associates.

MS. PICKETT: Donna Pickett, staff to the Subcommittee on Standards.

(Audience Introductions)

DR. STEAD: Bruce Cohen, Massachusetts, committee member and co-chair of the Population Health Subcommittee, no conflicts.

MS. HINES: On the phone, Vickie, are you with us?

DR. MAYS: I think so. Can you hear me? Great. Thank you. Vickie Mays, University of California Los Angeles, member of the Full Committee, and member of the Pop and Privacy Committee. I have no conflicts.

DR. STEAD: Welcome everybody. We have a quorum. Let me briefly review the agenda. We are going to start with some committee updates and then we are going to walk through the 2018 Workplan, that is a constantly changing roadmap that we are managing too. We will walk through it so that everybody is aware of it. The Executive Committee has signed off on it, at this juncture.

Then we will do Beyond HIPAA Environmental Scan where we hope to approve the report that Bob Gellman has developed for us. Then we will have a block on the Predictability Roadmap, break for lunch, and then continue with a planning session on the CIO Forum.

We are then going to have a committee round robin on the New Medicare Card Project to see what each of us has been able to learn by reaching out to our networks about whether the message has been getting through to the different communities with the publicity that CMS has been trying to make.

And then we will have an update on the commissions for evidence-based policy, in particular, the Act HR 4174. We will then have time to work on the Next Generation Vitals project. We hope to approve the environmental scan that Gib Parrish has prepared in conjunction with the Subcommittee, and then go into a discussion of different possible alternative approaches going forward. And then close today with a block on HHS, Approach to Fact-Finding.

Then in the morning, we are going to have a block on the terminology and vocabulary work, starting with an update on UMLS and in particular sort of its technical underpinnings from the National Library of Medicine.

Donna Pickett then is going to update us on ICD-11. We will after the break, have a block that Linda will lead around the environmental scan and next steps and then a briefing on the FHIR Interoperability Resources.

After lunch, we will then come back for an update on the Health Data Landscape by the chief statistician from OMB, and then we are going to close with a review of next steps and public comments.

Do any of the members have any questions or suggestions about the agenda or are we good to go? Thank you.

Agenda Item: Committee Updates

DR. STEAD: Then let’s briefly do a few updates. I want to acknowledge hard work of both staff and the committee that resulted in a very successful series of three virtual meetings at the subcommittee level at the end of November. I think that proved to be an effective additional way we can work without always having to be face-to-face. It gave a good chance for the Full Committee to join in with the subcommittees in the work. We had a fairly robust participation from the public. I think it worked quite well.

This fits with the fact that this year, we are shifting from four meetings to three. This is the first of three meetings. They are evenly spaced out in this federal fiscal year. That is where we are from my perch.

Alix, would you like to give us an update from your perch?

MS. GOSS: I had the pleasure of presenting to the Work Group for Electronic Data Interchange in December at their WEDI Con event. It was a really exciting event with a lot of great speakers, including some really robust half-day workshop type activities around the New Medicare Card Initiative. It was really good to be able to listen in to, but provided us with a direct opportunity to showcase the work of NCVHS and to focus in on our 2018 Workplan and have some interchange with their several hundred participants and getting feedback throughout the two-day event.

DR. STEAD: Thank you, Alix.

MS. HINES: I have a couple of things. As you all recall, it was a year ago this month that the committee successfully closed out the measurement framework. We had 30 subdomains that we thought were the right ones after using a very inclusive iterative process with stakeholders. I am happy to report that right now the 100 Million Healthier Lives group through the IHI, Institute for Healthcare Improvement, is well in the process of engaging with similar set of stakeholders. They have a Health and Wellbeing Metrics Development Work Group and a Health and Wellbeing Measurement Implementation Work Group. We are, as we speak, working on coming up with candidate measures for this framework.

We actually had a conference call yesterday. It is in the works. I just want to say. This is a beautiful example of the committee launching something, pointing to a gap and then handing it over to the private sector and letting the private sector run with it. I just want to say kudos to all of those who really pushed this, Bruce and Dave and Bob and Bill. I know you guys worked on this years before I came to the party. It is amazing to see where this might go. They are really serious about it. We have timelines and work plans and it will be interesting to report over the coming year how that goes.

On a more internal issue, we are working on improvements to the website and we are going to ask you all in the next month to think about a parsimonious set of key words for your respective subcommittees. We are going to make the website searchable. Our friends in the corner are going to help us with that. Please today if you want to think of eight key words or whatever, we would like to start working on this so that when we start the back end of this system, we can just tag all of the reports and letters. I just wanted to let you know about that.

And then some sad news. You might notice someone not sitting at the table this morning. Helga has actually gone to the dark side. She has taken a federal position. She is one of us. She actually started yesterday as deputy director of the DoD VA Interagency Program Office responsible for ensuring electronic health record interoperability for the military. Those who serve in the military, pretty exciting. As a government employee, she can no longer serve, but she will be with us for dinner this evening if you want to congratulate her and say good bye. She was only with us for just under two and a half year. I know I will miss her. She really contributed quite a bit to Pop Health and Privacy, but just wanted you all to know that there is a reason she is not here. She did just resign last week.

DR. COHEN: This is Bruce. I just want to acknowledge for the record, Helga’s incredible work, helping support all of our activities. It has been really a pleasure to work with her. Her point of view did not always agree with mine, which was really helpful for me. It was great to have the lively and productive interchange. Helga will be missed. Helga, if you are out there, thank you so much for all the fantastic work you have done for us.

MS. HINES: Unfortunately, that means we now have four vacancies. I would also like to invite you and the public to send suggestions our way. If you know of people who have expertise – as you know, what our three subcommittee foci are. Please send those suggestions. Make sure it is people who have the bandwidth. You know this is not light duty. I just wanted you to know that we are going to be thinking about that and trying to get that in the works over the next season. With four vacancies, it starts to hurt.

DR. STEAD: Thank you, Rebecca. While we are on the subject of departures, I want to take a moment and recognize Katherine Jones’ contribution to the committee. Her last meeting turned out to be in September. We did not say anything then because we were hoping that she was going to change her mind and continue to support the committee. But as the time passed, it became clear that she was going to step down as she had planned at the first of January.

She has been an absolute main stay in supporting the committee operations as NCVHS team lead and our contracts officer over the years. In one way or another, she has been involved in all aspects of the committee’s work, establishing and maintaining the infrastructure behind the scenes so that the committee can conduct meetings and accomplish our objectives.

We have had the benefit of trusting that all will be well and with her at the helm, it always was. She made it happen: meeting logistics team organization, contract support negotiations. She did it all with precision and she did it also very quietly that you actually did not know she was doing it.

She added another NCHS Merit Award this year to her collection that commended her for going beyond the call of duty to get tasks done with grace and cheer. We benefited directly from her approach to her work. As the executive representatives for NCVHS, I would like to express our appreciation and to say thank you to Katherine for her attention and dedicated service. Simply put, you are the best.

MS. KLOSS: In that same vein of thanking key people, this is the first in-person meeting where we have changed key staff to Privacy, Confidentiality and Security Subcommittee. I want to formally acknowledge for the record the work of Maya Bernstein over 13 years that she served as lead staff to the subcommittee. We have compiled a series of work projects over that period. I will not go through them all.

But suffice it to say that over these 13 years, the subcommittee and the committee through the work of the subcommittee, has had 27 days of hearings, 178 panelists. And when you are lead staff, you know that lining up each of those panelists is quite a lot of work. Ten reports, 87 recommendations to the secretary in three areas of work, privacy of electronic health records and sensitive information in EHRs, use of health data by communities and certainly areas of HIPAA regulation and compliance. When you look back over the 13 years, you kind of see the eras where the subcommittee focused on certain things.

We had a period where we were working on areas of sensitive information and more recently on areas of privacy and community and certainly revisiting some HIPAA regulations. I want to just on behalf of the committee formally thank Maya for her years of service as lead staff to the subcommittee. And I think she also is going to join us for dinner tonight so we can thank her in person.

At the same time, I am warmly welcoming Rachel Seeger, who is stepping into Maya’s shoes and has already shown she has big feet. She is doing a great job and has launched us well. And really we have felt almost seamless transition. Thank you, Rachel.

DR. STEAD: Thank you, Linda. Are there other updates from members of the committee at this time that needs to be surfaced before we move on to the work plan? Then we will begin the discussion of the work plan.

Agenda Item: NCVHS 2018 Workplan

DR. STEAD: The work plan has evolved a lot. I do think the right mental model for the work plan is this is a management dashboard. It is, in essence, what we are trying to get done and we move things in and out of it as circumstance requires. We are really working to try to pay attention to our collective bandwidth so that we can do a good job and actually get things done and out to the public and to the secretary rather than flailing at all the things we would really love to do, but do not somehow fit onto the plate. You will see that we have adjusted a bit. I thought I would just walk you through this.

The first row is the new Medicare project follow-up. At this juncture, we are hoping to do the brief biopsy or reality test of what of the messaging is in fact getting through. And other than being able to give that feedback to CMS, we are, in essence, going to be in monitor mode going forward, hoping that all will go well.

The health terminology and vocabulary work. We have been fortunate in that the National Library of Medicine has agreed to provide staff support to help us move this work along. Suzy Roy and Vivian Auld will be here tomorrow as part of that.

What we are planning to do is in the first quarter in essence put a bow around the environmental scan and the key levers and issues going forward. That will be the topic that we are going to work tomorrow. And then based on that, we are hoping to plan a stakeholder roundtable that would let us get input into the key issues, summarize that, and put it into some form of report by the end of the calendar year. That will in essence let us figure out what else we may want to do going forward, but we will hopefully get some substantive and useful on the table to define the landscape and the key issues. Is that fair, Linda?

Come down to the next row, which is the predictability roadmap. We are going to have a discussion at this meeting around the framework of what that roadmap is beginning to look like. We then hope to get additional input and in particular through the CIO Forum, which we are hoping to arrange for later in this first half of the calendar year. That will give us additional input, which will then play into what we hope will be an initial report with recommendations. We already have the summary of the report from last year’s workshop.

CIO Forum. You will learn a lot more about that later today. We are trying to design it so that it provides feedback, both for the Predictability Forum and to the degree possible for Beyond HIPAA. We see it as a dual branch point in our work plan. We are hoping to have that forum summarize what we learn and get that out in a deliverable.

As we go through all of this, I think it is really important for the Full Committee to keep in the back of their mind that based on what we come out of Q3 with, we will in essence be writing the 13th report to Congress on HIPAA. It is important as we manage the levers of this work plan that we keep that deliverable in mind because we are going to be trying to bring these things together to something we would be approving probably early in calendar 2019. But if we are going to do that, most of the work will be done when we come out of Q3, most of the input work. Just keep that in mind.

We took two items off the workplan: the Patient Matching Initiative and the Prior Auth End-to-End as simply being more than we can do. Both will be informed by the work we are doing around the Predictability Roadmap. We figured that from a bandwidth management perspective, that was an important change to make.

MS. GOSS: Can I add a note to that? I think it is also in addition to our own bandwidth issue, we noted that there was so much happening within the industry on patient matching and within prior authorization. We felt it was also much more collaborative to let them keep their work at moving forward and then have us elevated when it is ready to be brought forward broadly.

DR. STEAD: Well said, Alix. Thank you very much.

We have left a row in the work plan, which is titled NCPDP Version Update Request. That is in essence where we are going to handle time-sensitive requests from – the DSMO and also possibly the industry, depending on what happens to us. It gives us – we know there are some time-sensitive things we are going to need to do. They are still evolving of what they may actually be.

MS. HINES: There is a line for CURES and you may wonder what this is because several of you have not heard of this. We did include a one-page fact sheet in the agenda book. Hopefully, you saw that.

You may now be aware from the fact sheet that the 21st Century CURES Act asked the secretary to convene or actually mandates that the secretary convene a working group to study and report on uses and disclosures of PHI for research purposes. If you look at the legislation, it actually says the working group should consist of people like us. The thought would be instead of creating from a whole other group, why not use a FACA that actually has experience doing this kind of thing? The legislation stipulates you need members from NIH and CDC and FDA and the HHS Office for Civil Rights and a patient, but that is easily enough accommodated. That possibility is being explored here at HHS. We will keep you apprised if that actually comes to pass.

If it does, we will, as you can see, engage pretty rapidly on trying to get this done. The legislation basically gives this work group a lifespan of one year to do all its work, have a hearing, and develop a report to the secretary and then sunset the next day. That is the new congressional way of keeping groups from going on and perpetuity is giving them a lifespan.

DR. STEAD: Knowing that we may need to do that on one hand and also recognizing in no small part because of Bob Gellman’s work in the Environmental Scan that we will do in a minute, how big the Beyond HIPAA space is. We elected to narrow the scope of what we are going to try to do in this year.

What we are proposing, and we will get into some of that later today, is that we would pick a couple of exemplar use cases, if you will, problem cases that are at the intersection of the regulated and unregulated worlds as defined in Bob’s report, with the regulated world being the things that are really regulated by HIPAA and the unregulated world being everything else. That seems to be a likely sweet spot for developing recommendations. We thought if we worked to examples, which would give us something that we could say, but it would also tell us a lot about what other work might be useful in this space.

This was partly trying to open up bandwidth in case we are asked to do CURES, but I think we also felt it was the best way to actually get something useful done in the near term. Is that fair, Linda?

MS. KLOSS: It is and I would just add that we thought that the experience of considering what useful framework in these particular targeted areas might be that could inform the larger picture later on. We would also learn and inform where we go from here.

DR. STEAD: Thank you. Next Generation Vitals. We are, as I said earlier, hoping to approve the report on Uses, Users, and Financial Aspects that you got in the email in advance of the agenda book. That is the fact based or at least the first set of facts that we decided we needed after we had the very informative hearing. We are also developing the summary of the hearing and that will be ready for approval in the spring.

What we are going to do in this meeting is talk through a set of alternative options for possible approaches forward that the Pop Health Subcommittee has developed that we can test run with the committee as a whole.

We think those alternative options could give us an opportunity to reach back out to stakeholders and get the kind of input we would need to be able to make pretty concrete recommendations because the summary report of the workshop is going to be just that. It is not actually going to be our recommendations. That is the current lens on how to handle that.

In terms of the Commission on Evidence-based Policymaking, we have basically said we need to wait until a legislation is final and HHS develops its understanding of what it is trying to do so that we can then align what we might do with what HHS is asking for.

Truth be known, if we do end up doing CURES with the work plan as it is constructed, we will not have the bandwidth to do anything in this set of things. If HHS comes forward with things we need to do, we will have to adapt and something else will have to go unless there is somehow resources that will allow us to do it. I think from a bandwidth point of view, mainly we would probably be trying to collapse around what we had to do. Again, recognize the work plan is – plans are important, but plans are what you have. Life is what happens while you plan. Just recognize that we are already for life to happen as we move forward.

Then HHS Data Access Issues. There have been a number of symptoms, if you will, that different stakeholders are experiencing difficulty in getting that information that they have been dependent on. We do not feel we know enough to do anything at this juncture other than some fact finding. We will begin to discuss that this afternoon to basically try to figure out the best way to find out what challenges people are experiencing so that we can figure out if there is anything that we can do usefully as a committee that would help with that.

The Parking Lot looks big, but we have actually pruned quite a lot of stuff out of it. One of the things I have learned over the years. If you go back and look at these lists from two years ago, you will discover that we have actually checked a lot off and we have moved a lot of stuff from the Parking Lot of two years ago into this work plan.

The Parking Lot. Reimagine HHS, which we are really – never got a clear indication of what HHS could need from us. That is a case where our ear is open.

The ACA Review Committee. In essence, I think we feel that the most useful work we can do at the moment is the Predictability Roadmap. We know there is no bandwidth and we cannot tell that there is actually any interest in us doing something else at this juncture. We will see. We may want to move something there back into the plan for 2019.

Patient matching and Prior Auth, we have already mentioned.

Collaboration with the ONC FACA to ensure consistency in how we are identifying issues in reports is a very important topic. Rebecca and I are meeting with ONC for a broad conversation about that tomorrow. Nick and Alix and I believe Rich are meeting with ONC around the standards components.

The hearing on edits, audits, and enforcements. I think we are sitting on at this juncture.

PARTICIPANT: Correct. It is tied to a lot of the Review Committee aspects.

DR. STEAD: Accounting for Disclosures. It does not appear to be of particular interest at the moment.

Guidance on Best Practices for Data Access and Use. We really simply do not have bandwidth, but the briefing we are doing this afternoon with the chief statistician and our HHS access fact finding relate to that topic.

Data Use and Service Agreements for Wearables and M-Health. I think it is down use of Beyond HIPAA. A lot of the information in the Environmental Scan shed some light on that.

As also with impact of changes in Privacy, Confidentiality and Security on Data Access.

Another topic out of the data work group that is in the Parking Lot is standards for webpages and use of infographics and data availability for HHS data sources that support health. I think a lot of what might come out of the evidence-based policy world might actually play into that.

The piece around the DSMO, et cetera, is all in the space of the Predictability Roadmap, I believe.

A new topic is a complaint that we have received that certain of the clearinghouses and so forth are imposing excessive fees that are presenting barriers to administrative simplification. And the Standards Subcommittee is going to process that complaint as it has time.

That is the list of things that are in the Parking Lot. Actually, as I go through it, I am not sure we cannot prune it a bit given some of the work that is underway. We may collapse the Parking Lot a little bit.

Are there any – is anything missing from the Parking Lot?

DR. LANDEN: Not missing, but just to be clear. Just because an item is in the Parking Lot does not mean we cannot pay attention to it. Is that correct?

DR. STEAD: Absolutely, particularly at the subcommittee level. In Tom’s past, we had a list of things we were working at the subcommittee level. We will periodically bring that back. This is really trying to have a coordinated lens on the things that we are trying to pay attention to as the Full Committee – and that eats a lot of the bandwidth of the subcommittees, but the subcommittees are obviously free to look at whatever else they think is important and to then surface it.

MS. HINES: Can I just do a little housekeeping. Ruth, if you could take us back up to Next Gen Vitals, I am sure this is or maybe not obvious. I do this 24/7 and you do not. You will notice the blue text or the blue highlighting, refers to when we hope there will be action or approval for an item. The green means we are going out to obtain something from our stakeholders and the purple is when we are having some kind of a subcommittee meeting like a hearing, a roundtable, or a forum. That just helps us when you look at the whole work plan and lining it up. You can see in each quarter how many hearings or even in a year what are we trying to do and it helps with resource management. If you were not clear why certain things were highlighted, that is the thinking that helps me when I see purple. How many hearings and forums are we trying to do in the next two quarters?

DR. STEAD: The other thing that is important that this has helped us do is we are really trying to use substantial blocks of our Full Committee meeting time to work these key priorities in the work plan. We are doing mini hearings in addition to substantive design kind of work amongst ourselves, not simply approving things. We are trying to space them into the schedule as we put it together.

MS. GOSS: Rebecca, along with the coding aspect, I noticed – if you go to the very top, please Ruth – the candidate topics for meetings and convenings. We are fully anticipating receiving a DSMO change request to advancing NCPDP. And doing that is a virtual hearing. My question is does this include only physical in-person —

MS. HINES: No, that is because you added it and I did not go back and put it in the top.

DR. STEAD: You also may want to come down and make sure we have that correct in the row.

MS. HINES: The way to phrase that, Alix, would it be DSMO change request from NCPDP?

MS. GOSS: Regarding NCPDP. I do believe. I am looking at Nancy. The change request is expected to move forward and eventually be sent to us as a letter of recommendation.

PARTICIPANT: I know a letter was being drafted. I do not know –

MS. GOSS: It is imminent enough.

MS. HINES: But everything that is in a row should be listed at the top. That was an oversight on my part. I will add that. Thank you.

DR. STEAD: Let’s just scroll back down one time with an idea of the color coding. Stop where we have color coding. The roundtable is currently – we are currently trying to target that for Q3. We have tried to spread these things out a bit. We have tried to line them up. That is an example of going – the virtual outreach around the Predictability Roadmap.

MS. GOSS: This is going to be interesting on the CIO Forum. I think after we get input from the Full Committee today to build onto the feedback we got in November as well as the subcommittee discussions, we are going to have to figure out some creative timing to help get that feedback, so things can actually line up, to your point, ultimately in 2018 if we can really advance this work plan in a way then we have a set ourselves up for a 13th HIPAA report.

DR. STEAD: Does that need to be turned purple or green?

MS. HINES: The virtual hearing should be green. I will add that.

DR. STEAD: We are thinking that if we do the CURES work, it would involve an in-person meeting of the work group and then downstream of that a two-day hearing.

Then vital statistics hearing would be in Q3, we are currently thinking.

DR. COHEN: Depending upon what else is in Q3, maybe Q4. I just do not want to overload us with Q3 workshops and hearings.

PARTICIPANT: Q3 spans three months.


DR. STEAD: If there are no other questions, that is the work plan. Is everybody good with that? Thank you.

Do we want to slide into Beyond HIPAA a bit early?

MS. GOSS: As we are getting situated on that, Bill, I just want to clarify. Tomorrow at 2:30 we will be able to do the fine tuning to really know how we want things to line up. There is a lot of advance, federal register notice and scheduling that we need to do. Is that part of what you are thinking there or is there no spot for that?

DR. STEAD: Yes, I was thinking that was where we would do that if we do not make decisions – going through the two days. But I thought that is where we would clean it up because we have almost all of us are staying for work – almost all the co-chairs, a lot of the co-chairs are staying for work. We will be here, which is unusual –

How do you want to handle this?

Agenda Item: Beyond HIPAA Environmental Scan

MS. KLOSS: Just a couple of set up comments in terms of how we will proceed with our block. And then we will get right into it.

We have two goals for this next hour. One, as Bill said, is to review the current what we think is the final draft of the Environmental Scan report, take questions, comments. We would prefer not to take any editorial issues. We will deal with those offline if any remain in the document, but substantive comments, questions. We certainly will have time to have some discussion around issues. I think as an environmental scan, the purpose of this document was to inform the committee. Rather than just to review of document, this is our time to make sure we all understand the issues that this report teases up so well. I am not sure how long that will take, but I am just arbitrarily saying 30 minutes on that.

And then 30 minutes on our second agenda, which is to review options for going forward. Bill introduced from the work plan, reminding us that our original plan was to go from this Environmental Scan Report to then laying out integrative models for how best to protect individual’s privacy and secure health data for uses beyond HIPAA.

We had some insights that came really through our second round of hearings that suggested maybe there was an interim step here that could be very useful and valuable and have some practical value in the short run and also reflect the bandwidth issues and make our ultimate goal more successful. Our idea was then to, as we touched on identify a couple of areas where we could look at problem cases, if you will, at that junction, that intersection between the regulated and unregulated world.

And what we want to do in the second half of this is to discuss what those candidate problem cases might be and see if we cannot develop some consensus around that so that the subcommittee then can go forward and better define that and develop a work plan around that for further discussion at our next meeting.

We are not starting with a blank slate. And actually a couple of issues emerged in the hearings and we will highlight them as we go through the report and then come back to discuss how we all think about those topics and what the opportunities are.

I do not know if it would be your wish, Bill, to review the report and then take action before we move into discussion of next steps, probably, while it is fresh.

DR. STEAD: Since the report does not contain recommendations and we have had a chance to review it in previous calls. If possible, I think after this half hour of conversation or whatever it turns into, we have a few extra minutes. I would like us to see if we are at a point we can approve it. If so, I would prefer to do that.

I noticed when I read it again very carefully yesterday a number of editorial things that can be cleaned up that I think we need to talk about. They are minor. That we normally clean up after we approve things. If we stay to the substance, I think that would be great.

MS. KLOSS: That is our game plan. I thought what we would do is just start with any overall observations on this report and what it does for us as a committee. I know when we stepped off into the Beyond HIPAA world, we knew it was big. But what this report reminds us of is just the vastness of it, but also how far down the path we are. In that way, I think it is a really valuable contribution.

Bruce, do you have an overall comment?

DR. COHEN: Thank you so much. Great job, Bob. It was really a wonderful education and a fantastic overview, very provocative and thoughtful. This really adds to the combined works of the National Committee and carries on the trend of having incredible foundational documents to think, not only for us, but I think for a much broader community. I think you did a fantastic job. Thank you very much.


MR. COUSSOULE: I was going to second that. This was really educational. What came to my mind is I would like every MPH student to read this. This is foundational. I think, Bruce, you said it very well. I have nothing else to add. I learned a lot and I really appreciated having it.

MS. KLOSS: I find I have already used it as a reference. I think that will be a real usefulness for our committee. At the same time, things are changing so quickly that – updated every six months, I am sure.

DR. STEAD: May I just do a little bit of a mixture of reflection and question? The section on the definition of health information does an excellent job at showing the complexity and the intersection of data user and purpose. Is the take home from that that we cannot or do not define health information? You make it very clear that HIPAA dealt with the problem by in essence the framework that builds around covered entities. I just did not know what your intent is that the reader would take – the logical take home to the reader from that section is. Would it be fair to –

PARTICIPANT: Bill, can we reference that section specifically?

DR. STEAD: It is the challenge of defining health information. As I read it – the first time I read it I thought – I wondered whether our goal was going to be to come up with a definition of health information. As my take home was the definition – what you are really talking about is not whether it is health information or not, but whether it is something that should not be abused almost. I would love to know where your head is.

MR. GELLMAN: This is informed in part — I was a congressional staffer for a very long time. I actually drafted a health privacy bill back in 1980 and again in 1994. Definitions, if you are writing legislation, are obviously very important. If you are really careful, you can do a lot of the work in the definitions and you can hide what you are doing very neatly in the definitions too.

But the question I think that you are asking – the answer, if you will – there is no answer of course, but the answer is it depends what you are doing. If you are writing legislation, if you are writing a rule then you have to know what it is you are talking about. You have to pick a piece of the universe and say this is what we are covering.

But if you have a different goal in mind, if you are doing what you might call soft law, standards, best practices, it does not matter so much. You can have fuzzy borders for your definitions because you are not imposing requirements on people that are enforceable. You are saying this is a good idea. This is the kinds of things we would like to see people do and let them figure out how they are going to do it themselves and whether they are going to apply it to this or that, maybe up to them rather than you.

DR. STEAD: I felt that point was made clearly in the report. I am just wondering whether it is possible to say that the definition for any – that the definition, in essence, is the intersection of content, user, purpose, and possibly the subject. If, in fact, it is impossible to find health information by the meaning of the data itself, the content, which I think is where most people come in, it might be useful to make that point clearly. I will just say that a definition takes these things working together. You have to set the right bar in each of those things. Am I misreading it?

MR. COUSSOULE: Can I ask one clarification? Part of the question I would ask is why are you trying to define it in such a precise way. Time gets in the way of some of this. The world has changed a lot. If we are trying to get to a definition, I would ask – I think it was Bob – why are we trying to define it in such a precise way. And then you can get into how you might want to define it. Do you know what I mean? To your point, whether the data itself – used the model —

DR. STEAD: If that is the case, I think it would actually make the report more approachable if it almost said that upfront. I got quite far down this, thinking I was going to come out with an answer to the definition before I realized I was not. I am not quibbling with anything that is said. I am simply wondering whether there is any way we can make that piece more useful or not to people that do not live in this space as much as we do.

MR. GELLMAN: I think that you cannot define health information for all purposes. You have to have a purpose. You have to have a context. You have to know what it is you are talking about because in some context, health information can be precisely defined. I will not say narrowly defined, but it can be precisely defined. In other contexts, everything is health information. I think you have to state your context and your purpose and then decide what it is – what is possible to do within that context and what would be useful within that context.

If the committee would want to recommend – I am not suggesting this – legislation to cover commercial activities outside of HIPAA that involve health information. You have a whole series of complicated definitional problems that would be extremely hard to solve.

There is a rule, the old 80/20 rule. You can solve 80 percent of the problem easily. When you try and solve the other 20 percent, you run into trouble. That is a thought to keep in mind here. You cannot be comprehensive.

DR. STEAD: I think we spent enough time on this question. I just wonder whether a few words somewhere might make clearer that you should not try to define health information without that context. That might even come toward the beginning.

MS. MONSON: Just a comment with respect to what Bill was saying. Because this report encompasses Beyond HIPAA, I actually like how generic and objective his comments are related to the definition. Because when you go outside of HIPAA, there are hundreds of definitions of health information. I think part of this evaluation when you look Beyond HIPAA is should we be defining it. I think the more we are objective in basically stating that, there is a whole world outside of HIPAA. It gives us the opportunity to evaluate whether there really should be a health information definition that is broader than what currently is defined in HIPAA.

DR. COHEN: One more comment. I think the appropriate reference is 1964 Justice Potter Steward who said I know it when I see it in another context. But I think the same thing applies to health information here.

MR. GELLMAN: If I could point out on line 153 or thereabouts, it says how can you tell what constitutes health information in the absence of the definition. The inquiry may require a determination of who has the data and for what purpose because much depends on the nature of the data and the context and the purpose.

DR. STEAD: I am just wondering whether the actual statement is you cannot define health information without a determination of who has the data. I just wonder whether there is a tighter way to do it.

PARTICIPANT: More declarative.

DR. STEAD: It is your report. It at least stimulated this set of thoughts in my head. Thank you.

DR. LANDEN: I think there are so many great ideas coming forward here. But one of the ones that struck me is kind of the context. When HIPAA developed, we lived in a world of data flow from providers to payers and vice versa. By the way, there were lots of clearinghouses in the middle. Our collective frame of mind in 1994, 1996 when HIPAA was in the works was that system. That was basically a facts and mainframe world at the time with those three key players, hence, the covered entities.

As we look around us now for all the reasons cited in this very comprehensive work, I am not sure that same frame of reference stands thus the HIPAA definitions are in question. One of the things that occurred to me is are we talking about health care privacy and confidentiality policy or are we talking about privacy and confidentiality policy. If we are talking about the latter since we can no longer define or contain health care, are we looking more at some of the European examples that are in the paper as a broader policy and in hence less of a need to define health care definitions or health care information definitions that we are talking about now?

MS. KLOSS: Let’s go back to Section I and just scroll through by section and see if there are any observations, comments or areas for the discussion? I think, Rich, you raised one that would be of interest to me to have a little more discussion about how – are we, in fact, handicapped now because we have industry specific approach? That is really what you are saying, Rich, rather than a cross industry approach like a general data protection regulation. It just seemed to me as I always think about that is that horse has left the barn. It just does not seem like we are going to go back and rework the world we have even though a general privacy cross sector seems more logical in this Beyond HIPAA world.

MR. GELLMAN: If I may offer a thought. A hundred and some countries in the world have privacy laws and all of them are – they are all variable, but most of them look like the EU laws in broad brush and they cover everybody or almost everybody under a set of standards. We are the major outlier here. If there were more time and more interest, I could go on at great length at why it would be practically and politically extremely difficult to do here what the rest of the world is doing. That is just something that is extremely hard to change. There is some support for it here and there, but it is just inconceivable to me. I have been working on privacy for a very long time that we could ever get there.

MS. KLOSS: I think that is really an important background for this whole area of inquiry. I have just spent a couple of weeks in Europe. The news was full of the general data protection rule and how it is going into effect in 2018 and all of the work that is being done to prepare for it and some skepticism about how well it will work and how it is affecting business. I think it will be a very interesting next 12 to 24 months and something that as our committee keeps kind of looking at the environment that it would be useful to understand the lessons being learned in that implementation.

I do not think there should be any – nothing much changed between our review in November and now about Section I, the scope of the project. We have talked some about the challenge of defining health information. Is there anything else there that you want to comment on?

MS. LOVE: This is a great report. I felt when I was reading it that I kept thinking infinity and beyond.

On line 75, what jumped out at me and it could just be the world I live in and the state, which we do not get into here, but it says that PHI that passes out of the regulated world generally becomes unregulated data in the hands of a recipient who is not a covered entity. I just was trying to think of an example because we work pretty hard at least in the regulated part of the state world to make sure that does not happen. I am not saying it is not happening. I was trying to think of an example.

MR. GELLMAN: If you look at Section 512 of the HIPAA rule, there is a list of – it depends how you count – a dozen, two dozen, three dozen disclosures that are authorized without the consent. Public health is a good example. Research is a good example. Health oversight is a good example. Law enforcement is an example. National security is an example.

MS. LOVE: I guess what I am thinking is is that unregulated. It just comes out of the HIPAA box.

MR. GELLMAN: It is no longer regulated by HIPAA in the hands of the recipient unless the recipient is a covered entity. In many of those cases, that is not the case. This is an area where data escapes.

MS. LOVE: We worked really hard to get some of those escapes in. I spent a year on that.

MR. GELLMAN: I am not arguing that all of those disclosures are inappropriate, although I would be happy to quibble about a lot of them, not necessarily about the main purpose of them, but procedures and rules that apply. Unless the data goes into the hands of, for example, a federal agency that maintains it in a privacy system of records, it may not be subject to any rules. If it goes into the hands of a state agency or a private entity, it is not subject to a HIPAA rule. There could be another regime out there or some sort or another that applies like the privacy act of federal agencies, like a state law to some state agencies or even a private sector law of one sort or another, but generally the data escapes HIPAA.

DR. LANDEN: Another example would be the patient disclosure. If a patient decides to disclose the data publicly, it is not protected.

MS. KLOSS: Let’s move on then to dilemmas and examples. Any comments? We are still framing the issue here.

Trail of data? Your use of examples helps a lot. All the stories. It just really made it interesting. They were detailed enough. If you are not an expert mired in this, you can follow it.

And then for this section beginning Line 431, the tentative conclusions and definitions. Any remaining comments there? Ownership, control, and consent. It seems like every once in a while, we see a flare up of interest and grabbing the issue of ownership. Are we in one of those flares now? It is not an ownership issue. I think that is a really important issue.

MR. GELLMAN: This has come up just as you said all the time. Somebody comes up and says patients own their data. That is the solution. You hear this in connection now with block chain that this is giving patients ownership of some sort. I have said this for a very long time. Ownership is not an answer to anything here. There are rights and responsibilities on all sides, which is what HIPAA defines. At a very broad level, HIPAA does it very nicely. It does not matter who owns the data and you will never get anywhere in my opinion by trying to tie ownership rights to anybody.

DR. LANDEN: I think ownership also has a very fuzzy definition. You have to get very precise about defining exactly what ownership means if you are going to talk about saying – what does that confer upon them? I think that is another one where if you are going to really get into that model, you have to get very specific about the definitional side of that.

DR. COHEN: Is there a distinction between ownership and stewardship?

MR. GELLMAN: Yes. That is the idea of rights and responsibilities. As a covered entity, you have responsibilities. You are steward of data. They do not use that term in this context, but that is exactly right. You have to do certain things. You have to protect the data. You have to provide access. You have to provide rights to patients and you have to meet your own responsibilities as a record keeper. It is a stewardship concept.

DR. COHEN: Maybe when we think of unregulated and Beyond HIPAA, the concept of stewardship should be a focus, one of the axes we think about in terms of policy.

MR. GELLMAN: Perhaps. When you get out of the health care context, just looking narrowly, every doctor I assume will recognize that his or her patient has an interest in the record and will facilitate that in some way whether there is a law or not. Some will do it better than others or whatever, but we have definitions now.

When you get into a commercial context with health data, there will be people who say I have the data. I collected the data. I own the data. The data subjects have no rights or have few rights because I have a commercial interest in this data that I collected. They will push back against the notion that they have to provide – they have to recognize the interest of data subjects. Not everybody in a commercial context will say that, but many will.

MS. KLOSS: There is no authority to specify what the rights and responsibilities and to enforce that. You cannot make it happen.

MR. COUSSOULE: Bruce, I really like where you are going. The idea of talking about stewardship which would mean either kind of rights or obligations of individuals with how you choose to contextualize the data as far as is it health information or not health information. That is an easier way to think about it than ownership. Ownership gets very fuzzy.

DR. LANDEN: From a similar to stewardship, a lot of the Canadian privacy legislation and regulation both federal and provincial uses the term custodianship, similar concept. You can have multiple custodians and you never really have to address ownership. Keep it a different matter.

MS. KLOSS: Bob, I know that early struggle in organizing this report was how to define Beyond HIPAA and the idea of the regulated world versus the unregulated world is the way the rest of this report really is framed. Any comments about that framing? I think it is logical and easy to get your head around and useful as a shorthand for us when we talk about issues. I think the next few pages talk about HIPAA law and then the unregulated world.

Any discussion of fair information practices, which really are the cornerstone of stewardship, our rights and responsibilities? As you recall, when we did the stewardship framework for community health data, we used the privacy principles. We have certainly from time to time pursued this approach.

MR. GELLMAN: It is worth pointing out I think that fair information practices were originally invented by an advisory committee at HEW, predecessor of HHS. For more nickel, it is perhaps one of the most influential advisory committees ever because fair information practices more or less took over the privacy world. It all started with an advisory —

MS. KLOSS: Then the section on big data. Any lingering questions or concerns or areas you want to discuss further? Even defining big data.

DR. ROSS: While you are right there because one of the things I thought might be a typo – actually know what it was. What is PII on line 790?

MR. GELLMAN: Person identifiable information.

DR. ROSS: And then there was another place that had PPI.

MS. LOVE: Line 851 says PPI.

MR. GELLMAN: That is the quote from an all of us research protocol. It is probably privacy protected information. I do not know.

PARTICIPANT: Did you say 851?

MS. LOVE: Line 851. I just see PPI on page 24.

MS. KLOSS: If there is nothing else on this section, I would like to move us to the next section on personal devices and the Internet of Things. This is the area that highlights some topics that we might want to advance as our next task. This section did change some after the November virtual hearing because we had focused on having experts talk to us about the Internet of Things and some work being done there. This is the section that changed the most since the version we reviewed earlier.

I think it is useful to have these terms defined because I think they are thrown around a lot. I think we have put a stake in the ground here. What is a personal device? How is it part of the Internet of Things? Where does it fall in the regulated versus unregulated?

We heard testimony. I am on the section beginning on 1386. We heard testimony from Kevin Stine and colleague at NIST about the work that they were doing on infusion pumps and the growing recognition that some of these devices are sorely wanting in terms of security and any thinking about privacy and security upfront and the risk that it brings when they connect to the regulated world to the technology of the regulated world. Jackie, this was certainly addressed by your cybersecurity taskforce. I think the NIST work was referenced in that taskforce and referenced here.

That is one of the areas that we thought could be a problem case to be probed early. Is there a stewardship framework or some model for formalizing the way in which there is improvements in —

DR. STEAD: I think of an infusion pump that is Vanderbilt Hospital as being part of the regulated world. Am I missing something?

MS. KLOSS: Maybe it is not the infusion pump. But maybe it is a –

DR. STEAD: A pacemaker may be a different issue.

MS. KLOSS: Or a heart monitoring device that a patient is using on their iPhone.

DR. STEAD: That I totally get.

MS. KLOSS: But I think that is some of the area that is growing quickly. And the app is in the unregulated world, but it is connecting. It is sending data.

MS. LOVE: This is where I got a little over my head here as we started talking into the Internet of Things because I started thinking that less information and more security and hacking. My thermostat at my cabin can be hacked. But I do not really care other than somebody could turn it down to 40 degrees and break my pipes. I started getting blurry here.

I think I was pretty clear going in that the information practices and custodianship and all of that. And then I got into the Internet of Things, which is just about everything. To me, the real concern as a consumer is who is hacking. I do not care about the information. Again, I am over my head here.

MS. MONSON: There are a lot of cross pollination between them. I will give you an example. Amazon Echo. You would not probably care about that. That could adjust your thermostat. But it also today can tell you the wait times. It can tell the patient where to go. There are lots of cross pollination between the device world and the patient world. It just becomes more and more connected as Silicon Valley looks for opportunities to make the patient experience better. And most of that is very unregulated because it was not contemplated, as Nick mentioned before, this whole evolving innovation area. It just has never contemplated those things because it was –

MS. LOVE: More artificial intelligence. My grandkids think Alexa really is in there. They have wonderful conversations with her. I think are they listening.

DR. ROSS: Mine is more of a question of scope for this committee. When you bring up devices, to me one of the big concerns is the hack-ability of the devices themselves, the software engineering, et cetera. Within the covered entity side within the HIPAA world, the governed regulated world, use of these devices now and their hack-ability is an issue. But is that part of the scope of this committee or is that somebody else’s scope? That is not information per se. I do not know. I am just asking.

DR. STEAD: From my perch, if HHS had not had the cybersecurity group or taskforce then we would not need to be worrying about – but I think for the purposes of Beyond HIPAA, we do not need to worry about the hack-ability of things like an infusion pump that are for the purposes of this I think within the regulated world. We need to be worrying about that in other hats.

MS. KLOSS: I do not think of this challenge only about hacking. I think of it as what is the data. What is the stewardship responsibility? Who is the steward? What is the stewardship responsibility? What is the quality of the data and its usability and interpretability? I think there are other issues than hacking that are squarely in our box.

MR. GELLMAN: I would agree with that. Security is clearly a very important issue in this context. But as the Internet of Things tracks everything you do, everything you watch, everything you click on, everywhere you go, and there is an awful lot of data there. We can go back to the question of what is health data. But a lot of it is going to be health data in some context. Even if it is not health data and this may get beyond the interest and jurisdiction of the committee, it is still the same issue of what happens to the data and who is collecting it, who is maintaining it, who is profiting from it, and what are the rights of the data subjects.

MS. LOVE: I think the report starts getting at that, the transparency issue. On my Fitbit, I would like to know – I am not so concerned. I would not commit a crime wearing my Fitbit. Apparently, that can be used against me. But that transparency needs to be communicated better. What is inside Alexa? I need to know that. I think that starts getting at that because it is hard to regulate this stuff.

MS. KLOSS: Bill points out that we are kind of morphing into the second part of our meeting with this particular discussion. We are going to come back to this because we have to decide where we want to go next. But perhaps we can get through the report and call the question on that and then move to next steps, and then return to this issue about whether some aspect of devices is of interest or the committee has an appetite and feels that would be an area for contribution.

We are going to models, where protections exist in the United States. And then laws in other domains. What is there for us to draw on? Any questions there? We had a little discussion about the EU, general data protection. And evolving technologies for privacy and security.

Finally, Section VI, evolving consumer attitudes. I do not mean to squelch discussion. Are you okay? Have we covered it?

DR. COHEN: On the technology for data security, I thought we had some conversations about synthetic data, about the production of synthetic data as an alternative to de-identified as a way to still provide rich connections without losing the value of the data, but really just completely disconnecting it from re-identification. I did not see that in here.

MS. KLOSS: Did we address that in big data?

MR. GELLMAN: No, I do not think there is a specific mention of that. It is a technique. It is like any other technique. It has advantages and costs to it.

DR. STEAD: I think we put it in the CID report.

MS. KLOSS:  Yes, we did. Which is footnoted. I think Bob’s reference – techniques for anonymization and discuss the differences between de-identification and anonymization.

MR. GELLMAN: My goal in discussing this was to present – I think it is a fair comment, but my goal was to present – at a policy level rather than to try and discuss individual technologies. I think the points that I thought needed to be covered were made otherwise. Maybe there could have been a mention of it.

MS. KLOSS: I have it in my notes. Bill, do you want to call for a vote?

DR. STEAD: Someone needs to call for a motion.

MS. KLOSS: Do we have a motion?

DR. ROSS: I would move to accept the report.

MS. GOSS: Second.

DR. STEAD: And this is subject to our usual editing. Any discussion? We have a motion and a second. Any comments? Vickie, are you on the phone still?

DR. MAYS: Yes, no comment. I am good.

DR. STEAD: All in favor? Any opposed? Any abstained? Congratulations. Thank you.


MS. KLOSS: I want to once again thank Bob. I do not think this could have been anywhere near this kind of report if we did not have somebody with such deep expertise doing the writing. Thank you very much. You know you went over and above the good of the cause and we really appreciate it.

DR. STEAD: Absolutely. Dave said every MPH student should read it. I think this will turn into a very helpful piece, not just for the committee and policy world, but for the industry. Thank you.

MS. KLOSS: We have got almost 20 minutes to turn our attention to where we might want to go next. Again, as you will recall, we had this idea of going broad and ruling from here to then beginning to consider what frameworks or models might be possible to enhance the stewardship. I think the way we said it in our goals was lay out integrative models for how best to protect individual’s privacy and secure health data uses outside of HIPAA protections while enabling useful uses, services, and research. Pretty lofty, ambitious.

The November hearing allowed us to think about some areas where we might focus in a more targeted way. And two of those that emerged were the discussion of registries, which are very commonly used throughout health care where information is captured. I will just reframe a little bit.

Actually, Dr. Leslie Francis was one of our testifiers. She has just done some research. You know that Leslie was a former co-chair of the subcommittee and a longtime member of the committee. She and her colleagues have just some research on registries. She has gone from registry data collection and use processes to how the data is maintained. Once it is released from the covered entity to the registry, the fact that there really is no consistent way the data are managed or used or protected. Most covered entities contribute data to some registry and the data is released into the unregulated world for good purpose. Most of the registries are performing really valuable purposes, but how the data are managed and how the custodians perform in that regard, is all over the map is what her research really highlighted to us.

She suggested that this could be a practical area for some short-term attention as an example of an area beyond HIPAA that could perhaps allow us to make some useful recommendations.

MS. LOVE: Do we need to define registry? A cancer registry – is not a shock trauma surgeon registry. Just saying.

MS. KLOSS: Absolutely. I think you are right on target. That is one of the things we want to discuss. First of all, is this a topic that everyone thinks – that you understand well enough to have an opinion on, and do you think this is an area for short-term deeper dive, in which case then what questions do we need to tackle and certainly defining even limiting scoping registry would be a first topic.

Two questions. Is this in or out of scope that you think has value? Then where do we go next to start? I think our thought was if you look at the plan that we would do some of this scoping and laying out, if you will, like do a project scoping document for Beyond HIPAA exploration of registries and do that before the next meeting. That would be how we move forward.

Let me hear from Bob and then Bruce.

DR. STEAD: And then Alix.

DR. PHILLIPS: Thank you, Linda. I do have a conflict here because I lead a national clinical registry that is also a qualified clinical data registry. We are a covered entity. We did that very specifically even though it was not required. It is very interesting. It is highly unregulated right now. I would be happy to contribute as long as I can stay clear about the conflict.

MS. KLOSS: But you have a lot of knowledge that you can help us do some definitional work.

DR. COHEN: I guess it goes back to Denise’s comment. I would be interested depending upon how we define what the scope of registries is. Is it the cancer registry or is it state registry of motor vehicles? Is it sex offender registries? The concept is so broad, some of it, I think, would be priority, but some of it would not. It would be of less interest. I think to me it is part of the committee’s work.

MS. KLOSS: The way that Leslie’s research – I have not gone back to the formal report. But she was describing it to us in her testimony as patient data collected for specific purposes.

DR. COHEN: That is a very narrow definition. If it is not HIPAA covered, it might be in mixed entities like health department registries or other clinical registries.

MS. KLOSS: For purposes of her research, she went on to say it may be limited to patients with specific conditions, specific known exposures, specific treatments, and then registries may be funded from private dollars, charitable contributions, pharmaceutical companies, professional organizations. Her research was fairly narrowly defined.

DR. COHEN: My response would be I think in this report, we unearth so many broad policy issues. I would like us to see if we could move the ball forward on broader issues rather than on more narrow issues. I see the focus on health care related registries as being more narrow.

I would also like us to think in terms of consumers and broader population as an area of focus rather than on some of the more clinical aspects and implications for non-HIPAA health-related information.

MS. KLOSS: In general, you would be – we were thinking of doing some topics that were at the intersection of the regulated/unregulated and where registries are is that clinical data is provided by –

DR. COHEN: I want us to jump off the cliff.

MS. KLOSS: Okay, you want us to jump off the cliff.

MS. MONSON: On that note, specifically mentioning – this is an area that my organization has struggled with for a long time. We have more than a thousand registries that we participate in. It is very important to our patients that we continue to participate. I can tell you from a privacy and security standpoint, it has been one of my worst nightmares in the sense that it is very unregulated. You cannot get them to agree to business associate agreements with them. Really, often times I feel like we are just handing over data and do not know what happens from there. That is not really in the best interest of patients in doing it that way. It just has been a really challenging area.

Robert pointed out that some of them decide to become covered entities. Most do not. Most are really challenging to deal with from the health care perspective. That is not the norm at all. This is an area that I think is very much in the intersection of regulated from the covered entity standpoint because we are providing the data, but unregulated when it is passed off to them. This is the space where a lot of the registries have completely taken advantage of that. I often find myself in conversations with clinicians who feel really passionately about getting that data because we get data back for maybe cardiology or something of that nature.

I do not want to provide the data from a privacy and security standpoint because of the risks attached to it because there is no promise that they are going to treat it with the same care that the organization that I work for would. We often get into very heated discussions so much so that even the General Counsel gets involved in some of these items because they are that significant. It is a huge pain point for covered entities.

It may seem like a small issue, but it is not really a small issue when you are sending data to over a thousand registries. That is pretty significant.

MS. KLOSS: Alix and then I think, Vickie, you have your hand up.

MS. GOSS: It seems to me that we are also tripping into some of our other discussion, Bruce, related to our sustainability of the registry systems in the public health informatics architecture within the United States. I hear your desire to jump off a cliff from a more broad perspective. There is an intersecting point here with some of the work product that we are going to have later in the day that starts to tie up some issues that all maybe we can have an influence on and make better because we do need to have the information flowing so we can better learn, come up with better ways to care for our population, but we also have to help support those. There is that tension that Jackie was talking about is something that I think we need to put squarely in our sights and I think the use case around registries helps us do that.

DR. MAYS: I think Alix started going exactly in the direction that I was going to talk about. I think that registries are important, but I think we have to make sure that we understand how large the scope of this is because there is the clinical side. There is the public health side. There is research side. And they kind of function differently to some extent even though we are calling them registries in terms of the extent to which there is regulation. In the research world, we are to do one thing, which is different in public health because it is covered maybe by the Department of Public Health versus some of the clinical ones.

But I do think it is a good space for us because this is a growth area. Registries are being set up for all kinds of things. I think the most important part is for us to decide what is the space that we want to be in.

I still want to agree though with Bruce’s notion that we heard a lot of things that came out of this report and the hearing that we also could focus on. But I think the registry issue is a growing one of importance.

DR. STEAD: I support this and maybe a way to think about framing it is I think the registry is a particularly good example of leakage from covered entity to unregulated world. And therefore, we might narrow the scope to that intersection. It would in essence be movement of data from a covered entity to a registry that is not a covered entity. It would put Bob’s – it would not count, for example.

I would also pair this topic because I think we need to do two. I think a registry is a very nice example of leakage. I think consumer devices are a nice example of something that originates and is predominantly outside, but may cross over. I think that if we work those two problem cases as a set, we would learn quite a lot.

MS. KLOSS: And the data is flowing the opposite direction.

DR. STEAD: The data would flow the opposite direction.

MS. KLOSS: I can see the visual now.

DR. LANDEN: I also support the inclusion of the registry concept for the next step and would note that under meaningful use, register reporting is a requirement so register reporting is not exactly voluntary for providers.

MS. GOSS: I would also play with the convergence aspect that we are struggling with.

MS. KLOSS: Alix, a little more detail.

MS. GOSS: Rich’s comment about the meaningful use aspect and the amount of effort within the United States by providers to meet those quality payment type of objectives and being able to use a registry submission as one of those functions that they perform to help them meet their obligations and the dynamics within the states with having a variety of architectures very HL7 based and using that data in a variety of ways. You start to see that there is this linkage with some of the attachment rules that we have recommended we adopted, the intersection of administrative, clinical, and financial data and how do those all work together. All of a sudden, I think I am jumping off the cliff of the topic here.

It keeps us thinking in the way of how does the data really move and for the right reasons at the right time to get the best outcomes.

MS. KLOSS: That is a really interesting dimension of this because is this an area that on the one hand, is sort of an implicit requirement that providers be prepared to be able to do this through an electronic health record. But on the other hand, the stewardship provisions are not baked in with regard to what happens when you do it.

DR. STEAD: The other thing is as Bob points out, registry can elect to be a covered entity and therefore it would not require a change of law. There is a model.

MS. KLOSS: In the five minutes we have remaining, can we turn our attention to the consumer device?

MR. COUSSOULE: I wanted to explore I think, part of where Bruce may or may not have been going in regards to the larger question. I like the idea of talking about the boundary side of where things tend to bridge the gap. One question would be there are lots of classically or historically non-health information that is used to infer decisions that impact health.

I do not know if that would be part of the discussion in regards to looking at devices or personal devices or something like that. It could be everything from purchase history to psycho-social data. We do that today. We use it in my business to try to help us gauge somebody’s propensity to respond to care plans and things of that nature. It is not health data at all at the core, but we use it to try to infer activities that are definitely in the health data realm. I do not know, Bruce, if that is something that you were thinking more about or that kind of model. I am not sure how I would frame it. I am just trying to think if that is something we would want to undertake at all.

MS. GOSS: Social determinant of health data.

DR. COHEN: I see a lot of cliffs emerging. That comforts me in many ways. I am hearing the discussion. I see the potential breadth. I like Bill’s two-way model, in particular, investigating these issues bidirectionally I think will add a lot to the context of the conversation.

And also I think the point that Alix made about liking to other activities. I am trying to think about how do privacy and security regulations run vital statistics vary across all the jurisdictions. They are in health departments. I would think most of them are non-covered entities with respect to their data collection. As we move more information from medical records or getting more information from public health safety if we are going to be integrating medical examiner information, I see there are a lot of potential connections between this activity and some of the other issues that we might be embarking on. I am moving more in this direction.

Thank you all for trying to help me understand this.

MS. KLOSS: I want to make sure we end on time. I do not know that we can probe too much too deeply into consumer devices. We will have to follow the same frame we just talked about. We are going to have to define what we mean, scope it in some reasonably clear way, and move from there. If you think this is the right way to move next rather than boiling the ocean or jumping off the cliff then what we would do is scoping documents for these two areas of inquiry.

DR. STEAD: That is the way I thought that bidirectonally might help you scope the initial dive. If we are looking at consumer devices that are capturing information that they have a reason to want to share with their health providers. That gets us out of the thermometer probably and maybe narrows it enough that we could get a first look that we could then broaden later.

I think we have to thank Linda and the committee for being so diligent. It is awesome work. Again, thanks to Bob. You have us moving in a really helpful direction.

In the interest of the Predictability Roadmap, we will stop on time and restart at 11:15 in a predictable fashion. Thank you all.


Agenda Item: Predictability Roadmap

DR. STEAD: We would like to call us back to order. Alix will lead off on the Predictability Roadmap. Thank you.

MS. GOSS: Welcome back everybody from break. We are going to go ahead and dive into effectively what is going to be an hour before lunch and an hour after lunch for Nick and me with Lorraine’s support to talk about the Predictability Roadmap and give you an update. It is more than just an update because it is also going to prime some of the discussion and thinking that we need to solidify during our CIO Forum session or discussion, which will be predominantly after lunch. At least that is the way we have designed it. But we are fluid and flexible.

We will first tee you up with context and hopefully along the way clarify any questions you have and then enable us to take a break for lunch and then really dive more deeply into the CIO Forum to garner your thoughts as we start to design that engagement activity.

MR. COUSSOULE: Alix, I have one question. I think the document she is going through I do not think was part of the eBook.

MS. GOSS: Correct. It did not get distributed but it will be available on the web.

From a Standards Subcommittee perspective, we have a variety of charges or activities, that were included in our charter, two of which are very germane to the roadmap conversation in regards to providing outreach in a public forum for standards and also to make recommendations to the Full Committee regarding electronic transactions, terminologies, identifiers, clinical doc, and security measures. These are two of the six charges that are germane to the specific topic. It might be helpful just to set some context for those who are listening in the audience.

The Predictability Roadmap is something we have been talking about forever it feels like at times. We have been giving you a variety of updates. For me, this is something that I have been working on, trying to create predictability since I sat literally on this side of the table years ago. What I am really hopeful is that this body can actually advance the conversation, or we can all agree that the way we have got it is going to just suit us just fine.

The value proposition though has been pretty clear whether you have looked at Full Committee discussions or Review Committee reports or industry testimony that we need to create and enable greater flexibility in more rapid implementation of changes to allow organizations to meet their business needs. That is at the crux what this is really all about.

We want to identify and act on the right short-term challenges in this effort in addressing the barriers. We want to make sure we have the right actors to help us identify solutions and break down the barriers. We have been gathering information to guide our development of recommendations to improve the flexibility and responsiveness of the ecosystem for national standards.

Overarching issues related to the barriers deal with technology, changes in policies, industry operations, and procedural changes that take place in the system.

We are really asking a variety of questions as we engage with industry participants about what needs to be adopted and by when, what standards are really needed and for what purpose, whether or not we have the collaboration tools and whether we have the right standards being adopted at the right time for the right purpose.

Over the last year or so, we have undertaken a number of —

MR. COUSSOULE: Can we go back for one second – a couple of contextual points. One of the premises that we are operating under is although a lot of progress has been made, there are challenges similar to what we talked about earlier in regards to the passage of time creates challenges within the framework we are operating on just because of changes in technology, not so much policy, but technology and operations processes.

Where we are at today although when it was established worked pretty well does not necessarily respond to the changes that have happened and where we are at today. There is the premise that it is insufficient today. That is a starting point. If you do not believe that then the work does not make sense. You have to believe that the premises where we are at today does not sustain what we need to have today. Some of these questions we are asking start from that framework.

MS. GOSS: Building on that premise, we engaged a variety of participants in helping us to establish a foundation on which to build this exploratory effort. We started with information gathering and conference calls in the spring, specifically with the standards development organizations and operating rule authoring entities. We are talking about ASC X12, the National Council for Prescription Drug Programs, the Health Level Seven, NACHA, whose acronym I am forgetting at the moment, National Automated Clearing House, and CAQH CORE’s operating rule entity.

So that we can make sure that we understood really how they functioned, what were the similarities across the organizations and the challenges they are experiencing, what are the opportunities, and also to make sure that our subcommittee as a whole had a really robust foundation.

There was a very intense grid that was produced of all that information and it is available on the website. It is a really good snapshot of how these five entities function in the ecosystem.

Having validated that information with those industry participants, we wanted to pivot from what is to what could be. We held an appreciative inquiry visioning workshop in August of 2017 on HIPAA’s 21st birthday and the day of a solar eclipse.

The full day workshop brought together not only the entities that I mentioned before, but also a number of industry participants. It was really interesting to see folks that wanted to come play in this conversation because they have been involved in the conversation for a long time. They have a stake in trying to make it better. We are very grateful for their interest in their support, ranging from the VA to a number of other private sector entities.

We produced a summary report. Lorraine produced a summary report from that visioning workshop called an appreciative inquiry. We then were able to start to create a set of recommendations. I should not say recommendations. We created a set of ideas on how to frame the concepts that came out of that appreciative inquiry workshop. We have also I believe posted the summary of that report. At the last Full Committee, we gave you an update on the themes that we had identified.

We have held a session with the entities, the operating rules and standards development organization entities to talk about the summary that we produced. We gave them a chance to look at the report as well as the beginnings of our thinking to produce a spreadsheet of taking the themes and what are the opportunities and what would that mean and where might we go and what kind of benefit might we get from implementing some changes.

We have gotten their feedback on that and we have been able to validate that we are still on firm ground from their perspective and we did not miss interpret something from the appreciative inquiry workshop.

Nick or Lorraine, do you want to add anything to that?

Without much further ado, here are the themes again. You might notice that the titles have changed a bit. We are continuing to hone our thinking and our specificity about what we are envisioning.

The first one is the standards development processes. The second one is standards adoption governance. The third is data harmonization. Thank you, Bob, for that report you sent via email today. Federal adoption process is the fourth one and covered entity designation is the fifth area that we have been looking at.

What I would like to do on the subsequent slides is to take each one of these and give you a little bit more of a context in what we think it will look like when we have a roadmap that will make a difference. This is the beginning of starting to put more specifics to what are the types of recommendations that we are going to need to look at. If we know where we stand today, we know we have a vision for improving it in the future then we can start to meet everything in the middle and get to a sense of detailed recommendations that we can then bring forward for the Full Committee’s vetting.

MR. COUSSOULE: Just to add on a little bit there. We tried to be equal opportunity challengers to this. You could think of it as either everybody’s ox being gored or everybody participates. We were trying to be not too prescriptive of one or two things that several individuals may think would matter, but tried to be very broad about lots of different parts of the ecosystem and how might each of those change or evolve to address improvements. It is a little challenging. Sometimes when you do that for people who are in the middle of the process, it is often times easy to say my stuff is good. Everybody else is terrible. If they just change, we would be better. That is kind of natural for the way we all try to do better ourselves and then always try to get other folks to change to what we are doing.

Some of this, as you might imagine, the process is a bit challenging to try to get everybody to think about the ecosystem including themselves and how it could all get better. This is not meant to be pointed towards anybody. It really was meant to be broad, in regards to how do we look at all the pieces and look at how each of them may be improved. It does not mean that all of those will be recommendations at the end or any particular one would be. But we try to be pretty broad at looking at all the potential in the ecosystem.

MS. GOSS: I think it is really important to pick up on that last comment from Nick. What I am going to be showing you today are not firm recommendations. It is a point from which we can start to engage the industry, the end users at this point when that is the crux of the CIO Forum discussion.

We have a general direction we want to head in. We need to start to get more input on that potential path and that engagement of the CIO as we are thinking as the end user’s perspective into the conversation will enable us to then further refine our thoughts so that we can then start to create very specific recommendations and we may then likely have a formal hearing on those recommendations that would enable us then to get more of a broader industry collective view on very specific recommendations and then enables us to produce something that the Full Committee can then vent and submit to the secretary.

MR. COUSSOULE: One other thing to add is we did not go through this and try to make judgments about which items might be easier or more difficult to implement. We would love all your input on that to talk about for these individual items or areas that might be addressed, the likelihood of success or challenge of getting it done. We could recommend big things that may not have any chance of getting done or smaller things that may have a high chance of getting done. Whatever that right mix is. We would be interested in the other committee members inputs to either likelihood or challenges associated with some of these that might just make it into our recommendation model.

MS. GOSS: One of the things that I have been remiss is the inclusion of HHS, specifically CMS and the National Standards group because they do have a role in promulgating the versions of the standards and operating rules. As NCVHS is a part of the process so is CMS after we make our recommendations to HHS. I should have included the two of us in that earlier dialogue and I apologize.

Before I get going, any questions?

First, let’s talk about the standards development processes. Ultimately, we want to make sure that the schedule is defined and well understood. The standards and operating rules are – the goal is to have standards and operating rules implemented more frequently and consistently in support of administrative efficiency improvements.

Standards and operating rules are implemented more frequently and consistently in supportive of evolving health care business changes. Not only do we want to be efficient in how we are exchanging, but we also want to keep pace with the business models that are evolving. And that we want federal rulemaking processes more rapid and consistent to allow business implementers to plan for resource allocation and effective change management. What you have are three concepts of things that we are trying to achieve by looking at ways to improve the standards development process and streamlining it.

I would like a high level of personal specificity and what that means, talk about the definitions from earlier. But we have to be mindful that we need to hear more from the industry and the end users to help us to know what that level of specificity and timeline really should look like. But in the absence of one, we can offer something for people to respond to like standards with base version may be promulgated for an upgrade no less than every ten years and the implementation guides for those based versions may be updated every two years.

For those of you who may not be standards wonks, the reality is is that some of the standards have a base and then they build implementation guides off those versions. And other standards worlds or standards development organizations have a base version and their implementation specifications marry together. We have a diversity of situations right now.

Operating rules are based upon what is promulgated. There is an interplay there that we need to be mindful of. But if we know that there is a base version, for instance, in the X12 world, like currently today we are using version 5010, there is an implementation guide that for let’s say the claim that is based upon version 5010. It is constrained by the functionality of that version 5010.

If the situation was that we adopted the version let’s call it XYZ for a standard as the base, why not be able to upgrade that as an implementation specification used in the industry every two years, but not make the big bang change from version XYZ to ABC?

DR. COHEN: A quick question. Is there a specific set of standards – an explicit set of standards that you are talking about here?

MS. GOSS: Yes. We are talking about the standards mandated under the transactions section of the HIPAA administrative simplification provisions and the corresponding regulations. We are talking about medical standards for X12 that are based on X12 and the pharmacy standards that are based on NCPDP, and then the operating rules, which build on those other standards as well as the NACHA for supporting the EFT and ERA functionality.

DR. COHEN: Would those include the ICD updates?

MS. GOSS: Sort of, but what I would like to be mindful of is that we want to keep this around the data standards and not get into the vocabularies, the code set aspect because all of a sudden it got really big. What we think we can do is bring the topic of vocabularies and terminologies or code sets like ICD-10 into the conversation as a result of the effort that Linda has been undertaking. We have the Predictability Roadmap for the standards, the transport, and the data structures. We have terminologies in vocabularies, which are going to help us get to that code set, but we are not going to try to merge them until we get further down the road.

DR. COHEN: I guess it would be helpful for me and I think maybe the general context, if you could at some point explicitly list the specific standards that you are referring to for the roadmap.

MS. GOSS: We can include those for a future – a slide deck update is part of our scoping document. We did that so long ago. I think maybe we should also say what is out of scope.

DR. COHEN: Yes. Exactly.

MS. GOSS: We can make a slide for next time for context. Thank you, Bruce.

MS. STRICKLAND: I have one suggestion, Alix. It might be helpful to folks who are not deeply embedded in the standards, understand what kinds of things are in the base versus what kinds of things will change with the implementations as those happen every two years. Somethings are not changeable unless it is in the base standard.

MS. GOSS: Do you want to expand upon that a little bit for folks?

MS. STRICKLAND: Basically, there are – if you were to do a change request say to either at a field or change the length of a field or something like that, that is going to be in the base standard. But the rule around that use such as this may be used for the Medicaid ID or certain rules around it that can be used in the confines of the size and shape and what is existing in that standard can change. That would be the implementation. Things that lay on top of the base can change. But if it is a major change like it is a field size or field add or delete or what not or even potentially the usage required versus not, those types of things are in the base standard. We have to be aware when we are talking about a base not changing for ten years.

If you actually had a change request that needed that base to change, we have a period of time that we are going to be on that base. And the implementation cannot change that no matter how we move. Just for the context for folks who are not aware of what is the standard versus what implementations can do. Does that help?

MS. GOSS: I am too close to it. It makes perfect sense to me. Some people are kind of thinking about. I see your card up, Roland. Do you want to go?

MR. THORPE: Can you just give me – we are talking about the word data. Can you define to me what data means in this particular instance because I have heard Medicaid ID number. Then I have also heard – it may just be my lack of knowledge of the standards, but I have heard data ID. Then I heard we could not use ICD-9s. That is different. When we say data here, what exactly are we talking about?

MS. GOSS: We are not talking about the data standards. I am talking about the structure and the obligations for how to use that structure to perform different business functions: claim, eligibility, enrollment, remittance, claim status, prior authorization. I forgot one. It is how do you perform the basic functions within the medical and the pharmacy world to get data to move between covered entities, a provider to a payer with a clearinghouse, maybe or maybe not in the middle, and what does that electronic data interchange transaction need to look like and what rules of the road is it obligated to comply with.

Any other questions?

In the standards development process theme, we really are trying to make sure that we have the ability to have standards that meet administrative efficiencies as well as the business needs. There are two dynamics that occur within the standards world related to the base functionality and the structure and then the rules of the road that goes with it.

In addition to the standards world, the United States landscape expects that we are going to have rule making because of the 1996 HIPAA law that says time to get ready to go use this new version and implementation guide. We have identified that there are opportunities for more rapid and consistent promulgation of those so that the industry can have newer versions more quickly.

There is a provision within the federal rule making that lets updates to occur, but we have not really exercised that. Since the initial adoption of 4010, we updated to 4010A1, the A1 meaning addenda to fix some of the things that were broken when we tried to implement it and then 5010. In 20 years, we have had two major versions. That assumption that Nick mentioned earlier is that it is just not working for the responsiveness.

Part of getting new versions, in addition to the standards development and operating authorizing entities, using their fundamental work to get new versions developed, there is also this coordination process. DSMO, the Designated Standard Maintenance Organization, were created along with the HIPAA rules, to help coordinate the data content committees like the National Uniform Claim Committee, National Billing Committee, and the Dental Content Committee, along with the standards bodies, X12, NCPDP, and HL7.

Those six organizations with the support of some HHS folks or CMS folks, are the ones that were imagined to have all the change requests funnel into them, come to some level of agreement and then push the changes down into the applicable body. And then an iterative cycle would enable a new version to come about, which would include those change requests.

What we found in the industry is that people initially might have gone to the DSMO, but they really now are just going directly to the standards body and playing there. The DSMOs still do a lot of coordination. They do a lot of extensive participation within the standards body and trying to make sure that we have the harmony across paper and EDI worlds. But there have some shortcomings and there is also some new from a funding perspective and also industry playing at that table envisioned.

We also know that we have some larger thinking going on around the convergence and data dictionaries and how to make all this stuff fit better together. We want to take a look at the standards adoption governance process.

Any questions on that? Any extra comments, Nick or Lorraine or subcommittee members?

When we look at the third area of data harmonization and cohesion, we want to make sure that everything is really working together to support the goal of interoperability. There has been some discussion historically around the creation of the United States Health Information Knowledge infrastructure. That is affectionately referred to as USHIK. We also have a ULMS. NIST has done a bunch of work. There are also some opportunities as we look towards the convergence with clinical data to try to really make sure that we are thinking about data harmonization at a higher level to support longer term interoperability.

There is some thought around having a coordinating body to oversee the activities, ensure that we have that harmonization across the data dictionaries and thus getting back to the interoperability objective.

Any questions? Vickie, any questions?

DR. MAYS: I am doing pretty good.

MR. COUSSOULE: This is the one area that really ties in with the terminology of vocabularies – is going to be talking about tomorrow afternoon as well.

MS. GOSS: As I mentioned earlier, the adoption of national standards is led by CMS’ National Standards Group. Typically, they act in response to a recommendation we have made. We know that we would like to have rule making following a reasonable timeframe after an industry vetting process.

Good or bad. We have all been trained in the United States to pay attention and to upgrade when we see the federal rulemaking happen. Unless you are a very progressive innovative type entity, you are usually not pushing the envelope to say let me take on a new standards and get that approval that I need to from the feds to have trading partners play together to try something new and visionary.

MS. KLOSS: As I look at this first bullet, I wonder if we might want to use a word other than approved because the rule making process has its own formal approval process. This is saying have been approved by an industry sanction review process. I would think that that might be a different level, a formality and that this looks like we are stepping on the rule making process.

MS. GOSS: I read this as we want to make sure nothing gets advanced until there is a Kumbaya and it has gone through its due process.

MS. KLOSS: But it would not be approved.

MS. GOSS: I think it is because of a standards development rule. It has to go through an approval process before it can be advanced for consideration. I get your sensitivity. I am just not sure where to go with it.

MS. KLOSS: I do not know what the right word is, but I think we do not want to say we are taking – usurping the rule making.

MS. DOO: It is meant for the ANSI approved processes that each organization has to go through.

MS. GOSS: It is a due process. But not all of the standards bodies are ANSI approved. We are trying to also walk the fine line of dealing generally with different types of organizations.

But I think this also may get back to we have not only gone through an iterative development process with the industry and then brought it forward, but we may be also tested it and piloted it.

MR. COUSSOULE: I think where this might get – I think this is a particularly challenging one. Let me skip to the bottom bullet first to try to make the one point. The process takes a long time and trying to get something implemented across a complex industry ecosystem like we are in takes a long time by its very nature. The challenge becomes how do you deal with those entities that want to move faster because the need is there that are willing and able to and trying to figure out the balance. I do not want to get into semantics right now about that, but trying to figure out the balance between how to move an industry forward in a reasonable way versus allowing people that want to drive forward and to explore and get creative to not to not hold them back. I think that is where the balance becomes very complicated in this place. I am not sure it is easily addressed today.

MS. GOSS: Maybe we just say supported in that bullet. I think that might get you to the point of not making it confusing with the HHS processes.

One of the balancing acts – I want to echo Nick’s sentiment, the balancing act of supporting those who want to push the envelope with those who are maybe more struggling to do the foundational type of technology standards, we have to find the way to cradle everybody within these solutions because we have such a diversity out there. We do not really want to add further challenges to the resources constrained already.

I think, Nick, you sort of covered the last bullet. I am just going to make sure I address the middle one, which was that to do the implementation, you really have to understand where the guardrails are and where you are expected to drive. Having clear and timely guidance will help the industry as well.

The fifth and final themed area addressed the covered entity designations. We have sort of touched on some of these earlier this morning. You can elect to be a covered entity, but not everybody does that for a lot of valid reasons. But the business associate dynamic especially when you think about the Omnibus Rules are really an effective way to encourage compliance with the laws and regulations that a covered entity follows.

Enforcement being consistently applied to covered entities and business associates and outcomes used for education and outreach would be an attribute of success and guidance that supports the appropriate beneficial use of standards and operating rules for all parties to the transaction.

What we are doing is we have been honing our thinking down to the last five slides that I just presented to you. What we want to do is take this body of work and the recommendations, details that we are developing and use that as a basis to feed into the CIO Forum. I am going to look to Nick to decide whether you want to start to introduce this topic now or call the question for lunch because I am looking at some pretty tired faces.

DR. STEAD: Let me just ask a question or two. I think this distillation is a dramatic advance. I whispered to my colleague here that I was glad this was being recorded because we needed to get your comments – take the transcription and maybe we can put some flesh around the bones without doing more work.

Where in this journey of getting ready for the CIO – before we close this part out because the next block is around how we design that input session. Are we going to take another stab at beginning to suggest possible recommendations that relate to these or will that work not be until after the CIO Forum?

MR. COUSSOULE: We thought about this a good bit. And part of our thinking – I will speak for myself. We would like to challenge the participants in the CIO Forum with at least some suggestions even though they may not be the committee recommendations, in order to get their thinking about what is coming next. We will take this information and at least pose that as part of our – at least I think we could pose that as part of our questions for them to address at our hearing or workshop, without saying these are the recommendations specifically, but more to challenge and to get the thinking around ideas.

MS. GOSS: Because we really want to also hear what predictively it looks like from their perspective. If we come out and say we think it should be XYZ kind of like I did in slide one, there is a balancing act. I do think the subcommittee will continue to do some work around the themes and related recommendations development as a part of getting our prep work done for the CIO Forum.

MR. COUSSOULE: We could conceivably suggest things that we may not even believe are the right recommendations to generate that thinking process and the pros and cons.

DR. STEAD: It is a little bit like what we are trying to do later with vitals where without trying to get at recommendations, we are saying laying out a number of potential alternatives.

MS. GOSS: That is a good way to put it.

MS. KLOSS: I was just reflecting on Bruce’s earlier comment. All things standards are always a world unto itself. I expect that we are going to have the need to pretty well define what standards are we talking about and what are the issues. I wonder if some kind of background shortened briefing based on the Review Committee report may not be a really important part of –

MS. GOSS: I am not quite following you, Linda.

MS. KLOSS: I guess I am into the CIO Forum now. Front ending this with specific standards that we are talking about and their current status.

MS. GOSS: I feel like we already did that homework and we put it into the project scoping document that lists. We can resurrect it. But I think you are taking it further and that is what I am not sure about.

One of the things that I feel very –- I feel time pressured to try to make progress on the topic and if the committee members feel that they need an orientation to what are the standards and how do they all work together, we are happy to do that. But I would do that as an offline discussion.

MS. KLOSS: I was thinking of the audience at the CIO Forum. You are right. It is probably adequately covered.

MR. COUSSOULE: Would this be something that we could just include because a lot of it I believe was probably in the report to Congress? We would just pull out of there as a preface almost to the individuals that we would ask to participate.

MS. KLOSS: Right. That is all I was thinking.

MS. GOSS: I think that goes along with some our discussion. The subcommittee calls where it is like who are we going to get that is going to come testify because we really are – we want to make sure we get somebody who understands what it takes for a business to implement, but also how the standards enable the business model to be achieved. We started talking about is it CFOs, is it CIOs, is it CTOs, is it directors of EDI. Then how do you get a hearing where you have good – your questions prompt good discussion and input, but you have the ability to have a good round robin discussion on the fly and then you have also got the dynamics with associations who are going to be more able to speak from one angle compared to somebody who is an actual implementer who can speak to a different one.

I think you are touching upon some of the balancing act that we are struggling with. And maybe we want to make sure that when we send out the questions, we also put that context of standards as a part of that as a reference, so they know we are talking about these operating rules.

MR. COUSSOULE: We will get into much more discussion about participants and why and scope and skills, et cetera. If I am hearing you right, Linda, just to clarify. If we are trying to make sure we frame it such that this is the scope of things we are asking you to respond to then I think we can easily do that just with documents that have already been put together to call out and make sure that as a reminder this is the scope of work that we are actually talking about.

MS. KLOSS: That is all I am saying.

MS. GOSS: I think it is a good idea.

DR. STEAD: Maybe picking up on what Linda saying if I am reading between the tea leaves correctly. With the Review Committee, we basically said let’s double down on I believe four or five of the standards of the transaction. One possibility would be to frame your questions around that subset just to give people a narrower platform. I do not know if that is where you are headed.

I think the idea if I am hearing you right of the five biggies and the explanation under them that you have given is sort of one —

MS. GOSS: When you are talking about five, you are talking about our five themes.

DR. STEAD: Right. I get that that you want to have that one round of conversation at that level. I am sensing you want to have another round one more level down, if you will, some competing alternatives of possible recommendations. I do not know whether that will be helped by constraining the scope in some way. Obviously, to the degree it would be if we could reinforce the point from the Review Committee that we really ought to focus on end-to-end beneficial occupancy of those five then maybe we ought to be trying to focus on predictability in that space also. I do not know.

I think that Alix has one of those tired faces that suggest that maybe – I am sensing the desire to start lunch now and to regroup at one. Thank you. Let’s adjourn.

(Lunch Break)


Agenda Item: CIO Forum Planning

DR. STEAD: Okay colleagues, let’s reconvene. Nick, take it away.

MR. COUSSOULE: Welcome back, everybody. What we are going to walk you through now is our current thoughts in regards to the CIO Forum. Let me first take a little bit of a step back, the slide even before this slide, to talk about exactly what this is again. Our objective, when we are looking at the predictability roadmap, most of the participants that we have talked to so far are creators of the standards and operating rules.

Now, it does not mean that they are also not practitioners in lots of ways for people that are participating in it. But these were the groups and organizations typically that are involved in the creation or promulgation or development of the standards and operating rules.

Part of what we also wanted to obtain was information from the practitioners on a day-to-day basis of those standards and operating rules to understand from them directly what are the challenges and issues and opportunities that they do face in regards to the current operating rules and things that might becoming that create also challenges for them as far as the current process works and challenges inherent in that process.

At the same time, when we look at the folks that make that group up, they are not all CIOs, chief information officers in this context, as opposed to chief investment officers or others. These are chief information officers. The reason we settled on that title from a practical standpoint is we want to make sure we can understand not just from the folks who are day-to-day involved in setting up DDDI transactions and doing those kind of things, but that had, in some cases, a slightly larger picture of what the business is trying to accomplish and the challenges inherent in the current process. 

So yes, we will likely have some people that are direct practitioners of developing and implementing those transactions. We will also have some folks who may not be involved directly, but understand the challenges inherent in the standards and operating rules the way they exist today, and the way the process evolves today.

We will likely have some CIOs. We may have some CFOs. We may have some other folks that are involved in running different operations from a clearinghouse, et cetera. But these are generally practitioners to help understand the challenges inherent in that. 

Please others interrupt me and clarify. You have a lot more history of this than I do, many of you here. But that is the context originally. 

At the same time, as we were looking at kind of the beyond HIPAA work, a lot of what we have talked about earlier, we also thought since we are going to get some of these folks with this kind of background and skill set and rules in the room, we may also do a little bit of what if. What if is coming down.

We have got to be a little careful that we don’t too much get into a what-if and not enough into the roadmap kind of exercise. Instead of trying to do two different forums for this, we thought we would try to create some amount of leverage with the folks in the room, a lot of which would likely give us good information and feedback from a beyond HIPAA standpoint, as well.

So that is the thinking process. If you go to the slide 12 here, the idea is a one or two-day forum. To be honest with you, we are not quite certain, at least in our minds, how long this needs to be, to be able to get all this information. 

Again, the purpose is to solicit input from a diverse group.  So this could be, and we will talk a little bit about who the folks need to be. But it is not just kind of IT, CIOs from health plans like myself, but also from providers, provider groups, from intermediaries, from clearinghouses, from others involved in the process of actually implementing and running the standards and operating rules. 

Some of the questions that we would ask those folks, how their vision for predictable updates in health care includes using standards and operating rules. This is really getting into a little bit there. Is the current update schedule frequently enough? What is the ideal schedule? So really more about from a practical standpoint, the way that the process works today, kind of what works and what doesn’t and what changes might you have? At a high level, that is there.

The last bullet, I think, becomes a very important one, which starts into the future looking of what they are trying to accomplish and what their business challenges might be. But also, how it relates directly to the standards and operating rules. So what changes do you see happening in the ecosystem that necessitates attention that might impact the roadmap from a predictability standpoint? Questions, comments? 

So then we were thinking through this process of saying, what do we need? And so, we are trying to figure out what kind of expertise do we need to bring in the room as part of this discussion? So what kind of either backgrounds or roles or skills do we need? What kind of organizations? I hinted at some of them before, whether they be everything from the delivery system to the payment model, and everything in between that promulgates or that meets the standards and operating rules. 

Again, what kinds of questions? This is where we get into a little bit of do we prompt them with some potential changes or opportunities that might happen or that might be envisioned to let them react to would that be better or worse, or how might that be better or worse, et cetera. So instead of just blue skying it to what your problems and challenges are, we ask them for that. But we also taunt them a little bit with, here are a couple of changes that could potentially be made. Would that be better or worse, and why? Then how might we adjust those changes? 

I think ideally, we would prompt them with some potential changes that we have garnered out of the thinking and the information we have gathered so far through the inquiry workshop and other work that we have done, to be able to solicit their feedback.

Some of the other challenges, if we look at the kind of use case side of it down below, what are the changes that are happening organizationally that matter? This is how the health care ecosystem is changing, where payers are becoming providers, providers are becoming payers. There is a lot more interaction and integration happening. How does that matter?

What kinds of innovations are coming in, whether they be operational innovations or technical innovations or payment models innovations that might be happening to change that. How does cybersecurity play into that challenge? And then interoperability, more of a broad term there, but how might that be positively influenced by the existing system or changes to the existing system and structure? Questions?

So then our next steps were to actually design and conduct the forum. We laid out a little bit of a kind of straw man agenda. It is not in your book partly because one of us just kind of made it up based on our discussion. We had a subcommittee call last week where we were talking about this. We just started framing up what the agenda might look like. Let me toss a couple of ideas out to try to solicit your input and feedback.

AS we conduct kind of an information-gathering session, we can either have people come in and sit up here one at a time and present to us their thoughts and issues and challenges. And/or we can come in and have three or four people sitting up here with either similar by design or dissimilar by design backgrounds and rules, to then have more of a roundtable discussion.

The current thinking is the roundtables would probably be generally more productive. Although, we may ah veto have some kind of a mix. That is a question. If we are trying to gather this kind of information and feedback from this kind of group, how might we think about the sessions, if you will, the chunks of that day to get the best information and interaction. 

DR. KLOSS: I suppose there is a third model that everyone is around the table. There is a structured set of discussion areas. It is really less like a hearing, more like not necessarily the appreciative inquiry, but I’m thinking like maybe more of the work we have done on some of the pop health sessions. More of a true roundtable.

DR. ROSS: Before I could answer your question about the best approach, wind back to what does the future look like the next two years, the next five years? Does the committee have a sense of confidence that you would be able to say to people you have invited to say, we think the future looks as nice as follows? Or either this future or that future, but in effect, lay out the proposition of this is what we are reacting to.

I haven’t heard that. So otherwise, without that, it is going to be people being asked for suggestions. But they are giving suggestions based on their view of what the future is. Could you align people?

MR. COUSSOULE: I will give you my two cents and let the others weigh in. Part of the challenge with that is can we, in any reasonable way, predict the future? Or do we lay out a couple of different models of the options?

DR. ROSS: Sort of a scenario planning exercise says if the following future happens, what would you think is the best course to follow? That is one approach to take. But can we lay out one or two or three of those, what those futures look like, so that with some degree of confidence. You are not just having a bunch of different people throwing out ideas based on their view of what the reality is going to be.

MS. GOSS: I am hearing two separate things. One, there is the response to the predictability and what does that look like? I do think we are envisioning that we are going to give them something to react to. 

But I think there is also this visioning, getting input from what they see as coming down the pike for them, to make sure our thinking is broad enough. So I would ask Nick and Rich. I apologize if I just jumped in on you. 

DR. LANDEN: I think one of the values that I see in this is to understand from our panelists, who are from organizations whose day-to-day bread and butter down in the trenches utilize the standards and operating rules. What do they see as the future? If we get six or ten people who say the future is there, there, there, there, that gives us one set of answers. If we get a consensus saying, we think the future is there, that tells us more.

On the other side of the coin, I would not want to go in and give our view of the future to them and ask them to react to that. I understand normally that —

DR. ROSS: I understand exactly where we were in this. You really want them to say what they think the future is going to be. 

MR. COUSSOULE: I think there is a little bit of a combination because we can certainly lay out some things that we see based on the feedback we have gotten so far in regards to some potential, things that are happening today that aren’t necessarily done, but that are changing like payment models and integration of the communities between historically a separate delivery system from a financing system. I think we can certainly lay out some of those changes conceptually without getting too specific into the actual future.

MS. MONSON: Perhaps there is an opportunity, too, to include Silicon Valley because a lot of the ideas of what they are doing aren’t even in the hands of like chief innovation officers. And yet, they are partnering with lots of health care organizations to do lots of innovative things that might provide some perspective to what the future looks like because they are just forward thinking. And oftentimes, they are hundreds of steps ahead of the rest of us before it even becomes an idea.

MR. COUSSOULE: That is a good point. I can just give you one. It is not anecdotal, it is real. I am actually going out this week to meet with some folks talking about artificial intelligence as applied to some of the processing stuff that we do directly. So yes, I think that is a good point.

MR. THORPE: Nick, just to answer your question, I like the second approach, where you bring in different viewpoints. We can hear different viewpoints if we are talking about where they see the future is going, as opposed to just one sharing their viewpoints. I think we will get more bang for the buck in that way.

MS. GOSS: You like the panel on a specific topic, and then make sure it is a cross-segment sort of representation on that panel on a particular topic. 

MR. THORPE: Is that what you asked Nick? I am not sure that is what you asked. I do’t want to be guided. Nick is the one that needed to clarify.

MR. COUSSOULE: I will give you the answer I want in just a moment.


MS. HINES: What you said is what I heard him suggest. 

MR. THORPE: Then yes. I am sorry for the long-winded thing.

MR. COUSSOULE: When we have done some of these sessions in the past, and I have been doing this for about two years, so I don’t have the history that some of you do, but we could conceivably give people five minutes, four people, and then spend 40 minutes going around the room. There are different ways for us to be able to allow people to weigh in directly, and then have more of a roundtable, too. I think that is an option, as well. 

DR. LANDEN: One other consideration I just wanted to get out on the table is that the reason we chose CIOs, by extension, we are talking all CFOs, CEOs, CTOs, CMOs, is at the strategic level, this is the group of people that has to make the hard choices on what they invest in, when they invest and how much they go for. Part of their job responsibility is to make sure that their organizations have the capability to do whatever it is, at whatever point in the future. Hence, we got like three forward-looking years out there. 

So for us to understand from the industry the decision-making process about what they would invest him, what they wouldn’t and what the what the role of standards has to be, both to support where they are going and to react to where they are going.

DR. PHILLIPS: I am thinking about the groups that don’t have CIOs. There are still a lot of rural and small providers out there who are affected by standards and have no idea what to do. 

MR. COUSSOULE: I think one of the things we also talked about that we would likely need some kind of either groups or associations as applicable, in some ways to be able to represent. It is easy to think about big systems like at Blue Cross or Vanderbilt, that have lots of folks that could be engaged in this.

But to your point, that is part of the ecosystem. That is not all of the ecosystem certainly. How might we reach out to that?

DR. PHILLIPS: Some of the regional extension centers, especially in some of the more rural states, might have a really good sense of how they are trying to solve some of these problems for solo practices or rural practices. Indian Health Service might be a good place to talk with. I know they are going through a process of revamping their IT systems.

MS. HINES: I am an alum of the Federal Office of Rural Health Policy. I will just chime in. They were actually created as a result of unintended consequences of federal policy affecting rural areas. So between Bob and me, we can hook you up with some of those folks.

DR. COHEN: Don’t ignore community health centers and urban areas, as well.

MS. GOSS: That is where maybe some of the associations because it is very hard for those organizations to offer up testimony. But I know in Pennsylvania, we have the Pennsylvania Community Health Centers that represents them as a voice. I love the idea of the rural health policy folks, the FQHC folks and the RACs really do help tap into that, along with the Medicaid focused.

DR. STEAD: I am really hearing this is now more from being a CIO forum, as I believe it originally worked its way onto our work list, into an implementers. It is an implementer’s forum. It is where the rubber hits the road.

MR. COUSSOULE: I don’t want to lose sight. I think Rich made a really good point. We want to make sure we also get information and feedback from the folks that actually are responsible for the investment decisions that get made.

DR. STEAD: I am hearing that may be one group. If you look at the spectrum we are talking about how, that is becoming a group, not the central group, unless you want that still to be the nucleus around which you are evolving, at which point you would be creating quite a different balance. 

MR. COUSSOULE: I will speak for myself and please weigh in. I think one of my concerns early on when we started talking about getting feedback from the practitioners was that we would end up with people so far in the weeds. That would be valuable information, but we would lose sight of the structural question about value and benefits.

So trying to find the balance between real-world challenges that exist today by people that are practicing them, as well as opportunistically how we might get to potential value in the future. I think it is a mix. We have to have kind of both ends of that to make sure we get good direct feedback from real live issues today versus also future-looking opportunities.

DR. STEAD: So then you are going to be constructing a matrix of key perspectives and we are going to be filling the slots. 

MS. GOSS: It sort of seems to be building on the idea of having a set of questions that we almost want to ask people to answer those questions from the two different perspectives, the decision makers versus the implementers. You really get two different sets of issues there. 

I agree with Roland and the idea of having different perspectives on a panel to get input. But we also run into time constraints. What I like is that we can ask for that more robust written testimony to give us further input, and like just be able to showcase the key items during the actual panel discussion. It kind of balances it. This is what I am starting to hear from the discussion.

DR. LANDEN: I think again going back to what I said earlier, the organization needs to be a nuts and bolts user. The organization, to which will be sending out the invitation, needs to be a nuts and bolts implementer, standards and user of the standards and operating rules. The individual needs to be at a strategic level, not a technical level, strategic level. 

So when we talk about the small organizations, rural providers, practitioners, those organizations really don’t have much at the strategic level. I am very appreciative of hearing the suggestions about the recs and the associations and the organizations that have been mentioned who would be able to offer a strategic view for those small organizations. 

MS. HINES: I would just not write off the fact that because they do have associations, the National Association of Community Health Centers, they do also think strategically as a group. So you are right, they are small organizations under themselves, but most of them, especially the more seasoned ones, work at the leadership level nationally or the state.

DR. MAYS: I agree.

MS. HINES: Thanks, Vickie.

MS. KLOSS: If we were able to allocate two days to this kind of listening and learning activity, we could also consider having day one be the CIO forum and day two be other smaller provider organizations or other users. I suggest we at least give some thought to that because I think the nature of the discussion, if we had a day with some CIO, C suite folks, could be a little different. I think we could do it in two stages, two listening sessions. I think that might be worth considering. I think the dialogue changes.

MR. COUSSOULE: I think there are definitely different constituents that would have different perspectives on both challenges and value. Whether we could fit it in one day or do it in two is just something, as we start going through the details, we will have to figure out.

DR. COHEN: Would you want those panels mixed to have to conversations among the different perspectives, or do it iteratively among more homogenous groups. I just don’t know what the constituents would be. But you should think about that.

MS. KLOSS: My reason for thinking about that is my gut feeling that these are really complex sets of issues. The level and understanding is just going to be really diverse. 

MR. COUSSOULE: I think in some ways, it would be quite difficult to have people from a very large system sitting around a table with people from a much smaller system because the challenges are just not the same. I do think you need all the viewpoints. Whether they would be sitting in the same panel, if you will, or maybe we would have a different panel. Scale might be a divider, as well, scale or complexity, as well as a particular business area. I think it is worth thinking about. 

I have done that before, where when you start mixing scale in, the discussions diverse very quickly because they don’t have the same kind of challenges at all. 

MS. LOVE: My caution, and I think this came up on our call, is especially if they are at the strategic level. My experience with panels and speaking is sometimes the strategic folks come in and out. I mean, they are not hanging out for the whole time in the whole meeting.

MS. KLOSS: Right. That is why I would say you can do a well-organized one day and then another well-organized one day. At the end of two days, we have had pretty board listening sessions.

MR. THORPE: While I appreciate all of that, I am trying to understand how we get the syntheses of the different viewpoints. I appreciate the scaling, but I think I am just trying to understand how we get the syntheses of that. I think it is lost on day one with the day one 9:00 session is lost with day two 1:00 session. I am all for it, but I just think let us not forget about how we get the synthesis. I think that was the initial question of what we were trying to do is to gain some syntheses of viewpoints in an efficient manner.

MS. GOSS: And building on your point, I think synthesis is aided by the written testimony submission and sort of the hindsight and review that happens after the testimony. I think the synthesis is important. But I also want to have some of the tension of those different views. So like on the fly synthesis, I don’t know if that is really the right thing I am trying to get at.

But I want to challenge the idea of sort of with the players, but it is how do you get that bulls eye to narrow down enough to understand that you are going to actually be able to create something that is a benefit to everybody, regardless of their point of view. Doing that on the fly is pretty tough. I think that is our goal.

MR. COUSSOULE: So as we design the forums, obviously identifying the participants, we talked a good bit about timing we will have to work through in conjunction with other things happening, as well as the pure logistics of pulling it all off with enough information and notice to be productive.

The question set gets interesting, as well. We were talking about how do we prep the folks coming with the specific questions we would like them to answer or the open-ended questions we would like them to address or the challenges. We have been through a little bit of that work effort at the subcommittee level, trying to start gathering some of those in a little more detail.

We will obviously look for everybody here’s input. I am not sure we are going to run through that today, although we can certainly toss it out for some kind of bigger ideas for what we might want to team up for those individuals. The idea being we would ask them to respond to things as opposed to totally blue skying and ideally with some amount of storytelling as part of that exercise, as well. Questions or comments about that? 

I guess the one question I would have for the folks around here and certainly the people that haven’t been in some of the subcommittee work is are there one or two or three questions you would think about that we would want to pose to folks to try to get them creatively thinking about the challenges or opportunities here? 

MS. GOSS: I think from a standard subcommittee perspective, we will focus in on the sort of trial preliminary recommendations related to the roadmap. I am really curious from a pop health PCS perspective. Is there anything in your wheelhouse that we should be thinking about including as sort of those broader, what are your challenges, what is your vision sort of perspective?

DR. STEAD: My sense is we may be having a bit of challenge getting from the conversation we just had and the fact we have not come to closure on that for the questions. Maybe we can go back and forth. As long as we are unclear about what we are going to call it and how we are going to populate it, and how we are going to structure it. Maybe if we can wash that from our heads for a moment and try to come at some key questions that we would actually like input from the various kind of people we have talked about. I think we had best do it now because spring is going to be upon us. 

If we could brainstorm, what are some of the key questions we would like to know that are what is making us think about bringing this group together? That I think might be very helpful. I know that one piece of that is the reaction to version 0.X of the predictability roadmap. 

MS. GOSS: That is going to be the brunt of what we want to talk about. It is really this other visioning part to your point about what are those couple of questions we might want to ask them around. We are only going to have so much time to be engaged in conversation. I think we wanted to be able to hear from our fellow committees.

DR. STEAD: What I heard early on in the conversations about this was that one of the things we wanted to know were what were the key things in some space that were keeping them up at night. I think this played back to Rich’s original idea of what this thing was about. 

It is possible that we are actually, from at least their purchase, worrying about the wrong things. Maybe you want to back up and share a bit of that to maybe help us try to get some of the key questions down.

MS. KLOSS: Don’t we have a starter set on page 12, if we back up. 

MR. COUSSOULE: To Linda’s point, if we looked at it, there are some of those questions. I think we have got both, what I will call, backwards looking or current state kind of questions, which some of these are. Is the current schedule frequent enough? What are the challenges to implement? How does your budget cycle work and how does that influence by the pace of change or not pace of change? 

The other side of it is the more future looking questions with payment models changing. How does that influence with integration and acquisition models, et cetera? How does that influence this?

MS. KLOSS: Maybe that is a way to organize the questions. We have got certain questions around process, around current process and potential recommendations for improved process, so we get some reaction on some of the straw man recommendations as we were talking about before. 

And then we have a set of questions around their visioning of how standards play into improved business models. Is there another category?

DR. STEAD: I think one of the problems, I think most of the type of people that we have mentioned would have no idea of what we are talking about around some of the key questions with the predictability roadmap. I think we somehow are working our way toward a mismatch. I think we have got to try to unpack it somehow or fix it somehow. 

DR. COHEN: This might be moving in a slightly different direction but putting on my population health hat, I mean, will the outcome of these discussions have any impact on individuals or patients or groups who use aggregate data to assess and monitor population health? Is that an anticipated outcome, or is that not relevant to this level of discussion? Or will the outcomes be transparent to those individuals and those needs?

MR. COUSSOULE: I am not sure I know the answer to that.

DR. LANDEN: Let me take a stab. The short answer is I don’t think we know. One of the purposes for the longer term, the five and ten-year out vision, is to ask the question to those organizations, do they believe that specific question will be something they will have to gear up and be ready for at some point in time? Then we work backwards with them saying, okay, do the current standards and operating rules and implementation guides, do they deliver on that or do we need to look into other things like apps? 

DR. COHEN: That is my questions for this group. What is the ultimate impact on individual health? Or is it just a systems improvement that will be transparent? What would the impact be on users of the data that result from more predictable transaction standards?

MS. HINES: I don’t see a relationship between when patients experience. I could be wrong. I mean, maybe if the transaction process doesn’t go smoothly, the patient ends up has a big muddle with their provider getting reimbursed.

MS. GOSS: And how does the need for patient-generated data in today’s care delivery translate to the reimbursement model changes that are occurring between the payers and the providers. I mean, there is some interplay. And part of the challenge we have is we may not always have a visible direct thread. But the data from the patient provider interaction and the patient’s own experience are having an interplay with how the health care system is financed and paid for. 

DR. STEAD: Every piece of my nervous system says that we have turned this into a bridge too far. I would just pause it for the subcommittee to think about, that we ought to take this back and make it a chief information officer forum. We have been on a journey, and journeys are important. They help us understand the spectrum of what we are dealing with. 

But I think we need to come back to thinking about it being a CIO forum, with the narrow lens on that eye, focused on the questions you have got on this slide. That, I think, we could figure out how to put that together. I think it would have some useful results. I think we could ask them some key questions about the beyond HIPAA piece. I mean, I think that is doable.

MS. HINES: With the friendly emphasis amendment that that last question on the slide, combined with what is keeping you up at night, shouldn’t get lost.

DR. STEAD: It is fine to have that last bullet be what is keeping the chief information officers up at night. That is completely different from your chief investment officers, I mean, who aren’t going to have an idea what those first several bullets mean. I will be quiet. I have said enough.

MR. COUSSOULE: A couple of things. One, I will point you to the NE book. There is actually a little more detail framing out of the forum starting on page 89, 90 and 91, 92, which probably gets back towards a little bit more of the original context. We did spin around a little bit today, which actually I am kind of with Bill there. I think that actually is helpful to sometimes spin around. I wouldn’t try to stop that. 

The one area where I might, I won’t say disagree, Bill, so much, but just to make sure we conceptualize this. I will just use an example of me. I am a chief information officer. I couldn’t tell you how to program standards for EEI for Adam. 

But I clearly know what I can and can’t do that I am trying to accomplish in the business side because of the challenges inherent in that is trying to find the right mix of folks that can actually balance that. They are not all going to wear the same hat and the same title, but trying to find people that actually get that portion of it. We are not interested in telling somebody what are the real challenges of implementing X12 in your organization.

It is not really about that. It is about what are the inherent business challenges because you can’t or it is more difficult or it doesn’t move fast enough for those kind of things. It is going to be a bit of a balancing act. But I would default to a little higher level rather than a lower level.

MS. HINES: I am just rereading the purpose statement on the scoping document. It is clear as clear can be. The question is do we just need to go back to that purpose statement. You obviously put a ton of thought and time and subcommittee reiteration on and say, how do we manifest this purpose statement. I think you have got it.

MR. COUSSOULE: Denise, did you have a question before? I am sorry. I thought I saw your tent up. 

MS. LOVE: Just to follow Bruce, they may not know about the input and the standards, or maybe they do. But they do know that they are reporting to hundreds and hundreds and hundreds of entities. How do standards simplify that reporting? That is just my biases.

How can we somehow link or find out, or can we at all, that the more standardized things on the front on, the easier their reporting job is on the backend. I am not sure all the CIOs connect that. They just know they are reporting a lot of different things. They get claims paid over here. Anyway, that is in the lap around the room. I think we were brought back home.

MR. COUSSOULE: Let me try and go on a little bit because I know we are about out of time.

DR. STEAD: We are good with time because we have actually got an extra 15 minutes. It doesn’t mean we shouldn’t bring it to closure. We will all be happy if we keep moving when we get out of here. That said, let’s land the airplane.

MR. COUSSOULE: Again, if you look at the forum scope, project scope, and details starting on page 89, it runs four pages, that is our latest thinking on that. I think some good feedback today in leading us to making sure. I think we will kind of revisit that to make sure we are complete and that our focus is appropriate.

Assuming for the moment that we get past that, and we are able to schedule and conduct the session, it would likely be in the second core going back here. What we would do with that information, and some of this is starting with the end in mind, which is where I tend to go, is the whole purpose of this is to get feedback that then provides input into our roadmap options and exercises. 

If we start out framing the questions around existing challenges, opportunities, solicit that feedback and get some of those opportunities, it would then I think provide another viewpoint into what recommendations might we make in regards to the predictability roadmap and potential changes in that process.

We would incorporate that feedback into our roadmap exercise. And then from there, I believe we would be prepared to draft a little more formal draft of recommendations, which we would then socialize with kind of all of the participants. This would kind of cycle back to the folks that we had gone through with the inquiry session. The SDOs, HHS, et cetera to validate, challenge and weigh in on those potential recommendations now. 

We need to be clear that the recommendations are the committee recommendations, and that there will likely be some challenge with that. But the idea is to be able to validate or at least understand the challenge and issues associated with any given recommendation that might be made.

Partly to go back to what I was talking about this morning when it is conceivable that we may have recommendations that would be easier to implement. Some of them might be much more complicated to implement. We would need to, I think, want to understand that context along with the recommendations themselves. 

DR. STEAD: I was still really coming back now to where we have been through the journey to some of your original questions about how to structure this thing. One thought would be, now that we are going to narrow this to people that, in essence, are chief information officers of one or another, and try to have it up at the level of the roadmap, not in the weeds. 

Then one thing you could do would be to use a questionnaire to obtain input about what they see what are the big challenges they are facing as health care changes where standards might help and aren’t, where we don’t have standards that might be helpful, and where are the standards and processes that we have now in the way of responding to those changes. Those two questions could keep it narrowed down a little bit.

MR. COUSSOULE: I think we need to narrow it. If we start asking people what keeps them up at night, that is not productive.

DR. STEAD: All I am sort of thinking, if we could get that in advance, you could then bring people in and share that. As a subcommittee or the planning group, however you would like to tackle it, you could figure out which aspects of that were worthy of group discussion. I am still trying to figure out how to manage this, if practical, into a day.

If we could manage at least that session to a day, I think the discussion we had on the subcommittee call about the fact that we might then have a second half-day, which is a subcommittee augmented by whichever the committee could participate, would actually try to turn this into the decisions for deliverables. So that when we got done with this, we had it in a forum we could finish it up and move it out. 

I think we have got to get an idea around that part to then come to the question, are you trying to land this thing? When are you trying to land this thing, which is your sequencing question? We have got to get a little lens on the prework. To the degree we could nail some of that down, at least as a straw person, that the subcommittee could then refine.

MS. GOSS: Yes, we really need to have this pretty much all figured out this month in order to do all the federal register obligations and, more especially, the advanced time to distribute the questions, so that entities can really vet them fully before preparing testimony.

I like the idea. I just haven’t noodled on how that all fits in as a way to get input that then further refines the way you facilitate the discussion to get that synthesis of really cross perspectives.

MS. KLOSS: One of the potential advantages of the questionnaire could also be that we could then get at two levels of input. The CIO then, Nick, you can go to your team member that is more in the weeds, and answer some of those questions. And then have that part of it kind of off the table. We don’t need to get into process discussions necessarily, at the one day. 

MR. COUSSOULE: Also ask for written testimony to address some of these things, as well.

MS. KLOSS: We could. But as soon as we ask for written testimony, you really up the ante for prep time among a lot of people who aren’t used to preparing written testimony. That is why I get more into having this meeting be more of a scenario or a strategic discussion, rather than testimony.  I just think most people don’t know how to do this.

I mean, we could get the weeds, some of the process stuff taken care of before, summarize that, have some discussion. And then really facilitate a good discussion amongst the CIOs. I think they would maybe find that kind of experience more of a learning than formal testimony. 

DR. STEAD: What you say at least resonates with me. I think it fits. 

MS. GOSS: I am processing it. If we are looking to try to figure out how to schedule this, yes. 

We would be very also careful that we would be information gathering in a way that would leverage out tools, work within the federal rules, give us the timing to develop it, get the resource out there and then be able to get that back in time to be able to then see if there is anything we want to clarify. But then focus our actual in person event in a very different facilitated way. 

MS. HINES: What I would say is just lay out what all the pieces are and then work backward. Let’s say you want to do this April 15th, and here are these eight things you have to do, does it work out on the calendar?

MS. GOSS: I think part of the original thinking was that maybe we could do it in April because we were trying to. If we were all going to be together for a hearing any way or another roundtable workshop, forum, whatever it is, from a cost benefit perspective, if we are all going to be here, try to maybe make it two or three days’ worth of an effort. Don’t put it onto another full meeting. I am just trying to line all those different things up.

MS. HINES: I would say next step is to lay out what all those pieces are, develop an information-gathering document, identify the people. I think getting it on their calendars, so that we know they can come, is probably the most important first step. And then we can backfill in what has to happen beforehand. Do just a pert chart.

DR. MAYS: Alix, do you have the resources? I think that always comes up. I know you all are stretched thin. Are there particular things that you would need to help make this happen in that timeframe?

MS. GOSS: My initial reaction to that question is that, with Lorraine and Janelle’s assistance, and their focused effort on the roadmap and this forum, it will likely set us up for success because of the work that Bill has done to get us support from NLM on the terminologies and vocabularies aspect. I think that we have been trying to avoid the dynamic to which you speak.

MS. HINES: I am assuming, Lorraine, you will monitor your time because a lot of this is on you and Janelle. So basically, Vickie, as long as Lorraine and Janelle are okay with their other responsibilities because NLM has now stepped up on this other standards piece, I think we are fine in terms of bandwidth. I think bandwidth is our biggest challenge.

MS. DOO: We will do the work we have always done. I will do that piece and pursuing the logistics for the facility, we would still coordinate with you.

MS. HINES: That is always the hardest thing is getting a space that is acceptable that is available, and then getting it on the calendars of the people you wanted to come. If we can crack those two nuts in the next month, the rest is a cakewalk.  

DR. MAYS: Try the UCDC Group. We have a facility there which, because we are a state school, you can probably use.

MS. HINES: That is great. We will revisit that with you because I know you offered it before, but it was such a short time that they weren’t available. But if we are thinking months in advance, it might work out. 

MR. COUSSOULE: Let me wrap up. I actually do want to thank everybody for your input into this. I know it may seem like we spun around a good bit, but it is helpful to do that and bring us back to focus.

DR. STEAD: Thank you for having the patience to deal with it. I think this journey will help us a lot going forward. 

MR. COUSSOULE: The last thing I would cover before we go onto the next topic, though, is the other ongoing subcommittee activities. We kind of start in with that, with the predictability roadmap, and then went into the CIO forum. We have a handful of things going on, as you see on page 15, slide deck as we speak here.

Alix hit on a couple of them earlier today that we still spend subcommittee members keep an eye on what is happening in other parts of the ecosystem as far as the other activities. Some of those were on the roadmap that Bill walked through earlier this morning. I guess I don’t know if I need to cover these or any others because we really covered them as part of the roadmap exercise this morning. We just wanted to close the loop from a standard subcommittee. But I think we already talked about that. 

So with that, other questions or kind of wrap up the topics for the predictability roadmap or the CIO forum or comments? 

DR. MAYS: I just want to say thanks for how clear both you and Alix were in your presentations. It was helpful given that I am on the phone. I really appreciate the time you put into thinking through your presentation. 

MR. COUSSOULE: I am not sure you realized it, but that was a shout out to Lorraine, so thank you.

DR. STEAD: Do we want to morph into the New Medicare Card round robin?

Agenda Item: New Medicare Card Project/MBI Follow Up

DR. STEAD: I think I will facilitate this. Just to repeat the purpose, we had a very helpful update from CMS at the November 29 virtual Standards meeting on the outreach effort they have been making around the New Medicare Card in follow-up to some of the concerns that we raised. What we emailed and asked each of you to do was to reach out to your very different constituencies and to be ready to share with us a sense of whether the message is getting out, or who it is getting out to and who it is not getting out to, so that we can make sure that CMS has that feedback to help them. 

We can do tents, or we can literally just go around. I think I would literally go around and see everybody had found out. We will start with Denise.

MS. LOVE: As far as the NAHDO or National Association of Health Data Organizations and the state health care data world, the message is out. They may be getting it either through CMS or through payers or providers. But there is a great deal of uncertainty as to the Social Security number itself. I think the message is out that the new beneficiary card and number will be issued. 

My members wanted NAHDO to call a meeting with CMS. This is a good time to talk about this. I have some emails that even came through this morning to clarify that the Social Security number is still available because many states have in their regulations and laws, reporting laws, from providers and payers, requiring Social Security number. That is one part of it. That is not the Medicare part.

We have a bunch of states getting Medicare data extracts through ResDAC, the Research Data Assistance Center. They want assurance, and I provided assurance because in our previous discussions, I heard that they could still get the Social Security number. They want some assurance that Social Security number will still come through on the qualified entity and the state research data extracts. So the Social Security number is not going away because they are linking and doing longitudinal analysis for multi years. This is a real important issue for them in an analytic linkage standpoint.

My understanding and what I have told the states that I have had interactions with, and we had an all-state call about two weeks ago, three weeks ago, was that the Social Security number will still be available on the research data extracts from Medicare. I guess I just need some assurance —

MS. KAY: This is Monica from CMS on the new Medicare Project Management Office. Just to address that and to answer the question, you are absolutely correct that Social Security numbers will not go away, especially for the research purposes. What we are asking people who use the information for their data registries is to update their data use agreement. If you can send me that question to our CMS new Medicare card SSN removal box, I can get you a complete answer to that.

MS. LOVE: Would your staff from CMS be available if states want a call just to ask any questions? Would that be an effective, so they are not hearing it just from me? But they could hear it from CMS. Would that be something that I could talk to you also about in that submission?

MS. KAY: We are having an open door forum, I believe, on the 23rd with states again that we could push out that information to you, where we share some of that data and some of that information. 

MS. LOVE: Okay, on the 23rd of January? 

MS. GOSS: This is Alix. I just want to clarify. Did you say that since the SSN will still be around, that it would still be available as part of the ResDAC extracts, and that there was a data use agreement update aspect? I just wasn’t sure I captured it.

MS. KAY: That is correct. The SSNs are not going away for the states and their interactions. You are absolutely right that there are rules and registration in place where they have to collect it. What is going away is that SSN-based health insurance claim number. We try to be clear about the distinction between the two because we know that the SSNs are used for different purposes. 

Now, I am hoping that Lois Serio is on the line, as well.

MS. SERIO: I am, and Monica, that is correct. We have been continually letting our state Medicaid agencies during our calls make them aware that we are not changing the Social Security number. But as Monica said, we are having a state stakeholder call. We could certainly add that to our deck and make sure we get that word out again to all of our state entities.

MS. LOVE: On the data use agreement, so when the states get the research extract, if they re-release under the data use agreement, that would be the data use agreement that they would need to update?

MS. KAY: I think we need to step back. If you would send us that question because as far as the states using SSNs, that doesn’t change. I don’t know if that affects the data use in particular. What is perhaps needing to look at the data use is just to make sure that when there is a HCN number in relation, we make sure that everything is updated to include the new MBI. If you would send us that particular question, we will research and look into how that will affect the data use agreement.

DR. COHEN: It sounds like you have certainly been in touch with state Medicare agencies. Have you been in touch at all with state registry of vital statistics offices because they are active users of SSNs for a variety of the same reasons that Denise mentioned?

MS. SERIO: I don’t think we have specifically reached out to that group. We would love to have an occasion to talk with them. They may have attended some of our all state calls. Again, when we had the last state stakeholder call, some may have (off mic). But we would certainly be willing and would appreciate the opportunity to talk to them directly if there is any type of the call or venue that would be workable.

DR. COHEN: NAPHSIS, the National Association for Public Health Statistics and Information Systems is the organization that contacts all of the 57 offices. They have ongoing calls and communications. I would suggest reaching out to them, Shawna Webster. We can send you that contact information if you need. But setting up a call through their ongoing monthly calls to update them about this, I think, would be really helpful.

MS. LOVE: One more thing, one of the emails that came through this morning is one state’s understanding is Medicare will not send out SSNs once the transition happens. I think that is misinformation. We are getting some emails and questions that vary by state. We need to have this clarified.

MS. KAY: Thank you for letting us know. As I said, we have continually responded to those questions about SSNs. But it sounds like we need to do more in our communication to make with the states, to make sure that they are aware of that. So if you could send us that contact information, we would be appreciative.

MS. LOVE: I will. These are states with reporting laws, about 40-some states with reporting laws. They are outside of Medicaid. 

DR. MAYS: I just want to follow up on what Bruce was bringing up. The group that I talked to were researchers, particularly those who tend to use mortality data and need to do tracking in their studies. I don’t think the word is out because they are very concerned. I am wondering if you have had any opportunity to reach out to researchers in general who utilize SSN, so that they can really have greater clarity as to what is going on.

There seems to be a lot of anxiety about either a cost that is going to occur in terms of trying to access data that they access before, or that there is going to be a scarcity. I mean, that is the anxiety that this will be another data point that people can’t get to.

MS. KAY: We have had a couple of different conversations with our researchers, data registries and other groups. But what I will do is to make sure to communicate that back. It sounds like we might be missing a few folks. 

We have communicated the fact that the use of the Social Security number is not changing. And again, we just need to be clear that we are just talking about the health insurance claim number versus the Social Security number. I think that is where some folks may be getting tripped up in understanding what we are talking about.

If you are using SSNs today, the Social Security number, you will be using it tomorrow. If you are using the health insurance claim number today, you will be using MBI tomorrow. That is how I usually speak about it in presentations. If you are hearing directly from certain sources that they are not clear, or they need additional communications, please send that to us, so we can reach out.

DR. MAYS: I think you may want to reach out to things like the population centers and the demography groups. Those are the ones where I was doing a reach-in to see kind of where they were. That is kind of the feedback that I got. And also worrying that there is going to be some cost, that if the states have to do something to change things, then it might cost them more. That was the other thing came up as to whether or not a cost is going to get past that. Which I know you can’t account for, but that is one of the concerns.

DR. STEAD: Thank you. 

DR. LANDEN: In a small sample group, numbering no more than 12, I asked around and, with one exception, moi, no one was cognizant of the changes coming up. I did get in the mail a nice letter nicely explaining the changes. My takeaway is, okay, just like my annual insurance care, I have got a new Medicare card coming. I will have to remember to take it with me at my next visit. That was about the extent of it. Those who did have an opinion thought it was a good idea to remove the soc number from the ID card. 

MS. SERIO: We did add the beneficiary information into the latest 2018 handbook. That was really our first touch with the beneficiaries directly that a change is coming. Our communication plan is structured that actually at the end of this month, we will start going out, now that open enrollment is completed, and the holidays are over, we will start pushing out and communicating more directly with the beneficiary.

We have lots of outreach planned, not only on the national level, but as well as on the local level. So folks should start hearing, and beneficiaries should start seeing and hearing more about that starting at the end of January. 

MR. COUSSOULE: I talked to a number of my peers about this. We have all had kind of projects in the works for    quite some time to make this all happen. I am just talking about health plans, sorry, just to be clear with everybody. Our concerns were less about whether the health plan was prepared and more about whether the provider offices were prepared.  

MS. SERIO: We have reached out with a letter to all Medicare providers explaining to them the operational processes and what is going to be happening. Making sure that they are going to be ready by the start of the planned mailings. They are also working on a provider tool, so that the provider will be able to look up the new number for their patient through the Mac portal. 

We also have a whole provider page on our website that we are really trying to do our best to make sure that all providers are aware. We have asked the states to reach out to their providers. We also have had, and are having, quarterly provider open-door forums. We continue to spread the word with the providers.

MR. COUSSOULE: Just to be clear, I have not, and I don’t know any of my peers that have, polled any providers to figure that out. That is just a concern. A concern is not necessarily about whether they would be prepared, just whether the providers would, not based on any specified outreach and feedback or anything like that. Just so I am clear.

MS. GOSS: A lot of the feedback I have received is analogous to feedback you heard from Denise Love. I am very curious to see the answer to the inquiry or question she will submit, so that we can be very clear that those who are not in Medicaid, those who are not necessarily just a public health department, but those who do reporting in state-based analyses related to health care costs and quality have a very clear picture of their obligations and impacts under the CMS ResDAC file receipt.

MS. KAY: If you can just send me that direct question, what I can do is take that back to the subject matter experts that work with ResDAC. But it shouldn’t change if they are using those Social Security numbers today.

MS. GOSS: Yes, the understanding was that they should still be able to get the SSN for the historical files, so that they can effectively do a crosswalk moving forward, so they can maintain the integrity of their datasets from a longitudinal quality and price analysis perspective.

So it seemed like it was pretty straightforward. But the more we have talked about this, the murkier it has become. I will certainly work with Denise to get that question to you directly over submitting it to the mailbox, if I have understood you correctly. 

MS. SERIO: Yes, that would be helpful because again, as we state, and maybe the Social Security number stands, it will remain in all the files. If it is just a Social Security number, Social Security is still creating it and developing it. They are still sharing it with CMS. It is still in the files. It is a total separate entity.

If you are just dealing with Social Security numbers, nothing changes, no additional costs. It is the same business process that occurred today will continue to occur. But we will make sure we focus on that from an outreach perspective to make sure we get to the stakeholders who seem to be a bit confused. 

MS. LOVE: One more thing, providers and payers are not prohibited from collecting Social Security number just because of this policy. But that is another concern always that we will have some interpretation by a provider or payer somewhere that says we are no longer allowed to collect Social Security number on our clients because Medicare is issuing a new beneficiary card. That is a misinterpretation of the policy, as well. I am going to also make that clear to our states. I hope I am right.

MS. SERIO: You are. That is correct. 

MS. GOSS: So one last piece. Monica, I thought your team did a phenomenal job at the early December workgroup for electronic data interchange conference, not only from the educational session, but also just getting a lot of good questions and input from industry on the whole new Medicare card. I am hopeful that the questions they asked are turning into also a Q&A on the website.

It sounds like there will be some follow-up as far as promoting a next listening in kind of information exchange session that may include other participants. I see Charles shaking his head yes. Thank you for your support of that discussion.

MS. SERIO: Yes. We have taken all of the feedback, and we are currently in the processes of cleaning up our FAQ documents, so we can share it on our website. I am scheduling a couple of external stakeholder calls as we go through the life cycle of this project to ensure that all of the providers, partners, stakeholders are ready. And then to have other checkpoints where we ask you how is it going before we finally move over to the MBI in full on January 1st, 2020. Please look for some of those appointments where we have those discussions. 

DR. STEAD: Linda?

MS. KLOSS: Nothing to add to Rich’s summary.

DR. COHEN: I just wanted to say thank you for your outreach to the specialty societies. I checked in six months ago, and I have seen something every two months from our specialty society to physicians about what transition you are going through, so thank you. 

I am getting Medicare data both through the ResDAC and as a quasi qualified entity. And I am not sure on either process I have seen anything about whether I have an option to continue to get Social Security number. I will do due diligence and respond to you through the website that Rebecca just shared with us.

But thank you for your thoroughness. I will say that my 16-year old said they are really issuing these as paper cards. I think it is almost time for NCVHS to have a Medicare beneficiary subcommittee. 

That aside, one question that I haven’t asked yet, I am connected to the vitals community, the vitals folks, I am sure, will continue to collect social, but I don’t know whether they will consider expanding to collect MBI. Directly, I think most of the systems aren’t set up to do it.

I don’t know whether they will need it, except in one instance if there is going to be more linkage of vital records with hospital records and health care records, and health care records no longer collect social, but just collect MBI. Then they are systems that will need both SSN and MBI. This is a consideration down the road. I don’t know that systems are set up to do both right now. It could be a huge technological issue to have that capacity.

MS. SERIO: Our objective in this whole project, or one of the main objectives, was to continue current business processes and not create anything new. So as the business processes occur today in the use of the Social Security number, it will occur tomorrow. The only change would be that we are replacing the current Medicare health insurance claim number with this new number. That was our goal throughout this project, so that we could maintain as much consistency through the various operations that work with in health care. 

So what happens today will happen tomorrow, unless it is revolving the health insurance claim number. Then again, that is just a replacement of the number. For the most part, the hope is that the process itself, the business process, will not change.

DR. COHEN: Well, the unintended consequence could be a lot of health care entities will replace SSN with MBI. There will be other systems that won’t have both. I don’t know whether you considered those kinds of business decisions that might lead to discontinuities. 

MS. KAY: I think some of the tenets was to not be disruptive. And our communications thus far has been to, as much as is possible, to keep your business process the same, and that we are only changing that health insurance claim number.

I think as we start to move into the usage of the new MBI, and see how it proliferates through the systems, we will see what unintended consequences or how it falls out in the end. But our direct charge was to not disrupt business processes. The legislation only asked that we remove it. We are following that legislation.

MR. COUSSOULE: I would think, just to weigh in a little bit, because the changes is only happening for Medicare beneficiaries, it may have a lesser impact because if social is what is used to link all the individuals together, that doesn’t change because of this. It really only changes from a claim flow from the Medicare beneficiary’s perspective. 

I think there is a little bit less of an issue than it might be if you assumed that if social is used today, it continues to get used. This is really more about claim flow from what is covered, what is not to the doctor’s office getting paid, not so much the back end of analytic side. I am not trying to trivialize that.

But I think that we have got to be a little careful of generalizing that because social is going away from the HCN perspective, that all the backend things are all of a sudden going to change, and no one is going to collect socials anymore. That is just not right because we are only talking about a small segment of the population that is impacted.

MS. HINES: In two years, will the doctors’ offices, the smaller ones, collect SSN on top of the new MBI? Okay, that is the question.

MS. KAY: If they are using that in their processes today for financial information, they can still ask that question. On the flip side, the beneficiary has every right to not give it to them. That is the way it currently is today.

MR. THORPE: I spoke to researchers just like Vicki, and I had the same response. But the biggest issue was the cost, will there be a cost passed down. I don’t know how we best get that information back out.

I spoke to Health Services researchers not a part of the population centers. I think Vicki speaking to those people part of population center and my speaking to people that are not in the population center, I think that provides a broader swath, but gives us the same answer. I just wanted to make sure that we could get the information out if it hasn’t been put out to the researchers with regard to cost. 

MS. MONSON: Mostly reached out to the large health care providers similar to the one that I worked for. I am not sure where that letter went to as far as the audience. But I know Sutter has not received the letter to our knowledge. The large health care providers that I reached out to had not, as well. I am not sure who it is addressed to. But it certainly has not gotten to the large providers. 

So in the cases where I reached out, it was the first time that they were hearing of it. We were surprised with respect to it. So knowing that, Sutter, for example, is affiliated with 5000 small physician practices. I can’t imagine that they have heard about it if we haven’t because usually we are the ones who are messaging to them. I think there is still a pretty big opportunity with respect to the provider space to provide more than a letter to them.

And again, it would be also helpful to know who that was directed to. Oftentimes, when you are a large organization, things get lost in the mail. They are not sure who to route it to. So that could potentially be the issue, as well.

MS. SERIO: Thanks for that information. What we would tell folks and all providers would be we do have the copy of the letter on our webpage. So providers who did not get it or who are part of a large system could go on there and see a cop of it. Now keep in mind of the specific letters were sent with a little bit of specific information about their particular mac. But the overall contents of the letter is on the webpage under provider tab. They can also reach out to their mac to get the letter or to get additional information.

I think the big takeaway and communication to give to the providers, the rural, the smaller, maybe perhaps the ones who are embedded in a larger practice, would be to go to our website. Under provider tab, that has all the information the provider needs to know. It does have the letter. We are providing materials for providers. They can order tear-off sheets, posters for their offices. That would be the main communication would be to go on that site and get the information.

MS. MONSON: I think that all sounds great. But we have to get them to understand that they have got to go to the website for something to get to the information. If they didn’t get the paper letter, they don’t have any initial communication to understand that. I think that is the message that is missing that needs to be communicated broader.

MS. SERIO: Thank you. We continue to talk to and speak to that. We will continue. It is also on the MLN factsheets that were sent out.

MS. KAY: Just to add to that, so the actual letter was physically mailed, as well as the blast that comes through our Medicare learning network. They should also be getting that information, as well. That talks about Medicare card project, as well as what they need to do to get ready. Please, by all means, if you could just provide us with that information of people who may not have received it from your organization, we can definitely make sure that you get it, so it can be proliferated.

MS. STRICKLAND: I work with a couple of state Medicaids, and they are aware of the initiative and have projects in the works. 

DR. STEAD: I have been fairly persistent at trying to find out what Vanderbilt is or is not doing in this space. Admittedly, we are now a little over a month out from our epic conversion. Many people are still focused on sort of the basics of making sure that everything is flowing. 

But I think it is safe to say there is a general lack of awareness, at least at the upper levels of the institution. There may be something working down in the innards at some place. But if so, I at least have not been able to find it. 

And whenever I talk to any person, they present their view. If I talk to the CFO, she says, I have been assured that the Epic updates will handle this, which I am sure they will. When I ask, do we know if the Epic updates will have been installed, we actually don’t know that answer. 

You get similar kind reactions from chief information officer. My concerns, and I will eventually slog through this at Vanderbilt, but my concern is what happens on April 1 when a new beneficiary walks in, and therefore they don’t have an old card. I know the information is on the web. I have looked at it. I like it. I mean, it is wonderful. But our front desk teams, who are in many ways our weak link as a health system, aren’t going to know how to deal with this. I may, by brute force, overcome that. 

I know that I am not pointing fingers at anybody. I know that everybody is trying to do their own thing. I am not pointing fingers internally to all these different people, each of whom speaks from their perch and what they think their responsibility is. But what we are not doing, as best I can tell yet, is preparing as a system, so that our patients don’t have troubles when April 1 comes.

I recognize the only real challenge on April 1 is the new beneficiary that turns to the program at that age. So I remain concerned, as I guess all I can say. I have reached out to a few other large health systems again at the senior levels. At the senior level, they are sort of what. They make a note. I will look at this. Maybe somebody is working on it down in the organization is what they say. 

I still wonder if there is some way we need to actually make sure that we have connected to the C suite of at least the large health systems, just so we can tickle their itch. 

PARTICIPANT: I recommend an advertisement at the Super Bowl.


MS. SERIO: First of all, we have been working and reaching out to the practice management vendors to make sure that they are aware and outreaching to them. Secondly, we do understand your concern about what happens to the newly enrolled beneficiary. We have worked through what if, what happens if someone comes in, doesn’t have a card, doesn’t have a new number. 

We are working with our 1-800 call center. We are developing a web portal tool for the beneficiary to go in and get their number. We want to make sure that no one loses access to care and claims are paid. We are working through those sort of what if scenarios and trying to make sure that all those possibilities are covered.

DR. STEAD: From my perch, what I have been able to find on the web looks quite effective. I am just concerned. The beneficiaries may have the wherewithal to go after it. I am pretty confident our front desk service people will not be able help them do that. I worry that there will be challenges, but enough said.

DR. KAY: We have done working with our friends at HATA, the Healthcare Administrative Technology Association, as well as Paycom, to talk about those front office challenges that they may have. Our communications with them is that they have been preparing, and that they are getting access for their front office staff for that secure tool that will be available to get that information based on a couple of key pieces from that beneficiary, which includes their first name, last name, Social Security number, date of birth and I believe an address. I think that was the fifth element.

They will be able to access that tool. And that is some of the information in that provider letter, where we tell folks to please get registered with your mac to ensure that you have access to that secure tool. On the flip side, the beneficiary will also have access to a tool to obtain their MBI. What we are trying to do, as Lois stated, is to provide those contingencies when or if a beneficiary comes in, and they don’t have their MBI information. 

MS. SERIO: We can’t say it enough that if you are concerned about the larger health care practices, institutions, and there are any types of venues that we could call in or speak to, we are more than happy to help get the word out from whatever area that you are worried about. Please let us know.

MS. MONSON: Have you facilitated with the American Hospital Association. It might be useful to have a webinar through them. They have good channels of communication across most organizations and pretty broad.

MS. KAY: Yes, we have, and we have also invited them to our open door forums that we have been having on a quarterly basis, as well.

DR. STEAD: Thank you. I think we have managed to graduate to the break on schedule. We will regroup at 3:00 to get into the Foundations for Evidence-Based Policy. Thank you Monica and Lois, very helpful.

PARTICIPANT: You are welcome. Thank you.

(Brief recess)

Agenda Item: Foundations for Evidence-Based Policymaking Act of 2017 (HR 4174)

DR. STEAD: I want to welcome Amanda Cash. She is the Senior Advisor for Evidence and Evaluation and the Assistant Secretary for Planning and Evaluation, HHS. She is going to spin us up on the recent legislation.

MS. CASH: Thank you for having me. I am not quite sure what it means to spin you up, but hopefully that’s a good thing.


I am going to talk a little bit about the Commission on Evidence-Based Policymaking and the subsequent act that came out of that Commission’s report, but before I do that I am just going to give you a little bit of background on the evidence movement generally, if you don’t know.

In the previous administration there was not just a focus from the administration but also from Congress and from academics on really using evidence to drive decision-making in a way that we hadn’t before in low-cost and high-value kinds of ways.

One of the easiest ways to do that is through the use of administrative data, so there was really a push from OMB to focus — for the federal government, the Executive Branch, to focus on using the data we have to make the best decisions we can about programs and policies that we are trying to implement or that we have already implemented and we need to learn and improve upon, or maybe they are just fine. I think that’s mostly the case.

Probably around 2012, 2013, Speaker Ryan and Senator Murray really were interested in trying to do something on evidence-based policymaking specifically, and a book came out called Moneyball for Government. I don’t know if any of you know this book, but a lot of what you saw in terms of what OMB was saying and what OMB was telling the federal government to do in terms of chief evaluation officers — which is now in the bill and was in the Commission’s report — and more capacity-building for the federal government, a lot of it came out of this Moneyball for Government book. It was written by several former OMB directors, other representatives and congress people from the Hill, and it is an interesting read.

After that book came out, there was this notion that we should do something, so Senator Murray and Speaker Ryan decided they would try to pass this bill to get this commission going. It took them a few years, but eventually they passed it in 2016 and they created the Commission for Evidence-Based Policymaking Act, which basically said we are going to have this 15-member commission. They are going to do a study, a very in-depth dive on the evidence-building community across the federal government, and they are going to recommend to both the Hill and to the White House what the government should be doing to use our data more effectively for evidence-based policymaking and evidence-based decision-making.

The other big ask in that act was essentially should the government have a national data clearinghouse of some sort so that the public and researchers and academics can access data to do the kinds of analyses that maybe we don’t have the capacity to do in the federal government, or to replicate those analyses that we are doing. That was really the notion behind the Commission, and they had 15 months to actually come up with a report that they shared on September 7th with the White House and with the Hill.

They came up with 22 recommendations that focus on these four sort of buckets, if you will: modernizing privacy protections, improving access to federal government data, strengthening federal capacity to build evidence, and implementing a national secure data service.

The National Secure Data Service is the biggest new recommendation out of the report. This would not be a clearinghouse; it would be a data service that essentially, if you are a researcher, an academic, or if you are anyone from the public and you want to have access to what is generally secure data, you would apply to this service. You would get de-identified data to run your analysis in I think a secure data facility — I think that is as yet to be worked out. A lot of the details of the National Secure Data Service are as yet to be worked out.

You would essentially get that dataset, do what you want with it in a secure space, and then, when you were done analyzing your data, the data disappears. It is not actually archived so it would not be a clearinghouse. You could not go back and do the same kind of analysis again. These are mostly for privacy and security concerns.

I can tell you, just based on attending most of the meetings for the Commission, by far and away the biggest and most controversial issues were privacy and security of data when you have public access to data like that.

On September 7th, the report from the Commission was released. There were several public events. This was a very bipartisan effort. One of the things that Senator Murray’s office and Speaker Ryan basically said was we want to have legislation almost immediately out of the gate based on these recommendations. Their staffs were at the ready and the House came out with and passed a bill, the Foundations for Evidence-Based Policymaking Act of 2017. There are a few more slides after this that sort of compare the recommendations and some of the titles in the bill.

There are three actual titles in the bill. The first one is Federal Evidence-Building Activities, and that is where a lot of the capacity-building and infrastructure changes to evaluation and evidence communities would happen. That’s where the creation of the Chief Evaluation Officer is, the Chief Data Officer, so, really the capacity aspect in the federal government. The other two titles are focused on data. There’s the Open Government Data Act and the SEBC title that is really focused on privacy and security.

I should also note that I am a stand-in for my colleague, Rashida Dorsey, so, if you have really complicated data questions I will do my best to answer them, but if I can’t I will get back to you. And we have Maya here if you have any questions about SEBC who can help us with that.

The House passed this bill, and very shortly thereafter the Senate passed an almost identical bill with just a few changes, and the thing they left out of the first bill was the National Secure Data Services because that I think is the most complex recommendation out of the report and they need to think on that some more before they actually put it into legislation. There are a lot of details yet to be worked out.

You will see here at the bottom, the Bipartisan Policy Center has received funding actually from the Arnold Foundation to have a person whose sole purpose really is to work with the Hill to educate them and help them as they implement the Commission’s act, and he was the deputy for the Commission staff which was housed at the Census Bureau for the 15-month period that the Commission was active.

I forgot to let you know that — you guys had Sherry Glied here in September to speak with you. She is a former ASPE and she also was on the Commission, so you probably had a lot of information given to you from her.

This is just an overview of — Rebecca, I think you put these slides together, so thank you for letting me use these. If you are on the Subcommittee for Population Health, you have seen these slides. She has categorized these into a few things she felt were most relevant to the committee.

MS. HINES: Care of the Bipartisan Policy Center. I basically plagiarized their work.

PARTICIPANT: (comment off microphone)

MS. CASH: The Bipartisan Policy Center — The Arnold Foundation was really interested, and several other foundations. There are a lot of foundations that are really interested in increasing the use of administrative data for decision-making in the federal government, and the Arnold Foundation has a former lead for the evidence team at OMB, now is a vice president, and this has been one of her big ticket items for a very long time. She wanted this to remain in the bipartisan space, which is why she went to the Bipartisan Policy Center and said would you be willing to start an evidence movement, starting with the Commission’s recommendations. That is why they funded a person, whose name is Nick Hart, to actually go and do this and implement the recommendations.

The Commission members are all still very much in contact with Nick at the Bipartisan Policy Center. There is still very much community, which is great.

So we have an agency official for data policy. A lot of these things HHS already does. Several agencies within the federal government do not have all of the things you will see here, but we are actually ahead of the game in many instances, as we are with an agency official for data policy. We have a Chief Data Officer.

The codification of Statistical Policy Directive Number 1, that’s something I am not exactly familiar with so we can come back to that.

The risk assessment and analysis of data sensitivity we do in varying ways. These are recommendations that came out of the actual CEP that she has referenced here, and then the bill section numbers.

Improving secure access to data — Again, this is the major intent of the Commission and of the law, or the bill, which is to establish data inventories with metadata. This was a really big issue. A lot of people have come out and said — and they said this at the Commission meetings — we don’t even know what data is there. We don’t know who has what data; we don’t know what elements are in these data. SEPs, we don’t have access to them.

Again, HHS has mechanisms for putting data out to the public. Many of you have worked with a lot of our data. We have data.gov, we have so much public data. We are very data-rich.

Let me back up. OMB will provide a lot of guidance to the federal government based on this bill in terms of what would go into a data inventory, what is a data asset, how are we going to include data assets. So, once we get guidance from OMB, assuming that the bill becomes a law, we will know more about what will actually go into the data inventory and what will have to be included. Would every dataset have to have a data dictionary — questions like that have yet to be answered.

Availability of data for statistical activities — We do that quite a lot already.

Single process for researcher access to data — We do not have that. We have several access points for researchers to access data and it really depends on what kind of data you’re trying to access.

And then an Advisory Committee on Data for Evidence-Building. This is a committee that would be formed strictly to figure out what to do with the National Secure Data Services. I could see this committee potentially providing input into that committee if formed.

Enhancing government capacity — This is more in the first title of the bill. This would change a lot of how we do our daily business in terms of the evaluation community, and somewhat in the data community as well. There is a requirement that we would have to have annual evidence-building plans. These evidence-building plans would be for four years, but we would have to update them annually. That is a lot. That would have to roll up, if you will, into a government-wide evidence-building plan that OMB would be responsible for, according to the bill as it is written now.

This is actually not in the Senate version of the bill — the coordination of evaluation units through the Interagency Council for Evaluation Policy. Right now, the Interagency Council for Evaluation Policy is an informal body that is co-chaired by OMB and a rotating federal agency. The House version initially had the Interagency Council for Evaluation Policy in the bill and it was very much modeled on the Federal Committee on Statistical Policy, but it is not in the Senate version of the bill. So that was axed.

And then, establishment of Chief Evaluation Officers. This would be akin to the Chief Data Officer. And an Inventory of Evidence-Building Units. That I think in essence means an inventory of evaluations that we are conducting at an agency level, which would then, in theory, feed into the agency evidence-building plans.

And these last two I think are focused more on what would potentially be useful for you guys to look at, which is enhancing privacy protections for federal evidence-building and strengthening the evidence-building capacity within the federal government.

There is a lot in the bill that would change or add to how we do our business on a daily basis. In terms of you as a committee, I think what would be helpful is just for you to sort of stay abreast of what’s happening. We initially thought that the Senate would take up the bill pretty quickly after the House did, but I think that’s on a much slower track now. I don’t anticipate, based on what I am hearing, that anything will be passed at least in January and maybe not until March, if it is passed. I could be wrong. This is strictly speculation.

We are happy to share what we know when we know it with the committee, but I think what’s important for you is to know that this is happening and that it does have implications for data, how we use data, how public and what is made public from our data, and how we are coordinated as an agency in terms of data collection and evaluation. I think you guys are focused more on data so that’s why I’m focusing more on data, but I know more of the evaluation side.

With that, I will take any questions or comments.

DR. COHEN: Amanda, is there any pre-work that you could suggest we do until things coalesce a little more?

MS. CASH: Yes. If you enjoy doing pre-work, my suggestion to you is to go read the report language. That is public. It’s 84 pages, and it gives you a lot of the intent behind each one of the provisions and a lot of the background material that Speaker Ryan’s staff and Senator Murray’s staff used to actually come up with the bill. They cite where they used the Commission’s report, they cite where they used GAO reports, and there’s a really heavy focus on GAO’s reports because they are also a Legislative Branch agency, so it stands to reason.

There is a lot of really good background information in that report language.

DR. COHEN: Is OMB doing anything?

MS. CASH: They are. They are very well involved and speaking with both the committee staff and also the Bipartisan Policy Center in terms of communicating what we as an Executive Branch have communicated to them in terms of our both support of and issues with the bills.

DR. COHEN: Is there any of that background information that would be helpful for us?

MS. CASH: I am fairly certain that we cannot share any of that background information publicly, but if it does become available publicly then I think, as soon as we could share it with you, we would absolutely be able to share that with you. As dry as the 84-page report language is, it’s actually quite useful, and I think that will also really help you. There is a lot of reference to OMB materials in there as well.

PARTICIPANT: I hope you can answer, Amanda. Besides reading the 84-page report, and thank you for that, are there any particular sections that we are likely to be asked to assist on?

MS. CASH: That is a good question, and I think that probably, if you look at Title 2, that’s the title that is focused more on open data, and I can imagine that is where you might be asked to contribute. I have no idea if this will be asked of you or not, but I could maybe see a world where the committee, if formed, for the National Secure Data Service, they would maybe want to come to a committee like this and ask what your experience has been with HHS and HHS data.

MS. BERNSTEIN: I have a little suggestion about that. In my reading of the bill, there’s a section that requires agencies to maintain a catalog and an inventory of data sources. Agencies, as it turns out, are already required to do that under the Paperwork Reduction Act, but the extent to which they do comprehensively differs agency to agency. Sometimes they focus on the main assets that are the most popular or the most high value or however you want to measure that, and not every one of them, which it’s hard to know. I haven’t read the 84-page report yet.

One of the things it requires in addition to an inventory catalog of data assets is a bunch of metadata, and one of the things I am focusing on is privacy information. It wants to know how this can be shared, what the rules are and so forth. But there are like 12 or 15 items — who is responsible for the data and so forth.

It occurs to me that this group is very familiar with a lot of the data assets in the Department and are also familiar with what would be most useful to users of the data, because that’s what this section is supposed to do. It’s supposed to give metadata to individual users.

So, to the extent that you have constituencies that would be users of that metadata and that descriptive explanatory data, if you are prepared to give advice about what kind of those items, I think that would be helpful to us when, should the bill pass, we get to putting that together.

MS. CASH: Thanks, Maya. I think that is a great thing to say. One of the things you will see if you read the bill carefully, either the Senate or the House version, is that a data asset is extremely broad, extremely broad. That is somewhat concerning to us because we have a lot of data that we would not consider a data asset that the public would necessarily want to access or need to access. We have a lot of data that the public should access, for sure, but how that will be interpreted by multiple parties will mean a lot to us.

DR. MAYS: This is Vickie. I have not read the 84-page report but the question I have is can you talk about the sense of how they want to approach the data in the sense of going through secure data centers versus having data be more open and available? Do you have a sense of that issue?

MS. CASH: That is a complicated issue.

DR. MAYS: And very important.

MS. CASH: Yes, I agree with you. It is very important. I think a lot of what the Commission heard at least from people who have either tried successfully or unsuccessfully to link data, access secure data, use data at the federal government and, in particular, when trying to link data, is that it can be sometimes extraordinarily challenging to get through the administrative hurdles, at least internally for us, much less just get to the linkage part.

The administrative hurdles can be almost obstructive at times because it is really hard. Data use agreements, things of that nature, different interpretations of how the data can and should be used — there are a lot of administrative hurdles.

I think the National Secure Data Services is an attempt to overcome some of those hurdles because that way you sort of get out of the business of doing a data use agreement for every single linkage that you want to do every time you want to do a different kind of linkage. Even if you want to use, let’s say, claims data, let’s say you want to use Medicare data and you want to link Medicare data to four different datasets. You would have to, in theory, have four different data use agreements.

DR. MAYS: Right.

MS. CASH: The goal of the National Secure Data Service is to alleviate part of that so it’s more efficient for people who want to access data.

I am not sure, Vickie, if that answers your question exactly, but, as I said, the National Secure Data Service is not in this bill. It will be in a separate piece of legislation because there are so many details to be worked out about that. At least that is my understanding. I do not know that as fact; that’s my understanding.

DR. MAYS: The answer is in the ballpark. Here is what I am concerned about. We have data which we can pretty much freely use as an understood data use agreement and it is pretty simple. But if you start seeing every dataset as a potential linker and you determine that what you want to do is have that data be linked to something, then what was once simple becomes more complex for a data analytic approach that was going to be simple.

It just seems, from at least earlier what was talked about, particularly when you have economists at the table and they want some of the IRS data and other data, that some data is really simple and it shouldn’t be a problem. So I guess there need to be levels of concern about data and I am hoping that it doesn’t get to be too broad-brushed and that some of the things we did simply we won’t have to do more complexly in terms of trying to get to access the complex data.

MS. CASH: I agree with that. Because there are literally no details on the National Secure Data Service, on how that would work. That’s not a thing that is real right now. I have a very hard time answering your question.

DR. MAYS: Okay. Maybe it’s something that would be pre-work that we want to help them to think about. Maybe that’s where we’re going. Is there some way that we can make sure we give advice, based on our experience, that might help develop that pre-work?

MS. CASH: I think that is a good idea. I also think that, when and if a committee is formed for the National Secure Data Service, you would plug naturally into giving that committee these kinds of pieces of information, especially based on your experience as a committee, as a whole.

DR. MAYS: Yes, that is what I mean.

MS. LOVE: You probably said this and my brain is slow this afternoon. This would not replace the research center —

MS. CASH: The Virtual Research Data Centers or the FRDC.

MS. LOVE: Yes. But the other data flows like we just talked about like Medicare state research files, that wouldn’t affect those data flows would it? Everything would have to go through the research center, or just some things?

MS. CASH: That has yet to be determined.

MS. LOVE: That kind of scares me.

MS. CASH: Yes. I don’t think the goal is for everything to go through the National Secure Data Service. I think the goal of the National Secure Data Service is to make it easier to link data and to access data.

MS. LOVE: Similar to what maybe Census is doing with their massive link center.

MS. CASH: Yes. I think —

MS. LOVE: The current data flows through departments that people are used to getting like the state research files through RSDAC from Medicare.

MS. CASH: Right. It’s my understanding that nothing is going to change right now. I will tell you that. I don’t think the intent is to take away access to data.

MS. LOVE: The problem is we have tried some of the research centers through SEHS — you get four people that go there —

DR. STEAD: We are nearing the end of the time and I appreciate the update. From my perch as sort of a generalist, what I’m hearing — I did cheat and read the report and I did like it, and the pieces of it that were picked as foundational makes sense. It, in fact, creates a mechanism to deal with the next level of detail around what the Secure Data Center might look like.

What I’m really hearing you say is that the law has got to pass. OMB has got to figure out how to deal with it across agencies, since HHS is already doing some of this. And then HHS will, in essence, be responding to guidance it gets from OMB based on the law, because this is cutting across all sectors. Therefore, what we want to do in essence is stay alert, but largely wait until we see what — have another conversation with the right people from HHS as you are beginning to decide how to respond to whatever you get from OMB. That’s actually where it will be useful.

Am I hearing that correctly or am I misreading?

MS. CASH: I think you are hearing it correctly, and I think, based on what’s in the law, OMB has a lot of responsibility in terms of determining and interpreting some of the bigger issues in the law. I suspect that OMB will work closely with agencies, especially agencies that are big producers of data and generators of data such as HHS, Census and Treasury. I don’t think that we will be excluded from those conversation based on what I’m hearing, but I also don’t know exactly how that process will go.

But yes, I think in essence you are correct.

DR. STEAD: Because in essence it’s going to be a coordinated effort. That is one of the things that’s different about it. Okay. That helps.

MS. BERNSTEIN: I have one other thing. If the prediction is correct that should the legislation move not until later in the spring, I think all of you in your individual or outside professional capacities have the ability to look at the bill and the report, and all of you who don’t live in the District of Columbia have representation in Congress and you should talk to them about what is in this bill. We don’t know what opportunities there will be to change or affect the language in it, but, not as a committee but in your other capacity you might consider looking at it and figuring out whether there is something that’s of concern to you in your professional environment that could be helpful information for your members of Congress.

The bill is quite broad and sweeping and will, in fact, change the way we deal with data in many, many ways and, depending on how it’s implemented, could be quite burdensome to the Department. The intent is not for it to be burdensome to data users, obviously.

MS. CASH: That’s right. The intent really is to ensure that more people have more access to data for decision-making purposes.

DR. STEAD: Thank you very much.

So, who is going to carry the baton as we move into Next Generation Vitals?

Agenda Item: Next Gen Vitals 2017: Discussion and Full Committee Approval

DR. COHEN: The next 75 minutes we are going to be talking about vitals, where we are and where we’re going, and to begin the discussion to provide a level set in context, Dave will start us off.

DR. ROSS: I think we are going to talk about the vitals hearing and the report that Gib developed, but it occurred to me that maybe it’s worth just making a comment of historical context here.

You may not realize it, but it wasn’t until 1933 that Texas became the last state to contribute data on birth and death to the federal government, so we have been less than 100 years in this country of having states agree to share at least the data they have on births and deaths, such as it was or has been. So, full reporting was a big thing to get to, just agreeing to send in what you’ve got.

Over the last 70, 80 years, NCHS has worked very incrementally to enable a national picture. There has been this, what I would refer to as, tortuous effort at times that the federal government has had to go through to get the states to contribute data, taking it any which way they could. Over time, that has evolved to agreements on standard birth and death certificates, and that has molded over time. But this has been a slow-moving and not fully accurate data process, but it seemed as good as it could be for a long time.

I think our hearing held in September was an acknowledgement that times have changed, that the public and policymakers expect accurate, timely data, and we have a national vital records operation that is built around a very antiquated paper-based world. It has been gradually automated in ways and there are electronic birth and death systems in many places, but we don’t have a national capability. But yet, the absence of that national picture in a timely way has its problems, so this hearing was held.

As the slide says, these data really play a very essential role. Of course, they play the key role in establishing the fact of birth or death. These data are national security assets. They are critical to all public health. The most fundamental denominator data we have for understanding health dynamics is vital records data. They are critical to understanding trends in population health and healthcare, and they are used in a number of commercial uses. What we have today is a fragile system and it’s at risk if we don’t do something to change it, and that is what this hearing was about.

There are some opportunities, we concluded, that certainly reduce redundancy. Redundancy means unnecessary added cost and errors, so that can be fixed. Timely reporting will save money. We are trying to get our arms around how much money it could save, but it probably could save a lot of money for the Social Security Administration to not pay benefits to dead people — one immediate savings for just that one agency. We have a number of data gaps that could be closed, and there’s the opportunity for more appropriate use of these data, broader use, and, of course, the establishment of identity.

The workgroup came up with a statement of vision: a sustainable, secure and robust vital records infrastructure that meets the nation’s needs for timely and accurate information. In other words, it’s time to move into the information age.

We posited this guiding question: How do we transform today’s vulnerable vital records data collection network into a network of state systems that produce accurate and timely information supporting the full breadth of local, state and federal data needs? We just have to always remind ourselves this is a federated public health system. It is owned by the states. So, putting together a national picture is a great act of diplomacy, a constant act. NCHS lives this on a day-to-day basis, right? I think marvelous work has gone on over the years, but we have an opportunity.

Bruce, let me turn it over to you.

DR. COHEN: Great. For the next 70 minutes or so, we will be building on essentially what we have done since the hearing. The hearing was just a fantastic exchange of information from a broad cross-section of stakeholders in the vitals community who presented information, clarified points, raised more questions and suggested ideas moving forward.

Since that hearing, I will be reporting on and discussing three things that we have been pursuing. First, we commissioned a report that was sent to everyone on the National Committee around the uses, users and systems that Gib Parrish did. Gib, are you on the phone?

DR. PARRISH: Yes. Can you hear me?

DR. COHEN: Yes. Great. I’ll be calling on you in a little bit to add some feedback after I briefly summarize the contents of your report.

MS. HINES: While you are doing that, Bruce, I just want to remind everybody that it’s in your email from December 21st from Rebecca Hines, if you want to pull up the report. Hopefully you read it and are informed and it is available for you to look at electronically.

DR. COHEN: One of the goals for this conversation is to get consensus and agreement about this report so that we can post it on our website so it will be available to the public for their use moving forward after today’s meeting. If there are any questions at any point in time, please feel free to interrupt me.

The second activity we will do today is just have a brief update. Kate will give us a brief update on where the hearing report is at and what the timetable is for finalizing that report. The largest chunk of time that we would like to spend today on is discussing alternative approaches about how we as a national committee, with the focus on the Population Health Subcommittee, should move forward.

You got several handouts throughout the day about those activities. One is called Vitals Alternative Options with Rows A through F that we will be discussing and, also, a couple other handouts that focus on sort of a mini scoping document for Row A labeled An Alternative Approach for Vital Records System V0.1, with the certificates of birth and death attached. We will get to those in a little bit.

Let me talk a little bit about Gib’s report. What became clear throughout the hearing was the complexity of the uses of vitals data and the lack of clarity about who pays for what, so our first action item was to commission Gib to do this report to summarize the breadth of uses and the information flow and the data sources for vital statistics, and to create this background document that would be a foundation for mutual understanding of the current status of the system.

We also asked him to begin to investigate where the resources came from to fund vitals at the jurisdictional level. I will use the words jurisdictional and state interchangeably. There are actually 57 jurisdictions — the 50 states, New York, Washington and the five territories which are dependent vital registration jurisdictions.

The report is an incredible accomplishment. It’s a rich compendium of tables and graphs and information that summarizes the use and users and the funding sources, particularly Tables 1 through 4, and I will highlight some of that information. There is a summary of the data systems with descriptions and contents and who is custodian of these data systems and who are the users in Gib’s report. That is Table 5.

Perhaps the most challenging table is Table 6 where Gib tries to lay out a scenario describing the revenue streams. There are two incredible graphics that sort of summarize the flow of information around the Birth Registration System and the Death Registration System, just really wonderful summary overviews. And not to be neglected are the incredibly valuable appendices to this report that detail the user organizations, and Appendix C is the most comprehensive summary I have seen about the detailed descriptions of the data systems themselves.

As I have been here in the National Committee, one of the real wonderful movements forward has been the creation of these reports. We heard this morning of an incredible foundational work that totally supplements the work that we as the committee do. The measurement framework Gib did also did an environmental scan. This is another example of a great resource that is not only available to us in our deliberations but provides a much broader community access to information to understand really seminal public health and healthcare delivery issues, so this is another incredible example building on the tradition here at the National Committee.

I will just briefly highlight some of these tables. This is a table that looks at examples of uses and users of identified birth records. We use these for a variety of things. Certainly, there’s the Enumeration at Birth program where SSA — when I was a kid, my mom and dad had to go to a social security office to get me a social security card. That no longer happens. It all happens relatively seamlessly through the Enumeration at Birth process using birth certifications. I am sure we have all used our birth certificates to get driver’s licenses, passports and other important documents.

Here is just a list of examples of identifiable records that are used. Not to be overlooked are the registries that use the birth and death information — birth defect registry, immunization registries. This is an example that can be linked to some of the work that we discussed earlier today.

One registry that I actually use to link identifiable birth data with is the Assisted Reproductive Technology Clinics which collect information way before births actually occur. As part of an ongoing research project we have linked in several states’ actual birth outcomes to assisted reproductive technology clinic data. It’s a fascinating program.

Here are some examples of uses and users of death data. Certainly, infant mortality not only is a death indicator but is a seminal event that talks a lot about the quality of life in our communities in population health.

Here are examples of programmatic and research uses, and certainly the importance that we were just discussing of the potential for benefit-paying organizations, government agencies, as well as others, to use these death records.

This table looks at uses and users of de-identified data, primarily for health policy research, generating statistics to help drive community initiatives as well as local decisions made as well as federal policy.

This is a table that looks at de-identified mortality data. Certainly, close to Vickie’s heart is the National Violent Death Reporting System which is an emerging powerful user of mortality data, as well as the focus on understanding opioid deaths and emerging epidemics.

I won’t go through these overviews of the system, but these two charts that Gib developed are just wonderful, powerful, comprehensive approaches to really appreciating some of the complexities of the flow of information in the Birth Registry System and the Death Registry System.

I wanted to end my quick overview before I turn to Gib by reading some of the conclusions that Gib drew on page 23, and I will quote here. “In spite of their importance, relatively little is known about the actual functioning, funding and long-term stability and viability of vital records offices and vital statistics programs, both individually and as a whole, that collect, manage, archive and make available vital records and statistics and constitute the National Vital Records and Statistics System. Many public and private users appear to benefit from vital records and statistics, but relatively few of them appear to directly fund the Vital Records and Statistics System.”

And Gib goes on to recommend that to better understand the system and to aid in undertaking future improvements, he recommends a systematic effort to obtain additional information. And when we get to the part of the discussion that focuses on where do we go from here perhaps Gib can talk a little more about those recommendations.

Before I entertain any questions, Gib, do you want to add anything to that overview?

DR. PARRISH: I think you did actually, an excellent job of giving an overview of the report. You went through some of the tables and figures and gave I think a good sense of really the variety and extensive uses of vital records and, also, my conclusions that talk about some of the potential problems with the system at the present time and some additional information we need to try to better understand the system and to try to make a plan for improving it in the future.

Thank you very much for your remarks, and I am here to respond to any questions or comments that people might have.

DR. COHEN: Do people have any comments or questions or suggestions about the report that was circulated amongst us all?

DR. MAYS: I wanted to ask about something that I think may be a gap and whether we need to deal with it, and that is the issue of vital statistics in our territories. We made sure we talked about these issues relative to Canada and other places, but if you look at things that have been happening in terms of the disasters, the resources and control over the vital statistics in some of the territories, it’s really just problematic.

I’m just asking should we not think about that as either something to address separately or something that we should also put in this report.

DR. COHEN: I think that’s a really good point. I am going to put that on the list of things we can discuss later as a potential avenue for future work. I don’t think we need to include it in this particular report, but I think it’s a point that is worth thinking more about and finding some more information as a possible avenue for us to pursue.

DR. MAYS: My concern is if we try and do this federated system, that they not get left out. If we let this go, and that is part of what we recommend, then I think we need to think about at least mentioning it and saying we are going to do something further. Then, if people want to act on the things that we have talked about, this is not even going to be in their consciousness to think about.

DR. COHEN: Okay, thanks. I would like for us to be able to reach consensus about the content of this current report subject to minor editorial changes, which we always need to pursue to finalize something before it gets put on the Web, and particularly making some of these charts accessible will be a challenge before this gets posted as well.

Do I hear a motion? Do you have a comment, Dave?

DR. ROSS: First, I want to thank our colleague, Dr. Parrish, for putting this together. I think at the hearing it was clear that we felt there was a need for better clarity and documentation of the issues and how the system works, and this report really lays that out.

Just like I said this morning about Bob Delman’s report, this is another one that every MPH student ought to read. This is really fundamental. It ought to be part of what everybody learns. Even old people like me, who have been around this for a while, learned a lot, so I thank Gib for having put this together. I think it’s another wonderful statement for the National Committee to have helped sponsor the creation of documents like this. This is just fundamental, it’s a great resource, it’s a great reference, and I’m glad we did it.

MS. HINES: I will send it out to the president of ASPH.

MS. KLOSS: I couldn’t agree more, and I am still in shock at all I learned at that hearing, and this is just a terrific recap.

The report ends with conclusions, and one is reading along and just really wanting to dive in and make recommendations, but that is not the purpose of it. But there isn’t any sort of mention here about what’s next. I just wondered if a sentence or two could be added that this is part of an ongoing project by NCVHS.

MS. GOSS: But isn’t this like an extra thing that came about in addition — so you’re thinking about how to link this back to the large summary.

MS. KLOSS: As I look at page 3, the purpose of this report is to present the uses and users, the sources of revenue for vital records and vital statistics. It is part of a larger — when it stands alone, one wonders — wow, I want to jump right in and offer some recommendations. And I just want to make it clear how this links to the broader body of work, because if this gets posted first they just won’t understand what else is contemplated, necessarily. Unless I have just missed something.

MS. GOSS: I agree with you, Linda, in that I struggled a little bit in understanding where this was in context to the wonderful meeting that we attended and the recap, and you really have to go back up two paragraphs to actually understand that it’s being prepared. So I think you make a really good point to put this in a context because it does look like it will —

MS. KLOSS: Because it’s coming out first, that’s why.

MS. GOSS: Absolutely. I agree with you.

MS. KLOSS: It organizes all of the discussion —

DR. COHEN: Yes. So more contextual information about why this report — I don’t have it in front of me.

MS. KLOSS: More as input to additional work that the committee will be doing.

DR. COHEN: I don’t know whether there is any of that contextual information in the Introduction or not, but I think in the Introduction to introduce it and then at the end to say how it fits into the journey is an excellent idea.

Do you have that down, Dr. Parrish?

DR. PARRISH: I hear that. The best context that there is currently is on page 3 and it’s just a brief sentence, but I understand what you’re saying and we will try to provide some more in terms of the context.

MS. HINES: Gib, I think we will do it on this end, and I think we’re going to put it actually on page 3, because when someone starts reading the report they are going to want to understand how does this fit in and not make them find page 23.

Gib, I think what we’ll do is we will work with you, but I think we’ll propose some broad language that addresses — from someone who is not breathing this. We appreciate you bringing fresh eyes and making sure it’s clear how this fits into the committee’s work.

DR. MAYS: Can I ask another question? Is it possible, if we decide what we want to do next, that we can actually say what the next steps are that we are going to take, so that once we get people to read the report they will continue to come back looking for additional material.

MS. HINES: Vicky, we are going to get into what the next step is now, and we can just talk generally and broadly, and we can put that in this introduction of what the committee is doing as of winter 2018.

MS. KLOSS: I think just another sentence saying this report will be used as input for the further development of — just kind of like what Bob did in the preamble. I think the words are there in this morning’s report that can be adapted.

MS. GOSS: True to fashion of the role I play in NCVHS, I would like in the beginning in the background and purpose that we just add the word standards. We have health data, statistics, privacy and national health information policy. I think we also do a lot around standards, and I wasn’t sure if that was just an assumption in regards to how data —

MS. HINES: We actually have standard language but because Gib wrote this we forgot to send it to him, so we will just make sure we use it. Good catch. We need to use our standard language. I just didn’t clue into that because Gib actually was kind enough to write the Intro for us.

DR. COHEN: Great. I have heard a couple of little editorial things, additional language to explain the context and inclusion of the standard language around the committee.

DR. CORNELIUS: I make a motion that we accept the report with some minor corrections that we just discussed, and finalize the report and post it.

DR. ROSS: Second.

DR. STEAD: Any discussion? All in favor?

(Chorus of Ayes}

DR. STEAD: Opposed? Abstained? Congratulations.

DR. COHEN: Thanks, Gib. It will be a wonderful resource. As soon as it’s done I want to make sure to have a lot of folks in the vitals community — make them aware so they can have access to it and use it as well.

DR. ROSS: To that point, when are we officially able to share this with other people and use it publicly?

MS. HINES: I would say once we make those edits.

DR. ROSS: Then it will go up on the site?

MS. HINES: Yes. We do have to make it 50A compliant. And we are working on a new logo and I would love for everything in 2018 to have the new logo, but that should be done within a week. So, maybe a week.

DR. ROSS: Great. I want to host a seminar at our place that brings together some university faculty and CDC people along with our own staff and use this. Our staff really liked the idea of using this as a broad educational opportunity for people and I want to try that out.

DR. STEAD: Gib, thank you very much.

DR. COHEN: Kate?

MS. BRETT: The next section of this presentation is about the summary report. What Gib did was kind of answer the questions that came up, but the part of the hearing which was very — I have been looking at the transcript actually these last couple of weeks and I am just amazed. Every time I read them I get something more out of just how much information was shared in those two days.

This is just a quick rehash of the vision, guiding question and objectives that we posted multiple times about the hearing, and I think we did a pretty good job of answering most of the questions although it raised as many questions as it answered.

Here is the structure of the summary report. I will say it’s still being drafted. We had hoped that we would have a version to share with you all and it just was not meant to be. The structure of it will be typical of any summary of a report on a hearing with, first, the Introduction, some key concepts because they were confusing — we still stumble on the issue of vital records versus vital statistics and what do those words actually mean. And what the DMF — People in the community know that really well but the rest of us struggle with those kinds of acronyms.

A description of who was there. I put a lot of effort into making sure it was geographically diverse in many, many ways. And then the findings, both the data uses that were given out, the complexity of just how hard it is to collect the data, and all the different participants and the people who work on that effort — everyone from the those hospital people who have to talk in both Spanish and English to the mothers of the babies that are being born to the funeral home owners. So, all of that rich detail that, when we looked at the most recent version, we realized it summarizes what we found but not necessarily all the details, so that is our next step.

And then talk about the major challenges that we heard from the people out there. What are those challenges from the federal side, from the state side, from the data users’ side and from the data collectors’ side, all of the various challenges.

And then, hopefully, summarize everything into cross-cutting themes and findings. Now, that’s going to be challenging but that is the goal, and that’s why it’s taking a little bit of time because there are so many different ways to categorize the information we heard, and to make it in the way that is most useful for our next steps is what we will work toward.

What you do not see is next steps that NCVHS is going to do because we have made, in the Pop Health Subcommittee, a clear decision that that would not be in the summary, that the summary will simply be a summary of what was heard. We’ll talk about where this plays into our strategy, but the thoughts about what we are going to do next are not going to be in there.

Here’s the summary of where we think we are going to go. We have seen a draft. In December we decided we needed more details. The subcommittee staff; i.e., me, is working on the hearing transcripts. I am going to be sending it out soon so that we can add that detail to the report. We are hoping to have a next draft by mid-January, although I haven’t really told Susan that and I hope we can do that so quickly. It all depends on our communication.

But we are hoping that by February we will have a pen ultimate draft completed. We need to send both to everyone in the committee as well as to all of our hearing testifiers. We feel strongly that they need to see their words on paper and make sure that what we heard is well documented. But we are also only going to give them 10 days to review and send feedback because we really want this to go up on the Web by early March is our goal.

I think that is all my slides.

DR. COHEN: I really need to thank Kate for the phenomenal amount of work she did helping organize these two days, reaching out to all these different folks and agencies and organizations and tirelessly following up to get participation.

I also need to acknowledge Susan in the back who has been our fearless and tireless writer in trying to pull together so much information that we heard from such a variety of different folks to come up with a cogent set of themes. It was not easy and she has done a wonderful job of creating that structure that we’re going to work on to fill out. Thank you both so much.

Any comments on this? Good. We can move on to the fun. I know it’s late in the afternoon and this is like a mid-morning right after coffee exercise. Put your minds back to the beginning of the day when everybody was bright and bushy-tailed because we have some generative thinking that I would like to explore.

Agenda Item: Next Generation Vitals for 2018

DR. COHEN: What we would like to do for the next half hour is really talk about where we go from here. I guess we have really three goals. One is to review this table of ideas that have emerged and get feedback from us all about what we think possible priorities should be moving forward. Secondly, if any of you have any suggestions or new ideas — I heard one from Vickie now to think about exploring what’s going on in the territories and make sure they are not left out of any future work in terms of support for their vital statistics enterprises.

And the third is, if you have strong feelings about which of these priorities we should pursue or if you have strong feelings about me over-promising given our bandwidth of what we can actually do, I would love to get that feedback. I am going to briefly summarize this table and then call on specific folks who suggested some of these ideas to provide us more detail.

Idea A came from Bill. Bill has this really wonderful idea to preserve the federated system but make the data flows more specific rather than general as a way to improve the efficiency and direct outputs to where they need to be.

The second idea is something that we heard actually from several different perspectives, which is developing a system for rapidly reporting deaths. Researchers at NIH were quite adamant about wanting to know how their clinical trials would be improved by knowing this information rapidly, and we heard from commercial enterprises how the social security Death Master File no longer serves this function, and how much money could be saved if, in point of fact, we could rapidly identify deaths as they occur.

The third idea is how to create standards for jurisdictions because, again, there are 57 different jurisdictions with their own sets of rules and regulations for sharing information. What can we do to promote a more consistent transactional process across jurisdictions?

We heard from coroners and medical examiners — again, this was a great learning experience — that there is no standard, accepted database or way to transmit their information into their state vital systems, which then need to be sent to NCHS before we can generate national data. What could the National Committee do to help promote that?

The next idea was the one that I was describing that Gib recommended in the report he wrote about getting more information so that we really understand in more depth what the costs are for running vital records offices, who actually pays, how to reduce the redundant transmission of information — just collect much more information that can then really be a much more solid basis for making future recommendations based on a much more thorough understanding of how this information flows and how it’s funded.

Kate suggested after reviewing the report more thoroughly the issue of better leveraging of technology to improve the vitals system.

And the one we just heard from Vickie is better understanding and promoting of vitals enterprises in the territories. I know there has been some work. NAPHSIS and NCHS have developed very basic transmission systems, but some of the territories are having problems implementing in any kind of coherent way, processing and transmitting vitals.

With that overview, I am going to go back to some of the folks who proposed these ideas so that they can share their thoughts in a little more detail. Bill, do you want to describe this first idea?

DR. STEAD: Yes, thank you. First, all of you have a two-page document that we passed out that includes the key ideas that Bruce has summarized on the table and then a graphic, and I will try to walk you through both of them.

You have also got two things that I at least found extraordinarily helpful in realizing the magnitude of the challenge, which are the 2003 Standard Certificate of Birth and of Death, which I will use to actually walk through and suggest what might end up in different buckets if we wanted to do this.

DR. COHEN: This is the most recent standard.

DR. STEAD: These are the 2003 standard, which I believe, based on Gib’s report, has been adopted by a subset of the states. We are 15 years out, and for reasons that Dave hinted toward, it is where we are.

The fundamental thought here — and I think if you will look at it you can see how we got here. These forms are very complicated. They contain information that anybody trying to think about vital statistics would like to have. It’s easy for me to understand how the information got here.

The challenge is I can’t think of any one person in the chain of custody that would have a chance of answering them correctly, particularly when I discovered things like some of these things are being filled out by coroners who are simply elected. They have no training. None.

So we talk about using this to understand the opioid crisis, and I do not know what the percent of correct reporting of deaths occurring by opiate is, but my guess is it’s in — Finally, in my summary — I did this over Christmas and I tried to dial down — I said arrow, arrow, arrow, less than 50 percent. I started out saying less than 10 percent, but I decided that might be extreme.

The simple idea here is let’s decouple the information that we need to capture, the fact of a birth or the fact of a death, which might actually be simple enough that we could collect it correctly. On my little chart I gave you some of the examples.

If you look at the birth certificate, the first 19 fields are pretty essential to the fact of birth. Whether mother’s education is necessary for the fact of birth — It’s hard in many cases to know who the father is, much less what their education is, so that was the first thing I began to drop out. The rest of the first page actually looks to me to be pretty close to fact of birth. But look at the back side of it.

This is, in essence, an epidemiological survey. I think a very interesting thing that might actually fit into Gib’s piece is what is the percent of any one of these fields that is currently captured accurately. I think it is going to be much greater on the birth, which is largely picked up in the hospital, largely picked up while at least the mother is present, than it’s going to be on death, which is in a very different situation.

So, Idea 1 is to separate the two. Identify the minimum pieces and only request them if the person that is going to be filling out this thing has a significant chance, greater than 80 percent, of getting it right. Otherwise, we may want it but there is no point in including it. It’s just noise.

The other thought which really comes out more clearly on the diagram — I took the wonderful way that Gib depicted the current flow of information on the back diagram and, just for birth — I didn’t draw this for birth and death — I basically suggested what would happen if we had the fact of birth, which you will recall from the hearing and in Gib’s report is most of the time captured in the hospital, so it’s actually probably captured pretty clearly.

But suppose we were to report it as, in fact, the vital record into the vital records office. It would work with the local registrar as it now does. If you think about what you actually see on the birth certificate, it would have everything you actually see when you go purchase your birth certificate. That part of the process could stay intact and maintain the federated system, but it would dual report. It would go — At the same time it went into the state and jurisdictional system it would also go to some point in the national system, probably something in CDC.

We would then take the other information we wanted to capture, and we would in essence identify the granular subsets of information that could become available at different points over the life course, some of them at birth, some of them at death, and report them in buckets where they are actually being captured currently because we are building up a database over time, and let them flow through a public health surveillance system.

I am drawing that distinction to live within the bounds of HIPAA, which we discussed again this morning, because if we do the public health surveillance to a designated public health agency, then that is a mandated disclosure under HIPAA, so we can do that under current law and regulation. We can then link those pieces together as appropriate — much of the conversation we have heard today around the Evidence-Based Policy Act would provide one mechanism at which some of that linkage could be done; there can be other mechanisms — simply on the basis of public health surveillance.

So, the simple idea is to truly strengthen the federated system by limiting what it has to handle and to strengthen the public health surveillance system by letting it get, in essence, sequential case reports over time. So that is one alternative.

MR. COUSSOULE: The question becomes if, in fact, this simplification is made, who loses, and are they really losing valuable information if the information is not good in the first place?

DR. ROSS: Nick is asking a really important question, and I think the answer is we are not quite sure, and it may not be — I read what Bill is suggesting, which I happen to find very attractive because we know we need — and I think the hearing said it loud and clear — we need to get notification of birth and death in a much more timely way. The way we do it today carries with it an oxcart full of other data that takes time to fill up and, therefore, creates slowness and makes it cumbersome.

So your question is, is that oxcart full of other stuff, and will it continue to get gathered. I think we need to look into this. When I saw your recommendation, Bill, my question was — it hits, as an engineer, my spirit exactly right. It is time to pull this stuff apart, but we had better study this a little bit and make sure we actually understand because all the barnacles grew onto this boat for a good reason, and now we need to take a look at that.

I do think we have to answer your question, but my guess is that some of this is — all the risk factor data and stuff like that — is understandable, needs to be gathered, but it doesn’t necessarily need to be gathered in lockstep with the final declaration of the documents the way they are now put together. This is the information age, so basically, we should pull this apart and look at who needs which pieces of data when. And notification of birth and death in a really timely way is a game-changer.

I don’t know if the committee is at a point to make, say, a firm recommendation, but at least we could say could we do a next analysis that would allow us to tee up that recommendation.

DR. COHEN: And building on that, I think that is exactly the question we need to ask: how could we improve that piece of information.

I can answer some of the questions that you asked, Bill. First of all, most of the information that comes from the mother exists probably before the birth because the parent worksheet now goes out in the mail or electronically before babies are born. Secondly, the information that is supplied from the medical record is added to the birth certificate within the first 24 hours after delivery. So, a lot of the data exist in a timely fashion, and a lot of it is high quality because it comes from the appropriate sources. But there is this intractable transmission delay that is related to not the actual collection of the data but a lot of what I would call externalities that need to be addressed.

Death data are a lot more problematic, particularly on witnessed deaths and external causes. Actually, one of the issues around opioid deaths is the epidemic was hidden because there were so many cases pending toxicology that the number of opioid deaths was vastly underestimated. So the problem wasn’t that the deaths that were labeled opioid were incorrect; the problem was not getting the system to evaluate all of the causes of death that might have been substance abuse-related. The cause of death information has always been — you know, how accurate is the cause of death information, and that is a whole other issue.

But I think the fundamental question of how do we speed up the transmission of the basic facts of birth and death to get them to the people who need them rapidly is something that is certainly worth pursuing.

DR. LANDEN: In looking at these in the information age starting with the Certificate of Live Birth, all the information that Bill is talking about that can be done at or prior to the start of the birth would be part of the electronic medical record. And in this day and age we have 90 percent of hospitals and, depending on specialty, somewhere between 70 and upper 80 percent EMR adoption by physicians, and under current public policy and ONC guidance — we are working on interoperability — all the information that’s available up to the time of birth lends itself to an application, and the application can do the reporting very quickly.

The other components here, things that come after study or after lab tests or an interview with one or both parents that may or may not have taken place before birth, can be added later. So I don’t see any conceptual problem to Bill’s proposal about the fact of the birth being reported almost real time.

It’s a different discussion around Certificate of Death because we’re talking about all sorts of stuff that does not happen predominantly in hospitals, and we’re talking about coroners and others that don’t have EMRs that lend themselves to apps. We may need to think about different processes for birth and death, and I notice you don’t have fetal death in here, which would go more along the line I think with the live birth in hospital phase report. But there are a number of things that could be automated and done right away and other things later on.

The bottom line is I think it’s a viable notion and a good posit.

MS. GOSS: I’m back on the barnacles on the boat for a variety of good reasons beyond just my sailing interest. It has been a herculean effort to get the data flowing, even with today’s recognition of some of the quality and timeliness issues. It seems to me we have this great new infrastructure in the United States of capturing the electronic medical record — I am going to focus just on the birth aspect because I think there’s a whole bunch of complexity and social dynamics that go into the quality of the death reporting and attributes of causes.

It seems to me that we do have a great federated infrastructure. We have a new breadth into trusted exchange of information from system to system, and to get the birth data flowing quickly should be pretty easy. To get the needs of the epi world seems to me to almost be better suited to a federated kind of architecture or harnessing what we have today because there’s a reason all that stuff is being captured, as was said before.

And I am really worried, back to Nick’s point, about what’s going to get lost in all of this and how it’s being leveraged. As we look to the idea of maybe having a further report or analysis done, it may be that we have to look specifically at that aspect of what’s going to fall to the floor and what are going to be the unintended consequences of suddenly trying to pivot, but then to try to tie it into the visioning of what is that next — what do we look like in 5, 10, 15 years. And maybe we start to solve some of the funding aspect by the ability to do federated queries, which at least in the Pennsylvania environment was envisioned as being something we wanted to support downstream just for public health objectives.

DR. COHEN: So, good news/bad news situation here. We have six more minutes to go through seven more ideas. Clearly, we are not going to be able to get through that, but everybody is so engaged in this specific idea I am going to suggest that we just continue this discussion around this idea and we’ll figure out how to get feedback on the other ideas later. Is that okay?

DR. STEAD: I would err on the side of talking about the other ideas because this was meant to be one of many alternatives to spur discussion. It was not intended as something we would get to where we want to approve.

You can continue to mine pieces, but I think the landscape of alternatives is important because we may discover that some of them work together.

DR. COHEN: Certainly, B works with A because that’s developing a system for rapid reporting of individual deaths for a variety of reasons, and that is consistent with one of the things we wanted to do here.

Gib, do you want to talk about your idea, which is getting more information?

DR. PARRISH: Sure. I’ll just briefly remark on that. In trying to compile the information that I was putting together for my report it was difficult to get information particularly related to the financing of this whole system. One of the things we heard at the hearing last September was a concern that it has just been inadequately funded.

So it seemed to me that it would be very helpful to better understand the whole system, both its potential as well as its limitations, if some additional information could be gathered. I think it probably wouldn’t be too difficult to gather most of this information. An organization like NAPHSIS, the National Association of Public Health Statistics and Information Systems, that essentially represents the state and territorial vital records offices I think could conduct a survey that would be able to gather probably 90 percent of the kind of information that I suggested. Then that would help us to better understand both the flows of money through the system and, also, it would help to understand some aspects of the flow of data through the system as well. That is the reason for both of my suggestions.

DR. COHEN: Great. It’s nice to have a suggestion and a potential mechanism to follow through. Dave?

DR. ROSS: Bill essentially said this, but I think most of these ideas tie back also to the financial consequences. It’s going to take money to bring about change. What we heard at the hearing is that we really don’t understand exactly what the current costs are and the full understanding of revenues, and we certainly started to enumerate all the different people who benefit but don’t pay. I think the conclusion generally was we need a new financial model for this whole enterprise but we don’t know what that is.

So I would argue one of the things that this committee should stand behind is trying to get some further knowledge, as Gib said, about these costs and revenues, who pays and who benefits, and quantify them in a way that we can start to think about proposals of different business models. Short of those different business models, even an idea like Bill’s won’t fly because you’re touching an existing enterprise that is going to be threatening to a lot of people if we don’t understand how to make it better and what that will cost.

MS. KLOSS: My question is more relating to what the subcommittee sees as the process for developing recommendations and at what level would recommendations be in the report. Will the report be a report of the meeting but not make recommendations? And then there’s a third phase where some options are developed or there’s a vision for the new world developed with a variety of recommendations.

I’m trying to understand how these eight fit into where we go next.

DR. COHEN: My vision is these might be generally mentioned in the report but certainly no specific recommendations. This discussion I think is to figure out what we are doing next in terms of work, what makes sense, is there any low-hanging fruit, are there suggestions about what should be priorities, who we need to get in touch with and how we move forward.

MS. KLOSS: It just seemed like there were just a myriad of recommendations that were possible from the hearing.

DR. COHEN: Yes. Rich?

DR. LANDEN: Two more thoughts. First, on the death side, there’s a lot more money that rides on time of death, whether it’s turning off payments like social security that theoretically terminate at time of death or simplifying and turning on payments that start at the time of death — for instance, life insurance. So, funding on the death side of the equation may have more opportunity, shall we say, that on the birth side.

Second, for both birth and death, one of the things that is not mentioned in here and I’m not sure whether it’s appropriate or not is what about error correction. Somebody gets declared dead in the system; how do we make them undead if they really didn’t die? Where would that responsibility lie in the system we were thinking about building?

DR. COHEN: That actually very rarely happens, but one thing the jurisdictions and NCHS have been really good at is putting in quality control mechanisms for the data that are generated. They are really incredibly strict and it checks for the contents of a lot of the data.

I am hearing essentially two major themes. One has to do with the process of rapid transmission and transaction of information and what the impediments and challenges are to change the system so that information, at least basic information, flows more rapidly to the people who need it. That is one bucket of ideas to pursue.

The other bucket is how are we going to change the business model or finance this or understand who pays or make suggestions about how to make the system more sustainable from a revenue point of view.

So I’m hearing those two general themes as avenues that we want to I think drill down on more to come up with ideas in those two buckets. Is that a fair summary? I am trying to figure out where we move next as the Population Health Subcommittee. I don’t know that we are going to reach any finality today, but if we come up with suggestions in those two buckets, I think all of the proposals here would fit into one of those.

MS. HINES: Bruce, I would just like to point out — and I showed this to Linda — that I think our work plan is on track given the conversation today. What we discussed is refining these approaches and getting feedback from the stakeholders, meaning the people who attended the hearing plus those that didn’t, that we know of, along with finalizing the hearing report. I think that is really our work for the next few months.

And then work up to a hearing where we would, as we have done with other Pop Health things and that Standards did this August, actually put it all out on the table and say is this it, thumbs up, or did we miss the mark and that kind of thing. Then we can really pull together some short-term and perhaps longer-term recommendations and activities we think are in order and put it in a letter to the Secretary if that’s appropriate.

DR. COHEN: Great, really helpful. As you think through these, if you have any — and I apologize for not being able to take all the comments — please email me so we can make sure your ideas are included. Thanks.

DR. STEAD: Thank you, Bruce. Now Bob will bring us home.

MS. HINES: Vicky Booth, are you able to join us?

MS. BOOTH: Hi, Rebecca, this is Vicky.

Agenda Item: HHS Data Access: Approach to Fact-Finding

DR. PHILLIPS: Vicky, your timing is perfect because I was going to thank you and Rebecca Hines for helping me organize this initial framing of the data access planning phase presentation, so thank you for joining.

We are very early in this process, and the idea here is stimulated by feedback we have gotten from friends of NCVHS and others suggesting that the data they have had access to are now gone, disrupting businesses and disrupting other efforts.

I want to take a walk through just some of the data access elements. Not all, but some of them have disappeared over the last couple of years. I’m going to talk specifically about the Community Health Status Indicators, the Health Indicators Warehouse, the Behavioral Risk Factor Surveillance System which is not gone but certain elements are less easy to access, and the Health Data Interactive.

Community Health Status Indicators had a long history, starting out at HRSA in the 1990s, but really was a cooperative effort of several different public health organizations and state-based health officer organizations including the Public Health Foundation, ASTHO and NACHO. It had public health profiles for all counties in the United States. It was really launched in 2000. It got unplugged in 2003 and then was re-birthed after a lot of public support from the public health community and re-opened under CDC in August 2012.

It had close to 300 measures at the Census tract level; 78 core measures there in particular including mortality by age, race and gender; had seven different social determinants of health measures at the Census tract level; had standard errors around those estimates and a means and range for peer counties meaning that counties could compare themselves to each other. In fact, it became a major source of data for community health needs assessments that are required for fairly qualified health centers, for county and public health departments and for public hospitals.

MS. HINES: And for organizations applying for federal grants such as from HRSA and SAMHSA.

DR. PHILLIPS: Right, thank you. So there was a very large use case for this.

It was shuttered in August of last year. Twenty-one of the core measures in fact are no longer publicly available. If you go to the website it actually redirects to the County Health Rankings and Roadmap site, which is really CHR&R, which has a number of data elements but doesn’t cover the range of data that were available under CHSI. It does have 29 core measures but doesn’t have standard errors around them. There are no Census tract data available, no mortality data that are stratified by age or gender or ethnicity or race. So it’s a resource gone that had quite a bit of use.

The Health Indicators Warehouse actually presented a lot of BRFSS data along with data from other sources. It had a rolling seven-year average of BRFSS data so that you had greater reliability and stability of the information. It was decommissioned in June of 2016. With the loss of CHSI and the Health Indicators Warehouse, you lost any source of the seven-year rolling BRFSS estimates.

I was trying to look at some of the businesses or apps that used the Health Indicators Warehouse, and My Blue Meter was actually an application that was developed using HIW and allowed veterans to pull down from My Blue Button data from the VA so they could combine those data elements and look at their health compared to their peers. It was designed to help them structure ways to improve their health, so there were business cases tied to HIW independently.

BRFSS is still here, but, as I said, you can no longer access the seven-year rolling averages. This is one of the data sources we have had a complaint about, that it doesn’t support existing tools. Community Health Rankings and Roadmap continues to need BRFSS data and it indicates that the new data are modeled, but average users may not appreciate the extent of the standard error loss issue.

500 Cities, which was partly funded by the Robert Wood Johnson Foundation, does have city-level and Census tract data for approximately one-third of the U.S. population in the most populated cities. These are modeled estimates of 28 different BRFSS measures of health outcomes, behaviors and services. It doesn’t cover most U.S. counties or include social or environmental determinants of health, and because the indicators are modeled, the estimates cannot track change or monitor intervention impacts because if you don’t have the seven-year rolling averages you can’t look at trends.

There was a recent evaluation published — and this is actually a live link if you open up the presentation — that evaluated 10 of the 28 modeled estimates. For example, in Boston, it reported that four of 10 measures significantly overestimated the prevalence compared to direct estimates, and the four estimates were of binge drinking, obesity, frequent mental distress and frequent physical distress. Obesity is a frequently cited figure from BRFSS, so to have it as one of the overestimated when compared to direct estimates is fairly concerning.

The Community Health Rankings and Roadmap website actually lists three limitations including that the confidence intervals constructed from these methods appear much smaller than confidence intervals reported from direct survey methods in previous years, so it has the limitation statement there, but people continue to use it with the risk of their using incorrect data because it really does lack clarity about the meaning for the quality and reliability challenge.

Just looking at some of the applications that are affected by the loss of the seven-year rolling average, Policy Map, Community Commons and Opportunity 360, all three use data to populate the proprietary tools which really becomes a concern when they’re using modeled BRFSS estimates rather than the rolling averages.

Another example of the 500 Cities estimates that have come into question is that smoking rates in one Census tract is estimated at 12 percent, but when you go to Opportunity 360 it’s listed as 21 percent. So, how the data are being used, and their reliability problems are going to start to compound as other applications start to draw on them.

Health Data Interactive is a tool that had 14 different data sources. It drew on Vital Statistics, National Health Interview Survey, NHANES, NAPHSIS, the hospital discharge datasets, Medicare beneficiary datasets, and it was used to create interactive tables on health and wellbeing of the U.S. population and also to create maps. It had pre-tabulated measures with several covariates including age, race, ethnicity, gender, year and geographic location and income and urbanicity where it was available. It had standard errors around each of them with upward and lower bounds of 95 percent confident intervals for users who wanted to perform additional statistical tests. And many in the data user community did use them for those purposes.

It closed in 2016. This was the main source for looking at suicide and injury mortality for emergency department visits and the reasons for those. It was a mainstay for creating charts and maps for the data use community. It also was a main source for looking at healthcare access and insurance availability across the country. We no longer have that source either, and this is a live link if you want to see that.

Some of the concerns as we started to think through that might be logical questions for us to address were data access has been lost or has been taken away and it is unclear why. Some of the questions around that are is it just too costly to maintain the data infrastructure. Is it too costly to maintain it? So, getting to some sources about why we lost these critical data sources.

Some of the data have been moved into research data centers, RDCs, and part of the explained goal for that was to be able to connect them to non-publicly accessible datasets for important research purposes, but by moving the public data into their RDCs, it locks them up from a public access perspective. This includes common things like the National Health Interview Survey or its derivative, the Medical Expenditure Panel Survey. Vicky Booth, who I think is on the phone, can speak to this, but her students frequently pull down MEPS data that are no longer available.

Then there’s a concern about data potentially being removed for political concerns or for beliefs, whether that’s around climate or about prison status. There is just concern about, again, reasons why it was taken down.

The imperative here that we see as being of high importance is that it’s impeding commercial interests, not just for the business side but the idea that people create businesses around improving access to data and also translating them into information that the public wants and needs. Entrepreneurs’ needs for reliably available data is a driving concern for us. I would say that just today in our discussion about evidence-based policymaking there were a number of elements of the Commission, of the bills that came out of that, which touch on this as well.

Some of the committee questions that we have started to frame are which data are no longer available, really trying to take stock of what we have lost; which data are no longer provided reliably, so, kind of which have been dumbed down even if they are still available; and which data are more difficult to access including having to go to RSDACs or Research Data Centers. And then, identifying which communities need these data and why, so, how were the data previously used and how have those uses been disrupted. What decisions and activities did the data support, so, what is the user community around some of the applications that were using the data, and which commercial interests are affected. So, very basic questions that we don’t have answers to right now.

We — I am the committee right now, the subcommittee of the Population Health Subcommittee — we see as next steps, with a lot of help from Vickie and Rebecca, doing in this quarter really just the fact-finding, those very basic questions, trying to understand the user community and what the applications were. And if there’s enough interest in creating that focus and fact-finding activity, then getting into what do we do with them and how do we respond to it.

I will stop there and take questions.

DR. MAYS: This is Vickie Mays. I just wanted to comment because, indeed, I was the one whose student had the problem because of MEPS and NHIS.

But the bigger issue here — One of the reasons I asked the question I did earlier when we were dealing with CEP is because there seems to be a tendency to move these datasets into RDCs so that a certain type of research can be done which is much more poverty-based, economically-driven. I think it would be important, as you try and find out the users, that we are really clear about the kinds of things they use it for because I think we are slanting in another direction around what evidence-based policymaking looks like in terms of kind of focusing on a more narrow agenda.

MR. THORPE: First of all, thank you for this conversation, and I want to join the committee because I am very interested in this. I have some clarifying questions.

The second data point, you said data is moved to the RDC to allow it to be linked to this restricted data. Does that mean that when they moved it they no longer — none of it is any longer publicly available? Oftentimes when they do move it, it’s for a reason of privacy or linking to geographical locations.

Also, can we have the Director of NCHS come and address some of these questions for us? Because the MEPs — well, the NHIS and NHANES are right at NCHS. Am I correct?

DR. PHILLIPS: Sure. Vickie Mays, do you want to speak to that directly about what has been lost and what is still available particularly around MEPS or NHIS?

DR. MAYS: What is interesting is that you used to be able to link them and you can’t link them anymore. We were doing fantastic research on being able to understand not just the status of health and mental health, but on the side of MEPS you can look at patient experiences, what drugs they use. It was like you got to see what happened in the healthcare.

The problem is you can only do that if you go in an RDC, which, for training the next generation of researchers, there is no money to send them to these RDCs. It really is going to impact the kind of training that we do of students, as well as our own research, in terms of being able to do this work. Because the RDCs — it’s not the up-to-date way of being able to enter, and how long it takes and what it means in terms of when you’re trying to do a dissertation both in terms of cost and time.

MR. THORPE: Vickie, just so I can understand, are you talking about just linking NHANES and MEPs, or are you talking about other datasets as well?

DR. MAYS: I’m talking about those two in particular. That is where my experience lies. It used to be that what we would do was sign an agreement with HRQ, get MEPS and link it to NHIS and move on. Now, HRQ won’t let us do it and NCHS won’t let us do it, so they both have said you can’t do it. I understand maybe why they’re saying it, but it’s like the Census has provided statistical methods for being able to link sensitive data that I think other groups need to take advantage of.

MR. THORPE: Yes, I share some of those similar concerns with my students. I just wanted to clarify that it was between those two.

DR. MAYS: Yes.

DR. LANDEN: In the first bullet, which data are no longer available, the third question I would like to see addressed is are these data available from any other source or combination source, because if they were eliminated because the data are available elsewhere, that’s one thing. If they have just been eliminated and are not available elsewhere, that’s a very different sort of need, so I would like to get a sense of are there alternatives. What is the next best available alternative for those data sources that you have cited that we have lost?

DR. MAYS: I can answer that. In most instances, they are not available. That type of data are not available.

MS. DOO: This may be a naïve or old question. I just wonder if the data that is on healthdata.gov where you can see some of the datasets, if that is not viable and useful or if it’s old or not accessible for your purposes.

DR. PHILLIPS: Some of these were part of healthdata.gov and are just gone.

MS. HINES: Well, but healthdata.gov is a catalog; it doesn’t actually have the data. It just tells you that they exist. There is nothing downloadable there. It is literally an inventory.

DR. PHILLIPS: It will take you to a website. Did you say the website is gone or it’s no longer available?

MS. DOO: That’s what I was wondering, so they are not maintaining it anymore?

MS. HINES: Correct.

MR. COUSSOULE: I am trying to understand what the end game is here. What are we actually trying to do at the end? I get the fact that there are datasets that are not available. There are questions about why. What are we trying to get to in the end? What is our objective?

DR. PHILLIPS: One of the more basic objectives is to make data available that are collected and make it available in a way that communities have already demonstrated they will use it to assess health in their own communities or compare the health in their community to others.

I haven’t seen anything that says we lost any of these data-sharing mechanisms because there was no user community. In fact, many of the user communities are getting fairly vocal about the fact that these are gone.

DR. ROSS: My experience has been that a desire for certain kinds of information surfaces and then groups act to gather the data and produce the information, build the tool, whatever, that’s necessary to do it. Or somebody within the government, an agency like CDC — take like Community Health Status Indicators — has kind of a vision and sees a way forward and has access to enough resources to get something started.

But what we don’t have, and this is to your point, we don’t really have any kind of national level, federal level, agreement about the degree of responsibility that taxpayers want to go to in order to inform the public at large around health in many ways. Consequently, none of these systems have their own business case developed to justify how long it’s going to live or how it is going to be supported. There is no line item in the CDC budget that is clearly aimed at congressional intent saying we want to inform the public; therefore, we have allocated money this way.

So these things come and start to find some users, some receptivity, and then budget times get hard and whacko! I have been a part of those conversations at all levels at CDC over time and it is painful. But we don’t have an agreement or any way to put budget staying power behind a lot of this. I think that speaks to lack of intent, lack of understanding on the part of Congress as to why this actually creates benefit. We don’t give voice to the people who do benefit. Maybe some of them will speak up, but those are small groups and it needs to be a pretty powerful voice to say we want this, or else it has to be commercialized.

But I can tell you upfront the groups that start these systems never take the basic informatics 101 principles to say what is the plan from start to finish of this thing. They just start doing it because they got access to some money. And then later they whine and say, hey, somebody turned it off. Well, the guys turning it off at the budget level within an agency are saying, gee, it seems to be replicated by these other systems and this is yet sort of unique — take Community Health Status Indicators — but it’s also sort of like these other things that somebody else is paying for. Times are tough. Well, that one goes. That’s what happened there.

I’m sort of throwing my hands up and saying this is a difficult problem, but it’s ultimately tied to money and lack of will to say why that money has been allocated.

MS. HINES: Dave, I just want to add on a few things and echo that I was at the inception of two of them and in both cases there was a very vocal, active user community and the federal government was saying we need to make these data more available, and rather than email-by-email, request-by-request, let’s just take a systematic approach to these.

There was a champion leader who then — you are right — did not have a sustainability plan but basically got the resources pulled together, mobilized, and made these things happen. And then, as soon as that leader was gone, the project went away.

But in two of these there was a vocal community asking for this information. Smart people such as ASTHO and NACHO and Public Health Foundation were brought together with epidemiologists and the right people to make sure it was done well.

DR. PHILLIPS: But no sustainability plan.

MS. HINES: Because, as you say, there is nothing in legislation. There is no place in the federal Department of Health and Human Services where community-level data live. Not in CDC, not in HRSA, SAMHSA, NIH. There is no place where there’s a line item that Congress says this is important; we value this, and we are going to fund it to make sure it’s available.

So the situation we see is the community says we need it; a leader comes in who gets it, makes it happen, and then times change.

DR. MAYS: I think there is an issue of what the responsibility is in terms of monitoring and surveillance, and I think the case has to be made that the absence of data is an absence of the ability of the federal government to do what it says is its mission.

DR. PHILLIPS: Particularly in light of the evidence-based policymaking report, too.

MS. GOSS: Perfect segue because that’s my question. I am trying to link the earlier conversation with this one and figure out if there is some intersection of all of this. Is there?

DR. MAYS: Well, I worry there is one because it’s starting to want linked data to be kind of like a primary source, which means then that you make it less available sometimes.

DR. STEAD: As I listen to this, I think from the committee’s perch the question on the table is whether additional fact-finding would be helpful at this juncture. As we look forward, we know we have got the interest in what we have called the health data ecosystem, which touches into this space. We may well be involved in the follow-up to the evidence-based decision-making piece.

MS. HINES: We’re going to hear tomorrow on the health data landscape from the chief statistician.

DR. STEAD: I think the question that was in my mind when we first began to discuss Pop Health’s probing in this is whether there is something useful in the nature of fact-finding and then summarizing that could usefully help people be alert to unintended consequences of some of these kinds of kind of changes. Or — and, Dave, you have done a wonderful job of describing how these kind of things occur — or do we say understood; we really need to deal with this in the context of some of those larger things when we get bandwidth and time to do it? I think that is really the question in front of us today.

Is that fair, Bob?

DR. PHILLIPS: I think it is. To answer Alix’s question, I think the Commission on Evidence-Based Policymaking and the bills, for that matter, give us some impetus to support this fact-finding for a very specific area and use cases and datasets. I don’t think it’s fair to say we should combine those efforts. I think there will be a more concerted effort around the evidence-based policymaking once the bills are passed and we have a clearer idea of where it’s going. But I think it give us some real authority to deal with these particular issues head-on.

But I want to hear from the rest of the group. Roland volunteered — thank you, Roland — to join this effort, but I would like to hear from the rest of the committee about the importance of doing the fact-finding around this. If you don’t think it’s important we don’t have to do it.

DR. COHEN: I will be happy to help out, too. I think it’s certainly important and I think there is a real connection. We’re talking about data access, whether it’s at the geographic level or at a national level, just to be able to combine datasets. It is all part of the same, I think, commitment. The federal government hold these data in trust for the residents of the United States to use; we don’t collect the data to sit on a shelf, so the goal here should be to maximize its utility for a variety of purposes.

I think that is what CEP ultimately is trying to do, and certainly this exploration and fact-finding will help us understand if there have been landscape changes that might fit into this world view to maximize the utility of these data and access to this information.

MS. GOSS: Could you clarify what the fact-finding would be going after?

DR. PHILLIPS: Part of it would be to ask the user community to give us information about how the data were used and their importance and what the loss of it means. And particularly around evidence, how they used evidence for local policymaking or local planning or local evaluation.

That could feed into — certainly, we have listed here in the second quarter feeding into a visit with the Data Council to present a summary of those. But I think it also could lead to something bigger even, a hearing perhaps. We haven’t laid that out on the timeline but that could be a way to get a very focused group of those people in a room to talk to us about what happened.

MS. GOSS: So it’s just an HHS data access issue. BRFSS is something I think of from a state perspective. Is there a state aspect in all of this as well?

DR. PHILLIPS: Oh, yes.

MS. GOSS: Okay.

DR. PHILLIPS: The states and counties I think are particular data users who can let us know how they use them, what the loss of them means, whether there is an alternative source for those data for them. Absolutely.

MS. LOVE: So you mentioned specific data sources, but is there a larger question that existing data sources not mentioned are at risk in this larger — like HCUP?

MS. GOSS: You have a good point. What else is going to fall off the cliff.

MS. LOVE: I am feeling the infrastructure is eroding. I have been doing this for 30 years and I feel we’re starting to now recede and go the other direction in our investments into the future.

DR. PHILLIPS: Denise, maybe that’s part of the fact-finding, is to find out from the user community what other datasets are rumored or they are hearing may go away.

MS. LOVE: Well, I think any data system that is funded with appropriations could be at risk. I don’t think we can take for granted — I know at the state level, every year you can’t take for granted that the data that are funded today will necessarily be funded in perpetuity.

I like to think that our public officials invest in the data today so that we have a good future look.

MS. HINES: Denise, would you like to join the three of us?


MS. LOVE: I didn’t mean to call out one data system. I’m just using that as an example, but it is alarming. MEPS is a very popular data system.

DR. PHILLIPS: Housed in an agency whose future is uncertain.

MR. COUSSOULE: Is there a disconnect between the data creators and data users? It seems like in some ways there is. If something is gone and there are some upset people, did the people who decided that it’s going know there were going to be some upset people or what the impact of it would be?

MS. HINES: Yes, sometimes.

MR. COUSSOULE: Part of it I think is going to be understanding that tie, because that gets into the value generation, value recognition questions. So, part of where my head is going with this is to ask people what is no longer available — that’s backwards-looking — but to also understand, by the way, what is not going to be available tomorrow that I don’t know about yet, and how do I prevent that from happening.

I would be more interested personally in making sure that going forward it’s better understood to mitigate problems or at least understand impacts as much as let’s fix something that happened already. I am just trying to think of how that linkage is made between where the cost goes to create something versus where the benefit is being derived to utilize something.

MS. HINES: I think, to Dave’s point, until there is actually appropriation that is built into the resourcing of HHS, that is going to be really hard to accomplish.

DR. STEAD: I am hearing you have a team to help you with fact-finding.

DR. PHILLIPS: Absolutely. Thank you.

DR. STEAD: And we will adjourn. Thank you.

(Whereupon, the meeting was adjourned at 5:25 p.m.)