Department of Health and Human Services

National Committee on

 Vital and Health Statistics

Full Committee Meeting

February 6, 2019

Hubert H. Humphrey Building
Room 505A
200 Independence Ave., SW
Washington, D.C.


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

Agenda Item: Welcome

STEAD: Good morning everybody. Welcome to the February meeting of the Full Committee. Let’s start with the roll call if we would, starting with members. I am Bill Stead, Vanderbilt University, chair of the Full Committee, no conflicts.

MAYS: Good morning. Vickie Mays, University of California Los Angeles. I am a member of the Full Committee, Pop, Privacy, and Review Committee of the Standards. I have no conflicts.

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

CORNELIUS: Lee Cornelius, University of Georgia, member of the Full Committee and Population Health Subcommittee, no conflicts.

COHEN: Bruce Cohen, Massachusetts, member of the Full Committee, co-chair of Population Health Subcommittee, no conflicts.

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

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

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

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

STEAD: Members on the phone please.

PARTICIPANT: (off mic)

GOSS: Good morning. This is Alix Goss. I am member of the Full Committee, co-chair of the Standards Subcommittee and Review Committee and have no conflicts.

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

STEAD: Rebecca, would you lead off for staff?

HINES: Yes, thanks, Bill. Good morning everybody. Rebecca Hines. I am executive secretary to the Committee with CDC, NCHS. And I just would like to note we do have a quorum. In the room –

DOO: Lorraine Doo with the Centers for Medicare and Medicaid Services, National Standards Group, lead staff to the Standards Subcommittee.

HERRING: Geanelle Herring, CMS, staff to the Standards Subcommittee.

ROY: Suzy Roy, National Library of Medicine.

KANAAN: Susan Kanaan, writer for the Committee.

STEAD: And then we will do members of the audience.

(Audience introductions)

STEAD: Welcome everybody. Let me just briefly walk through the agenda because we have a full plate. We are going to consider action on three letters and on the report to Congress. We are going to start with the Predictability Roadmap and the draft letter for action and next steps. Then we will have the update from ASPE and then we will move into the health terminology and vocabulary, the two letters that have been drafted for action and discuss next steps. And then in the afternoon, we will discuss the report to Congress and continue action on it. We hope to close the day with the discussion of the 2019 workplan. We have some time toward the end of the day where we can bring back items for action with revisions we have wanted to make over the course of the day if need be.

And then this evening, we are going to have a social dinner where we are going to honor Dave Ross, Bruce Cohen, and Linda Kloss service on the committee and shed a very heartfelt tear for losing their participation going forward.

Then in the morning, we will start with committee updates and then we will have a block on Population Health where we look at the progress that has been made on operationalizing the measurement framework by the coalition for 100 Million Healthier Lives and then have a discussion about Healthy People 2030 and then Steve Schwartz is going to join us to talk about the vital statistics and plans going forward there.

Just before lunch, Jon White will join us from the Office of the National Coordinator so that we can continue the discussion of collaborative work between the National Committee and the HITAC Federal Advisory Committee.

Then time after lunch to come back one more time if we need to finalize our action items and then we will after lunch work the plans for the Health Information Privacy and Security Beyond HIPAA working session, which has been calendared for March, take public comment, and then close down and adjourn.

Any questions or suggestions about the agenda or are we good to roll ahead? Okay. Then I think that Nick and Deb are going to lead off with the Predictability Roadmap with Alix chiming in by phone as need be.

Agenda Item: Predictability Roadmap: Draft Recommendations

COUSSOULE: Yes, Bill. Thank you. We are really going to attempt to do two things in regards to the Predictability Roadmap this morning. I am going to first walk through a little bit of a summary of how we got to where we got to today, a little highlight of the last few months through this exercise. And then Deb will walk us through the letter, a recommendation letter that we would like to send up. Hopefully, I will try to get through this presentation portion relatively quickly. Most of you have been through a lot of this already. If I am going too fast, please slow down and ask questions, but I am going to attempt to spend more time going through the letter.

Again, from the outcome of the hearing on the Predictability Roadmap recommendations, we really have spent a couple of years working with industry in lots of development organizations and operating rule authoring entities, visioning workshop. We held a CIO Forum. We had presentations to multiple stakeholder groups and seeking input from lots of different parties on this. It was pretty clear that we had some challenges. We have gotten really good feedback in regards to a lot of those challenges.

We conducted a hearing in December and the purpose of that was we teed up a number of potential recommendations, calls to actions, challenges to the regulatory authorities as well as the industry in general and to discuss those recommendations and get input from a large number of industry players across the industry on that.

I want to make sure that we on behalf of Alix and I and the rest of the committee thank all the people that have been involved in this, not just in December although we do thank you very much for spending a lot of time with us in December, but thank you very much for the time throughout the last couple of years to help us get to what we believe are some pretty solid recommendations to make improvements going forward.

What we heard was what we will call a pretty urgent need to accommodate the business and technology changes in health care. Now when the rules were defined and HIPAA was put in place and the Administration Simplification Rules were put in place, a lot of really good progress has been made, but frankly the world has changed, which it attempts to do on us sometimes faster than we would like. The standard development process as exists and I will say the whole process from conception to implementation to adoption is challenged to keep up pace wise with the changes and challenges that are happening in the industry.

What we wanted to try to help was to ensure that the regulatory process enabled the updated standards, reduce the administrative burden, which I think we would all agree has been a laudable goal from the get-go and certainly has not changed at all.

What we were trying to do is to look to the prior work, identify the barriers at each stage of the process. There were no ox that was not gored in this process, no stone that was not left unturned. The idea is we wanted to clearly make sure that the standards process, the federal process is part of that, the industry implementation that we looked at all those pieces to try to understand what could have an impact on improvement going forward.

When we looked at the, I will call, basis of the recommendations, there were a number of different areas for improvement. Some of them were in the federal process. I will read a couple of these because I think they are worth highlighting. The visible enforcement of existing regulations. It is just to make sure there that as we say this is what we want to do across the industry, it only works if everybody does it. We want to make sure that that is visible. Guidance and outreach. Even the enforcement is really about education. It is not about punishment. We are really trying to make sure people are educated through to be successful in this process. Responsiveness to NCVHS recommendations in a timely and predictable regulatory action. Again, as the pace has changed and the industry and their needs and demands have changed, we want to make sure that we can keep up with that through the entirety of the process to get new standards in place.

We also look for improvements across the standards development organizations and the operating rule authoring entities and their processes. A few of the highlights there is to increase the diversity of participation. We have lots of willing participants in this process. They give their time and energy to this willingly and freely, but sometimes it does not always represent the cross section of the industry and players that we would like partly because it takes time and energy and difficulty freeing people’s time up to do that.

We also want to make sure we are supporting innovation through this process to the evolving business and technology challenges. I think we are all aware of the technology challenges and how fast that is moving and the new capabilities that are available on it seems almost daily basis along with the challenges in the industry with moving away from how care was delivered, how it was paid for, how it was ensured. Those technology and business changes are moving much faster and our ability to keep up with that it is going to become very important or has become very important.

Skipping down to the governance and oversight, a lot of it is really about creating visibility and transparency. It is not necessarily about anybody purposefully hiding things or any of that. It is not a malicious kind of question. It is really more about how do we make sure that there is visibility from all players into what is happening so that we can understand, address, act on and challenge those things.

And then ensuring the value is coming. We have no interest in promoting standards for standards sake. We want to make sure that it is having the right level of impact and positive impact on the industry in total.

Then to the December hearing. We had a two-day hearing in roundtable format. We literally sat around a big table or big conference room, trying to get impact from lots of different players, 36 different panelists from diverse stakeholder groups. You will see in the next couple slides, we will not go there now, all the players. I am not going to read those off. They will be in the documents for you all to see who was involved in this.

We asked the panelists to come in and be prepared to discuss the recommendations that we sent. Those recommendations draft are also in the appendix here. I am not going to walk through those either because you can look at those. The idea was to tee up a lot of those challenging questions and ask them to consider four questions as part of that.

I will read through these. One is would the recommendations improve the predictability of the adoption of administrative standards and operating rules. We will oftentimes get into a slight debate about what predictability means. It means really two things and I will speak up and I will let my illustrious chairs or co-chairs as well as committee members weigh in. It is both to understand what is going to happen and when, but that is not really enough because if I told you something was going to happen, but it is 12 years before it happens, it may be very predictable, but not necessarily effective. We want to make sure we are talking about both predictability from an understanding perspective as well as continued motion and the expectation of change and how that will happen.

What other recommendations are critical? Not only tell us do you think it would help, but what are we missing.

How can we achieve the desired outcomes? What can we do? If we believe that there is value in there, what can we do and how might that work?

And then what are the unintended consequences? We all know oftentimes you will do things that look really good and from one vantage point and create challenges and opportunities or issues from another vantage point. If we went and did this, what else might happen that may not be as positive as we would like so that we can accommodate that and address that as well and look at that input? Again, we ask both for people to participate at the hearing and discuss as well as submit any written comments. We got significant amount of written comments. I will actually cover that in just a little bit.

Skip two more slides. We are going to walk through the panelists. I think that is all public information at this point in time and it will be on the website.

The themes from the hearing, what came out. One, we could improve the timing of federal regulations or guidance following a formal recommendation from NCVHS to adopt. Oftentimes it seems like a black hole. Things will come in. It is just a difficult and challenging process and so trying to understand and have visibility into that and ideally make that happen a little faster if we could. It was certainly one of the themes that came out.

And then visibility, as I said. The visibility is a theme that is going to come up regularly through these discussions and it did come regularly over the last couple of years through these discussions so that we can understand as an industry what is happening at each stage regardless of the body who is involved in the wait process, if you will, or the action process.

Two was to promote and enable voluntary use of updated transaction standards and our operating rules. And really this was more about how we can challenge and be innovative with what were the challenges that are faced in the industry with willing partners without creating an anarchy and kind of everybody out on their own.

One of the challenges of any kind of standards process as you build standards to create commonality and then create leverage and efficiency. At the same time, you want to support innovation, but you want to make sure that innovation does not create anarchy and one offs. It is trying to find that right balance of ensuring consistency and efficiency in the industry as well as allowing for innovation to see what might be different or new that will work. They will not all work, but what might be different and new that could be effective and eventually adopted by everybody.

The key bullet on this one is the second one here, which is willing trading partners. The idea is we want to make sure that the innovation can happen when there are willing players looking to be innovative and not necessarily force people to go there that either are not ready or are not willing and do not believe it is effective for them.

Third theme that came up was to improve access to information from HHS. You see the bullets. The status of regulations, the guidance and education on policy, enforcement, et cetera.

The fourth theme that came up is to expand access to education about standards and operating rules. Most of this obviously comes through the industry. I think there is some opportunity to hopefully get some leverage out of the federal process or the federal entities as well to help that across the industry, but clearly that comes out of the industry.

The fifth theme was to remediate the process and operational issues within the standards organizations. We have gotten a lot of good feedback and there has even been a lot of progress made from the different standard development organizations to look at how their internal processes work to make and support some of the challenges that we have already talked about as well including timing and the cost for participation.

Again, one of the issues I referenced earlier was this is done generally by willing volunteers that give their time and treasure to do this. They should all be lauded for that, but sometimes we need to try to figure out how to get others involved that may not always have that time and effort. But it is important enough to do that so that the entire industry is represented in the development and eventual implementation of those standards.

And then number 6, developing a new methodology to effectively evaluate the standards and operating rules. This one was one of the more challenging topics. As we go through the letter, you will recognize that we do not believe by any stretch we have solved that, but we do think there are some real opportunities and in particular the updating repurposing of the DSMOs, the Designated Standard Maintenance Organizations. That is really about the process that has worked well as established, but creates some challenges now. Lots of good input again from the hearing participants. In regards to the challenges, not always simple answer to this problem. Clearly, a good bit more work and we will address that also in the recommendations.

Number 7. Identifying the value of the standards and operating rules before the recommendation or adoption. That gets to my point earlier about standards are supposed to be put in place and adopted to drive efficiency. If they are not going to add any value then you do not necessarily want to do them or you may not want to do them on a timeframe that is not valuable for the industry or disruptive to the industry.

A good bit of information. We really need to understand cost benefit of each of those as well as we can as well making sure that the testing is valid and applicable.

And number 8, improving the effectiveness and visibility of the enforcement process. The complaint management process. I think there is some anecdotal and some real feedback that there is probably more challenges out there that have been discussed and so trying to make sure that they are visible without the challenge of potential downside to people reporting issues and challenges to make sure that we are in fact enforcing those regulations. But again the idea behind that is more about education, understand where the challenges are and what is happening than it is about punishment.

The written comments. We also got significant written comments. We received 30 or thereabouts and in fact, there is even more that have come in subsequently, which we welcome, by the way, just so everybody knows. It is oftentimes we have very specific timeframes we give people to submit information, but the committee is always open to any kind of feedback that we can get from the players in the industry to help us over time regardless of whether it is tied to a specific deliverable or not.

We have received lots of written comments. Over 30. Some of them very substantive so not necessarily three words in regards to I like this, I do not like this, yes or no, but very specific feedback about why something might be good or challenging. We welcome all that. It is easy if everybody thinks the same way, but usually they do not and when they do not, you usually get the better answers when you work through the mechanics of that.

As I said, we get consensus on lots of things that we were talking about, but also substantive additional input and ideas and not always consensus on certain things. Again, that is where we get to better answers and help guide our recommendations.

It was pretty widespread support for enforcement and education recommendations. Again, enforcement to really drive consistency and education to help make sure that we are productive in how we actually implement.

There was support for regulatory recommendations with many constructive recommendations and suggestions from the group in regards to how to ask and what to ask for that it would actually make a productive difference across the industry.

And then number 5 there is very diverse commentary on recommendations pertaining to the DSMO and new governance concept. We will cover that a little bit more when we get into the letter itself.

The fundamental recommendations that came out that are part of the letter are listed here. I will actually read them word for word so that people that are listening can understand them, but we are not going to go into them in detail here. We will go into that when we walk through the letter.

The first one is to remove regulatory mandate for modifications to adopted standards and move towards industry driven upgrades. At very high level, it is about reducing the regulatory challenge of getting standards implemented and allowing the industry to drive more of that change.

Number 2 is to promote and facilitate industry’s voluntary testing and use of new standards or emerging versions of transactions or operating rules. Again, I covered this a little bit earlier, which is about how do we enable innovation with willing partners hopefully to demonstrate significant potential for improvement going forward without losing sight of the efficiency and effectiveness that we try to drive through standards.

Third is to improve the visibility and impact of the administrative simplification enforcement program. Again, that is very similar to the analogy of what is happening with the privacy and security side of that through ONC. How do we create visibility into willing or challenging players in that process so we can then use that information to help drive consistency and then education?

Four is to provide policy-related guidance from HHS for administrative standards adoption and enforcement. We believe that HHS, I think, can play a larger role in some of that communication and enforcement and guidance through with obviously lots of support from the industry. We will go over that as well.

And number 5 was to reevaluate the function and purpose of the Designated Standard Maintenance Organizations or the DSMOs. Again, more to come on that.

I am going to walk you through next kind of what is going to happen next and then we will circle back to the letter itself. What will happen is we are going to review the letter. Our planned follow up activities. It is going to seem a little premature, but it made more sense to try to cover this before we go through the letter was that to collaborate with a lot of players in the industry, HHS, DSMO, WEDI, et cetera on what DSMO 2.0 or its successor might look like. We have had, again, lots of good feedback, but I think there is a lot of work to do to try to make sure that that is, one, not only are we going to do good things going forward, but make sure we do not lose value of what has already happened or go backwards.

We will collaborate with the Office of the National Coordinator and HiTAC so the other federal advisory committee really on the convergence of administrative and clinical standards. This has become more and more obvious and challenging as we go forward and we think there is real opportunity for us to do that. We got some good feedback through our sessions including the meeting in December. We have already been working with HiTAC and ONC and we believe that there is really good opportunity for us to go forward as our National Committee to try to look at those things in conjunction to make improvements over time.

The third is we will develop work plans to evaluate opportunities for evaluation of standards and operating rules. I know we have time as our chairman indicated earlier to go through the work plan later on. We believe that there is good need to coordinate the work plans obviously across the Standards Subcommittee. As always, there is more work than we possibly can get done. It is trying to pick the right priorities and sequencing with the rest of the work that is happening in the National Committee and the industry.

And then fourth is to update our Standards work plan in conjunction with the Full Committee’s work plan.

The next steps we expect hopefully today and tomorrow. We will review the recommendation letter to the Secretary and solicit support and ideally submit that letter. I will preface it a little bit with what we really want to focus on today in regards to the letter are the substantive and tonality of the questions and not necessarily a comma or a period. We do want to make sure that that is valid and we will take all that input, but we want to make sure we do not get caught up in that too much today, but give the committee members sufficient time to make sure that we have the right themes, the right points, they are well understood, the tone is appropriate, et cetera. Deb will walk through the letter in a minute. And Alix and I will be the bad guys of trying to push it along if we run into some of those challenges, which may be more productive offline than online just given the timeframe that we have to abide by here today.

And then ideally, we will submit that letter this quarter and then produce a scoping document for some next steps, updating a narrative report, et cetera.

With that said, any questions generally from the committee members about the work up here before we go and dive into the letter?

We can put the letter up in just a minute, but just before we get there, are there any questions about the progress so far or what has happened that we can help with? Anybody on the phone?

GOSS: I think you did an awesome job – set up and I want to acknowledge the Subcommittee’s work on efforts over the last couple of months. It has been substantial and a great team effort.

COUSSOULE: Thank you, Alix. I think that is absolutely correct.

LANDEN: Rich Landen. In light of Alix’s comments, I also need to commend industry. They were extremely forthcoming and helpful in identifying the pain points and opportunities and giving us some good thinking about unintended consequences, different perspectives. It has been a very impressive collaboration on all fronts. I do not want to leave out our federal partners either.

COUSSOULE: Can we pull the letter up on the screen please?

STRICKLAND: Our initial focus will be on lines 12 through 20. As others have mentioned, this has been a tremendous work in progress. We think we have a very solid letter here. There has been several iterations, tremendous amount of attention to the detail of this letter to make sure that we are getting the messages that we need to get to the Secretary across clearly, to make sure that we are representing the industry’s desires and in the end to hopefully get some actionable efforts out of this.

What we are going do is as Nick had alluded to, we are not really going through and change the entire framework of this letter. What we are looking for is blatant things that need to change. Any wordsmithing we will certainly circle and move on. What we would like is for you to just take a look at these paragraphs as we go. This is the intro and frame up for this recommendation letter.

Take a look at that and read through that. Let us know if there is anything we need to change.

HINES: Just to point out that this is the track changes are what have changed since you saw it in the E-Agenda book. This is a week’s worth of canoodling.

STRICKLAND: Any questions on this section?

KLOSS: I think these changes are useful.

STRICKLAND: Great. If we can move down to 22 through 34, this is really going through the Standards Committee’s work and introducing the concept of the five recommendations.

COUSSOULE: I think just one comment. Part of the effort there is to make sure we clarified and understood and recognized the support we had from lots of different parties as several members have talked about through this process. If we have missed anybody that is glaring, please let us know. We believe we are trying to cover and recognize that.

STRICKLAND: Any comments on this paragraph?

If we can move down to 35 to 40, this is really highlighting these actions the Secretary can take.

COUSSOULE: This is Nick. I have one comment on this. It is a little wordsmithing, but I think it gets into a tone. In the first sentence, which says recommendation, described in more detail on the following pages, address policy and procedural actions that the Secretary can take to achieve predictability. I think achieve is a little bit of a strong word here. I would actually say something more like materially improve because I am not sure unless we are getting into a real definition that achieve is a challenging one.

STRICKLAND: We will take that under advisement.

GOSS: This is Alix. I support that because it is really predictability comes from the standards world as well as the adoption implementation process – a good modification.

STRICKLAND: Any additional comments here? Once you are done with that, Lorraine, if you could move to 41 through 44. Any comments here? Great.

If you could move down to 46 or 47 through 57, this is the recommendations. For members, I did just email this version to you so if it is easier to look at it on your screen in front of you, you have it.

This is just the high-level recommendations. As we advance through the letter, we will get into the details of each one of these. If you want to move to 58 through 68, this is a little bit of the background of HIPAA and why we are here. Anything there?

The next section is 69 through 79. This is really about where we are now.

HINES: Deb, I do not know if you saw. I suggested a rewording of Line 62 through 65. I did not know if anyone has any comments. The rewording that I suggested is in the comment that is not showing on the screen right now to reorder the ideas here a little bit. The alternative might make more sense, have a more smooth flow, but I leave that up to the members.

LOVE: I think my problem is I have seen it so many times, it is hard to wordsmith here.

LANDEN: I think the change that is the alternate that is suggested there introduces a little bit of I will not say concern, but there is a little bit of – it kind of affects what we were saying. I am going to need some more time to think about that, but I am not totally comfortable with the alternative language.

KLOSS: I like the shorter first sentence. I think that is helpful.

PARTICIPANT: That is the intro to both. It is after 22 –

KLOSS: I like it then.

DOO: The first is the same. It is the second one that is different, Rebecca.

HINES: I like your alternative. I think it is a little more declarative.

PARTICIPANT: It flows differently.

STEAD: The thing that I am not parsing is it begins to create a distinction between – it reads like it is creating a distinction between administrative simplification and standardization. That is what bothers me –

PARTICIPANT: That is fine.

STEAD: I think that can be fixed and still keep your flow.

DOO: So another word beside standardization. Is that what you are –

STEAD: Go back to the comment. I am just trying to process. Go back to the comment place, Lorraine.

GOSS: Bill, while you are processing, if I could weigh in. The sentence as written, many in the industry agree that standardization is necessary and has made a quantifiable difference really reflects what we heard. I am with Rich.

STEAD: I think this general consensus that we want to stay with the original language. Anybody have heartburn about that?

STRICKLAND: If we could move down then to 69 to 79. Any changes or suggestions to this paragraph?

Lorraine, if you could move down to 81 through 92, that is I think going to be a challenge. We have a split page there, but let’s – first section. This is really going into how we came up with the recommendations and overview. Any comments on this section?

Let’s move onto the little two lines on the other page. Anything there?

Seeing none, if we move down to 97 to 104, this is the updates process, allowing us to use – removing the mandate and allowing us to use other adopted standards to move forward. Any comments or changes there?

COUSSOULE: One question I would ask. Most of us on the Standards Subcommittee have been going through this for a while in lots of details. If there is something that needs clarification or a question by the other committee members, please ask because we want to make sure that it is not only understandable to us who have been in the middle of it for a long time, but to others who come at it with a slightly different vantage point. If you have a question or a comment about that, please go ahead and raise it here.

STRICKLAND: It is very clear to us because we have seen this 17 ways until Sunday. Lots of different ways. We have wordsmith this letter.

COUSSOULE: Just ask. Anybody on the phone with any initial comments?

GOSS: I am good.

COUSSOULE: It is hard to see when you raise your hand on the phone so please just interrupt us when it makes sense.

STRICKLAND: Let’s move down to 105 through 124, sort of what is not working today. Any comments in the first section? Anything here? Very good.

Lorraine, if you could bring it down to the next section. Any comments on 131 through 137? Okay.

Seeing none, let’s move on to Recommendation 2. This is the voluntary testing.

COUSSOULE: Just to weigh in a little. One of the challenges here is trying to ensure that the innovation and new ideas and methods could be implemented without losing the efficiency gained in the standardization. Hopefully, we have hit on both of those points. If it is not clear or any questions about that, please ask.

STRICKLAND: Okay. Going down to see the rest of Recommendation 2. Finishing up on Recommendation 2, any comments on Recommendation 2? Great.

Let’s go ahead and take a look at Recommendation 3, to improve the visibility and impact of the administrative simplification enforcement program. Any questions there? There is a continuation of this on the other page.

COUSSOULE: Let me again weigh in just a little bit on this. There was significant discussion about how public this becomes. If you look at the privacy programs, the violations – the security and privacy ones, they are published. It is very much of a list of entities that in fact have done this. Our focus was really to try to drive education over time. There was a good bit of discussion about whether you make the offending entities, if you will, publicly called out by name. We think if there has been some kind of action that has happened at the end, I think there is clearly an opportunity to do that. But it was really more about how do we recognize when it is happening to drive how we might improve education as opposed to trying to necessarily name the offenders directly. We tried to find that balance in here. If committee members have any comments or questions about that, please let us know.

STRICKLAND: The next page has a couple of sub-bullets and C. Any comments on this section? Great.

Recommendation 4. Provide education access to the lessons learned from the enforcement process.

PHILLIPS: Sorry to be ignorant about this. Is there a point at which someone is not compliant that there is a heavier hand?

STRICKLAND: Yes. That is already part of the enforcement process. It is just really bringing about awareness. What we were talking about in some instances was to allow people to see what other people or entities are doing wrong so that they may read it or see it and go yikes. We do that too. We were wrong. We should change that. It is really just trying to bring about areas where the enforcement is finding issues, but bringing it to the industry as a lesson learned so that they can change as well.

COUSSOULE: To be blunt, if there are instances where there may be large players in the industry trying to drive their own model, enforcing people to do things that are not really required in statute, we want to make sure that that is as visible as it can be. Hopefully, that does not happen very frequently, but you do have – there is an opportunity for that and we want to make sure that as visible as that can be, to make sure that innovation is allowed to happen by willing partners. Willing is really the key word in there. By willing partners. And then ideally, good things come out of all that innovation and that becomes a fodder for standards going forward. But people are not necessarily – everybody is not forced to go there because there happens to be one player that says this is what we are doing. I do not really care about anybody else.

Again, it is not like we have evidence that that is happening at scale, but there are some anecdotal and fear, we believe. I think creating that visibility will only assist to that to all the players in there, recognizing when something is happening to go oh. Either I did not understand or I am going that too. That is a problem. The idea being to drive education over time, but also to create a downside for people that are willfully in violation of the rules.

STRICKLAND: Any additional questions or comments on that section? Great.

Let’s move on to Recommendation 5. It is where we start talking about the reevaluation of the Designated Standards Maintenance Organization, the DSMO.

LANDEN: Question for the fellow members of the Committee that were not into this. Do you need an explanation of the DSMO? Do you need to understand the difference between a designated standards maintenance organization and a standard setting organization or a standards development organization?

COHEN: I do not know whether you want to address Rich’s comment before mine. Again, I would like to hear a little more information about the input you got and how the conversation around DSMO 2.0 evolved.

STRICKLAND: The Designated Standards Maintenance Organization was highly valuable and a very functional organization helping in the very beginning of HIPAA, trying to move change requests from the right locations. It sort of was a funnel through which change requests would come in and to get routed to the right standards organization.

After a while, each organization, each standard organization had its own method for accepting changes into it. It is sort of all kind of bounced off this bubble. The DSMO became pretty much ineffective in that fact that the requests were not coming to them. They would just go directly to the standard organization themselves and get handled that way.

The theory and the thought around it was great. It worked. It did its function. At this point now, we are trying to take a look at it and step back and say what is it that we need with the industry today and what are the things we need this organization to do going forward. That is really what we are looking at here.

The comments that we got I think were pretty consistent around that that the DSMO was not really something that folks used at this point anymore. That was pretty clear in both the testimony that we saw and the written testimony as well.

COUSSOULE: I think I will weigh in a little bit and I will ask Alix to weigh in as well because I know she has strong opinions on thoughts on this. We were a bit provocative in our initial draft recommendations to the group when we went into the committee meeting in December and said what if we just turn this off. Then there was a concern.

That was a recognition that, yes, it may need to evolve to be effective today, but it was not established and had no purpose and was not effective before. If you just stopped it, what would happen differently?

As we kind of went around and around because it was an animated discussion and a very good one with lots of strong points about while there are things that need to be different that would be better, it does not mean it goes away. Maybe it gets adjusted. As we look through that, it was this is really a next step to say let’s take a deep dive look at this and say what actually needs to happen for it to be more effective. There are others that have a lot more history of this than I do.

Alix, did you want to weigh in on this?

GOSS: I do, Nick. Thank you. The DSMO definitely has had a critical role especially when you think about balancing between the data content and the standards itself and providing some oversight and broader view of the stakeholder’s perspectives and those that may go to a standards development meeting.

As we live through the DSMO over the last 15 or plus years, they played a critical role – support and acknowledge that, but also understand that we are coming into a new era, especially when you think about the convergence of clinical and administrative data.

What will we need for the next generation? We did the next day kind of got provocative and saying let’s just disband it. And what we heard was there is value and the industry wants some overarching coordination and maybe there is a way to design – invigorated DSMO, aka DSMO 2.0 – it cannot only help carry it forward the value, but extend that in a way that can support testing and piloting value propositions, outreach education. It is very clear that the industry has been listening and actively engaged in improving the HIPAA processes around transaction standards of operating rules – organizations and the supporting organizations like WEDI and trying to really help the industry – efficiencies – it was the problem with HIPAA –

But there is more that we need to do especially when we think about reducing burden, letting industry drive more and balancing the business needs of the technology innovations that is out there. The feedback we got at the hearing was really eye opening and that we need to have some more conversation around this because it really was not clear that everybody was on the same page about what exactly should be the full scope, how would we find it and what value – and how do we not just add another layer of burden for people to pay attention to and participate in, but really giving us the opportunity to – recommendations to bringing – together – leveraging the work that we, as a Subcommittee did, in proposing the original set of recommendations with the feedback the industry gave us and providing an opportunity first and more collaboration.

STEAD: That was very helpful, Alix. This is Bill. I just want to underscore one point. The first four recommendations are ones where the Subcommittee and several of us that were participating came to a clear recommendation that could be acted on now. The Recommendation 5 says there is a lot of hard work that still needs to be done to figure out what to do in the space of DSMO 2.0 and what we are really recommending is we begin to get about that work. There is a big difference between the way the first four recommendations are framed versus the fifth to underscore that.

MAYS: The recommendations have been great and I am glad you just made that comment because it was kind of part of what I was going to ask. But then I want to ask one more thing about this one. The groups that you just listed. Is it that they are the kind of up and coming going forward? Is it that they should be – if we are doing this reevaluation, would those groups be important to be participants in that reevaluation and therefore we should begin to have our umbrella be broader to include them?

COUSSOULE: I will speak for myself and then let others weigh in. That is absolutely the case. We have some really effective stuff that is happening and some advancement that is happening in the individual organizations that are improving in pace, in visibility. I think there is a lot of really good work happening. And then the question is how does it happen in total and what might be the overarching mechanisms by which it is advanced. I think it is going to involve all of those players. It will involve us. It will involve the federal government and certain agencies there as part of this process. It will be a broad group that will need to be involved in how this is more effective going forward than it is today.

GOSS: If I could build on Nick’s comment – prime candidate for discussion of – collaboration.

STRICKLAND: Vickie, I think to your comment, if we look at some of the language here and it talks about NCVHS plans to develop a new project to include industry engagement to inform further recommendations to help support HHS in this evaluation. Again, we did not call out each of the individual bodies in here. A lot of them are called out earlier in the letter when we talk about the input that we got. Again, it is certainly worth considering. Do we actually call them out to be more explicit here?

PARTICIPANT: They are also in the regulations.

MAYS: I believe broad umbrella is always helpful. If we could call them out to let them know, maybe they get to the table faster, but I do not know which ones. This is where Rich —

LOVE: I think they are probably aware of who they are. I am not sure calling them out adds anything at this point. That is just my opinion.

DOO: Deb, would it be helpful if we named – we have the reference to the regulation here as a footnote. Should we also name them maybe in the footnote at the bottom since they are defined there? Would that be helpful?

STRICKLAND: I think so. Perhaps.

DOO: Because we could do that.

LANDEN: I think this kind of shows a partial answer to my question about understanding what the DSMO is, who is the DSMOs are. DSMOs were created at the dawn of HIPAA when there were concerns about changing the system. We now had a federal mandate in place where standards were going to be developed by the standard setting organizations, namely X12, Health Level 7, National Council for Prescription Drug Programs. And yet at the same time, you had a longstanding, several decades of experience with the system for what in the trade is called the data content committees. National Uniform Billing Committee, National Uniform Claim Committee, and there was a claim committee under the American Dental Association that developed all the standard claim forms, initially paper and then morphing into electronics.

When HIPAA was created in foresight, you had what could have devolved into a power struggle between these two groups and the DSMO concept was created as a check and balance to ensure that the best aspects of both systems were forced to be considered in the overall development and adoption and implementation process for these emerging standards so were newly required as mandates under HIPAA.

What the evidence over the last 15 years has shown us is that the check and balance is really not necessary because number one, all the entities involved, the data content committees and their constituencies, the SDOs and their memberships have found a way to work together, develop some trust.

Secondly, that the SDO processes we have talked in some of our meetings about the American National Standards Institute accreditation by which the standards organizations are obligated to have openness, transparency, take public comment. There is a lot of redundancy in the system. Since this check and balance was one of not the exclusive, but one of the high priorities. Now the evidence shows this priority is no longer really needed by the industry. That led us to our conversations about the future of the DSMO.

In the foresight thing, the check and balance was not required. We know that by hindsight. Now we are again at foresight looking. What will the industry need now as a priority as we get into this convergence of administrative data with clinical data and all of a sudden the universe expands again? There are many other bodies that develop standards, vocabularies, terminologies that are not part of the HIPAA mandate, but are part of this new universe.

The proposal here is to start the thinking process of what should the DSMO morph into in order to bring some collaboration across all these new entities that will have some as yet unknown role to play over the next 10 to 20 years. That leads to a very concrete reason for declaring success on the DSMO’s primary check and balance role, but also opening the door to what does the successor of DSMO look like. I hope that provides some context and background and Monday quarterbacking as far as the check and balance, but also still looking into the future. What are we going to need down the road?

LOVE: And clearly, we struggled with that and it is going to take a lot more discussion. What I heard from the comments was the current system is fragmented, complex, and does not add value. But I am having trouble envisioning what that new DSMO structure might look like and not just be a gatekeeper or goal post guarder. That is going to take another year of discussion at least.

COUSSOULE: It will require lots of input. I am sorry to weigh in on personal opinions on what the end game is, but I think we have had enough discussions and input of the challenges without a clear answer for the outcome. I do think it is going to require lots of input to get to a place that is better, but does not cause any challenges along the way.

STEAD: Again, as we try to navigate our critical path. When we started the Predictability Roadmap, it was bigger than an ocean. We have identified four very concrete recommendations to the Secretary that I think we know how to do. We have identified the next biggest area that needs much more exploration. This can now be a much more targeted. We need a very broad group of stakeholders focusing on it, but it would be at least a much narrower piece. As we try to work our way through the iterative process of finding a way from where we are to where we need to be, that is what we are trying to do with this recommendation.

COUSSOULE: I think there is also – some of the challenges are depending on the reaction to our recommendations. It could also help guide the next steps for the DSMO. Those are not independent items.

KLOSS: I think another dimension of the difference between Recommendations 1 to 4. They are clearly in the purview and authority of the Secretary to take action to move these recommendations and adopt these recommendations. And Recommendation 5 is at that juncture of public-private. We talked a lot in December. We talked about the benefit of rethinking of a new version of a public-private initiative.

Again, I think always to underscore the idea that we are looking for something that is not tying us down, but is empowering and enabling to move faster. It is not at this point something that we know the answer to, but it could take forms that are different than at the dawn of HIPAA when the DSMO was contemplated as an essential part of moving forward. But now, we need mechanisms that can accelerate the pace moving forward. I think that is one of the interesting debates and challenges going forward.

STRICKLAND: Any other additional comments?

PARTICIPANT: Any questions on the phone from members?

GOSS: I would add a little bit to the commentary that my colleagues have already offered, which I support. I think we also have the challenge of how do our overall lessons learned and identify shortcomings or hurdles get addressed in this next version. For instance, how do we reach out to the smaller provider practices and get their involvement? How do we ensure that we are testing and improving our functionality before we adopt something? How are we really sustaining an organization’s ability to try to do – community collaboration and moving towards that convergence, which is kind of on an interesting trajectory right now. I think that the conversation that we envision undertaking over the next year is really going to have to kick some pretty hard tires on designing something that a visionary as somebody said earlier for the next 10 to 20 years to ensure that the industry has the ability to understand the changes that are needed, the value of those changes, and the timing to actually implement them in a way that gets them to that greater predictability in addition to the changes the Secretary can make to enable more of an industry-driven cadence and responsiveness to the needs that also underpin the concepts of predictability that really reflect – recommendations.

MAYS: I just want to say, Alix, that I 100 percent agree with you. I think when we had our first draft and I wrote about things like what about the Federally Qualified Health Centers and the Indian Health Service. There are all these little entities that really are still struggling and they are nowhere near the level that you are talking about. I think if there is anything that I can do over the next year is going to be bring those up. There are groups that I work with. And to try and reflect those voices or make sure that those voices are in some way reflected so that in the next as you talk about going forward, we can try and have a way that everyone is progressing at the same level. They eventually get there, but it is just a slower, more painful path. Alix, I really appreciate your comments.

GOSS: I want to build on that because – a little bit when we talk about the convergence of clinical – talking about capture the data effectively at the beginning, enable downstream – use of that in a more effective, technologically-enabled methodology – population health, public health – supporting researchers. There is a whole bunch of threads to this collaboration and industry-driven consensus building around what the next set of governance needs to look like.

LANDEN: If I can add just one more thread, as we are looking forward, I think the discussion has shown how big of an issue that this rethinking of DSMO is going to be. One of the things we have not mentioned yet – Alix introduced it when she talked about the convergence of administrative and clinical. But as that convergence happens, we now have to think about patients/consumers who have historically not been part of the EDI equation. HIPAA is all about covered entities. Patients are not covered entities. But now we have Internet of Things. We have rules coming out of HiTAC and ONC, allowing apps into the clinical side. Those apps are going to be going to be in the administrative side. We have patients. We have consumers. We have app developers that we need to think about as we do our outside the box crystal ball gazing for what this new iteration of DSMO needs to be and how it is to serve us and how we structure it. There are a lot of challenges and opportunities ahead.

That is why I am very happy to see that this recommendation is phrased to make it very clear that this is the start of the process. We are not at a point of recommending a concrete solution.

COUSSOULE: Rich, you just hit the nail on the head. Part of the reason this discussion even now is getting complicated is because it is. It is a reason why we did not – that we were not prepared. I think the issue was not prepared. Here is what actually needs to happen, but we know something needs to give. We believe it is important enough to have referenced here and talk about it as a next step for an action item for us along with the industry.

LOVE: I just want to go on record, echoing what Vickie and Alix and others have said. As the user base expands, we also have the – beyond industry, the user base includes public health and research and do not always have a voice at the table.

This new DSMO is going to have to manage some incredible tensions because right now the industry pushback is that it is not needed to pay a claim or if it is not needed for our business processes. But I really feel that the vision has to be that the business processes are the business of public health, community health, and population health and they have to be baked in. This new DSMO will be incredibly important, but this is the part of the letter I struggled the most with and I think we will continue struggling with. Thank you.

COUSSOULE: The last paragraph are really just a summary and wrap up that taken together, we believe these lay the groundwork for approved adoption kind of going forward and we stand ready to assist.

Any questions about this or other parts of the letter?

STEAD: I cannot believe I missed until now. Is it full adoption or full implementation or full adoption and implementation? We have tried to restrict our use of the word adoption since Review Committee time to adoption and regulation or rule making. We have tried to use the word implementation for what the industry does to actually incorporate it into our systems and processes. I did not see it for some reason until just now. I do not know if that is an issue or not.

COUSSOULE: I actually made a note about this one. The word or the frame I used, Bill, was progress towards a more widespread implementation. I am not quite sure what full adoption means.

KLOSS: There is a dimension of adoption here too because we have some standards that our language have not been adopted. I would support adding toward full adoption and implementation.

GOSS: This is Alix. I support that – we always have to remember that it is really up to the choice of the provider whether they choose to do electronic transactions or not and like the capacity and the provider or a payer or clearinghouse —

COUSSOULE: I think as a directional statement, Linda, I would agree with that and – ideally because that is what drives value and at least across the industry, in general. There are always going to be individual circumstances, but if that is what we are looking to derive as part of this change then I think it is worth saying.

STEAD: Lorraine has a draft, which I think has been carefully worded. It says renewed progress toward full adoption and widespread implementation. Does that get it?

PARTICIPANT: Is that okay?

PARTICIPANT: It sounds good.

STRICKLAND: Does anyone else have any other comments? I think we made it through the letter.

STEAD: One more thing on tone. Come to the last sentence. It gets cut off there. The Committee looks forward to supporting the Department’s efforts to move these initiatives forward. We will incorporate your feedback to help frame the remainder of the Committee’s – is the tone – is that tone – does that create the wrong tone? Is there a way to make that better?

COUSSOULE: Better in what way. What are you trying to accomplish differently here?

STEAD: I do not want to sound like we are making a demand on the Secretary. It is all the tone work we have been trying to do on both – on all three of these letters and the report to Congress as we have been trying to get them to the right place.

KLOSS: I would recommend that we start that sentence. I do not really think it adds anything substantive. We better work on the 2019 work plan before we are likely to get feedback. I would just cut it.

STEAD: Does anybody have heartburn with simply cutting it? It avoids a potential tone issue.

COUSSOULE: Personally, I do not think it detracts from the points we are making. Anybody on the phone with feedback?

GOSS: I would like cutting it because I think – help inform the Subcommittee for their effort —

COUSSOULE: Let me try to bring us to a wrap. What I would like to do now is to recommend that we finalize this letter and submit it to the Secretary pending only minor cosmetic changes because we have a few that we – a period here, a comma there plural where it should not be. There are a couple of those that we need to know to adjust. We did not want to get into that level of detail here. But I would like to recommend moving this letter forward just subject to what I will call very minor changes in grammar.

GOSS: I would love to second that motion.

STEAD: We have a motion and a second. Is there any further discussion? I will call the question I guess. All in favor? Any opposed? Any abstained? Congratulations.


STEAD: Do we want to take – we have a few minutes before break although nobody would get upset if we went to break early, but it is a chance to come back to the discussion of next steps if you want to. You had it briefly at the end of your slides and I did not know if you want any further discussion or input to the Subcommittee about next steps of whether you are good to fly.

COUSSOULE: I think we are good. Let me just reiterate what we had talked about. Obviously, the follow up to get to this letter, but that we would do – the Subcommittee would do a scoping document in regards to how we actually frame up the work and effort to DSMO 2.0 for lack of a better term. As part of that, we would be obviously seeking lots of input from the other Committee members and then seeking some industry input before it moved too far along forward.

But as you even noted earlier in the presentation that we wanted to collaborate with HHS, with DSMO, with WEDI, with the other industry players on what that is going to look like. I think the next step is really about trying to craft up the scoping document as we –

Alix, anything to add to that?

GOSS: I think you hit the nail on the head – we are going to frame – document and we are going to know that the input – will be balancing our in-person collaboration with the industry – as we understand the overarching Full Committee’s 2019 work plan and – to engage industry.

STEAD: And then my understanding is update narrative report. We are talking about the narrative report of the hearing that we already have a draft of. Is that correct?

GOSS: It is my understanding that – in the document we released in September. And then we will have a second document, which will – summary of the actual two-day hearing in December. There are actually two parts. But I think that the narrative is more about the corrections that we received or admissions that we received to the extent the report that Lorraine has put together and definitely want to do a shout out to Lorraine because she is – partner – patient, calm, and persevered through our – or so versions of this letter —

STEAD: I appreciate that clarification. I just want to put an unbelievable note of thanks on the table for the Subcommittee, the staff, and the other members of the Full Committee that for all practical purposes have been an hour and a half call once a week since the hearing for all practical purposes, not to mention close to that running up to it. This has been taking something that was this big and distilling it down and getting the tone right has been a journey and it has just been an unbelievable volunteer effort. Thank you.

I think we are going to call the break. We will – do you want to start back at 10:50 or do you want to try to start back as smidgeon early?

PARTICIPANT: Let’s just say 10:15.

STEAD: Okay. Have a good break. We will regroup. Awesome morning. First half of the morning.


STEAD: Linda, we are going to have you go ahead and start with T&V and we will come back to ASPE.

KLOSS: Moving right along, we are on a roll here this morning. On behalf of the Standards Subcommittee, I will lead off the discussion on health terminology and vocabulary for this morning and we have three items on our agenda first to look at two recommendation letters: one on Selection Criteria for Adoption of Health Terminology and Vocabulary Standards and Guidelines for Curation and Dissemination of these Standards. We will talk a little bit about the careful selection of each word in that title.

And then a second letter on recommendations on Regulatory Simplification for International Classification of Diseases.

And then finally, if time permits, we will move forward, a document that is in the back of the E-Book and the work plan and just wrap this up by looking forward at Scoping Document for Evaluating Pathways to ICD-11 because we will kind of be in that mindset and we might as well take that up as we are talking about this cluster of topics.

Just as a reminder, again, this work comes out of our initiative on health terminologies and vocabularies, which we led off in 2017 by committing to look at the changing environment and implications for the timing and approach to help terminology and vocabulary standards adoption. The needs, opportunities and problems with development, dissemination, maintenance, and adoption of these standards and practical actions that HHS might take to improve their support or their processes that contribute to the adoption of these standards and their implementation. That was our broad, initial project scoping set of goals.

I think as you know, this has been a journey, not unlike the Predictability Roadmap. Maybe it does not have quite as long a tail. But we began in 2017 by developing the project scoping and actually we had two hearings in front of the Full Committee on aspects of terminology and vocabularies before we launched into working collaboratively with the National Library of Medicine to do what I think is a pretty remarkable environmental scan, pulling together an extraordinarily complex environment. And in a way that I have had feedback from colleagues who teach these things in colleges and saying we have never had a document that pulls all this together so effectively. They are using it to teach from. I think we did something really important in that environmental scan.

That then allowed us to host a roundtable last August. And out of that roundtable, we brought forward in September to you a roundtable report and a series of consensus kind of recommendations or if you will, a path forward in terms of near-term, mid-term, and longer-term recommendations. The little bubble then, the gold bubble, which you saw last September, the bubble was around that stuff on the bottom middle. Now it is the top right. We are bringing forward two letters of recommendation to the Secretary and a narrower scope for what will be the next step of this.

I think a useful action we took in September was to say – we called a wrap to the first scoping project. What we have now going forward is kind of a second scope of work. Again, having gone broad, looked at the environment. Now, we have kind of gone narrower and looked at what pieces we can pick off for action recommendations and work forward if that makes sense.

Again, I think very similar to what Predictability Roadmap is doing and going broad and now going forward with a project scoping document, looking specifically at DSMO 2.0.

This is just the same slide you saw in September where we came out of our extraordinarily productive roundtable and again thank you to our NLM partners to other agencies that have supported us in this endeavor and to all of the industry folks that contributed to this work. But we said there were several near-term projects and that was to update principles, policies, and practices under the control of the Secretary to make those recommendations.

At first we thought we will do one letter to the Secretary with the output that we got in these kinds of short-term areas. But as we got to writing, we realized that we would make a clearer message if we split it into two. We are not necessarily going to talk about mid-term or longer-term. They are on the table. They will be part of the Roadmap going forward for the Standards Subcommittee in the HT&V area. But we hope we will through these letters wrap up what we identified as consensus areas where we thought we had enough information to forward with the recommendation.

I think this next slide is going to ask you to call up the first letter. No. Again, you saw this in September. There was consensus out of the roundtable that said we were ready to update the principles to guide adoption of health terminologies and vocabularies. This was a document approved by NCVHS in 1998. I will not go through all the sub-bullets because you see them kind of coming back in terms of a set of updated what were then called principles, but we are now calling criteria.

We also felt that we had enough insight to develop a first set of principles for updates to terminologies and vocabularies. While we call those principles, last September when we were thinking about this, we changed the title to guidelines. These had not been existing because obviously the challenge before the committee and the dawn of HIPAA was to get standards adopted, but we were not thinking ahead to the updates. These two we surfaced as priorities.

We set a near-term opportunity was to scope a project to evaluate ICD-11. Those were the three near-term outputs that we presented to you in September and these three are now embodied in two letters that directly flow from the environmental scan through the roundtable through this distilled set of opportunities.

Is that clear? Any questions?

Now, we go to the letters. We are going to first look at the Recommendations on Selection Criteria for Adoption of Health Terminology and Vocabulary Standards. As the title suggests, we are presenting two sets of standards, one on selection criteria for adoption and guidelines for curation and dissemination of these standards. As I said before, the selection criteria are an update to our 1998 principles and the guidelines for curation and dissemination are new.

I do not know if we need to go through the background. But the first page does – the first paragraph does talk about what this is and the second paragraph notes that with this letter, we are also conveying two reports. That is an important purpose of this letter, not only the criteria and guidelines, but also conveying the environmental scan and the roundtable meeting summary.

Page 48 of the E-Agenda book. Sorry. I meant to say that we are taking these letters up in the reverse order with which they appear in the book.

Third paragraph —

STEAD: The logic of that being that the criteria letter provides the mechanism that we would use in the second letter.

KLOSS: It is broader and the second letter will use the criteria that we adopt.

STEAD: We will take a pause in T&V and welcome Sharon.

Agenda Item: ASPE Update

ARNOLD: Hello everybody. Thank you so much. Apologies for having to adjust the schedule for me.

I thought I would talk a little bit about some of the things going on in the department and the Secretary’s priorities and just to kind of give you a sense of where things are. I appreciate this opportunity to address this committee and note that it is my first time here. I am very excited to be here.

Many of you may know that Secretary Azar has identified four priorities in the department and they are bringing drug prices down without discouraging innovation, expanding the availability and affordability of insurance coverage, reducing the risk of opioid overdose and transforming our system to one that pays for value.

In particular, I want to point out that two of those initiatives are particularly reliant on improving data and interoperability and just want to highlight kind of the links between what the department is doing and what this committee is doing and has the potential to be so helpful to us. In particular, as we track the opioid epidemic and try and identify where we are making progress, we note that the data is really not very good in part because we are limited to survey data in many cases. As we try and collect more timely data, there are all kinds of problems with representativeness, interoperability, et cetera. We look to the work of this committee to help us identify a path forward.

Also, in transforming the system to one that pays for value, we are moving towards value-based purchasing. One of the tenants of that is maximizing IT and promoting interoperability and in particular identifying ways in which to facilitate coordination of care, providing transparency around price and quality, et cetera. A lot of that does also rely on better data, interoperability, et cetera. We really look forward to this committee’s work and help as we move forward in that area.

What may be less well known are kind of internal work that the department is doing to become more effective, efficient and accountable. We call this the reimagined HHS initiative. I do not know how widely it has been shared.

But one of the major aspects of that effort is leveraging the power of data and developing and implementing a data governance structure to enable accessible integrated data as an enterprise asset that drives insight and action.

But really predicated on this is understanding how to link data, how to facilitate better data, how to use data and very importantly to understand some of the privacy issues around data and how to protect privacy. And, again, very important the work this committee is doing.

The President recently signed into law the Foundations of Evidence-Based Policymaking Act. For those of you that have not studied this in detail, it has four titles. The first title focuses on evidence building activities. This includes an expansion of strategic planning to include the development of evidence-based plans. The appointment of an agency evaluation officer, designation of statistical officers and establishment of an advisory committee on data for evidence building that is run by OMB and then the establishment of new or updated occupational series, a career path for program evaluation.

Title 2 is also called the Open Government Data Act and really changes the framework of data assets with the presumption that data assets are made public and that they will be open by default, made available to the public in a machine readable open format without restrictions unless there is a privacy reason or other reason not to. That really shifts the paradigm around data for the department. It establishes a chief data officer position and a chief data officer council that produce a biennial report to OMB.

Title 3 relates to confidential information protection and statistical efficiency. And basically, that is a reauthorization of CIPSEA with a few enhancements. This section also defines evidence as information produced as a result of statistical activities conducted for statistical purposes, which is somewhat at odds with the discussion of the rest of the law. We are still kind of trying to figure out what that means. It may constrain the context of the evidence building and evidence plans throughout the law, but we are still working with our lawyers in trying to understand this.

And then Title 4 is miscellaneous provisions and a specification that no additional resources are provided for this. As with everything else, we are always trying to do more with less. We are very focused on trying to figure out how to implement this law. It goes into effect 180 days after signing, which is not very much time for a lot of activity. We are trying to understand and figure this out and anticipate that we will be calling on this committee for significant assistance.

Internally, we have a data council that I think you are familiar with and we have been looking at the environment and watching the evidence-based decision making bill become law. We have identified a number of activities that we are undertaking as well. We are focusing on a data-oriented workforce, trying to improve the department’s workforce on data scientists and identify and consolidate job descriptions, recruiting, training, et cetera.

We are also looking at how we might establish a data catalog that is called for in the Foundations bill that there will be a government-wide catalog. We are looking at our assets and resources internally to identify how we might catalog all the data resources we have currently and that we will be making available and thinking about how to update, et cetera.

We are also doing some work on data governance and privacy, again, to try and make sure we understand how to make data available, link data for decision making while also respecting privacy.

Another activity is improving the department’s use of and ability to do data linkages so making sure that we are aware of the latest science in this and that we are doing this where we can and where appropriate with the latest scientific evidence.

Finally, we are also trying to document standards, establish document standards for data set documentation. I think that the extent of documentation that exists around the department in terms of data sets is very varied and we would like to establish some internal standards and try and make more consistent and better the documentation that is available especially as we will be making more data available. Those are the kinds of activities that we are doing internally and again I think this is very complementary with the work that you do and has the potential I think to work really well together. We are looking forward to working closely with you.

In particular, we are hoping that you can continue to provide guidance around standards. I really look forward to your work on the Predictability Roadmap and your forthcoming recommendations around health terminology and vocabulary standards. I think these will continue to be very helpful as we move forward. Obviously, the issue of privacy is top most. We are looking forward to your continued guidance around privacy especially with the new law. We will need to clearly identify privacy protections and exclusions and your guidance will be exceedingly helpful.

As we continue to examine the requirements in this new law, I am certain that we will come back to you with very specific questions. But as I said, we are in the very early stages of trying to understand what it is and what we need to do.

That at a high level is kind of what is going on. What we see ourselves doing and where I think this committee can be particularly helpful to us as we move forward. I really look forward to working with all of you.

I would also like to turn to a little NCVHS kind of business with respect to the membership. I am pleased to report the Secretary has approved Bill Stead to continue as chair of the committee until the end of his tenure and has approved Denise Love to serve another four-year term. We are really thrilled about that.

I am also pleased to announce that the Secretary has approved a new member to join the committee. Frank Pasquale is a professor of law at the Carey School of Law at the University of Maryland. He is an expert on the law of artificial intelligence, algorithms and machine learning. He has been recognized as one of the ten most cited scholars in health law in the United States. Frank frequently presents on the ethical, legal, and social implications of information technology for attorneys, physicians, and government officials and has appeared before this committee to testify in the past. Frank has researched health data policy and work that recognizes both the rapidity of technological advances and the unintended consequence of the interaction of legal rules such as privacy, intellectual property, and anti-trust laws.

Frank graduated with a Bachelor’s degree from Harvard University, has a Master’s of philosophy at Oxford and earned his Juris Doctor at Yale. We are extremely fortunate to have Frank Pasquale join this committee. Although prior commitments prevented him from being able to be here today, he will be here tomorrow and I hope you all give him a very warm welcome.

I would also like to say a very warm thank you to the members whose terms have ended. We are very grateful to Dr. David Ross, whose term ended in December with deep roots in public health and informatics from his leadership days with CDC and serving on numerous IOM committees. Dave’s major contribution was to the conversation on strengthening US vital registration and statistic systems, helping the committee to clearly articulate the need to prioritize and focus on vitals on this juncture. We appreciate his bringing on the ground insight together with a global perspective throughout the committee’s discussions and development of the measures framework. He worked with local health leaders to bring the local government voice to fully inform the committee’s work. Dave was a dedicated partner with the Subcommittee on Population Health and we already miss him. His role as CEO of the Taskforce for Global Health now occupies all his time and then some.

We are also grateful for Dr. Bruce Cohen’s eight years of service, two full terms. He was appointed co-chair of the Subcommittee on Population Health soon after arriving with extensive experience working in Massachusetts Department of Public Health. Bruce has brought a real-world perspective to the challenges facing the US vital registration and statistic systems. Working in partnership with David Ross, his work on the next generation vital statistics shed new light on the growing challenges facing these systems and the data that we as a nation rely on from them.

We have been really impressed by the way Bruce approaches these conversations with such humility and with a great respect he garners throughout the vital community, which was instrumental to the success of the committee’s hearing in the fall of ’17. We gained numerous insights from this work and the NCHS Board of Scientific Counselors is now benefitting from that hearing report and follow up.

Bruce worked with Bill Stead to refocus on a more expansive view of population health and concern for small area data. With Bruce’s leadership, the committee produced a seminal environmental scan, grounded in the social determinants of health and focused on approving availability of and access to data to bolster data-focused multi-sectoral health improvement efforts at the local level. The work continues beyond the committee now, having sparked the institute for health care improvements 100 Million Healthier Lives to advance the NCVHS measurement framework towards implementation.

We are also truly grateful for the dedicated service of Linda Kloss, who has served with distinction on the committee for eight years. Linda has outdone herself, an instrumental member, serving as the co-chair of the Subcommittee on Privacy, Confidentiality, and Security, misnamed as she served as the solo chair of the Subcommittee for most of her tenure.

In this role, Linda leaves a legacy tirelessly focusing on approaches to improving the Health Insurance Portability and Accountability Acts, Privacy and Security Rules, resulting in many outstanding work products particularly recommendations to HHS on Section 1179 of HIPAA, recommendations on HIPAA minimum standard and recommendation on the de-identification of protected health information under HIPAA.

She has also been serving as an active member and principal in her own right of the Subcommittee on Standards, taking the lead on numerous large efforts on behalf of the Committee’s Standards work. Not only has she made significant contributions toward the Committee’s efforts to define a Predictability Roadmap for the updating, adoption, and use of health data standards, rules for administrative simplification and clinical interoperability, she has been leading the effort in health terminologies and vocabularies.

She organized a large-scale environmental scan report and convened a roundtable of experts to identify the primary gaps and opportunities for improvement in maintaining, disseminating, and adopting code sets, the fruits of which will be seen here during this meeting.

Finally, as the highly adept facilitator, Linda created an environment at each hearing and roundtable that encourages participation. We really appreciate her service.

Please join me in thanking Bruce, David, and Linda for their tremendous service.


ARNOLD: I also want to note that this is the 70th year of the committee. I look forward to working with you on the continued legacy and really helpful products that you produce. Thank you so much.

STEAD: Thank you for joining us and sharing those priorities and the kind remarks about our graduating class.

COUSSOULE: Bill, how much time has to pass before these members can be reappointed?

ARNOLD: I am happy to take any questions if anybody has some.

MAYS: Good morning and thank you for being here. One of the reports that our Committee sent was on In talking about, we talked exactly about the issue of being able to have a place where there would be a catalog of all the health data sets. I am wondering if you have had a chance to see it and to think about some of the things that were recommended in that because it was about data access and use and the catalog, et cetera.

ARNOLD: I, unfortunately, have not had a chance to read that in detail, but I look forward to looking at that and coming back to discuss the recommendations with you. I am sure that we will find them very valuable as we move forward. We have struggled a little bit with maintaining catalogs, keeping things updated and fresh. I am hoping that the recommendations in there will allow us to move forward in this direction. Thank you so much.

STEAD: I will mention one other prior product that may be helpful given what you just shared. We had a process and wrote a white paper that really described how you might tag data sets with metadata that would make it easy to see how they could fit together and let you know what you were looking for and trying to link. That might be a helpful resource in this process.

LOVE: Thank you for your comments. I appreciate them so much. I just feel that there is an orbit developing here that is similar to the state orbits. I just wanted to I suppose plant the seed that in the state orbit, we are struggling with value-based purchasing and data for that and access for that, opioids, using pharmacy and prescription drugs. States are making headway with, believe it or not, claims data on that. And linkages and de-identification. All of those things are hitting the states as well. To the extent that those orbits can be brought together to get some synergy, I am on board with that. Thank you.

PHILLIPS: Sharon, very welcome, this approach to understanding the data strategies that are coming down the pike and how it fits with NCVHS and how we can be helpful so thank you.

As you mentioned in talking about Bruce’s eight years on the committee, tomorrow is a really important culmination with 100 Million Lives coming and talking about the well-being and the nation framework. It lays out the elements that have been where there are sufficient use cases to suggest that these elements are important and where to pull them from.

We had a hearing last September that also brought community stakeholders in to talk about the data that they have lost access to that they use for community health needs assessments and other purposes. We would really love not only your guidance, but your invitations to us on how to help link those needs up to this federal data strategy that is moving so fast and the conflicts that happen between security and access. How do we from that process produce data that local communities can access and use reliably? We would love your help and your guidance and invitation to work on that.

ARNOLD: I am really looking forward to it. As you can probably guess, we are struggling with the demands both internally to HHS for data and externally the kind of explosion of data assets and resources and flat or declining budgets. We are trying to prioritize what we can do within our current resources. I suspect we are not always making the right decisions. Input about priorities is always helpful, but kind of recognizing that our resources are incredibly limited and getting more so. I know you know because your resources are also limited as ours are. It is tough to always continue to do more with less. That is the mantra.

Thank you very much for the opportunity to come talk to you. I really look forward to working closely with you. Thank you.

STEAD: We will go back to Linda.

Agenda Item: Health Terminologies and Vocabularies: Draft Letters

KLOSS: We will go back to the letter on criteria and guidelines. I think Bill was just commenting on our rationale for reversing the order from what it appeared in the E-Book and that is that we see the ICD-11 as an opportunity to really apply the selection criteria so the criteria come first.

The first page, the third paragraph of this letter kind of gives us some history on standardized naming and coding of complex health concepts. Then the next paragraph is NCVHS’ role with regard to patient health data, our environmental scan. I am just kind of going to walk through. You stop me if anything just is not clear.

Line 51, important paragraph where we define that a limited number of terminology and vocabulary standards are referred to as named standards and the definition that we adopted for these as laid out in the environmental scan.

With enactment of HIPAA, the US government’s role in the collection, exchange, and protection of health data was explicitly recognized, leading to NCVHS’ development of Guiding Principles for Selecting Patient Medical Record Information Standards between that period of 1998 and 2000.

We are setting up then the work products in this letter are the result of after nearly two decades of experience with named standards. And based on our comprehensive environmental scan, we have set forth two sets of criteria as appendices, which will guide evaluation of new standards and serve as a reference to raise the bar for development, curation and implementation of health vocabulary standards that are not named standards. I think that is an important part that we think laying these out does provide an industry reference and could have the potential of raising the bar or being a reference point that perhaps those who are acquiring a terminology product will ask some questions about or include in specifications or somehow be more critical as they approach the adoption of standards for their own use that are not named standards through the secretarial process.

Our two recommendations are pretty straightforward. We are asking the Secretary to adopt the criteria in Attachment A and the Secretary to adopt the guidelines in Attachment B.

Any comments on either of those recommendations or the rationale or how they are worded of what may not be clear to you? Obviously, the meat of this is in the attachments.

COHEN: My comments have to do with the attachments or should I wait?

KLOSS: Why don’t you just wait? We will delve into each attachment.

Let’s go back to just – I mentioned that we worked hard at getting the titles to these two documents to be clear. We had principles. We sorted with guidelines. And then we decided that criteria were the right noun for Attachment A because these would be used in the more official capacity of the secretarial adoption of named standards. Criteria were used in that light.

Attachment B, because it relates to how organizations that manage and have terminologies curate them and disseminate that. Processes that are not really directly part of the regulatory process. We used the term guidelines as a way of encouraging again the more standardization of how these things are done or again raising the bar. Does that make sense?

This is still kind of part of that process of getting to a named standard. B is for those organizations that are managing named standards or other standards its guidelines for what reflects contemporary ways in which these kinds of standards should be curated and disseminated. Criteria versus guideline.

Now, we are will get to Attachment A please. As I said, this is where the meat of this recommendation comes.

COHEN: I spent eight years not wordsmithing and I have my final chance and I am going to use it. Line 130, when you say ANSI and ISO, there is no previous reference. You should spell out what those really are.

KLOSS: We will. Good.

COHEN: I can leave happily now. That is all I had to do.

KLOSS: That is it? Okay. Thank you.

PHILLIPS: I have said at every one of these meetings, it is always an education for me and Linda, you have been one of my main professors. Thank you. I am sorry to see you leave.

On line 149, Recommendation 11 on the criteria document, clarity in lines of responsibility among stakeholders and then it lists them. Is that a new process? Is that a common process? Is that calling for a common process? Is it going to be understood?

KLOSS: Actually, we broke out. We had this all one set of standards and then one of our aha’s was that criteria 1 through 8 relate to characteristics of the standards themselves and 9 through 11 relate to how they are implemented.

I guess what this is saying is that we want these lines to be explicit, transparent, and clear. Nobody does this work in a vacuum. I think that relationships between stakeholders including the sponsor, the regulators, the vendors and end users should be somehow clear and explicit as part of an evaluation process that would allow, for example, a recommendation for adoption by the Secretary.

PHILLIPS: Who does that? Who clarifies these lines and rules?

KLOSS: I guess I am going to go back to our earlier discussion on DSMO. There is not a DSMO type organization in this particular domain. We raise the issue of governance as a near-term longer-term issue with regard to vocabulary and terminology standards. I think our thinking is that that would come out of a mid-term step of doing a strategic plan for terminologies and vocabularies. We see that as something that needs to be done. It is probably a mid-term work. And out of that needs to come a discussion about how we get better coordination, more deliberate coordination than perhaps exists today where really each system has its own governance, but there is not a collaborative mechanism to bring them together.

We have identified that as a need, but we did not put it as a near-term, but it has to come up. But I think at the time we had the roundtable and Bill, I know you had this insight that that governance mechanism needs to come out of a strategic planning process for vocabularies and terminologies going forward.

You are right to question it, but I think having it here is a good anchor point. If somebody is coming forward and saying we seek adoption of this new standard, there ought to be a pretty clear set of how we all work together. For example, what kind of stakeholders have been brought together to help guide the development and set the policies and practices around this? This has been done in a vacuum. Has it been a more collaborative process? Because every one of these things hit so many stakeholders.

STEAD: Can I try to maybe unpack that a bit? I think that the way I thought this might be used is in essence if we are going to consider a terminology for adoption then the process that uses – the relationship amongst these should be documented for that terminology. At this juncture, I am not suggesting we try to – I am not thinking we could try to provide overarching coordination. That is work to be done. If there is some way to be clearer without using the word clarify that we are talking about initially something as simple as documenting what they are.

I think that is our intent at this juncture because as we work the iterations of this and had to, we in the end split. One through eight are things that most existing terminologies and vocabularies do not meet. But I think there was quite a lot of consensus at the roundtable that this is what we need to work to achieve going forward.

This should in essence be the scorecard that you would evaluate against. It is not that we would reject everything that did not meet the bar. Again, I do not know if that needs somehow be clarified. We are trying to keep this as simple as it can be. With that unpacking, we need guidance about how to —

KLOSS: Bill, I would just amend one thing you said. The one through eight, most systems do not meet it. I think what we have learned and what is revealed in the environmental scan is that they meet it in various ways. Not all systems meet all eight, but some excel and do very well at some and not so well at others. We have a more variable environment and certainly we have some systems that are leading in best practices in some of these.

I do not want to say that our conclusion is that they are deficient because there are some very effective processes. They are just highly variable across. At least now as we look at the current named standards, there is variation. I think that underscores the use of the word criteria, checklist criteria.

LOVE: Speaking of variation and wordsmithing, I hate to be nitpicky, but as I read it, this jumped out on line 45 of the letter. It is really not the number of systems that is the problem, but adding the number of systems and variation in their purposes, ownerships, and ways, I think made more sense to me than just the volume or the numbers. Is that my interpretation? Because it is really not the number of systems. We could have more too, but it is just that they vary in their governance, their purposes.

KLOSS: Except if you read through, certainly all the appendices and the environmental scan, the number also can be daunting, not the number that are necessarily named.

COUSSOULE: The number had a potential overlap – which is part of the challenge.

LOVE: As I read it, it is just in terms of the number of systems and variation in their purposes, ownerships, and very small change. But that is one thing that jumped out to me.

KLOSS: How would that change it? In terms of the number of systems, their purpose – because we were pointing out that the variation is – the complexity is because of number and because of purposes and because of – I think they are all discrete contributors to the complexity. I do not know.

PARTICIPANT: (off mic) It seems like the purpose itself was not – they all differ or they could differ – it is a wordsmith —

COHEN: The report actually describes the complexity and variation so maybe variation goes up in the beginning in the environmental scan.

KLOSS: That works.

COHEN: Another wordsmith from me.

KLOSS: There you go. You are having a bonanza day. We are going to have a hat trick before we are done here.

Anything else on Attachment A? Yes, Nick.

COUSSOULE: As described in the recommendation, the title does not actually match the title of the document. It is just to make sure the wording is – criteria for selecting, adopting and then attachment A is criteria for adoption and implementation.

HINES: We just need to update to get them consistent.

STEAD: Make the recommendation match the attachment.

KLOSS: Let’s go to Attachment B. This is a new set of guidelines.

STEAD: Let me just add. I do not want to lose what I think – on number 11, 149, could we just say documented – replace clarity in with documented. Bob, would that remove the interpretation that we might be implying coordinated oversight as opposed to just making it clear? Writing it down. I think that is an improvement.

KLOSS: We are going to spell out ANSE and ISO and footnote that and make this change to 11. Otherwise, I think on A, we are okay.

Go to B. When we went into the roundtable, we were using the word maintenance for this process of periodic updates and receiving questions from people who work with the vocabularies and recommendations for changes. NCHS and CMS have a very long-standing coordination in maintenance committee. We were using that word maintenance. We came out of the roundtable with consensus that the better word is curation just like in a library or a document where we have a very deliberate process for how things get changed, adapted, modified, moved forward and that we were convinced coming out that curation was a word that we should be using rather than maintenance. By dissemination, we mean this whole release process. Both of these reflect pretty complex set of processes in and of themselves, but curation is kind of the whole update process and dissemination is the release for use, release for implementation.

Because this is a new set of guidelines, we tried to be – to keep it to those things that were pretty fundamental, knowing that the committee and the department should help maintain these guidelines with experience over time. We are asking for a transparent process, curated by a range of experts who have the skill to precisely and unambiguously make modifications, using accepted content, development practices that optimize data quality. You can appreciate that each of these sentences is fully packed with very important concepts and curated to assure backward compatibility and full and clear documentation regarding additions, changes, and deletions preferably computer processable and time stamped. Again, that starts raising the bar. We do not expect that that is fully in place. But if we are using these systems in a digital environment, these should be guidelines that are more aspirational.

Maintained using open and timely processes for request and consideration of additions, changes and deletions. We saw and described and laid out in the environmental scan a full range from digital daily updates to submit your requests in paper with 13 copies. Just kind of laying this out and beginning to raise the bar we think is an important contribution.

Open processes for requests, full disclosure of decisions and the rationale.

Released according to publicly available release processes at a cadence that balances the importance of enhancements with update costs and aligned with overall standards adoption roadmap. We are putting a placeholder for having a strategic plan and having this also on a more transparent Predictability Roadmap.

Version updates to named standards accomplished through least costly and disruptive sub-regulatory processes. That is a pointer to the next letter we will be looking at. It reflects what we just recommended for Predictability Roadmap for administrative standards.

Responsive to customer needs for support services and timely answers to questions about how to apply and use the standards guidelines, maps and other resources. We heard complaints and again wide variability and how easy or hard it is to get an answer to how do I code this.

No or low cost ways to obtain updated standards, implementation guides and map and other resources. We are hoping for economy of processes and using electronic resource and dissemination methods that minimize cost and licensing barriers. Again, looking forward to leveraging terminology, technologies as they further develop.

STEAD: We have cards up from Bruce and Vickie.

COHEN: I really like this set of guidelines. I think the words curation and dissemination are perfect for the broad overview. I was just wondering whether you had any vision or ideas about who in HHS would be responsible for providing this guidance because it seems very broad without that sort of focus.

KLOSS: And the header to this is HHS will encourage use of the following guidelines. This is not a regulatory action.

COHEN: Would it be left to the devices of each data holder or data curator, the agency they are in, ASPE? I would like to just understand more –

KLOSS: Or the industry as a whole.

COHEN: Somebody at HHS is going to be encouraging the use of these guidelines according to the first sentence. Who might that be?

STEAD: It is a good question. I will use this to point out something that Linda I do not think specifically talked about, which is that we were very careful in of the letter anchors NCVHS’ role in recommending these in HIPAA, which is where our role originated. We have been very careful to avoid limiting the applicability of these two attachments to things that relate to HIPAA. We note in the footnote on each attachment that as we did in the environment scan that we are suggesting these apply to terminologies and vocabularies that are adopted through regulatory or sub-regulatory processes. In the environmental scan, we noted that the two then current were the ones related to HIPAA and the ones related to promoting interoperability, formerly meaningful use.

The thought would be since these are guidelines and we are encouraging use that it would actually be something that when any part of HHS did something that touched this space that these guidelines would help them.

We had good involvement from Mike Lincoln and Steve Brown at the VA in the conversations that led to this. Our colleagues at NLM were engaged in that conversation. I think that that is actually the way this would happen. We were not envisioning. That does not mean we should not discuss it. We were not envisioning that there would be a single point office. We envisioned the Secretary would approve these to be used as guidelines to encourage or as a checklist for adoption. That is where we are. We need to know if the committee thinks that should be changed. Is that a fair statement?

KLOSS: That is helpful. Thank you.

MAYS: Actually, my question was very similar to Bruce’s, but then I have a comment. My question really was that I think it is just very general. When things do not land someplace for someone to be the place of questions, the place where it is clarified and there are case examples and all that then I think it just hangs out there. I actually love what we are recommending, but I guess my concern is it just is there. I just do not think the Secretary’s office without it having a relationship to something is going to be mindful of making sure this happens.

My second thing is actually more of a comment. The first was a question about should we do that. But the other is a comment. That is about curation. I would not have known this if it had not been for a committee that I sit on at the university. But there are all these different kinds of curation. There is data curation. There is digital curation. There is social curation, which they use in terms of a lot of web stuff. I am assuming and I try to plug certain ones in. I am assuming we can still leave it as just curation, but there are a couple of places where I think it would help to modify by saying data curation. Because once this goes out and people think about are you talking about digital assets and if you are talking about digital assets being curated then that is a little different than what happens to the data. That would be my only comment. I am fine with it either way.

STEAD: I do not think data curation actually applies to this. This is curation of the semantic content and relationships of the terminology that you would use either in the capture of data or in the tagging of data that you capture. That shows your question is a good one because this is curation of a semantic knowledge resource in essence. It is not curation of data.

MAYS: I am hoping the average person knows that.

STEAD: I would not go that far.

MAYS: I think that some of the people when they read it will think about those other uses. Is there a little place somewhere in the beginning to say something?

STEAD: Then do we say semantic curation? Would that help?

MAYS: I think if in the very beginning that is said. It modifies it when you say curation in the beginning. Then these things do not all need to be modified. I think if we just say it once then we are good.

PARTICIPANT: I think perhaps we go back to the letter.

MAYS: I did not mean in the recommendations. I meant the very beginning —

STEAD: Let’s look at line 90 thereabouts. Curation is the process for managing the content of a terminology or vocabulary. That is the phrase. Is curation is the process for managing the semantic content? Would that help?

MAYS: I think it would.

LOVE: This could bring us to lunch pretty quick – I am trying to be good. I really am. I am trying to understand – this is a great document. I do not have anything really wordsmithing now to add. I am trying to get my head around – this seems aspirational and very good, but operationally, I am trying to think how it would work. I am thinking of the Predictability Roadmap and is it too much of an ask for terminology maintenance organizations to have some sort of cycle of update and predictability as well. If that is even outside of the scope of this, that is fine.

And then what is HHS’ authority comes back to that and there were public health emergency or anything like that. Can they draw on some authority to fix some of these problems? It is just my ignorance.

KLOSS: Let me answer the first question first. Every one of the terminology and vocabulary sponsors has that process. They have a process. We have some folks here who – Suzie studied this in preparing large sections of the environmental scan. One of the challenges in that environmental scan was pulling out all the information about how these processes work associated with each vocabulary. It is not that there is not a process. Everybody has a process. They are not all the same. They are not always consistent. They are not always best practice.

And then I think the second part of your question goes back to our earlier discussion on the road ahead for the committee’s vocabulary work and that is needing to develop a strategic plan and recommend a governance process perhaps at some point.

STEAD: Right now, we have the similar links to one of these lists 2000 criteria, whatever they were called. What we are really trying to do is take advantage of the 20 years of lessons and the roundtable and the environmental scan to say this is what a modernized version of that looks like and we have learned enough that we now know these would be pretty good guidelines for curation. They are not the process. The process is part of the intermediate term work that we know we have to come back to and the stuff we have to scope.

One of the things we are going to talk about – if we can get this letter done, one of the things we will be talking about is how to actually test using this with ICD. We would actually use ICD as our training – that is the idea. Is that fair, Linda.

KLOSS: Yes, that is fair. And going back to Bruce’s comment, I do not think it is unusual for the committee to make a recommendation and we do not often tell the Secretary how to do it. We would encourage the use of. It really is up to the Secretary to decide how to do that. You are shaking your head, Rebecca. I think that is true. We do not. We do not say who to assign it to.

COHEN: I appreciate that point of view. But building on the comment about ICD-11, clearly the agencies that are going to be involved are primarily NCHS who is our representative. Maybe it makes more sense to say HHS encourages its agencies or its programs to use or something like that. I am just thinking some kind of direction because every program or agency or entity has responsibility in regulation or sub-regulation that would be covered here and that would help provide more specific guidance to the Secretary. Something just general like that.

KLOSS: I like that. HHS will encourage its agencies and programs to use the —

STEAD: Do we want to try to see if we can take action on this letter and move on to the ICD letter?

KLOSS: Yes. We have editorial suggestion on lines 44, 45. We will look at whether adding an “and” and moving the reference to variation forward makes that clearer. On page 3, line 89, we will add semantic in front of content. We will spell out ANSI and ISO, change criteria 11 by substituting documented for clarity and add Bruce’s suggestion to the header on Attachment B.

LANDEN: Shouldn’t the outline also be in the recommendation itself on line 71 and 83?

KLOSS: We are more direct in Attachment A. I do not know that we are saying there HHS will use the following criteria. I think that issue is relating to Attachment B.

STEAD: Because adoption is not done by everybody. I would prefer to have the additional text on Attachment B and the recommendation related to attachment –

Subject to those editorial changes, do we have a motion to approve?

PHILLIPS: So moved.

STEAD: Second? Any further discussion? All in favor? Any opposed? Congratulations Linda. Now – number three.

KLOSS: This one you will like because it is a little more concrete. Not easier. Now we are kind of going back to the thinking that we went through with Predictability Roadmap. This is the Recommendations on Regulatory Simplification for the International Classification of Diseases. This came about through our environmental scan and the roundtable as a real aha moment. Because as we laid out the processes side by side for the named standards, we realized that the ICD path was the only path for updating that required regulation. That the rest of them whether it is CPT, whether it is HCPCS, all of the other named standards, LOINC, were being managed, maintained according to a schedule from the sponsoring organization. And every time they made an update they did not have through a full regulatory lift. This letter then conveys recommendations for an approach to simplify the adoption of future versions of the International Classification of Diseases and related health terminology and vocabulary standards.

We reference our role and we again reference the two reports. Line 23. HIPAA refers to these terminology and vocabulary sets as Code Sets defined as any set of codes used to encode data elements, such as tables of terms, medical concepts, et cetera. A limited number of named code sets are identified. Section 1174 and this is important of the Act recognizes the unique challenges of maintaining dynamic medical and health code sets and requires the Secretary to review the adopted standards and adopt modifications as appropriate, but not more frequently than once every 12 months in a manner that minimizes disruption and cost of compliance. That is in the Act.

Having studied these then we offer three strategic recommendations. HHS should use a sub-regulatory process to make version updates to the International Classification for Diseases in the same it handles updates to all other HIPAA code set standards.

Then the three paragraphs that follow that describe how ICD gets developed, what our process was for moving from ICD-9 to ICD-10 and then the second paragraph contrasts that to all other updates. We make the argument why that is both in line with the natural progress of these code sets and is allowable in the Act.

Any questions on Recommendation 1 or the rationale? Everybody okay with that recommendation then?

Two. We are calling for HHS to resource a project to evaluate 11 and design a plan that will ensure a smooth and transparent transition at the optimal time. NCVHS recommends using updated criteria for adoption to underlie the project that makes key milestone decisions based on objective assessment so apply the criteria in the first letter, criteria for adoption in the evaluation of when and whether the US should move from 10 to 11.

We outline the timeline. The clock starts ticking in May 2019 when the World Health Organization adopts 11 for worldwide use with an effective date of 2022. This starts the clock ticking on when the US is going to start using this for mortality, cause of death reporting and whether ICD-11 is adequate as a morbidity classification system for the US or whether the US needs to develop a clinical modification as it did for ICD-10. But we are suggesting that that go through a formal evaluation process to make those decisions and that we not leave it until sometime in the future, but begin to scope out that project.


MAYS: This is a really serious recommendation. It is a great recommendation. It is a really serious one. But there is something about the tone. I am going to channel Bill. There is something about the tone that does not really convey how critical it is to do this because of the implication so exactly what you were saying.

First, it starts with HHS should resource a project. Is resource another word for fund? What is it you really want them to do? Resource can be sending a person to just pay attention. I think we should ask for what we really want there.

And then the second is I do not know what this first sentence means. The first recommendation was not academic. I think we could drop it in the sense of – I am not sure what we are trying to say. I think you are trying to say that this is a very critical recommendation that is not being made lightly.

KLOSS: We are not making – change the regulatory process in one just because it is a nice thing to do. But change it because it is going to be called into – we are going to have to use whatever this process is again on the horizon.

MAYS: But it is something like that. There is something about more serious and I do not quite know how to say it, but I know I want to dump that sentence. I want to change the word resource.

KLOSS: I did not know how to say resource, but certainly in my mind, it is not just money. It is people.

PARTICIPANT: HHS should implement because that implies people and money.

GOSS: How about invest?

KLOSS: Invest works for me.

MAYS: I like that.

KLOSS: I like that. I think it is not implement. I was trying to – this is going to need a little bit of a critical mass.

LOVE: And even that – later in the sentence, ensure a smooth – I would think it is facilitate because I do not ensure – we can ensure even with resources.

PARTICIPANT: Enable or facilitate?


COHEN: Design a plan or develop a plan?

KLOSS: HHS should invest in a project to evaluate ICD-11 and develop a plan that will enable a smooth and transparent transition. Excellent.

MAYS: Should it be said in a very near – because there is a time – issue here.

KLOSS: It does not have to be done in 2019. We need to start.

MAYS: But that is what I mean. You need to do this in a very near future. It is not immediately. The urgency of this needs to be in somebody’s work plan for this year to start this process.

KLOSS: Or in the next year’s budget.

MAYS: You have to do that. You have to start paying attention this year. Something like in the very near future. HHS should in the very near future —

KLOSS: If you read the paragraph that you are suggesting we drop that first sentence and I think that is fine. We have spelled out kind of the timeline going forward. It will take some time to do the cost benefit research. It will take some time to make these critical decisions. We need certainly plenty of ramp time to decide when to adopt. Even if we start in 2020, it is years. I think the message is start now, do it right.

MAYS: I would like the modifier time to be in the recommendation because in some instances, this other stuff is going to get separated and it will be – some people will just be looking at the recommendations. I think there is an urgency of this.

KLOSS: Invest now in a project?

STEAD: HHS should invest now in a project.

KLOSS: And then I think we have consensus that we will drop — the first recommendation was not academic. We will just drop that. It does not add anything.

STEAD: While we are trying to get this right, we will stick – HHS should invest now in a project to evaluate ICD-11 and develop a plan that will enable a smooth and transparent transition – I think the next is a little vague. NCVHS recommends using updated criteria.

PARTICIPANT: The last letter.

STEAD: I understand that. It has to stand on this alone. We are going to need to come back. We need to figure out how to reference the actual attachment we just did to make it –

PARTICIPANT: Why don’t we just footnote it? See letter to the Secretary.

CORNELIUS: Just it in parentheses.

STEAD: Add the footnote.

PARTICIPANT: We already referenced the letter on the next page – lines 81 to 85.

CORNELIUS: In bold, you are saying a statement and referring to something and therefore you have to point to it.

KLOSS: Maybe we do not need that as a part of the recommendations. Maybe it detracts from the recommendation. I think it would be stronger if we just bring that out in the narrative or in the rationale.

STEAD: So have a one-sentence recommendation.

KLOSS: And then we can footnote the letter on line 81.

STEAD: I think this is complex enough that we are going to want to bring this red line back in the time we have this afternoon for doing edits.

PARTICIPANT: Too bad I am not up there because it is not really –

STEAD: I understand. I think that is just process wise if we want to get – let’s get through the rest of the letter so we know —

KLOSS: Let’s go to 3. HHS should rename ICD-10-PCS so it is clear that it is a US procedure classification and has no connection to the World Health Organization’s International Classification of Diseases.

This is kind of clean up thing. I think the background is laid out here. But when we went from ICD-9 procedure classification, which was in International Classification of Diseases version of procedure codes to 10 when the World Health Organization did not have a procedure classification system. The US CMS developed PCS for use as a substitute. It is not an International Classification of Diseases. Certainly the World Health Organization was not happy that we were calling it that. It does not seem appropriate that we would be usurping the ICD brand, if you will, for a procedure classification developed by CMS for use in acute care in the US. That is the rationale.

STEAD: But the reason this is important is because the current naming misleads generalists like me to think that if we elect to update ICD-10-CM to ICD-11 or to ICD-11-CM, as the case may be that we also have to upgrade ICD-10-PCS to an ICD-11-PCS. I think we have convinced ourselves that coupling does not in fact exist; therefore, we need to remove the ambiguity so that everybody sees we do not have to – we can decouple them and therefore have a more agile update process, which – right back into the Predictability Roadmap.

COHEN: My comment is and Bill helped explain it a little. I think this recommendation is distracting from the core of what we want to say, which is we need a different approach to adopting ICD-11 and we need to start now. When you add this – I think this is important. I almost see this as a separate note or letter. I think the letter would be stronger just to focus on new criteria, ICD-10 or ICD-11. Somehow I was right with you and then after I re-read this, it sort of distracted me from the enormous importance of getting ICD-10 to 11 right. Just a thought.

MAYS: At first, I had kind of this how is this coupled. Bill did exactly what I needed to understand better. But as soon as I understood that then I am going to agree with Bruce. It is almost like maybe this should be here because I think it needs some additional background about it so if it could be separate. I think have people be able to come to this to understand the coupling is not there. No crosswalk. No nothing. Why it is it was chosen to – why this was chosen. I think it would just be better if it were out of this letter.

KLOSS: I would just challenge you a little bit. Why does it matter why it was chosen? We just have a situation where we are calling something.

MAYS: Because I think for people in international settings to understand why we are doing what we are doing so that they can have a sense of – this is just for the US. Why did we do this and what is the background for it so that there is some understanding? I think the confusion is in the name. If it continues with that name, can you tell me why the US chose to do this and whether others should consider the utility that is being used for, whether or not they should do it as well?

STEAD: Is somebody on the phone trying to say something?

We are one minute from when we need to —

KLOSS: We will hear from Rich and from Nick and then we will regroup.

STEAD: We will figure out how to regroup and come back.

LANDEN: For the exact reasons that, Nick, you just described, I think I disagree with her and Bruce’s opinion that this does not belong here. I think it is tied in with the whole way we need to think about ICD-11 upgrade.

But I absolutely agree that it needs more explanation for the reasoning there. Because as many times as I have read this draft and even though it is implied in the sentence beginning on line 102, 103 that does says it does not need to be tied. That needs a lot more explanation because as I said, I read this half a dozen times. It did not occur to me that we can move to ICD-11 without changing off of ICD-10-PCS. I think that reasoning needs to be spelled out, but I would not recommend we do as a separate letter.

COUSSOULE: Very briefly, I agree with Rich on this one. I think the point of – if you go down to the next paragraph, which talks about these recommendations taken together, ideally we will improve the process versus the last time. I think by including that, it really does get to what does it take to be successful with the transition. By the way, this is not required. I do think they actually fit together. Whether we have the right language in there to explain it well enough, I do think they actually fit together to talk about a better approach transition from 10 to 11.

STEAD: Let me make a suggestion that we have talked about how to cure this illness to see whether – I think what we might do is just make the recommendation be very simple. HHS should clarify that ICD-10-PCS does not need to be updated with ICD-11 or something like that. Make it simple. Figure out what the simple statement because that is what we are trying to get clear. Renaming is one way to make it clearer. But our real purpose is to make it crystal clear that the upgrade can be decoupled.

But I think what we are going to have to do is write something offline and come back. We will do that after – we will bring it back after report to Congress.

KLOSS: I am okay. I still feel kind of strongly that — I think I understand why it was given that name because it was part of that package. To communicate to the industry this is the next generation. I think it is clarified.

But I also think it is finding a way over time to rename it properly. Maybe not rename. Name it properly. I would just call it procedure coding system. I think it is the ICD tacked on to it that is the problem because it has nothing to do with the World Health Organization. We are going to run into problems down the road if the World Health Organization continues its development of a procedure coding system version. I just think it forestalls problems down the road. I think renaming – I would encourage us to do both.

STEAD: I am going to play agenda cop. Linda has the great advantage. She is the chair or co-chair of this effort. You can do your best to re-draft it. We will bring a red line of this letter back toward the end. I think we have maybe agreement. We want to try to keep it in, but in a way that makes it clear. Let’s take that cut and try to bring it back and let’s see where we are this evening.

We will adjourn until after lunch. We will re-meet at 1:30.

HINES: Before everybody gets up, we need to count for dinner tonight to give to the restaurant. Please raise your hand if you plan to come. I have 12, 13. There is slide right there and I can email this information to you. It is a 15-minute walk from here or a five-minute ride. On the table there is all of that information.

(Lunch Break)


Agenda Item: Report to Congress

STEAD: Let’s regroup and begin to work on the Report to Congress. What I suggest as an approach to this conversation, I have put together a short Power Point that will let us walk through the complete report at high level to really make sure that we are seeing the key messages together. And then we will come back and look at whatever parts of it we want to look at in terms of working through the direct text itself. It will be a two-pass process, if you will.

To start, this is the purpose. We are trying to do two things with this report. First, we are trying to meet our statutory requirement to report to Congress regularly on the implementation status of HIPAA and the administrative simplification provisions. And we also want to outline ways at which HIPAA needs modernizing to enable the now much evolved digital health system to more fully support needed improvements in innovation and health care in health while reducing costs and administrative burden. These words come straight from the report. We have worked very hard at aligning the words of the report with the words of the letter. I am really trying to make sure we see the current wording as we walk through it. That is what we are trying to do.

We have been on a journey to develop this report that began in August. We developed an initial approach to the report, given what we had been hearing in the work related to vitals, to the Predictability Roadmap, to T&V and to Beyond HIPAA. All of them pointed to this, this need for a call to action to modernize and accelerate progress and the status report outline.

Then we discussed that at the executive committee in August and then at the September Full Committee, we walked through that report at the beginning of the meeting so that we could have – the fact that we were trying to build this report in front of us as we worked the projects that I just described.

We then had a Full Committee brainstorm of the types of actions that the legislative and executive branches and the private sector could take together to accelerate progress.

And then in the September Subcommittee, we had a good – Executive Subcommittee, we had a good discussion of this. We began to work on the streamline set of the actions that came out of the Full Committee brainstorm. We made the decision to limit what is now Part 2 to the pieces that were focused on the status report of on administrative simplification. Part 2 is now solely focused on the congressional mandate.

And then we added Part 3 to let us move the population health data connection into that section as an intact section. We wanted to clarify what part was the status admin simp and what was the additional intersection we see from the pop health connections, play back what Sharon just said about two of the four priorities of the department being the opioid data and pay for value. All that clearly relates to this intersection.

Then we worked in subcommittees to draft the actions for the three different actors. We worked in subcommittees to draft the status report. We assembled them and we worked with CAQH and others to get the data we needed to clarify the current rate of progress, the current trajectory, if you will, and the magnitude of the opportunity if we could accelerate progress.

We had the Predictability Roadmap hearing in December which I think really clarified for any of us that were present how much consensus there is in the industry that we have a real opportunity if we can do something differently.

And then we have been – at the same time we were writing these three letters, we have been iteratively refining and tuning the message in the report, getting its tone where we think it needs to be. The original tone could have been read as suggesting you wanted to dismantle HIPAA. That has never been our intent. We have now, I think, got the tone where it attempts to make it clear that HIPAA was a necessary and excellent start. We are building on that. We need to change the trajectory to deliver 20 years later on what is now the opportunity. We are trying to have that message come out very clearly. Susan has been wonderful in the way that as each new version of the three letters came out, we adapted the Report to Congress to keep them all harmonized as we went along. As you look at the language in the report, you will discover it is directly taken from the letters in many cases. That is sort of the journey that we have been on.

Coming out of that journey, these are, I think, the three key messages. HIPAA was a visionary law that put the country on a path towards standardizing electronic health transactions and protecting patient health care information. It has achieved considerable success. However the regulatory processes put in place have not kept up with the changes in technology and health care. Our central message in this report is that revisions to the current HIPAA rule would facilitate the agility industry needs to keep pace with the opportunities and challenges of today’s ever-changing health care landscape.

The data to support – the curve on the left are the graphic refinement of the graph of the curves that were in the report. What I want to do is just briefly walk through the data. First, it supports the exponential top curve, which is trying to depict the rate of growth of the volume, quantity, if you will, of health data.

The lower curve is trying to communicate our current incremental trajectory of increasing the volume of that that is standardized. And the gap between the two lines is the gap we are trying to suggest ways we can close.

The data that supports the top line. The curve on the right-hand side comes from two reports, one that was in 2013 and one that was in 2018. Both were done by the consulting group of the International Data Corporation, IDC, one in conjunction with EMC, and the later one in conjunction with C-GATE.

Basically, what they predicted in 2013 was that the volume of health care data at that juncture was .153 zigabytes, where a zigabyte is one billion terabytes. And that volume was projected to grow to 2.3 zigabytes by 2020.

The 2018 report basically confirmed that – the 2018 estimate for the health care data sphere was 1.2 zigabytes, which was on track for what the 2013 report said it would be. Looking back five years later, it is still trending the same way, and they projected, as you see in the bottom right of that slide, that the health care industry rate of growth would be 36 percent compounded annual growth rate, the largest of any industry segment in terms of the rate at which it is growing. That is, if the will, the fact base behind the upper line.

The data about the rate of current progress. The table at the upper left of this slide shows the rate at which we have added named transactions that were adopted in law or regulation. Then the rate at which we have been able to adopt the transaction standards to support those and the rate at which we have been able to adopt operating rules to support those standards. And then below that, the percent or the number of the administrative transactions with the operating rules adopted in regulation.

The key message there is 20 years later, there are still some transactions named in the statue, which we have not been able to adopt standards for. There is a gap just related to the law.

The table in the bottom is in the draft report as you see on this slide. It comes from the data from the CAQH index. CAQH released a new version of that in 2018 right before we were completing this draft to Congress because it came out in late January of 2019.

What it shows is the percent of industry implementation of the 6 of those 11 transactions that have been widely adopted, widely implemented in the industry. You can see that there is still a gap, things like remittance advice is less than 50 percent but certain things like the health care claim submission rate are close to 100 percent. That gives you some feel for the rate at which we have succeeded in implementation. You can see the rate at which it is improving. If you look at things like the health care claim status, it jumps from 50 to 70 percent over the last five years.

In the upper right hand column, you have a table that CAQH developed for us based on the index. And what it actually does which I think is very helpful is they basically looked at the 2018 index and they said what would it cost the industry if all of those six transactions were still manual. That cost would have been $78 billion. They then calculate the savings from the ones that are electronic, which is $68 billion. If we hadn’t passed HIPAA, we would not have that $68 billion in saving. That is an example that we have made progress. You see the remaining opportunity which is $10 billion on that data, which are actually medical and dental claims as the part that it relates to.

The bottom table on that chart is the data that the index is based on the time it takes to do a transaction if you do it manually versus electronically and the savings that results from that.

Now, the big aha to me is I had many conversations with that team and with others and they were extremely helpful. The index was very clear. They are calculating the savings from the transaction itself. They are not able to step back and say what if the transaction were completely electronic and seamless end to end from the electronic health record system through the revenue cycle system and through the claim management system of the payers and back and again.

Nobody has tried it to do a detailed analysis of that because of the historic separation of revenue cycle systems and electronic health record systems. That in my mind is actually the canary in the coal mine that says what convergence of clinical and administrative standards is essential. That is a very important aha and it took me a good while to really understand it and I am really grateful for the number of people that put up with what must have seemed like silly questions on my part as we went through that process.

Then what we did was step back and say okay. If we cannot get an estimate of the opportunity for complete administrative standards, working up from detailed transaction data, let’s go back to the most recent estimates of the cost of administrative complexity. The Health Affairs blog in 2018 had a very useful extrapolation of that cost based on a very well-referenced paper by Don Berwick that was in JAMA in 2011. They basically used the health care expenditure data to update those projections. In essence, what they came out with was the midpoint of the current cost of administrative complexity of $312 million. That is the midpoint.

We then said if you took the $68 billion that we have saved and you added it to that $312 that is still out there, you end up with $380 billion. What is 68 divided by 380 billion? It is about 17 percent. I have trouble dealing with numbers as big as a million. Let’s fix that in the draft. Good point. Then we said okay. Let’s just pick an upper bound because the $68 billion does not, for example, have the pharmaceutical claims in it. It is reasonably conservative to think that the percent of the opportunity we have gotten to date is probably less than 25 percent of the opportunity, just trying to help people see the magnitude of the gap. That number is in the report. The 78 billion and 68 billion once corrected are in the report. That is where that data came from. We footnote it, but we did not put these kinds of tables in the report just to try to complete the complexity down.

(Sidebar conversation)

STEAD: Now this is an important figure. We had a placeholder for this in the report. We did not have a real figure in the report. The point we are trying to make here and the language on this slide again comes directly from the report. We draw on our assessment of the status of HIPAA implementation to identify actions that the – it is actions, not recommendations, to identify actions that the government’s legislative and executive branches along with the private sector and community-level entities might take separately or preferably jointly to introduce into HIPAA the flexibility and pace that today’s rapidly evolving environment demands.

Our suggestions are predicated on distinct roles for Congress, the executive branch and the private sector actors that we believe will facilitate efficiency and coordination. Concerted action across all of them will produce compounding effects. What we are basically proposing is that we want to have Congress do the high-level task of specifying the policy, accountability, and resource strategies.

We want the executive branch to focus on regulatory rule making, engagement, and coordination. And we want industry in the private sector and community-level actors to have actual implementation and innovation to respond to needs. In essence, this really came out of the Predictability Roadmap hearings. The technical details need to be worked out and proven in the industry and adopted. They need to be responsive to the regulatory guidelines and they need to be enforced and they need to be empowered and optimized to achieve the policy recommendations from above.

But if you look at the existing laws and rules, all these levels get in our mix and that is where a lot of the complexity comes from. That is a key point.

The other key point is this relationship between the standards and privacy and security component of administrative simplification and the new business models that surround population health management and community well-being, which reduce the need for health care, the ultimate form of simplification. It tries to make that inter-relationship clear.

The actions to affect change are at higher level. We will go through them word by word in a bit. But at this juncture from the viewpoint of standards for transactions operated in associated rules, terminologies and vocabularies, the key actions would be to modify HIPAA, clarify roles and responsibilities as we just mentioned, increase timeliness, give the industry needed flexibility and strengthen regulatory enforcement where needed.

In the privacy, confidentiality, and security lends to strengthen enforcement and protection, extend the rights of data subjects, increase the education guidance and support research and catalyze community of practice. That is the high level.

Then part 2 is the status report on administrative simplification. And the first thing we do in that is try to provide a concise definition of what we mean by administrative simplification because it is really hard for people to keep that clear in their heads. And basically, the administrative simplification provisions of HIPAA were intended to help the health care industry control administrative costs, speed up processing, and protect the privacy and security of health information.

These provisions included standards to move the health care industry from manual and computer-based administrative transactions to electronic exchange and requirements to the Secretary of HHS to create standards to protect individual health information. These provisions apply to HIPAA-covered entities, which are health care providers, health plans, health care clearinghouses and business associates of covered entities. That is the scope of part 2.

Nick and Deb, will you walk us through the themes from the standards and operating rules?

COUSSOULE: Some of this in the Report to Congress will sound a little bit duplicative of some of the things we went over a little bit earlier today. But the main themes, as we looked over the last couple of years in regards to transactions, standards and operating rules, where one is the current standards promulgation impedes the full utilization of technology. Again, we covered that a good bit this morning and that the process may not be fast enough or take advantage of changes in both business need as well as technology enablement.

Two is the timing for the availability of new versions of transaction standards or operating rules for administrative – is unpredictable. Obviously, we heard a good bit about that this morning and has spent a lot of time in the last couple of years going through that path.

Third, covered entities cannot use new technology or standards voluntarily in that their own pace to the constraints and existing HIPAA statutes and regulations. Again, we covered that a good bit this morning as well and as far as enabling innovation to happen hopefully not at the expense, but at the future benefit of standardization and efficiency.

Fourth bullet, HHS enforcement of the administrative simplification provisions of the HIPAA statutes and regulations is ineffective in their impact on industry compliance. I think that that is again specific to the administrative simplification provisions and not necessarily the privacy provisions, which has become much more public –

And then fifth, the lack of HHS-sponsored or –supported education and technical guidance on the appropriate use of the adopted transactions and operating rules undermines the industry’s successful adoption and implementation of standards. Basically that we believe that HHS can play a more prominent role in helping the industry by – support in education and technical guidance, not necessarily developed by HHS, but provide –

(Operator interruption)

KLOSS: — a deliberate pathway toward convergence of clinical and administrative data domains is key to realizing – and administrative simplification.

Then moving to privacy, confidentiality, and security, today there are two health information worlds, one that is regulated by HIPAA and the other that is largely unregulated, that is, “beyond HIPAA”.

De-identified health data carry real risk of re-identification, a risk that grows into the future as datasets are combined and data tools become more sophisticated.

Protection of privacy and security requires management, compliance, and enforcement across the life cycle of the information.

And finally, data protections grounded in Fair Information Practice Principles remain the essential building blocks for data policy.

I think it is clear where all those themes flow from.

STEAD: And just for context, in this section, we have from the – since we pulled pop health out of part 2, what we did was put the action part, which is analogous to the actions in part 1 for the parts that directly relate to administrative simplification and the themes and we put them together of the steps. Put them together is part 3.

COHEN: There is always a discussion about how population health fits into this report. I think my preface is Bill made an excellent case. A healthy population essentially eliminates the need for transaction and is the ultimate administrative simplification.

The second connection, which I think is equally important, is population health is the sum and great part of individual’s health and the data that is collected for individual health is subject to HIPAA regulations. The population health data is essentially a summative aspect of HIPAA protected data.

The three buckets of HIPAA-related population health activities that we highlight in this report. The first one is the measurement framework, which is sort of a culmination of a long-time journey over the last – since I have been here. By creating this framework and populating it with health measures, we really simplify the approach towards collecting population health data.

The second activity that has more recently emerged and that we discuss in the report is the concern about access to population health data for researchers, public health, policymakers and the community. Sharon touched on some of the initiatives today and Bob will talk a little more about it tomorrow perhaps. Access to these data and protection of these data is an area certainly related to protection of privacy and security and the balance between providing information and making sure it is secure.

The third area that is certainly germane is the need to protect and enhance the foundational public health information system, which is vital statistics. Births and deaths primarily form the core of our information about the health of individuals and also the establishment of identity, which I think will be more and more germane to discussions as we move forward. Those are the three themes that we highlight in this report.

Bob, do you want to add anything?

STEAD: Thank you, Bruce. Then Section 4 is very brief. We framed this conclusion and next steps so that we would repeat it in the conclusion – the optimal relationship of legislative, executive, and public-private sector action. And then obviously we will continue to do assessment and then we want to help the department in any way we can. And then we lay out taken from the letters the next steps. For Predictability Roadmap, it is largely the DSMO work. For T&V, it is the ICD-11 assessment project. We will have to come back to that. And then the health, privacy, and security framework for the 21st Century as the hook for the March hearing.

Again, this report is scoped as calendar 2017 through calendar 2018 and therefore all that we have used languages, we have been refining the letters to make sure the messages are right and the tone is right and they fit together. The parts of it that we are doing first part of this year in essence are the next steps in part 4. That is basically at high level how the whole thing hooks together.

It seems to me what we ought to do is pause for a second from the download and find out if there are questions or suggestions at this high level. And then what I am thinking we will want to do is to walk through word for word at a minimum the two call for action blocks and some of the detail and the status report pieces at the word for word level that we will need to see based on where people’s heads are.

Vickie had hers up and then Denise.

MAYS: As I listen, it is different between what Bruce said and maybe what is on this slide, but it really made me worry a bit because this is being presented under HIPAA. The protections, the access, and the use of this data is not the same as in health care, the individual’s health care data. It kind of got mushed together it seemed to me. From the point of being a researcher, from the point of the voice of the community, we do not want those same rules to apply. And it just seems like it is pretty seamless here and you might think that.

And your statement, Bruce, about the health of the individual is summative and to population health, there are very different laws that protect and give access to. My concern is this being so seamless here that it raises the issue of whether to put some of this under HIPAA to some extent.

On the very first or second slide that you had which showed the arch of the data, throughout this is the difference between health data and health care data. It is the same issue to me. Health care data is a different domain to me than the health data. Sometimes we are using the word public policy here. I was trying to figure out if that should have been public health because it says established in public policy and health care. I am not sure.

COUSSOULE: Vickie, can I ask a question of clarification there? How do you reconcile with the transition that is happening into a value-based care model where health is becoming part of the equation and not just health care? I am just trying to understand your process of that.

MAYS: I have no problems with that. What I do is when the case is being made about the data itself and you are making a case about health care data using health data and health data is so much larger. It is almost like we are not doing the truth of what the case is. I agree with what you are saying about what we have to use, but it is very early in this where we start to make a case and we use health data. I think it is like this is HIPAA. We should probably come down and do this based on health care data because that is the origins of HIPAA.

And then I think later to say that in order to do what we do well, which is that is an example of it, we need broader data.

STEAD: The data I quoted was actually health care data. When I actually went back to get the basis, the data on the 2013 said those were the estimates of health care data. Now health care data increasingly includes other data. That is a good pick up. We can actually change the – it will be accurate if we change on Figure 1. If you go back to Figure 1 where it says volume of health data, if you say volume of health care data, that will still be accurate. And then you would say volume of health care data standardized. On this one here. Volume of health data and volume of health – just put care after both of those will in fact be accurate. We would have to correct the legend on that —

LOVE: My brain is fuzzy. But a lot of the health care data is also translated into population and public health data as exempt from HIPAA. It kind of had the same issue as where does HIPAA end and the HIPAA issues because a lot of my world takes health care transactions and translates it into population data sets. But for a public health use, it is exempt from the HIPAA restriction. I just wanted to be – I think I had the same sort of question, but mine was a little different. Since I am new at this sort of, what is the scope of the Report to Congress? Is it all of our activities for the year or is there a certain stipulation in the Report to Congress? I guess that is just my ignorance.

STEAD: The mandate for the Report to Congress, which is in the appendix to the report so you can actually read it, but this is the definition of what is in scope of the mandate. As we have done in the prior report, we have to make sure we explicitly do that. We can say the other things the committee thinks need to be considered alongside. We are not limited to the mandate. We must address the mandate. That is really the reason we made SPART-2(?) be totally focused on the mandate. Does that help clarify?

LOVE: That helps, but I think – and I do not have a solution, but somehow separating the HIPAA from the other is important because my world is hard enough without having the population health data mixed up with the HIPAA standards.

STEAD: One thing you need to keep in mind when you are using HIPAA in that way, you are really talking primarily I believe, about the privacy and security aspects of HIPAA, which are a key component of this. But the standardization of the data itself which you also care about is a good by-product of the part of HIPAA you are not referring to.

LOVE: I think I understand. And the other question which probably should not be asked, but I am going to ask it anyway. Because in my world the issue of identifiers and the provider ID is just a mess, it is silent on this report, but it may just be off the table forever and ever. I just have to put it out there because it is making life difficult for standardization linkage and population health and value-based purchasing.

STEAD: That is another example of something that was part of the original law that has never been adopted or implemented.

I think our message here is going to be much cleaner if we thought about – if we are really focusing on how do we build on the progress we have made to reset the trajectory to achieve today’s opportunity. We could elect to do it differently. That is how we have done it.

PHILLIPS: It is the same point that we are at a stage where we are trying to mingle health care and health data for very important purposes, not just value-based care, but population health. We keep getting stuck in that interface around the security of how do we do that, who can do it, how do they do it, what has to be expunged after it is done and then standardizing the process that people are doing it differently all over.

Having just been the last two days in Portland, Oregon with this very concept of how do you deal with social determinants and social risks in the medical setting and how do you take the medical setting and move into the community. The data that allowed to happen is where we are stuck.

The standardization process gets even more harried as you start to collect social determinant data from patients 100 different ways across 100 different systems without the ability to standardize it either at the collection site or where it needs to be used at the population level. This is a security and standardization issue for us.

STEAD: I get the point because it is the space I live in in my day job. Are you suggesting we do something differently in the report because of it or does this go under the important work we have to continue to do?

MAYS: I wanted to talk to the standardization because I think it is more than just the privacy. But the question is the standardization that is done under federal auspices may be very different than what is useful at a state level. I think it is a matter of actually calling it out to make sure that that seen clearly as not one size fits all, but that there has to be some kind of interoperability as oppose to one size fits all.

LANDEN: I guess I am sharing a lot of sentiment with my colleagues in the HIPAA data protections. Not all data is protected. It is just that PHI, the protected health information, which is a dozen and a half or two dozen elements protected under HIPAA. Once it gets outside of HIPAA even the PHI is no longer protected and they can get outside of HIPAA either legitimately or something other than legitimately.

My thinking is we need to tie the pop health back and some of our other thinking into the recommendations that I think in Linda’s – HIPAA concept. That it is no longer possible to circumscribe the HIPAA PHI and we have a new mission that is a lot broader so I think later on in some of the details that comes forward. But in these high-level bullets, it is kind of lost.

STEAD: As we get into the actions once we finish this high-level conversation as we look at the actions under privacy and security, see if we capture what you are talking about. I believe we do.

LANDEN: I think, Bill, that it is in there because the drafts I read it is in there, but I am thinking that we may need it somehow referenced a little bit more clearly at this higher level.

STEAD: This set of slides has no purpose other than this conversation. They are drawn from – these slides were drawn from the report, the language and the report, in an attempt to give you a high-level view of the whole thing. There are whole sections of the report that are not represented here at all like the developmental view. We do not need to get these slides right. Informed by these slides, we need to get the report right. Is that fair?

COHEN: I apologize if I was a little too – I did not mean to imply that data that currently are not covered by HIPAA should necessarily be so. If you look at the framework, the whole intent of the framework, I would say 90 percent of the data of the measures that populate the framework are not HIPAA covered. Vital statistics are not HIPAA covered. A lot of the public health data, the registry data is not HIPAA covered, but it all contributes to population health. Again, the connection for me, administrative simplification, the goal of the framework was essentially to develop standards that could be adopted and be used and as Vickie said in a variety of settings at the national level and at the state level and at the community level, which is the ultimately administrative simplification for me.

And the concerns that HIPAA focuses on I will be it on a very small set of personal health data are certainly the concerns we have with the Beyond HIPAA issues of protecting the privacy of the data that go into establishing population health and the data sets, but are not necessarily HIPAA covered. That for me is the connection of the focus of our population health activities to the importance of including it in this Report to Congress.

STEAD: Are we to where we have had enough high-level conversation that we ought to come back to the language and begin to see if there are things we want to change or not or are there other things we need to do at high level? Do you want to try to bring up the real report?

Susan, my guess is we ought to go to the introduction and go fairly fast until we get to places people want to stop. I think we have been through the executive summary. I do not think we need to go through another overview, which is what the executive summary is.

HINES: Go to page – it is page 1 of the section of the main body, not the executive summary, the whole body.

STEAD: You all have seen this in the E-Agenda Book. I do not know if there are things in the introduction that would give people pause. They are basically trying to at the start lay the foundation of what HIPAA was and what it has accomplished and set the stage for the updated Figure 1, which is the figure that is – are the roles that we think are appropriate for Congress and the executive branch and the private sector based on what we have learned in both the Predictability Roadmap and T&V work and the Beyond HIPAA work to date.

HINES: This is page 66 of the E-Agenda Book if you are looking at it online. Here is the updated graphic.

STEAD: Does the concept we are trying to make in that graph in the text, which we really pulled out on the slide, is that good with everybody? I think that is a key contribution of the report. I was seeing a lot of head shakes. Let’s keep trucking.

MAYS: For some reason, I keep struggling with this and we keep saying that what we have not kept up with are changes and technology and health care. Doesn’t the industry belong in there somewhere? In the text. I am doing text now. I am on page 66 and it was in his slides. I am actually on the text now. We keep saying that about those are the only two. I thought we needed to put industry in. It is in the paragraph that says however. It is the third line. The protections for patient’s health care information, the regulatory processes it put in place have not kept up with changes in technology and health care. Shouldn’t that be have not kept up with changes in the industry technology and health care?

STEAD: To me health care is the industry we are talking about.

MAYS: I took that as the system of health care, but not the industry. There are all these industries like they just did stuff – standards, those group of people, but it is fine. If it is not hitting anybody else, it is fine. It just seemed like it was too narrow for me.

STEAD: Are we okay leaving it as is or do you want to change it to keep with changes in technology and health care industry? I prefer the more general term if you can live with it, but I am not allergic to changing it either. Let’s truck ahead.

If people are good with the – we are basically good with that graphic and the text around that graphic. I think that is a key piece.

For my perch at least, the rest of this section simply says what the four parts are. I think they are probably okay. Then are we okay to go to the first of Part 1, the call for action?

We start with the world has changed. That is where we bring in the reference to the IDC papers. And there we actually say the volume of health care data has multiplied by eight times. If we fix in the figures, we will match. That is a good catch on your part. Are people good with that?

Come on down. The change in the reimbursement system. That is pretty straightforward.

LOVE: In the first bullet, do we want to add – in bullet one, it says – I think it says quality – or the second bullet. Care coordination and quality transparency. I would add and price transparency.

STEAD: Pressure for care coordination, quality, and cost transparency or care coordination and quality and price transparency. Good catch. That will fit in with today’s – what we were told today about priorities. That is a good add.

PARTICIPANT: — here quality and cost transparency.

LOVE: There is never going to be transparency and cost, but that is why I go to price.

LANDEN: I think in my recollection we took it out because the statement that precedes that is paying for outcomes, which is not something that is price based.

STEAD: I understand, but keep that – but they are both current terms that are important. One is paying for outcomes and the other is having individuals know what the prices are. I think both can be in there. I think that is okay.

Then this is the figure, which came from OCR about the rate of increase of breaches. Here is where we put in the data where we have – B is in there correct. It is billions, which references back to the health care blog and related papers. And then that flows to the figure, which that figure which if we change – if we insert care between health and data in both of its labels and in the caption at the bottom. It will be three changes. Are we good?

Then come on down. Before you get to that last paragraph, it really sort of summarizes again the forces behind the opportunity.

PARTICIPANT: It is page 71 of the E-Agenda Book.

DOO: Bill, Mya was just saying in your Power Point, I think that graph had a citation. You may just want to have a citation for the graph that was just above there. The trajectory graph. That one.

STEAD: That is what is in the box.

DOO: Just some reference to how it was created.

STEAD: All the data — go back up to the box. There is the top line. The top line of the graph reflects those sources. Go back up to the first thing. The first box at the top. Volume of health care data. Those are the references that are the basis of the top line in the graph. We walk you through. Going through the sections of this text, some in the graph, they are summarized. You build as you go down this page. We need to figure out how to reference each of the pieces back to the graph. That is an editing thing that can be done.

Then the developmental view was an important add that I think came out in a very helpful way that really tries to walk through the way the laws have built on each other, the first one being HIPAA, then the Medicare Prescription Drug, Improvement, and Modernization, then HITECH and then ACA and finally 21st Century Cures. And then you have the table that is the data from CAQH Index. And the 68 billion which comes out of that. Those were the part of the data I walked you through. Are we good with that block?

Possible future. This basically simply is trying to say what is possible if you just look at what other industries do currently in the consumer space.

LOVE: I think it is under possible future, the first paragraph is I think an important omission. Just one word. The very first paragraph before personal health information. I thought it should say easier patient access to their personal health information. It is just not anybody’s personal health information.

STEAD: Good catch. Enough on the possible future? Linda.

KLOSS: Do you think we want to imply that – I do not want this future to sound like it is too far in the future. A lot of this relatively possible now if it were just more enabled. I just wonder. The first sentence. Looking ahead, it is instructive to consider what would be possible. I just wonder if we should not make some inference that technologically it is possible today. Do you want to add a sentence after the first sentence to saying indeed these improvements are technologically possible today? Something to that effect because I do not think we are looking at a future world. I think we are looking at a —

STEAD: Do you want to change the title of a possible future? One thing I am trying to avoid is saying – the reason I put possible and this is sort of normal way I deal with iterative stuff – it is one possible – I think for us to say it will happen. One question is should we change the title. Another thing is looking ahead, it is instructive to consider what is technically possible now if HIPAA administrative simplification and privacy protection did more to enable. Is that better or not?

KLOSS: It makes it more compelling, I think, because we could reap the benefits sooner than is implied here.

MAYS: I actually wanted to go back before that because it just has been bothering me to change the title because we are talking about developmental. Maybe it is either its life course or milestones. And then when we get to this possible, it is like we started to talk about the next milestone, the next activity. I am not sure I think it is developmental at first. It kind of is getting to what you are saying about —

KLOSS: I was fine with the developmental because we are showing the flow of this. I just thought as I looked at this now, we do not want this to seem like a distant future. And what brought that home was I just read that NAM report on the patient-centered – I think I sent it around.

STEAD: Do you want to – say possible future with –

KLOSS: Plausible even.

STEAD: What:

KLOSS: Even plausible or I do not know.

STEAD: Does looking ahead work? We have replaced possible future. Let’s keep trucking. Then do you want to change the first sentence? It is instructive to consider what is possible now if.


STEAD: Did you capture that? Is that where people’s heads are? I think they like what is possible – what is technically possible now. They like the “now” word. The second time we have used it today. Let’s keep trucking.

COUSSOULE: Do we say to enable health are to take advantage of opportunities? I am not sure that is the right wording. Enabling health care. It is kind of vague. Do we say the health care system?

STEAD: The health care system. That is fine. That makes sense. Other comments on that block or have we got it where it is feeling pretty good?

PARTICIPANT: (off mic)

STEAD: We have already addressed it.

HINES: That is what it says. I have a version in front of me, Bruce, that says that. We are both taking notes.

STEAD: Let’s keep trucking. I am sensing that section is okay now. Let’s move to resetting the trajectory: new strategies for new opportunities. We repeat this idea of the distinct roles.

LOVE: Can we go back to looking ahead? I do not understand the last sentence before all the what ifs under looking ahead or possible future. It just does not – the information technologies driving.

STEAD: I do not know where you are.

LOVE: The last sentence of the paragraph before the what ifs. It just does not seem complete to me, but maybe it is just me. It just seems clunky. I have fog brain.

STEAD: I think it is a problem. This whole thing is clearly going to have to have an editorial pass or two. What I am hoping we can do is get to where we have agreed on the content.

HINES: Denise, the issue is just that include is not the right verb.

LOVE: It just reads weird to me.

HINES: Include is the verb and it is not resonating for people to have include be the verb.

STEAD: It is a complete sentence now, but we will have to figure out how to smooth it. Let’s make a note and move on. Are we good with this section now?

Let’s go to resetting the trajectory. I think we have talked through most of that. I guess we can come down to actions needed because this, I think, we really need to look at carefully. Actions needed to effect change: transaction standards, operating rules, and terminologies and vocabularies. The introductory paragraph. It is the thrust that we had in the previous slide. Is it okay? Seeing yeses.

Come down to the Congress block. Modernize HIPAA and related instruction and legislation, directing HHS to streamline the processes as appropriate with agile return on investment-based rule-making, adoption, and enforcement processes.

What we have begun to put into the Predictability Roadmap letter is concrete examples that actually we think are already in the scope of what the Secretary can do. What we are trying to do is communicate to Congress to direct that that is the level. It is this idea of things working together to clarify if that is really the level that HHS should be doing.

LOVE: How explicit? On the second bullet under Congress, the sub-bullet, which is great. To require all entities participating. We do not really get into that. Will the reader necessarily understand what you are saying or is that our issue? This is worker’s comp and some of these other non-covered entities.

DOO: (off mic) — not necessary —

STEAD: We are basically saying instead of – obviously, you could do this in many ways. We are trying to keep these actions up at a level that will get people’s attention of what they need to work out how to do. We are not trying to prescribe how you actually do it.

In the Review Committee thing, we had the basis of this where in essence that one of the things you could do is expand the definition of covered entity. There are lots of pros and cons of that for lots of reasons.

The thing we really need is for everybody participating in a transaction to be required to use the standards. How we achieve that is their call.

LOVE: I was just putting my head in like a staffer reading this for a congressman. I totally agree with the bullet.

DOO: The question could be anybody who is receiving or sending a transaction could be considered a covered entity and similar to what some work that OCR did with business associates. It could be a discussion of who then becomes a covered entity under HIPAA. I think what Dr. Stead is saying is we would like to ask you to consider having the conversation about who becomes a covered entity when using a transaction.

LOVE: As long as it is clear to somebody else reading it, it may be clear to us. That is all.

HINES: What needs clarifying, Denise and Lorraine for the lay reader?

LOVE: I was just thinking if it is a junior staffer reading this. I do not if it means something to other people. As I read it, I thought what do I do with that. Is that clear?

BERNSTEIN: Maybe it helps to clarify what you were saying. When you say that an entity who participates in the transaction will be a covered entity, you are implying all of the other standards, privacy, security, and everything else. That is not what you meant.

DOO: This is only to what I understand is this is only talking about exchanging administrative transactions and operating rules.

STEAD: We could replace participating. Mandate to require all entities that send or receive an adopted administrative transaction. Is that clearer?

PARTICIPANT: I think it makes it clearer to a third party.

STEAD: That is what we mean. Let’s fix that. Good catch. Let’s keep trucking.

LANDEN: Bill, real simple. In the next bullet where we talk about the DSMOs, to stay consistent with how we spell and abbreviated DSMO in the letter.

STEAD: We need a little S after DSMO.

LANDEN: After organizations.

STEAD: After organizations and after the O inside the parentheses. Doesn’t the abbreviation got a little S on it also?

LANDEN: That is a matter of debate, but that is the way – yes, that is the way we did it in the letter.

STEAD: However it comes out of the letter or the report need to match. Let’s keep trucking. Good catch.

And then assign responsibility for recommending a path to convergence and over a decade, not over six months because it is going to take a decade. Are we good on the actions for Congress? I am seeing heads nod.

Executive branch. Here we should be real consistent with what you have seen in the letter. This may go a little smoother. Let’s keep trucking because we have a lot to do.

DOO: I do not think you need to use the word revamped in front DSMOs because you are not referencing a thing. It is just DSMOs.

STEAD: Do we want to change the word – revamped is not a very good word. It is in that sentence twice. But do we keep the revamp right after the bullet or does it go –

PARTICIPANT: Revamp the HIPAA regulations.

STEAD: Modernize the HIPAA regulations to eliminate. Kill the second revamp. Let’s keep trucking. Replace revamp with modernize right after the bullet and then kill revamped and put an S on DSMO. Let’s keep trucking.

The ROI. Basically, the idea that pre and post-adoption with sometime between, there should be an ROI study that basically provides the cost benefit for adopting and shows that we have gotten it or we have to adjust.

LANDEN: In the next bullet in the first sentence, enforce implementation of adopted standards. Why do we have demonstrated ROI in that sentence? Can we just take out and demonstrated ROI? I am not sure what ROI has to do with compliance.

STEAD: The reason it was put there and it is fine to have it come out was that to date we have things that have been adopted, which did not have an ROI thing to attach to them.

LANDEN: Are we suggesting if there is no ROI, they should not be enforced?

COUSSOULE: I agree with you, Rich. I think the idea of an ROI is not really relevant to the enforcement.

STEAD: What I am hearing is we just drop – good. I am hearing everybody is good with that.

BERNSTEIN: Can I just ask you to go back for a second? I am an interloper here. Susan and I had a little colloquy about the first block under Congress. We noticed that the second bullet says that Congress should require HHS to develop and fund a process. Of course HHS cannot fund anything without an authorization from Congress. Maybe you want to say that Congress should require and fund if you are going to say that rather than HHS should fund because we do not have any authorization to fund anything without —

STEAD: Do we just say require and fund.

BERNSTEIN: That would be better.

STEAD: Require and fund HHS to develop a process.

Were we okay with the enforce bullet? We drop demonstrate ROI out of the collaborate bullet.

LOVE: On proven bad faith actors. That sounds a little accusatory. How about chronic or repeated? Okay.

STEAD: Leave it as is. The collaborate bullet I think is clear.

Do we need the public awareness bullet in this one or not?

Private sector.

LANDEN: Before we move off of that, Bill, can I do another editing nit. In the second last bullet, we use standard development organization all small. In other places, we have capitalized the S, the D, and the O and/or use the acronyms so just review and be consistent.

STEAD: Good catch. Do you have that note, Susan? Your preferred mode is to have it capitalized or not capitalized?

LANDEN: The preference would be to use the acronym once we have defined it.

COUSSOULE: Just go about three bullets down and we have the same question. We just may want to check and make sure it is consistent we use throughout the document.

STEAD: Anything else or are we okay? I would love if we can to actually go on and work through – I would like to get through the actions to privacy and security before we break because we have a lot to do.

BERNSTEIN: There is a bullet here that seems misplaced. The develop public awareness bullet. It seems like it is not clear why it is under transaction standards rather than say privacy.

GOSS: Rebecca, I think you asked me a question. This is Alix. Yes, I am good for now.

STEAD: Are you asking whether we remove the develop – move it to privacy?

KLOSS: I think there may be a public awareness initiative around the transactions and maybe that is what we were contemplating. I think public awareness with regard to taking advantage of personal health data of privacy and security risks and so forth probably does not belong here. But isn’t a consumer awareness with regard to —

HINES: Is this not covered in HITECH or 21st Century Cures?

STRICKLAND: This seems out of place. This does not seem to go with our theme. We did have a theme about sharing lessons learned and enforcement and that kind of thing, but not —

STEAD: My gut would be we drop this bullet here and as we go through privacy, we debate if something needs to be there or not. I think we are probably okay. I think we have this well covered in privacy already.

PARTICIPANT: I was wondering why it was here, not why it was valuable, but why it was in this place.

STEAD: Let’s drop it from here. With that, are we okay with the transaction standards?

Let’s work our way through privacy, confidentiality, and security if we can. The intro is really the language we have on the slide.

We are going to break after this block. We have a lot to do.

Congress. We reworded these in the last set of process to make them less prescriptive in how things might be done, but to get the key things that need to be investigated on the table.

LANDEN: I have one editing nit in there. In the first and third bullet, we capitalize federal and in the second bullet we did not. We need to be consistent throughout the document.

STEAD: both of those should be lower case.

PARTICIPANT: (off mic)

STEAD: I am hearing the three bullets themselves are okay.

Executive Branch. Most of this comes out of the DID in other letters. Are people seeing challenges with it or are they okay?

LANDEN: Question in the first bullet. Executive Branch. We say protect identifiable and de-identified health information when releasing it to individuals and entities. Do we need to clarify by individuals, we do not mean the person to whom – the individual to whom that data pertains themselves? I am worried that this might be misread to say we cannot give identified data to the patient himself or herself.

STEAD: Is there any reason that we need anything other than entities that are not covered by HIPAA and other privacy laws? I think we can just drop that phrase. Good point. Does that solve your —

COUSSOULE: Entities would cover something like researchers or other things – it might be an individual, but you still cover —

STEAD: I think simplifying it gets us there. Good catch.

Work with other federal agencies.

Research agenda. Straight out of the DID letter. Are we good?

Establish avenues for reporting, investigating and preparing rapid response guidance on emerging threats to health information privacy and security. I think that is new. Are we good?

BERSTEIN: The medical device and apps are also new, I would think. They are not covered by HIPAA.

COUSSOULE: We need to also ask Congress to do a similar thing at a slightly higher level in the last bullet for congressional activity.

PARTICIPANT: That is in the executive section.

COUSSOULE: — one just above that, the last bullet for Congress. We basically have a similar thing from policy standpoint – enabling legislation.

PARTICIPANT: If they tell us to do it.

COUSSOULE: That actually fits because we talk about how these have to become – work together well.

STEAD: We have both bullets there. We are trying to show the alignment. Are we good?

MAYS: We are saying we are asking them to implement reasonable and appropriate health data security and privacy practices. But one of the other issues is that they do not tell people what these are in any intelligible way. I am under Congress.

I thought in our hearing one of the things that we were a little bit concerned about is the warning that people are given. I am just saying is this an opportunity to add one more piece. We are just asking them to implement reasonable and appropriate health data security and privacy practices. That is just the protection. But what about informing people as to what those are?

COUSSOULE: This is where the congressional role would be established in the federal standards. The executive branch role is establishing the standards and protocols for use.

MAYS: It would be down in another – which level? At the executive?

COUSSOULE: The question would be how does it get communicated. I think that would happen at the executive level.

BERNSTEIN: I would think that would among the standards and protocols —

MAYS: I just did not want to leave that out because it was a big thing —

LOVE: I have a couple of questions on the private sector. The third bullet. Can we clarify? Work with government to become more transparent. I do not know what you mean and how that would work. Private sector. Help me out. How would you work with government to become more transparent? Is there another way of saying it?

KLOSS: I do not think we need the work with government.

LOVE: That threw me.

And then the last bullet I am confused also. Catalyze communities of practice to improve data protection practices across all entities that hold these data. How would you catalyze communities of practice to do this and to improve protection practices?

KLOSS: We do not say how, but a lot of communities of practice – their data, end data users and they have no clue about –

LOVE: But by communities of practice we do not communities. We mean some kind of sharing of best practice, some mechanisms for best practice sharing. Learning from as more experience is gained.

CORNELIUS: Why don’t you say best practice?

LOVE: NADO does this all the time on phone calls with – I just had three states on a phone call to share how they are de-identifying. Is that what you mean?

HINES: How would it be to say catalyze communities to share best practices to improve data protection across all entities?

LOVE: But I do not see private sector doing a whole lot of —

STEAD: Private sector needs to do this.

KLOSS: They are doing it, but that is our purpose in making the recommendations. They are not doing it now.

STEAD: These actions are actions that we suggest the private sector should be doing.

LOVE: Just some of the private sector entities I work with would not necessarily nationally get together and share best practices of how they are disseminating information. Is there a public-private — catalyzing is good, but what is going to catalyze? I struggle with this one because I guess I work a lot with –

PARTICIPANT: Some of these are aspirational?

PARTICIPANT: But are you suggesting –

PARTICIPANT: We are going to have Optum call up Blue Cross and say let’s work together on sharing data. What is going to catalyze that?

COUSSOULE: I think I would view this as our role or our communication vehicle here is to encourage the private sector to share best practices not to instruct them exactly what to do.

STEAD: Sharing practices on protecting data, not telling them to share data.

KLOSS: And not intellectual property or algorithms, but these are actions to enhance privacy, confidentiality, and security. And what we are really saying on this is everybody does not have to start from scratch on their own in a vacuum.

PARTICIPANT: It is aspirational. I just had two major companies pull out of these things because it is hard to share data and –

PARTICIPANT: We are not saying share data –

PARTICIPANT: — sharing best practices for protecting data.

KANAAN: Bill, could I ask a question there? This is Susan. I had provisionally changed in line 3 of that same bullet. It said whether or not it is but it was with the referent was not clear. Is it correct to say whether or not the data are covered by HIPAA or is it the entity that is covered by HIPAA? What is the correct – it is the entity, right? I need to fix that. I will.

PHILLIPS: I just want to weigh in. What we really need is for industry to help dispel myths. I think part of that is about best practices. I cannot tell you how many CIOs and general counsels of health systems tell me they can or cannot do certain things because of HIPAA. They either hide behind it or they do not know or there aren’t best practices for them to lean on. Some of it is intentional, but some of it is just ignorance. Not that they are ignorant people. It is just that there is lack of clarity in best practice sharing.

PARTICIPANT: — go uphill, upstream – is there something missing in the Congress of executive branch?

LOVE: That is where I get back to – private-public – it has to be catalyzed by something and that is where I almost see that as an executive branch function to bring them along for that network and shared practices because I just do not see it occurring naturally with all the other things on everyone’s plate.

COUSSOULE: I think there are two very different thoughts there. To back to Bob’s – yes and I can tell you because I have seen this first hand as well that there is an ignorance of what the rules really are – not about stupidity, but just a lack of knowledge about what the rules really are, what I can and cannot do to still be within the rules. Sometimes it is used as a crutch. Sometimes it is used as a blocker. Sometimes it is just I do not know. That is an education question that is a little different than what is the best way to do it if I am actually trying to share information. There is almost like two different thoughts.

STEAD: They work together. If you look at bullet two under the executive branch, that is promulgating guidance. That is beating it down. That is the public part. This is the private collaborating to innovate new practices that can then be fed back down through the next set of guidance. And some people will do that and other people will not. If anybody does, you will get the flywheel moving.

The way the public-private works, Denise, is the public part is either in Congress of executive. And the private part is in the bottom. We originally mushed them together and we split them back out as we have been through the iterations if that helps.

STRICKLAND: I think the first bullet in that same executive branch box also has information about sharing. Reasonable and responsible steps included establishing data sharing agreements, business associate agreements. We could sneak something in there about sharing best practices.

STEAD: Do you feel we need to add something there or with this conversation, are we good?

COUSSOULE: I think the second bullet talks specifically about entities not subject to HIPAA. Bob is talking about even entities that are subject to HIPAA – may not necessarily understand the rules or how it might apply.

STEAD: What do you want to change? I am just trying to understand. Have we decided we want to leave it along or have we decided we want to make a change? Have we done what we can do to the call for action?

Then I suggest we take our break. Let’s keep it to ten minutes and be back at 3:30 because we have work to do.


STEAD: We are now ready for Section 2, which is the status report. The first paragraph and the – the first paragraph says what administrative simplification is at high level. And the next paragraph builds out how the parts of that relate to Transaction Standards and Operating Rules and then the third piece builds out the part related to the Privacy and Security Rules. As you look at that part, are there any challenges?

Major themes and takeaways for 2017 and 2018. It relates to describing the process that NCVHS has used working with the industry.

Number one. Current standards promulgation impedes the full utilization of technology. Is the text under that okay? Seeing heads nod.

Then the timing of the availability of new versions of transaction standards or operating rules for administrative transaction is unpredictable.

LOVE: Appropriately available and appropriately sized. Did we purposely just want to – do we want incremental? Appropriate to one may not be appropriate to other. But I just wanted to call it out. If it means anything to anyone else, I am fine with it.

STEAD: Nick or Debra?

STRICKLAND: NCVHS have been told by industry – NCVHS that they need appropriately available and sized updates of medical transactions.

LOVE: I had written incremental, but I do not know if that is what you were going on.

STRICKLAND: I think one appropriately would be fine.

KANAAN: I think it is a little ambiguous without – it is not clear that the word appropriately modifies sized without reiterating it, I think, even though I realize it is kind of clunky.

KLOSS: When I read it, I thought it added a little emphasis.

LANDEN: That is my recollection is we did want to emphasize both the availability and the appropriate size.

STRICKLAND: Do we want to use the same word or a different word?

LANDEN: Appropriate is going to mean different things to different people at different times to different standards development organizations.

PARTICIPANT: Some may say ten years is fine and others want every other year.

COUSSOULE: I apologize. I struggle with what appropriately sized means? What does sized mean?

PARTICIPANT: (off mic)

COUSSOULE: I think we ought to be explicit in that regard then.

PARTICIPANT: Maybe appropriately incremental updates.

COUSSOULE: What are we trying to actually get to?

LANDEN: I think our conversation has been about instead of one big lump every ten years, we want more frequent, smaller, more easily digestible bites.

PARTICIPANT: Why don’t we say that?

COUSSOULE: That is what is said in the next sentence. I get hung up with what appropriately sized means? I think big, small, short, long. It is a tough one.

COHEN: But alternatively, you would not want to be updating the ICD every other year. It is appropriately sized by decade rather than —

COUSSOULE: Instead of saying that, do we say more frequent? Maybe it is just me. I just get caught up in the appropriate size. I really do not how to understand that.

LOVE: You could just take NCVHS that they need or want smaller, but more frequent updates to standards without prolong rule making.

COUSSOULE: Let me try one thing. If we say appropriately available and appropriately sized, how about more frequent instead of either of those?

STEAD: The industry would not like a term that says more frequent. They do want it more frequently, but if they are too frequently to be absorbed. Is there some way – in writing this report, it is not intended to be implementation level detail. It sits on the letters and reports that are attached. It is in fact trying to communicate the story that sits on top of it.

PARTICIPANT: Would the phrase more timely be better?

PARTICIPANT: Appropriately paced. Appropriate increments.

GOSS: I think that the problem is that the industry really — one change does not equal another change. Part of the problem we are trying to do is speak to something that reflects a diversity of opinions and what is size and what is cadence that is appropriate is not equal across the industry nor reflective of a consensus around the change. We are trying to get to I think what Nick said which is this industry-driven consensus-based agreement on what we should be adopting and when.

For instance, our NCPDP community for upgrade for the pharmacy transactions came very well-orchestrated in knowing what they wanted as far as changes and that there were value in those changes and when they wanted to implement it and even the month of the year that they did not want to implement in. It is that kind of responsiveness to the industry’s implementation needs that I think we are trying to reflect in this appropriate word selection.

KANAAN: Just call to your attention that the next sentence clarifies that point.

HINES: I think the sentences really have to be looked at together. One is the lead to the other.

PARTICIPANT: I think we should leave it.

STEAD: Linda recommends leaving it. Can we tolerate leaving it? I have lived through these hearings and I am the generalist in that role. The two sentences taken together relate what we have heard. Taking them apart or changing them I think will not match what we have heard. Rich is saying he agrees.

COUSSOULE: One last point. Did we say medical transactions or administrative transactions?

STEAD: You are talking about administrative transactions and medical being a class of administrative.

GOSS: I think we take out the word medical and would suggest that to link this sentence with the next one, we change essentially to further.

LANDEN: I am not sure we should change essentially to further because I think essentially tells the reader that we are clarifying the previous sentence. Further would be adding a different thought.

I would also point out that in the recommendation itself, the bold type above this paragraph’s text, we refer to them as administrative transactions. I would suggest we just end the text itself. Just delete the word medical before transaction. Just say updates of transactions.

STEAD: I think we are sold. We have agreement.

Let’s move on to number 3. Covered entities cannot use new technology or standards voluntarily at their own pace, due to constraints in HIPAA statutes and regulations. This is one that we talked about a fair amount in the Predictability Roadmap letter because it is one of the recommendations in that letter. Are we good with this?

Number 4. HHS enforcement of the administrative simplification provisions of HIPAA statute and regulations is ineffective in their impact on industry compliance.

PARTICIPANT: (off mic)

STEAD: So its. The text under that okay? Again, it draws off the Roadmap.

Then the lack of HHS-sponsored or –supported education and technical guidance where appropriate use of the adopt transactions and operating rules undermines the industry’s successful adoption and implementation of standards.

COUSSOULE: Undermines is kind of a strong word. It is an intentional word. Undermines sounds like it is on purpose. Hindering. Hinders.

STEAD: Hinders?

COUSSOULE: Yes. I just think undermines is like it is purposeful.

STEAD: Second of recommendation 5 replaces undermines with hinders. Anything else?

And then we have the reports.

LOVE: Under number 4, as I read it, on the very last sentence under number 4, is the need for proactive incentives, with associated education – what I was saying proactive incentives in my note is in the form of – what is a proactive incentive? That is just my ignorance as I read it. A related issue is a need for proactive incentives with associated education, which would decrease the need for enforcement action. Is that benchmark reports? I was trying to think if I were someone that is needing to comply, what is an incentive other than not getting an enforcement?

STEAD: I thought the conversations I remember from the various hearings and roundtables had to do with clearly communicating the return on investment and value of doing them so that people understood. It was not talking about paying them to do them. Is my memory of that correct, Linda?

KLOSS: I do think there was some discussion of using the available levers too. I do not think there was one approach, but that HHS does have various ways. Carrots and sticks is the discussion I recall in December, using the levers and using the —

PARTICIPANT: At the state level for data policy is benchmark reports to show how your organization lines up with data quality and completeness on certain fields with education or feedback of how to improve that. As I read it, I just felt like it was not clear.

PARTICIPANT: But the tactics are not here.

PARTICIPANT: Right. Just some sort of incentives.

STRICKLAND: I think that if you read it all in context from the middle down, I think that just by sharing the regulatory enforcement provisions and lessons learned from the compliance reviews, that in and of itself is a proactive incentive. It is like don’t make the same mistake type of a thing. They are being proactively educating and saying this was a problem over here. Let’s not keep repeating it. And then that is associated with the education and then obviously if they are not making the same problem then we do not have continued additional enforcement.

(off mic comments)

PARTICIPANT: I think reading it in context works to me.

PARTICIPANT: Susan Queen has a comment.

QUEEN: I like the word levers. The use of the word incentives at least from the federal government perspective often is in the form of monetary. I just would recommend leave the levers.

KLOSS: I just think that throughout here we have not gotten to the tactical level. I do not think we need to do it in this recommendation. I think that is the point.

LANDEN: An alternative might be to just delete incentives. The sentence would read a related issue is the need for proactive education, which would decrease the need for enforcement action.

PARTICIPANT: That works for me.

STEAD: Linda, are you okay with that? That takes out the carrot, but we cannot have everything.

KLOSS: Sure.

STEAD: We just simplified it.

HINES: A related issue is the need for proactive education, which would decrease the need for enforcement action.

STEAD: Good. Sold.

Recommendation 5. We have changed undermines to hinders. Do we have any problem with the paragraph under that? Are we good? We are done with transactions, standards, and operating rules.

Roll ahead to terminology and vocabulary.

LOVE: — change we made to the report earlier. The first sentence in the second paragraph. Just make it consistent with what we changed earlier is something about variation.

STEAD: Complexity and variation.

LOVE: Just so it is consistent, whatever we did there.

STEAD: That is going to have to come across from the T&V criteria for adoption and guidelines for implementation letter. There is a change in that sentence and that letter that needs to be brought into here because we have made them match. From the T&V letter. Good catch, Denise.

LANDEN: Just another nit. The second word terminology in the first paragraph. No need for that to be capital.

STEAD: We are clearly going to have to have an editorial pass that deals with capitalization all through this. A good catch.

Are we good with the overview?

Major themes. Theme 1. The US named standards for terminologies and vocabularies are in place, but coordination across standards is lacking and under-resourced, presenting a barrier to interoperability. Does that paragraph work for people?

  1. DOO: In the second sentence where it says and the first set of named standard was adopted in 2003. Is that supposed to be and the first set of named standards? I know we are not supposed to be doing –

PARTICIPANT: We all missed it. You read something six times and eventually you just do not see.

LANDEN: In the terminology and vocabulary letter that recommended the update of the criterion and the guidelines, I do not think either of those letters or I do not think that letter ever stated that what NCVHS had recommended had ever been adopted.

KLOSS: It was in the footnote.

LANDEN: I was just questioning. Is there a conflict here between the letters and what we are saying here? And if it is in the footnote —

KLOSS: It was used. We recommended principles and named standards were adopted. I think we can assume that those principles were used for that. I think it is a reasonable leap.

STEAD: To be crystal safe, we could say HHS – replace the first adopted with used. I think that is – I do not think that loses anything and it avoids potentially over stating. We have our adopted at the end, which I think is where it really belongs. That works.

Number 2. HHS regulatory process is applied unevenly for named health terminology and vocabulary standards, causing costly delays and complexity in adopting the revised versions of some standards.

And the rest of that subtext reflects the letter, but not any of the parts of the letter that we have diddled. I think it is still valid.

KLOSS: Will we change the tense here. It says NCVHS will be recommending.

PARTICIPANT: Just say has recommended if we approve it today or tomorrow.

STEAD: We have a note that based on how we do with the letters, we will have to change the tense. I think Susan has that all the way through.

COHEN: In the second line of 2, US does not need periods. We go back and forth. Whatever we adopt we should use consistently. I do not know what the federal standard is referring to the US.

PARTICIPANT: In the footnote, there are no periods.

COHEN: Periods or no periods.


COHEN: Abbreviating the United States, US.

STEAD: Otherwise, are we good with the text under rec 2?

Rec 3. Greater coordination across terminology and vocabulary standards is needed to ensure that redundant terminology and vocabulary concepts are useful and the gaps are addressed.

HINES: Do we want to say purposefully redundant; otherwise, the unschooled mind might say why would we want redundant.

PARTICIPANT: I do not think that would hurt.

STEAD: Change useful to purposeful or –

PARTICIPANT: I would say add – that purposeful and redundant. Intentionally redundant. That is better. Thank you, Susan.

KLOSS: It gives more credit to the current state though. I do think that some of the redundancies are not exactly intentional or purposeful. They may still be useful or not. Maybe it is getting too in the weeds.

One of the questions is which of the redundancies are useful and which are not. I do not want this to assume that they are.

PARTICIPANT: Keep the modifier or lose the modifier —

STEAD: I get that. Do you want to have are purposeful and useful? I think that was said once. It comes downstream – I think that gets at what you were really trying to do. You can figure out how to handle the ands.

A deliberate pathway toward convergence of clinical and administrative data domains is key to realizing health transformation goals and administration simplification. That is really one of our key pieces through this whole thing. Are we good?

Privacy, confidentiality, and security overview. Para 1? Para 2? Paragraph 3?


PARTICIPANT: Yes. That is correct.

STEAD: Paragraph 4?

HINES: Rachel, does this work for you since this is OCR? I just wanted to make sure that the paragraph with the extensive OCR references is good.


STEAD: We are good – down into chief focus in – are we clean into major themes and takeaways? Linda is nodding yes. Denise is nodding yes.

Then number 1 today – there are two health information worlds. One is regulated by HIPAA and the other is largely unregulated. That is beyond HIPAA. And then the associated text and then the Beyond HIPAA environmental scan as a future report.

LOVE: Just a quick question. Beyond HIPAA – we are using it in two different ways. One report is Beyond HIPAA, but is this one outside of HIPAA? One is a theme of Beyond HIPAA in one of the letters.

HINES: I have noticed that the project NCVHS Beyond HIPAA is capitalized. I am almost thinking we should italicize it to make it clear that it is our project although it does say Beyond HIPAA initiative.

KLOSS: It is in the first parenthesis.

HINES: In that case, it is not our project. It is just referring —

LOVE: I was thinking when I read it is it is really what we mean here and number one is outside of HIPAA domain or outside of HIPAA instead of beyond HIPAA like the future, just outside of HIPAA

PARTICIPANT: Do you want to do that?

STEAD: The way I think we have used Beyond HIPAA in our project is not future, but outside of HIPAA. Is that right, Linda?

LOVE: Absolutely.

KANAAN: I intentionally added that parenthetical thing just to kind of give an extra little point toward the project.

STEAD: We are good with that.

COHEN: It is not regulated by HIPAA, but it might be regulated under other information practices.

KLOSS: I think that is why the theme says largely unregulated.

COHEN: Does that address non-HIPAA laws?

KLOSS: It is not saying – it is completely unregulated, but it is largely unregulated.

COHEN: It is largely not covered by HIPAA because there are dozens of other privacy statutes that cover huge data sets.

KLOSS: When you read that theme, does that not convey that idea that one is regulated by HIPAA, the other is largely unregulated? That that would mean HIPAA or any other law.

COHEN: Correct. Is that your intent?


COHEN: So privacy laws that protect Department of Education data and other information acts at the state level and federal level regulate access to those data, but they are not HIPAA.

PARTICIPANT: They are a patchwork.

KLOSS: But for the most part, one’s health data – the majority of health data once it is released by a covered entity or business associate, it is not regulated. It is largely unregulated.

COHEN: For instance, all the cancer registry, vital statistics have their own laws or regulations regarding privacy, access, and they are very heavily regulated, but they are not covered by HIPAA.

BERNSTEIN: In some states. They are not regulated at the federal level uniformly. From state to state, those protections differ.

COHEN: Unregulated at the federal level? If you are comfortable with this.

LOVE: I think what you are getting at is many data are regulated. I think of the same thing.

KLOSS: But if you were to look at the zigabytes or whatever we talked about earlier on the whole, once health data are outside of the covered entity or business associate, they are largely unregulated. I think that phrase is accurate.

LOVE: Hospital discharge data sets in 40 states have laws that mandate the collection and are heavily governed and regulated by that state law. They are not unregulated.

BERNSTEIN: I think what Linda is trying to say is that – but do not let me put words in your mouth. That is a small subset of health data in the world. We think of health data as hospital data or claims data, but there are tons of other types of health data that are Fitbit data, that are credit card data that are out there in the world whether consumer generated or industry generated of other kinds that are not regulated by any of those regimes.

LOVE: Much of it is largely unregulated. I just do not want to make a dichotomy. You have HIPAA regulated and unregulated.

LANDEN: Largely, it comes close. I am kind of starting to agree with Bruce’s point that when you look at the Department of Education regulations for schools and what not and you look at the mental and substance abuse, that is not a small pocket. That is federal regulations. I am wondering if there is some way we can at least acknowledge the existence of there are some areas that are regulated, but it is still true that most of the rest of our 23 gazillion bytes are unregulated.

KLOSS: I guess I will press a little harder on this. I think this is a really important point to underscore. If we add too many modifiers to it, I think we lose some of the punch. This was really an essential theme for the Beyond HIPAA environmental scan that we are now bringing forward and underscoring.

I think to say that one is regulated by HIPAA, the other is largely unregulated is not inaccurate.

KANAAN: Would it be acceptable, Linda, to put some kind of a modifying sentence in the narrative that acknowledges these other arenas, not in your theme, in your bold face —

KLOSS: I would certainly maybe underscore the state.

COUSSOULE: I would be careful. I actually agree with Linda on this one. It is really important to make a strong point and you say largely unregulated. It does not mean there are not pockets of things that happen. But I think the strong point is HIPAA has very specific guidelines and there is a whole lot of stuff that does not fit under that – the real point trying to be made there.

KLOSS: And the earlier themes were that that was because data is digital. It moves. Even where there are pockets of regulation, again, this patchwork quilt. If it is regulated when it is in a hospital discharge data set, what if moves someplace else? We cannot weak this point, I think. I think it is just too foundational – what we are going to be doing in the Beyond HIPAA next round of stewardship development.

COHEN: I appreciate your point and I will defer to your judgment. I think it is more accurate to say private sector data is largely unregulated. I cannot think of any case where government data is not governed by privacy regulations. To be accurate, commercial or private data is virtually unregulated or largely unregulated. There is a huge carve out for all government data sets, which are I would say 100 percent regulated in terms of privacy protections.

LOVE: This is a political point just from state legislatures and others that they just do not want to get that concept that if it is not HIPAA regulated then it is unregulated because —

KLOSS: I would be alright with adding something about the state, the existence of state regulation in the second sentence in the narrative. I think that makes sense. We know that some states even go beyond HIPAA. But generally, that also applies to the covered entity data.

STEAD: I am also hearing Bruce make the point – does compute that most government data is under some rule of some sort.

COUSSOULE: Most data when it gets to the government. The government does not always create a lot of the data. On the vital side, clearly it does. But if you are talking about general health information that comes from the delivery system as a whole. Anyway it is where it starts. It might end up there through any number of vehicles. It is very well regulated when it gets there.

SEEGER: Perhaps speaking in reference the fact that HIPAA sets a federal floor for privacy and acknowledge that there is a patchwork of state laws. But those laws address state agencies and often local and county health departments. There is largely no enforcement of those laws. And what we are talking about is really the environment of health data outside of those agencies.

PARTICIPANT: We better get our heads together and write a couple of sentences.

STEAD: My sense is this is something that we are going to have brought language back. This is the first thing we have gotten stuck on.

PARTICIPANT: We will construct a couple of sentences to insert here.

STEAD: It sounded to me like Rachel was on to a way to deal with it.

SEEGER: — and make it better.

STEAD: Bring it back. Okay. Let’s keep trucking. Let’s just ignore the rest of that paragraph for the moment. Whatever language change we make here we will need to look back at the call for action and harmonize them.

Number 2. De-identified health data carry real risk of re-identification, a risk that grows into the future as datasets are combined and data tools become more sophisticated. In essence, the anchor in our previous work. People good with that?

Number 3. Protection of privacy and security requires management, compliance, and enforcement across the lifecycle of the information.

LOVE: One little tiny thing. You mentioned lever here in the middle of the paragraph. Maybe clarify one lever. We used levers earlier.

KLOSS: I do not think we did use it. I think we talked ourselves back from that. My note said to myself that compliance enforcement is the lever and I was thinking one lever.

PARTICPIANT: We could put one. I think that is good.

STEAD: That is a good catch. And the unregulated beyond HIPAA world. We will have to tie that. We will have to make sure that does not need to be adapted once we understand the previous language.

Are we good with three?

BERNSTEIN: Can I just ask what was meant in the last sentence of Section 3 of the first paragraph? It says industry has weaker safeguards. Weaker than what?

KLOSS: I think this was the point that the health care industry is a particular target because it has rich data and it is kind of known as less robust security than others like the financial services industry.

COUSSOULE: Would you say something like the industry is either not as mature in its protection capabilities or something like that?

KLOSS: That would be fine.

COUSSOULE: The healthcare industry – is not as mature in its information protection safeguards.

STEAD: Last paragraph. Four is data protections grounded in Fair Information Practice Principles remain the essential building blocks for data policy. Are we good?

Are we into Part 3? The overview.

LANDEN: In the last sentence there, I presume the committee we are referencing is NCVHS. Is there a reason we are using committee instead of NCVHS?

HINES: Because the previous sentence says NCVHS conducted a major project and now the Committee in ’18 also we undertook a project. We do this all through the whole report. We, the Committee, NCVHS are all interchanged. You do not want to say NCVHS 400 times.

LOVE: This is getting nit-picky. I am sorry. In the middle of the paragraph. While HIPAA focuses on discrete transactions and privacy and security for individuals, the sum of these health care transactions contributes to the health of the US population. I thought that was a bit much. How I characterize it contributes to understanding of the health and the performance of the US health care system. I just see it as – I do not think the transactions contribute to the health.

PARTICIPANT: It was supposed to be health data. Somehow that got lost.

BERNSTEIN: Privacy people would say that parts of the privacy rule do contribute to health by having people have access and be involved in their data and participate with their doctors. There are parts of these things I think that do. It may not be a complete statement, but I do not want to discount.

LOVE: So the sum of the transactions contributes to the health of the US population.

PARTICIPANT: You might add something to expand on the thought.

PARTICIPANT: Denise, to contribute to the understanding of –

LOVE: Also, the performance of the health care system. That is how I see transactions aggregated.

LANDEN: Or management of the health of the population.

KANAAN: I have never been very comfortable with this sentence. We are trying to establish here a connection, strengthen the sense of connection to why this is in a HIPAA report. But another alternative is not to include this sentence just to make a radical proposal.

COHEN: That is way too radical for me, Susan. Health management or understanding of health, any language like that.

HINES: How about the sum of these health care transactions contributes to the management of the health of the US population.

STEAD: Or the sum of these health care transactions contributes data.

HINES: Contribute data to the management of the health.

LOVE: Because I do not think we are managing health. I see it as understanding. Data lead to understanding.

HINES: Data to the management of the health. That was the original intent.

STEAD: I think the aggregate of these.

PARTICIPANT: The aggregate. That is better, Bill.

PARTICIPANT: Aggregation of these data –

STEAD: We know what has to be fixed here. Can we move on?

MAYS: Can I do a couple of other — we talk about vital statistics data that is now in jeopardy. There are a couple of words in here that I think are pushing things a little too much. Jeopardy and then later this issue of data missing was widespread. I think they are just ratcheted up a little too much.

HINES: In the previous work the committee did instead of saying in jeopardy, we came up with at risk.

MAYS: If NCHS were sitting here, what would they say about this?

HINES: That is what was discussed at the hearing.

MAYS: I guess I do not think we want to say it that way. I do not want to undercut public confidence in the data without more explanation. It just seems like it is too hyped up.

KANAAN: One of the themes also expands on this point.

COHEN: I appreciate your concern with the word jeopardy. If we could find another word that indicates —

STEAD: We have used the word fragile before.

MAYS: That I would like even more because that is the issue of if we do not do things, the system is fragile because it needs updating. It needs monies. I am fine with that.


MAYS: That is probably really the truth, but I do not want the public to think they cannot get their birth certificates. And then the widespread later. I just think also should go.

COHEN: It is the system that is not fragile. It is not the population health data that is in jeopardy. That is not really clear in that sentence, Susan.

STEAD: We have said before the vital records and statistics system are – can you fix that without us having to do it? We will fix that.

PARTICIPANT: And widespread, Vickie?

MAYS: It is the third from the bottom. Focusing on access to data in response to widespread concerns. I think – concerns.

STEAD: Good catch. Both are good tone fixes. Are we good then if we get those fixed?

Theme 1. The NCVHS Measurement Framework for Community Health and Well-Being offers a practical approach to organizing the data essential to understand the health of populations at national, state, and community levels.

MAYS: It is a tone thing. NCVHS took on the challenge of looking at how to measure. It seems like NCVHS was concerned about the lack of. It is almost like we just took a challenge, but it came with a history of being concerned about the lack of a framework at a community level.

HINES: We could add a clause due to the or as a result of the Committee’s concern, the lack of data available. They examined how to measure.

MAYS: Yes because where it really came from was after Linda’s data stewardship and hearing what the community was saying to us, but otherwise it does not have a context why we did it.

KANAAN: You don’t want to use the word challenge or you want to contextualize it?

HINES: I think we need a clause, Susan. Something like as a result of the Committee’s concern or findings, the lack of data at the community level. Something like that.

KLOSS: I think the community use of health data initiative broadly, not the privacy stuff, the broader use preceded the privacy focus so I think as part of NCVHS.

COHEN: It was really an extension of the community’s learning systems when we heard from communities that they needed more local data.

KANAAN: I think that is a really good way to ground it. It was the Committee’s concern. It was what it heard from the –

COHEN: From communities about the lack of access to data. You should know something about that, Susan.

PHILLIPS: This is my fault for not fixing this sooner or bringing it up sooner. This paragraph again I think overemphasizes the HIPAA protected sources of data. A lot of these measures were health survey data. They are not just health care HIPAA-protected data. The sentence these data are aggregated from individual health data, some of which are HIPAA-protected, all of which came from use cases all across the country where the data are being used now to impact local decisions.

A lot of the work that went into this was not just about looking at data. It was actually the use cases that boiled up from the communities. We had an extensive study that showed use cases. I think it is important, again, emphasize that this came from the ground.

STEAD: Did you capture that, Susan?

KANAAN: I will work with you on that, Bob. It is the sentence, these data are aggregated from. We will work on that.

MAYS: In the next sentence where it says the framework enables local officials. Shouldn’t we also say local officials and communities because it is not just officials? I think we want to get the community involved here.

STEAD: Framework enables communities.

KANAAN: Another inconsistency in this whether to capitalize framework. What do you all want? Do you like to capitalize it?

HINES: If we are talking about the Committee’s Framework, yes. If we are talking about frameworks – no.

MAYS: I would take out the work succeeded. It is like patting ourselves on the back. Other people should tell you that. But the Committee –

PARTICIPANT: We will just say we developed.

COHEN: Should we mention the US News and World Report as well as an adopter of the framework, if we mentioned IHI?

PARTICIPANT: That is a good point.

PARTICIPANT: The place Chris is at. Did they use it too?

COHEN: That is into the IHI – community comments – working with them.

HINES: We could say after that sentence before we go into 2017, the US News and World Report, whatever it is called, communities project adopted this framework.

COHEN: Somewhere maybe at the end. I have not looked.

KANAAN: Do you want to see where I put it and see if you agree. Continues to evolve as a national resource that is already being used by or that the US News and World Report is already using.

HINES: I would say adapted for its community whatever initiative, Healthiest Communities Initiatives or whatever it is called.

STEAD: Healthiest Community Ranking.

PARTICIPANT: Words to that effect. Does that work?

PARTICIPANT: I would say project or initiative.

MAYS: It is almost like there needs to be a sentence in here that talks about how heuristic this is because it is not about we are keeping it the way it is, but people really using it and that is what it is going to do out there.

KANAAN: To evolve as a dynamic national resource, could you say?

COHEN: I would actually separate out rather than make it a clause —

HINES: Susan, I have some of that captured in this version so we can melt them.

STEAD: Do we have enough to let you two land this and feed it back?

Access to small area data is critical for managing health care costs and supporting community-focused population health management.

MAYS: I know we are trying to do this because we are trying to be under HIPAA, but small area data is critical for managing health care costs. I can the other part, but I am not sure exactly how it is managing health care costs. Managing health care costs to know a small area data. It gives people options, but I do not know if it is managing health care costs.

HINES: What about the move to value-based payment. Aren’t those data – Bob, you know more about this – needed to move that forward or are they not using – I thought they were, but —

PHILLIPS: The specific case of using social determinants to adjust payments. The IMPACT Act of 2014 is still percolating through HHS. I think the next report coming out in October about whether and how they might do it. It is a specific cost case.

MAYS: I think then it is the possibilities. This sounds like a done deal. As I point to it, I do not think you will find it. It is a critical component with the potential —

HINES: Why don’t we modify that phrase, Vickie, and maybe use for adjusting payment for health care using social risk factors. What is our citation there? There was supposed to be a citation there from you that I did not follow up on. That is the piece. Vickie, we got you.

STEAD: Good with the rest of that paragraph?

Three is a sustainable system for vital registration and statistics data is essential to tracking the health of the nation. These data also are critical to establishment of individual identity and the protection of national security, as well as fundamental building blocks for health surveillance data, such as tracking of opioids and influenza epidemics. Despite its importance, the viability of this federate system is at risk. Given what we said before, do we say despite its importance, this federated system is fragile? Trying to be consistent.

PARTICIPANT: If you prefer.

STEAD: Is this the language we used in the letter?

PARTICIPANT: Do we say is it risk or fragile in the letter to the Secretary.

HINES: I will pull up the letter and tell you exactly what was said. But I am pretty sure when we wrote this – I remember we had this whole discussion at the time of how to frame it.

MAYS: I think there is a difference in something that goes to Congress and the Secretary. I think the Secretary has the context for it. Congress reads it and it is a little – they need a little more explanation. I would still stick with since this is going to Congress, fragile —

LANDEN: An editing nit here. We use federal once initial cap and federal in another place in the same paragraph lower case. Throughout the document, we should be consistent.

COHEN: Susan Queen, I know we are independent form NCHS, but NCHS has a lot of skin in the vitals game. I just wanted some – I know our wording might be not the words NCHS chooses, but I just wanted some general – if you had any general thoughts about this.

QUEEN: I think what Vickie was suggesting about how it is described in a report to Congress as fragile rather than at risk is a good suggestion. If you were to say at risk, it would be at risk of what. I just think if you are trying to get a message across succinctly about that there are concerns and the committee is recommending X then just saying that it is fragile is a better way to go.

STEAD: I am hearing that we say despite its importance, this federated system is fragile. Can you live with that, Bruce?

COHEN: Yes. Thanks. Any other thoughts about this?

QUEEN: No, I think the changes that you have been making are very positive in terms of softening the wording about raising alarms about the widespread concerns, but there are concerns, et cetera.

KANAAN: Just to clarify, did you delete the viability of in theme statement.

STEAD: Yes. Just say despite its importance, this federal system is fragile. We did say the system requires immediate attention to maintain and improve its quality. Is that okay or do we need to strike the word immediate for Congress? So requires attention.

PARTICIPANT: The letter to the Secretary said urgent, but that is okay.

STEAD: What they are doing is distinguishing between what we say. That is fine. I think other than that, are we good now with this piece? Can we roll into new strategies for new opportunities? The intro paragraph is – Congress, three bullets. Bullet one, legislation that would form a federal, interagency office whose mission is to make community health data publicly available, including support for data linkage and integration.

PARTICIPANT: Enact legislation that would form.

STEAD: With the verb or are people good with the statement? Enact legislation to address the current significant risk of the sustainability of the US Vital Registration and Statistics federated systems. I am guessing the word significant needs to go away.

Revise legislation to expand the collection of commercial self-funded claims data and generate —

LANDEN: Can we go back? Don’t we want to use the word fragility there instead of risk?

COUSSOULE: The other question is – legislation on legislation on funding. We spent a lot of time talking about that when we were going through this exercise before. Enact legislation and provide funding.

PARTICIPANT: Then just to address the current –


PARTICIPANT: But then where does sustainability come in?

STEAD: It goes away.

COHEN: I would prefer including fragility and sustainability. One is it addresses the current status and the other is to develop a future system.

KANAAN: How about saying to ensure the sustainability of and leave out – to ensure the sustainability of and not even mention fragility.

COHEN: That is fine in this case.

MAYS: Can I ask a question either of your or Susan? When it says the US, does that mean that it is territory – are we responsible also for the territories?


MAYS: Do we have to say include that in there?

COHEN: There are 57 jurisdictions. I think it is implied.

MAYS: Sustainability of the US Vital Registration and Statistics – is that cutting –

COHEN: They are part of the US –

MAYS: So we do not need to say it?

QUEEN: I noticed you all have used National Vital Registration.

HINES: We got that from a report. Kate Brett, the lead staff, gave us that phrase from a report that DVS had issued. We just came up with that catch-all because you have vitals registration and then you have the statistics. We wanted to sort of have one – we were using the word vitals, which does not —

QUEEN: It is usually NVRR or National Vital Statistical Systems, NCSS. It would not be the US – however you want to pull it. But earlier you referenced – is it NVRR in here?

HINES: I think it was National NVRS, I think. In other words, this is something we need to go back and make sure we get right. We will just put it on the list.

QUEEN: I was talking with Bruce earlier. What we phrase it now is National Vital Statistics System, NVSS. But if you are interested in making sure that the notion of the registration —

STEAD: Yes, the registration is a very important thing. There is a sentence in the letter or the report that defines. We had to create a composite term and we did that back —

QUEEN: Sorry. It is VRSS, Vital Registration Statistic System.

CORNELIUS: Which system is most geographically expansive as in US territories.

QUEEN: They both include all 57, but if you want the registration areas to be clearly acknowledged —

STEAD: And the registration part of it is actually what relates to interoperability in HIPAA.

LANDEN: Point of information, we do explicitly state territorial level at the top of page 28. It is in there.

STEAD: We are gaining.

Revise legislation to expand the collection of commercial self-funded claims data and generate standardized claims data in all states to support policy/population health applications. This is Denise’s bullet.

LOVE: I am fully cognizant that I live in the political fray. I just do not know how much in the fray that NCVHS wants to be.

In the report itself, there is really no context. It just kind of jumps out the bullet, this ERISA thing. I have plenty of wording I can provide for a little contextual background.

PARTICIPANT: We have a footnote – give us your footnote —

STEAD: What we would like to do is to keep it in the footnote, not have it in the text because we actually think there are examples of the whole thing.

PARTICIPANT: I just wanted to call it out and make sure.

CORNELIUS: Real quick question, Susan. That system we just referred to, does that also include the Indian Health Service?

QUEEN: No. But the registration of deaths including deaths to American Indians is part of the National Vital Statistics System. Indian Health Service is the provision of the – usually the provision of the services.

COHEN: The events are covered by the state registration. If an event takes place on a reservation, it is reported to the state registrar. It does not include IHS per se as an entity, but all the events are – the only events that I think are not covered are military deaths that do not take place in this country because DoD is not required to report them to the states and to the feds.

QUEEN: But US residents, non-military that are out of the US. They do come back through the state department. But I have to admit. I do not know the specifics about military deaths that are not on US soil as to whether or not –

COHEN: That is a very technical point.

CORNELIUS: I am trying to make sure when we are being expansive that we are not leaving out critical elements of the US population. That is the reason I asked the question.

COHEN: The vital statistics and registration system should cover all events that occur in the United States.

MAYS: But what would not happen is if it was a violent death that occurred on an Indian Reservation. It would not end up in the system because they cannot investigate.

COHEN: they cannot investigate including in – reported to the state as a death.

STEAD: I do not know if there is any way we can somehow —

HINES: The phrase we used through the hearing and all that work, I just looked it up, is US Vital Registration and Statistic Systems, VRSS

STEAD: With an S on it.

HINES: With an S because the registration and statistics are separate.

STEAD: You put them both together.

PARTICIPANT: Would you take US off though?

HINES: That is what we have used. I have no –

STEAD: I would prefer for us to use what we have used and to the degree we can.

PARTICIPANT: As long as you are consistent with however you have been describing it.

STEAD: It is well documented and all of the nuance that has been on this table is well documented in the environmental scan. To the degree we can footnote those –

PARTICIPANT: You mean the hearing report.

STEAD: The hearing report and the uses and Gibb’s report. I am just trying to know where we are. Are we where we can continue to move?

Executive Branch. Create guidelines/policies for both intra-department and inter-departmental data use, collection, access, and sharing that returns public access to federal data assets routinely used by state and local entities to assess and improve health. Is that problematic? Are we good?

Address the weaknesses of the Vital Registration and Statistics federated systems to ensure long-term sustainability. You will make sure that aligns up with whatever we just did.

Fill critical information gaps to support policy/population health applications.

Integrate the collection of Medicaid data in other population-based data. Are we good?

Then community-level stakeholders and private sector partners. Develop and use the NCVHS Measurement Framework for Community Health and Well Being and offer input on barriers to accessing related data.

MAYS: That one – develop and use. We now know there are other versions out there. How about build on or something, but not – it is almost like we want them to take it as their own.

HINES: The reality is it is going to be develop and use the next generation. It is not going to be ours. It is going to be the one that we are going to hear about tomorrow because that is actually going to have a platform and data that people can access whereas ours is the framework.

COHEN: They essentially use our framework as the starting point to create their expanded version. Just like ours, it will be dynamic in change as well.

STEAD: Build upon is consistent with what we have done.

Generate and expand access to health and well-being data for small geographic areas and small population subgroups.

Form health and community use —

MAYS: Can I just – because I think small geographic areas is one thing, but small population subgroups. It is not just population subgroups.

PARTICIPANT: You just want to add small in front of population?

MAYS: Yes, again, just to emphasize that.

HINES: Got it.

STEAD: Form health and community use-case collaborations to inform Federal Data strategy, value-based purchasing and price transparency. That ties back into the –

PARTICIPANT: Should we say the Federal Data Strategy because there is one?

STEAD: We have wrestled that to the ground.

Then Part 4. The conclusion restates the role s for congress, executives and the private sector. It says it is a Federal Advisory Committee. We will explore aspects of the transformation that are within the purview of our Charter, highlights three opportunities and says that we look forward to additional guidance from HHS. That seems pretty safe.

What we did with each of the others. Paragraph 1 under Predictability Roadmap provides context. Paragraph 2 describes in essence the letter piece and then below that comes what we are going to do, the work we are going to set in motion to provide it. We have to put an S on DSMO and an S on organization. The fact that it sets the Predictability Roadmap. It will set the stage for harmonization of administrative and clinical transactions. It restates the essential question about our HITAC scoping document.

Are we good? Are we good with Predictability Roadmap?

T&V. Same basic structure.

MAYS: In the last sentence before that, we get to health terminology. HHS and Standards Development Organizations. Shouldn’t that be cap or is that just what they refer to is like that?

STRICKLAND: Usually we do the SDO or we – just capitalize Standards Development Organizations, SDO. We did that in other places, didn’t we?

HINES: I guess we have been talking about through the Predictability Roadmap and this report about these Standards Development Organizations, not just any. I think because we are being very specific and we have actually given it an acronym elsewhere that we need to capitalize. Either that or get rid of the acronym. If you have something that has an acronym then you capitalize the things that build the acronym. It stands to reason.

STEAD: What I care about is you figure out a way to be consistent through the report.

HINES: My understanding is Standards Development Organizations, SDOs, is agreed upon acronym and usage. If there is disagreement with that, we need to know it for this report.

STEAD: I think we have previously said that it is okay to use capital S, capital D, capital O and little S.

HINES: Well because we acronized. You cannot acronize something if there is no —

STEAD: Health terminology and vocabulary standards and systems. Paragraph 1 is right out of the letters. All this test is right out of the letters.

PARTICIPANT: — change the tense.

STEAD: Depending on what we get done. We have that one done so we can do that one.

PARTICIPANT: Instead of drafting it should say has submitted. By the time this report comes out, they will have been submitted.

PARTICIPANT: This whole section – has tense issues.

STEAD: Which will have to be fixed when we get done. Other than tense issues, are we okay? We did not say anything in this that we have not yet – we did not do anything with this we disagreed with. I stayed away from PCS and that language.

The rest in T&V okay?

KLOSS: It feels like four needs some kind of wrap in coming back to a HIPAA report purpose.

STEAD: I looked at that. We did not do such a thing in the 12th report, but that does not mean we should not improve for the 13th.

PHILLIPS: Bill, specifically does the data essential for management of population and community health does not appear in the conclusion and next steps?

STEAD: Because it is not part of – I was keeping this – it is its own piece for this purpose.

MAYS: Right here before we start privacy and security, it says NCVHS is developing a new scope of work for project to assist. It seems like we should be specific on what we are doing or delete it.

PARTICIPANT: Where is that?

MAYS: Right before you start a health privacy and security framework. It is the last sentence. It seems like it is a mystery or something.

STEAD: The truth of the matter is we are developing it. We do not have it yet. It is the item on the list that we are not getting to on the agenda today. It is to develop a scope of work. It is like we said we were going to develop a scope of work for the DSMO. I am trying where possible. I know we have the tense problem. I am trying where possible to say this is the work. Keep the stuff that is done at the end of December 2018 and this stuff we are doing now, but we do not have it yet.

MAYS: It just seems like we should say either know something we are going to do or to offer to do something.

STEAD: We are developing a scope of work to assist HHS in the evaluation of ICD-11. That is a true statement.

KLOSS: — sentence before to say what it is about.

STEAD: If you want to say to assist in HHS in this evaluation of ICD-11, if that makes it better, fine. That is fine. Just add of ICD-11 at the end of the sentence.

HIPAA privacy and security. Are you all good with the way that is written?

MAYS: I just have a question. Why is it a framework and not like stewardship or something? I thought a lot about this. Why is it framework? I think if you put stewardship in front of it –

PARTICIPANT: — framework –

STEAD: It is more than stewardship.

PARTICIPANT: I think it says that.

STEAD: This framework is more than stewardship. It includes stewardship.

MAYS: What is the framework?

STEAD: We will be talking about that tomorrow. These are next steps, not steps we have already taken.

MAYS: If I was to read this and I am a staffer, I would go look on the web. Is there a framework I can read? It sounds like a done deal. That is why I am saying in some way that you have it or —

KLOSS: But not if you read the paragraphs.

MAYS: A framework seems like something you have developed. That is what I am saying. The framework seems like – the frameworks seem very done.

KLOSS: Conclusion and next steps.

STEAD: Do I sense if we — the real question is where are we. We have a few pieces that need to be – we have a lot of editing to do that is basically editing.

HINES: I appreciate all those who have responded to emails in the last hour and a half. I have them all.

STEAD: What are you thinking that we look – that we look at a red line or that we see if the group is willing to take action that we agree on the content and that we want to – we agree on what we are trying to say and you want to bring it – I am just trying to figure out where are we in our collective agreement and how do we capture that.

CORNELIUS: I like the idea of agreeing to the concept and letting the executive committee deal with this editing and pulling it together. Sixty percent of this is grammatical letters and what have you. We spend a lot of time diving in. I know we are trying to draw closure. We have faith in the ability of the powers that be that draw closure on this.

STEAD: Do you want to make a motion?

CORNELIUS: I would like to make a motion that at this point we accept the report in concept based upon our discussion and that we will turn to the executive board to tie up the loose ends.


STEAD: We will want to slightly reword that probably and take out words like turf. There is a motion on the table and seconded. Any further discussion? We have a card up. Rich.

LANDEN: I support the motion, but I would like the opportunity to review a red line just in case.

HINES: We will include that in the process.

STEAD: For this meeting, we are basically saying we have accepted this subject to editing to the edits we have agreed to that there will be a red line that will be passed by the Full Committee on its way for approval by the Executive Committee. Is that the process that we have now agreed to?

BERNSTEIN: Passed by the Committee – you can review it. You cannot vote on it —

HINES: To ensure that the edits does not change the meaning.

PARTICIPANT: There will be an opportunity for you to review it.

STEAD: By adopting the report, we are saying we agree to the meeting and at least I because I have done this and other things, we will object to anybody that tries to use it as a process to change the meaning.

CORNELIUS: That is the point.

STEAD: Because what we are basically saying is we agree to the meaning. We will send the red line so that the Full Committee can verify that they are comfortable or say that we have done something wrong and tell us and then the Executive Committee will in the end be done. We have done this before and it has worked well. Is anybody uncomfortable with that?

MAYS: We just have a few people that are not here. They have not had a chance. Let them at least – I guess I do not want to forbid somebody from commenting. Let them comment and if it changes something, let the Executive Committee decide it.

STEAD: Who is not – because they all have the report.

CORNELIUS: I have a practical question. When are we expected to submit the report?

HINES: When it is done.

STEAD: The other practical fact of the matter is that this report – this is an environment in which this report will be useful. This report is not going to get more useful sitting on the vine. With all due process to make sure we are doing it right, we should go on and get it done expeditiously.

CORNELIUS: The reason why exactly my issue is I hear what you are saying, Vickie. I think if you want to submit a report on a particular date then you factor that into the timeline it takes to draw closure. I do not want to spend a year going back and forth over comments. I am not that person.

MAYS: It just seems like we do not have a few of the people in the room who are usually here even though we have all had a chance.

CORNELIUS: Give them two weeks.

HINES: Alix was on the phone the whole time until a few minutes ago.

STEAD: And Jackie was on the phone. And everybody was given this ten days ago.

CORNELIUS: I would give them two weeks from the close of this meeting. The same I would do in any other activity. It is in the report. It is in the record. It is public notice. They hear it. If they cannot do it in two weeks, I am moving.

MAYS: Actually, it is not the response. What I am saying is if somebody had a comment and it might slightly change something, let them make their comment and then it is up to the Executive Committee to accept or not accept.

CORNELIUS: You and I just disagree with how to do it. I hear what you are saying. I am for inclusion. I got that. I am not saying not to be inclusive. I am saying that I do not believe in fiddle and faddling on something. If we put it out, we give them the opportunity, we set a date and then we move forward. That is what I am about.

MAYS: I am fine with all that. It was just that when Bill said no changes that just made me —

STEAD: My intent was no changes in content, meaning that is where I think – I am going to be uncomfortable accepting changes in meaning without actually getting us back together and approving. I think that is actually our charge as a Federal Advisory Committee. That said, getting the text so it clearly communicates what we think we have all talked through leaves —

HINES: We have a quorum and if a member could not be here today, they will see the red line version like everyone here today will. That is all we can do.

STEAD: We will call this particular item done. I think what we will have to do is huddle a little bit. Do you want to bring back language on ICD-11 now? Let’s do it.

HINES: It is up on my screen. Greg is getting it up on that screen. I will start reading it to you. HHS should invest now in a project to evaluate ICD-11 and develop a plan that will enable, assure in transparent transition.

And then number three is —

STEAD: Point of order and I hate to do this. While we are trying to get the right version, I just realized we did not ever vote on that motion. Let’s vote on it. All in favor? Alix, are you on the phone?

CORNELIUS: For the record, I will say I accept the motion as amended by you and then we vote.

STEAD: All in favor? Any opposed? Any abstained? Congratulations team. Now back to Linda.

HINES: Should I read new recommendation three while they are pulling it up? Linda has reworded Recommendation 3 to say HHS should clarify that ICD-10-PCS is a US procedure classification system and is not a product of the World Health Organization. That is the recommendation. HHS should clarify that ICD-10-PCS is a US procedure classification system and is not a product of the World Health Organization.

STEAD: Let’s read what comes below.

HINES: The system referred to as ICD-10-PCS was designed by CMS for coding hospital-based procedures. This development was undertaken by CMS because the WHO’s tenth revision of ICD did not include a procedure coding system, thus, it was necessary for CMS to develop a system for procedure coding to be used with the adoption of the tenth revision of ICD –

PARTICIPANT: It basically says to make it clear that those are not related without explicitly saying –

HINES: The ICD rubric was attached to the new US system presumably to make it clear that this system replaced the earlier ICD version. However, it is not a WHO developed or maintained vocabulary and it would be preferable to rename PCS to remove the ICD reference. This is particularly important because the WHO is developing the International Classification of Health Interventions, ICHI, as a tool for reporting and analyzing health interventions for statistical purposes.

To prevent misrepresentation, HHS should consider renaming ICD-10-PCS to accurately identify the organization that owns and manages the system, which at this point is CMS. Changing the name will clarify the updates to the US Procedure Classification System do not need to be tied to updates to ICD and vice versa.

If you could roll down to number three, Greg. That is everything I just read.

MAYS: I think it is really good. I do not know who wrote it, but whoever the group is. It was really good.

HINES: Linda and her co-chair Linda.

STEAD: Then do you want to ask for a motion?

PARTICIPANT: Yes. I would like a motion to approve this.


STEAD: The motion has been made and seconded. Is there any discussion?

COHEN: I still think it is stronger without this. I understand the desire, but I still think the letter is much stronger without this. That is my humble opinion.

STEAD: I think that a minority report could possibly be in order because my sense is the majority favors keeping it in. There is a motion and a second. Any further discussion? All in favor? Any opposed? Do we want to vote no? Any abstained? One. We are done. Congratulations Linda. Thank you.

Team, never in the history has NCVHS approved three action letters and a Report to Congress on the same day. This simply reflects unbelievable preparation of all of you. I have never seen an effort.

I think we are adjourned. We will think about whether we need to tune the agenda at all. I think actually we are okay. Keep trucking.

(Whereupon, the meeting was adjourned at 5:25 p.m.)