[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

June 21, 2017

Hubert H. Humphrey Building
Room 705A
200 Independence Ave., SW
Washington, D.C.

TABLE OF CONTENTS

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

Agenda Item: Welcome

DR. STEAD: Good morning. Let’s get started. Linda.

MS. KLOSS: Good morning. Member of the Full Committee. Co-chair of the Privacy, Confidentiality, and Security Subcommittee. No conflicts.

DR. PHILLIPS: Bob Phillips with the American Board of Family Medicine. I am a member of the Full Committee, the Executive Committee, and co-chair of the Population Health Subcommittee. No conflicts.

DR. COHEN: Good morning. I am Bruce Cohen, Massachusetts. I am a member of the Full Committee. I am co-chair of the Population Subcommittee. No conflicts.

DR. ROSS: Good morning. I’m Dave Ross, Taskforce for Global Health and Emory University. I am a member of the Full Committee and a member of the Population Health Subcommittee. I have no conflicts.

DR. CORNELIUS: I will take his conflicts and I have no conflicts either, but I am Lee Cornelius. I am at the University of Georgia. I am a member of the Full Committee and Population Health. It is good to see everybody.

DR. LANDON: Good morning. Rich Landon, Florida, member of the Standard Subcommittee, the Review Committee, and no conflicts.

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

MR. COUSSOULE: I’m Nick Coussoule from BlueCross BlueShield of Tennessee. I am a member of the Full Committee, co-chair of the Standards Subcommittee, and member of the Privacy and Confidentiality Subcommittee. I have no conflicts.

DR. RIPPEN: Good morning. Helga Rippen, Alertgy. I am on the Full Committee, the Privacy Subcommittee, Population Health Subcommittee, and then also the Data Working Group. I have no conflicts.

MS. STRICKLAND: Debra Strickland, CONDUENT. I am a member of the Full Committee and the Standards Subcommittee. I have no conflicts.

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

DR. STEAD: Thank you. Do we have any members on the phone?

MS. MONSON: Good morning. This is Jacki Monson. I am from Sutter Health. I am a member of the Full Committee, as well as a member of the Privacy and Security Subcommittee. I have no conflicts.

DR. STEAD: Thank you. Let’s begin with staff. Rashida?

DR. DORSEY: Good morning. My name is Rashida Dorsey. I am the Executive Staff Director for the NCVHS. I also serve as the Director of the Division of Data Policy in the Office of the Assistant Secretary for Planning and Evaluation. I have no conflicts.

MS. HINES: Good morning. Rebecca Hines, Executive Secretary of the NCVHS. I am at CDC National Center for Health Statistics. I am standing today. Do we have any staff on the phone?

MR. LINCOLN: Mike Lincoln from the Department of Veterans Affairs. I don’t have any conflicts.

MS. HINES: Any other staff on the phone? Let’s do staff in the room and then we will do the audience.

MS. SQUIRE: Marietta Squire, staff to the committee.

MS. JACKSON: Debbie Jackson, National Committee.

MS. JONES: Katherine Jones, National Center for Health Statistics and staff to the committee.

MS. DOO: Lorraine Doo, CMS, staff to the Standards Subcommittee.

MR. SORACE: Jim Sorace, ASPE and staff to the Standards Subcommittee.

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

MS. KNAPP: Katie Knapp, Veterans Health Administration.

MS. WILSON: Carol Wilson, Veterans Health Administration.

MR. WALLER: Pat Waller, Cambia Health Solutions.

MR. SHIPPY: Scott Shippy, Center for Medicare and Medicaid Services

MS. NARCISI: Jean Narcisi, American Dental Association.

MR. STELLAR: Charles Stellar, WEDI.

MS. COKER: Gayle Coker, BlueCross BlueShield Association.

MR. DECARLO: Michael DeCarlo, BlueCross BlueShield Association.

MR. RODE: Dan Rode from Virginia.

MS. WEIKER: Margaret Weiker, NCPDP.

MS. TUREK: Kelley Turek, AHIP.

MR. KISER: Reid Kiser, CAQH.

DR. STEAD: Thank you. Let me briefly review the agenda so that we know the flow of the two days. We are going to start with a welcome from Rashida for ASPE and then do brief updates on committee activities. Then we are going to deal with the first action item, which is the Health Plan ID hearing recommendation letter. We, if possible, need to make any changes and actually get the final action on it today. Then we will do the action item on the hearing summary from the claims-based databases. We will be able to have the discussion of that and, in particular, a discussion of any next steps the committee might take in that space this morning. We have reserved some time tomorrow for final action on the summary if needed.

Then in the afternoon, we are going to have three hours devoted to two panels, which are the start of the environmental scan on our terminology and vocabulary work, which is a major new initiative that we are getting into as part of our workplan. We will then have brief updates on the next generation vitals effort and the Predictability Roadmap and try to get us out of here at 5:30 so that we can make it for the dinner at 6:30.

We reconvene tomorrow morning. Reminder, it is a half-hour earlier on the second day, at 8:30. We have time on the claims summary if we need it. Then we are going to revisit the social security number removal initiative with the questions – the responses that CMS has been able to give us based on our discussion at the February meeting. Then a block on our strategic plan, which we need to decide if we are comfortable with it in its current state or if we want to update it. Then update by Charlie Rothwell from the National Center for Health Statistics, an opportunity to meet with Don Rucker, the new national coordinator.

In the afternoon, we will have a work block on beyond HIPAA scoping and our overall workplan before public comment and closing.

Is everybody comfortable with the agenda as laid out? Okay.

Let’s take a minute to celebrate and welcome the new members. We have Debra and Roland here. We have Jacki on the phone. We thought we would let you provide a little bit of color commentary about yourself and your interest in the committee. Do you want to kick this off, Debra?

MS. STRICKLAND: Sure. Again, my name is Debra Strickland. I work at CONDUENT Health. I have been in the Standards industry, X12 and WEDI, for about 20 years. That is really my background. I worked at a payer for 17 years. I worked as a consultant working with various Blues. Then I worked for a technology company that did EDI standards technology. Then I find myself now working in the Medicaid arena. I have a fair amount of experience in various payer organizations and also the standards. I have been testifying here for NCVHS for many years. I did have an interest in becoming a member, so I am happy to be here. Thank you.

DR. THORPE: Good morning, my name is Roland Thorpe, as you know. I am excited about being here for a number of reasons. All I know is academia. I have been in academia all of my life. I have a strong interest in trying to leave the world a better place than I found it, particularly with regard to underserved minorities. My research has focused on health disparities across the life course. I am the Deputy Director for the Hopkins Center for Health Disparities Solutions. I also – the last ten years, I have been focused on black men’s health. That is where my research resides.

On a lighter note, I am happy to be here. I am very tired of the D.C. area. I spent my birthday, which was Monday, in the D.C. area.

MS. MONSON: Good morning. I am Jacki Monson. I am currently the Chief Privacy and Information Security Officer at Sutter Health. I have lots of expertise in privacy, information security, and compliance. I just finished a with Health and Human Services’ Healthcare Cybersecurity Taskforce. Our report was finalized just a couple of weeks ago.

DR. STEAD: Welcome. Rashida, would you like to take over?

Agenda Item: ASPE Welcome

DR. DORSEY: Good morning. I would like to welcome you to the June meeting of the National Committee on Vital and Health Statistics. I would like to extend the welcome to our new members, who are participating in their first full committee meeting today. So, again, welcome and thank you for joining us.

This committee has an almost 70-year history of providing recommendations for HHS and tackling critical and complex issues in health data, statistics, and national information policy. I thank you all for your service. Dale has gone through the rich agenda that we have. I am looking forward to the meeting today.

I have a few personnel updates to share with you. Since our last meeting, we have new leadership in ASPE. John R. Graham is the Principal Deputy Assistant Secretary for Planning and Evaluation and the current Acting ASPE. Mr. Graham is an expert health economist and executive with career experience in health policy, global capital markets, and military leadership. He joined ASPE in late March and previously served as a senior fellow at the National Center for Policy Analysis in Washington, D.C.

Mr. Graham was able to briefly attend part of the Health Plan ID hearing that the committee held last month – last May. If he is able to attend any part of the full committee meeting this time, we will certainly introduce him so you have an opportunity to meet Mr. Graham.

A few other updates for ASPE leadership. Karen Townsend is the new Deputy Assistant Secretary for the Office of Disability, Aging, and Long-Term Care Policy. Brenda Destro is the new Deputy Assistant Secretary in the Office of Human Services Policy. John O’Brien is the Deputy Assistant Secretary in the Office of Health Policy. We now have the full complement of deputy assistant secretaries at ASPE. Laina Bush, as you are aware, is the Deputy Assistant Secretary for Science and Data Policy.

There are two items that I wanted to also share with you during this update. First, is Reimagine HHS. In early May, Secretary Price launched a new initiative for the department, Reimagine HHS. In the spring, you may be aware, the White House asked every department in the federal government to compose a plan for optimizing the way we serve the American people, including reorganizing some aspects of our work. HHS is using this as a great opportunity to reimagine how our entire department can better support the health and wellbeing of all Americans.

Reimagine HHS will be guided by six principles: engagement, empowerment, service, performance, stewardship, and sustainability. The areas of focus are connected to the HHS mission, including the healthcare system, public health, economic and social wellbeing, scientific advancement, and management and stewardship.

Reimagine HHS efforts are underway. We are very early in the process. However, it is likely that data will play a role in some way. So, we will keep the committee apprised on that front. At our next meeting in September, we may have more updates to share and things that would be relevant to the committee, particularly related to data. So, I wanted to mention that now.

The other item I wanted to briefly touch on is the 21st Century Cures Act. The 21st Century Cures Act contains a broad range of provisions related to scientific discovery and research, medical product development, leveraging technology to improve patient care and outcomes, and improving substance abuse and mental health prevention and treatment in the United States. The Act also contains a number of provisions related to data privacy and using data for research purposes.

So, there are two provisions, in particular, that the Data Policy Division in ASPE and the Data Council will likely have a role in. As this committee engages and has a history of engagement with the Data Council, I thought this would be relevant to share here. These include issues related to data sharing and the protection of identifiable and sensitive information.

Section 2013 is the protection of identifiable and sensitive information. In summary, this exempts from disclosure, under the Freedom of Information Act, individually identifiable biomedical information, as well as information that reasonably could be used to identify an individual, gather use in biomedical research. Agency-determinations to grant such exemptions would have to be made in writing and made available to the public. So, that is one area.

Another is Section 2014. That is data sharing. This permits NIH to require recipients of NIH awards to share scientific data generated from research, provided the disclosure of data is consistent with applicable law regarding human subject protection, privacy, security. Informed consent, protected health information, trade secrets, privileged or confidential information that would be exempt from FOIA is also exempt here.

So, there are several other provisions related to privacy, as well, that are in the law. At some points -maybe perhaps at our September meeting, the committee might be interested in having a more full briefing on 21st Century Cures and where the Department is. There could be some ways where the committee might be able to advise the Department as we move forward.

The second big piece of Cures that I think would be of interest to this committee relates to provisions specifically relevant to ONC and interoperability. There are several health information technology provisions aimed to improve interoperability and electronic health information exchange.

These include – this is just a high level summary – convening stakeholders with the National Institutes of Standards and Technology, NIST, to develop and publish a trusted exchange framework and a common agreement among existing networks, providing technical assistant and conducting pilot testing with NIST on implementation of the trusted exchange framework, promoting a nationwide interoperable health infrastructure and network of systems through the development in support of EHR certification criteria and the required attestation, developing a standard reporting process and imposing penalties to deter information blocking, monitoring EHR vendors, developers, and network exchange organizations that may block to protect their market share. The law does define information blocking.

Supporting real-world testing of health information exchange by promoting the use of application program interfaces between different kinds of systems. Establishing a digital contact directory for healthcare professionals, practices, and facilities. It also replaces two federal advisory committees with one ONC Health IT Advisory Committee.

Tomorrow, Dr. Rucker will be speaking to the committee, in particular about the Health IT Advisory Committee that the NCVHS will coordinate with. He will likely also touch on some of these other areas of 21 Century Cures. Again, this is something for the committee to be mindful of. Moving forward, as we move to planning for the September meeting, this, again, might be an area where the committee might like to have a fuller briefing. Thank you.

DR. STEAD: Thank you, Rashida. Are there questions from the committee related to Rashida’s welcome and update?

DR. MAYS: Rashida, thank you for the update. I think it really helps us to get a sense of where things are moving and how the committee can intersect.

I have a question about a couple of things. One is the data issues. I know that there has been a push to have NIH and others share their data. I am wondering if on the other – well, let me add the other piece so other people know. There has been a change in terms of the Common Rule. So, for example, in terms of the IRB, the informed consent is broader. Some of us, as researchers, are getting a little concerned about the broad sharing is great and good for the overall sense of having data, but we also are concerned about how communities are experiencing this. We are getting some pushback from communities and feeling like all of their information is out there and it can be mashed up. I am hoping, maybe at some point, there can be some discussion that adds in making sure that we are going to be able to get the same number of individuals participating while we are talking about this open data.

My second comment has to do with if you could talk about what you see as kind of the intersection between the committee and ONC, in terms of the technology stuff, particularly the stuff that the workgroup has done. If you could talk a little bit about that.

DR. DORSEY: So, the intersection between ONC and the NCVHS and the work that the committee has done –

DR. MAYS: Where we might be helpful going forward.

DR. DORSEY: I would actually like to pause on answering that until we hear from Don. There is some staff-to-staff interaction that we have been having between – from ASPE and ONC. I think that will – the comments that we hear from Don and the interactions that we have with him. And then also I would like to follow up on some of those staff-to-staff level discussions because, in particular, as it relates to Cures, there were some ways that potentially the NCVHS could be supportive of the work that ONC is doing.

That is certainly a priority for them. ONC was also very early on trying to flesh out what they were going to do internally. So, one piece was – I am thinking that relates to Cures – is for us to hear from ONC their initial plan of what they are proposing to do because they have a huge list with 21st Century Cures.

There is a timeframe and a very aggressive timeframe for which they have – so, that is certainly one area where I would expect that the committee could be supportive. Some of the meetings that I have – I have had some meetings with ONC there just very early on. I mentioned the Reimagine HHS. That – as we were starting to really move into implementation part of Cures and looking into that, Reimagine HHS was layered in. So, there was certainly – there was some focus that was put in that area. I am circling back with ONC.

Your point about participation and response rates with – I am saying response rates – for communities being concerned about how their data are being shared is an important point. We will be coordinating with NIH as the implementation of this policy is developed. That is certainly something that we will be discussing.

DR. MAYS: But also coordinating with the people.

DR. DORSEY: Yes. So, NIH – I would see NIH as being that conduit that would be having more of that interface with the community, rather than our office.

DR. CORNELIUS: Not to miss out on the other side of the issue as it relates to NIH and the data sharing, there is also that piece about the scientific community as it relates to data sharing. This is a big issue. On the surface, it is a good notion. Yet, you deal with exactly what data elements would be shared. What happens as the mash – not just from the community side, but the scientists protecting and releasing data. I keep thinking about what NIH factors are having discussions at the same time we are and how can we interconnect with each other.

Agenda Item: Brief Updates

DR. STEAD: Thank you, Rashida. In terms of brief updates, first, Barbara Evans has decided that she needs to resign from the committee. She has been given an additional appointment by the University of Houston to serve as a professor in computer science and engineering in addition to her just really expanding her role in the law school. She thinks this will make the time that is needed for NCVHS impractical. We want to thank Barbara for her contribution, in particular, the lasting impact of the de-ID letter, and recognize that this creates – continues to create a gap in the Privacy and Confidentiality and in our own membership.

Next, Rich, would you like to update us on your presentation to the National Plan Automation Group?

MR. LANDEN: Absolutely. Thank you. On behalf of the Standards Subcommittee, I made a presentation to the National Plan Automation Group. The National Plan Automation Group or NPAG is an organization comprised of EDI professionals from BlueCross BlueShield plans nationwide. Attendees are generally middle to senior managers at Blue plans with responsibility for the administrative transaction standards and for managing the EDI business processes with provider organizations.

From the NPAG website, they describe themselves as a forum for the exchange of questions and answers about all aspects of EDI. Its objective is to bring people together to share knowledge, mistakes, and successes. It is a down-to-earth, roll up your sleeves group. They are working professionals. This is not a policy group.

NPAG meets annually at different locations. Conferences are business opportunities offering NPAG members a chance to gather information and share details of successes and failures with EDI, network with other plans for information sharing and idea sharing, learn from the current technology trends and marketing strides from experts within and outside the Blue plans, including vendors, and to identify BlueCross BlueShield plans with similar EDI networks, again, giving future contacts for sharing information on ideas. That was from the website.

My takeaway is that my presentation was an update of what I presented to them last year on behalf of the National Committee on Standards related activities primarily. I did, just in passing, touch on all of the activities of the committee, but the focus was on the Standards and the EDI transactions. This year, I highlighted the report to congress that we just produced and talked about the upcoming Predictability Roadmap.

What I brought away – these are my personal thoughts. These are not anything that NPAG handed me. NPAG members reflect their BlueCross BlueShield plan responsibilities, manage a generally robust and healthy EDI-based administrative transactions business system. That business has demonstrated over the years, significant advantage to Blue plans and to providers for enhanced and efficient standardized processing, i.e. less manual handling of routine transactions and faster, more consistent, less expensive claim eligibility and payment processing. All of that to the mutual advantage of the health plan, the provider, and ultimately, to the person or the individual variously described by those stakeholders as their insured, their patient, or the consumer, also, then to the employer or the health plan sponsor.

There appears to be accepted value, generally accepted value in adopting newer versions of standards, although the business need for the time period between version updates is not at all clear. It seems to be a “not too slow, not too fast” kind of need. Version updates are sometimes critical for certain individual transactions, but not for all of the transactions. That – the difference in the value of return for transaction updates dilutes the overall cost/benefit return from general version updates.

Importantly, while people have a careful eye on the future and particularly evolving technology and business models for – you know, for example the ACOs, accountable care organizations, there seems to be a bedrock value for evolving EDI standards. There seems to be – again, my impression, not anything that NPAG said – my impression there is a near zero enthusiasm for any sort of disruptive, new technology that would lead to rip and replace of the current infrastructure. With such a well-embedded base, IT executives will not want to, again, “bet the farm”, to use a term I learned from a mentor many years ago, on any revolutionary approach, no matter how attractive or promising it may look.

Any questions, I will be happy to respond.

MS. HINES: Did you raise the Predictability Roadmap with them and get any feedback on that?

MR. LANDEN: I talked about the Predictability Roadmap, pointed to the materials that at that date were available on the website, talked, in general, about what the plans were. I got no specific feedback for that. The idea of predictability was kind of baked into what I described as how I interpreted their reaction, as far as desirability about versioning update.

No specific information, but a general recognition that it is an issue. I hope through their representatives, their trade associations, primarily, and through their individual plans, that we will get good input during our Predictability Roadmap process. The Blues have, in general, been very good about providing that.

DR. STEAD: From my perch, as we think about this comment, as we get into Health Plan ID, as we come back at terminology and vocabulary this afternoon, we have got to be extraordinarily careful to put the absolute minimum necessary into transactions that have to move amongst complex systems, where everything has to work together. We have to have ways of making data accessible and understandable outside of transaction products in places that don’t move through the transaction.

I think one of the ways we – as we try to be predictable about the things that have to move through transactions, one key is going to keep that as small as possible, while using other techniques and technologies to let us have, if you will, semantically understandable data that is not pushed through those pipelines. I think that is a real – I think that is something the industry probably needs help with. We will see how that unfolds. I just think that comment, the Health Plan ID, and the terminology, at least to me, hook together in that way.

MR. LANDEN: I think that is a point well taken. I did not focus on that this presentation, which was about a month ago, month and a half ago. In the presentation I did last year, I did to the same group, I focused more heavily on the intersection, the challenges, and the opportunities of the business of insurance, namely the eligibility, the claims, the payments as the core, and how the line between those and their data flows are blurring with the clinical data. The group was made aware of that last year.

We didn’t have any particular follow-up or feedback in their May meeting. Hopefully, they took it back to their plans and have escalated that for internal plan discussion. Yes, that is a challenge and an opportunity we are clearly facing.

DR. STEAD: By way of example, this – one of the pieces of our charter is outreach around the topics that we pursue. As Rich did when invited to do this, then we do a handshake with Rebecca, which helps make sure that the content and so forth are available to you and, also, to avoid conflict of interest.

If you are representing the committee, then the committee has to pay travel and so forth so that we are no conflicts continues to ring true. This is an example of that. Then we bring it back into this update block so the committee knows what has happened.

On other fronts, the healthdata.gov letter and report are now ready to go to the Secretary. They are in the final processes of non-content smoothing and preparation. The staff team’s work in that has been remarkable in our recent reports. I had to go into the Pop Health report yesterday. The work that was done after we turned it loose is just remarkable. Thank you.

Just thanks to the committee. When we began to huddle around our workplan in November, it was very clear that we had a backlog. So, if you just look at what has happened since the beginning of the year, the report to congress, Privacy, Minimum Necessary, and deID, the Pop Health measurement framework report and recommendations to the Secretary, and then the Standards rapid response to CMS’ need for the Health Plan ID hearing. It has been an unbelievable period of time. I cannot over-emphasize how grateful I am to each and every one of you for the ways that we have all worked together. Thank you. I look forward, as we work our way through today’s meeting, in really balancing the scope of what we are trying to do with our bandwidth and effort. We are doing the most important things, but in a manageable way to the degree practical.

With that, if you are ready, Nick, we will move to the Health Plan Identifier hearing recommendation letter.

Agenda Item: Action: Health Plan Identifier (HPID) Hearing Recommendation Letter

MR. COUSSOULE: I am going to walk you through, at a relatively high level, the letter, itself, with a little more time on the specific recommendations. Questions or comments, please interject along the way. I know a number of us – we have been through a lot of iterations of this. I do appreciate all of the time and effort and feedback from many members if not all members of the committee at this point in time.

Initially, the letter just conveys a little bit of the history of the HPID. In that, originally, called for under HIPAA and then the ACA suddenly – subsequently required the Secretary to adopt the unique health plan identifier based on input from NCVHS. Our role in this was quite early on.

Beginning in 2010, we had a number of hearings to solicit feedback on this topic and had issued some letters outlining those findings, without any what I will call formal recommendations, but really more findings and observations from the feedback in the industry.

Final Rule got published in September of 2012 on the HPID with two specific categories of requirements. One was enumeration of the health plan IDs. Secondly, was the use in HIPAA transactions. Also adopted was another entity identifier to function for entities that weren’t health plans, but would need to be identified in HIPAA standard transactions.

So, fast-forward a couple more years. There were some more concerns that we began to hear as a committee from the industry and stakeholders about the HPID policy. So, we again convened some meetings in February and June of 2014, to evaluate those concerns and made a recommendation to the Secretary at that point in time, pretty clearly that the industry feedback we got was that there was not a whole lot of value specifically in the transaction process with regards to HPID and that the routing problem, which was, I think, originally envisioned to help solve, had been resolved by the industry using more standardized payer IDs, as described in that letter. Now, these letters – subsequent letters will also be attached to this as reference points along with this letter recommendation.

They concurred at that point in time – again, this is late 2014 – that the HPID shouldn’t be required for use in transactions. It shouldn’t replace the payer ID that was used from the routing standpoint. As a result of that feedback or certainly with that feedback in mind, HHS announced an enforcement delay in the regulation pertaining to the health plan enumeration and use in transactions – in HIPAA transactions, as adopted in the HPID Final Rule.

Fast-forward a couple more years. We were requested to revisit that and solicit industry feedback again, which, again, fit right into what we do. We had to conduct a testimony or held testimony in May for the Standards subcommittee and got lots of input from all across the different players in the industry. It was quite consistent with the input from prior years.

Fundamentally, that the payer ID, which was used to route transactions, was sufficient with not a lot of challenges with that that would be resolved by the health plan ID, such that the original – at least envisioned in regards to transaction routing had been solved and that a transition at that point to HPID may be more problematic than it would actually solve.

The other topic that came up was in regards to the use – other uses for the Health Plan ID, health plan identifier. The primary objective was to – was in the HIPAA standard transactions, but there was some generalized language in regards to potential secondary uses. There really weren’t any specific that came up that were either pressing or thought through in a way that would warrant the continued use there. Although there were some interesting thoughts, nothing that had really been fleshed out that was in the feedback we got from testimony or in the committee members’ review of that that would warrant continued use or consideration of the health plan ID.

After that deliberation and feedback, we had three recommendations. That would be the bottom of page two on your note. First one was that HHS should rescind its Final Rule issued in September of 2012, which required health plans to use the HPID.

Second recommendation was that the HHS should clearly communicate its intent to rescind the Final Rule to all affected industry stakeholders and that HHS should provide the applicable guidance on the effect a rescission may have on all parties involved. Again, the reason for that one is just the shear timeframe required to implement all of the changes through their regulatory and statutory processes would be sufficient enough that the notifying and then communicating the intent would be important. Third would be to continue the 2014 enforcement discretion until the publication of the final regulations, assuming that the HHS decided to issue a final regulation rescinding the HPID Final Rule.

So, those were the recommendations of the Committee. I think we had one change since this letter was put into our deck. I think we had one that was really just a clarification of a quote. I think she added the change in. Sorry, just trying to clarify that. Other than that, that is my kind of – to read out an overview of the letter. Any feedback, comments, questions from committee members?

DR. STEAD: I have the ultimate of a nit question. On line 40, which happens to be right where you are is that the industry has or the industry had moved? I am just trying to – does that sentence connect to the previous sentence?

MS. HERRING: So, that sentence is actually a direct quote from, I believe, the September 2014 letter. Rich, did we get the direct quote from that letter that you wanted to place?

MR. COUSSOULE: Actually, I think that, to your point, it was a quote from the letter, but it is not specified as a quote from the letter. I think had would probably be the right term.

DR. STEAD: When I read – it made me think somehow the NAIC identifier was different than the payer ID in the previous thing. I think they are actually the same.

MR. COUSSOULE: I think it has the same – effectively, the same meaning. I think that would be correct. It referenced that it was a previous comment from the letter.

DR. STEAD: Now, we have quotes, which were not in the version that I had. I don’t know how one resolves that. Somebody smarter than me will need to figure that out. I don’t want to end up with it being – people thinking 40 and 41 are a different identifier than that referred to on –

MR. COUSSOULE: I’m sorry. The version I am looking at doesn’t have the quotes. Again, it is one of those if you have the quotes, it has got to be what the – I would take the quotes out and reference it.

DR. MAYS: When I read recommendation two before, I thought it said something – different emphasis than when you are reading it now. It is on the word should clearly communicate its intent. It sounded like, when you were talking today, it is really an early communication. Is clearly the best descriptor of what you want or is it about early communication? It may have been when I read it, it was fine and then when you explained what you were trying to do, which is what it takes to get this out and kind of slow down, it needs to be done early. So, I was just confused now if it is clearly or early.

MR. COUSSOULE: I think the intent here is, in recognition of the process taking a while, to run through that change process that HHS would – we would appreciate if the decision is made to let the industry players know the decision – in clear terms, that it is going to happen. I think we could probably try to wordsmith that one, but I think it is the same.

MS. KLOSS: It is really upon adoption of recommendation number one.

MR. COUSSOULE: Not so much adoption of recommendation number one, but clearly communicate the intent to adopt – intent to implement recommendation one.

MS. HINES: Do we know how long one will take based on past history?

MR. COUSSOULE: You will have to ask others here that are more familiar with that process.

MS. HINES: And we have a new administration. The question is if number one takes a year –

(Comment off mic)

MS. HINES: So, there is an annual process is what the lead staff is saying. So, it could take a year or more based on lead staff in the room.

MS. HERRING: Are you saying we should be timely based on when we know that it will be available for us to communicate it to everyone?

MS. HINES: So, instead of clearly, say HH should expeditiously communicate it?

MS. HERRING: We should clearly and timely communicate it.

DR. MAYS: I think it is HHS should communicate clearly and early.

DR. ROSS: It’s about all affected stakeholders, right? So, all of the people who need to know about this – assuming the administration or the Secretary accepts the recommendation, what we are saying is then immediately notify all affected stakeholders that this is in progress.

DR. MAYS: Exactly.

MR. COUSSOULE: To indicate that it is – should clearly and timely – I think that is an enhancement that makes sense. I would agree to that. Again, we have to recognize that all three of these recommendations really go together. It is, yes, we are going to do it. We are going to tell everybody we are going to do it. We are going to make sure we continue the enforcement discretion so it doesn’t gum up the works while we are in that process of change.

MR. LANDEN: The underlying assumptions under two and three are that HHS will decide to accept our recommendation and will rescind the rule. If they decide otherwise –

MR. COUSSOULE: If they decide otherwise, then two and three really don’t – I won’t say are irrelevant, but they don’t have the same level of import. Certainly, two wouldn’t have the same level of import. Three would be – if HHS didn’t decide to rescind, then three becomes important on its own, in regards to the enforcement discretion.

MR. LANDEN: One of the damages we are trying to prevent is that the Final Rule is still a final rule. It is just under enforcement discretion. Industry is still struggling with do I have to implement or not. One of the things we are trying to communicate is to have HHS clearly say no, thou dost not have to continue to try to implement HPID.

DR. COUSSOULE: I think that is a good clarification, Vickie.

MS. HINES: So, HHS should clearly and timely communicate?

DR. RIPPEN: I guess I am – this is not a nuance of timely or not. It is a different question.

DR. MAYS: I think it is communicate first and then clearly and timely.

DR. STEAD: I am not sure clearly adds anything. HHS should communicate its intent to rescind the HPID Final Rule to all affected industry stakeholders as soon as a decision is made. Does that get it where you are trying to go? Then I hear Helga wanting to raise a different point. Can we put that edit – did you get that? Great.

DR. RIPPEN: So, this is just a question because I am not really as familiar with the nuances of this one. Assuming – so, it is currently said that you have to use this. Right? We are talking about one to two years, potentially, before a decision is made. There is a cost associated with industry that has to actually act on it now. Right? There is an act that says you need to do this. I guess what is the – balancing something that is required and saying, well, two years later, you don’t have to is a big cost, too. I guess was that taken into consideration is my only question.

MR. COUSSOULE: I guess the way I would answer that is the enforcement discretion right now basically put it on hold. The rule is there, but basically HHS said we are not going to enforce the rule now. I mean publicly said that, didn’t just kind of behind the scenes, but very publicly with enforcement discretion. That is why the third recommendation becomes quite important in this. If, in fact, they are going to change the rule and it is going to take a while, that makes sure we continue the enforcement discretion so it doesn’t create that level of churn.

Other questions? Comments?

DR. STEAD: Do the generalists in the room think that this is clear? This is an attempt to actually put a very complex issue to bed. One of the things I discovered when I became chair and had to put the report to congress to bed and, therefore, went back and read everything we had done in those three years, that I had not been paying as much attention along the way as I probably should have. It is really – in particular, for the new members, I want to really emphasize what we approve, we are approving as a full committee. Therefore, we cannot – we need to listen to the subject matter expertise of the people that are deep into an issue, but we need to make sure that the net result is something that we each understand and stand behind. I just wanted to pause and make that explicit.

So, are we at a point we are ready for a motion to approve the letter as edited? Dave just said yes. Is there a second? Lee is a second. Any comment? All in favor? Any opposed? Any abstain. Congratulations.

(The motion passes.)

DR. STEAD: I think this is a nice example of interaction between the committee and the Department. We were asked to do this. We were helped in doing it. The subcommittee turned it around, both thoroughly and with speed. Thank you.

MS. HINES: And a big thanks to CMS for staffing this with Geanelle Herring and Lorraine Doo. We couldn’t have done it without you both. Thank you.

DR. STEAD: My own bias is we should keep moving. We are ahead of schedule. I am in favor of keeping moving and leaving the break at 10:45 as scheduled. We can stop in the middle of the APCD discussion if that is okay. Let me turn the floor over to Bob Phillips, who has been shepherding this effort for the Pop Health Subcommittee and the ad hoc workgroup. Thank you, Bob.

Agenda Item: Action: NCVHS 6/17/2016 Hearing on Claims-Based Databases – Summary of Submitted Testimony

DR. PHILLIPS: Bill, thank you. I am indebted to the ad hoc workgroup, who helped with this. What I want to do today, similar to Nick’s effort, is give a high-level overview of the testimony and resulting summary of that from a workshop done a year ago on all payer claims databases. This was a focus of our workplan for 2016. That hearing was convened a year and four days ago, June 17th. We had considerable input from a number of stakeholders in framing the concerns and opportunities around all payer claims databases, many of whom are in the room. We are quite grateful for their help.

There is a summary of the – a transcript summary up on the website that was put up in a timely fashion, within the 90-day requirement. We needed to dig into this further to give a more thorough rendering of what was actually submitted to us.

So, the report you have actually is a summary of the submitted testimony and, as I said, a snapshot of what is still a rapidly changing area. In fact, the front-end of the report notes that there have been a couple of major happenings since the time of the workshop. It is a snapshot and not meant to be an up-to-date summary of where all payer claims databases are. It really does extend the public and private dialogue about how claims-based database resources should be supported and how they have evolved as health data resources continue to expand.

So, the agenda was really organized around three areas, policy and reporting issues, which included value, purpose, structure, public reporting, and policy considerations, and also data supplier and uses. There was a section on federal and state issues related to all payer claims databases and then a third on standards, particularly around background, emerging issues, and challenges. We have organized the report around the themes, not just around the structured agenda. We have laid out the headings, the major headings of those themes for you here with a summary at the end of potential future considerations. We really – the ad hoc group really held back on coming to conclusions or actual recommendations, but wanted to highlight some potential future considerations for us to discuss here.

MS. HINES: Bob, for the benefit of our new members, the ad hoc workgroup is the fact that this didn’t really live in any subcommittee. It was a group of volunteer committee members, some of whom are in the room today. Two important ones are not, Denise Love and Alix Goss, but Helga and Vickie and Nick and Rich, I believe, and Bruce, in addition to Bob and Linda, really stepped up on this. I just want you all to know that this was one of those cases where it ended up sort of being a committee-wide activity. Those who had an interest and availability plugged in, in fits and starts, over the last year.

DR. PHILLIPS: Thank you, Rebecca. Next slide, please. So, the summary you have, again, is a summary of the written submitted testimony. Even since sending this out, Rich has provided some very helpful feedback and some corrections that we will make to the report. I wanted to give the group a chance to talk through any of the – any concerns or any additions or subtractions they would like to see.

MS. HINES: One change was made by that ad hoc workgroup. There was a conference call after you got your materials. This yellow highlighted area is new from what you saw in the packet.

DR. PHILLIPS: As I said at the introduction, this was added to just suggest – this really was a snapshot. Since the hearing, the APCD Council has put out a considerable discussion since then about the claims data – APCD data layout standardization and then a related notice of proposed rulemaking was also released just a month later after the workshop with comments. Again, this is an evolving area and still remains on our workplan.

DR. STEAD: Let me, again, just try to underscore how Bob and the ad hoc workgroup have tried to frame this. Just to underscore. Bob has already said it. In essence, at the Executive Subcommittee, we discussed earlier drafts that, in fact, had potential recommendations. We decided that we had not had – as a committee, we did not have enough information and we were not – we had not formed any common view that could support those kind of judgments. That has all been abstracted. It can be considered as potential future work if we feel that we want to – it is important for us to engage in the space.

As you look to this summary – and I think Bob and the ad hoc group have done a good job. As you look to it, make sure that there is nothing that implies the committee is making any judgment. Because our goal is not to. Our goal is to summarize what we heard. I think the committee – I think the workgroup provides value over what we heard in the categorization of the testimony and in the reorganization of the testimony under the categories.

I think that is a useful framework, an overused word for our committee, for how you think about the different components of this work. But we need to be – everybody should have the lens that we want to accurately relate what we heard as a evidence base to help us and others decide what else we might need to do. We want to make sure we have succeeded in scrubbing from it anything that looks like the committee’s judgment. Is that fair?

DR. PHILLIPS: Absolutely.

DR. STEAD: Then let me ask, related to the yellow text – because I think – I can’t remember which of the conversations I heard. The risk of that yellow box is that there has been important other activity that is not noted. So, whether – so, one question is whether it should be there has been considerable activity, period. It is not covered. Do we run a risk that by citing those two items and not being in a position to do an inventory of what else important might have happened by other groups, are we at risk? I just raise the question.

DR. COHEN: To address that, I would add in the beginning of the second sentence, the phrase, for example, the APCD Council. So, it is not implying that we are comprehensive, but we are noting some work.

DR. STEAD: My concern is – has there been considerable activity around things other than data layout?

DR. COHEN: That is right. Rebecca, you are right. That would be a better place. There has been considerable activity around APCDs or something like, for example, data layout standardization. Just to imply that we understand that this is an ongoing, rich source of activity and we are just noting some explicit highlights.

DR. PHILLIPS: Rebecca, I would actually move “since this hearing was held” to right where your cursor is now.

MS. KLOSS: I am just wondering whether – rather than calling it out as a note, whether an additional sentence could be added to the paragraph above. We state what the intention of this summary is. I think we could add certainly – can we say it is continuing to evolve? I guess I am not convinced it needs to be here, the note. Perhaps it just can be summarized in –

DR. ROSS: What I heard on our last call of the ad hoc group was that there was concern that this – because we are a year out and there has been other activity that people might see this summary as a contemporary summation of what exists. I heard there was a need for a disclaimer to say that other activity has been going on and maybe to point to some of it.

MR. COUSSOULE: Would it be more – sorry, I don’t mean to interject. Would it be – I have a bit of an issue with it, as well. I mean this is a pretty fluid area. Any time, we cover a topic that is relatively fluid, there is always a risk the day after the hearing something comes up. Now, this has been delayed a bit, obviously, timewise. So, it may be useful to say in this fluid area – you know, recognizing that this is a point in time snapshot of feedback that we got. I am not sure that it is necessary to call out say considerable activity. To me, that implies something different than might be the case.

MS. HINES: In the workgroup call, we talked about a footnote. I don’t know if you want to just –

DR. STEAD: I, at least, would advocate that we not include specific examples because I don’t think we are in a position to provide a balanced set of examples. I think, therefore – so, I think –

MS. HINES: So, you would advocate, Bill, of deleting this?

DR. STEAD: I support where I think Linda was trying to go, of somehow noting in that paragraph it is a fluid space and a year has passed or something like that.

MS. KLOSS: We put the date of the hearing at the header. So, I just can’t come up with the words, but I think an additional sentence to the paragraph would do it.

MR. COUSSOULE: This raises – without the risk of going down a rat hole – a slightly broader question that any time we go and do something like this we get new information that we read in the press or we that we know in our jobs or from whatever we do in our day to day life. At some point, you almost have to kind of call it the way you heard it, recognizing that there may be changes. How do we – we want to make sure that we are not kind of interjecting differences of what we might have heard without the context of having lots more input from other parties. Do you know what I mean?

DR. STEAD: You are right on, Nick. I think that is where, by making this a summary of the hearing and taking out all judgment, it really needs to be a summary of the hearing. In other things we do, particularly – well, when we are writing something that reflects the committee’s collective judgment, we can reflect anything we think is appropriate and the balance or non-balance – the makeup of the committee is what produces the balance. Our trouble – our challenge here is we have really got to keep this clean as a summary of the hearing. I, at least, in reading it – it is very helpful to me to sit down and read it as it is. That is much better than the summary that is on the website. We then have to decide, do we want to do something else that positions us to think more broadly? We need to keep those two separate. We have been challenged by that.

DR. ROSS: So, the transmittal of these summaries, I would think that is where you note that this was a year ago, it is a rapidly evolving situation, but the document is the statement of what we heard at that point in time.

DR. STEAD: We are, in fact, not planning to transmit it. We will replace what is on the web.

MS. KLOSS: Which are very cursory minutes.

DR. STEAD: With this.

MR. LANDEN: I’m struggling – I understand the theory that this has to be limited to what happened as of that date, but we are also looking at here we are a year later. Who is going to be reading this? Are we doing them a disservice not to footnote, if that is the vehicle, something as significant as an NPRM? Now, I am not recollecting what the content of that NPRM – whether that is significant or not, but I do see that as an issue of balance. If we are posting a document June of 2017 reflecting a hearing that came a year ago, don’t we have to – shouldn’t we, in the interest of full disclosure to the reader, not change the reporting of the events of the hearing last year, but giving them a heads up that there is other stuff they want to look at? I think I am more onboard with the intent of the workgroup for including the note, but I also recognize it is a delicate balance. My sentiment is to footnote the NPRM.

DR. RIPPEN: Again, I think that therein lies the challenge. The question becomes how does one keep current any document that we may have? Now, we can say, well, this is unique because it is a year. But I think overall, as a committee, we have to have kind of – create maybe guidance as far as what – when we have a hearing, regardless of when it is published, this is how we are going to handle it.

If we want to, for example, on the website, have someone that is a content expert to say here are things that might impact it, that could be one way. It doesn’t address the document, itself, but it highlights here are places that you may want to go if you want to be up to date. It is a lot of work, the implications of that. Again, I think as a committee, just from a process perspective, we do have to have kind of guidance as far as how we want to handle these things.

For all of our reports, are we going to have footnotes that say there might be changed? Do we just say a report on something that happened is a report on something that happened? I don’t know. I think as a committee, we have to come up with whatever it is that we are going to be and be consistent about it. In this case, I guess I am biased because I believe that it is a summary of a hearing and that we shouldn’t be referencing specific things because then the question is, you know, what makes the cut or what doesn’t make the cut. It then maybe reflects some bias of our own perspective. I understand all sides. It is just we have to make a decision which way we want to go and then apply it consistently.

MS. STRICKLAND: So, I just have a comment about – at the end of this paper, the summary, we do have potential future considerations. I think that perhaps a summary of since the writing of this paper or in summary – we could add something at the end of it that says these are other activities that the committee is aware of that may be of interest to readers of this summary. It does not mean it is part of the summary, but it says that we are aware of other activities that may be important to the reader that they may want to go and reference, instead of maybe footnoting.

DR. STEAD: For clarity, that last section were potential considerations that were raised in testimony, not considerations raised by the ad hoc workgroup.

DR. THORPE Helga stated exactly what I was going to say. Basically, when I read the title as it is now, it is a summary of what happened June 2016, not what took place after 2016 to June 2017. I agree it would be a nightmare to try to, every time something changes, if we are trying to be consistent with all of the documents – I think that is a heavy lift.

MS. KLOSS: That, too, was my point. When we look at anything on our website or any website, the first thing you do is look at the date and then you mentally understand that there have been some changes and what it is reflecting was the status of June 2016. I would be more comfortable with either embellishing that last sentence – or just leaving this reference out – and leaving this reference out.

DR. COHEN: I guess I am – I agree with Rich’s point more. It is – I would like us to develop a standard, but it is impossible because of the way we do our work. We can have some guidelines about approaches. Usually, reports come out in a lot more timely fashion. So, I am troubled by the time interval between when this happened and when we are really releasing this report.

I guess a compromise for me would be in the paragraph above, adding a sentence that says something like the committee recognizes there has been considerable activity since this hearing was held and then footnote several examples are this and this. I really think we need more specificity for this particular report. In general, I would agree that reports should reflect only things that happened during specific hearings.

DR. PHILLIPS: I agree with Bruce, generally, about having guidelines, not absolutes about how we approach it. This is a special case.

I didn’t bring this issue up. It was brought up during the workgroup call. I thought it was a good idea. If in the next section in our discussions about what we want to do going forward, if anything – if we do go forward, my concern about including this goes down because we will be taking this into account. If our decision is to not go forward, then I really do think we need the footnote just so that – there will be a hard stop and folks looking at this as it is newly uploaded need to know that there are some important things like an NPRM out there.

DR. STEAD: I am trying to – let’s go Nick, Helga, and then Linda, back to you.

MR. COUSSOULE: I think there is a real risk with outlining something that has changed without getting into a lot more detail. Again, I think the idea is this is supposed to reflect what we heard. If we go and include – frankly, we all know we have differences of opinion here in what we would approach, how we might approach it, et cetera. If we include something, then we all go back and say, well, let’s include these other three things that happened, too. That is where the risk comes in with something like this.

I think the biggest challenge we have with this particular one is the time delay, as Bruce said, between when we conducted the hearing and when we published the information. I do think it raises significant risk of what we would even select to include if we get specific about what would be included after the fact. I could bring up a couple of other examples, just things that I know in my own work. I am like that is really not – I think the purpose here – if we choose to take it up as a further detailed more work effort, then all of that comes into play in all of the experiences we have since then. That is just my opinion.

DR. STEAD: Let me take the prerogative of the chair and see if I can make – what if we were to put a sentence at the end – if we killed yellow and put a sentence that said the committee reminds the reader that this is a rapidly changing space and that this hearing summary is dated? Just be honest about it.

The process change we have made as a committee, is that we have said no, we are not – as a committee, we are not going to do anything that isn’t homed in a subcommittee. The fundamental – the reason this is dated is because it wasn’t in a place that it got actively worked. Population Health and Bob, in particular, were kind enough to let us move this into their process and they have gotten it to this point. Rebecca and Rashida and I have locked arms and you will discover on our workplan anything – however it cuts across all committees is homed into one subcommittee going forward. That is the process fix. So, we don’t plan to be dated again, at least on my watch.

So, maybe if we just have that stated – just calls it clear without – you know, it just says – it is stated. I will just put that out there.

Now, let me – I’ve got to – let me go back. So, Helga, Linda, Rich, and Lee.

DR. RIPPEN: I think that there may be a way to highlight both, but in a very different way. So, we have a report. It is a summary of the report. We could create a new thing called an addendum or kind of a note that is on the website that could maybe – especially if the committee feels strongly about highlighting certain things. It is not the document. It is a separate component that says, by the way, reader, there are some things that you may want to take into consideration. Have that not as part of the document, but where you can find the link or kind of a note. It would be very unique cases.

Again, I am just trying to figure out how to get – not have a problem with the report and always having to figure out what to add in it, but then allow for committee members to maybe provide a summary or kind of an addendum sort of thing, but not part of the report. So, just trying to figure out a workable solution if people feel strongly.

MS. KLOSS: I have a specific recommendation for this. If you look on the bottom of page two, where we described the APCD, we do include the link to the Robert Wood Johnson Foundation. We could, in that paragraph, include the link to the APCD Council. I think that is the valuable thing in this note. It does help the reader know where to go to get updated information. I think it does belong in that second paragraph under background. It would be helpful to include that link. I think that would kind of take care of it.

DR. STEAD: So, would you put that link in right before where you have APCD Council lists 19 states? You would put the link to APCD Council there?

MS. KLOSS: I would put it right after that, right before the reference to the Robert Wood Johnson. That is the source for current evolution and activity. It should be in the report.

DR. STEAD: So, we have heard Linda’s – does anybody – let’s try to work this in pieces. Does anybody disagree with that suggestion as one change? You disagree? Keep that in your pocket. Let’s continue to run the list and see where people are.

DR. LANDEN: I like Linda’s change, just including the link where the Council is already cited. Back to the issue of consistency in our approach, yes, I think we need consistency, but I think the consistency policy that I am looking for is kind of a bifurcated consistency.

We know that as a committee, it takes us a long time to do things. HPID letter took 30 days. This one is a year. We have had other documents that have been in the pipeline two years. I think our policy is clear – the fundamental policy is clear that if it is a hearing report, the content is only about what is in the hearing. I don’t hear any disagreement with that. Consistency for consistency’s sake, in my mind, at least, is not a good policy.

For our policy, I would propose something like, you know, it is the hearing, except if the members in the workgroup or the subcommittee think the timeliness is such that we do a disservice to our readership if we don’t call out something. I think that should be our policy. If it is timely, we stick to the content of the hearing. If it is not timely, we put responsibility for initiating any exception to that rule with the subgroup, subject to review and approval by the full group. That would be the policy approach.

Back to the content of this letter or this report, rather, I think a potential compromise would be where we are talking about the earlier inclusion there, if we add a sentence that explicitly calls out that this report excludes any developments after the date of the hearing.

DR. STEAD: That is good. That is a much better way of saying what I was trying to do. Thank you, Rich.

DR. CORNELIUS: It was just to suggest that when I heard the phrase dated, I – no. You can say that things are changing or things have – I like the suggestion that was just made, but dated puts out the notion why even bother looking at the letter. It is not relevant when you use that phrase.

DR. STEAD: That is a good comment.

DR. MAYS: I also want to do a combination of Helga and Rich at this point. I think that what would probably work well is some acknowledgment that, you know, this is the time period that this occurred. It is kind of how to do it. The how to do it – Helga was saying, as kind of an appendix or something- I am going to say it is still at the letter, but it is kind of – or in the report somewhere, but it is kind of said either at the beginning that this report was done blah, blah, blah, blah, and materials after that may not have been included in the deliberations or it is at the end after the recommendation.

I think that we need to say we deliberated on the hearing we held as kind of our standard and then those times where we do something differently, then we say it. I think it should kind of be in the report so that people – and probably early on, so that as people read it and they know that something else has happened they don’t go, well, what is wrong with these people, we have done such and such since then. Then they stop reading because they think we are just like yesterday’s news.

DR. ROSS: I am just looking at our website. I brought up the committee’s website. When you go to the recommendations and reports, it just has a date beside each report. If I am a reviewer from the public coming and looking, I can look at the date. If it is a year old – I think the kind of – the wording that we have, I support that. It is acknowledging that it is a fluid environment. When we put the date, it says this is the date this took place. It is a report of what we heard then.

DR. COHEN: So, should we backdate this report when we put it up? When we list it on the website, it will say 2016.

DR. KLOSS: Because it is a summary of that meeting and replacing the current summary that is already there.

DR. ROSS: So, I think the wording we have, the inclusion of the APCD site, gives the reader a way to go look for more. Short of us adding entire guidance over all of these different reports, that is going way beyond the mission of this committee.

MR. COUSSOULE: I just wanted to comment if I go even back and look at the title of the document, it is a summary of submitted testimony. We are trying to cover for the fact that it is a year late. I think it raises a real risk of us doing something that we will regret later, setting something in motion that lets us interject bits and pieces into something that is not really relevant. I think we have had an interesting discussion about whether we want to move this forward or not, which I think is a perfectly valid struggle to have. Really, I struggle with the interjecting things that happened after the date in any level of detail. Saying that it is fluid and that there are changes and recognizing that as part of it, to me, that is reasonable.

DR. STEAD: My sense is that we may have consensus around adding a sentence along the lines of what Rebecca has got there. We may want to wordsmith it a bit. And adding the additional link where Linda proposed so we are giving people access to sources other people are maintaining. It is clear those are the people that are maintaining it, not the committee. And clarifying that this would, in fact, be posted under the hearing date in the website.

MS. HINES: It is going to be posted in two places. It would be posted with the hearing, as well as where minutes go. It would say June 2016.

DR. STEAD: Are people good with that? So, let’s look back, Rich. It is hard. I know different people – so, it plays into what Nick just said. We are going to get into the discussion of what else we might need to do. At its heart, there is disagreement at this juncture, given what we know on what we might recommend. Therefore, we are not going to – I don’t get a sense that we have a chance of this group voting for anything specific without a lot more work.

MR. LANDEN: I am good with our brilliant chairman’s proposal. However, I point out that in our page footer, we have got a date of June 2017. Is that going to go – is the June 2017 date going to go away from the footer in the document? Can it go away? If so, then I am good.

MS. HINES: It can go away, Rich. I also wanted to acknowledge that Rich sent some very helpful basically smoothing edits like a stray word or closed quote, but there was one of your comments, Rich, that I do think the committee needs to discuss, if you don’t mind. I don’t want to be talking with one person about how to resolve it. I think it should be surfaced. It is on page nine.

As you all know, most of the sections are literally a summary of the testimony. So, for example, access to data and data release policy starts off, few testifiers focused on specific details of data release policies with the State of Maryland as a notable exception. Thank you, Rich, we will spell that out. That is a very typical section.

Then when you go to Section E, Delivery System Reform and Payment System Reform Implications, Rich, you noted that, here, we used the phrase, the committee noted, and nowhere else do we say that. So, your first suggestion is that we say NCVHS members noted – if people are okay with that – that numerous states and entities are investing in claims-based databases and asked how relevant will these systems be as payment reform moves forward. I just wanted to make sure, since this is an observation of what occurred, that we change the committee to NCVHS members.

The second part of his note says – well, the other note is that, is this actually all just written testimony. Clearly, there are comments here that are not just written testimony. So, we should probably take the word written out because there are some pieces of information in this report that basically describe what happened. NCVHS members noted – well, that is not written testimony.

Those are the two things, of all of your notes, Rich, that I think rise to the level of discussion.

MR. LANDEN: That latter one, is this just the written? What was submitted?

MS. HINES: It is not.

MR. LANDEN: I don’t think it is, but both the title of the document and the third paragraph of the opening page of the document very explicitly refer only to written and submitted testimony. Instead of changing that, I just suggest we add oral presentations.

DR. PHILLIPS: This, specifically, was an omission of mine. The workgroup felt that we should strip out all of the committee comments. This is one that got left in. We stripped out all of the committee discussion from the hearing text. I think this really should just be stricken and leave it to the peer-submitted testimony.

My understanding is that everything else is compliant that it was the submitted testimony, either slides or submitted notes, not from the commentary. If that is not the case, then we would need to make that change up front.

MS. HINES: So, there is agreement we should just remove this whole item? Okay. What was the other? So, then the – then in terms of – then we wouldn’t add oral. It is just summary of submitted testimony.

DR. COHEN: Why don’t we just delete submitted? Summary of testimony?

MS. HINES: I think that is actually probably more specifically accurate. We are going to be really precise.

DR. STEAD: The other thing I would – one other little thing I noted, on page six, bottom of page six, under two, Governance Structure, I would kill the APCD Council there because that is a direct repeat of what was put previously. That just is redundant.

MS. HINES: So, just kill this whole item?

DR. STEAD: Yes. It is redundant.

MS. HINES: We have agreement? Okay.

DR. STEAD: Now, from a process point of view, we have a block to actually take action on this in the morning. What we might do is let you make the rest of Rich’s changes. We go on, take our break with an extra five minutes because we have been good and come back and discuss what we want to do – what we might do next. Then we will be free of the summary for the moment.

We can really get at where we are and what we think would be appropriate and where it would set in priority of things we need to do. We would be informed by that as we slept on this overnight. Come back. See the track change version. And do the vote on accepting the summary in the morning, where it is scheduled. Is that, process-wise, a good way to handle this?

DR. ROSS: Just a simple clarifier, back to Rich’s question about the date in the footer. I just want to be sure, looking at the website – so, it will get posted showing June 17th, 2016 as the date of this report. Is that right?

MS. HINES: Basically, we have had so many drafts of this that I insist on version control. I needed that.

DR. COHEN: The date that are on the website are the dates that reference the work, not when it was posted.

MS. HINES: Yes.

MS. STRICKLAND: I just have one minor typo on page four, the first section, five, and the first paragraph, enabling –

MS. HINES: Yes. We got that. Thank you.

DR. STEAD: Another internal note to all of us. Things that go in the e-agenda book that we are going to be discussing and taking action on need to have line numbers. We just – it is unbelievably helpful.

Okay, then let’s take a break until 11:00 and then come back and discuss what we might do next. We have a lot of time so we can really get into it in some depth.

(Break)

DR. STEAD: Colleagues, let us see if we can come back to order. Is anyone on the phone?

MS. MUNSON: Jackie Munson is on the phone.

DR. STEAD: Thank you, Jackie.

Bob, would you like to guide the discussion of whether we should do something else in this space and if so, what.

DR. PHILLIPS: Sure, thank you, Bill. It is an open question. I mean APCD is still on our work plan with Population Health being the owner of that. This really was an issue that Walter Suarez brought to us and with his departure from the committee it lost that kind of key leadership. We don’t have Alix Goss with us today. We don’t have Denise Love, both of whom this is a near and dear topic for them as well. But it is an open question about whether the committee feels we should proceed forward.

I offer here examples of topics to explore just to provoke some thinking before we get to decision making. If you saw in the summary of the hearing upfront, the layout was supposed to get to a roadmap for achieving greater standardization and the role that NCVHS can play in this space. In the summary, we wound up with potential future considerations because that discussion of a roadmap never really fully happened. So it’s a bit of work left undone but we need to decide if we want to do it.

So some of the topics to explore that came up in the hearing are; is there a need for assistance to states with the development, improvement and sustaining of APCDs. There was a discussion about the common data layout efforts and as you noted in the attempt at a disclaimer, there’s been a lot of work in that space since the hearing. There was quite a bit of discussion, particularly from payers at the hearing about a federated platform to make the standards for APCD and the contributions to APCDs more common.

There was a discussion about the need to include Medicare, Medicaid and the VA, Tri-Care and the Federal Employee Health Plan into APCDs. It’s happening in some states but not in all. And then finally, there was a review of related claims data consolidation and linkage efforts. This is not an exhaustive list. This is just some of the topical areas that came up during the hearing that we could work on.

So the most basic question that I’d like to have the committee chew on is should we continue this work. And if we are then what additional information do we need and how do we want to get it. This best mechanism. Do we need another hearing? Do we need a workshop before we make decisions about recommendations and then the real question, do we want to make recommendations to the Secretary because not all of the work of the committee results in recommendations? And it could be just more fact finding and creating a forum for people to have the conversations around this. But do we really want to get to a point of making recommendations to the Secretary.

So I propose we just kind of do a round robin, Bill and I talked about this, just make sure everyone’s opinions get on the table. We’ll do that and then we’ll open it up for conversation if we can. So Rich, are you prepared to talk about it?

MR. LANDEN: Never sufficiently prepared. The reason I said that in all facetiousness is it’s very complex and it’s woven so tightly and with other initiatives, some of which we as NCVHS are invested in; others which are totally outside our purview. So I don’t know the answer to the question. I think there is certainly potential and opportunity there but whether it rises to the level of an NCVHS priority or not, I will not know until after I have the benefit of discussion from everybody. I would especially call out Denise Love who is not here today.

My questions that I would offer up to help us make the decision is – and this is kind of in keeping with our conversation earlier about everything that’s happened since our hearing a year ago. What is being asked of NCVHS by whom? Are there issues related to all player claims databases that we as NCVHS need to weigh in on that the private sector is not already addressing or other agencies or other FACAs, advisory groups are addressing? So is there a specific need for our expertise and intervention?

DR. CORNELIUS: I’m just having this grin on my face and Rich and I were talking before we began today, thinking about the longevity of our work and so when I’m thinking about the all payers claims database, I’m asking myself not to close doors that we might have to reopen one or two or three years down the road just based upon a fluid health environment. It’s not so much whether we should continue but how and how to anticipate the five, ten-year gain.

DR. ROSS: I am just asking myself why NCVHS? What’s our role? What’s our scope? We advise HHS so therefore what are we asking HHS to do? Are the states asking the Secretary or asking us for specific guidance? I don’t know. I wish our most informed members were here to tell us. I would pretty agree with probably anything Denise says. But it’s not clear to me that there is a specific ask that this committee needs to address within our scope as a committee.

DR. COHEN: Can I answer your question? So we advise the Secretary and I think HHS has a pivotal role with respect to the future of APCDs from several perspectives. From the technical data collection perspective, just the way vital statistics is a state jurisdictional system but the feds and NCHS developed standard common data collection minimum dataset that drives the whole system. The same thing with hospital discharge data. These are two analogous systems where the feds played pivotal roles in developing standards that allow states to develop and move forward. I think the feds have the same opportunity, the same obligation in fact to make some sense out of the APCDs to develop a common vocabulary or a common minimum dataset that all jurisdictions can use if they develop APCDs. So I think as an advisory committee to the Secretary, we’re well positioned and should take up issues around standardization of datasets. So that’s one perspective.

The second perspective is wearing my population health hat. We haven’t even scratched the surface about how these data are being used. In states like Massachusetts that has essentially full coverage for insurance, claims databases that link commercial data with Medicaid data and Medicare data and some other datasets essentially provides the Holy Grail of understanding what health services are being used because all health services generate claims, whether they are pharmacy claims or other kinds of claims. And the potential use for understanding issues is enormous from the research and population health perspective.

Let me give you – I used to do some work in infertility. There’s no population-based estimate of infertility in this country or in any state level. Claims that generate medication for infertility or visits to physicians regarding infertility would provide a denominator for what may be an emerging problem. Substance abuse, pharmacy claims, linking APCDs with the emerging pharmacy monitoring systems. So I’m interested in looking at the content of the data from a population health perspective and I think the committee can work in that space and also the space around developing a standardized approach to data collection.

DR. PHILLIPS: Thank you, Bruce. If you look at the summary of the hearing there are a number of places where NCVHS was asked to do specific things. Whether it was looking at a common technical architecture and making recommendations to HHS about developing that, whether it was about supporting states in developing this, it was the inclusion of federal claims data in those.

And then there were some comments about being mindful of the way states are currently using them and not if there is a common platform or technical approach or architecture, it shouldn’t get to be a problem for states in continuing the work they are doing. So I think there was considerable suggestion that NCVHS continue their role.

MS. KLOSS: I would agree with that. I think there were three overarching opportunities, the standards or the architecture, the data itself. Financial support for the sometimes struggling entities that are trying to do this at the state level. And third, the availability of data, making sure that the databases that were in the HHS possession were being made available uniformly.

I personally have been conflicted about the committee’s role in recommending the advancement of any of these because it’s not necessarily at a policy level and I have also been conflicted with now, is now the time to recommend full throttle support for all payer claims databases. These are not new projects. They’ve been around for a long time and we know the availability of data at the state level is going to be even more important if we see health reform roll out the way it is, at more of a state locus. The data component of that’s going to be really critical. So it does seem, and then payment reform. It does seem like this is the time to monitor but not do new work or formulate recommendations because I just think this is going to undergo some pretty major change.

So my feeling at this point is that we monitor but not actively hold other hearings and I think that becomes clearer when we look at the whole work plan and balance things.

DR. PHILLIPS: Linda, not as a challenge, but from someone naïve about how we monitor. Is there a mechanism for us to do that?

MS. KLOSS: Well, I think the members who are expert can give us an update every six months or so and what’s going on and are there new struggles emerging, new needs emerging. I just think to dive into this with our limited resources at this point just – I’d have a hard to time staying at that that rises to the priority.

DR. STEAD: I found rereading the summary to be extremely helpful and pointing out the dimensions of the space because in essence right now this is largely state-led payers that deal with multiple states which most do, or many do, end up having to deal over and over again with related but different issues. So I think Bruce has done a nice job of capturing the potential. I think the summary captures some of the problems.

I think the challenge is that with the nature of the change in reimbursement, there’s going to – you either end up narrowing what you collect in a transaction-based world or you end up dramatically increasing it. There’s not a good way to – I at least am not able to currently envision some middle ground between those extremes and therefore I think it is a risky time to act.

I could see the case for a very targeted hearing on if there was going to be a minimum dataset that was actually minimum, and therefore standardizable, would that be a good idea and what would it look like. I could see us asking some targeted question if somebody said it was a priority for us to get at this. So I guess in many ways I would sort of – I’d be interested in knowing whether CMS or the administration as they are rethinking health reform felt that there was something that would be timely for us to do at this juncture.

MS. HINES: So just to add to what Bill said. Coming from the population health world where I see opportunity is that HHS has data that was raised by many of the testifiers that they can’t easily get at and so it there was real need – I mean you’ve got Medicare, Medicaid, Tri-Care, FEHB, there’s all those existing administrative data, if you will, and if HHS could organize itself to make that uniformly available, because it’s already here basically, that would be – I don’t know if I would say low-hanging fruit, that’s probably an exaggeration. That’s a bridge too far in our communal language but having worked at HRSA for almost two decades, I’ve always seen that the opportunity for a department to organize itself is always there and the benefit would probably be huge.

So that would be, given what we heard, having read the testimony a number of times from all of the various parties, the standards piece was the cry for help. We’re dealing with 20 states, it’s driving us crazy on the one side and then we can’t get ahold of the X, Y, Z federal data on the other. And so if you wanted to talk about two things where the committee could weigh in, those would be the two areas.

DR. DORSEY: So I just had a point that I wanted to raise just for the committee to consider, somewhat in response to David and Bruce’s comments. There is a big interest in this concept of federalism by the administration. If any of you have an opportunity the executive order on reorganization specifically calls that federalism as one of the priority areas for which governmental agencies are to think about reorganizing and perhaps restructuring their work so should the federal government be doing this. And I would just say as you think about your recommendations, keep that in mind in how you prioritize your efforts in what you do.

DR. MAYS: About a year ago, I stepped off of the Institute of Medicine’s Board on Military Health. It’s actually called, The Board of Select Populations. And there were a lot of discussions about their data and when I’m looking here in terms of the inclusion of Medicare, Medicaid but Veteran’s Administration, Tri-Care, I think we would be doing a service and it’s one I think that they would be very interested in. They want it, for example, to have – except the guy who ran the board stepped off – they wanted to have a meeting with us to figure out, for example, how to put veteran’s data into some of the NCHS data that we’d collect with some collaboration on their part.

So if we think about the ACPD, I think that if for no other piece, that’s an important piece. I think another customer for us is really SAMHSA and that’s a priority for the Secretary, is to deal with the opioid problem that we have, to deal with a lot of the substance abuse issues that are going on.

So I think we actually just need to talk to different people that are not necessarily around the table to get a sense that we really have, I think, some expertise that could be utilized to move things in ways in which some other groups have actually said they are interested in moving.

MR. COUSSOULE: A couple different things. I do think that there’s a significant benefit to be gained in the utilization of consolidated datasets and several people have brought that up already. I do that in my own kind of other life other than committee. I think the challenge for me is where do and how do the feds kind of play in this game, so from our recommendation’s perspective.

One of the bigger challenges I see that may be applicable is to help guide the creation of some standards that allow the data movement to flow. Now, there’s already ways that happens in industry in regards to other standards, whether it be transactional standards for the HIPAA transactions, et cetera. So I’m not sure the feds would do it necessarily, but could potentially help guide the creation of some of that to make it simpler for all of the parties to interact and make that data more available and accessible.

I also think there’s significant risks, and I think that’s one we tend to ignore in some of this. And when you talk about the SAMHSA kind of model or data access or visibility or ownership and governance processes. So I think the practical challenges of doing this are very real and very large and I’m trying to understand how we play in that as NCVHS. So I’m as much struggling with what our role is to advocate for, research, make public, try to gather than I do. I see some of the value and benefits of being able to access aggregated datasets.

I tend to also be in the risk side of this because I own that part of my day job and I think there’s some serious challenges so I’m not sure how we – to be honest, I’m struggling with how we play and what our role is to advocate for that.

DR. RIPPEN: I guess I always try to approach things from a big picture perspective and then how do things fit in. So that there’s some consistency and some – and we can head off some implications. So if I step back and say okay, so what is this – what role does this play in the bigger data ecosystem? Because nothing is really just by itself.

So there’s a claim base ecosystem with the databases. There is a determinants of health datasets from the different agencies, from the Pop Health. There’s the NIH research dataset because now they are saying if we give you money, you’re going to have data. We have HHS databases via CMS as it relates to all the ERH reporting so there’s even more and more data that’s in different departments. We have third party datasets, PCORI, for example, that’s collecting everything too. Then we have the infrastructure, the HIEs. We have the billing.

So we have a lot of data systems out there and a lot of information. So the big question is if I look across all of them and I think about well, what are our priorities and especially from the context of HHS, that’s something we have to think about.

And then, if you look at all the groupings, it’s all the same. What’s the data structure? What are the standards? Are there differences with regards to interoperability? Are there nuances of governance? So again, going back to then how do they – not only all these datasets and these bigger ecosystems, are there some opportunities to think through what are some good practices or not, right? Because what makes one different than the other?

And then there is the question of okay, limited resources, right? And when I talk about it not only from the committee perspective but then also what are the recommendations are we going to be making. So we know that we are in a resource-constrained environment and there’s a big need. There are big needs. And so as we start thinking about how we should prioritize I know that we’re going to be making asks on the population health side with regards to supporting data at the local, federal potentially, vital statistics, claims-based databases and all these other things.

So I guess my thought is before we can make a recommendation we kind of have to think through how do all these things play and how do we prioritize and I know that might not say how we do it but I’m just throwing it out.

MR. COUSSOULE: One other thing just for everybody to consider as part of this discussion is there’s a big distinction between policy recommendations and tactical day-to-day challenges of executing some of this. And I think in this world we’ve kind of gotten bound up in both of those. So I’d ask you to think a little bit about that one as to how we separate out, do we address tactical challenges of execution or are we trying to reflect on policy challenges?

MS. STRICKLAND: So, I’m a little bit of Rich and a little bit of Linda in that who is doing the ask. Is there an actual ask of the committee? It’s hard for us to even put together a community to talk about this and have dialogue if we don’t know have a focus because we’re kind of all over – even the recommendations from the individual states. We’re kind of in various pockets, of general information.

So we don’t really have a specific ask and a specific ask from, say, HHS Secretary or whatever. So if we’re making a recommendation to HHS, do they even want it? They didn’t ask for it so – I think we need to look at what is the ask, what are we charged with and to other points, do we have the bandwidth to do that given the priority items that we have on our plate and is it important, to Linda’s point now, to do this activity. So that would be my comment.

DR. THORPE: I’m just listening to the conversation and I share some of the same sentiments as Debra’s with regard to prioritizing our current workload and just trying – I’m trying to grapple with the idea and understand what is our real role here and what true impact can we make given Nick’s comments. So I’d probably like to hear a little bit more on clarifying that before I can make a final decision.

MS. MONSON: This is Jackie. I don’t have any strong opinions either way.

DR. PHILLIPS: Wow, we ran the gamut there from monitor to full throated recommendations with a lot of in between about prioritizing. How would this rise to a level of priority with other recommendations we’re making to what’s our customer. Who is our customer here and how do we limit the scope of our work to, in an effort to federalize, to really empower states, are there recommendations we could make there around federal data accessibility? I don’t mean to try and summarize all of that so conveniently but that was a number of the things I heard. So let’s open for conversation since it really matured around the table.

DR. ROSS: I am trying to think also is useful, very useful conversation. Are there priority health issues that would be informed by APCDs and therefore the better standardization of APCDs, like veteran’s health or opioid use or determinants of health. So is there something there that would also interest the administration in hearing a recommendation of some type? I think there is but it’s a frame, a way to think about this.

DR. COHEN: I really enjoyed this discussion and I thank you all because one of the things that it brings up for me is defining what our role is in the current environment. And for me, we have an opportunity to be a bully pulpit. We have the opportunity to be proactive in spaces that other folks aren’t. We’re a FACA to advise the Secretary and HHS but when we speak because of our history and experience, everyone does listen, in the private sector, at the state level and a variety of other researchers.

So we have an opportunity and I’m concerned that if we become too risk adverse and wait for people to ask, inertia will take over and we will lose the momentum historically that we’ve had of being innovative in really important ways to support improving the health in this country.

So I want us to keep our eyes on the prize. We are a FACA. We have the ability to establish our agenda. We need to guide the Secretary in the Department of Health and Human Services and we have the opportunity to take on tough tasks and not to be asked but determine our own role. That’s the way I view us and I don’t want that to fundamentally change. We’ve been really successful at stepping up to meet challenges where other people feared to tread and I hope we continue to do so in the future.

DR. PHILLIPS: I still hear an open question about priority too. Not that we don’t want to deal with this necessarily but maybe if it doesn’t rise so – Bill you had your tent up first.

DR. STEAD: It seems to me that the part of this that is closest to our sweet spot is what HHS could do to make the federal data more easily accessible to these projects. That’s a relatively constrained question. And I’m not hearing somebody else working that space. There are people working some of the standard dataset spaces, some of the other parts.

So one possibility would be for us to ask Pop Health to consider how that focused area or some other equally constrained view – if we’re going to do something it would need to be constrained. I think it would need to play into the federal role in supporting federalism. And so that would be an example that could fit into something that could turn into something we could work. So I think – I’ll just posit that as one.

And I think the other is clearly the standard dataset issue but my sense is other people are working that and that’s the place that’s going to change – that’s the place where I think the change in reimbursement and so forth might have the biggest impact. So that’s maybe how – that’s one way to thread the needle, just put it out there.

MS. KLOSS: I had come to the same conclusion that we certainly seem like we had agreement that at minimum, the available data should be fully utilized that is in the possession of the federal government and it would be certainly in the best interest of everyone. That could be something that we could frame a recommendation around really without having another hearing. I think we know enough about that from the hearing we held to frame a recommendation on. So that was – I kind of just settled there.

DR. PHILLIPS: I heard the issue of customer come up a couple times and the issue of opioids perhaps with SAMHSA as a customer. I would love folks to think is there a case-building function that we might have to talk about the way the APCDs could answer important questions for federal agencies. Is that work we should do, could do?

MR. LANDEN: I’m struggling to organize my thoughts. I think I’ve got three separate ones. I don’t know how they relate to each other. First, to answer Bob’s question. I see this as not rising to a policy level and not getting down into a project level but somewhere in the middle, kind of like a white, white paper saying for those states or those jurisdictions who want to consider an APCD, these are the kind of things that you need to consider and find somebody other than NCVHS to actually do the development of the thoughts that we might list as NCVHS. And that would address the things of minimum datasets, access to existing databases. Per your last question, get into what are some of the privacy considerations and how might they be resolved by whom. So we can do something kind of at that level.

My second thought is that this is sounding very parallel to what we will consider later in the agenda on the Next Generation Vital Statistics. We’ve got very much state level activities that are fragmented and in some similar challenge there.

And then finally, what was in the hearing summary is there’s a lot of cost and obligations put on stakeholders to generate this data, to maintain the data, to get it available. And in an era where by national policy we’re moving away from a claims-based system to a value based system, is there an impact there that we, as the NCVHS, need to consider by anointing a claims-based data system or are we somehow putting up a barrier to a non-claims-based system to which by policy HHS and others are evolving.

DR. PHILLIPS: Any other comments? Bill, I like the idea of wading into this in a very narrow way may be actually supportive of a federated model of going back to state needs. We’re a year out from a hearing. I almost wonder if we need to learn what’s happened in this space since then, especially around the standardization of data architecture. Are there still issues unresolved? Is there need for a white paper on best practices as Rich was offering and I think Helga talked to as well. Or is that already in existence? Maybe to scope out some of our role yet.

DR. RIPPEN: I was just going to say that again, given the kind of flag for vital, again I think going back to say how do all these pieces touch each other or impact each other. It makes it a less heavy lift for anyone but it does require some work as it relates to saying here are all of the pieces and datasets that may have, that are touched or created by HHS, for example. And if somehow funded by the government. So that’s everything from PCORI to CMS data that people want and that kind of thing.

Because a white paper is a heavy lift for what best practices are. Though we have components for privacy and things like that. So I guess, I’m just concerned about – we can do a lot of things that are really important and data is, I guess, valuable. We all know and can have impact. So do we separate it out, is everything separate or is there an overarching. And I’m worried that we sometimes are like this because we want to get something done and so I’m just worried about that we’re not doing the how does it fit and then prioritize or two-for-one.

DR. PHILLIPS: You talked about the data ecosystem earlier, is that the idea that we shouldn’t focus on APCDs but we should be thinking higher about how do all of these data interact and is there a place for NCVHS to comment on that.

DR. RIPPEN: Because that way we will understand the nuances of one versus the other because it’s all about the cost too. It’s yet another thing and unless we can understand ecosystem and kind of the components, in the end we’re just making recommendations that are more like this as opposed to stepping back and saying here is where we are now. Everybody wants to get into population health or getting data appropriately to the right people so shouldn’t we step back and just think about how they all play.

And then we can make a decision about well, no it’s spaghetti, forget it but we’re just going to take this one stand or well, now if we just add the sauce – take the analogy. Totally inappropriate direction. But the question as far as we’ll be more informed, I’m just worried that we’re doing some of the challenges of stove-piping and I don’t know if that will help us really get to a bigger picture or if we need to. I don’t know. I’m just making that suggestion.

DR. MAYS: I think there are a couple of problem areas that I’m wondering if we were to add a bit of work that we might be able to make a contribution. And that is, it’s just some of what you’re saying but a little different which is we’ve talked before about kind of linkages and the ability to look at a problem in a much broader way. And we know that we have data from veterans. The veteran case I think is a really interesting and specific one. We know that veterans will utilize the VA data. We know they utilize data outside of the VA. But we’re not able to get a complete picture.

And I’m wondering in terms of thinking about this, particularly in the area of things like substance abuse, opioids, et cetera, if it isn’t a way of contributing to a problem that HHS is trying to solve and at the same time doing it within the context of not just the problem but the data ecosystem and saying this is an example of where some fixes would actually help us to be able to better understand a problem that we’re trying to solve and it’s these data silos that are making it difficult.

It’s these inconsistencies and not having standardization that makes it difficult. So it’s like taking it as kind of a case study and trying to fix the data ecosystem to some extent, more so than it’s just about APCD but APCD is the example that we could bring some sensible changes to.

DR. STEAD: I think this is a rich conversation and my sense is that A) this needs to live in Pop Health. I think Bruce made a pretty good case for that and that plays back a little bit to Dave’s points also. So the real opportunity is in the population limbs that these kind of datasets can provide with other kind of datasets. And so I think that that’s the right locus for the work.

I’m very intrigued by Linda’s statement, or suggestion, that we might be able to do something useful and limited, possibly without further information. That could be explored at Pop Health and see if you wanted to surface something or it might be that we needed to have a very targeted conversation between key federal players that have control of those datasets and probably the APCD council or something that would be the voice of the people interested in getting at those in a way that’s simple for states. I think if there’s a sweet spot, that’s where it is.

And I think then I’m also sort of hearing that over the course of doing the Vitals work, we may, in fact, learn something or get a framework that might be, to some degree, conceivably more reusable for the things beyond that first step. I think the business of how we get the data that the federal governments already got used appropriately in this space, that would be the narrow first piece. We would then learn from Vitals about what enabling the states looks like and then maybe we could try to reapply that. So I could see this stepping over that kind of frame over time if that makes any sense. But my sense is you’ve been informed by this conversation and we probably should return it to Pop Health to work.

DR. PHILLIPS: I like that very much. Can I raise one other question? So the narrow lens effort of pushing data back to the states from federal sources is clearly an opportunity. But I’ve heard a couple examples of a federal case making too for why the federal government should care whether it’s around opioids or it’s about the fact that the VA can’t look across who it’s supposed to take care of with one lens because their veterans are in so many different health settings.

I wonder if there’s an opportunity to look the other direction of what are the federal stakes, the federal government stakes in making sure that APCDs can inform national level questions of importance. Is there anyone who thinks that’s a bad idea for Pop Health to chew on?

PARTICIPANT: Could you repeat that, Bill.

DR. PHILLIPS: So the opioid case is a very specific one but the fact that the Veteran’s Administration can’t – they only have pieces of the data picture for their people they take care of. It’s when they touch a VA outpatient clinic or hospital, they don’t know what happens even in Tri-Care, much less than the private health care system. So there’s a federal interest in seeing APCDs inform that picture of what’s happening across their charge. That’s a more complex issue than the opioid question.

DR. COHEN: I see really separable paths and this is a really interesting suggestive blend. I think the states in developing APCDs, the folks who are doing that are frankly I think less interested in getting access to federal claims data. The development of essentially commercial all pay claims databases at the state level is a very different piece of work than accessing federal claims data systems which we’ve talked about whether it’s the federal health benefits or VA.

I think those are very different audiences. I’m not saying one is better than the other and what you’ve described is the folks in the systems that are focused on federal claims getting access to state developed other data sources so they understand their populations better.

So there are actually three separate paths. One helping states develop their APCDs, two helping the research community get access to federal claims data systems that aren’t ubiquitously available and the third is helping federal agencies that have claims, narrowly defined claims systems understand their populations better by getting access to other kinds of data. So they seem like separable buckets to me for us to think about where we can have a shorter term impact and then a longer term impact if we want to go down those roads.

DR. PHILLIPS: I also want to say, although I think living in the Population Health space is really nice, there are other folks who are very, very interested in this and I don’t see this as an exclusive Population Health effort so I would encourage other folks who aren’t primarily affiliated with Population Health, to join this venture wherever we land.

DR. COHEN: The one question I would actually leave to our audience and I’d love during public testimony, if you feel comfortable, to tell us there’s a couple things that were in the hearing that we are leaving on the table. The need of the payer community to have some standardization, if not a federated model for data exchange and the need of states to have payers supply data. So if there are folks in the audience who during the public testimony period would like to tell us whether those are things you think should be on the table for us still, I would welcome that testimony or input.

DR. STEAD: I think we can bring this block to closure. So we now have an agenda management opportunity. We could elect to go to lunch a half hour early or we could elect to pull forward the predictability roadmap discussion from the end of the day. In a way that could easily open up a little more time for Vitals or allow us to get out of here a little bit early at the end of the day, if people would be comfortable pulling predictability roadmap forward. You’d like to step into that opportunity, Nick? Does anybody have any concern with us doing that?

MS. HINES: So, it is not 4:45 in the afternoon for those who are on the line but we have an extra half hour so Nick Coussoule is going to kindly give us an update on the Standards Subcommittee work.

Agenda Item: Updates: Predictability Roadmap

MR. COUSSOULE: Okay, I will try to give you an update on a few different things, topics that we have. One, we covered already this morning, the health plan identifier, I don’t think I need to go into that any further. Second is to talk about the predictability roadmap and I will try to walk you through, I will walk you through where we stand on that and unfortunately my colleague, Alix Goss, is the most knowledgeable of this so I will try to do her service. Lorraine will correct me when I go awry.

And this is not to get into too much of the details but really to provide you a general updated context as to where we are right now and the things that are coming over the next 6 or 12 months. And then we can talk very briefly about the operating rules, adoption, refresh which we expect to come sometime soon. There are probably others in the room who actually do know more about the details of that than I do. So can we skip to the next page please, actually we’ll skip right passed the HPID and go to the next page.

So to refresh all of our collective memories in here, the purpose of the predictability roadmap is as we look across the industry, standards and operating rules get implemented in different ways for different parts of the kind of health care ecosystem. And one of the real challenges with that is to try to understand when they are going to come such that the implementers can also predict and plan for the efficient implementation to take advantage of the standards. And they don’t come in the same timeframes. There’s different processes that happen in regards to the different kinds of standards and operating rules.

And so the general thinking process is can we explore and try to discover opportunities for us to improve that process and the predictability of that process, hence the term predictability roadmap, such that we can enable all the players in the health care ecosystem to more efficiently and effectively plan their own resources and implement to get the value driven by that standardization.

So again, the expected – that’s the purpose, the expected outcome of that is to solicit from a number of different entities, so whether it’s the standard development organizations, the operating rule entities, HHS, or other parts of industry including the payers, providers, et cetera, who actually implement the different rules and standards and operating rules, is to solicit across that ecosystem, what are the current challenges posed in the current way the process works or processes work? What are opportunities to improve that process, whether that be regulatory or operating, et cetera? And then what might that look like if we were to implement and what value could we derive?

So this is a pretty large, complicated endeavor. Where we are right now is that we have engaged, started to engage some of the participants in this process, in particular the standard development organizations and the operating rule authoring entities. We have sent information gathering requests to them. We will have conference calls scheduled with each of them in July. And really that’s to try to get some individual feedback on opportunities, challenges, what might be best for them, what they might think they might do better, what they might think others might do better to inform us to be able to craft a hearing that we’ve scheduled for August 21st.

So it’s a multiphase process is to try to get some preliminary information to be able to guide a more expansive hearing in August that will be chaired by the subcommittee workshop. Hopefully out of that workshop comes the next iteration which could conceivably be some recommendations or it could be more information to guide the rest of the discussion and pursuit.

So if I follow that process kind of naturally out, first is to kind of recognize the problems. So how best can we get information about what the current challenges and issues are in a little more granular detail from the participants in the process. If you recognize the folks we’re talking to in July are the standard development organizations and operating rule entities, not the actual implementers of the standards. So that’s going to have to come as well because to derive value, it’s not just do we created these great standards, we now have a good process to create the standards and operating rules but how do we actually implement them and derive value?

So there are further steps that we haven’t outlined here, these are the steps in our process to try to get from the developers and purveyors. Now, we also recognize that the implementers of these standards are all involved in the development of the standards. So these are not separate and distinct groups and entities that go through this process. So it is a very intertwined process.

But again, those next steps are we’ve solicited some amount of information from these entities already. We will do some conference calls that will be public as well in late July. The week of the 17th, they are all scheduled for the 17th to the 20th week at this point in time, again, to hopefully then prepare us for roughly a month later for a workshop and then subsequently from that workshop ideally what comes out of that is some amount of recommendation or further work effort that will come up in the fourth quarter.

We have a work plan that follows along exactly with this into the Standards group that will obviously be dovetailed in with the rest of the Standards subcommittee as well as the rest of the work of the full committee into our work plan which will be reviewed tomorrow at least at a high level I think in the full committee workplan. Unfortunately, I will not be here for that discussion but I will happily weigh in on that.

So that’s it. Any general questions about that at this point? I’ll move on to a couple of other –

DR. STEAD: Am I right that the current thinking is post the workshop, you’re hoping to develop something, an approach that then would be the subject of a hearing, is that –

MR. COUSSOULE: That’s the thinking for us, Bill, yes in that again we recognize that so far, the groups that are, I’ll say, most involved right now and will be over the next 60 days, are not all of the groups that need to be involved to talk about an implementation of or recommendations of changes in how much they would matter. So there are going to be subsequent bodies that will need to be involved and others can weigh in on this, like Debra or Lorraine, others that are heavily steeped in this and have been for a long time.

MS. KLOSS: I would just add to the earlier discussion we had about customer, this comes out of hearings and status standards adoption hearings many times over with the request from those who are responsible for implementing changes to have greater predictability. So we’re not doing this just because it seems like a nice thing to do. This was a request from several years ago that now has really got a solid work plan around it and we’re making progress on something that really we were asked to commit to.

MR. COUSSOULE: Let me go to the next couple pages then we can back up to more generalized questions, if you don’t mind? So let’s skip – really this is – we’ll probably use this slide or something like it as well as the next one to be a continuing education process for the members of the committee who are not as steeped in the process.

But if we look at this, basically this is the way a standards updated adoption process works at a pretty high level today, that the industry identifies needs and requests changes. We have standards and code sets into the operating rules and there are different groups involved in making those come to fruition so the Designated Standard Maintenance Organizations, the DSMOs, and the voter denied and sent to NCVHS. NCVHS has a very well-defined role in this process of accepting or making those recommendations to the Secretary of HHS for the standards and code sets, the operating rule entities make their own requests to NCVHS to have the rules approved and sent to HHS.

And then we do regularly conduct hearings to get feedback. So this is a vicious cycle, that sounds really negative, not a vicious cycle but this is a cycle of life. You can look at it that way. An iterative process to go through, both for existing standards as they change as well as new standards as they become important as the industry and ecosystem changes.

So if we talk about Population Health, we talk about the different ways that payment structures and models are changing, this process will need to accept and understand and influence those processes as well, be influenced by those process changes and industry dynamics as well.

DR. STEAD: One of the things that excites me about this work is that you are getting your hand around the set of work that has to happen for all the pieces of one change. And you’re talking about how to make that predictable. I think that’s going to give whatever answer you come up with, and the input we get from the hearing about the feasibility of implementation, is going to tell us something about what size effort can be moved through such a pipeline. Because we’ve not – at least as far as I know, we’ve not actually gotten all the pieces together, at least not in my time on the committee at this level. We’ve had conversations about doing what you’re getting ready to do before.

I think once we actually see that, that’s going to inform us, do we need to build parallel pipelines? How do we control the funnel of what we’re putting into the pipeline? What alternative ways do we want to set alongside the pipeline? And that’s where I see the connection from this work to beyond HIPAA.

So I see this as a building block that is going to be extraordinarily helpful in helping us understand the magnitude of the challenge as we try to make the information base of in particular health care in this case much more health care and much more administrative parts of health care. So that’s an interest in the lens that I’m going to be trying to learn as I watch you go through this work.

MR. COUSSOULE: One comment and then we’ll proceed with further questions. As I got more and more involved in this in a little more granular level of detail, the interconnectedness of this process from the recognition of a challenge to the derivation and recognition and realization of value is frankly hideously complicated. And so I think when we try to decipher this down into manageable components and look at opportunities, there are certain things that can probably be done relatively quickly and some that are very long term entails.

So I think it will be important for us to try to recognize that distinction to where we can have an influence and make that kind of changes and recommendations. So that’s why I think very many folks in different organizational entities and participants in this ecosystem are going to have to weigh in. Because if you twist a lever up here and don’t realize that it effects six depths removed, that’s pretty negative or pretty positive. I think that will get complicated.

DR. MAYS: I think you are starting to ask, when I’m sitting here pondering and it comes from Linda having brought up this issue of the customer – so with the customers asking for kind of a better flow in this process and to make it work better, are the customers asking about specifics, like were there problems that customers in these different groups want. Because I could kind of see getting into the hearing and there are some people that want to push for a specific and then there’s some people that it’s the process in and of itself that if we could bring some semblance of reasonableness and time and effort, et cetera, we would just be very happy and then would go on and do their own specific cases.

MR. COUSSOULE: I think part of the challenge here is defining the customer. Because if we are talking really about transaction flow, it could be the provider of service. It could be the payer of that service or the approver and authorizer of that service. There are a lot of people in there that derive different sets of value depending on how the process works.

So, for instance, I work for a health plan. So we process lots of transactions, health care transactions with providers of service as well as intermediaries and so how that process could get simplified and more predictable. If the chance standard changes once every five years, the world changes too fast and the standard hasn’t kept up. If it changes every month, there’s no possible way to implement that in any rational way without having 100s of people sitting there going and doing it. So it’s trying to find that balance across the different players in that system that actually are the users to derive that value.

Some of the players in the organization, a lot of them are not for profits and they are like us, they are people that do this on a volunteer basis, they don’t do it full time, they don’t necessarily get paid for doing it, so how can you greatly influence that. So it gets a little complicated in trying to make sure that the players can figure out how to derive value and so the customer side of that and derivation of value is very important.

You know, we really haven’t talked about that a lot. That’s what drove the work effort initially of a lot of the customers recognizing the pain and challenges of doing it.

MS. DOO: On the other side, there are customers that are prepared and ready to use updated standards because the standards are necessary in order for their business to be done and I will just use an example because she’s here and she’ll jump if I’m wrong, and that’s the pharmacy industry. And those standards, kind of like the banking industry, get updated on a regular basis at a smooth basis and they need them in order to conduct their business because the patients need that information or the pharmacies need that information and they can do it because that industry is ready in a different way than health plans and they are nimble in a different way.

And we’re not keeping up, let’s say from an HHS perspective in adopting them in a timely enough basis to do it right. So there’s part of the industry that – it needs to be predictable, can they rely on health plans doing it, the pharmacies doing it, HHS doing it on a regular routine basis that they know they are going to get the updated standard to be able to do their business properly to benefit everybody. So there’s a number of customers in there.

MR. COUSSOULE: And I think the pace of change across the kind of general ecosystem here is just increased and so a process that may have worked very well in the past may not work very well now because the shear pace of change and the magnitude of those changes may be sufficient to break, if you will, or make more challenging the process has worked fine in the past. So I think all those topics are going to come up.

MR. LANDEN: This is more in terms of further background related than a question. But the list of stakeholders here, the key stakeholders by and large are themselves consensus organizations, or in the case of DSMO itself, Designated Standards Maintenance Organization, it’s a coalition of consensus organizations by their charters, each of those consensus organizations and several of them are credited by the American National Standards Institute so there’s a whole slew of criteria their charters need to meet as far as due process, public comment, whatnot.

So as we layer consensus organization upon consensus organization on consensus organization and then get into the federal rule promulgation process, which again is essentially parallel in that it’s got rulemaking and public comment, one of the challenges is well, what happens if a problem is identified later in the system, how do you go back and get the consensus organizations to change things when each of them have their own charters that require that due process and you get into this endless loop of repetition which is – it’s a known problem to the industry. The industry recognized this back when this process was created.

The DSMO itself, was a brand new creation, did not exist before HIPPA, and the DSMO was created in part to answer some of these questions. Well, here we are 20 years later. What’s the same? What’s changed? What new opportunity is there? What’s different now? Can we do this smarter and quicker and more predictably. As I mentioned in my MPEG report the value may be very different for a versioning update on one transaction set than on another.

We talked about pharmacy versus a non-pharmacy claim. So there’s lots of moving parts here. Tremendous amounts of interdependency and this is all in the rule promulgation piece of it. It doesn’t get into the implementation piece post final rule promulgation. So there’s other things and then there’s –

MR. COUSSOULE: I won’t go into it in detail but this is an outline and you’ll have it for your records but this is an outline of the federal process. So even after we make a recommendation, there’s a very well-defined process that has a number of steps and q-times by design in there for feedback et cetera. And again, I won’t walk you through this. You can read your thing. A simple version of that.

But again, to recognize the complexity of if all the prior entities and groups get everything done and then we go through the federal process, which is – I’m not saying it’s bad, it’s necessary but it creates another level of complexity and time and challenge with making those changes.

So really the purpose when I even step back is to try to – how do we look at this in its entirety, including this process because we will actually want the feds obviously to engage as well and talk about what might make it easier or better in the world that they live in to do this in conjunction with industry players to do that. Sorry, Linda, you had a question.

MS. KLOSS: I just want to make it more complicated because I think the request for the predictability roadmap came from the end-user customer, not the standards development organization or even the intermediary but the providers and the payers and the health plans that have to adopt it. And the technology companies that have to incorporate it. So I think that, to your point, once we understand what the making the sausage process is like and look for opportunities there through that process, we need the voice of the customer of those who then have to take it and I think, to your point, pacing is really an important part but so is sequencing.

So I think as we’ve thought about it, it’s both sequencing change so we don’t get into some of the 50/10 ICD-10 conundrums that we’ve faced in the past that have been costly but also pacing. We’ve got this first part really well framed out but I think this first part will tell us how to frame this issues and discussions with the people that have to adopt it.

MR. COUSSOULE: Other questions, comments. Anything further to add Richard, Deb? Bill, I’ll turn it back to you then.

DR. STEAD: Thank you, Nick. Then I think that we will take the liberty of going to lunch five minutes early. And we will see everybody back at 1:30 where we will launch the terminology and vocabulary work and we’ll have a lot of people joining us so I encourage people to be back so that we can start on time.

(Luncheon recess)

A F T E R N O O N S E S S I O N

Agenda Item: Health Technologies and Vocabularies

MS. HINES: Who will be joining the committee for dinner this evening? A show of hands so that they can call the restaurant. You can raise your hand if you’re going to the dinner social this evening. And there are a few people not here, maybe ten? Is there anyone on the phone, a member or staff or anyone that wants to identify themselves on the phone please?

DR. STEAD: Linda, take it away.

MS. KLOSS: Good afternoon. We have really been looking forward to this afternoon. I just want to take a few minutes to frame up what our agenda is and what you’re helping us kick off here today. As part of our work plan the committee has developed a scoping document for what we’re calling a health terminologies and vocabularies project.

And our overarching goals as shown on the slides are to take a contemporary work at the health terminology and vocabulary landscape, consider the changing environment and implications for timing and approach to terminology and vocabulary adoption, needs, opportunities, and problems with development, dissemination, maintenance, and adoption of terminology and vocabulary standards, and actions that hopefully recommendations will come out of this for actions that HHS might take to improve this phrase of development, dissemination, maintenance, and adoption.

This topic is, well how we structure this afternoon or how we’ve launched this is to break it into a couple of phases. So we’re going to do a series of briefings, starting today, and we’ve invited those who are part of the federal family to be in our first briefing, and we expect then in September to invite representatives from non-governmental developer and other stakeholders to round out sort of our environmental scan.

And then our goal through this phase one is to prepare a report summarizing sort of this current state or what we learned from the environmental scan, and then move on to a second phase probably next spring where the committee will discuss issues relating to that same phrase, standards, maintenance, dissemination, governance, coordination. We expect we’ll probably have a hearing next summer, and then that will come later next year in a report in a letter to the secretary.

So we know this is a fairly large project, and we’ve scoped it carefully we believe, but we’ve set out today really as civs to learn as much as we can learn. And that will help us lead the way. So it’s important I think also to kind of be reminded that this is very much part of the NCVHS charter.

There are two statements in that charter, that we are to study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of data, and that we are to advise the department on health data collection needs and strategies, review and monitor department data and information systems and so forth.

And the committee over the decades, this committee is almost 70 years old now but over the decades it’s had a lot of engagement with this issue, and most recently set out the criteria for adoption of code sets 4:55 and standards, but during my tenure, and I’ve been on the committee now six years, I guess going on seven, what we’ve done is sort of write letters of recommendation encouraging the adoption of ICD-10, but we haven’t stepped back to look more broadly at this terminologies and vocabulary environment and how it’s changing, and so we feel this is a right time, we couldn’t really do this while we were still caught up in that change, but now we’re at a good time.

So our first panel, this is just terrific, we’re so grateful that the National Library of Medicine has come to instruct us and tell us what is going on with SNOMED, LOINC, RxNorm. And then our second panel of the afternoon will be the family of international classification, the ICD family of classifications.

And I’m particularly proud that we have Patty Brennan, the Director of the National Library of Medicine, and Betsy Humphrey, Deputy Director of NLM here to kick us off, followed by Susan Roy to give us a SNOMED overview, LOINC overview by Daniel Vreeman, and RxNorm, Patrick McLaughlin. So we’re really grateful. And I want to thank my project scoping partner, Bill Stead, for having had quite a hand in helping to put this illustrious panel together for us. So Patty, I think you’re going to start us off.

DR. BRENNAN: Greetings, and thank you very much for allowing the National Library of Medicine to extend our insights and experiences with standard terminology to this group. We’re particularly interested that you are interested in this topic, at this time. We are at a point where data driven and data powered health and healthcare is within grasp, and it will only be effective if we can take advantage of existing and emerging terminologies. I’m going to turn the time over though to Betsy and our experts here, but I’ll be here for the afternoon, except for a one hour period, 2:30 to 3:30 when I have to step out. Betsy?

DR. HUMPHREYS: Thank you. It is a great pleasure to be able to talk to this group, I have had a lot of interaction with it over a number of decades, and it’s all been extremely positive. I won’t go, we’ve already heard this, so this is the order we’re going to present. I just want to remind all of you that when HIPAA was passed it required the NCVHS to address standards for clinical information.

And you see the quotes there, study the issues related to the adoption of uniform data standards for patient medical record information, and I have to tell you that we’re real glad that we don’t have to keep saying PMRI anymore, 2016, so I’m not going to. And to then report on what they found and recommendations for what the federal government could do to advance this. You had the committee at the time, not later than four years after the date of enactment.

Generally, this committee always comes through at the right moment. So it was in fact, 2000, July of 2000. The committee issues what I thought was a really fabulous report, and I’m only highlighting a couple things that are directly related to what we’re going to speak about. But as far as I am concerned this report is still good reading, and you might want to go back and look at everything it said in terms of looking at what you wanted to have happen that didn’t, and what did, and it may give you a good background for whatever recommendations you make in the future.

But at any rate it said two things that were directly related to NLM. And one was hoping that the federal government would provide funding to accelerate the development and promote early adoption of PMRI standards, and this should take the form of support for enhancement, distribution, and maintenance of clinical terminologies, and then they said possible ways of doing this were government-wide licensure of comparable arrangements.

And then the terminologies should be available for US-wide use at little or no cost, and also encouraging NLM to augment our existing unified medical language system to have more mappings between the medical vocabularies and the administrative and statistical code sets that were being recommended of course because of the administrative part of HIPAA.

And so this was 2003, and key NLM milestones that relate to this was that when you made this report the UMLS was ten years old, the first contract that we made with the Regenstrief Institute in order to support them in ongoing maintenance and free dissemination of LOINC had been issued just the year before the report came out.

NLM and other federal agencies, AHRQ had provided support for the development of LOINC earlier, but this was essentially reacting to this notion of how can we set something up that these can be maintained and usefully disseminated in an ongoing way.

And then after your report, in 2001, we had the first release of RxNorm, which had two purposes. One was to help us in doing an effective job in linking medication terminologies within the UMLS, and the second was to fill a gap in available terminologies for medications and electronic systems that had been identified by HL7 and drug information providers as something that would be really valuable to have.

And then in 2003 NLM concluded a license for free US-wide use of SNOWMED CT, and we were of course at that time negotiating with the College of American Pathologists, but later on in 2007 the International Health Terminology Standards Development Organization, now perhaps mercifully called SNOMED international, acquired the IP and began taking responsibility for the maintenance and dissemination of SNOMED.

So with that as background happening either before or after year 2000 report, in November of 2003 the committee sent a letter to Secretary Thompson with recommendations for PMRI terminology standards, and they recommended a core set, SNOMED, LOINC, and a collection or set of connected things called the Federal Drug Terminologies at that time, which included RxNorm, the FDA unique ingredient identifiers, and the VA drug classes. And then the NCVHS went on to say to the Secretary designate the National Library of Medicine as a central coordinating body for PMRI terminology standards.

The Secretary accepted your recommendations and designated NLM as that coordinating body early in 2004, and there was of course, and many in the room here were involved, a lot of outstanding work my outstanding people in other committees and other activities that were put in train after the executive order to create the Office of the National Coordinator, and then in 2004, and there were advisory committees set up to that, and there was of course the High Tech legislation in 2009, and so in 2010 we end up with SNOMED, LOINC, and RxNorm all designated as US standards for EHR certification and meaningful use.

And this was really started by the recommendations from you all in 2003, and earlier recommendations that gave support for some things that we wanted to do that have been I think very useful. We are here just to show these things are being heavily used in conjunction with meaningful use.

One of the requirements in meaningful use is that you be able to deliver patient specific information, patient information related to things in the electronic health record. One of the ways you can do that now is to use our Medline Plus Connect, which is an API where you send a code from any of these systems here or from ICD-10 and we will through an API return information that’s specifically related to that disease, that drug, that test.

And I can tell you that in the year 2016 we got 64 million such requests coming direct from patient portals or patient records. So I’ve been quite interested in connecting electronic health records and digital libraries for a long time, so that’s one of the things that makes me very happy. I’m now going to turn this over to my colleague Suzy Roy.

Agenda Item: SNOMED Overview

DR. ROY: Good afternoon, I am Susan Roy. I’m going to jump right in and start my overview on SNOMED CT. And if you guys have any questions please feel free to ask. So SNOMED CT is a clinical terminology with a global scope that supports the recording of clinical information at appropriate levels of detail using relevant clinical concepts. There are currently over 300,000 concepts in 19 different domains, and over a million descriptions and over a million relationships.

There are many features of SNOMED CTs, but one of the key features are the extensibility mechanisms. Even though there are many concepts, descriptions, and relationships, like I just said, there are actually ways to customize SNOMED CT including the use of reference sets, also known as subsets, content extensions similar to the US extension of SNOMED CT, which I’ll explain in just a little bit, and the ability to create and use expressions.

The terminology is designed using description logic. This has actually many benefits. The structure of SNOMED CT allows information to be entered using synonyms that suit local preferences, while recording the information in a consistent and comparable form.

And the hierarchical nature of the terminology actually permits information to be recorded with different levels of detail to suit particular uses. So SNOMED allows additional information to be added by combining concepts where the available concepts are not sufficiently precise, and this is an example of post-coordinated expressions.

Additionally, the terminology allows for a range of different options for immediate and subsequent retrieval to address immediate as well as longer term clinical requirements. That is, the nature of the SNOMED CT hierarchies actually allows the information to be selectively retrieved and reused to meet different sorts of requirements at different sorts of generalizations.

Just as an example the concept, pneumococcal pneumonia, is a subtype of bacterial pneumonia, which has a defining relationship that specifies that the causative agent is streptococcus pneumonia, and you can see that this actually allows that the organism causing the original disease can be analyzed. And really that’s the strength and power of SNOMED CT, because of that concept model and being based on the use of description logic, the terminology actually enables an approach for reasoning and analytics to process biomedical data, and specifically those data found in electronic clinical records.

There’s actually a really deep history of SNOMED CT going way back to the 1960s, and while I find it absolutely fascinating I will save the committee and won’t go into that today. But as Betsy mentioned right now the terminology is actually owned and maintained by SNOMED international, also known as the International Health Terminology Standards Development Organization, IHTSDO. This is a not-for-profit membership organization governed and advised by the members, with one designated member from each country or territory.

The National Library of Medicine serves as the SNOMED International member for the United States, with representation at the levels of the general assembly, member forum, and also on a number of advisory groups. And also NLM serves as the United States National Release Center or NRC for SNOMED International, meaning that NLM is the sole distributor of SNOMED CT terminology and derivatives within the United States.

In 2007 the NLM, on behalf of the Department of Health and Human Services and for the United States was one of the nine charter members of the IHTSDO. And over the past ten years the Standards Development Organization has grown to be 30 members strong. To have this rich collaborative international scope and buy-in is actually what really helps to strengthen SNOMED CT from the clinical content all the way to the technical specifications, and of course also in terms of sharing policy lessons learned as well as the sharing of implementation cases.

SNOMED international maintains and produces the SNOMED CT International Addition, which is released twice a year in January and July 31st. The January 2017 International Edition, just to kind of give you an idea, included 5123 newly authored concepts as well as an additional 14,000 changes made to already existing concepts. SNOMED International also releases additional SNOMED CT derivatives throughout the year, and some of these derivatives include mapping files, subsets —

DR. STEAD: When a change is made to an existing concept, how is that handled? Does the meaning of the concept change?

DR. ROY: It depends on what has been inquired. So if it is just a simple retirement of, an inactivation of a concept because it’s no longer clinically relevant, it doesn’t actually change the concept meaning, it just means that it’s inactivated. However, if there are additional relationships or additional descriptions that are added to it it might change. It depends on what is being requested and whether or not if it’s clinically valid.

DR. STEAD: Thank you. I want the real discussion to take place after the panel, but I think we need to get short clarifying questions while they’re fresh.

DR. ROY: Absolutely. So, as I said, in addition to this international release they also make a number of derivatives available throughout the year. We, the National Library of Medicine, we actually maintain and produce the US addition of SNOMED CT.

This is also released twice a year in March and September 1st, and the US addition of SNOMED CT includes the most recent international addition combined with the US extension of SNOMED CT. And the US extension of SNOMED CT are US specific content that are not appropriate for the international addition but are need by our US constituents.

And rather than having our users download two separate files and combine those data, we actually provide this as a service, and we create the US edition. And I should also mention that the US edition of SNOMED CT, this is the version that is actually specified for US EHR certification and to attest for meaningful use.

The March 2017 US Edition, again which also included the 2017 International Edition, in that release we added 490 new concepts, almost 2000 new descriptions, and 3600 new relationships. And similar to SNOMED International, at the National Library of Medicine we also provide additional products and services that many users find extremely useful.

Mapping files, subsets, value sets. The most notable is the SNOMED CT to ICD-10 CM mapping file, and this is used to provide the ICD-10 CM target codes for billing from clinical data that has been encoded with SNOMED CT. And as I alluded to in the previous slide, as the United States NRC, National Release Center, we make all of these SNOMED CT products available to US users.

We actually incorporate the SNOMED CT affiliate license as part of the Unified Medical Language System, UMLS, Metathesaurus license. So as long as a user has a free UMLS license they have access to obtain and use SNOMED CT freely throughout the United States or through any one of the other 29 SNOMED international members within those territories.

DR. STEAD: The ICD mapping table is a US language you maintain —

DR. ROY: ICD-10 CM is a National Library of Medicine product, correct. SNOMED International produced SNOMED CT to ICD-10 map. So as many on the committee knows it’s extremely important for a terminology to be able to be flexible and be able to add new content as biomedicine is constantly changing, and that’s because of advances in clinical practice as well as clinical research.

Specifically, also here in the United States healthcare providers are required to use SNOWMED CT to attest for meaningful use. So the need to be able to have a terminology that’s easily flexible and can accommodate for these user needs as well as the changes in biomedicine is extremely important.

So maintenance on SNOMED CT occurs via a number of different ways. One of the most notable of course is by submission from users. At the National Library of Medicine, we actually have an application called the United States SNOMED CT content request system, USCRS, which allows for users to submit for content changes or additions.

And really USCRS benefits are twofold, because it allows for users to easily submit for these change requests, and also the application allows for transparency of the status requests. So anyone can actually log into this application and see what sorts of new content or changes to the content are being made, which things are being approved, and which things are being modeled for upcoming releases of SNOMED CT.

Similarly, at the international level SNOMED International also has a request system to receive and track content submitted by members. So as an example, if an end user here within the US submits some content that it actually applicable not just here in the US but also at the international level, our content manager Dr. Jim Case can actually forward that request to SNOMED International for potential inclusion into the international edition. And of course, if it’s included in the International edition it would then also be included in our US edition of SNOMED CT.

Another way that the terminology is maintained is via collaboration agreements with other organizations. So this usually happens at the level of SNOMED International. And just as an example, in 2015 they created a work agreement with INSERM who produced Orphanet, the reference for nomenclature and classification of rare diseases.

And within this agreement Orphanet actually delivered rare disease content to the international release. And this was really important, because SNOMED CT content authors didn’t have to go and scour the biomedical literature and data in order to find some of these new critical rare disease data. By working with the actual content efforts within Orphanet they were actually able to bring in some of this critical new terminology, new data into SNOMED CT.

And finally, SNOMED International recently restructured their organization to include international advisory groups. And with these advisory groups they can actually enlist upon and nominate individuals as well as volunteers from member NRCs, National Relief Centers, as well as from within the International SNOMED Community. And these advisory groups center around areas that are critical for the ongoing maintenance of the terminology, specifically around the editorial, terminology release, and content managers groups.

What these groups actually do, they provide a mechanism by which topics such as the modeling of a new sub-hierarchy of the terminology can be debated, tested, and approved by this expert panel, and then they can actually provide guidance to SNOMED international for continued maintenance of the international addition.

So another area of I guess great debate lately has been around the frequency of releases as well as new data formats for SNOMED CT. As I mentioned the international and the US editions of SNOMED CT are both released twice a year.

While we’re not currently set up, we can actually technically we have the ability to release more frequently, so monthly, or weekly. And there has been considerable conversation around this because it would be really nice to be able to model to the most up to date version of the international edition, or for our users to adjust data at a more frequent time point than six months.

However, every single time these conversations come up it’s very apparent that users simply cannot ingest SNOMED CT data in that amount of time. Even updating twice a year, we’re finding is sometimes laborious. It’s a laborious process apparently to try to feed this into all of their downstream users. And this also lends us to a lot of time starting a discussion, well, what if we changed the format?

And we started to look into some of this. We just recently moved from Release Format One, RF1, to a new RF2, Release Format Two specification. But what we’re actually finding out is that many of our users are still trying to update their systems from the old legacy RF1 specification to the new specification, and making a change in the release specs this soon will be really burdensome on our users.

So what we’ve done instead at the international level, we’ve actually created scripts that people can run either on the international release or on the US edition where they can produce an OWL format of SNOMED CT. So they’re actually able to produce an RDF version of SNOMED, and that has actually been found to be beneficial to many who want to get around that RF2 specification.

So while more frequent releases are not really in the short-term roadmap, it is possible. But mostly we wanted to let the committee know that it’s actually good to continue to have these discussions with users as well as experts around the US and around the world, and also of course with SNOMED International with regards to looking forward with SNOMED CT data or release frequency.

It’s actually really critical that the future decisions around these topics are centered around member use cases. So we’re talking both in terms of policy as well as in terms of implementation needs and maybe possibly even more importantly implementation capabilities.

So SNOMED CT is used in over 50 countries around the US, and I have a couple of use cases centered around newborn screening and one of our fellow member colleagues in India. But in terms of time I’m probably just going to skip over these, and I could always provide these to the committee, because I want to make sure that my colleagues have time to talk today. But those are very elegant use cases, and there are many more, and I would be happy to provide additional use cases in coming months and years that you guys need.

So I wanted to kind of end my overview on SNOMED CT to reiterate the fact that the clinical terminology is well aligned and harmonized with other technologies and SDOs. While the terminology and NLM included, we acknowledge that the high cost of creating and maintaining maps, these mappings are actually necessary within the current environment.

So it’s crucial that SNOMED CT can cross-map to other terminologies, classifications, and code systems, and here I’ve just listed a couple and a few I’ve already mentioned today. And it’s also important to note that SNOMED International continues to build strong partnerships with other SDOs.

And again, I’ve listed a few here on the slide, GS1, HL7, Trillium Bridge, even Regenstrief, which Daniel will talk about LOINC as soon as I stop. But this really shows that the organization is committed to ensuring that the needs of the members and users are met by harmonizing and working with other terminology SDOs, and this will eventually lead to stronger, more clinically validated SNOMED. And with the NLM, being able to work with SNOMED International and not just here in the US community but all around the world, it’s really leading towards better interoperability and overall healthcare.

DR. COHEN: I just have a couple of questions about training and how difficult the learning curve is for use.

DR. ROY: So, at the SNOMED international level currently they have, they’re calling it e-learning, and they have an e-learning server, and they’ve actually started to provide a number of different courses. So these range anywhere from a one to two hour webinar up to like a six month training course.

And these center around SNOMED CT basics, SNOMED CT implementation, SNOMED CT content development. So people can sign up for these courses to learn all about SNOMED CT. There is a little bit of a ramp-up, just like with all other technical areas, but there are some mechanisms currently in place. Now what that looks like going forward, we do know that right now SNOMED international is committed to continuing these educational courses. What it looks like for how we’re going to spread that more in the United States, we’re talking to others to find out.

DR. HUMPHREYS: And just to let me comment that in general, a lot of the courses that are given by the IHDSDO are designed for implementers of SNOMED CT within systems. We’re not talking about six months for somebody who is using a system that has to capture the organisms using SNOMED under the hood. That is the whole issue of how effective our electronic health record systems are in terms of interfaces or our public health systems or whatever.

DR. ROSS: On the key partnerships, WHO, does that involve the regional WHO regions like AFRO and WPRO do you know? Because on the map it showed no representation out of Africa and I’m just curious if they’re involved.

DR. HUMPHREYS: When Susie was referring to the 30 members, a SNOMED license is free for use in countries in the lower economic according to World Bank formulas, those that are low economically developed, it’s free. So if you add those countries to the 30 we’re really talking more like over 70 countries where SNOMED is free, and it’s in the other countries, and it actually is used or has been incorporated in open MRI implementations and so forth in Africa, and in other underdeveloped places.

MS. KLOSS: Do you have any way of tracking whether users are current? What happens if they implement the March version and don’t get around to doing the September, and then what happens the next March?

DR. ROY: We don’t actually track, while we can see who has downloaded we don’t actually track who has actually implemented within their local EHRs. But I’m assuming that once they try to go and send a particular, to try to attest or try to show that they meet an easy QM, and if that particular value set has been updated to the most recent release of US edition, and they don’t have those particular codes, or some of those codes have been retired, they won’t be able to get the full transmission. So while we don’t have a direct mechanism there would be that mechanism that could kind of tell us.

MS. AULD: Technically if they don’t keep up with the current version then they are in violation of the license. We’re not actively pursuing that.

MR. COUSSOULE: What time frame makes it in violation of the license?

DR. HUMPHREYS: I believe it is 12 months. I think that they recommend six months, so that you get the most recent update every single time, but you’re in violation after 12 months, one year.

Agenda Item: LOINC Overview

DR. VREEMAN: Thank you very much for the opportunity to share a little bit about LOINC with you this afternoon. If you could go into the next slide I’ll just jump right in. So LOINC is a vocabulary standard that focuses on one particular part of the interoperability puzzle. Lots of kinds of health data are stored or represented in a paradigm that you might think of as sort of a question and an answer model.

So whether it’s in the electronic health record or being passed in a message or a document or an API, there’s sort of one part of that which identifies the variable. This is a heart rate, or this is a serum sodium measurement, or this is a blood pressure, right? And then the actual result value, the instance of what this is for my patient, is stored in a different part of that structure, and so you pair those two together and you have sort of a record of what was being transmitted.

LOINC is focused on creating codes that help with that first part, what is this test? So LOINC is a universal standard for identifying health measurements, observations, and collections of those things, which could be things like laboratory panels, so you order a CBC but you get back a bunch of different independent results. Or things that are more loose collections like clinical documents.

So it’s explicitly sort of targeted for that particular domain of things: test measurements, observations, collections of those things. LOINC was created and continues to be maintained by the Regenstrief Institute, which is a not for profit research organization based in Indianapolis Indiana, and is supported by several sources, but one of the primary sources from the National Library of Medicine, which is now a non-fed got invited to a fed panel.

But our role is in developing and curating LOINC, but also we recognized from the very beginning that standards are only as good as the sort of scope or breadth of the people using that meaning. Standards that are only used by two people, not so helpful. Standards that are used by a lot of people, much more valuable.

So from the beginning we’ve been curious to develop and promote techniques or methods and resources to help people implement the standard. And so that includes sort of a software program that helps people map their local terms to LOINC terms, as well as resources such as mapping guidance documents, helping target to what are the most frequently or most likely terms that you might be interested in for a particular purpose, as well as educational resources and the like.

But when I think of LOINC and its distribution, I actually think of that whole collection of things, because the terminology by itself is really kind of one piece, we want it to be out there and be used, and so we spent a lot of times thinking about the ways in which we can support that.

Similar to SNOMED, LOINC’s development model is driven by the community if users, meaning that new concepts are added to the terminology based by requests from the people that are using it. As they are linking their local variables to LOINC codes and they notice that there is something missing, they can propose and make requests for new content.

That is actually a really important part of the standards development process, because it helps us be nimble and agile, meaning it’s the community and the sort of breadth of that community which is feeding us insights, and we aren’t as a central coordinator responsible for keeping up with all of the latest things in all of the different domains of healthcare. But it also helps us stay pragmatic, meaning that we’re only creating content that is actually used in somebody’s system. They’re asking us for it because they have something worth recording this and sharing that they want.

And to date that has generated about 84,000 different codes, which we at the Regenstrief institute make available at no cost worldwide for both commercial and non-commercial purposes. The LOINC license essentially allows pretty open use of the terminology with one main caveat, which is you can’t use LOINC or any of the other things in it to build another standard, which would sort of defeat the whole purpose of why we’re doing this in the first place. But it’s free for use worldwide.

So we publish LOINC in a similar frequency as IHTSDO does or SNOMED does, which is major releases twice per year. And that again has been an ongoing source of conversation essentially as long as LOINC has existed, but that six-month cadencies about the in-between balance between being able to rapidly deploy stuff and add new content, and the user community and the frequency with which they want to update or have to deal with updates. So there are some subtle things that we can talk about in between strategies, but time and time again as we’ve come to that conversation this is sort of where we end up.

The graph in the background shows you actually the growth in codes over the history of LOINC. So starting at the bottom left is the first release of LOINC in 1995, and the upper right-hand corner there is sort of the most current release and sort of the 84,000. And so one of the things you might notice is that we’ve been doing this for about 20 years, and there are still more codes to create.

There isn’t this sort of plateau period. And you can think about that in a couple of different ways. One is that life in medicine and healthcare continue to evolve and change, and there are new things emerging over time. In addition, there are new domains of content which people previously maybe recorded in more loose structures around paper forms but are now increasingly trying to record and store and exchange in standardized electronic formats, and as that happens the need for standard terminologies to represent those data elements grows as well.

so we see these things for example in the areas of genetics and in patient reported outcomes measures and things that people have been recording for quite some time, but now they’re gradually transforming the way that they actually record them into electronic ways. So last year about 50 organizations in 14 countries requested new terms. I might also have mentioned that the kinds of people that make requests for terms is kind of evolving in changes too.

So in the last few years, I’m thinking four to five years or so, we’ve had about 40 different instrument manufacturers or vendors of laboratory test kits who produce products that have come and requested code. So in the time that that product is being made available on the market that standardization is there as well, and that has been an emerging and delightful occurrence.

Each release we add on average about 1400 or so new terms, and so we stay busy. That content creation is handled by the Regenstrief Institute based on these requests, but are informed by the policies and standards set by our advisory body, which is the LOINC committee.

I’ll note that as Betsy mentioned LOINC has been included in the UMLS as an additional distribution mechanism since 1998, and in that context provides connection between LOINC and the other vocabularies that are represented there. Today LOINC is used broadly around the world, so there are registered users from 166 different countries, now around 47,000 or so of them.

And I mention this partly to give a quick sense of maybe where we started 10 years ago in the 2000 recommendation and where we are now. That has grown probably tenfold at least. And there are many different kinds of LOINC users, and so when you think about the adoption, and we ask questions about education and so forth, it’s actually important to recognize that breadth of the user base.

So who are LOINC users? Well it includes federal agencies like the CDC, it includes reference laboratories or radiology centers, actual care organizations, laboratories, electronic health record systems, professional societies, we’re building registries, insurance companies who are receiving data and helping support care management programs and so forth.

Obviously, health IT vendors like EMR vendors. I mentioned insurant manufacturers. But health app developers are users as well. Curiously if you use your iPhone and record your height and rate in the health app and you go to export that data, inside are standard codes including LOINC codes and SNOMED codes for other kinds of variables.

And so it’s a broad picture of what the user base is. LOINC has been adopted as an official national standard in more than 30 countries, and through the in some cases heroic efforts of volunteers been translated into 18 variations of 12 different languages. The standard itself was downloaded about 10,000 times last year, and our online browser which is another one of those resources that we make available had over a million page views last year.

Last I wanted to mention a couple of things about how we as a standards development organization and the curators of LOINC interact with other people to give you some flavor of how that works. So we’re committed to working openly with others who are trying to solve this interoperability problem, recognizing that many of us have different roles to play in solving this problem. So I mentioned sort of this idea of what does LOINC do, it’s the code that represents the question or the observation. Of course, that has to fit in the context of some exchange between two parties.

And so in the informatics world we talk about semantic standards, which are the standards around these code sets and vocabularies, but also syntax standards, so the standards that define sort of the structure that that data is organized in as it goes between systems. And so there are STOs such as HL7 and IEEE who are more focused on that syntax side, defining the structures of how information is organized.

And LOINC is designed to sort of fit inside of many different sort of flavors of that, so whether you’re passing a HL7 version two message, or you’re sending an XML document, or you’re using a fire API sort of programmatic call from one system to another, you still need and depend on having standard coding to support that. And so we have specific collaborations for example with many standards developers who are focused sort of on that space to make sure that the two go hand in hand together.

IEEE is an interesting example of that, so IEEE has done work on defining standards for medical devices, whether ICU machines or home glucose monitoring devices. And those specifications are sort of at their fullest potential when inside the actual sort of transmission spec there is also the coding to go along with it, so that the receiving system, whether it’s an EMR or some other system, can understand what that variable being emitted from the device is. So we have an ongoing collaboration with IEEE and others like CDISC and Hl7 in that regard.

But then there’s also this domain of collaboration, and in some cases even unification between developers of standardized terminology. Suzy mentioned our partnership and working collaboration with SNOMED which is designed to build connections between LOINC and SNOMED and to reduce or eliminate as best possible duplication of effort, but making it seamless for users who are using the two together to get the benefits of both.

But in another case for example with the RSNA who had generated a terminology for radiology procedures called RadLex Playbook, we’ve been working with them together to actually unify our approach, rather than just maintaining a harmonization or collaboration to sort of say hey let’s do this together, and that work is coming to closure and fruition by the end of this year.

In the briefing document, I provided as background I went into a little more detail on sort of other key collaborations within the US that you’re free to peruse as you see fit. I listed them here just to give a sense to the committee as sort of scope within US agencies and institutes that are using LOINC and in many other cases other standard terminologies like RxNorm and SNOMED for important projects.

And so whether that’s sort of the representation of a key patient reported outcomes measure like promise, how do you get that into an electronic medical records system and then share that data across settings when it’s an outpatient to inpatient and so forth, what you need is standardized terminology.

So we’ve represented for example all of the promise items in LOINC. I could spend a lot of time going through all these fun examples, but I’ll sort of spare some of the details and mention maybe just one other, which is for example CMS which is embarking on an effort stimulated by the IMPACT Act of 2014 to standardize the assessment instruments that are used in post-acute care settings.

So in post-acute care, as a clinician there are differ instruments that you must fill out, the MDS for skilled nursing, the OASIS for home health, IRF-PAI for inpatient rehab and so forth. And they’re embarking on a process to standardize those instruments across those settings, but also paying attention to the terminology standards that would enable electronic sharing of that data across settings in a way that the computers could help aggregate and store, and so we’re looking closely with them to create a LOINC representation of those instruments.

And then last, I mentioned our key support financially from the National Library of Medicine, but other sources as well, including the Regenstrief foundation and a number of other NIH institutes that are supporting specific kinds of content development work and other key projects.

So developing for example items that represent things that would be in a chronic kidney disease care plan is one example, and work to build additional resources for LOINC that we call equivalence classes or roll-up groups being supported by ASPI and others. So there’s a broad range of funding, which is important for us as a nonprofit to be able to make the standard available for free at no cost to the user community, which we feel is critical to promoting uptake and adoption.

DR. HUMPHREYS: It is a joke within the National Library of Medicine that when I call on Patrick there is always very little time left.

MR. COUSSOULE: How is the institute funded?

DR. VREEMAN: The overall institute is through the typical academic model, so grants contracts with a core set of funding that comes from the Regenstrief Foundation which is a separate entity.

Agenda Item: RxNorm Overview

DR. MCLAUGHLIN: Thank you for having me. So as Betsy mentioned, Rx Norm was first developed by the National Library of Medicine in 2001 within the UMLS, and was first released as a standalone product in 2005. So it’s a fairly new standard, but it’s growing rapidly and uptake is moving right along. In the simplest form, you can think of RxNorm as a set of drugs and codes, what we call RXCUIs, or RxNorm Concept Unique Identifiers. That’s really all RxNorm is, although there’s a lot of extensibility beyond just those codes and names. RxNorm represents drugs from the prescriber’s point of view.

Our normalized names provide an ingredient, a strength, and a dose form. I’ve got an example here of Warfarin Sodium, one milligram oral tablet, simple as that, those are normalized names so we’re using the basis of strength substance, a set of units that go along with the dose forms, which we also curate, we’ve got our own set of dose forms which we use. For branded products, which we do have in RxNorm, we simply tack a brand name onto the end of it.

So it’s very simple, easily parseable names. But RxNorm is more than just a set of codes and drugs as you might imagine, it’s actually a terminology that’s derived from many other commonly used public and private drug terminologies. These includes the FDA structured product labeling, SPLs, which I’ve got listed here, but also things like First Databank or FDB, Gold Standard, SNOMED CT, all of these are included in RxNorm, and RxNorm is built on top of it.

So if you don’t find something in RxNorm, it means all of the sources within RxNorm don’t know about that thing. That can include drugs, NDCs, and so forth. But the great thing about having all these terminologies within RxNorm is that you have the inherent linking there. Systems that are using these different products, these different vocabularies, RxNorm can be used to mediate messages between these different systems.

RxNorm does not contain everything though. Things like drug classes, indications, adverse events and drug-drug interactions are not in scope for RxNorm. RxNorm is a nomenclature, we provide normalized names for the drugs. But what we do provide is lengths to things like drug classes through the VA’s NDFRT, the National Drug File Reference Terminology, and the WHO’s Anatomical Therapeutic Chemical Classification or ATC. So the functionality is built in there from these other terminologies, but in terms of RxNorm it’s not in scope.

So just to give you an idea of the size of RxNorm, we have about 19,000 generic products at this time as of the June 2017 release, and then we’ve got about 11,000 branded products for a total of about 30,000 dispensable drug products. I’ll go into this more in a little bit, but in total there are about 113,000 RxNorm concepts with the NLM authored names, those normalized names.

So we’ve got a lot more data in there. Every time I say something I’m going to mention that we’ve got more than what I just started out with. So NDC codes, we’ve got lots and lots of NDC codes. Attached to the 30,000 drug product concepts we’ve got 230,000 active NDCs, or NDCs for actively marketed drugs in the US.

So if you go back to what I said before, RxNorm represents drugs from the prescribers’ point of view, here’s where this really matters. So the NDCs represent drugs from the packaging level, or the pharmacy level. And so you’ve got 230,000 NDCs, where in RxNorm that’s limited to a set of just 30,000 drugs. So there’s lots of NDCs for each drug basically.

What we also provide is access to 400,000 other NDCs for previously marketed drugs that are no longer on the market. We’ve got that available throughout programming interface —

DR. STEAD: Who currently mediates the assignment of the NDC to the RxNorm concept identifiers?

DR. MCLAUGHLIN: That is our editors in house in RxNorm. I’m going to cover that.

DR. HUMPHREYS: With the chief source for all the new ones being SPLs, the Structured Product Labels that are submitted to the FDA.

DR. MCLAUGHLIN: That’s right. And so the final bullet here, that we’ve got many more attributes than just the NDC codes. I’m showing application number, UNII codes. And this is just meant to say that the extendibility of RxNorm is really great, there’s a lot of interoperability that can be done with all of the data we have captured within RxNorm and all of its sources of data.

So I mentioned all the drugs and their names and all of the sources that provide information to RxNorm. We also have a graph, a rich graph of relationships that connect all these concepts together. And this is where that 113,000 concepts really comes in. So hopefully you can see this. Actually you probably can’t. But this is a screenshot from our RxNav browser, developed by Dr. Olivier Bodenreider and his team in the Lister Hill Center, but this is a browser based tool for accessing the RxNorm data.

And what you may be able to see here in orange highlighted is that example I gave before, warfarin sodium 1 MG oral tablet. That’s the generic drug. We’ve got all of these other components of that drug broken down in various ways. So we’ve got the branded drugs on the other side, Coumadin and Jantoven, so there’s relationships that connect those. We’ve got the precise ingredients, so just the warfarin and sodium.

And basically, what this allows users to do is connect any set of data within RxNorm based on their use case. So if they need things at the ingredient level rather than a fully specified drug, we can make that happen, or they can make it happen with use of RxNorm and these relationships and the extensible graph.

So, RxNorm maintenance and release process. I’m going to not talk too much about this hopefully, but I will say that of all our data sets most of them we get on a monthly basis, with the exception of the FDA structured product labels, which we get through Daily Med. We get those on a daily basis, and I think we get probably 85 new and updated labels every single day.

So this editing team that Tammy Powell at NLM heads up is a pretty incredible team that does a ton of work every single day. The editing process is done within a home grown editing system that takes advantage of algorithmic matching on things like the source codes that we receive, descriptions of drugs that we’re getting from our sources, and then other things like NDCs. That’s another easy thing to match on and find out where sources are saying one thing is the same as another.

Our editors use the SPL text quite a bit, as Betsy already mentioned. That really is the source of truth for a lot of this information. Because what we’re getting from some of our sources is just a string, and so sometimes that can be hard to go on. So when we have a structured product label in DailyMed it really helps out with the editing process.

Another important aspect is the NDC editing, and that’s done by our editors as I mentioned. They remove duplicates, resolve conflicts. So our sources don’t always match and say one NDC belongs to one drug, they have conflicts, so our editors resolve those. They flag obsolete NDCs.

So if our sources all say that an NDC is obsolete then we flag that as obsolete. And then finally they provide a single set of NDCs for actively marketed drug products. And this is something that doesn’t really exist anywhere. There is no central repository of active NDCs, and so RxNorm is sort of the de facto standard for that, because we take all these sources, the commonly used sources, and resolve all those conflicts and propagate to the 11 digit HIPAA format.

So I just want to mention here that major editorial policy changes are informed by user feedback. We have lots of users of our data, we give them an email address and say hey, contact us and let us know what you’re thinking. So we hear from EMR vendors all the time about things that are not properly matching in our systems, and we respond to that very quickly.

The National Council for Prescription Drug Programs is a wonderful ally, we’re one of the members of that organization. We take advantage of all the work that they do, they provide a lot of feedback to us, as well as other stakeholders. There’s lots of stakeholders that are using RxNorm in implementing our data.

One of the editorial policy changes that I will mention is that we recently changed our injectable drug product modeling. So we changed those dose forms to be more specific for injectable products, and we took a lot of feedback from our users before we went down this path and figured out this remodeling process, and that was very valuable information.

So now I want to talk about our releases just a bit. We release the full RxNorm data set with all of our sources within it on a monthly basis. We also provide weekly updates, so every single Wednesday you can go and get all of the new drug products that are listed on structured product labels on daily and pull that from our downloads.

We make our data available in many different places and formats. In our full release, we’ve got something called rich release format, which is really pipe delimited text that’s meant to be loaded in a database. But Olivier Bodenreider’s group has extended the usability of RxNorm by providing a lot of other applications and tools that can be used to take up the RxNorm data, such as the RxNorm API, and other APIs like the NDFRT API.

DailyMed is another source where you can get the RxNorm data linked directly to SPLs. We’ve got the RxNorm browser that I already showed you. The RxMix Data Processing Tool allows you to submit a batch of codes or terms to this tool and build a workflow, so that you can end up with whatever data you want that’s included within RxNorm, whether it’s the normalized names, the RXCUIs, NDCs, ingredients, you can process all of your data in a batch format that happens on our servers and then we just send you an email so you can grab that text and do what you will with it.

Suzy mentioned, and Dan also mentioned that their products are available behind the UMLS license, as is RxNorm, it’s a free license, so really the content that’s authored by NLM is freely available, and what I don’t have listed here is that we actually provide that freely available data as a separate download of where you don’t have to log in at all, and so users can just go in and grab that data and start working with it.

RxNorm and use. RxNorm is a heavily used product as a result of meaningful use, to name one thing. Its monthly releases were downloaded over 5000 times in FY2016, and the API, which I mentioned from Olivier’s group, was queried over 800 million times by 20,000 unique users in that same fiscal year. So it’s heavily used.

I’m not going to go through all of these, although this is kind of the very important part of my presentation, is the use cases of RxNorm, the adoption of RxNorm. But if you read the bigger text here, some of the common use cases are e-prescribing information exchange, such as the DOD and VA exchanging military and veteran health information, formulary development, so the RXCUIs and drug descriptions are used in the CMS formulary reference file, value sets that are referenced in the electronic clinical quality measures for meaningful use, these are built upon RxNorm for medication data.

And then finally analytics is a huge use case for RxNorm. The odyssey group takes advantage of the RxNorm data and RxNorm API to really process these large patient medication datasets. So this is a very strong, and it’s a newer use case for us, and really our tools, the tooling we have with the API in some of those other applications I mentioned are really useful in the analytic space.

And then finally, sort of unique to RxNorm I think is the fact that our sources, the other vocabularies that would use RxNorm or we would partner with are actually built into RxNorm itself. So the relationships, the partnerships are inherent in our data. Tammy Powell and her team worked with these groups, they’re our partners who work with them on a daily basis, providing feedback, they provide us feedback. So it’s a great loop of information going on with all of these sources here.

What I do want to mention here is that recently, this was just one of the things we’ve been working on, is a project to better align the RxNorm active ingredient, active moiety and basis of strength substance information with the IDMP and SNOMED CT drug model. So that will provide a way better mapping between RxNorm data and SNOMED CT, which you heard from Suzy earlier.

And then finally I’ll just wrap this up by mentioning, I’ve already said this a bit, but there are code sets within these data sources that aren’t inherently mentioned. So the UMLS CUIs, RxNorm grew out of the UMLS, and we include it in the UMLS. So we have links to over150,000 different terminologies through that unified medical language system, Metathesaurus, those concept unique identifiers.

And then a few FDA unique identifiers, we’ve got the unique identifiers for ingredients, and then finally I mentioned NDCs, and I hope I mentioned it many times and got the point across that we’re strongly linked within RxNorm to NDC data. And so now I’ll stop, I know I rushed through that, but I think we should open it up for questions.

DR. STEAD: I want to ask just one question for one expansion a bit by Betsy I think before we get into other questions. I think the committee will be variable in their level to which they understand UMLS. if you could just take a couple of minutes to describe the idea of UMLS as a knowledge base, not as a standard terminology, and how that ricochets into a lot of the other things we’ve heard, I think that would help the committee.

DR. HUMPHREYS: The unified medical language system, Metathesaurus, was divided as a method of basically identifying from large number of different control vocabularies and classifications that had been developed for variety of different purposes to identify across them those things that actually meant the same thing. So the UMLS is organized by concept, it’s a concept based system.

And for people in the world today they’ve heard of concept based systems, but in fact I think that UMLS Metathesaurus was the first concept based system. So what this allows you to do is to identify when something coded or described in one of these vocabularies actually connects directly to something else in another, and really means the same thing, and it’s not based on just the words, that could be quite different, and it’s not based on the fact that everything with this name means the same thing, because that isn’t true either.

So in the UMLS world you can actually identify that there is this name that has been used to name five different concepts, and the UMLS will help you understand that the word means this when it’s in this source, but it doesn’t mean that if it’s connected to another concept in another source. So what this has been hugely valuable for in addition to forming the base of a lot of direct mapping between these things. Because where the things mean the same thing the UMLS really has in many cases already taken care of the problem, we know this means the same as that.

But the other thing that it really does is provide a resource that is extremely heavily used in the analysis of textual data, whether this is electronic publications, or whether it’s clinical notes, or whether it’s anything that’s been written, it’s hugely valuable, or where you’re even dealing with text where in the middle of it they embed one code, but the rest of it is in text, because it also includes the codes from all the systems where it’s connecting there is just a huge number of uses that you can do with this. But it is not appropriate to use as the coding system for any set of data, because it has information at all levels of specificity.

So if you could take anything out of the UMLS to encode your lab data, then somebody might pick something that would say blood test, and the next person might pick something that would be one of the specific blood tests in LOINC, and depending on your purpose this would be useless, you would have very uneven specificity for the same kind of data. Which is why when you want to capture data in precise form you need to specify what is the control terminology that you’re using for that piece of data. Then the UMLS will help you get from that piece of data to maybe related information in whole lot of other places.

So I think that one of the things we have to remember is we’re dealing in the world of big data, but when you are dealing with a person’s health situation, their information, their medications, you’re talking about small data, and you want that small data to be hugely accurate, otherwise how can you use the big data to analyze what the interactions are, what are all this with this person.

So I think that I’m a huge believer in both of these things, natural language processing in deducing new knowledge from what’s been written before, all kinds of statistical and wonderful techniques, I mean this is fabulous stuff and we’ve seen it come a long way in the last 20 years, and I will give the UMLS some of the credit for that, particularly in the biomedical space, but that doesn’t get us over the fact that really if it’s your test we’re a heck of a lot better if your test result is labeled with LOINC, if your medication is captured at one of these levels that we can then connect it off to the others, and if we actually know that if somebody diagnosed you with X and we have a name for it. So I hope that’s helpful.

DR. COHEN: So, one for Patrick, and sort of generalized questions for all the panelists. I want to get a better understanding, and maybe it’s a longer discussion, of who the users of these systems are. Like for the system Packard described is it retail pharmacy organizations, what percent of your users or retail pharmacy organizations as opposed to hospitals, as opposed to insurers, et cetera.

PARTICIPANT: All of the above.

DR. MCLAUGHLIN: unfortunately, that’s the answer.

DR. COHEN: Do you have —

DR. MCLAUGHLIN: No. Tami Powell is no the line, she may have more information on this with her interactions through NCPDP, but really RxNorm is heavily adopted across a lot of these different systems.

DR. COHEN: So the prescription monitoring database in the state health department would use this, or CVS would use this? The answer is yes, or how do we know?

DR. MCLAUGHLIN: Yes, it is mandated that medication information is exchanged using these RxCUI, within those systems, yes. That doesn’t mean that they’re not also using another one of these terminologies that I mentioned, or even another one that I haven’t mentioned. It would be in conjunction with RxNorm.

DR. ROY: I would say the same for SNOMED CT. It is required that they use SNOMED CT for problem lists. Our users are everywhere from EHR vendors, they have to use this —

DR. COHEN: So when I go to my doctor’s office and she records my symptoms in Epic, it would be using SNOMED?

DR. ROY: Epic is a huge major user, I’m on the phone with them all the time.

DR. COHEN: Then my other general question was does the UMLS include sociodemographic concepts as well. So if I typed in race, it would have a standardized definition of the categories, if I said Cape Verdean —

DR. HUMPHREYS: Just to reiterate, the UMLS is the union of terms and concepts from over 150 different sources. So if those 150 different sources have collectively three definitions of race or whatever, then all three are in there. And so it is not establishing a single standard for every purpose, it’s something that would help you understand that there might be three very different definitions of a certain term.

DR. COHEN: So, if I typed in Cape Verdeans, it would say the 1997 revised OMB standards classified Cape Verdeans in this way.

DR. MCLAUGHLIN: No it wouldn’t. It is dealing with the content from controlled terminologies. So no doubt one of them probably has Cape Verdean in there, but that’s because there’s a controlled terminology, and there it is. If that particular controlled terminology has textual definitions, then that textual definition comes along, we have the entire content of these vocabularies are in the UMLS, so we would have the definition, but it wouldn’t link out to the XYZ federal register notice from OMB about this or whatever.

DR. THORPE: I just want to go back to this race issue. So what race information is in the database? Can you share with us that? I’m a little confused about the three different definitions and things, and also what other social demographic information is there as well?

DR. HUMPHREYS: As I say, the Metathesaurus is a database of terminologies and classifications. So essentially its content comes from machine readable terminologies. So a number of the machine readable terminologies that are in there definitely have race information. So —

DR. THORPE: Can you give me an example of race information?

DR. ROY: Can I call a friend? Is Dr. Jim Case still on the line? He’s the content editor for SNOMED CT US Edition, and also a head terminologist at SNOMED International.

DR. HUMPHREYS: Could you describe the race terminology in SMOED for us, Jim, if you’re there?

DR. CASE: The race terminology in SNOMED was derived from a number of external sources, and has been added into SNOMED. Unfortunately, it’s not something that is as well maintained because of the different views of race and ethnicity internationally, and so there’s kind of a confluence of the two within that in order to meet international needs.

DR. HUMPHREYS: Give a specific example. Give a couple of the terms, I think that’s what he needs to know.

DR. CASE: I didn’t have it up right away, let me open it up here so I can take a quick look at what we’ve got.

DR. HUMPHREYS: The issue would be some terminologies would say okay, we have these races, we have white, we have black, others would say no we don’t have black, we have African American, somebody would say we have black and within that we have African American and we have other, and then some would say Asian American and some would say no, we have Chinese, we have Chinese American. So if any of those derivations, if any of that approach had been used in any of these terminologies they would all be in there.

DR. CASE: For instance, we have the typical classification of race such as African American, Caucasian, Hispanic, Latino non-Spanish. But then we also have things in here like Bulgarian and Czech. Those are listed as ethnic groups, as opposed to a strict ethnicity themselves. So the association of jurisdictional origin as opposed to actual social and demographic representation. And there are probably 200 or 300 of these in SNOMED currently. It is an area that has been brought up for review, but we haven’t actually taken a look at it in great detail.

DR. MCLAUGHLIN: The UMLS does not purport to give the right answer when you’re looking for the set of race codes. It contains a lot of control terminologies that have this information in there, and where there’s synonym those things are mapped together into a concept. So it doesn’t say use this terminology, it’s the best one, it just says here are all the terminologies, depending upon your use case pick the one you need.

DR. STEAD: To the degree I understand RxNorm and the related terminologies, I think it’s nice example of how manufacturers produce a new brand, assign a new NDC code, we have the FDA and the SPL coming out every day, we’ve got the incremental additions of RxNorm CUIs once a week, and this doesn’t break everything, and they’re independent related things.

At the other end of the spectrum we have trouble keeping up with six month updates to SNOMED. Why? Is that a fair question?

DR. HUMPHREYS: I think that additions are easier to deal with. Strict additions and strict deletions. And you have to, because if you’re prescribing application allows somebody to prescribe a drug that’s off the market, it’s an immediately significant problem. And it’s easier in some sense. Some of the SNOMED changes will be, in a sense I think we’re sort of there on the same thing also with tests, we have a new test, and so we need to get it in the system quickly because it’s a good test, or at least for some users they want to use it.

And then eventually we know that a test is not used by anyone anywhere, and we flag it as obsolete but we can’t get rid of it because we always have to keep the back for the medications, because this longitudinal analysis of data is a big important useful use case. On the other hand you really don’t want that stuff in the mix when you really want to order a test that you can get today or prescribe a drug. SNOMED is dealing in the space where we’re more dealing with the organization and the understanding of changing medical knowledge.

What this disease categorized as X, is it really, or do we now know it wasn’t? Or we have emerging, if we have brand new diseases that’s not such a problem as long as we know what kind of a disease it is, we can get it in there. But if we suddenly realize that this whole way we’ve structured the leukemias and the lymphomas does not match what we’re doing now, then you’re talking about potentially large reorganizations.

Or as Jim was just saying, if you look at a whole area and say over time we added things when people wanted them and needed them, but this is not organized in any useful way for reasoning, so now we’ve got to look at the Bulgarians and the Czechs and these other groups and whatever we have here geographically, and we’ve got to come up with a model here that’s going to meet current use cases.

So therefore, I think if you built your thing around the other use case you might easily be able to agree that this is a new improvement and it’s wonderful, but on the other hand it could really disrupt something in your system.

MS. KLOSS: I have three areas to probe if we have the time. First, I would like to go back to the question or the discussion around the content request system, on the assumption that this I what triggers a reassessment, one of the mechanisms, and I know you cited three. Does any organization other than SNOMED use that content request system? Is the US system then directly linked to SNOMED international? Or do they use the same system in all 30 countries?

DR. ROY: No. So, the US SNOMED CT content request system is specifically just for our US edition. And it did up until recently have direct connections with the international content request system. Actually, we’re in the process of upgrading and migrating our tooling so that we will once again directly connect, so that when those content requests come in, and Jim can forward directly to the international release, there are a couple of other members who are also looking to see at their local request systems, because some of the other countries are using different applications, so that they can also forward directly to the international release.

DR. HUMPHREYS: But this is the direction I think. It is a sensible direction for NLM, and we’re able to move in that direction because of the development of a stronger technical platform at SNOMED international over time, and these things develop at different points. So we now in terms that we recently made some decisions where we looked at what’s the sensible thing for us to do, and the sensible thing for us to do is to move to these tools when they’re ready to take us, which is probably going to be pretty soon, and that’s going to actually be very beneficial to us from a financial point of view —

DR. ROY: That’s actually going to facilitate efficiency as well, looking at some of these mechanisms where, because the request system just receives the requests, and Jim can converse back and forth with the users, but also looking at connections not only with an international request system but also with our offering tooling, so it’s looking at the whole kind of ecosystem, like Betsy was saying, the tooling infrastructure.

MS. KLOSS: Do you use a different request system?

DR. VREEMAN: We do, and a different authoring environment, so the technology platforms are quite different, but essentially, they can be thought of as a defined template, and there are a couple of different formats that people can make a request, including sending an email with a spreadsheet template filled out.

MS. KLOSS: And if they direct something to you, that really isn’t a LOINC matter, it really belongs RxNorm or SNOMED or something else.

DR. HUMPHREYS: You are on the right page. That is absolutely something that we’ve been discussing, and you get things to a certain point and then you can think about other better things to do. And a really good development is agreement where when in a number of cases where the test or the question is over here in LOINC, and the answer is an organism or something, that in effect the answers are going to be in SNOMED CT, so we’re building these additional connections among all of these going forward, and it’s a good direction, and being able to eventually get to the point where people can say here’s my concept and we can kind of easily seamlessly direct it to the place that can handle it I think is definitely on the long-term improvement list.

MS. KLOSS: Then it seemed to me that when these requests come in you turn them pretty quickly, if you receive the update from SNOMED international in January and turn a US release in March, that’s wow time. What magic goes on behind the scenes?

DR. R: No one on my team is allowed to go on vacation during February and August, and I’m not even kidding. We do receive a member’s release of the international edition just a tad bit early. We don’t hold SNOMED international to an exact date, but we do receive that where we can actually star the process of the reconciliation process between the US extension and the international release. But essentially the one month for each release.

MS. KLOSS: And then you have some clinical review mechanism that allows you to —

DR. ROY: Dr. Jim Case —

MS. KLOSS: Because you would have to do that.

DR. HUMPHREYS: Susie said earlier that the US Edition has content that is particularly valuable in the US, and might not be valuable elsewhere, and that’s true. But it also has content that has been needed right now in the US or soon in the US, which will then eventually probably be in the international thing. And one really good thing is that we enter it in, and it doesn’t get another identifier when it becomes part of the international release, what a concept.

MS. KLOSS: Would you care to comment on what things worry you about the current process, or what the priorities are for making all this better in the area of again development, maintenance, dissemination?

MS. AULD: I would say, just because of what I do, I work a lot with setting up the contracts and the funding, the powers that be still don’t necessarily fully comprehend that these standards are not set in time, they are constantly changing and evolving, the knowledge is changing, the tools have to change, and this has to be funded, this has to be properly funded. So please say that.

DR. HUMPHREYS: I have a few ideas which I can send you. They’re larger ideas in some sense. And they’re related to this. Our colleagues at ONC have done a tremendous job with their advisory committees and moved mountains, and we’re very grateful to them. We have not yet sort of identified the US National Standard nailed down for some key parts of the electronic health record, like the imaging reports and the path reports.

And I really think we should do that. I think we should do that, and we should identify in those cases where terminologies are involved in those we should, and I think in most of these cases the terminologies, particularly now that we have RadLex integrated with LOINC, I think we’ve got the coverage in these but we could have it.

But I think we don’t have that specified and we don’t have that done, and so really there are countries where they have implemented electronic health records throughout the country, where one of the driving things that made the Electronic Health Record System really valuable and useful to the local practitioners, the general practice people, was the fact that they could get the path reports and the radiology reports and all this stuff back.

And so it seems to me that we’ve made great strides, and I know we don’t want to maybe lay down any new requirements in the short term, but I don’t think that that should prevent us from specifying what the national standard is, even if we haven’t required it to be used in particular cases yet. So I think that would be good, that would help put this all stuff together. And I know I’m being followed by my great friends and colleagues from other parts of the department.

MS. KLOSS: We need to adjourn, but to be continued.

DR. STEAD: And please do send that e-mail.

DR. HUMPHREYS: Yes, I will.

DR. STEAD: Thank you all, this has been awesome. As a committee, we’re going to need to be quick because we need to reconvene at 3:15. So we’re taking back the extra five minutes we got at lunch.

(Break)

Agenda Item: ICD-10 PCS

DR. STEAD: Let’s reconvene. Donna Pickett is on the phone, and Pat Brooks is also going to be on the phone, so Bob is going to drive from within the room in addition to doing his part of the panel.

MS. KLOSS: So we are turning our attention to the international classification family or the international family of classifications overseen by the World Health Organization, and as you know I think many have met Donna Pickett who has been at our meetings in the past, but she’s the Chief of Classifications in Public Health Data Standards for NCHS and she is going to give us an overview of ICD-10 C-AM, the migration and development of ICD-11, and she’s going to describe the coordination and maintenance processes, and then Pat Brooks who is with CMS and overseas the ICD-10 PCS will update us on that. So that’s our process.

And then our own Bob Phillips is going to overview the international classification of primary care, which is part of that family of classification. So with no further ado Donna, are you with us? Are you on mute, Donna? Pat, would you lead off for us?

DR. BROOKS: Sure, I’ll be happy to. I should also mention I have Rhonda Butler from MMM with me on the phone, she’ll be doing the most part of the presentation. And MMM is our contractor to CMS, developed by NPCS and helps us maintain it. And so starting with my slide, if you go to the second slide you’ll see that we’re going to be talking about ICD-10 PCS updates, and the fact that CMS does maintain the procedure coding system, ICD-10 PCS.

And this coding system is only used for inpatient procedures, and we update the system annually, it goes into effect October 1st, and for those who haven’t seen it we have now posted the 2018 ICD10 PCS update. And I give you the website, and once again that goes into effect October 1st 2017.

The next slide, Donna is going to go into more detail on this, but the ICD-10 Coordination and Maintenance Committee, or we call it C&M, is the committee where we discuss requested updates to the coding system. And it meets twice a year. The next meeting is September 12-13, and if anyone has any code requests they’d like to be considered, we have an email address that people send procedure coding requests to us. And you can read all about the ICD-10 Coordination & Maintenance Committee, in particular the procedure part is on the website I give on that slide.

And then the final slide I’ll be covering is that you can participate in these C&M committees through a variety of ways. You can sign up to come in person at the auditorium, you can participate by free conference call, or you can watch livestream. And I should also say if you aren’t available the day of the meeting and you want to see what happens you can even watch those livestreams later, because we did post them. And you’ll see at the bottom of this slide where you can see information on prior meetings of the coordination and maintenance committee. And at this point I’d like to turn the meeting over to Rhonda Butler, who will go into much more detail on IC-10 PCS.

DR. BUTLER: Thank you. The next slide shows the three topics that I’ve been asked to cover. I’m going to be covering the first two at a fairly high level, just a basic overview of the structure and the development cycle, because both of those feed into what I’m going to be talking about in the third part of this hopefully 15 minute presentation, discussing the updates to the ICD-10-Procedure Coding System since implementation in the past two years.

First of all, the development history of ICD-10, I just wanted to give you a little snapshot to remind everybody that this has been a long time coming, it’s been sort of waiting in the wings for a couple of decades now. So we’re up to 2017, and although ICD-10-PCS was updated annually between 1998 and 2017, that really didn’t become a serious proposition, it wasn’t done in earnest until we started collecting backlog items in the few years leading up to implementation and the need to pass to major updates since limitation.

Again, the key attributes of ICD-10-PCS, there are four of them. They are complete, it’s expandable, these are architectural attributes of the system. It’s multi-axial, and it has its own definition.

There’s the first two, completeness just means that the system was designed so that all substantially different procedures have a unique code. And so the example given there is that if you’re going to perform procedure to excise this specific body part, the right upper lobe of the lung, you can further specify whether it was an open approach, a thoracoscopic approach or a bronchoscopic approach.

So you can further distinguish those key substantially different procedures. The fact that it’s expandable just means that as we know a coding system is never finished, because technology is always changing, and the structure of the system allows us to incorporate that new EPL as it’s needed to become a unique code.

And so as you see here, the two examples at the bottom, dilation of right femoral artery, during the backlog when we’re still under the partial code freeze there was a proposal for this new technology, a drug coated balloon angioplasty, and so that information was added in that part of the system to allow a unique code for that new technology.

Multi-axial is just a bit more precise term for what normally we refer to as the character, meaning the codes are seven characters long, and each one of those characters, in other words axes, each axis of the classification specifies a stable same type of information, for example the third axis or character of the code specifies the root operation, while the fourth axis or character of the code specifies the body part, the site of the procedure.

And then the fourth attribute, definitions, people mean different things when they use the same word, and also in a dictionary the same word will have multiple meanings. And so ICD-10-PCS tries to elevate that difficulty in understanding what something means by providing its own definitions for terms that are used in the system. And there are two examples of root operations with their specific PCS specific definition.

So let me just remind you the structure of the codes are seven characters long, it just as easily has been represented as a giant spreadsheet. If you think of the seven characters as seven columns, then the individual cells or expressions of that character we call a value. Being that the general type of information is stable, for example a device is stored in the sixth column or the sixth character of a code, and then the specific value in this example is D, intraluminal device. And again there are 34 possible values for any position within a given context, a specific table, a specific section of ICD-10 PCS, et cetera.

There are 17 top level subdivisions in the procedure coding system, and they’re called sections. Three examples are medical and surgical, obstetrics, and measurement and monitoring. And within each of those sections we have varying numbers of root operation tables. That’s how the system is presented, in tables that are organized around the root operation.

In medical and surgical section, there are 31 of those. In obstetric section, there are 12 root operation tables, and in measurement and monitoring there are two root operation tables, one called measurement and one called monitoring. And then again, the way the table is formatted, the first three values of the first three characters are the same within any given table, and then the four columns give those valid combinations of values. And the next slide gives you an example of a table, just so we can consolidate what I’ve been describing here.

The example of the table in the next slide is ICD-10-PCS table 0FB, in the hepatobiliary system and pancreas, the root operation of excision, and you can see the first three characters are all the same so they’re stored in the header up there, the root operation is defined, and then you have columns four through seven that specifies the specific valid combinations of values, and that’s what creates code in ICD-10-PCS.

All right, next I’m going to talk about the ICD-10-PCS —

MS. KLOSS: Rhonda, this is Linda. Could you speak into the phone a little more? We’ve had some people who are on the phone with us that are having a little difficulty hearing you. Are you on a speaker phone or are you on a headset?

DR. BUTLER: I am on a headset, and I will turn my volume way up. I will talk much louder. I pay a price, because when you guys talk, it’s pretty near painful level, but I’ll do it for the team. Alright, so the development cycle, next slide, consists of as Pat mentioned it’s an annual update cycle, with the changes posted in June and effective October 1. The changes come from the biannual meeting of the ICD-10 Coordination and Maintenance Committee.

(Technical problem)

MS. KLOSS: Please identify yourself who is on the phone.

DR. BUTLER: We were at the annual update calendar slide, which I think is the next slide after the example. The changes for a given cycle include proposals for PCS at least, include proposals from September of the previous year and March of the current year. So for example the update just posted includes changes proposed at the September 2016 meeting and the March 2017 meeting.

The basic types of CNM agenda items are what we call proposals, which are typically they’re formal written proposals developed by a specific organization, and they most often request new codes, additions to the classification that create new code.

And then the other general type is just it’s general category, which we call Agenda, and those are individual public requests that are sent to CMS, and/or recommendations coming internally from the cooperating parties, and they also work closely with the Coding Clinic Editorial Advisory Board.

Just a few words about the process during the partial code freeze, because that really eats into what we’re talking about when we talk about the first two updates after implementation. C&M meetings were held as usual during the partial code freeze. The proposals and agenda were presented, and we had public comment period, and that went on for four years after the partial code freeze, because as you know we had a two-year delay, so what originally was going to be a two-year code freeze became a four year. During that time, a few new technology proposals for new PDS codes were allowed to be included in the annual update during the partial code freeze, but that was all, and all the other proposed code updates were saved to be implemented after the code freeze ended.

These are public meetings, and so just as a reminder that the comment period for all of those meetings and for ongoing meetings are accepted for one month from the day of the particular meeting. Anyone can write in and express their opinion, and the most recent comment period for the March 07 CNM meeting ended on April 7th.

So after the comment period is over CMS reviews all the comments received, and their internal team plus the contractor will meet to discuss the public comment and reach some final decision as to what changes will be made, and then those changes are implemented in the ICD-10-PCS database.

After that, the PCS output files, the files that comprise the official content are posted on the CMS website, and they include these sub-bullets here among many other files, and those are available in readable format, text, and XML for technical users to be programmed to, and then PDF files for coders and coding educators and the general public.

So after posting the update the cycle begins again with the September CNM meeting, and so the September 2017 agenda will be the first round of proposals and agenda for this next fiscal year 2019 update year. And then March of 2018 will be the second round of that. And just a reminder that the next update, fiscal year 2019, will be the first update cycle of more or less normal scope, because it will be the first one that occurs after the backlog of code freeze proposals have all been implemented.

So now I’m going to talk about that. The last two years of updates since implementation, these two annual updates since the end of the partial code freeze have been quite extensive, those of you who have been following the update process, for two reasons. There was a backlog of both these types of CNM agenda items, both proposals and agenda, so both external formal proposals and internal proposals, and then also the ongoing full agenda of new proposals for the past two years at a total of four CNM meetings since ICD-10 implementation, all those were worked through and comprised the last two annual updates.

CMS chose to take a phased approach to implementing the backlog of changes accumulated during the code phrase because that request came in from organizations who felt like doing the entire backlog in one year would just be overwhelming to their organization.

So in the first update year what was included in the annual update in addition to the C&M proposals for that year were the formal proposals that were presented during the partial code freeze and those that receive public support, so that was the last update, FY2017. This update, FY2018 included all the internal and agenda items, all the internal and external public requests that were not formal written proposals collected during the code freeze, and then also the C&M meetings for the past year’s cycle.

So just high level I’ll give you a couple of examples of the kinds of things that went into the fiscal year 2017 update. There was a new root operation, profusion, that was created, and it classifies procedures that are performed on marginal donor organs to try to get them in shape so that they will be successful as transplant organs.

So it’s a back table operation on lungs or livers with new technology. The thoracic aorta, more body part detail was added for that, so it was split into two body part values, one specifying the upper and arch portion of the aorta, and the other specifying the descending portion of the thoracic aorta. Lots and lots of new codes were created when additional device values specifying the number of vascular stints were added to the system.

And also, a fourth example, we greatly expanded in that update the number of qualifiers or the application of an existing qualifier that specified where a vascular procedure was performed, if it was performed at the bifurcation of a vessel.

So here are just some tables used so you can see how this plays out in the reality of the PCS table. 6AB was an all-new table, that was profusion. The next one just shows you the two new body part values, thoracic aorta descending, that was split, and then the new body part value X, thoracic aorta ascending/arch.

Expanded the use of existing device and qualifiers. I combined the third and fourth examples, they’re all visible in this one table. You have additional stint, number of stint device values, and bifurcation is specified in the qualifier.

So the same kind of high level, some examples of the kinds of things that were added in the last fiscal year update to ICD-10 PCS, the root operation extraction was applied to new body systems that specify biopsy by needle aspiration technique. There was a new body part added to all the tables for the hepatobiliary for the common hepatic duct. It was a left and a right but not a common. Greatly expanded the application of the use of the endoscopic approach value, the PCS table.

And next slide, the new proposals for changes, among those presented in the last update cycle, a couple examples from September and a couple examples from March. There was a proposal for a REBOA procedure, Resuscitative Endovascular Balloon Occlusion of Aorta at the specific temporary occlusion of an aorta in an emergency situation when a patient is at risk of bleeding out for a severe wound, so it gives them enough time to repair the primary wound. It was also a unique qualifier value added for influenza vaccine for public reporting.

New proposals for March 2017, there was a new device value added to specify a specific type of hip implant made of oxidized zirconium, there was a new qualifier value added that specified specifically the sesamoid bone of the foot underneath the toe. And in the next couple slides I give you examples of how those look in the new updated system.

So there’s the new table extraction, and I also in this visual, I circle the approach, just to show that that is the case. Then lymphatic duct, common hepatic duct, and the REBOA procedure, the new qualifier value, it looks like you’re just flipping through those and that’s great. The new qualifier values for influenza vaccines.

And then the oxidized zirconium device value, and the hip replacement table, and then finally the sesamoid bone of the first toe, a new qualifier in the lower bones body system. And that’s the end of the formal presentation. I’ll turn it back over to Linda and Pat for questions.

MS. KLOSS: I just want to reiterate, make sure everyone on the committee understands that this ICD-10-PCS system and its design was brand new when it was implemented with the ICD-10 version update, while the 10-CM, this was a newly designed system, so I think that sort of probably adds to the number of updates that came about as this was being used in addition to certainly the effect of the freeze.

We’re going to go on and ask Donna — wait, Nick has one question, and then of course we’ll come back around later and probably have some additional questions. Nick?

MR. COUSSOULE: One question that is mostly related to the earlier discussion about what the kind of pent up demand for new codes, there was clearly some feedback that the sheer volume was going to create problems and challenges, so the decision was made to phase them in over time. How does that process work, how do you solicit the feedback from the entities that may have had the challenge, and how did the decision process get made to sequence that differently?

DR. BROOKS: That discussion occurred at our ICD-10 Coordination and Maintenance Committee meetings. That was probably — an organization such as the American Hospital Association, the American Health Information Management Association, they’re members, and they also conveyed that they supported this phased-in approach.

MS. HINES: For those on the phone, if you’re listening to the proceedings on the web, you’ll need to mute your computer because we can hear that come through the phone when you’re speaking on the phone.

MS. KLOSS: Donna, we wish you were here in the room, but we understand.

Agenda Item: ICD-10 CM and ICD-11

MS. PICKETT: What I am going to try to do is rather than do my entire presentation, I’m going to move through and try not to duplicate things that Pat and Rhonda have already said. But first clarification on the slide, I will not be talking about ICD-10 PCS.

This is the summary slide for mortality. I know many of you are likely aware that ICD has a strong, rich history in mortality, for which it was used in the US for many years. ICD-10 began use in 1999, and mortality obviously continues to use that. There will be another slide really that will look at the morbidity perspective of things, but this is just to kind of set the stage that this is mortality, ICD has been around a very long time, and other changes will be coming, which I know will gladden the fall.

The ICD-9-CM Coordination and Maintenance Committee, as Pat were describing the process, the process really has been in place for many years. We began using the CNM process back in 1985 to update iCD-9-CM, both diagnosis codes and procedure codes. On the diagnosis side IC-9-CM based on ICD-9 as published by WHO had no updating process in the WHO world, all updates were done for use in the US, so there were other updates that were using ICD-9-CM as their morbidity classification.

All proposals go through the C&M process, a little bit more challenging for us on the diagnosis side is not only are we receiving proposals from various specialty groups, medical and surgical, and other stakeholders, both federal and local state and other partners, but we are also keeping up with proposals that are being presented to WHO for the updating of iCD-10.

This is unique that WHO is still maintaining 10 and actively updating it, and so countries that are also using 10 or political modifications thereof are also actively updating, all of this going on while WHO is actively developing iCD-11. So, a few challenges there.

All of the proposals for ICD-9-CM update dating back to 1998 are still available on the website, but we created new pages off our NCHS website with a C&M process specifically for the ICD-10-CM update.

Just information letting you know that our regular updates are posted on our website both in PDF and machine readable formats very similar to CMS. And again, all that information is available and the webpages have been restructured most recently so hopefully things are a little bit easier to find than they were previously.

In addition to the agenda files we also have the guideline files with conversion tables and general equivalence maps. Next slide please.

These next two slides basically give you a summary between 2012 and 2014, which is during the freeze, of the types of proposals that came in from the various stakeholders. Not shown in these slides again are the proposals that relate to changes that were being undertaken by WHO for ICD-10 itself.

So as you can see from this current slide and the next one, many of the proposals we’re receiving for updates are actually coming from physician groups and other stakeholders.

So why an ICD-11? Yes, WHO has had an updated process in place for ICD-10 since approximately year 2000, but despite that updating process clearly ICD-10 as well is showing its age. The World Health Assembly adopted ICD-10 back in 1989. Many countries began fully implementing iCD-10 starting in about the mid-1990s. So you’ve got a lot of use here, a lot of changes in clinical knowledge, et cetera. So no surprise that an ICD-11 by WHO would be envisioned.

This is background information on how WHO setup their organizational structure for the ICD revision process. As you can see there were a number of clinical groups that were working closely with WHO in the development of ICD-11. All of the work of these various topical advisory groups have now been sunsetted as of October 2016. Next slide.

This slide shows a summary of the original launch of ICD-11 work, and the various phases of work that have transpired. Currently it is expected that the WHO will be submitting the beta version of ICD-11 to the World Health Assembly in May of next year.

Some of the original plans regarding ICD-11 were to have two separate linearizations, or classifications, one for mortality and one for morbidity. However, after much debate it was decided that the classification would be a joint classification used for both purposes, morbidity and mortality, with a shared maintenance. Mortality and morbidity both share the same structure but perhaps not the same level of detail. Next one.

A joint task force was formed by WHO in January 2015 to look at some serious deficiencies particularly on the content side that made classification unusable for statistical purposes. And I won’t go into detail here, but in last year’s presentation to the committee I did outline some of those challenges, and we do now have resolutions to many of those challenges.

The WHO did hold an ICD-11 revision conference last year in Tokyo. Member states were represented. A version of the ICD-11 was shown at that time. However, what was presented was not the finished product. There is additional work that still needs to be done, but much work has been done to move ICD-11 forward.

ICD-11 is undertaking field testing to ensure that the classification will be fit for purpose, including coding and statistical presentation, and WHO is also developing benchmarking files to enable some of the quality review work that needs to be undertaken. Next slide.

So assuming that the classification is found fit for purpose and that coders can use it and the output will result in usable statistical data, when do we think ICD-11 will be implemented? Well a rough estimate, depending on whether you’re talking morbidity or mortality, is approximately three years. However, you do have other countries that use the classification for much more than just statistical tabulation, and they have indicated that much more time is likely to be needed.

It also depends on how a country even for morbidity purposes uses the classification. Many countries use it for morbidity but only for inpatient acute care. Other countries at the other end of the spectrum like the US use the morbidity classification for inpatient, outpatient, home health, long-term care, rehab settings, et cetera. So again, depending on how extensive the use is that will obviously lengthen the time frame in terms of actually implementing the code set.

So I’ve quickly undergone an overview of the process, I want to touch on a few points related to some of the goals that WHO has laid out for the use of an ICD-11. So again, this slide, this is taken directly from the WHO website. The beta phase will be complete in 2018, with a finished ICD-11 likely going to the World Health Assembly for adoption. Now, many think that that’s sort of the end of the road, but in fact as it relates to implementation, 2018 is actually more of the start of the road, not the end of the road. And why do I say that? Next slide.

There are a number of things WHO was wanting to accomplish with an ICD-11, including ensuring that ICD-11 would be fit for function in an electronic environment, and that they had defined logical operational rules for actually implementing the ICD-11 in various environments, specifically looking at electronic health records and information systems.

Also part of the revision goals is that ICD-11 would be a multi-purpose coherent classification, useful for morbidity, mortality, primary care, clinical care, research, public health, and a number of other use cases. Also, the system would be able to produce multilingual reference standards for scientific comparability in multiple languages, not just French and English.

One question I’ve been asked frequently is has there been US representation included in this work. And in this summary slide you’ll see that the revision steering group and the revision steering group small executive group chair is Christopher Chute at Johns Hopkins, and there’s been other US participation on some of the crosscutting topic advisory groups, including the mortality tag which was cochaired by Robert Anderson here at NCVHS, the Morbidity Topic Advisory Group which I had the pleasure to serve as cochair, and for functioning and disability Seal Kennedy at ASPI, many of you know her, also served as a cochair for one of the tags. And again, overall we were looking at descriptions, content model parameters, and kind of the core of what needed to be in an iCD-11 classification, and specifically focusing on morbidity and mortality.

All the ICD entities will have descriptors so people understand what is included in a given category, and the descriptions are intended to be compatible with the content model, the diagnostic criteria, and applicable across the entire classification and all of its related versions.

WHO also had input from external reviewers. That report is actually on the WHO website, so I have the URL here. Information about the work of the joint taskforce is also available on the WHO website, with many reports that have been authored also available directly from the website. Next slide.

So recently, and I say recently, basically within the last eight months, there’s been a lot of content work going on, I won’t read through the entire list, but there have been some really thorny issues that needed to be resolved in order to finalize some of the work of the ICD-11 classification.

The next few slides are just intended to show you how some of the structure has changed for ICD-11. I will provide updated slides because all the chapters have now been sort of rearranged and I want you to have the most recent information, so I’ll be sending new slides for that.

There now are actually a total of 28 chapters. And there are new chapters which resulted in a reorganization of some of the chapters. But again content issues aside there are other issues that are also important that we will highlight as we continue the presentation.

Coding schema, this is going to be very important as you will see when I get to a later slide, but there are changes in the chapter numbering, the coding scheme itself, and some changes that likely will require other standard setting changes to accommodate the ICD-11 structure and conventions.

So one of the major differences in ICD-11 is a chapter that contains extensions. And so for each of the things you see here it is a new extension housed in a new chapter. So there are extensions for consciousness, substances, code usage, temporality, etiology, dimensions of injury, diagnosis timing indicator, whether something was or wasn’t present on admission. So there is a very fulsome chapter that has details for all of these issues.

This slide lays out the different types of extension codes, but again a lot more detail, some of which may be captured currently in administrative data as a separate data element as part of either like the 837, the UB04, or the 1500.

And again, a major difference between iCD-11 and iCD-10 is ICD-11 does have a content model which did not exist in iCD-10 or any of the other prior ICD revisions. There are a number of tools that are available for ICD-11 that WHO has developed, and you can actually look at some of those tools on the website. There is a coding tool where you can actually look up a term in the tool and see how that I snow represented in 11 and how it was represented in ICD-10.

The actual browser itself, so you can actually see the classification is available with registration. There are frozen versions which is a snapshot at a particular time, so those who are actually doing comparative work can actually use a frozen version and actually do some degree of measurement or analysis before the browser is actually updated. There is a review tool, there’s a translation tool, and there is also a mapping tool.

And for those who would like to be much more down in the weeds than I am covering here, there is online information on the WHO website, frequently asked questions, videos, and a lot of other information that you may find interesting.

During the beta phase, they are doing daily updates, which makes it so important sometimes to have that frozen version, so that when you go back and look at it the next day it’s still what you thought you saw the previous day. but on the WHO page you can also actually register to participate, you can actually look at comments that are being made on a daily basis on some of the different concepts that are in ICD-11, you can propose a new definition if a definition or a description doesn’t exist, you can volunteer to participate in field testing, for those countries that usually produce their own language version they can volunteer to assist in translating the ICD into other languages as well.

Some of the work being done now again is to focus on the scientific accuracy of the content within ICD-11, making sure there’s internal consistency, and that there is ongoing and continuous review as ICD0-11 is updated. Now, WHO has developed field trial parameters, we have a framework, and again their goal is to ensure comparability between 10 and 11, because obviously many people as has been mentioned today are concerned about trends and the impact on moving from one version of ICD to another version of ICD, and they want to make sure that they’re increasing consistency, improving pathways, reducing errors, and using the electronic tools that are available to produce a more refined product than some of the previous versions of the ICD that have been implemented in the past.

Various assessments are being done. Again, that information is on the web page. And as part of the field trials they’ll be looking at key uses, morbidity and mortality being primary among them, but also even within morbidity, the research setting, population health, clinical research, primary care and general care. And I know we’ll hear a little more information about that later. Again, 2018, this is the beginning of the road once ICD-11 is published. Next slide.

Now, some food for thought or kind of to prime the pump. This is the ICD-10-CM implementation timeline. Many of you know and love it or hate it, but again it is what it is, these are the facts. We had an evaluation of iCD-10 before launching into the need to create an iCD-10-CM. We had NCVHS hearings between 1997 and 2003, we had an NPRM in 2008, a final rule on 2009, another NPRM in 2012, another final rule in 2012, and an interim final rule in 2014. I’m sure the wisdom of this slide is not lost on any of you.

What I’ve done here is I’ve taken that very same slide I’ve just showed you and started overlaying dates in case this is something we need to talk about as part of the pathway forward. So if you start with 2018, and you add three years, and because the US needs to do an evaluation that gives you some kind of a ballpark to have as a frame of reference.

National committee hearings, again I’m taking the previous slide and just overlaying dates. But of course, by the time I got to NPRMs I decided that I would just put question marks there, because I don’t think we know what the future will hold. But again, if this gives us some type of a framework to focus on, we know we have our homework ahead of us, many of us do.

Now, there are many issues related to ICD-11 implementation that didn’t necessarily come up frequently as part of what needed to be done as part of the 10-CM implementation but were undertaken nonetheless. And one of the major ones was revising standards to accommodate iCD-10-CM.

Well, in that vein one must also keep in mind that revisions that are related to ICD-11 will likely have to go through a revision process in order to be implemented. For instance, under X-12 we had to change to the 5010 from the 4010 in order to accommodate the ICD-10-CM and ICD-10-PCS code sets. I think no-one would disagree that that’s likely going to be needed to move forward within ICD-11 implementation.

Then we have some other issues that aren’t quite crystal clear yet, but that may also raise some issues as it relates to implementation. At various points WHO has mentioned the intention to limit the development of national modifications, that being national modifications like the US ICD-10-CM, but also national modifications used in other countries, Canada, Australia, France, Germany.

There’s about a dozen or more countries that also have their own national modification. And so the question becomes can an international process that may not take into account unique circumstances in a given country really be handled well at an international level. Discussions obviously will be needed for that. And also, then what are the licensing implications.

And ICD-10-CM for use in the US, it is in the public domain, anyone can use it for almost any purpose. WHO did not have a license in place for ICD-9, they did have some licensing arrangements in place with collaborating centers for ICD-10, but I think in order to keep ICD-11 as standardized as possible there will need to be discussions on a pathway forward as to what the licensing implications are for use of ICD-11, and for all of the multiple purposes for which it may be used in a given national environment.

And with that, I know I went through this quickly, but I wanted to try to get through most of the major points. Linda, I will turn the microphone back over to you.

DR. COHEN: I was wondering about the notion of SNOMED versus ICD-11, are there thoughts that SNOMED will replace ICD-CM in clinical settings?

MS. PICKETT: I probably didn’t’ cover it well enough but SNOMED is actually, IHTSTO, is actually working in concert with WHO and ICD-11 development, so that they are complimentary. But again, depending on your purpose, if you’re talking electronic health records you’re talking SNOMED.

Again, for administrative data, and I think that might be the other part of your question, Bruce, for administrative data the ICD is still seen as a very valuable tool that SNOMED could handle it, but how you from an administrative perspective would take that SNOMED information and roll it up into something that could be used for statistical purposes, et cetera. I think the ICD, it’s agreed that it’s a partnership and they’re working together on that.

MS. KLOSS: A key question is how well that coordination is working and how it will serve the purpose of advancing automation as maps become computerized and so forth.

DR. RIPPEN: I guess just building off of their thoughts, because if everyone is working closely together, then perhaps you can leverage technology to convert one into the other, and so the systems that would have to be changed could be minimized So again, where does it happen and how do you mitigate? So it might be something to consider.

MS. KLOSS: Obviously we heard from National Library of Medicine, and it was our understanding that NLM prepares the maps from SNOMED to ICD, or the other way around. SNOMED International produces is from SNOMED to ICD-10, and NLM does the 10 to 10-CM.

DR. HUMPHREYS: Yes. And just in case you think we do it in two separate rooms, we don’t. There’s been ready collaboration and coordination across the activities, and our colleague, in fact I’m sitting in front of his name, has been involved in all of that.

I don’t know if Don Swede is still on the phone listening, he may not have been able to stay, and we can provide more information about the state of play between the WHO and SNOMED, they have been collaborating from the beginning, additional content has been added to SNOMED so that there is a better method of connecting certain things to the classification for 11.

And Don alluded to the fact that there was kind of a study to look at where were we with ICD-11, in 2015 I believe, and then some changes as a result of that, and as someone who sat on the SNOMED international general assembly for a while, I can tell you that the level of collaboration from the WHO to SNOMED International was not always there, and there was some disorganization I would tell you on the WHO side, but that was also what led to kind of a reboot of the iCD-11 process.

So I think we’re all hoping it will move forward on a better time frame, and it seems to be doing that, except once again some of the folks at WHO were instrumental in trying to put this on a better footing, have since left the WHO. I don’t have any basis for thinking that the new folks coming in won’t do a good job too, but we don’t have a lot of experience on that yet.

MR. LANDEN: Hi Donna, your presentation didn’t reference NICD-11-CM, and I know you talked about the 11 will include both mortality and morbidity, but you also mentioned national and US possible modifications. Could you just help me get that a little bit clearer, will there be a CM, and if there is any sort of modification, whether it’s a CM or just a national version, what will that do to the timeline for adoption that you put up?

MS. PICKETT: The WHO intent was to really limit the number of national modifications. And so in developing ICD-11 they actually did a scoping of the landscape of all countries that have national modifications, in attempt to bring in kind of like the best of the best of what was in a national modification into ICD-11. WHO’s hope is that by doing that landscaping work and actually looking at what a country had done, how it worked, if it worked, whether it could be tweaked and subsequently brought into ICD-11, by doing that there may not be a need for a national modification of 11.

However, there are countries, and I think the US would count itself among them, that would say but again the process of getting stakeholder clinical input from within your country where you do have consensus may be less challenging than trying to bring in a concept and get international consensus.

And there have been many instances during the updating cycle of iCD-10 by WHO where it has been shown that it will be a challenge to see where that goes. But on the other hand, you have clinicians in some countries that will say but in our country we can work this out now, why do we have to wait five or six years to work out the clinical consensus?

And I think each country will likely need to take a hard look at what they do in their country and the processes they set up, and also what regulatory requirements they may have, in order to help them determine whether they need to have a national modification or not. I would say most countries don’t necessarily have our rigorous regulatory process, but some do.

And again, for the US where we have the ability to update twice in a given year, whereas most countries don’t update that frequently, again it may be that the US may have a different set of questions that would be raised as part of national committee hearings for instance, because there is that balance between, and this came up during discussions related to other standards, not just the ICD, is how often is too often to update, but how too infrequent. And where’s the tipping point.

And each country may decide that there’s a different tipping point for them specifically, and what that tipping point might be at an international level, at least for mortality it looks like they won’t update any more frequently than every five years, but there are others that might have an issue with that as well.

MS. KLOSS: I think that if you’re good we will move on to the international classification of primary care, and then hopefully have time for some additional questions. Thank you very much Donna, and Pat and Rhonda and I hope you’ll stay on so we can continue the discussion. And we may have some public comment. So our own Bob Phillips.

Agenda Item: International Classification of Primary Care

DR. PHILLIPS: I just want to do a little scoping exercise first. If you have actually heard of the international classification of primary care, can you raise your hand? That’s very helpful, thank you. So, the international classification of primary care is part of the international family of classifications. I’ll start with a description of what it looks like and then get into how it’s generated and maintained.

So it is biaxial, it’s not multi-axial like some that we’ve heard about before. it has 17 chapters that are organized by body systems, that’s one axis, and then the other axis is a whole system of components within each chapter that start with symptoms and complaints, then diagnostic screening and preventive services, medication treatment or other procedures, test results, administrative referrals, and specific diagnoses.

So those are the two axes, chapters and components. One stark difference for ICPC is that it’s organized into episodes of care. So at every visit there’s also a question to the provider, is this a new episode, is this an existing ongoing episode, or is this a recurrence, which is an important feature that I’ll come back to.

It’s produced by WONCA, which is the World Organization of Family Physicians. Don’t ask me to explain why WONCA translates to that. But they have an international classification committee. The first ICPC was published in 1987 by Oxford Press, the ICPC Two was in 1998, and that second revision was accepted by the World Health Organization family of international classifications, it’s also part of UMLS here in the United States. It is an accepted classification in the United States, but it really doesn’t have a foothold in terms of use. The third revision is currently in development.

So another important feature is that it does have a place for the patient voice in terms of reasons for encounter. And this has actually migrated into ICD in some cases for primary care. It also has symptoms as a diagnosis in other cases where it’s appropriate, because often we don’t know what the diagnosis is, and so often we need to capture it as a symptom. It does accommodate social problems, as I said it is episode based and can track problems over time. It’s a lumping, not a splitting classification system. So it has about 1300 codes as opposed to what is ICD-11 up to now? I know 10 went to 25,000, it’s a lot.

But the lumping is important because I’ve used it, I know it can be somewhat frustrating to not be able to say what lobe of the lung has pneumonia. It allows you to create buckets that you can go back and look at epidemiologically to try to understand how symptoms become disease. And it’s not a terminology, it really is a classification system, but it is mapped to many of the existing terminologies.

So the revised ICPC-2 is mapped to ICD-10, it was also mapped to ICD-9-CM. It’s mapped to SNOMED-CT, and in fact there is a focus within what is now SNOMED International, the IHTSDO General Practice Working Group that helped create that reference set. And then there are windows for ICPC into several other coding and classification terminology schemes.

So there has been a strong effort to Helga’s point to try to make sure that this maps, so that if you’re using ICPC in your setting you can still map to other classifications or terminologies and produce data that you need to for a variety of other purposes, but maintain that data system for your own purposes.

And so one of the examples I want to talk about is Tranhis, the transition project that came out of the Netherlands. So ICPC is actually used now, it’s in 13 languages, it’s used in multiple countries around the world, but the Dutch have probably used it in the most advanced format. And it’s a good example of why the episode of care, the reason for encounter, and why the smaller buckets really matter. Because you can actually do epidemiology and look at the prevalence of shortness of breath for an age span, in this case 25 to 44 years old, and look at the probability of the final diagnosis for age.

So you can see that acute bronchitis is the most likely diagnosis, but asthma is right there in the middle, and pneumonia is quite rare for this age group. But if you move to an older age group of 65 to 74, while acute bronchitis remains up there, asthma drops to the bottom and pneumonia rises almost twofold, and heart failure becomes a much more common cause. And the reason this is important, not just for epidemiology and research, is that you can actually drive a decision support tool using this.

And a decade ago the Dutch were able to demonstrate that if someone comes in, based on their age, gender, and symptomatology they had a decision support tool embedded in their EHR that would actually tell them here are the most likely diagnoses and here are the diagnoses that you should be most concerned about, and in fact here are the tests that you should run to rule out the most concerning ones and help rule in the most likely.

And so you can also get comorbidities. In this case for men 45 to 64 or 65 to 74 for diabetes. So you can look at the common comorbidities that happen with diabetes and start to understand how those change over time. We actually used that we published a paper almost a decade ago looking at presentation of breast symptoms in women and the likelihood of those predicting breast cancer, and demonstrating there was quite a difference depending on age and which of the symptoms you should be concerned about and which ones not so much. And yet those often present with the same level of anxiety in our clinics, so it’s helpful to be able to do that work.

Larry Green who is a former chair of this committee, and Mike Kleinman who was a key link to the IHTSTO from the United States actually produced this document, perspective in primary care, the foundational and urgent importance of a shared primary care data model, actually followed a decade on an event that we had that AHRQ and WHO supported that I actually came and presented to NCVHS in 2008 about how ICPC actually offers the basis of a primary care data model, but it’s not the only way in, and why ICD-10 and now 11, why there is a need for some modification, maybe you ask maybe Primary Care Worldwide to try and create the same opportunity to use everyday frontline clinical presentation of patients to better understand what you should be concerned about and how that can drive decision support tools in primary care. So I kept it brief, and leave it open for questions.

DR. RIPPEN: So I know some of the hairy questions and challenges with EHRs and data standards have been around how do you capture symptoms, chief complains, and the problem list, because everyone does diagnoses and if you’re rolling out it doesn’t work. So some of the examples that you gave you could do with any core ICD code or something like that. What’s missing and where’s the overlap between this, because you do have certain patient reported things and the current standards, other vocabs.

DR. PHILLIPS: I think one of the key differences is the episode grouping, none of the others have an episode grouping that’s driven off of the clinical presentation and the provider. And it turns out over 20 years the Dutch, because they’ve done episode grouping, can do their own Framingham risk scoring for patients in their clinical population. But without the episode grouping you really can’t organize it.

DR. RIPPEN: When you say episode grouping, because you know in the EHR you do have dates of when somebody was seen and when it was captured. Am I missing something about episode grouping?

DR. PHILLIPS: We’ve tried to use dates within EHRs to do that. What gets difficult is to know is this a new episode with a different presentation, is this part of an episode, is this a depression that actually started 30 years ago and has been constant, or is it episodic? It is difficult.

DR. RIPPEN: Would you recommend then adding to current nomenclature classifications or somehow requiring multiple I guess?

DR. PHILLIPS: We have actually written about it both ways. You could bring some of the elements of ICPC into other classification schemes, or before ICD10 when the pressure was really on, and I thought that was nice that that slide demonstrated how long it took ICD-10 to come into being here, we actually saw that as an opportunity to bring a more primary care focused classification scheme that was actually easier to use to a US context, bring it into ICEHRs and use it as the way to bridge to ICD-10, because the mapping process actually made that pretty easy.

We missed that opportunity, but with ICD-11 there may be another. And again, SNOMED being a terminology and not a classification system, it’s always operating in the background. So bringing in ICPC doesn’t obviate SNOMED, it just connects to it.

MS. KLOSS: If somebody, if a practice were using it now they’d be capturing that data in addition to the ICD-10-CM, and so they’d have to be doing it because they were committed to gathering this kind of data.

DR. PHILLIPS: Committed, yes. If I choose pneumonia in ICPC, which has a relatively small number of opportunities, it can then say now for ICD-10 do you mean, so it almost becomes a search function like I do now when I type in pneumonia, and then it gives me the iCD-10 options, it would be the same thing. I’m coding it here, and now it leads to here are my ICD-10 menu of options.

MS. KLOSS: I wanted to go back to the mundane question of dissemination. I think I heard from Donna and from Pat that the ICD products, the systems are available on the CMS website, on the NCHS website. They’re also in UMLS. How is dissemination accomplished when a new version comes out? How do you think of dissemination in the ICD sense? Does that make sense?

Do you just put it up there and then really the nonprofit or the commercial world takes the systems and packages it in a variety of ways? So why have it on the NCHS website and on the CMS website, why not have it all in the UMLS, and that be the single source along with RxNorm and other? Has that ever been discussed?

DR. HUMPHREYS: Yes, but I don’t think that would work well because in order to integrate anything into the UMLS you have to establish, determine whether there’s synonymy between it and everything else that’s already in the UMLS. So that can’t be done instantaneously, and when people are publishing new editions of the ICD or the PCS or whatever, they’re making them available in advance because at some date certain everybody has to use them for some required purpose under regulation.

One of the things that I think is always important, and we sort of established it for the quality measure value sets, that it is at NLM in the value set authority center, is you have to know who is the authoritative distributor. That is, who is ground truth for this edition of this thing.

And what has been handled unevenly in the past is you would really like whoever is the ground truth distributor to have a sophisticated versioning system and so forth so that you can always go to that ground truth and say okay, well this is version number 52, but what exactly was version number 51? And I have to say that I don’t believe that WHO has been in the forefront of handling that in a good way.

And I can’t resist adding to all the points that I agreed with that Donna was making about the potential for real nationally different needs and how would these be accomplished, but I also have to say that WHO does not have a great track record of handling maintenance and updates in a wonderful way. So if we were then to try to concentrate in that spot the addition of content which has been considered important for a whole variety of purposes, administrative, statistical, regulatory, in countries around the world, it’s not an approach that it seems to match what we’ve seen happen in the past.

DR. STEAD: This has been a remarkable introduction to the committee of a very complex set of work. The picture that emerges to me is many efforts which are in fact making great progress in each incorporating similar kind of techniques and approaches, each dealing with an increasing number of purposes, at a time when our appetite for data that describe health, healthcare, the many aspects of the measurement framework that affect health that we don’t think of as health and healthcare. So we’ve got an exploding scope, and I see great progress, but maybe the progress is going like this and the scope of the space we could be considering for terminologies and vocabularies is going like this.

And so I think one of the tensions we’re going to have to work out as we work through our environmental scan is do we focus on relatively concrete things that might be useful in helping nudge people in the right direction, because they’re already moving in a better direction, or do we need to step back and actually envision one or more ways that could in fact work at the scale that we’re dealing with, and then come back from those and come up with some concrete things that would be useful next steps.

We’re going to have to decide if we’re going to have to reach out into the future and step back. And my gut is, my tendency is to try to do that. So we’ll have to decide whether that’s a good tendency in this situation or not. Because I can imagine as I listen to the kind of problems, Betsy you mentioned clearly version control, that means that you can always find whatever the record was coded in. That’s clearly got to be part of the future.

And what the meaning was at a point in time, so that you can unpack it. the minute you can do that you get a great deal of freedom in your ability to change structure and an ability to get things out there that people can be working back with the version code, just like Donna mentioned in the frozen versions.

So there are ways to deal with this. The business of what can be done internationally and what needs to be done locally, there are ways in today’s knowledge based world to maintain if you will a local extension that can then be observed, and you can then when you want to update things analyze across everybody’s local extensions and decide what’s now ready for primetime across the world, what part needs to remain local. So there are ways to create unifying frameworks if we want to go there. So I think that’s going to be some of the thinking we’re going to have to do as we move forward. I hope that isn’t too far out there.

DR. COHEN: If Donna and Pat are still on the phone, we’re going to be doing some strategic planning tomorrow, and I wondered if you had one ask for how the national committee could help support your ideas for ICD-11 or ICD-PCS, what would those asks be?

MS. PICKETT: I think I’d like to consider that a little bit before providing a response. I think there is a lot with ICD-11 that we just don’t know. It is certainly, its potential for implementation goes well beyond anything we’ve done with 9-CM and 10-CM in this country, and I think I’d like to be able to kind of think about it and come back to the committee, in writing, with maybe some high-level points.

MS. KLOSS: As this whole area of study progresses we’ll certainly be talking further. Pat, did you have any?

DR. BROOKS: No, I can’t really think of anything, just that if the National Committee notices anything that helps our process we’ve outlined how we meet and how we decide things, we’d welcome hearing from them.

DR. PHILLIPS: I have a question for the group. Most of what we saw today has been about supporting transactions, and while I think it’s really important to be able to send a prescription from my EHR to CVS and they receive it reliably, it’s really important for me to be able to receive labs from an outside laboratory and be able to read them and the EHR in a standardized way.

But getting the oxidized zirconium hip replacements is really about a payment scheme importance in my mind, and I wonder if we could lean on the last two letters of our name being health statistics to think about how can we use these terminologies and classification systems to really help us do the health statistics that we need to do to make them integral to learning healthcare system, rather than spending another decade trying to drive iCD-11 into EHRs unless we really understand that it’s going to improve our ability to understand health and healthcare.

DR. HUMPHREYS: I just want to say that I am a great believer in the use of standards, but I am not a great believer of standardizing every single thing that’s in an electronic health record. and I think people can say the scope is this, it’s that, it’s the other thing, but I do really think you have to be able to have a good reason why something, another piece of information or this or that requires standardization, and obviously one of the reasons that you want to standardize things is statistical, it’s having a more efficient approach to driving decision support and learning within a thing, and it is absolutely so that when the message goes from Gen(?) to X they can actually understand it over there, that’s critical. But I think that we don’t necessarily have to think that every single thing has to be standardized.

DR. BRENNAN: I really appreciate the framing that Bill just put on the conversation. I came here with a request for you and a request for you to bring back to us at NLM. My request for you is very much aligned with this last comment that health is so much more and we know it in so many different ways than the way we have construed electronic health records. And to be able to ensure that a learning health system leads to a healthy society we have to find ways to characterize things that are not currently in the electronic health record and may never be there.

In addition, the drive towards genomic discovery, better understanding of tissues, better understanding of proteins, is really leaving us with a whole other vocabulary challenge that has to be integrated, and I am concerned about the parallelisms that are going on across a very wide street characterizing biological phenomenon in ways that I don’t think we’ll ever map to the mapping that we’ve already learned how to do, may not be useful.

what I’d like to ask of you is that you think about the dimensions of health that must be represented in understanding the health of a society, in part which requires understanding the health of the operational units that should help deliver that, our care delivery systems, but go far beyond that. I would also like to ask you to consider what research agenda the National Library of Medicine should undertake to be able to accelerate or facilitate much of the work that sounds very human intensive in terms of standards management at this point in time.

We have the capability of investing in understanding curation and understanding terminology and understanding how natural language processing or machine learning might assist us in these ways. We also have the capability of looking at analytical models that might be able to help pinpoint what Betsy had recommended earlier, what terms, what ideas are important to create standards around, and how do we provide an enduring way to do them.

I’m asking you for two things, please consider health more broadly, we’d like to get into that game also at NLM, and we’ve begun to do that in the way that we are indexing our new literature and our new data sciences. And second, what research agenda could we carry out for you, or would you even like us to dream up to carry out for you, to ensure that the standards investments really achieve what we need for the health of the society. Thank you.

DR. COHEN: I’d like to take a quick response, just 30 seconds. And we’ve been on a journey for the last eight or nine years, looking at a broader notion of population health, and culminated in the measurement framework for health that sort of integrates a lot of the stuff you were talking about today, the traditional focus on clinical measures, into a much broader concept of what makes communities and populations healthy.

As I listened to the last several hours I thought how wonderful it would be if the detail and attention and the development in all of the domains and subdomains that are less traditionally the focus of activities around standardization measurement and common nomenclature could be integrated with the incredible work that you’re doing at NLM and these activities, we’ll have really achieved a quantum leap in our understanding of what makes people and communities healthy.

DR. BRENNAN: I have had the opportunity to review the framework. I’m excited about the framework. I ask that we think about the information if you will infrastructure for health as what we need to be placing our terminologies and languages around, and not simply an electronic record of health. So the information infrastructure may be much more ephemeral, it may be much less precise, and so the question that was raised earlier, what are we attempting to accomplish, which may change over time, describing populations through statistical mechanisms, or understanding a person, or ensuring adequate payment, are all important values, but we need to be thinking of them as driven not by a single electronic device, but by a range of electronic resources.

DR. MAYS: If we took and thought about just low hanging fruit, and that would be if NLL made everyone disaggregate race, ethnicity, and gender, we would have such better quality data. So as it comes in it’s like it’s required that the kinds of things that are deposited have better precision to them.

DR. BRENNAN: Well I’m happy to tell you that there is a taskforce that’s completing its report right now on basically inclusion of citizens across the lifespan in clinical trials research and clinically based research that is calling for a greater explication of race, ethnicity, and actually gender, didn’t quite make it as far as I would have liked. But to make it much more clear, in the ClincalTrials.Gov repository where we’re able to collect information, and we’re now in some cases required to see results reported, we are still restricted because the trials themselves are not always powered at the level that allow for disaggregation of the results based on race, gender, and ethnicity. So we have to work with if you will the sociology of science to help people understand that reporting by those characteristics is not the same as interpreting about those characteristics.

DR. STEAD: Thank you. I really cannot say how grateful we are for the expertise that has been brought into the room and the energy level toward the end of the day, so thank you very much.

MS. KLOSS: And on the phone.

DR. STEAD: There will be a little bit of a public comment right after we do our next block, but we’re now going to move onto vitals.

Agenda Item: Updates Next Generation Vital Statistics Hearing

DR. COHEN: This last conversation I think is a great segue. And it’s really late, and we heard so much phenomenal stuff today, I will be brief, which is a most difficult task for me, but I’ll try. So Washington DC is beautiful in September, and we’re going to be here for a week, so I suggest people come early the weekend before, bring your families, check out the museums, wander into the country. Monday and Tuesday are the days for our hearings, followed by the meeting.

Essentially our problem statement is, and hopefully we’ll have more of a chance tomorrow to talk about this in detail as we do some strategic planning. But the problem statement really is, despite how essential a vital statistics system is, it faces incredibly serious structural and resource challenges. And I don’t think folks realize that there is no central data collection system for vital statistics in the United States. It’s a really federated network of collection of vitals from the 57 jurisdictions that are compiled by NCHS, and that increases the fragility of the system.

We use vital statistics every day of our lives. We as individuals and as health professionals, we get birth certificates for our kids, we get death certificates for insurance, or when our loved ones pass away. So vital statistics is really the basis for not only understanding the health of the US population, but also are crucial in our personal lives as well as our professional lives.

And actually, vital statistics, Rashida was talking earlier about the importance of federalism, vital statistics is the embodiment of a seminal federalized federated system relying on the cooperation and interaction of the states and the federal government to produce a robust national data collection system. And federalism, vital statistics highlights the benefits of federalism, allowing innovation at the jurisdictional level, and highlights the challenges of pulling it all together to produce national data.

So what are we going to do. This hearing, the vision and guiding question is how do we transform this vulnerable federated data collection network into a robust timely integrated sustainable multipurpose information system that meets everybody’s needs, a very simple question. And essentially, we’ll do this all in two days.

The first day really we start out with a level set, and we’ll focus on getting everybody up to a basic understanding of some of the intricacies of the vital statistics world as we know it, and then we’ll hear from the data collectors, first local data producers, and then from feds, primarily NCHS, and other power data users, and around what the current status of data collection is and what the current status for a variety of users, I certainly described the enormity and breadth of the use of vital statistics, state users, commercial users, research users. So, day one is where are we now, and I’m sure challenges will emerge in these conversations.

Day two is reviewing these challenges and thinking about opportunities and potential solutions. And again hearing from folks from a variety of perspectives, government at all levels, researchers, business users, those folks who are responsible for developing the IT systems that generate vital statistics, just everybody we can to sort of increate our understanding of the complexity of the issues, hopefully moving towards future directions, and we’ve compiled an incredibly powerful committee for the afternoon panel, for the afternoon of the second day, John Lumpkin, Chelsea Richards, and Calvin Yew to help begin charting the course towards future directions, and then ending up with the committee thinking about discussing about where we go.

So where are we now? The agenda has been drafted, if you haven’t seen it just let us know, it’s constantly changing. The one pager, which I think is a really great summary of what I’m describing, is in your agenda books. We’re reaching out to identify speakers, we’ve identified some already, and we’re still looking for other speakers.

If you know of any folks who were involved in the world of vital statistics from any perspective who you think would add to our conversation, please let us know, and we’re recruiting folks to come and let their voices be heard. I will stop here and turn it over to my colleague in crime. I have to thank Helga and Vicky who were on the planning committee, and the cochair and visionary is Dave. Do you want to add anything?

DR. ROSS: I do want to say one thing. I carry with me my copy of the Constitution. And I do that because in the practice of public health in this country, in the American experiment, if you look at Article I Section VII, it starts to enumerate what the Federal Government is responsible for, like to establish a uniform rule of naturalization, or regulate commerce, or borrow money. It doesn’t say anything about public health. It therefore defers to the states.

I think what Ruth said here is really important, that the federalism construct of our Constitution in effect is forcing us to ask the question if vitals data could be more timely and/or more accurate, there are a host of federal purposes to which it accrues. So what’s that value proposition? I think this hearing will help ascertain some of that, and will help us understand if there is a case or a strong case for the Fed sort of paying for their part of that value.

Because right now we in effect impose a tax on the states to say give us your stuff, there’s a small amount of money, but honestly if you look at the financial flows that underpin this, Bruce called it vulnerable, it is, it’s a patchwork quilt, and can we actually make more power out of the information, but I think we have to just look at that objectively, and I think this hearing is all about helping make that happen, wouldn’t you agree?

So I think it’s long overdue and will help us determine if there is a way to the words on the slide integrated, you had a list of descriptors, robust, timely, integrated, sustainable, multi-purpose. We will ascertain through this hearing I think the degree to which that information flow to the Federal Government creates a value that needs to be supported. And right now it’s just not really understood, it’s just assumed this happens, I think.

DR. COHEN: Any comments, feedback?

MS. HINES: I would just like to say that as a newbie to this space, and being in the planning process, that I learned from John Lumpkin that when a baby is born there are seven systems that are hit. So talking about interoperability, if there were an opportunity here to get some of these systems to talk to each other, we would actually save a lot of money, time, and increase the quality of data.

So just in the few months I’ve been involved I learned a tremendous amount, encourage committee members who are not up on the system as I am not that there is a huge I think opportunity here, if you listen to someone for ten minutes you hear about all of this. So I just wanted to share I had no idea about that, and it was a good little, to me reflection of the opportunity.

DR. STEAD: Okay, we will bring this block to a close and we’ll do a brief period of public comment, will you handle that?

Agenda Item: Public Comment

MS. HINES: Is there anyone in the room that has public comment before the meeting adjourns for the day? On the phone? Anyone on the phone who has public comment, or on the WebEx? Anyone on the phone? Hearing none.

DR. STEAD: Move adjournment. Thank you all.

(Whereupon the meeting was adjourned at 5:15)