[This Transcript Is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Committee on Vital and Health Statistics
Full Committee Meeting
November 18, 2015
National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782
- Call to Order and Review Agenda – Dr. Walter Suarez, Chair
- Introductions and Welcome New Committee Members
- Updates from the Department
- ASPE, Jim Scanlon
- ONC-Interoperability Roadmap, Steve Posnack, Shana Olshan
- ACA Review Committee Briefing from June 16-17 Hearing – Ob Soonthornsima and Alix Goss (Review Committee, Co-Chairs)
- ICD-10-CM Implementation Discussion – Donna Pickett
- Subcommittee on Population Health with Comments from Dr. Karen DeSalvo – Bruce Cohen and William Stead (Co-Chairs)
- Subcommittee on Standards – Ob Soonthornsima and Alix Goss
- Working Group on Data Access and Use – Vickie Mays
P R O C E E D I N G S
DR. SUAREZ: If you can take your seats, we are going to go ahead and start. I think we are connected on the phone as well and through the web. I want to welcome you all to our National Committee on Vital and Health Statistics meeting of November, our last quarterly meeting for the year, a very exciting, a very important meeting for the National Committee.
My name is Walter Suarez. I am the executive director of Health IT Strategy and Policy for Kaiser Permanente. I have the honor of chairing the National Committee. In this particular, we are especially excited and certainly honored and privileged for welcoming all our new members, six new members that have joined officially the National Committee. Most of them I think are present. We do have perhaps one or two members on the phone. Very exciting time. I think this is one of the first times in probably the last several years probably going back to more than ten years since we had a full complement of all 18 appointed members of the National Committee together and fully in place. It is very exciting. It is very exciting because of all the topics and all the areas that we are now working as a National Committee and certainly all the things that are taking place in our health care system in the US. Very important developments. We are certainly in the middle of the third year of the ACA program. Very important developments around that too.
We are certainly going through a lot of adjustments and changes really transformative reforms in our health care system. We have lots of changes in the care delivery side, as you all know, and significant changes in the payment side as well. Along those changes, we are seeing a lot of developments also around public health certainly in the lead advisor to the secretary of health data policy and information technology and standards. I think we have an important and significant role around that, and certainly a lot of developments around privacy and security and data access and use, all of those areas that the National Committee has for the last several years and certainly will continue to provide advice to the secretary. Very exciting time. A very somber time as well.
I do want to take a minute to pause and really have a few words about the events that are happening around the world and certainly that are touching us all with the significance and challenging conditions and situations that we are living in this world. I want to take a minute to pause and reflect on the events that are happening in France and other parts of the world. Let’s just take a minute to reflect on that as well.
(Moment of Reflection)
DR. SUAREZ: Thank you. Many of us probably have friends or relatives or both that were close to all these events. Certainly, it is something that has touched us quite significantly.
We are going to go and start. We have a very busy full agenda for the next couple of days. You all should have received a packet of materials. We are going to go through very briefly some of the main points on our agenda. We always start with introductions and we are going to have some time to ask our new members to take a few minutes to introduce themselves a little more fully. I am going to ask the new members if you have already declared the subcommittee or subcommittees’ activities that you will be joining. Remember, you can choose more than one.
And then also of course we have the full bios on the packet of materials for all the members including our new members. But we would welcome very much a few words of your background and your interest in joining the National Committee.
And then we will have a set of updates from the department that we always include. Normally, we include all the updates in one single block in the agenda. This time we are actually going to have some updates at the beginning of the meeting and then we will have other updates later on today and tomorrow as well.
One of the big topics this time around is going to be on one of the new functions of the National Committee that the new members learn about and that we all have been working hard on is called the Affordable Care Act Review Committee. We will spend some time in the morning and having a briefing on the activities of the Review Committee.
And then in the afternoon we are going to focus on two of the core areas that we work on: Population Health and Standards. We will also actually have a chance to hear and be brief on the work of the work group on data access and use, actually three activities that we will be hearing in the afternoon.
And then the second day, tomorrow, we will start with a review from the National Center for Health Statistics. Charlie Rothwell is the director of the National Center, who will be with us. And then we will go into the Privacy, Confidentiality and Security briefing, during which we will hear also updates from our federal partners on activities around Privacy and Security.
And then we will have a chance to close our meeting with some discussion. It is great that we will have the full group together to talk about goals and objectives of the National Committee, some of the update, if you will, to our charge and our mission. All those documents we will talk about tomorrow and you all should have received in the packet those documents as well. That is our day and a half meeting.
And then tomorrow afternoon is our meeting of the Data Access and Use Workgroup. You all are welcome to stay as well tomorrow afternoon. Some of you are planning to do so. We will have a chance to focus our afternoon tomorrow on the Workgroup on Data Access and Use.
I think that is just some brief intros. I should have mentioned that we have a very special guest later today. Dr. Karen DeSalvo, the Acting Assistant Secretary for Health in the Department of Health and Human Services and the US National Coordinator for Health Information Technology, will be with us at 2:30 during the Population Health discussion. We will have an opportunity to talk to Dr. DeSalvo and have some very engaging interaction with her.
We will also hear from Donna Pickett during this afternoon about ICD-10. We will hear a little more about ICD-10 also this morning from CMS, but we will have a chance to talk about ICD-10 in two different contexts. One is the administrative world where ICD-10 has been implemented. We will hear later this morning. And then this afternoon, we will focus more on the public health and population health areas for ICD-10.
We are going to go ahead and go around and introduce ourselves. Please declare if you have any conflicts with respect to what we are going to be addressing this time during this meeting. Again, my name is Walter Suarez. I am with Kaiser Permanente and chair of the National Committee and I don’t have any conflicts.
MS. KLOSS: Linda Kloss, Health Information Management Consultant, member of the Full Committee, co-chair of the Privacy, Confidentiality and Security Subcommittee, member of the Standards Subcommittee and no conflicts. And Review Committee.
MS. GOSS: Good morning. I am Alix Goss. I am with the Pennsylvania eHealth Partnership Authority, the Commonwealth of Pennsylvania, member of Population Health at times, Framework Group as well, but I am the co-chair along with Ob Soonthornsima, who is unable to be with us physically today, but will be on the phone of the Standards Subcommittee and the Review Committee. I have no conflicts.
MR. LANDEN: Rich Landen with QuadraMed. I am a brand new appointee member of the committee. It is great to be here. I have been drafted into the Standards Subcommittee and the Review Committee. I am being lobbied by several of the other subcommittees. Still on the fence there. My employer, QuadraMed, is in the EHR revenue cycle, identification and patient self-service, information, technology, and product space. That is my current expertise. I am director of regulatory affairs there. Prior history includes a health insurance trade associations, both Blue Cross Blue Shield Association and AHIP, long-term participant at X12, some HL7 familiarity, long-term member of NUBC and NUCC. Ancient history, Colorado CHMIS for those of you who remember those days. My education and training. I have Master’s degrees in public health and business administration and eight years’ experience in hospital operations.
My current role has me delving heavily into meaningful use. It also has me as an active participant in the HIMSS EHR Association where I co-chair the patient safety work groups. That is another one of my interest. I participate in HIMSS and I am a volunteer with local fire departments and a couple of places where I lived. Currently, a resident of Southwest Florida. No conflicts.
DR. GRADY: I am Michael Grady. I am a senior fellow at NORC at the University of Chicago. I am also a self-employed consultant. Prior to that, I was the assistant secretary for Planning and Evaluation back in the Bush years. Prior to that, I was on the Senate Finance Committee staff, Joint Economic Committee staff, MedPAC, the Medicare Payment Advisory Commission, and the Congressional Research Service. I have a PhD in political science from the University of Rochester. I have also served in a parallel capacity for six years on the Board of Scientific Counselors for NCHS.
I did not think I had any conflicts, but I see we have a document from Pew here. I did actually talk to Dr. Eisen. I was asked by a friend to have a telephone conversation on this particular issue. I will probably be listening.
MR. COUSSOULE: My name is Nick Coussoule. I am also a new member. I am a senior vice president and chief information officer of Blue Cross Blue Shield of Tennessee. I have been in that role for about eight years. From a relevance perspective, I also sit on the Tennessee Health Information Committee, which is the group in Tennessee responsible for administrating the government work – all payers claims database. I led our ICD-10 efforts across the organization here as well. I am a little more familiar with that. Blue Cross Tennessee has been an alpha plan in the Affordable Care Act since the get go. In fact, we worked to help establish that process. I have been quite in the middle of the Affordable Care Act since it got started and implemented.
I am happy to be here from a committee perspective. I have been talking to folks about the Standards Committee as well as the Privacy, Confidentiality and Security Committee. That is probably where the bulk of my interest lies. I don’t believe I have any conflicts.
MS. JACKSON: Debbie Jackson. Welcome. Greetings from Rebecca Hines. I am taking notes for her to get back to her. We have communicated with the new members on orientation. Looking forward to working with you. Representing the NCVHS team.
DR. RIPPEN: Good morning everyone. My name is Helga Rippen. I am a new member. I come from Columbia, South Carolina. I was in Washington for quite some time. I am the president and CEO of Health Sciences South Carolina, a nonprofit, which actually brings together seven health care systems in South Carolina and three universities. I am also a faculty at Clemson and also the University of South Carolina.
I have done a lot of different things from an HHS perspective at ASPE as a fellow and then also a Rand, supporting the White House. I also was involved in the ICD-10 about ten years ago or more. I have a PHD in engineering. I am also a physician. My medical specialty is preventative medicine and population health, the American College of Preventative Medicine. Again, my passion is the appropriate use of technology to really have it make a different in health. I am very excited to be part of this group and I look forward to working on many of the subcommittees and working groups and look forward to working with all of you.
DR. PHILLIPS: Good morning. I am Bob Phillips. I am a family physician and vice president for the American Board of Family Medicine for Research and Policy. Prior to that, I worked at the Robert Graham Center for 12 years and was director for eight and did a lot of work for AHRQ on data standards for primary care, looking at international classification of primary care.
I am a clinical professor at Virginia Commonwealth University, a research professor at Georgetown. I still patients a day a week, working with an ICD-10 compliant EHR, my third in ten years, which is a very painful process to go through again.
I served on the Council on Graduate Medical Education as a special governmental employee, worked on a negotiated rule making committee for the secretary. I have some experience in these kinds of venues.
At the board, we just launched a national registry for primary care, which includes some population health assessment tools. I am very interested in the Population Health Subcommittee. I am interested in learning about the other subcommittees and which might be a good fit. Thank you.
MS. LOVE: Denise Love. I am no longer I guess, a newby on the committee anymore. That was my claim to fame. I am from the National Association of Health Data Organizations. I am co-chair of the All-Payer Claims Database Council and working in many states in the APCD world. I am a member of the Standards Subcommittee and I think the Review Committee. I am trying. No conflicts.
DR. COHEN: I am Bruce Cohen from Massachusetts Department of Public Health. I am the co-chair of the Population Health Committee. I think all the new members should become affiliated with us. A shameless pitch. We have a big tent. Everyone is certainly welcome. I see some of you were at our meeting yesterday, which was very exciting. We will talk more about it. If you have any questions about what we do, Bill and I are happy to answer. I am also a member of the Data Work Group and I have no conflicts.
DR. STEAD: Bill Stead from Vanderbilt University, co-chair with Bruce of the Pop Health Subcommittee, member of the Review Committee and chair of the Framework Work Group and no conflicts.
DR. MAYS: Good morning. I am Vickie Mays. I am at the University of California Los Angeles. I am also the chair of the Work Group on Data Access and Use. I hope that you will want to join us because our job is to get the data out, get it used. I think many of you from what I could read about your backgrounds are in a great position to assist us. In addition to chairing the Work Group, I am also in Privacy and Pop and the Review Committee.
MR. SCANLON: Good morning everyone. I am the Jim Scanlon. I am the Deputy Assistant Secretary for Planning and Evaluation at HHS. I am the Executive Staff Director for the Full Committee. I want to welcome all of our old members and new members. I appreciate everyone signing up for the cause.
DR. SUAREZ: Thank you. I think we are going to go to the phone to see who we have as members.
MS. MILAM: Good morning. This is Sallie Milam from West Virginia Health Care Authority, a member of the Full Committee and a member of Privacy, Confidentiality and Security. I have no conflicts.
DR. SUAREZ: Thank you, Sallie. Thank you. Welcome.
MR. SOONTHORNSIMA: Good morning. Ob Soonthornsima from CVS Health, specialty pharmacy division. I am a member of the Full Committee, co-chair of the Subcommittee on Standards, co-chair of the Review Committee, no conflicts. Our tent is also huge and we would love to have all of you.
DR. SUAREZ: Thank you for that. Do we have any other members? Anybody else on the phone? Any other members? Any staff on the phone?
We are going to go back to our audience. If you want to introduce yourselves.
PARTICIPANT: Margaret –- consulting.
MS. HOGAN: Katy Hogan, Department of Veterans Affairs.
MS. PHELPS: Ruthann Phelps, Veterans Affairs.
PARTICIPANT: Frank – Department of Veterans Affairs.
MS. PICKETT: Donna Pickett, NCHS, CDC, and staff to the Standards Subcommittee.
MS. JONES: Katherine Jones, CDC, NCHS and staff to the committee.
MS. TUREK: Kelly Turek, AHIP.
MS. KANAAN: Susan Kanaan, writer for the committee.
DR. DECARLO: Michael DeCarlo with the Blue Cross Blue Shield Association.
MR. ALFANO: Bill Alfano, Blue Cross Blue Shield Association.
MS. DEUTSCH: Terry Deutsch, CMS.
MS. BEBEE: Susie Bebee, ASPE.
MS. SQUIRES: Marietta Squires, staff to the committee.
MS. BOOTHE: Vickie Boothe. I am the acting lead evaluator for the Division of Community Health at CDC and staff to the Population Health Subcommittee.
DR. SUAREZ: Anybody else? That is it. Thank you. Thanks everyone. A couple of important points also. One is, as you all know, we are at the National Center for Health Statistics. We also thank the National Center for Health Statistics for hosting. We usually go back and forth between being hosted by the National Committee for these meetings and also at the Department of Health Headquarters, Health and Human Services Headquarters in Downtown DC at the Humphrey Building. We thank also the National Center for Health Statistics for hosting us today here.
The other thing that you started to see as new members is we do have a number of representatives from federal agencies that participate are involved in our work. We certainly advise the secretary on an array of issues, but we work very closely certainly also with agencies within HHS and sometimes outside of HHS in different areas. You are beginning to meet new members, some of the staff and some of the representatives from different federal agencies that participate and are involved in. We always try to reach to as many agencies as we can as a way of understanding the needs that they have for us to work on specific topics that we can advise the secretary and through certainly the secretary to the specific agencies.
The other theme I wanted to introduce to new members. We have been talking a lot about that over the last couple of years as the National Committee and that is the theme of convergence. You might have heard us say that in earlier discussions. We are certainly working a lot more now as a full committee. I am very excited to see the number of participation of members that have declared themselves members of a particular subcommittee across all the other areas. It is very significant and truly important to have all those perspectives whether we are talking about standards and dealing with very specific areas of the standards that are used in this country for doing administrative transactions and coding conditions and other things or whether we are talking about privacy and security or population health or data access and use. All the perspectives are very significant and important.
Sometimes we tend to be very much down in the weeds, if you will. It is very valuable to have someone from the national committees come in and step in and ask the question. Let’s just step back and look at the larger picture and see if we are really achieving the goals with those detailed discussions that we are having and the directions that things are going.
We are also – I just wanted to mention for all the members of the National Committee that we have had already the introductory conference call with – a meeting with the new members during which we introduced them to all the different elements of the work that the National Committee does and the processes and certainly all the ethics and professional responsibilities that we have as special government employees when acting and operating within the National Committee. We had the opportunity to introduce them also to the various areas of work that we do.
I know it is probably overwhelming to the new members all the information that we have been providing you and as you go along, you will find that in less than three months you will be experts again in all these areas. Again, your input and your expertise and experiences and perspectives are very valuable.
I think we are ready unless there are any other introductory comments from anyone. We are ready to move along in our agenda and begin with the updates from the departments.
MR. SCANLON: Thank you, Walter. Good morning, everyone. Let me give you, from the departmental point of view, some updates on some policy and data policy and planning activities and other initiatives relating to health data at HHS. As Walter said, later today we will have reports from specific components, ONC, CMS, the Office of Civil Rights, and so on. I realize we are going to have to give out a guide to the acronyms, Walter.
On the personnel side, you already know Dr. Karen DeSalvo is also serving as the acting assistant secretary for Health. She has been nominated as the assistant secretary for Health. She was voted out of the Health Committee. Now, we are hoping that the Senate will take action on her nomination as well.
Our chief technology officer is Susannah Fox. Susannah worked at RWJ. She also worked at the Pew Foundation. She worked a lot on the Internet studies. Remember, when Pew would look at how – are the American people using Internet for health and other things. Dr. Mary Wakefield, who was the head of HRSA, is now our acting deputy secretary. And a couple of folks in the statistical committee.
Many of you know Steve Cohen, who was the head of the Agency for Healthcare Research and Quality, the director of the Center for Financing and Access and Cost Trends. He is retired from AHRQ. He has now joined the Research Triangle Institute as a head of their division of statistics and research and surveys.
We have Dr. Pete Delany, who was the head of the statistical program and evaluation program at SAMHSA. Pete is going on a detail for the Office of the National Drug Control Policy. We wish him well there, but presumably he will return back to us soon.
A couple of words about the budget. We always worry about the budget. We are in the first quarter of fiscal year 2016. We have a continuing resolution until December 11. At that point, by then, before then, we hope to have a full year budget for HHS; otherwise, we are confronted with the possibility of having to shut down and so on, which we hope to avoid obviously.
And then we have already begun working on the 2017 budget. You have to stay. As you know, there is always three years of budget work, the current year, the next year, and one after. We have begun working on our 2017 budget, which we will send over to – that will be the president’s budget for proposal in January or so.
On the overall Policy and Planning front, we have updated our HHS strategic plan. It covers 2014 to 2018. It is available on our HHS website. I urge you all to take a look at it in terms of the overall framework in which HHS operates. Most of the activities that agencies and others do cascade from those overall goals and those overall objectives. We have four goals and 21 objectives. We have metrics to see where we are. We have annual and quarterly reviews of where we are on some of those strategic objectives and so on. Again, I think we will provide a link, but it is kind of a good overall framework for how HHS approaches our goals, objectives and where things fit in.
But in addition to the strategic plan, which is very high level, we have a number of other, as you would imagine, specific plans, strategic plans, action plans, and initiatives, dealing with specific areas. Our office, Planning and Evaluation, we really coordinate all of that work. We provide guidance and we have a tracking system. We try to have senior management look at where we are on all these various plans and to have people cross reference plans. For example, we have a plan. I won’t mention all of them. There is a precision medicine plan that I think many of you are aware of with the idea of a cohort, a million persons over the long term to follow in terms of a cohort. We have plans relating to preventing mortality and morbidity from opioid misuse, which we have been doing a lot of work on. We have a plan for delivery system reform as well, which many of you are aware of. Tobacco control, eliminating disparities, quality and safety and so on, global health. And on the human services side, early childhood health and development and human services as well.
As I said, in general, we try to be sure that we have some way of measuring progress on these plans and on these objectives. Again, ASPE, my office, plays a role in trying to coordinate all that.
I would mention. We have two proposed rules out. I think one of them just closed. One of them is of interest to all of you who do your research on human subjects including social science research. There is a proposal to revise the common rule for human participant’s research. It is the first time since the ‘90s, probably since when the common rule was first issued that there are this many changes. We have had updates previously. The proposal is still out for that until later in December. Just very complicated.
Many of you who are involved in IRBs and human subjects’ research, even records-based research and social science research. Theoretically, you are governed by the rule, depending on what it is. I think our major approach there was to make this a risk-based approach. You only ramp up requirements and procedures to proportion to the risk involved. And if there is little risk then don’t – again, let’s try to get rid of the barriers and so on. For example, records-based research and EHR-based research, social science research where the threat is more on the information disclosure side than it is on any interventional side.
And then related to that, we have a rule that arose out of the Affordable Care Act, relating to non-discrimination and health care. That proposed rule would eliminate – would make it illegal to discriminate in health care settings on the basis of numerous demographics, age, sex, race, ethnicity and so on and also transgender identity. They are gathering comments on whether or not it should extend to sexual orientation as well. Those comments are all in now and we will have to look at the comments and sort things out.
Let me turn a little bit to some of the policy areas and program areas and where data fits in. Obviously, health reform and the Affordable Care Act implementation is a major priority. It does not mean that anything else has slowed down. It just means it is another priority. We began earlier this month the third open enrollment period. Here, as you could imagine, each later open enrollment period becomes more difficult to find the remaining people who are uninsured, uninsured and eligible. There are a number of populations that are not eligible to participate in the market places. I think the general estimate was that roughly 10 million people are in that category of uninsured and qualified, eligible for a qualified health plan. I think the working goal is to be able to enroll at least a quarter of those. Just very difficult. But we are actually getting a fair amount. A lot of folks have visited the website and are beginning to enroll.
DR. PHILLIPS: Can I ask a quick question? With the closure of about 16 of the insurance co-ops, is there a specific effort to try and get those folks enrolled in the market place?
MR. SCANLON: Yes. There will be efforts to enroll them in other ways in those states. I think, again, it shows the idea that when you try to create new market mechanisms in health care, it is not always easy. This goes all the way back to health planning days. When you have to create entirely new entities that are not necessarily part of the market. Generally, you want to look at the market to make things work. And when you create something else, it often – it is just not something you can rely upon in every state in every setting. But, again, everyone will – there will be efforts to find a way to identify people and enroll people. There are a lot of efforts. We have done an analysis of where most of those uninsured but eligible populations live. There are some states and some cities where it is much larger than others. I think we are focusing specifically on reaching out to those people, having other groups reach out to them as well and trying to enroll them as well.
We have been very fortunate. This is because of investments we have made to monitor the implementation of health reform and its impact. Again, we are looking at more than just getting covered obviously. What happens as a result of getting covered? Are people getting access to care? Are they having difficulty? We are monitoring those as well.
But our strategy there has been a combination of our national surveys here at NCHS and AHRQ and other places as well as administrative data and then some specific research. We have gotten to the point now where we – and then we relied somewhat as well on some of the commercial surveys, the Gallop and some of the others, which are again response rates are generally fairly low. You don’t know really what you are getting until you have a gold standard kind of a measure like the Health Interview Survey. We have been able to monitor health insurance coverage.
We recently released the second quarter data for this year from the Health Interview Survey. We are catching up with an early release program at NCHS. It looks like we are probably getting some of the health insurance uninsured rates down to the lowest since we began measuring it back in – NHIS began and others. And some states are really at their lowest level as well. But, again, we have to keep it up and then we see what happens. Keep people insured and then look at what is happening as a result. Has access improved? Are people still having difficulty? Are they having to defer medical visits or drugs because of income, because of things like that as well? We are still able to monitor in health status as well. We are using that strategy.
DR. O’GRADY: We are talking about a population of about 10 million. Do you have a feel for whether these people have been eligible the whole – is this people who are newly eligible and so it is sort of an outreach just to have to kind of get them connected or is this people who have been not signing – this is their third year in a row of not signing up?
MR. SCANLON: Well, it is more. Some of it – Mike, as you said. Every year in health insurance, as you all know, there is a certain amount of churn. You never really get it down to zero. There are always people changing jobs, changing plans and so on.
What we can tell I think the HIS asked about – they asked about insurance in the past year and then currently and so on. And the other thing is we are looking at the long-term uninsured, the folks who really for more than a year have not had insurance and try to understand that a little bit better. I don’t have the numbers themselves, but it is a mix, as you would imagine. But many of these folks have not been. There are in that group that has intermittent coverage. They are always sort at the margin of employer coverage or something like that. We will do a little bit deeper dig here. Again, most of these folks are eligible for some sort of subsidy for the plan as well.
Again, in terms of the data strategy, which is the primary focus of this group, we are looking at administrative data, which is the market place enrollment data. We are able to publish ASPE. My office has done it and CMS has done it. We are publishing figures when we have them on – how many people are enrolled and generally where – at one point, we are even able to publish by zip code, but demographics and so on as well and who is getting coverage.
Again, we will continue that strategy. But, again, we are moving beyond just how many people are enrolled to the point where we are trying to see a little bit more of what do they have and what are they doing as a result. What is the impact of having it in terms of access to care and so on?
Again, as I said, this was the result of an investment data made a number of years ago where we pull all of our agencies together and we looked at what kind of data do we need for our surveys and administrative data to be able to monitor health reform. It cost a fair amount of money as Charlie will tell you. But we invested in it. We probably added 100 questions to the HIS at some point. We are trying to see where were people getting these plans. Were they part of the exchange or were they some other place? At any rate, we are now in a great position to monitor.
But, again, the lesson as all of you know is you cannot suddenly turn the faucet on and say what do we know about this. You really have to invest in these robust surveys well in advance. It cannot be an issue du jour. It has to be a continuing robust kind of an approach. Fortunately, we are benefitting from this and we hope that we don’t have a set back with the budget. We did oversampling. We added questions. We have added longitudinal components to the MEPS, various surveys. We are now getting good data to be able to do this. Again, this is not data for its own sake though we are always interested in the capability and infrastructure. This is really to improve health and health care and well-being. At any rate, we will be revisiting to see whether there are new questions we should be thinking about in the surveys.
The other area where sort of hand in hand with the enrollment is the delivery system reform. Many of you are familiar with this. I think we share the summary with the committee previously. This is the idea of really number one using information and technology to support the health and health care and of course that includes interoperability and health information exchange as well as the clinical side and clinical decision making.
In addition, it is trying to focus attention on the value of health care and bundling services rather than volume. And third, it is looking at arrangements that provide for coordinated and accountable care. These are emphases. HHS has at least from what we could control, we have, again, a plan and some metrics about where we would like to be in terms of getting people into health plan type arrangements, accountable care kind of arrangements and so on. Again, without data, you don’t even know where you are. You are pretty much – blind.
Let me just say a few other things if I have a couple of minutes. As Walter said, the committee even though we have separate subcommittees and work groups, I think the committee is at its best when it is providing an overall view of how do we bring all these various streams of data, standardization, data quality together again to improve health and health care. In many cases, what we are doing now in HHS is looking at more than just health – but also at social determinants and the other factors that are associated with positive health and well-being.
Within HHS, Mike will remember. The data council has periodically asked to pull everybody together and look at these kinds of issues. The strategy really within HHS as well for data is to look at these various sources, the surveys, research, administrative data, claims data, enrollment data and so on, programmatic data and then EHR data as it becomes available in a standardized way. When we look at these, we look at them with a convergence and with an alignment perspective in mind so that we are not creating a one off approach that is almost going to conflict with the ability to interpret data and availability later. We are looking at ways through standards, coordination and so on to try to bring these various streams of health data and human services data where we can so that we are heading in the same direction. When we plant something that we modify or add, we are doing it with a view of what the whole portfolio looks like so that down the road, all of these – in addition to their original purpose, clinical care, public health surveillance, research, whatever, that the use of the data again to monitor and improve health and health care and well-being that we will be in a position to have those work together and provide valuable data resources as well.
Again, the theme that the committee has in terms of convergence and alignment, that is also that HHS has. I think our general rule is that don’t create something new or change something and in the development of new ideas. Keep in mind that our ultimate goals are to relate to these various streams for data. Obviously, if they are not available, they don’t help anyone either with availability in mind with protection of confidentiality and so on. Those are part of our overall data strategy within HHS.
And then there are some specific areas. Let me mention two and then I will stop. Speaking of alignment, we were asked – I mentioned some of the initiatives we were undertaking previously. We were asked by leadership in HHS data council to take a look at to what extent are we asking – Mike will probably take two aspirin – how aligned are the questions and the data that we are collecting in our surveys in four areas? One is health insurance. The second is – health insurance coverage. The second area is behavioral health, mental health, and substance abuse. A third is tobacco control because we have a lot of initiatives now underway in that area. And a fourth is the LGBT kind of data. The leadership was interested in those areas because we have initiatives there and because there was in the past some variation in terms of what was being reported in terms of the prevalence or what the data was telling us.
We have had four work groups in those areas in the data council, looking at our whole portfolio of surveys, which is not that many by the way. It is like about 12 and it is really about half a dozen of the mainstream surveys that are not specialized surveys. We have work groups looking at these topic areas that I mentioned and they are looking at what is the amount of variation in questions and in data that we have now. Number two, do we know – is this intended or is this deliberate variation or is this just idiosyncratic? It is producing confusion without adding to any substantive knowledge.
And then we will try to make some recommendations about how do we align, where it is appropriate, how do we align the question and the data and give guidance to agencies about – when you are thinking of adding a question or you are modifying a survey, these are the places to look. Don’t make up a new question. Just a one off. But these are the areas to look. We make recommendations for specific purposes. If it is national, if it is state data, if it is longitudinal, we have – again, there is not one size fits all. In many of these areas, there is not a gold standard. It is suiting the data and the questions to what the purpose is.
We have actually made some progress. The four work groups will be – we press them to make some recommendations that we can provide to the agencies for guidance. Again, I don’t think these will be hard standards in the sense of gold standards. Some of these areas are developing. They will be best practices at a minimum and agencies will be asked to look at those before you make up something else. We are having a data council meeting on Thursday. If there is agreement, we will start pulling those together and run them through the HHS process. There will be alignment there as well.
The other area I wanted to mention was vulnerable populations and then I will stop. We have always had an interest in HHS and particularly in ASPE in assuring that we were able to have reliable data on many of the vulnerable populations. Many of them are very tough populations to get any data on. We are always looking at race ethnicity. We have developed some standards that all the agencies are using now on disability, on primary language. We are looking at now is there some – we created an initiative, which is beginning to bear fruit – sexual orientation, gender identity. We have added that to a couple of surveys and we will have some recommendations for more.
But I think there is great interest now in the American Indian population and tribal populations particularly where some of the social and health conditions exist and yet it is one of the toughest places to get reliable data, a lot of anecdotes and observational. There are many reasons why it is tough to get data on those groups.
What we are doing is putting our heads together in the months ahead and looking at what do we have now and then are there some strategies we can try to get more data on those populations, health and human services data.
At the same time, we are trying to look at our portfolio of administrative data like the claims data from CMS and other data and to see – I think we will probably try to pull together some sort of a resource. Again, it is hard to – unless you are an aficionado even within HHS, it is hard to know. If you are a user of this Medicare data for analysis, then you know that area. But there is other administrative data. I think there is a desire to number one shed a little light on it. What do we have, what is it and then sort of an assortment of each of those data resources? And then to see if there is not a way we could move forward in terms of making it available at least within HHS, again, under the proper conditions and data sharing for analysis and make it more broadly available as well. CMS, as you know, has done a good job with the Medicare and Medicaid claims. But there are other data sets too. I think we are trying to see if we could shed light on it and improve the data access there as well.
Let me stop there.
DR. SUAREZ: Thank you. Thank you for that detailed report. We already have some cards up. We will start with Mike and then go around the table.
DR. O’GRADY: I had a couple of different areas. I was kind of holding it for the end. In terms of the budget stuff you were talking about, Jim, some of the agencies and I think some of the data collection, but certainly correct me if I am wrong. For those of you who don’t know – told you are on continuing resolution and you are an agency head, you keep spending one-twelfth of what you had last year every month and that is how you are capped. We do have some agencies that are looking at – at least propose some fairly sizeable cuts. Is there a feel for – candidly, if I was still there, I would be spending my one-twelfth every – getting it out the door as fast as I could especially if I was looking at a big cut at the – once they do pass a budget. Do we have a feel for the impact on various data collection and data systems and what not in terms of what the budget implications are?
MR. SCANLON: Within HHS, we have -– where the budget is being developed, for example, the 2016 budget, the one that we are hoping to get full year, we have – when the budgets are prepared, our HHS data council and ASPE, we look at all the proposals across all the agencies. We look at our major portfolio, our major data systems. We look at what is being proposed, what is being changed. Are there cutbacks? Are there enhancements? This is basically like a cross cut. We do it for other areas as well. But ASPE and the data council do it for the data collection investments. This is not IT or things like that.
Pretty much the council tries to protect – if there is any duplication outright, we really try to put the kibosh on that right away. If people have money, there is a place to go. There are other strategies. We have always recommended to our budget council, the secretary’s budget council, pretty much at least holding the current level for all of our major surveys and major data systems. And pretty much the department supports that and then OMB usually supports it as well. All that does is get the proposal up to the Hill and then Congress declares that – and we start over again.
We are a little worried now to be honest because one of our agencies was either zeroed out or 30 percent cut. Our other agencies were a little – it is not clear. For example, we were proposing funding to continue all of the changes we made to monitor health reform and the ACA. We don’t want to have to lose that amount depending on where NCHS will fall. We do the best planning. We at least get all of that into president’s budget for HHS, but then Congress, which is their role. They decide what the overall targets are and then distribute them.
Again, you never want to predict, Mike, what Congress will do. I think folks are moderately optimistic that we will have a full year budget. Even AHRQ – who knows where they will end up. Probably end up somewhere between those two areas. But that would affect MEPS, for example.
DR. O’GRADY: ACA-related things will be —
MR. SCANLON: I am pretty sure we will find a way.
DR. O’GRADY: — probably Congress won’t support.
MR. SCANLON: I should not reveal all the strategy, but not all of it is line items. A lot of ACA is mandatory budget – but I think you are right. I think when you hear from Charlie tomorrow, there is always a worry that we will – when we look at what is coming up, it may set us back. We do the best planning and we submit the budgets to protect. I have to say the department at OMB has been very supportive of at least not losing ground and in many cases adding money to the basic statistical systems. Again, it depends on what happens on the Hill and what the other priorities are. Sometimes any issue can derail some of these things.
In terms of planning and at least getting them into the budget request, the department is pretty good about that.
DR. COHEN: This is a follow up to Mike’s about ACA. I know in Massachusetts we tried to develop very explicit research protocols to look at outcomes related to increased enrollment. For instance, in populations that were newly enrolled, we tried to begin to look at changes in staging of cancer diagnosis using cancer registries. We began to look at something called amendable mortality that might be more related to mortality outcomes related to access to care. We looked at preventive services, et cetera.
Are there specific research agendas developed to look at outcomes related for newly insured populations? Is there work being done at ASPE on that?
MR. SCANLON: There are analyses planned. We would probably use the NHIS and MEPS probably. And throughout HHS, there is hypothesis-driven research and there is grant research as well. I don’t know that the clinical side -– you mean the follow up for clinical.
DR. COHEN: This is an area that I think has been really under explored, looking at specific outcomes that one would expect that would occur after populations are newly enrolled in terms of the impact of access to care. I really think HHS at some level, perhaps even the committee in terms of population health, should be thinking strategically about what health outcome changes we would expect for newly enrolled populations. I would really like to see us move in that direction.
MR. SCANLON: We will be looking at — besides just insurance coverage, we will be looking at access to care. We can actually tell from the HIS and the MEPS if it is newly insured. We will be able to tell if they have a usual source of care, what kind of utilization have they made. Do they have access to care? The problem is matching.
DR. COHEN: The question is does it make a difference. It is a laudable goal to increase equity for the sake of enrolling folks. The real challenge I think is going to identify —
MR. SCANLON: There have been some studies. You can accept it or not. There was a study in Oregon when they do the Medicaid expansion. They have a waiting list. They could do a little experiment. They always find pretty good peer reviewed studies that not only does coverage increase your access in utilization, but it has some health outcomes as well. Again, you have to follow people.
And maybe the committee can look at this down the road. We have all the Medicare claims data other than the managed care. We have the Medicaid claims. For the rest of the population, other than our survey, NHMS and others, and other than a few all-payer databases, which it is hard to get that other data. We buy data. We buy some of the prescription drug data, for example. There are a couple of vendors that have all of that information. Claims data. There are vendors who have their client’s data. There are all-payer databases in a few states, but it is a little tricky. It is just not easy to do that kind of research. We cannot rely on what happens in Medicare to generalize what happens to the under population. That whole area of claims data for the under 65 and the non-public programs. Progress along those lines would be very helpful for us.
DR. COHEN: The other question I had, Jim – thanks. It is always a pleasure to hear the incredible stuff that is going on. Can we get copies of the draft questions for the best practices in those four areas?
MR. SCANLON: As soon as they –- it is still being sorted out, but I think as soon as that is – I will be happy to share that. What we have done is identified all the questions in those areas, which we probably would make available already. That is already available. The issue is now getting people to agree on how do you ask about smoking. How do you ask about insurance coverage? We pretty much have agreed. The changes that the Census Bureau has made. We are actually much closer to getting closer on insurance coverage measurement. In the LGBT area, we are really at the very early stage. You know more about that. You helped us actually with our first set.
I could probably share what the current questions are. But then I think what we want to do is have people converge. I cannot tell you how many times. Other agencies have called and they are saying we want to ask a health insurance question. They make up their own. That is not what we need. We have recommendations about what you do. If it is just one question, which I think I would like to say on all the surveys. One question. We know what that would be. It would provide a way since it is also the question that our major surveys use. It would always provide a way to benchmark against our national surveys. But I will see if we can pull together the questions that are being used now and then when we have some resolution. We are still in the making sausage stage on the guidelines. But I think everybody agrees we will move forward.
DR. MAYS: One of my questions actually is following up on what Bruce just said and that is in terms of the best practice questions, is there some way for us to be able to comment before it is a done deal. I am asking that because before we had talked about some kind of participation in the data council and I think because we are FACA. It is difficult. I don’t know if there is another way for us to be able to have some commentary because I know that particularly as a researcher, there are times at which variation is very specific because of the data set, but there are other times at which – right now, we are battling with some of the agencies around how they have asked sexual orientation, what they have chosen to leave out. I would like to try and make sure that there is some sense of comments if at all possible on that.
MR. SCANLON: Let me think about that. I don’t know. We used to invite the chair of the NCVHS to our data council meetings. The lawyers told us that we were making it into a FACA when we did that. We had to stop that. But we could certainly have committee members as resource folks at meetings or something like that. When we share something with the committee, it is public even before leadership has seen it. We have to be a little careful there. Let me find a way. We could probably do a briefing at any rate where the major content could be discussed.
DR. MAYS: If we knew what the agenda was then it would be if we thought we wanted to comment or something.
MR. SCANLON: Let me think about how we can do that.
DR. MAYS: My other question has to do with Census and NHIS redesign. The Census, people don’t know this, has made a pitch for a major change in how they are going to assess race and ethnicity. They want to do it as one item. The question is will that have any impact on our surveys. The Census is typically our frame that we use. I don’t know if there are any implications for that in terms of if the Census makes a change whether or not our surveys then also have to do the same thing. Either it is a best practice because they are actually finding that they think it might work better. I don’t know what the implications of that are.
MR. SCANLON: It is a good question. We actually have a standard, as you know. OMB requires all federal agencies and contractors to use a certain set of how to ask that question.
DR. COHEN: Minimum standard.
MR. SCANLON: Yes, minimum standard. We have actually added a lot more granularity as long as it can be collapsed back. If OMB made that a standard then over time it would be – whatever the Census does it would be – if that is what they adopt as a standard. If they change the standard then all the agencies ultimately would have to use it.
DR. MAYS: Is that something we should be thinking about and recommending? I am just a little concerned because this is a big issue in the field.
MR. SCANLON: OMB would not make such a change without public comment. That is a little different when it is a standard like that. At any rate, we will – actually has been following this closely.
DR. MAYS: And then my last question is about the NHIS redesign. This is an incredible time in terms of for them to look at their survey, decide what might go on, what might go off. I am wondering again if there is a way to have any participation in that, starting from even thinking about the budget issue. Apparently, there is no budget to do the redesign, but they have to do the redesign. We all want them to do the redesign as well as possible. I don’t know whether the committee is in a position to recommend augmentation of funds for the redesign. I don’t whether the committee is in a position to also be able to comment because one of the things at least when I was at the meeting that I put on the table was whether or not they will be able to put mental health variables in. That is our primary survey.
MR. SCANLON: It is our flagship. We will certainly within the department when things become a little clearer of our options, we will be looking at them. Ask Charlie when he comes tomorrow or later today where they are. The budget issue. I just don’t know how to deal with that. A bake sale probably would not raise enough.
DR. MAYS: I know the committee did make a recommendation some years ago when their budgets were getting cut about the importance of it. I just did not know if that might be useful particularly to emanate for the populations.
MR. SCANLON: It never hurts. It is not HHS or OMB. We have already proposed funds to do this. We will just have to see —
DR. O’GRADY: If I can jump in. I think Vickie has a good point there in terms of – because what you are going to put into that is going to be the administration position to have a somewhat more neutral outside group of experts to say it is pennywise pound foolish to not spend a little more on planning this thing because it is going to cost you tens if not hundreds of millions to do every year. Then somebody is smart from – legislation should probably put that letter in front of the people that say it is not just us that thinks this is important.
MR. SCANLON: You can advise us. You cannot lobby, not as a committee member anyway. Anything like that. It helps us to go on the record.
PARTICIPANT: An advisory letter might be good.
MR. SCANLON: Yes, the committee could write a letter. This is underway. But I think you would want a briefing from NCHS on what do they mean exactly and what are the – I don’t think Charlie – too much, but it would be worth a briefing from the NCVHS folks.
MS. LOVE: I am going to shift gears here and talk about all-payer claims databases in the states. We are making some great progress on getting a census of insured populations in states. Medicare has been phenomenal in helping and Medicaid is a population we are able to obtain. But there are some big holes. And one of them, Indian Health Services, is a huge issue in a few of our states. In my talks with tribal and some of the IHS folks, I think it is a culture shift paradigm. But I think we are going to need some guidance. I think they have a lot of data, but they don’t know it is okay to share. That is just one.
But the real issue and I don’t know if this is where I bring it up or who I bring it up to, but the alarm bells are going off on SAMHSA’s decision to roll back, release, suppress mental health and substance abuse and even someone wrote me this could also apply to private payers and their data sets. Basically, the most important population for chronic disease and all these population-based concerns in the states could go missing.
MR. SCANLON: You mean the administrative, the programmatic –
MS. LOVE: It is huge. It would create a hole so big for the states. I don’t know if this is the place or where to go and how to deal with it, but I think some of these states are having a —
MR. SCANLON: If it is a data issue, I know they had some trouble with that common data platform.
MS. LOVE: And just the filtering from the payers, the commercial, not only is that an administrative burden, but I don’t think it would catch 100 percent. It sounds messy to me.
MR. SCANLON: We would be open to a letter.
MS. LOVE: I think some of the northeast states are having a meeting on this very thing. I am suggesting whatever we can bring to the table.
MR. SCANLON: I think pointing it out, that would be helpful. With a letter or something, we could take that and have SAMHSA. I know they work with the states, as you know. There was some resistance. Their common data platform. I don’t know how it worked out. Now, I don’t know what their future strategy would be. But I think any advice you could give us on that would be helpful. I can take that to the leadership.
DR. SUAREZ: We have been thinking about doing possibly a hearing about APCDs actually and gathering feedback. That is the way we gather input from the industry about ways we can provide guidance.
MS. LOVE: The ERISA thing we worked on this summer and it is going to the Supreme Court December 2. We wrote an amicus in support of the State of Vermont. These populations are important, but again IHS is – I have my eye on, but I am really anxious to move on it.
MS. GOSS: Denise, to Walter’s point, sorry for butting in here. I am concerned that the APCD and our work plan will be kicked to some place later, at earliest in 2016. I don’t think I want to wait potentially until then because I am still trying to get my arms around everything she is saying.
MS. LOVE: This could affect hospital discharge data. If you look at psychosis, besides OB, moms and newborns, I think mental health issues and psychosis are like one of the top diagnoses going in for hospital discharge data from the all-payer databases and the hospital side.
MR. SCANLON: Are you referring to the confidentiality rule?
DR. SUAREZ: That might be something we need to discuss.
MS. LOVE: We think we understand 42 CFR and this is probably a follow up. SAMHSA is making a decision to suppress.
MS. GOSS: Suppress what?
MS. LOVE: The mental health and substance abuse diagnosis coming in claims data, which could possibly affect —
MS. GOSS: Are you are talking about revisions to their guidelines, Denise. Is that specifically what you are referring to?
MS. LOVE: I think there are policies – in a reversal, SAMHSA decided patient data relating to substance abuse and mental disorders should actually be suppressed from data handouts and this could include Medicare data.
DR. SUAREZ: Let me suggest. We are getting more into the – we will bring it into discussion perhaps.
MR. SCANLON: Their lawyers have told them that if you are a Part II provider, whoever they are, the original regulation or statute.
PARTICIPANT: This extends beyond Part II.
MR. SCANLON: It is hard to know who they are. But anyway, they felt they were – it is not something they wanted to do. They are doing things to try to address that. I understand completely.
DR. MAYS: There is a time issue with this. I am not sure.
DR. SUAREZ: We will talk about it later this afternoon.
MS. GOSS: We have a full agenda. It is important that our other subcommittees be a part of this.
MR. SOONTHORNSIMA: — subcommittee on standards – to discuss. I am not sure we will have that much time —
DR. SUAREZ: It might not happen this afternoon within standards. It could happen within some conversations. It will be brought into the agendas of different groups. Thanks for bringing it up.
DR. PHILLIPS: I hope this is a quick question. I just need a little bit of better understanding of how we relate to the HHS data council, formally, informally.
MR. SCANLON: This is the public advisory committee that provides advice from the outside. The data council is an internal – within HHS, we have a number of councils, which try to bring HHS together on certain issues. This is the data council that looks, but it is an internal group. It has representatives from – ASPE co-chairs with AHRQ. I think Charlie is now a co-chair as well. We meet monthly. We consider data policy and data collection strategy and standards and so on from a department-wide perspective. We also look at what investments are being proposed through data collection, but that is an internal group.
I try to bring issues to this committee here that arise there. Somethings are kind of internal deliberation. It is to solve problems within the department. We cannot really – we tried once to have a share of the NCVHS there. The lawyers did not like that all. But if the committee makes – it is a two-way street sort of. When the committee makes recommendations, we had Bruce and Bill come to talk about recommendations that the committee is making. And then we take here what we can or have the agencies come here to talk about it and ask the committee for advice as well. But it is the external advisory group. This is an internal advisory group. We have other internal groups as well.
DR. COHEN: The point is it has come up several times in the past. We should coordinate our activities more closely to understand what that agenda is and for them to appreciate what we can offer. It is a really good point. As we move forward, we should talk about how to do this.
DR. SUAREZ: Great. Anybody on the phone, Ob or Sally or have we had any other members showing on the phone first of all just to make sure.
DR. CHANDERRAJ: Raj Chanderraj.
DR. SUAREZ: Could you introduce yourself quickly?
DR. CHANDERRAJ: This is Raj Chanderraj, member of the Full Committee and member of the Substandard.
DR. SUAREZ: Do you have any conflicts?
DR. CHANDERRAJ: No conflicts.
DR. SUAREZ: Any questions for Jim from the phone? Okay.
Hearing, none, we are going to move next to – thank you so much, Jim. That was really excellent and always very appreciative. We are going to go to – we have a privilege of having actually Steve here, Steve Posnack from the Office of the National Coordinator. Steve has been one of the longest employees from ONC even before ONC started, I think. I have known Steve for a number of years and he has played many different roles, including pretty much leading the development of the many regulations related to meaningful use and standards certification process. Now, he is the director of standards and interoperability within ONC. It is a privilege to have you here, Steve. Thank you.
MR. POSNACK: I will be brief. I am here to give you just a one-on-one briefing on the recently published ONC nationwide interoperability roadmap activities. I do have a soft spot as Walter mentioned for NCVHS because before ONC had our own advisory committees, I was staff support to NCVHS in the beginning. It is always a privilege to come back and speak with you all. Some of the names and faces have changed. Others I have a long tenure with NCVHS and input as well.
I will dive right in. The big picture is the end of September, beginning of October is a very big six weeks for us. We first published the update to the Federal Health IT Strategic Plan. That was several years in the making. That plan covers 2015 through 2020. There are a number of goals. There are over 35 federal agencies that participated in input relative to the plan.
The fourth goal for the plan is around enhancing the nation’s health IT infrastructure. One of the main objectives for that is to implement the nationwide interoperability roadmap. I am here to talk about the roadmap component as well, but we want to give a big picture.
When we talk about interoperability, we always need to start with the definition. We have chosen the one that the IEEE has a basis for at least having some consistency in terms of what we are talking about in a less jargon plain language way, the way that we have described this is that individuals and the families and health care providers have the ability to send and receive and find and use health information in order to support their use for different purposes. That is the plain language way to describe what we are aiming at from the nontechnical perspective.
This process really kicked off in the late spring of around June 2014 when we first published the concept paper alluding to the fact that we would like to publish a shared roadmap. There is a lot of feedback on that. We also have our advisory committees that help IT policy committees and standards committees that have provided us federally advisory committee feedback. We had a number of opportunities for public consultation. We published a draft version of the roadmap at the beginning of this year and now had finalized it in the beginning of October. There were numerous opportunities for public input.
In terms of the feedback that we got on the roadmap, there is general agreement on the elements of the roadmap – particular subsections that we focused on. I think one of the criticisms that we received because it is a ten-year vision to try and lay out a particular milestone and actions was that I think a misinterpretation of our plan and our document and the timeline that we had to wait ten years to reach interoperability. We agree that that is not the point. And actually, a lot of the work that we did in responding to public feedback and comments was both to streamline the roadmap itself to make it less dense in terms of its overall page length and content, but have it more heavily focused on near term actions that everyone could agree to.
As you look at the roadmap itself and I am stealing my thunder from other slides, there is a first milestone period between now and the end of 2017. That includes from a quantitative perspective over 50 percent that milestone period over 50 percent of the actions and commitments that are in great detail for near-term steps that stakeholders could take.
One of the other recommendations around restructuring the document. When we put it out for draft, we had a construct of around five building blocks that we wanted to emphasize. That did not really resonate with folks. You will notice now that we have three themes that I will emphasize I think a more colloquial and accessible way to emphasize the particular activities that need to occur in the roadmap.
Confusion about privacy and security, which I am sure you all are well aware of as well. Boiling down simply again to just not understanding some of the HIPAA privacy and security rules and demystifying some of those aspects.
Additional clarity on standards. Obviously, this is interoperability roadmap. I think that is an expected type of comment to receive.
Mixed feedback on what we call governance. That is a word that means a lot of different things to a lot of different people, depending on the context in which you are talking about “governance”. In the context of the roadmap, we were really talking about how different health information exchange organizations or others that facilitate health information exchange relate to each other. Common rules of the road, how they share business practices, how they enable health information to be shared across different network infrastructures. We decided to use a different term and phrasing to describe that concept of being mutually accountable and having shared responsibility.
And then the last, which I think also should not be a surprise to NCHS given your HIPAA administrative transaction roles that call for unique health identifiers, which I will not re-litigate with you all around this table. You understand I think the constraints that are imposed on the department and in the roadmap at least, we did emphasize that again. But also acknowledge that there is nothing that prohibits the private sector from stepping forward to do that. There are ways in which we can support those activities, but also that we are going to continue working with stakeholders on the matching-oriented approaches that have largely been implemented across the industry today.
One other concept related to the roadmap itself. We needed principles to keep ourselves honest and then make sure that everyone understood the values that we were trying to bring into the roadmap. You will note here that there are a number of bite size sayings associated with these principles. The one that I usually emphasize as an example is we have this principle about building on existing health IT infrastructure. We wanted to emphasize that as we looked across this ten-year arc there are certainly areas where we know we need to make progress in an incremental basis and we are not advocating for anyone to replace in order to get to where we need to go.
In other cases, there is a tension between some of these principles, as we look to an environment and a vision where we want to see more person-centered care. The infrastructure that we have currently may not be good enough to get us there. That is where we may need to look at other opportunities to not necessarily build on what we have, but to create something anew.
Here are the three overarching goals and timeline milestones that we colloquially refer to as three, six, ten-year milestone periods for the roadmap itself. That is how the roadmap is organized as well. As I emphasized earlier, this 2015 through 2017 period really has the meat and detail and depth as far as we could see as well in a lot of cases with a lot of the stakeholder feedback that we received.
The other thing I should probably emphasize, which I neglected to do so earlier, is ONC is a coordinated and helps to facilitate a lot of these documents that are being created, but they are not ours individually. As you look at the Federal Health IT Strategic Plan, it is not ONC’s health IT strategic plan for feds. It is the Federal Health IT Strategic Plan.
Similarly, we call this is a shared nationwide interoperability roadmap. It is not our roadmap. There are a lot of things that we have committed to in the roadmap, but it also reflects a lot of stakeholder feedback that we have incorporated into it. We envision this being a living document that we can continue to add to and track with stakeholders over time as you all in your roles are successful with what you do.
As a quasi-neat infographic, this is the high-level structure of the roadmap. As I mentioned earlier, there are three themes. The first theme being focused on the drivers for interoperability. What are going to sweeten the environment, create an environment, create the demand and improve the supply of interoperability-oriented conversations and requirements overall? A lot of that is focused around a supportive payment and regulatory environment. That brings in both the department’s aspect in terms of how we pay for care, but as well as how we work with other stakeholders in terms of how they can incent interoperability through their policies.
I go through the particular kind of site mapping for the subsections of the interoperability of the roadmap next. I won’t go too deep into that.
The next section, which is really a majority of the roadmap, as you will see, focuses on both the policy and technical components. I am sure through your work, when there is a great technological solution that is but one-half of really what needs to be done. Ultimately, we have seen the greatest success when we have both the policy and the technology lined up to really make progress. We recognize that there are a number of aspects that are two sides of the same coin that need to be taken on, sometimes in tandem, sometimes in sequence, sometimes in proof from one of the other, but there is this real big interplay and interdependence between policy and technical components when you talk about interoperability.
And then the last being focused on outcomes. There are subsections focused on how you improve patient experience related to interoperability, provider experience related to interoperability, and then how we measure our success. That really breaks down into two components. First, being how we track everything that is going on in the roadmap itself and what we are accomplishing and whether or not we are meeting what we need to meet to really start to say we are making good progress towards this milestone period.
The other is, which I would say is more sobering for me as we work through this, is how we get better measurement and understanding of the types of outcomes that we are seeing as a result of interoperability and how we move to say it in a Twitter-oriented way. How we move from counting transactions to clinical outcomes as a result of interoperability. It is one thing for us to understand data is moving, but all the data moving in the world and millions of transactions don’t give you clear visibility into how that is really impacting care and changing both the patient and provider experience related to that data exchange taking place. That is another area where there is a discussion in the roadmap about how we want to evolve and work with stakeholders over time.
Above these boxes that have in a mysterious way disappeared underneath that milestone’s heading, there is the 2015 through 2017, 2018 timeline periods and then the actual structure of the milestone for each particular subsection in the roadmap. And within that and this is just a navigation as you pick up the roadmap having perhaps never picked it up before – a presentation from me earlier. This is just how a simple way for you to understand how it is constructed.
There is milestone text, which is particular to each subsection. And then within those milestones, there are two components. Calls to action. These are a mixture of federal agency calls to action and private sector calls to action. Where we said based on the feedback that we received from this community of stakeholders, they said this type of thing needs to be done. We are reflecting that call to action in the roadmap and in places as discrete as you can, targeting those particular groups to say you guys should step forward and do this type of thing.
As a corollary, we have commitments in the roadmap as well, which if you look at them are only federal. And that is because as we were going through the drafting process, it was within our power to work with our federal colleagues in advance of releasing something publicly to get commitment toward particular sections of the roadmap.
Many of the commitments you will see are ONC represented. That is obviously due to our investment in the roadmap. But there are a number of other ones from federal colleagues, particularly in the payment and delivery system reform components. Our CMS colleagues have stepped forward and committed to things as well.
At the end of the roadmap, we did something which I think helped streamlined the document itself in making it less dense, but also making it more valuable as a tool later on. We include aggregated or consolidated section tables for each of the subsections. They have the particular milestone in its discrete way and then the particular calls to actions and commitments. These are tear away sheets essentially in the roadmap that if you care about a particular subsection more than the others, you can take that one or two pages out and have that handy if you so choose to use that as something in your daily work.
As I mentioned, the driver’s section of the roadmap is structured around the supportive payment and regulatory environment. That is the one main subsection of that component of the roadmap.
The largely policy-oriented components of the roadmap include subsections B through F, which touch on both the health information exchange governance aspects, shared accountability components, and then many of the privacy and security-oriented policy aspects as well that we reflect in the roadmap.
The subsections here really reflect the technical aspects of the roadmap, looking at the industry need for enhanced testing and certification. Obviously, ONC runs the certification program, but we are not the only ones. There are a number of opportunities I think for broader industry collaboration as well as public/private investments in greater testing availability as a first way to help advance interoperability overall.
A number of specific subsections around the need for alignment around particular data semantics or the way in which data is represented in structure. And then other health IT infrastructure that is going to be necessary to move data from point A to point B.
Last, as I mentioned earlier, there is the outcome section, again, focusing on individuals, another focusing on providers and then the third here focusing on tracking our progress and measuring our success.
I believe that wraps up my prepared remarks. I am happy to answer any questions if you have any, but I wanted to make sure that since you all are equally an important stakeholder to the department from an advisory committee perspective that you understand, as Jim mentioned, all of the other plans and activities that are ongoing that are interconnected and I think mutually supportive. We are also engaged in a lot of the opioid work of the department as well. I am happy to answer any questions.
DR. SUAREZ: Thank you, Steve. Any questions?
MS. GOSS: Good morning, Steve. Thanks for that update. As co-chair of the Standards Subcommittee and Review Committee, we have been looking at a lot of the obviously administrative simplification. As we are a stakeholder in your world, you are a stakeholder in our world. As I look ahead and I should say looking back on some of our discussion on the interoperability roadmap when Erica was here and some of our convergence themes and knowing that we have the concept of attachments re-emerging for a hearing in February, I am curious as to your perspective on the role of the HIT policy and standards committee in participating in that dialogue as it is a nice linkage point between administrative simplification and meaningful use objectives with HL7 really bringing forward a new body or specifications on attachments.
MR. POSNACK: Thanks for raising Erica. She helped steward most of this. Let’s give her credit for the record. I have been her understudy, but with her having left ONC for other career opportunities, I am now permanently filling in the temporary role of her understudy.
I do think your point is really well put in terms of the convergence that we see. We did try to emphasize in the roadmap the need and connectedness between claims, administrative data, and clinical data. Most of the roadmap, I would say, is from a – a majority of it is focused around clinical data exchange with an understanding that I think we are going to cycle back around as we look at the living document nature of the roadmap to see where the bridges are pretty short between the two IOMs that we have to butcher a metaphor and to see how we can best align some of the work.
I don’t know if we ever talked about this before. Having a mixture of committee members across our advisory committee as well.
MS. GOSS: Specifically, I am thinking about the fact that we are planning for a February hearing on attachments. When Terry Deutsch, the lead staff for the committee, and I were talking, I was really wondering. Where does the HIT policy and standards committee fit in being a stakeholder that provides their perspective on the next steps?
DR. RIPPEN: Nice seeing you again. I do have a question as it relates to security. As you know, there is increasing concerns about vulnerability of systems. Health care is not alone. Unfortunately, health care has I think one of the poorer records as it relates to security. Given an aggressive push to connect more and more systems, how is ONC and others thinking through the core components of security especially to provide some confidence for stakeholders?
MR. POSNACK: Sure. I am not going to be able to do this justice as much as Lucia Savage, our chief privacy officer, would. Some of the sections of the roadmap that particularly focus on this do emphasize I think some of the renewed and other aspects that I don’t think we had previously looked at before, but have now had more of an interest in. I am blanking on the acronym that we have. Generally speaking, having the public/private awareness of information security sharing environments that other sectors have that health care does not necessarily have from a mature perspective. Working with our colleagues at NIST from an NSTIC and other perspectives as well as across the department. If I am not mistaken, our colleagues at ASPR, another HHS family member, assistant secretary for preparedness and response are part and parcel with the cyber security activities. There is an element of getting the right stakeholders together to share and make aware of cyber threats and other security components.
In other cases, we are partnering with OCR to help with continued work around security risk analysis and mitigation techniques.
We are also looking at areas where at least more closely related to our traditional bailiwick of electronic health records and others, work we can do with in a public/private way to talk about security best practices, penetration, testing, other factors along those lines that will help the industry mature going forward.
DR. RIPPEN: Just a quick follow up. Security is one aspect and then liability and then kind of who pays is the other. It is my understanding, I could be wrong, that traditionally credit cards – you have some — as a consumer, don’t have to deal with some of the financial implications. However, there have been some suggestions in the health care sector that is not the case. Individuals get hit. Again, something to consider as you think about policies to protect the consumers.
MR. POSNAK: Absolutely. As a trend, the kind of liability, breach-oriented cyber insurance, security insurance aspects of things has started to become a louder component of conversations and trying to figure out especially from a liability perspective where the line is drawn and where it is blurry. We can help if we can in some cases. It is a fair point.
DR. COUSSOULE: Can I add one comment to that? One of the challenges with this and specific to security, but even more general is there are a number of either legislative things that will need to be done or statutory things that will need to be done as part of the success of the roadmap. It is a nice document, but it is going to be very intertwined with the actual workings of the system to make it work.
A general question. Where do you see the biggest risks and the success of the roadmap given some of those other challenges?
MR. POSNAK: It is a good question. There are a lot of opportunities for success and a lot of opportunities for things to get mired down. I think the connections among the many different organizations that help facilitate exchange are something that we are watching and eagerly interested in participating in. There are a number of positive – there are a number of organizations that are making positive momentum in that area, but how they connect with each other and whether or not they can reach some alignment especially for the purposes of exchanging data at least for treatment is something that I think we will see the rubber hit the road I hate to say pretty soon meaning like in the next year or two where it is going to start to reach a critical mass of demand and interest for exchange.
A lot of the other things that Helga just raised from a privacy and security perspective. I think either this year or last year. Many of the breaches that we had were related to plan-oriented data and some of the prior ones from a health care provider perspective have been mistakes from laptops and mobile and other such events. Tomorrow we could have a massive breach issue from a clinical-oriented perspective and that would change the dynamic of the work as well. Some of the unpredictable entry points for additional challenge and distraction could I think also be – it is a lot of work admittedly and not a work that we are leading either. To the degree that there is a lot of interdependence between the work that needs to get done and sequences that may get out of alignment, that is where I think we will start to see whether or not we are making good progress.
DR. RIPPEN: Just a quick kind of closing the loop. The nuance too is that as you know, security is something that you have to actually address early in the process, not after the fact, and, again, just a reinforcement of best practices and learning from some of our colleagues and different departments. Nothing is guaranteed, but again it is a responsibility.
DR. KLOSS: I just wanted to remind everyone that we have Lucia Savage on our agenda for tomorrow as well as Rachel Seeger from OCR.
PARTICIPANT: Ask her all those hard questions.
DR. KLOSS: We will circle back on that.
I guess I have one general question. We have followed the work of the interoperability roadmap development. But in addition to that, what are some of the other really overarching priorities that the agency is now focusing on or is this becoming the organizing work of ONC overall? I just don’t have a sense of what the whole portfolio of the major priorities is.
MR. POSNAK: This is certainly a major factor and priority and something that is driving our organization from across all aspects of our work. Interoperability is obviously a core component. To give you other dimensions of areas of work that we work in, some are on safety from a health IT perspective. We have had work ongoing related to health IT safety and collaboration, collaboratory work with the private sector. We have work ongoing with our colleagues at CMS around clinical quality measurement. Generally privacy and security oriented with our colleagues at OCR. We still have a number of areas where we work on consumer empowerment and consumer engagement. Our Office of Programs also is still administering some grants and work with our regional extension centers. I am trying not to leave anyone out.
We have work on precision medicine as well, which we are also involved in that Jon White is leading. And broader delivery system reform efforts that we are supporting in the department as well with health IT being a poor enabling component.
I am sure I have left something out. That is many of the components of work that we have going on.
DR. GOSS: How about keep the broad picture?
MR. POSNAK: There is collaboration with CMMI and also you may be aware as a result of the – I still call it the SGR fix, but the macro legislation and the way in which the ambulatory docs are going to get paid in the future with MIPS payment system changes, working closely with our colleagues at CMS on that as well because it has an intersection from a meaningful use perspective as well as just broader work in terms of clinical practice improvement activities and the like.
DR. SUAREZ: That is a great overview.
MR. POSNAK: I am sure I left something out. We have a lot of dedicated people working over there.
DR. SUAREZ: Rich and then Michael and then we will probably have to move on.
DR. LANDEN: I had three questions. One of them was security. That has been addressed. Thank you.
The second is that the roadmap has presumptions in it that there will be solutions to some sticky items like identification, both the patients and providers and the care team, patient privacy rights and obligations and standards around consent management. I presume from what you have already said I should hold those questions until —
MR. POSNAK: I think Lucia would be best to give you the expert nuance of all those. I think the other thing – as you look across the roadmap as well and these are discussions that we always have internally. Some things got put in the three-year time period because we recognize that they needed to get started, not that they did not necessarily were intended to be completed in that time period as well. To your point, there is a presumption. Some of these really hard issues are going to need to be solved in order for us to build on what we need to achieve to reach some of the longer term goals and objectives that we have.
DR. LANDEN: That leaves my third question – roadmap references of learning system. Can you elaborate a little bit more on ONC’s vision of what constitutes a learning system for this country?
MR. POSNAK: Sure. I think as we framed in the roadmap, we have really I would say followed and lean heavily on what the Institute of Medicine put out as its vision for a learning health system. I think when we look at it more discretely from a health IT perspective, it is that health IT and interoperability are enabling the type of different learnings in – we would say in an ideal in real time or in ways that can help inform rapid and iterative changes in the future.
That is actually a good question. I did not emphasize it enough. It would say in the roadmap as well. Our ten-year vision for why we wanted to emphasize a roadmap for interoperability was to aim toward this learning health system concept. We recognize that at some points what it means for a learning health system is somewhat nebulous. It is not to say that you will know it when you see it, but it will feel different. It is supposed to feel different than it does today in a lot of context. I think that is the emotion that we were trying to bring to the roadmap as well, which I would not say you necessarily pick up in all the writings sometimes.
DR. O’GRADY: I just had a question a little bit off the roadmap. But the roadmap kind of highlights something that I have seen in this particular pause here for a long time and that is this is not a criticism. It is just a question. You laid out a ten-year plan. It assumes that you have the support to – you should lay out a ten-year plan. There is none of this year-to-year stuff. This is a good thing to do. But I did not know whether – are we at a point now about a decade into this process where you have the kind of evidence that you would want for people who are not true believers in doing this that there is a business case, that there is a return on investment, that there is a populations were being served who otherwise wouldn’t. Your presentation was about the plan. You will face leadership changes over the next few years and it is not clear everybody is on the same page as it has been for the last few.
MR. POSNAK: That is really important. We have looked ourselves at the commitments that we put in and had a lot of debate and dialogue before we signed our names to the dotted line – to say do we believe that we can take this on under our current resource constraints, which could require us to de-prioritize working in some others in full or in part to take items in the roadmap on.
The other element being we also do a lot of work from a data analysis survey research perspective as well. We have a dashboard at healthit.gov that I encourage everyone to go to check out that my colleagues at ONC maintained with a variety of things that helped to try and build some of this business case.
In other respects, I think some of the statutory changes that we have seen come in first with MACRA and at least on the horizon, either 21st Century Cures or what the Senate is working on now as well, will probably if they do pass it in this Congress or next have pretty profound changes to the way in which we operate as well. I think those are going to be those things that we are watching closely and engaging with our Hill colleagues on as they ask for what we call technical assistance and providing support too. They are aware of our priorities. The roadmap obviously helps with having some of those conversations to say we really think we need to make a great deal of progress. To Rich’s point, this is going to be a really important prerequisite to supporting a number of future activities. We either need more resources or a different way to approach it and whatever support the Hill can offer is always valuable there.
DR. SUAREZ: Thank you. Let me ask if there are any questions on the phone. Any questions for Steve from members on the phone?
DR. CHANDERRAJ: I was wondering if you have any chance of – how many people are – private citizens are currently looking for —
MR. POSNAK: In terms of individuals or carriers that would request access to their records?
DR. CHANDERRAJ: Yes.
MR. POSNAK: It is a really hard number to quantify. In the first stage of meaningful use there was a measure around providing electronic copy to patients who asked. And hopefully I am not rewriting history here. When the measures came in, some of them reported zero patients that asked for a copy of their information. Some of it I think to your point is there is not the education or demand or literacy to get folks motivated to do so. In other cases, I think we are dealing with demographic demand that would attenuate it.
As a parent myself now, I have now come up with a saying that there are parents with kids and kids with parents. I am stuck in the middle with both sides of that equation as a caregiver. I would say the demographic where I am now most interested in either helping with my kids’ care and getting access to their data or helping my mom or other folks in my family getting access to their data. I like to still think I am part of the young invincibles insurance cohort. I don’t personally have a high demand for my data. That is really a large – I would say bolus of the working population that does not have that demand. I think we are seeing that. But we are also in part of some of the other work. I think Linda mentioned. In trying to come up and work with the industry on ways in which to enable and empower people to get better access to their health information.
The trends in wearables and mobile health I think will – all sorts of other devices that we have nowadays will contribute to the sexiness of having health data and using it for purposes to manage your own perspectives like the quantified health movement. That is where I think we may see a more earnest demand in terms of merging some of this information together.
You all may be aware of participating with some of the other research-oriented work like the research kit that Apple has put out. Those types of activities and initiatives also seem to be an industry trend toward changing the way in which we engage with our health data that I think has a lot of promise.
I prompted another question.
PARTICIPANT: We heard at the NADO meeting from Dr. Brailer that these wearables that I am wearing and the digital data are operating outside of HIPAA. There is just no control or regulation, which does not really worry me as a consumer that much, but it should probably worry us as a society. It is just a comment.
DR. SUAREZ: That is something that we will probe actually tomorrow too. Thanks so much, Steve. This has been wonderful. I know the incredible amount of work that is being done right now by ONC. We just got a flavor of one of the major areas, interoperability. Thank you for joining us.
We are going to move to Shana Olshan. Shana, are you on the phone?
MS. OLSHAN: Yes, I am.
DR. SUAREZ: Okay. I want to first of all congratulate Shana on receiving the WEDI 2015 Health IT Government Champion Award a couple of weeks ago. Congratulations on that, Shana. We look forward to your report on CMS.
MS. OLSHAN: Thank you very much, Dr. Suarez. It is a pleasure to speak to you all again today. I apologize for not being there in person, which is my preference, but I did have a conflict today that I could not reschedule.
As you all know, on October 1, health systems across the country transitioned to the International Classification of Diseases, Tenth Revision, and I am pleased to report to you all that all signs to date indicate that the ICD-10 implementation has gone very well.
At the end of October, CMS issued information detailing the Medicare Fee-for-Service claims processing from October 1 through October 27. I will summarize that briefly here for you. Typically, Medicare processes 4.6 million claims per day and of those claims, historically, 2 percent of them are rejected. This past October Medicare processed 4.6 million claims per day and had a 2 percent rejection rate. We were able to determine what percentage of claims was rejected due to the invalid ICD-10 codes. Only .09 percent of the total claims submitted were rejected for this reason and that is better than the .17 percent we experienced during the end-to-end testing that we did. Medicare usually has a claims denial rate of 10 percent of total claims processed. And last month Medicare denied 10.1 percent of the claims it processed.
CMS is committed to quickly resolving the small isolated issues that have arisen related to national coverage determination to ensure the claims continue to process. Interim solutions are currently in place to permit appropriate and timely claims payment and in most cases claims inappropriately rejected or denied have been automatically reprocessed and no action is required by the provider.
For the handful of local coverage determination issues that were noted after October 1, CMS contractors have moved very quickly to take action, which is temporarily suspending edits and/or the claims, making fixes as quickly as possible and reprocessing those claims to minimize the impact on providers.
The HIMSS ICD-10 Task Force has been interviewing payers, clearinghouses and providers about their specific experiences with the ICD-10 implementation. They have recently summarized the results of the interviews with payers in the clearinghouses. They are going to share the feedback from the providers and hospitals next month. But overall, both payers and clearinghouses are reporting little impact on their day-to-day business operations and rejection rates appear to be holding steady or trending lower than they were under ICD-9. All of the payers interviewed reported negligible increases in their percentage of pending claims and statistics from at least one clearinghouse showed no change or even slight decreases in the overall denials from both commercial and government payers. And none of the parties interviewed have received a significant volume of provider calls or complaints about ICD-10. This information from HIMSS is consistent with what we have been hearing as we monitor the industry as well.
Given that we are now past October 1, I can shift my focus to the many other administrative simplification responsibilities that the national standards group has before it. The need for greater consistency in how we do our work including how we enforce the administrative simplification provisions came through loud and clear at the Review Committee’s two-day hearing this past June. I found the testimony at that hearing to be comprehensive and thought provoking and I look forward to today’s Review Committee discussion.
I want to share my preliminary thoughts about an evaluation framework that I planned for my group to use moving forward as it considers recommendations for new standards and operating rules. You will see that it needs a fair bit of more work, but I look forward to your comments on it so that I can develop it more thoroughly in a way that makes sense not just to me and my group, but to the health care industry as well. Nothing in this framework should come as a surprise because it focuses on the main concerns we all grapple with in the world of administrative simplification.
The evaluation framework that I have conceived has four main principles that should be met in order to move forward with the adoption of a new or modified standard or operating rule. The first principle is that the proposed solutions must solve a problem or a business need.
The second principle is that the proposed solution to that problem should lead to administrative simplification across the industry as a whole over the long term.
The third is that the proposed solution should allow for flexibility or adaptability to respond to changes in the health care industry or technology and not stymie innovation.
And the fourth and final principle is that proposed solution must be enforceable.
While I am presenting these in a linear fashion, an evaluation using these principles probably won’t follow a linear path. I want to go over each of these for a few minutes. The first principle, solving a problem. How do we define a problem in the world of administrative simplification? I start by reminding myself of the purpose statement in HIPAA about administrative simplification as it was amended by the Affordable Care Act. A simplified version of that statement is to improve the efficiency and effectiveness of the health care system by encouraging the development of a health information system and to reduce the clerical burden on patients, health care providers, and health plans. I think that this purpose statement dictates that in identifying a problem, we must identify a business need or business case to either improve efficiency and effectiveness and/or reduce clerical burden.
Does the identified business need represent something that should be addressed by the Department of Health and Human Services in the adoption of a standard or can it be addressed in other ways? Often times the industry finds ways to address the need absent government requirements.
Priority setting is also critical to this principle and to the framework as a whole. There may be multiple business needs. How should we prioritize the various needs?
In thinking about a business need, we also need to consider whether developing a solution to a problem for one segment of the health care industry might cause a different problem in another segment. If that does happen, the second principle might be important to resolving whether the proposed solution is appropriate to consider.
The second principle is again providing administrative simplification. Administrative simplification is the core of our business in the national standards group. However, determining whether a proposed solution to a business need or problem actually provides administrative simplification as a whole is challenging. Not everything can be measured easily. How do we know if the solution will increase efficiency or effectiveness or reduce clerical burden? We will have to consider both qualitative and quantitative approaches to measuring return on investment. In doing so, I recognize that we will have to make tradeoffs among the various segments of the industry. What may provide tremendous benefit for one segment may be at a greater cost to another. How should we go about deciding which tradeoffs are the correct ones?
I believe that as we make the calculations about providing administrative simplification that we do so in a way that focuses on the long term rather than the short term. Implementing anything new usually has cost. As a result, it is tempting to focus on the short-term costs rather than to take the long view.
Pilot testing may be an important way to determine whether a proposed solution will actually lead to administrative simplification. Voluntary adoption is another way to see if the industry truly believes that the solution does address a business need and in addressing it, provides administrative simplification. Both of these approaches require investments by the participating parties that may or may not be readily available.
The third principle is that of flexibility. In my conversations with the industry, I often hear concerns that the adopted standards often rely on older technology or do not position the industry for such things as a shift to paying for value rather than paying for volume. How can we adopt the standard or operating rules that promote uniformity and consistency while also allowing for flexibility or adaptability? We need to decide in what areas we think we may need such flexibility.
The two areas I usually consider are changes in technology and changes in the health care industry, but there may be others as well. We all need to think about this tension between the need for consistency and the need for flexibility. I believe it is possible albeit difficult to design solutions that strike a balance.
Finally, the standards and operating rules that we adopt must be enforceable. In many areas of government, the policy developers are separated from the implementers and the enforcers. My group has an advantage and that we both write the regulations and enforce the standards and operating rules we adopt. However, we can definitely improve on each of these fronts. And I hope that the evaluation framework we finally settle upon will improve the policy making.
My team is also developing a comprehensive enforcement strategy so that over time we will no longer hear from some members of the industry that the lack of compliance really has no real consequences. This strategy includes finalizing the certification of compliance regulations, improving complaint-driven enforcement and implementing the audit authority provided for us in the Affordable Care Act.
It is imperative that we consider the ability to enforce as we evaluate proposed solutions and ultimately adopt a standard or operating rule. Small changes in wording can shift the enforceability significantly without modifying the fundamental policy. These changes also have a potential to simplify the implementation of newly adopted standards and operating rules.
What I have here today is not new, but clearly articulating how CMS, in this case the national standards group, plans to evaluate recommendations. As I mentioned earlier, this framework is still under development. It would help me to hear from all of you today. If you think this framework makes sense, if you believe that it is missing something fundamental and whether it aligns with where this committee, in particular, the Standards Subcommittee, wants to be as we move into 2016 and beyond.
With that, I would like to conclude my remarks and open it up for any questions or comments you may have.
DR. SUAREZ: Thank you. Thank you for that. Wonderful new framework, really. As you know and for new members and you will probably hear more about it when we present – when we hear from the Review Committee, there has been work in developing some or advancing some formalized process for evaluating industry. We have been doing this since HIPAA was given to us as a responsibility, evaluating industry standards and recommending them to be adopted. Coming to better terms in terms of finding an approach that truly helps us do these evaluations in a more systematic way and ultimately helps us achieve the goals of the program are very critical. Very much I think in line with what we have been doing in terms of our own evaluation process.
I want to ask if there are any questions.
MS. GOSS: This is very exciting, Shana. Thank you so very much for giving us an introduction into your forming principles for your own internal framework efforts. I think that as we as the Standard Subcommittee and Review Committees advance our work over the next three or so months, it will be important for us to have some further opportunity to dialogue about this. I am still absorbing what you have just outlined. I tried to track and take notes. It is a little difficult for me at this point to respond, but it is certainly encouraging and exciting news and speaks to the partnership that we need to have between NCVHS and your group in advancing standards and operating rules and identifiers and code sets that truly help the learning health system evolve.
MS. OLSHAN: Thank you. Feel free to share any comments or thoughts that you might have later on with Carrie. We can give you something in writing as well.
MS. GOSS: It would also be great if you could give us something in writing so we don’t translate maybe what we heard in shorthand incorrectly. If there could be something a little bit more formal that we would receive, it might be able to then be woven into a more effective comment and response process.
DR. SUAREZ: Other questions? Anyone on the phone with any questions? I guess I will ask a couple of questions, more mundane-type questions. We regularly look at what is coming up in terms of the regulatory agenda and again understanding that there are no specifics in terms of the dates or anything. What is your sense about the pending regulations? I know we have regulations around helpline compliance certification and regulations about operating rules. Of course, we are, as a national committee, looking at the operating rules that have been submitted to us to evaluate. And then also regulations around Health Plan ID and attachments and then perhaps any other regulations. Could you briefly say a few words about those for the coming month or next year?
MS. OLSHAN: Sure. I am limited as to what I can say, but I will say what I can. On HPID, I think I mentioned this last time. We did get a number of comments on the HPID request for information. We have been reviewing all of those comments and trying to determine how we can move forward and reconcile the recommendations from the comments with the statutory requirement that there be an HPID. We are still working through what our next steps will be on that.
We are definitely looking at attachments. I cannot say specifically what we are doing yet, but we are so I am excited that it is going to be on the hearing in February. I think it will be excellent timing for us.
As you mentioned, we are working to move forward on certification of compliance. I mentioned that we do want to finalize those regulations and determine how we can move forward on that and meeting the statutory requirements that we have in the ACA.
We are looking at everything that is out there. I keep going back and looking at the testimony from the Review Committee. I am really looking forward to the discussion that is going to happen shortly and any further discussions on the Review Committee because that will also dictate some steps that we need to take possibly next year. I want to get a sense of where the important things are. We are going and looking at all of the past NCVH recommendations and trying to prioritize them with the ones that we have not taken action on in order to move forward on some of those as well next year.
DR. SUAREZ: Great. Wonderful. Excellent. Thank you so much for that. We have Rich Landen with some comments.
DR. LANDEN: Thanks Walter. This is kind of a down the road question, but given the fairly smooth implementation of ICD-10 and ICD-10 replaces 9-CM, which has been around 30 or 40 years, what is down the road? Every code set has a finite useful life. Do we have any sense of what the life expectation of ICD-10 is? And given how much the industry is changing and the CMS movement to value-based – reimbursement value-based purchasing, any idea yet on how we are going to establish the needs requirements for whatever code set will replace ICD-10 down the road?
MS. OLSHAN: As you may be aware, the World Health Organization has been working on ICD-11. That is expected to come out I think in 2017 I think was the last date I saw. Before the United States can adopt the new code set, there are many processes they go through. CDC works on the diagnosis code side of it and CMS works on developing a procedure code system to go along with it. My understanding is that ICD-11 makes dramatic changes from ICD-10. I am just happy that ICD-10 has gone as well as it has so far.
One of the reasons it was really important to move to ICD-10 is its level of granularity is going to be very important to the success of moving to value-based purchasing. I personally think ICD-10 is around for a while. But it might be a question you want to ask Donna Pickett this afternoon because she has much more experience in the coding systems and lifespans of them.
DR. SUAREZ: Yes, indeed. We were just mentioning that. Donna has already her first question before she even presents. I think actually that raises a very good point and that is the opportunity for the National Committee to listen to a more detailed presentation about ICD-11. I have heard and I actually have seen and participated in a number of presentations. It is truly a very different approach all together in fact. It is not the same type of framework that of course we had in ICD-9 or even in ICD-10. There is a lot more connections, if you will, to more granular terminology and vocabulary standards such as SNOMED. I think it will be helpful in the near future for the National Committee to – I know Donna is not prepared certainly for doing that today, but in the near future in the next meeting or next meeting – we can have a more formal presentation about that. Truly, this is something we need to begin to think about.
Last I think it was in September when I mentioned – I brought up the actual letter in which the National Committee formally recommended to the secretary and it was the National Committee that recommended the adoption of ICD-10. I think it was 12 or 13 years ago. If we start now with ICD-11 – I think it would be very helpful to have that type of a presentation in the near future.
DR. KLOSS: I think there is one other area that we might consider for work by the committee. I think it would be very useful to have a more formal assessment of how this transition worked and did not work because there are just some change management lessons to be captured in updating code sets and classifications in our interconnected health system. We just cannot repeat this.
DR. SUAREZ: When you say – do you mean ICD-10?
DR. KLOSS: Yes, but all code sets and classifications and looking kind of more macro, we have a lot of these updates going on not only ICD, but other code sets and they are all done on their own timelines without coordination, without any thought about organizing this for ease of industry adoption. I think this is kind of one of those macro things that is a little more at an operations level than looking broadly at what the standard is. I just don’t still think the US has the capability to implement, disseminate, update these kind of robust code sets the way we are going to need to have semantic interoperability-based health care systems. I think we should take a bigger look at this problem.
DR. SUAREZ: Great idea. Great point. I will turn it back to Alix and Ob on the Standards Subcommittee side, but also as a Full Committee. I think we have an opportunity next year perhaps to look at how in a macro way some of the next wave of transitions of versions of standards will be happening. The Review Committee reviews the implementation of current standards. The Standard Subcommittee is also responsible for looking forward into the future of how these transitions happen. We are on the verge perhaps and next year of receiving recommendations to move to the next version of all these transactions. Right now, all the administrative transactions, as most of you know, are in a version —
MS. GOSS: Did you mean 2017 next year?
DR. SUAREZ: Who knows? I am not sure the recommendation will come in 2017 or in 2016.
MS. GOSS: I am thinking it is late 2017 or early 2018 based upon discussions with –
DR. SUAREZ: The recommendations coming to NCVHS.
MS. GOSS: Yes, because it has to come out of the standards body. It has to go to DSMO and it has to come to us. It is some time at 2017 timeline that is rather fuzzy right now.
DR. SUAREZ: I think it is still helpful to have that conversation that Linda was suggesting next year in preparation of that.
MS. GOSS: I think this is a perfect segue for our Standards Subcommittee Work Plan and Mission Division objective conversation because we want to tip toe towards it for today.
DR. KLOSS: I just want to make one point though. I think it is too narrow to think of this is closest as a standard to be implemented. I think that the challenge for us is to look more broadly at classifications, vocabularies and code sets as a family of special complex change that we need to figure out how to do as an industry more efficiently.
DR. SUAREZ: Absolutely. I think we are implementing on other scales and other domains. There are other types of vocabulary and terminology standards like SNOMED and LOINC, which are required under meaningful use and all sorts of new genomic standards for coding and classifying genomic data in precision medicine, for example. And then also the terminology and codification for population health and social determinants of health and all these. Your point is very well taken.
MR. SOONTHORNSIMA: And the timing with all those changes is really a key issue for us as an industry and as an advisory committee. What we are hoping to do is align some of these things – the context of the changes in all these different domains. What is the appropriate timing when the changes can take place – and that is probably – greatest challenge as these changes are coming sporadically and not completely —
DR. MAYS: I just wanted to kind of support what Linda was suggesting because, for example, in the whole issue of the mental health area, it was just so much chaos and it still has not caught up well. You had DSM-5. You had the ICD. You had integrated care. There was not sufficient training for people. There is a LISTERV on one where every day somebody is asking about which code is what and how much they are getting pushback about using what they used before and they don’t know what to use.
The issue really is the timing, the training, what needs to be pushed out. It is not the standard. I am trying really to get to that. But it is the way in which it can be done so that you don’t have – I can only imagine for the amount of rejections that went on in mental health that it just created a whole lot of work. APA was scrambling to get little primers out for people. But it just would help to have a broader perspective of if we are making this change, this is the set of customers and can we align things.
DR. KLOSS: Very siloed industry. We don’t have the adequate infrastructure.
MR. SCANLON: I think we talked about this a while back and it was the idea – it is not just HIPAA – code sets. It is actually what is the arc in essence for – this would be EHRs as well. What is the arc for when these new classifications or code sets or revisions or so on are – again, I don’t think you can put months and dates, but it is sort of the gestalt for what is – how do you understand what really is coming, how they relate to each other. It was pretty high level. I don’t think we quite – we try, but I don’t think we quite succeed in merging the clinical side and the standards of classifications expected with the administrative simplification side.
Again, I would not even – arguing about dates. We argue about dates a long time. But I think conceptually, what is the arc in terms of EHRs and administrative simplification and when these standards would be expected to be ready?
I might just add that we had a delegation – ICD-10. We had a delegation from the Netherlands come a week ago to HHS. We thought we were going to be chided for being so late to adopt ICD-10. They have not adopted ICD-10 yet. They told us. So much for the Central European centralized health systems.
DR. RIPPEN: Just a quick comment. I cannot remember how long. There was actually I think a call for a committee at one point that was supposed to lay out kind of a trajectory. But it did not really happen in really laying it out. It was just reinforcement of how great health IT is. I think that applying wisdom and expertise to determine what are the implications and what might be an appropriate way to build often times standards and the implication for population health because it all ties together and also even the development from EHR systems and things like that is very important. It is a significant amount of work.
DR. COUSSOULE: I will be very brief. I think one of the challenges when you talk about the arc of change, I think talking about sequencing really does matter a lot. It may not have precise dates and times, but it matters because there may be multiple different roadmaps that all have significant dependencies, but don’t always intersect. Something like ICD-10 where originally it was going to happen and then it got delayed a year and then changed. Wait a second. How does that deal with some of the other changes and happening across the industry that impact lots of parties from a training, from an educational, from implementation? Being an operator on this one, that is very challenging looking over a long time horizon. Maybe this is – just ignorance generally of the committee’s function and role, but talking about these standards is only part of it. Talking about how it might actually come into effect, what the challenges are, how they play out other activities I think is also very important.
DR. SUAREZ: This is a perfect segue. Thank you again. Thanks, Shana, for your report. We will be going now into our first break. We are at 11:10. We are going to take, if it is okay with people, a 15-minute break. We will come back at 11:25.
DR. SUAREZ: I think we will reconvene. The first thing we want to do before passing the control to our co-chairs of the Standards Subcommittee is let you know about our dinner social. Every meeting we have a dinner for those that are new members. We always have a dinner in the first day of the National Committee. We have made reservations for this restaurant. It is not too far away, as you can see, a couple of blocks from the metro rail station and not too far away from the hotel either. It is very near the hotel. I think we need a final count of those that are going to be able to attend. If you want to raise your hand to see who will be attending. Denise is not here. And Helga is not here either.
MS. GOSS: As you may note, my co-chair, Ob, is not going to be in attendance because he is taking care of some priority responsibilities on his day job and is in Boston, which was an unfortunate conflict with this meeting. We are going to be highly fluid in how we handle what was the 11 o’clock agenda topic and also the 4:15 agenda topic. Terri, Ob and I have coordinated on a number of slide decks and content for today. We are going to be handing off the baton at various points and supporting each other to make sure that we cover all the critical nuances that we need to communicate to you and enable us to have a productive set of discussion today.
We are going to start out with the Review Committee in this session. Ob and Terri are going to predominantly be presenting the content for today’s overview of the Review Committee presentation. We thought we would start with some background materials, sets some context especially considering that we have new members. Having set that context, Terri is going to start us out with that.
She will then flow into the process that we undertook to fulfil our obligations under the ACA Review Committee responsibilities. This was our first time through the process. Then she is going to talk about the hearing and what transpired there generally. And then we will turn it over to Ob to handle the feedback and themes very generally.
I am going to put a big disclaimer on this folks. This is our initial thinking on themes. It is not to be translated into hard core recommendations. Please do not run off and say this is what they said and where they are going. It is where we are at this point in the process and we will be evolving the themes that you will see today to the next step of recommendations. Once we have completed going through the summarized recommendations from the industry through the 77 testifiers that we had. This has been a very intense process and it is something that we are all very committed to doing a very thorough job on because it is an awesome opportunity to help improve HIPAA, adopted in 1996 and iterations of regulations since then and to really help set us up for the next generation of health care delivery payment and administrative simplification.
Over to you, Terri, to talk about the background.
MS. DEUTSCH: Good morning everybody.
MS. GOSS: I am sorry. One more thing. Just to confirm, Ob, you are on the phone?
MR. SOONTHORNSIMA: I am on.
MS. GOSS: Thank you.
MS. DEUTSCH: The Review Committee is mandated by statute actually under the Affordable Care Act. It required that the Review Committee evaluate and review the adopted standards and operating rules and make recommendations for updating and improving those adopted standards and operating rules, which we also include the unique identifiers and code sets.
The statute also requires that there be a hearing held at least or not less than biannually and that as a result of the hearings that NCVHS or the Review Committee come up with recommendations to the secretary and so that these can then be implemented.
The secretary determined and delegated and designated NCVHS as the Review Committee. And NCVHS delegated that function to the Standards Subcommittee because the Standards Subcommittee had been performing the Review Committee functions in many ways prior to accepting this function.
For those of you that were not here for November when we had our November 2014 Full NCVHS Committee, we did a very large presentation about the Review Committee and we had designated what the charter was, the process, the deliverables, the hearing functions, and the role of the Review Committee with NCVHS. There are slides available for that that could help you just for the purpose of trying to maintain time. I am not going to go through all of those, but I certainly can answer any of your questions or give you some background if you would like to have that.
Our process and what we did is that we were looking to determine if existing standards or operating rules met the business needs of the health care industry and to see if it did not meet it, how would we recommend rectifying that, meaning would we recommend a modification or would we recommend that there be a different standard or operating rule adopted?
To be able to get the information that we needed to come up with these recommendations, we provided a list of pre-defined questions to the testifiers and ask that they have this presentation in five minutes with written documentation to follow. Our questions focused on the status of the HIPAA transactions and their standards and operating rules, the degree to which these standards, code sets, identifiers, and operating rules met the business needs or the business use.
Were there any difficulties, discrepancies, or problems through the implementation of the standards and operating rules? Was there an inability to adopt the standards and also were the standards and operating rules able to meet new or emerging technology or business needs or health care delivery system changes and also to see if there were any changes that were required to accommodate the standard and operating rules?
And then once we had that information, we were to then and we are in the process of doing is identifying themes, observations, or recommendations so that we can provide a letter to the secretary for DHHS and also to provide a report that would include the recommendations and observations, themes and recommendations for not only HHS, but for the standard development organizations, for the operating rule authorizing entity, and for the health care industry either separately or in combination.
We had our first hearing. This was a rather intensive hearing because it encompassed all of the adopted standards and operating rules to date. As a result, in two days, we had 77 oral testimony. And then we not only had the 77 oral testimony, but each of the presenters also provided us with written testimony. Some even provided written testimony on the panels or the transactions that they were not presenting to, but they wanted to provide feedback. We also had outside. We had the health care industry provide us. We wound up with over 100 written testimony. We have gone through all of the oral testimony, all of the written testimony to be able to make sure that we looked at and addressed everything that was presented.
And the hearing was focused on six transactions. The health plan enrollment, disenrollment and premium payment, prior authorization, health plan eligibility, benefit inquiry, response, health care claim or equivalent encounter, health care claim status, electronic fund transfer, and the electronic remittance advice and also coordination of benefits, which is not a HIPAA transaction, but it is involved in the processes and we did address that.
What I wanted to say before we go on to the themes is that we have – as I mentioned, we looked at all of the testimony and we have to date developed and looked at all of the issues that were presented, all of the recommendations that the industry has presented to us and we are in the process of consolidating, looking at it, identifying how we are going to approach it. As Alix mentioned and as Ob is going to show you, there was a great deal that was provided, a great deal of information that the industry has provided us with. They were very forthcoming and provided very good information. We want to make sure that from a responsibility that we reflect what these recommendations and findings that were presented to us are addressed appropriately. We are taking more time than we had actually envisioned before we began the hearing.
I am going to turn this over to Ob now.
MR. SOONTHORNSIMA: Thank you very much, Terri and Alix. Before we jump right into the content of the slide, I do want to comment. If you think about the changes, the process – that Terri just described, this has been highly collaborative. We are dealing with very – set of issues and there are so many – you think about the changes that are being – of the industry to make over the years. They are – technology and also the business model as we try to achieve the – simplification goals.
With that said, you will – the next few slides will describe contributing factors, feedback and themes. But generally, you can imagine that overall timing – complexity of these changes are – for the business to the – whether it is health – providers and other entities – business rules also do impact how the adoption of these standards – would take shape.
One of the things that we constantly ask ourselves is whether there is adoption and where the business model is being achieved. Often times it is really hard to answer that because the entities are somewhat struggling with the complexity due to the timing and cost and complexity of these changes.
Without any further ado, I will just jump right into the general feedback and some of the comments I just made might resonate. I welcome any feedback along the way as well. Let’s touch on the business needs. Significant progress is being made for sure. We have seen a lot of enhancements, continuous improvement on a number of the standards. We have also seen adoptions being made in some of the standards as well –
You think about some of the key success factors. We heard time and time again – response – there is a critical element to make any adoption of the standards successful.
One comment that I would add in our observations is for those transactions or standards that have been largely broadly adopted, they do take some time to adopt and evolve. We are talking a number of years, several years and long after the standards have been adopted. Implementation and usage of the standards do take some time to do. The progress does not come over night. Progress does take a number of years to achieve. And –
The second key bullet point here is around acknowledging that not all standards or operating rules are broadly consistently adopted. We know that based on the testimonies and also feedback from the industry. I touched on a little bit. If you think about the obstacles that – time and time again and through the testimony. Costly implementation. Timing of the implementation. The complexity of each and every single standard because it is not about just implementing the standards, but also business processes surrounding the end-to-end business processes in the systems are also having to change. Upstream systems, downstream systems have to be changed within the entities themselves whether you are in the health care – health care provider or a health plan – systems are impacted.
The other obstacle that we hear is the dependency on other stakeholders such as vendors. However, when you think about the vendors that are providing a lot of – they are making these changing. However, the timing of these changes is not always – in other words, you think about ICD-10 change that we talked about early today. It did take quite a bit of efforts from all the vendors, the vendor community as well as health plans and providers. The dependency – so many vendors out there. They have to make sure that these changes do meet not only the business needs and the requirements, but also the timing of the implementation – the mandated –
Value is also being questioned in terms of likelihood of future adoption. When you think about, as I said earlier, because it takes so long for those standards that have been broadly adopted. It does take a lot of time for those standards to achieve the level of adoption.
Now we have to think about going forward. Would we achieve value of the current adopted standards that are not enjoying the same level of adoption? Those are things that we have to think about. These are some of the observations that we – from the industry.
Another thing that has to deal with the value is once adopted, once implemented, how enforceable are these standards.
The other feedback we heard loud and clear is there are alternatives such as – registries, the alternatives that the business models have given the stakeholders to move towards over the years.
I will pause here for a moment. Alix or Terri, any other thoughts?
MS. GOSS: I am just going to move to the next slide in consideration of the timing. Keep going, Ob. Hold on, Ob. We have a question in the room.
MR. SOONTHORNSIMA: — the industry in many instances has moved on beyond the standards when the standards were first denied, adopted. And the – why the standards take so long to implement. If you think about the life cycle and rule making process, they take several years to complete from conceptualization of a standard or a version of a standard from the development life cycle by the – or operating rule entity – implementation by the stakeholders and lastly adoption or usage by the broader stakeholders. Those are four high-level steps. Obviously – each one down into – life cycle.
You can step back and look at some of the standards that are meant to support certain business processes, end-to-end processes and add the business model – other vehicles, other capabilities that the stakeholders would come up with and continue to evolve the business that way while we also have to implement the standards because they are mandated. Therein lies the dichotomy of the situation and the challenges that the standards – or operating rules or operating entities and the stakeholders have to interact.
MS. GOSS: I am going to pause here for a second for two reasons. One, I know that in addition to the concepts that are on this slide, we also have discussed piloting and testing as being a core issue. The processes that are layered between business requirement development to SDO development to the DSMO time process to the federal rule making process to get to the point where we have the start gun go off so we can all start to implement and adopt has been an overarching concern that has been presented to this body for dare I say over a decade if not longer and is something that we really are going to be looking at how to garner some efficiencies and get creative in what kind of recommendations we want to make.
I am going to turn it over to Robert for a quick question.
DR. PHILLIPS: It is not specific to this current review of the feedback that you have gotten from industry. It was more a question of why just industry. Are we tasked with looking at patients, other stakeholders in the HIPAA redesign process or are we really focused on industry needs?
MS. GOSS: We are an advisory group to the secretary of HHS. That is our primary audience. Coming along with that, when you think about the influences in Medicare and Medicaid, which are federal programs, those bring along other participants. When you look at HIPAA and you have providers, clearinghouses and health plans and payers in the mix, all of that to me collectively makes up the industry to me.
DR. PHILLIPS: So patients were part of this process?
MS. DEUTSCH: Maybe I can also add a little bit to that. There are designated covered entities that are in HIPAA. The requirement for administrative simplification. That it is supposed to improve processes. And when you are improving processes, that reflects the patients and it reflects some of the non-covered entities also. One of the things that we heard in the Review Committee is the impact of the non-covered entities that are involved in some of these processes and the complications as a result of that. It affects the patients indirectly. We, in a collective term, have called it the health care industry just to cover the whole umbrella and recognizing that there are some issues that have resulted because of the designation of certain entities as covered entities and not including the others as well.
Did I answer your question?
MS. GOSS: I think you are asking whether or not there was an actual patient sitting at the table testifying. Is that what you are asking?
DR. PHILLIPS: Or patient representatives. I am just trying to figure out who the folks were that offered the 77 verbal —
MS. GOSS: We would be happy to go into those details and provide you that. There is a huge laundry list. From a time saving perspective, we will be happy to have a side bar. Absolutely.
PARTICIPANT: It was open to anyone to make comments. Anyone could have done that because it is public. We have a list of quite a few entities that did provide written and oral and it is on the website. But we can also give you additional.
MS. GOSS: Since you sound so interested in the standards and the review committee —
MR. SCANLON: I thought Bob was asking about the privacy side of HIPAA. These are the data standards, the enumerated standards. The privacy side – you will hear more about that this afternoon. They also have a lot of outreach. It is not unusual to have patient groups participate in meaningful use and the privacy because they are affected directly obviously. And security.
MS. GOSS: I am going to move to the next slide.
MR. SOONTHORNSIMA: Good question. Thank you, Robert.
The next theme is around usability and enforceability. I talked briefly about – do exist as a result of the timely and evolution of – a few minutes ago. For example, we kept hearing this over and over again during the meeting – as an alternative. It does create quite a conflict when you have other alternatives. I don’t mean to single out – there are other capabilities as well. But it does – between standard adoption and other practical alternatives that exist. They are up against some of those standards that have yet to be embraced and used wisely. For example, provide a – comparable if not more information and additional capabilities. I can rattle off a few things, but I am not going to do that in the interest of time here.
But at the same time, propagating the portal and when you have a number of – each provider, stakeholder has to deal with, it could become – overwhelming and burdensome.
I think these are some of the business practices. That creates the challenges, but also an example of how the industry gets around some of the – adoption that we talked about earlier with the life cycle and the cost and the timing of those standard adoption.
A broader – of standards depends on compliance and participation from non-covered entities. For example, employers and vendors, government agencies were called out. They do have significant influence and do impact the adoption. We are now saying that we need to make them all or it has not advocated that. All these entities should be – covered entities, but that is something that several feedback, several testimonies have suggested from one – everybody be covered – and others a little bit more liberal.
We are just sharing with you what we are hearing from the feedback. This is one of the things that we have to think about as a Review Committee. How would we address this in a pragmatic and practical fashion going forward?
But I would argue that even without – entities – involvement over the years and – some of the standards adopted have been broadly utilized and quite successful. You have to look at this a little bit more from the use case perspective and how – non-public entities actually do play into the – adoption —
MS. GOSS: Ob has now covered a couple of the slides. We have two more to go. I realize that some of you have already heard this several times because you have been going through this with us since June. For some of the other folks, it is really your first introduction into understanding what we heard as a synthesized view and should hopefully set some context to help you with the report. Although the Review Committee is doing the detailed work, it is the Full Committee that will be obligated to do the final vetting on the report and support the recommendation to submit that to the secretary.
I am going to move on to the next – last two slides. Back to you, Ob.
MR. SOONTHORNSIMA: — think about – how sustainable – or likelihood of adoption for each and every one of the standards. As I summarized earlier in my opening, cost, resources and timing are among the biggest obstacles. This should not be any news to folks who are having to do this day in and day out.
The other issue that is related to the timing and cost is the fact that a lot of entities, a lot of stakeholders are questioning – and whether or not they will ever achieve the broader level of adoption – without adoption – therefore, proof of concept testing, again, continues to be suggested. This is not the first time – from the Standard Subcommittee, we have been hearing this over and over in the past years. We have several letters that we have provided the secretary over the years. We always include – proof of concept and testing. This is, once again, industry provides feedback in the common –
The next bullet point has to deal with – not all standards – greater degree of adoption. I think this is one of the things that we – as I said in my opening, some of the standards have taken years to get the utilization after the adoption of the standard. When you think about the business models that are shifting and the business practices that are changing, some of the feedback we have heard is some of these standards, we question whether or not – adopted – ever be utilized to the level that you – not all standards – you have to think about the timing, the timeline over the next three to five years and what the likelihood of – adopted.
Lastly, this is the common theme throughout. Education, education, education. There is a little bit more – if you look into some of the testimony and the written testimony, there are recommendations and suggestions to more targeted education – not broad-based stuff, but specific aspects of the transaction and standards, how the transactions are actually being used today – therefore, creates better awareness and demystify any pre-conceived notions or any common beliefs between the entities. For example, I heard about health plans have their claim edits and they have all these bylaw rules that are cumbersome. But when you really target what it is that they are looking to do, it actually helps streamline the transactions or rather the business profits between the providers and health plans.
These are some of the suggested recommendations from the industry. If we can target some of these things, help clarify and create awareness around these business practices, that might help – adoption from the provider side as well as health plans. Those are the overall high-level feedback and themes we have gathered thus far.
As Alix was talking – we will continue to deliberate on the themes. We have not honed in on the specific items – sharing that here. With that said, Alix, I will hand this back to you.
MS. GOSS: Thank you for everyone’s patience and indulgence as we ran you through those high-level feedback and themes. Hopefully, they are resonating among those who attended the Review Committee and hopefully some of those in the audience who have been anxiously waiting for some of the indications of where we are headed.
The next thing that we need to do is the committee – I would like to have some discussion here to clarify questions especially those who have not been engaged. But we, as a committee, are going to be scheduling a few more calls to finish vetting the detailed industry feedback to help us solidify our general list of themes and feedback items and then that will iterate towards recommendations and production of a draft report. We will see how far we get with that. While we have been working through this, we have been thinking about a format, a table of contents, and a structure for it. Hopefully, between now and the end of the year, we can start to pull that together and hopefully maybe even have a draft report in February, but that is really dependent upon the Review Committee’s participation and directions and the progress that they make.
I am going to open it up for some general comments.
MS. MTUI: Question from one of our online listeners. A comment. There has never been an official return on investment study conducted of this program with sufficient data from a statistically significant sample of industry. It is just a comment.
MS. GOSS: Thank you. Could you offer who that comment was made by?
MS. MTUI: Lorraine Doo with CMS.
MS. GOSS: Hello Lorraine Doo. Thank you for that input. If you have any suggestions or thoughts on that, you can coordinate with us separately. Anybody else have any questions?
MR. SCANLON: Can I ask one question? Were there ideas about – you mentioned the cycle. And HIPAA has a minimum time before you can change standards or modify, but did any of the testifiers indicate what that cycle of adoption and implementation and then the next cycle is? Is it two years, three years?
MS. GOSS: I am not quite tracking with you. Are you talking about the SDO timing? Are you talking about the federal adoption process?
MR. SCANLON: Federal regulation issue that requires the adoption of a standard or whatever it is or re-modification or a version. With EHRs, I think the industry was saying they needed like a three-year cycle or something like that. So don’t do any modifications of the standards before that. Give us time to implement the previous one. I remember that HIPAA had a provision as well. But I wonder if the industry folks thought it was —
MS. GOSS: I know that the industry, as a whole, has testified to NCVHS in the past. I know that specifically because I was one of those people sitting on the other side of the table, representing X12 and doing it along with Lynne Gilbertson and Margaret Weiker and at one point Maria Ward from an HL7/NCPDP perspective. We have some thoughts there that I think we can pull out of that white paper that they provided us. But I think there is going to need to be some – I think we need to think about the context of the adoption cycle. Once we vetted some of the other themes and feedback issues, we need to think about who is in the end-to-end testing, covered entities. They are all parts of the process. Until we vet those, I think it is a little bit premature to think about how we can make some other recommendation.
MS. DEUTSCH: What they did say and what did come out in the hearing was the fact that there are multiple other things that are coming out at the same time so trying to look at – and they did recommend and ask that we do a timing and sequence so that we are not – for example, meaningful use at the same time as other standards. Indirectly they did, but I don’t think directly any one said that they need five years or whatever timeframe.
MS. GOSS: I do think that there is a nice parallel to the efficiencies we have seen in the EHR adoption cycle and we definitely want to learn from other people’s successes.
DR. PHILLIPS: Just a quick question for clarification. SDO means something in my lexicon. What does it mean here?
MS. GOSS: It is the Standard Development Organization.
DR. SUAREZ: My comment was going to be with respect to your question, Jim. In the administrative world, we have not had the need to look at moving very quickly and concerns about moving very quickly with the adoption of standards because the cycles have been every other eight years. In 2003, we adopted the first standard, which was 4010. In 2012, we adopted the next standard, which was 5010. We are already in 2015 ending and 2016 starting and it does not look like we are going to be doing it until 2018 or afterwards.
PARTICIPANT: I think it is optimistic. I think it is more like 2021.
DR. SUAREZ: It could be even farther than that. We have not had the – the concern that actually has happened in the EHR world where we adopted standards every year and having to update and get recertified with EHR products and then get implemented the EHR products that have been certified and then implement the functionality that has been new. In the cycle, there has been at least according to the vendors, the EHR vendors have to be at least 18 months if not two years, but at least 18 months in order to allow for the final rule to adopt a new set of standards for certification and then the start of the implementation of those standards. That has to be at least a cycle of about 18 months. We were running into less than 18 months in the Phase 1 and even some of the Phase 2.
DR. LANDEN: Walter, if I could piggyback on that for the EHR industry. It is 18 months, not just from the final rule, but also any additional required collateral documentation, the validators, the test tools, the NIST test grips. It is 18 months from the time. All of that is available. It is not synonymous with the data or the publication of the plan or rule.
DR. COUSSOULE: This is as much a comment as a question. I think one of the things we tend to lose sight of as we are looking to implement both to capture and to define the standards and implement them, we tend to lose sight of the use cases and business value that drove us to create that standard in the first place. We have to make sure through this process that not only are we talking about how we will implement these things, but how we will in fact derive value from the implementation. That needs to be part of every conversation, every step along the way. It is often times easy to get caught up into how we are actually going to do it because I think that is where the industry change – you were just talking that it changes. It is not in decade cycles anymore with some of the stuff we are talking about. It is a lot faster than that. The pace of change will drive us to revisit in some cases the details of what we are trying to execute to make sure it still solves the problem we set out to solve.
MS. GOSS: That really speaks to the timeliness of our cycle as well.
MR. SOONTHORNSIMA: It speaks to the likelihood of future use and adoption of some —
DR. STEAD: I sense a disconnect between our ability to bring our Review Committee – and our comments about acceleration and time and the industry. From my perch at least, a committee largely has been in consensus about what we need to say since the meeting. We have to hold ourselves accountable. We need whatever help we need from Jim and others to deal with whatever support we need to get it done to be in a position to approve a report at the February meeting. If we don’t do that, it will be a year from hearing to report. We will have opportunities to create additional Review Committee reports. I think we have to lay out a critical path to get this thing done and I think we need to get it done, otherwise, we are asking the industry to do things that we won’t do. I just don’t feel good about that.
MS. GOSS: I don’t feel good about it either, Bill. We have been definitely challenged with committee member availability, staff availability. It has been very challenging especially with the volumes of it. I encourage the Review Committee members to respond to the Doodle poll that will be coming out and to provide the requested commentary and mark ups to enable us to get to that next stage.
I also would encourage the members of the Review Committee to go with the process and structure that we have been trying to approach this in the last month or two because I think we have also – we have been evolving this conversation around the body of work. We have had a number of very good and creative ideas, but it has also rebooted and delayed our ability to effectively vet all of the distinct recommendations that we got from the 100 plus testifiers. I think the disconnect on timing and producing the report. I feel it too and I would love to have a report generated and for commentary in January so that we could actually tie something up in February. But it is going to take a very focused effort of all of us and staff between now and the end of December.
MR. SOONTHORNSIMA: I totally understand where you are coming from and I completely agree. I also feel that the time we spent together over the past month has been extremely important because they do drive every comment, every feedback that the committee members provided. It really helped us ground our themes and what we think we should say and need to say. I think we are there. There are a lot of things that we are not talking about today. But we will take off line and talk about it some more. Now we are going to focus – we already started focusing on standard by standard, transaction by transaction. We are close to getting the draft. I think we will be there, but we do need that discipline and participation.
MS. GOSS: The last meeting that Ob and Terri and I had we got at the very heart of the conversation and how we think we can do some things to help advance getting to that report. I had talked to Walter and gotten the sense that we want a February report out. Hopefully, we could even maybe finalize it ideally, but we don’t really want to wait until the May meeting to approve it. It would be too late.
DR. SUAREZ: One of the alternatives that we have mentioned is throughout the entire documentation of feedback, we developed two types of recommendations. One recommendation is to the industry at large including recommendations to helplines to providers to vendors to others. And then another one, which is much more narrower, is the recommendations to the secretary. One very important aspect that I think should be emphasized is this level of recommendation that we are making this time around based on the Review Committee have a higher, if you will, level of rigorousness because the law says that the secretary has to act on the recommendations within 90 days, which is unprecedented. It is relatively impossible to act upon except to say the secretary has started to move things along on the recommendations, not execute the actual recommendations. But considering that, the type and the specific language of the recommendations to the secretary have to be very carefully crafted and prepared.
One of the suggestions in terms of next steps. We have been talking about this report and the report is certainly a very significant document. It would be potentially a significant document. It is probably going to be a significant document in the sense of the content, in terms of the background and analysis and all that of the feedback. The alternative was to consider focusing for February on the development of the actual recommendations of the secretary. Framing the recommendations in a document that is simpler and shorter with the expectation that we would also produce a larger report from the Review Committee that could be then brought up later on and approved later on. It will mean basically a year after we would have a full report.
Certainly, this is the first time we are doing this review. This is the most extensive review that we are doing. For the first time, we actually are sitting at the baseline for all the nine HIPAA mandated transactions and the current status and all of those across – of all the transactions across all the standards, the code sets, the identifiers, and the operating rules for those that are applicable. It is a very large baseline we are building. It is important to take the time to do it right for the larger report.
But for the secretary’s recommendations, one suggestion has been – if we see we are not going to be able to really generate a report for which we are going to gain consensus and we are going to get approved in February, we should have a Plan B, which would be extracting the specific secretary recommendations and making it simpler, shorter document that can be then presented as well to the committee.
DR. MAYS: I want to say that I think Bill’s point is definitely one that we need to pay attention to.
The other side is what Walter is saying. I want to come back to that. And that was there are these two things. One is the industry and one is the secretary. The secretary is used to getting reports. The question for me is whether or not a report is really what can move the industry. It is not just giving them a report and receiving it, but whether or not there is another format for us to consider.
I remember right after the meeting, we talked about things like should we write an article in either one of their trade places or in JAMA or someplace where it creates a very powerful kind of discussion that really gets them out of the weeds and gets a lot of different stakeholders to pay attention.
I want to think a little differently about the industry and what can move the industry to have the level of discussion because of the pressure of having it be a much more public kind of discussion.
MS. GOSS: They are interested. I got a request to speak at the HIPAA summit specifically on this topic.
DR. KLOSS: I was just going to say. I don’t think that is mutually exclusive. I still think we need a comprehensive report of the effort and then slide decks and some of the other.
MR. SCANLON: I might mention that the idea – we do this as well at HHS and even the IOM does it. You don’t have to wait two and a half years to do a full contemplative lucrative report. We often ask for shorter term deliverables, which I think you are talking about here. It does not even have to be one or two. A report means your analysis and your recommendations. It does not necessarily mean one big – there are ways to set parameters, indicate what the issues are, what will be coming next. And the industry can see and react to that.
By the way, I don’t think the industry just waits for us. There are industry standards. Maybe the implementation part of it is they are waiting for regs.
MS. GOSS: But hopefully industry is now participating at the standards development organizations or SDOs, helping to generate the next iteration of the standards that we expect to see in 2017 for adoption.
MS. JACKSON: Just another process and timing issue. I am so glad that Jim is here to help hear the plan of attack or purpose or intention of having various documents. And the committee has done this. We did this with populations where you have a summary of your material and then afterward worked on your recommendation. Now this is just putting it another way.
The days for the 2016 meetings between February and June. The last couple of years we had a time period in between there. A Full Committee – if you need some wiggle room, if you need some space to realize you need to have a gathering, which is a great place and a great space. Keep in mind for something in February, you would need something mid-January essentially to start getting it up. It goes on the web. Two weeks before the meeting. Maybe in this case, two or three weeks. Time gets away from you. In this time period now, by next week, people are shutting down and still do the middle of January. It is just that reality. Just to give yourselves – you have a little space in case you need to have a form or a connection as a Full Committee before June.
DR. SUAREZ: Great point, but having said that, we do want to try to the best we can to have something we can act on in February. That is, again, the entire full report. We can segment and we can structure the deliverables. As Jim said, it does not have to be just those two. The secretary with recommendations to the secretary and then the larger report. I feel the sense of urgency that Bill is bringing and I think we all feel. Certainly Ob and Alix and Terri do too. We want to try to work.
I am looking at the timing. It is February 17 so the middle of February. Basically, in essence, we have between now and the end of January to complete this.
MS. GOSS: Actually, that is not true. We have between now and the end of December for the committee to finish up their deliberations, finalize the text, get it vetted by the committee and then release it by the middle of – I would think January.
DR. SUAREZ: You are adding more details in this. I am just saying by the end of January, we have to have whatever is going to go to the committee for review and approval. In between now and January, there is a lot of things that you are already pointing to that needs to be finished including by the end of December, all the points that you made. I am just talking about by the end of January, we need to have whatever is final that is going to go.
MS. GOSS: Is it the end of January or did I hear maybe if this is going to go on the web?
DR. SUAREZ: No, the end of January. It does not have to be middle of January. It can be all the way to the end of January. We have three weeks, the first week, the second week of February and then the third week of February to work on that.
MS. GOSS: Is there a step in there that I need to be mindful with the Executive Committee?
DR. SUAREZ: The Executive Committee can meet in the early part of February.
MS. GOSS: Great.
MR. SOONTHORNSIMA: We can do an impromptu meeting too, Walter —
DR. STEAD: I will just advocate that while we are here, we lay out this timeline and then we work back from it. We have in essence – if we are going to get this done – I have been part of these discussions. I understand what we have been working our way through. I am not being critical. I am just trying to help us have the discipline to manage to our objective, which I think means we have to lay off the timeline. When we get to one of those steps and we see we cannot close it, we either have to adjust scope or we have to double down. I think we are all –- and say we are not going to move the timeline again. Once we get something that this whole committee is trying to assess if there are disagreements about it, that will put us into another cycle. Fine. But we have to get to the point that we can surface those disagreements. I am not trying to bring this to closure ahead of time. I am just trying to get it onto a discipline process. I think the time has come.
DR. MAYS: I just want to make sure that we are clear as to what we want too. I think Jim gave us some other ideas. Maybe we blew it up too big. I think if we can have a discussion about how to do maybe different pieces of it.
DR. O’GRADY: Just one thing. Mostly, we have talked about our own timeline. I would ask if it is possible from Jim. We kind of need to know what the secretary’s timeline if there is a decision to be made. I can think of a lovely IOM report that came out two weeks after the bill was signed.
MS. GOSS: Do you mean in regards to the recommendations we make?
DR. O’GRADY: Yes. Whatever the internal – it would be –
MS. GOSS: We have 90 days to respond to it.
DR. O’GRADY: I know, but decisions may be made on a different timescale. If it is all on the regular of what is going on. Like you say, different actors in this are not going to sit on their hands and wait for us. If the secretary is being pushed to make a decision, is being asked to make a decision at some point, it may totally be with what we know about and this conversation. But if Jim comes back to us and says she really wants to hear from us with two weeks earlier than we think – two weeks earlier than we think.
MS. DEUTSCH: Let me tell you what the statute says. There are calendars and timelines. We have not met this for a number of reasons. The Review Committee did not come into fruition until after the date that it should have been coming into fruition. We have lost a lot of dates and time. But it says that the report is no later than and I am going to adjust it because the date is wrong here. Three months after the hearing is when the report to the secretary was due. And then after that, it says that any of the recommendations to the secretary have to be adopted by the secretary through the promulgation of an interim final rule no later than 90 days after receipt of the report. And the effective dates of the amendments to existing standards or operating rules that are to be adopted are to be 25 months following the close of the common period of that interim report.
The fact is that having an interim final rule and the ability to implement is going back to what Walter had indicated. Is the timeline based on all of the clearances and many factors are not able to be accomplished? We are looking at the ways that the recommendations to the secretary are specific enough, that are achievable, and that have some meaning, which is a little more complex than just coming up with the list of all the issues and global themes, et cetera. I think that that is part of the issue. But if the goal is to have a letter to the secretary and it can be done that way. This just says a report. We can come up with a letter that is specific to the secretary and specific to HHS because the authority is only over HHS and then in the report, there can be recommendations that would affect, as I mentioned earlier, the rest of the industry.
I think that as long as everybody is focused on what are the issues that affect HHS, what are the recommendations that HHS should have and if it requires rule making that it can be done in the 90 days or as was mentioned earlier, is it something that has begun and is not needed to go through rule making?
DR. O’GRADY: That all makes perfect sense to me. I would just suggest that you double check with – to make sure that you don’t have a trip to Turkey coming up so a decision has to be made two weeks earlier than you think it is and therefore you are left out of it. Part of the notion here if you are the secretary is you are getting people coming in and talking to you on these issues. This an advisory board that is meant to give her a second opinion if you think of it that way from a technically expert group that also has some representative of various players and this sort of thing. You guys are killing yourself to get this all ready. And all I am saying is that timing is to – you are matching a timing that is in the statute and laying out the plan. All I am saying is that timing may get thrown off. Just call to make sure that – just to make sure that that is when the decision is going to be made so you have input into the decision or at least advice towards the decision. That is all I am saying. Check internally just to make sure we are still on the right track because I think most of you guys would rather not miss that window if it is somehow is not when we think it is. That is all I am saying.
DR. SUAREZ: We did check. Our customer in this case being the secretary in CMS, we did check with her. The understanding is that recommendations by February would be the right timing. I think we heard Shana mention that as well with respect to, for example, the hearing and other things. But I think that is the goal really.
I have very quickly five steps for coming between now and February. The first one I would say the Subcommittee completes the development of the packet, recommendations by the end of December. There are a lot of things between now and the end of December to complete that process.
Then the document, the packet is circulated to the Full Committee for input in January and the deadline for the Full Committee input back to the Subcommittee is January 20.
Then between January 20 and February 1, the report is finalized in terms of the input received from the Full Committee. The Executive Committee meets in the week of February 4 and makes the final approval to move forward. And then the report gets published in the NCVHS website the week of February 8, which is exactly a week before the National Committee meets.
MS. DEUTSCH: Are you talking about the letter or the report?
DR. SUAREZ: Whatever product.
MS. DEUTSCH: To the secretary?
DR. SUAREZ: Yes. Between now and December 31, we have the ability to on the Subcommittee level develop either the full report and have the possibility of completing it or consider whether we will have enough time to develop a full report and then focus primarily on the secretary’s recommendation with the letter. And then that is what gets developed by the end of December. That would be my suggestion in terms of timeline.
DR. KLOSS: I am just going to jump in here without all of the background facts. What are the barriers? I am a member of the Review Committee and I have been one of those who have missed the last – but it seemed to me that it was in pretty good shape. Do we need more resources? What do we need?
MS. GOSS: Can I answer this please? We need to finish a committee review and establishing consensus on what shakes out as being worthy to go into the next phase of either recommendations or industry commentary feedback report or whatever you call it. We are close. I appreciate all this feedback because it is very validating to the conversation that Ob and Terri and I have been having about how to get us to a point of getting a report out the door or whatever the work product is.
I think that Walter outlined a timeline that he went through pretty quickly, but I think it tracked already with where we were headed and the process. We have a Doodle poll already in the works or about to go out to the Review Committee as well as the Standards Subcommittee effort for getting those extra conference calls on the docket. That will be focused on getting to the detailed transaction section that is left of the compiled recommendations. And then Ob and Terri and I are going to take that feedback, distill it down to try to produce something of substance that we can then get the Review Committee feedback on before we kick into the overarching NCVHS Executive Committee and full NCVHS review.
The big barrier. It is called volunteer.
DR. KLOSS: I know. My next suggestion was is there an opportunity then to begin some of that. Could we do some work while we are here together? Can we just roll up our sleeves and make some progress?
MS. GOSS: We have some other obligations with our Full Committee responsibilities. We have Review Committee and Standards Subcommittee. We have tried to break them. This afternoon was to be around Standards Subcommittee.
DR. KLOSS: Why don’t we change that plan?
DR. SUAREZ: We will have a chance to do that during the meeting.
MS. GOSS: I think that it is certainly a viable option, but I don’t think that we came prepared to discuss that. I don’t think that there are a lot of people sitting in the Full Committee that would understand the background or have the reference documents. As I have experienced with people bopping in and out of the process that that is what has been creating additional delays, distractions, and protracting our timeline.
DR. SUAREZ: Sorry. I did not mean to say – you only have 45 minutes this afternoon. There is no time to do any of that in 45 minutes. I did not mean to suggest to do the review during those 45 minutes. I am just saying we can in five minutes concretely finalize the timeline, only the timeline.
MS. GOSS: It is sinking already with where we are at. I think it was great that you summarized it.
DR. SUAREZ: Just having it as a template, that will be the main thing. That is all I was suggesting to consider for this afternoon.
MR. SOONTHORNSIMA: Walter, I heard the feedback loud and clear. We are definitely on the same page – Review Committee to get this done by December to get a draft report in whatever shape or form. That means it has all the themes, all the key recommendations – and then work in January to get closer to a final draft. That is why we always earmark February. Now that you have given us a time in saying that the Executive Committee will meet on February 4 and get their approvals. That just solidifies a plan at this point. But that is what we are going to work towards. If we need to break the report down in what you suggested, that is absolutely —
DR. SUAREZ: Perfect. Thank you. Any other questions/comments to report to subcommittee? We are almost on schedule. We have the lunch break until 1:30. We will reconvene at 1:30. Thanks very much.
A F T E R N O O N S E S S I O N
DR. SUAREZ: I think we are going to go ahead and reconvene. We have Linda, Rich, and Nick to still come in. We will just go ahead and start. This afternoon we are going to start with the subcommittee activities. The first part is going to be focusing on population health. We have two topics on the agenda, two special guests to cover a couple of very important topics. The first is Donna Pickett, who will be talking about ICD-10 and a little bit about ICD-11. And then we will have as a special guest Dr. Karen DeSalvo, as I mentioned. She will be coming at around 2:30. And then we will have a break and come back and continue some of the discussion from population health and finish up the day with our Standards Subcommittee and then our data access and use work.
I don’t know, Bruce and Bill, if you wanted to lead this next part. We have Donna. Donna is the director of the standards group within the National Center for Health Statistics. I probably have the title wrong. I believe actually you took the position that Marjorie Greenberg had before. Congratulations on that too. It has been already a year at least. Donna also is one of the co-chairs of the ICD – coordinating and maintenance committee. She has firsthand experience, knowledge and responsibility over ICD-10.
Just a quick intro about ICD-10 and ICD in general. For maybe new members and others, we think of ICD in at least three different ways. ICD-10 and ICD-9 are used in the public health space as in vital and health statistics. That is something, I think, Donna is going to mention, how we actually in this country have been using ICD-10 for a number of years already, but it is only in certain vital reports.
Then the second area on the other end of the spectrum if you will is the use of ICD-10 in administrative transactions, which is what just started to happen October 1. That is where providers and payers use it in the transactions, the claims, and all that part.
And then there is the use of data that is captured and collected and reported from the provider and helpline side, mostly from the administrative transactions to public health for public health to use. That is one other area where the new ICD-10 is having already an impact. We wanted to just make sure that – we understood this morning we heard from Shana about the implementation of ICD-10 in the administrative world in the provider and health plan side. Donna, I think, is going to touch on these other ones. We were just talking before the start during the lunch break about some of the opportunities for the coming meetings to bring back this topic in the form of probably b February having a panel that will present on ICD-11 since we had that interest and began to talk about that. And then by June have another review of – by then we would have some experience on how public health agencies receive data from providers and payers in the form of discharge data or claims data. How are they experiencing the transition to ICD-10? That might be something that we add to the June agenda for our Full National Committee.
With that, I will turn it to Donna.
MS. PICKETT: Thank you, Dr. Suarez and the committee. As Walter just indicated, we were looking to divide up the three streams of work when it comes to the implementation of the ICD-10 code sets. CMS covered off on the administrative simplification part of it this morning, which was basically talking about the claims environment.
Also, as Walter just mentioned, ICD-10, as published by WHO, has been used by the US for death certificate reporting, underlying cause of death, and leading causes of death since 1999. Finally, we can say that for the morbidity side of the applications, which everyone is familiar with, October 1, 2015, 20 years in the making. Thank you to all of you, some of you who are around the table as well as in the audience who supported the effort. We finally are there.
For discussions related to ICD-11, here is hoping that when those discussions start that it does not take 30 years to move the discussion along. At that point, I don’t think many of us around the table will care about that. We will leave it to our successors to worry about that.
From the public health perspective and that is what Walter and I had talked about originally in terms of the presentation here for the committee, it was to look at the public health use or the impact of the use of the I-10 code sets. However, unlike the administrative side of things with the processing of claims, the public health side really has not seen the influx yet of the I-10 coded data. Some programs have either because they are collecting verbatim text that they are then coding internally for their program use, some that are receiving electronic data files may start to see some I-10 coded data coming in. But for the most part, public health with a capital P, capital H really have not yet seen the data coming through the door.
But that does not mean that they have not been preparing themselves for that to come through the door. For instance, AHRQ in the ICD-9-CM-based world had a number of tools and software for quality measures that they had developed for the ICD-9-CM world. For those of you who haven’t visited the AHRQ website, they now have a wealth of information about the migration of many of those tools to an I-10 based world. If you go to the HCUP page, they have a number of software tools and a number of applications that they have already migrated to I-10-based codes in preparation for the receipt of coded data coming through. Many other programs have done that as well both at the federal level and also at the state level. But, again, some of that has not necessarily been rolled out and been made apparent to everyone. But HCUP certainly has that information available.
Some of the CDC programs that are receiving coded data have already provided instruction to their external partners on how to submit I-10-coded data and that information is available on some of those. We can make some of those links that are currently available. We can make those available to you so that you can take a look at what is happening in terms of the landscape for the work that is being done. There has been quite a bit of work that is being done.
In fact, we heard from some external stakeholders that when the last delay was announced that they were ready and eagerly awaiting and then had to sit out for an additional year, waiting for October 1, 2015.
And then in sidebar discussions with NAHDO, again, I think they are seeing the same thing that their partners have done a lot of work to receive the data, but they have not received it yet. The analytic part and the part where people are going to be looking at impact on trends has not necessarily begun, but they have begun looking at the code set itself to see where there are some possible changes that affect what they have been doing either from a large data set or even if it is a focused disease entity like asthma or diabetes.
There are changes in ICD-10-CM where you have expanded details. That will be more information and programs will need to look at how they are going to review that data and see if they possibly need to consider changes in their analytics and reporting out in later years. Certainly not probably within the first one or two years, but also to look at issues that may have been dropped from ICD-10-CM. One example would be hypertension where WHO made a change that the detail that was in 9-CM for hypertension that talked about unspecified versus malignant versus benign is no longer in the WHO ICD-10. Again, 10-CM is based on the WHO classification. For those who may have been looking at that particular disease entity, they will need to make decisions about what they do going forward and working with their subject matter experts because many of the programs that are analyzing data or changing their case definitions work with their internal and/or external subject matter experts in making new criteria or further defining what is within the scope or not of the work that they do. Some of that work has already occurred with CDC and its partners specifically working with the Council on State and Territorial Epidemiologists and a number of other groups.
As Walter was mentioning, it is likely that more information will be available that we can present in June because – I am trying to think. FDA, AHRQ, and several other HHS operating divisions really don’t anticipate having data coming in until somewhere between April and late May, early June. They are not going to know what the impact is until things start to come through the door. Again, if you are talking about quarterly data, that still may not be sufficient data to actually base any decisions on.
I think when Walter and I were talking during the lunch break, we saw this as the opening of the discussion and not the end of the discussion with more information to become available in the future as public health begins to gather up the information and make its way through what the potential impact will be. They likely too will be reaching back out to their external partners as well in terms of refining criteria, et cetera. More to come as it relates to the public health impact.
Actually, Walter, if I may, I was going to turn to Denise from the NAHDO perspective since we have been working very closely together whether there were any things that I missed that you thought were important to toss out there.
MS. LOVE: I think you covered it. What has been interesting is in programs that are looking at the ICD-10, the important part I think has been it has made them reassess the ICD-9 base codes. In so many cases, they could not explain why they were collecting what they were in the first place and what clinical concepts were they trying to – and there were some missing. It really was helpful in some programs that evaluated their ICD mapping first to look at the base codes and then after the mapping and we have the tool and at NAHDO.org we also have the MapIT tool, some of the recorded webinars as well, and some SAS tools, conversion tools.
But then working with the programs to look at what is lost and what is gained in this new coding scheme. For instance, pregnancy. Now, you have a code for trimester. You have to rethink your clinical concept of what you are capturing. Is it pregnancy in total or are you looking at what trimester? DVTs, vein thrombosis was interesting because you have now more codes. Do you want the upper extremity or just the lower extremity, acute or chronic? It really is quite important. We have been working with Dr. Romano at UC Davis in this project to really think about the underlying clinical concepts that you are trying to capture and the codes and how you map those will vary and how inclusive or exclusive you are. That is all I will say.
I still have not figured out PCS. That, to me, is more dramatic than the CM, but it does not affect public health as heavily. We probably are not hearing too much push back on that.
DR. SUAREZ: Thank you. I think one of the interests that we had was the question about trending data and the transition of data that have been calculated using ICD-9 with now data as being calculated using ICD-10. There are certainly the mapping capabilities, but there is some refinement that creates some of the data – renders some of the data somewhat questionable in terms of training. That is one of the interesting points.
I will turn it to Bruce and Vickie in terms of questions.
DR. COHEN: Very, very exciting time. I am looking forward as we move forward. A question. Actually, a couple of questions. One is about comparability ratios and is anybody thinking about trying to develop those. You guys are laughing so I am sure this is something that you have talked about a lot.
And the other is does ASPE or NCHS or any other HHS entity have an overall evaluation plan set up or in place as the data become available to really monitor impacts not only nationwide, but on subpopulations where there might be differences in – that we might see due to the changes in coding.
MS. PICKETT: I am going to ask Suzie Burke-Bebee to join me at the table. Jim Scanlon had referred to work that was being considered in ASPE for a comparability dual coding study. I think Suzie has probably some additional insight in that.
MS. BEBEE: A little bit. I am Suzie Bebee with ASPE. About two years ago, I had the idea that we needed to do the same thing in this area as we did with mortality. There is a relationship that we have from ASPE and NCHS where NCHS is actually looking at the comparability piece. I have not recently been given an update. I am in the process of hearing about that, but we are looking at having an expert panel that is advising the center. Also, looking at recoding the surveys from nine to ten and from a physician’s perspective and then going from there to look at the process of those ratios.
DR. COHEN: That would be great if you could keep us involved. I think there are a lot of folks here from a variety of perspectives of population health and certainly standards who would be interested in this work and reviewing and being involved. That would be good.
MS. BEBEE: Our intent is that when there is enough information to share, we are intending to do that.
MS. PICKETT: There is some additional work that is being reviewed as a possible next activity from the CDC perspective as well. Once those discussions are further along and we have some concrete venues, we will definitely come back and provide an update on that as well. But we are not quite as far along yet in the process and what data we will be taking in to conduct those comparability studies. It definitely is under discussion.
MS. LOVE: Part of the problem is there have not been any available dually coded data sets.
DR. MAYS: I want to kind of go to the same place. Suzie may need to come back to the table because I want to ask another question. Again, I have brought this up before and everybody knows mental health is my thing. There is a chaos that exists right now. I am trying to figure out the best way to make sure that at the end of this process, we are going to come out better and not more confused.
From a research side what has happened is NIH, particularly NIMH has said we are not going to do DSM-5. When you start talking about crosswalks between DSM-5 to ICD, they have decided to do something totally different called RDoCs. They are looking at this diagnosis differently.
Then what you have are the people who are in the field trying to figure out what is the ICD and then in terms of this is what we used to do and we did DSM. They want to be in integrated care so they are trying to figure out what to do.
In this project, can you pay special attention or can you get people to really give you a sense of how mental health is fairing in this process?
MS. BEBEE: That wasn’t thought about in the way that you have described it. It wasn’t part of the planning. But we can certainly go back to the table and talk about what it might be and what it might look like going forward. This is very preliminary, but it is ground setting for going forward. But I think that is a great point, Vickie.
DR. SUAREZ: You talk about the use of DSM versus ICD for coding behavioral health.
DR. MAYS: It is two different concepts. One is from the research side for the public health issues. What happens when an agency like NIH or AHRQ is not doing it when they say I want to use something totally different? I don’t like the new DSM-5. The crosswalks are developed between the ICD and the DSM-5. If you throw one of them out, I am not quite sure where you go. There is that issue.
And then the second one really is the extent to which people don’t know the codes to use. In the old codes, they are not fitting well enough. It is just a lot of confusion right now that I think at a federal level, bringing some kind of clarity would help immensely.
DR. PHILLIPS: Just very quickly to this idea of double coding. The current EHR I am in and the one I was in just two months ago, both have you code in ICD-9 and then ask you to choose ICD-10 codes. I have been dually coding for at least a year. I don’t know if some of the EHRs that offer that would give you some insight into how these codes are comparable. It is a bit of a forced – because you are starting in ICD-9, you are already setting a template for what it is you might be looking for in ICD-10. But at least out of the gate, it might give you some comparable data. But it shows you the direction of specificity though on the frequency on ICD-10 based on what you put in ICD-9 because you are forced to choose one of the ICD-10 codes.
DR. SUAREZ: On the EHR side, you choose an ICD-9 code that is somewhat generic or whatever ICD-9 code you were choosing before. And then now you are going to choose an ICD-10 code that is much more granular. One too many issues are – the same code is going to be represented. The ICD-9 code is going to be represented in multiple ways. There is less of the one too many from I-10 to I-9.
MS. LOVE: But they have collapsed some clinical concepts. I will point you to a tool.
DR. PHILLIPS: I have used them.
MS. LOVE: The MapIT? Reverse and backward and forward.
DR. PHILLIPS: The other problem with doing it this way is if physicians often also choose whatever comes up first because they are used to getting this list this long. It is just too tiresome and not valuable to me necessarily in the clinic to say is this right leg, left leg. I understand the few to many issues, but it gives you an in vivo sense of at least how this process is working and what the comparability is because it might tell you that you need to do it differently.
DR. COHEN: And I also think that the needs for comparability in the clinical setting are different than at the population health setting. I think some of the issue of the one too many does not wash out completely, but it is taken when you aggregate up for population health surveillance, looking at trend analysis, it becomes less of an issue.
DR. SUAREZ: In some ways, the issues on the clinical side, in the administrative side, and in the population health side are somewhat different when you code.
One other area now is the use – for example, EHRs now have to have capabilities is the coding and the use of terminology standards like SNOMED, which are even more refined. It is a total different concept because it is not really a classification of diseases like ICD-10. It is much more of a terminology of clinical concepts. There is that type of a mapping as well. More and more we are going to see people natively coding on SNOMED that then will have to generate things into ICD toward billing purposes, for example. Billing is not using SNOMED.
DR. LANDEN: Another aspect that hasn’t been touched on yet is when you in this age of interoperability that Steve Posnack was talking about this morning. You take a code set from how it was originally captured. You map it. You transmit it to somebody else. If that somebody else re-transmits it then the second receiver of that data – are they going to keep it in – which code set are they going to put it in. If you have a one to many transmitted then map many to one, you could have two ICD-10 or ICD-9 codes. Same patient, same procedure, same diagnosis. Completely different code. That is kind of a one off case. It does not happen much, but for those circumstances that use it, it adds a very interesting degree of potential error into the coding base.
DR. SUAREZ: And then there is this -– I think Donna was mentioning one other – many different areas of implication, but one of them is quality reporting. I think that is one area where – I am still very interested in seeing how – just like with billing, the biggest concern was really maintaining the same level of reimbursement or payment as you transition to the other codes, the new code. With respect to quality measurement, how much of the quality measures that use and are generated using ICD are going to be changing because now we are using ICD-10 and it is much more refined? Trending again becomes a little bit of an issue. That other part is going to be interesting to see once we begin to get the experience of reporting data for quality purposes on ICD-10.
Any other comments or questions for Donna? Anything from the phone? Anyone on the phone with questions?
DR. RIPPEN: It is not really a question, but maybe a consideration. When we think about code sets, we understand that they change. You see this jump in codes if you look at trends because inherently that is the nature of changes in codes and how we interpret them.
But it would be nice to think about what sort of evaluation framework we should have as we do any changes in code sets. When we do pre and post, how do we assess the impact? I think if we can come up with something like that then we can have a roadmap kind of in place to learn over time the implications of changing these things and do a better job or at least be wiser in the future too.
DR. SUAREZ: Raj, is that you? If you could speak up a little bit so that we can hear you.
DR. CHANDERRAJ: I have a question, but I can email Donna and get the answer for that.
MS. LOVE: This is to follow a little bit on Helen’s. As you or programs or organizations delve into the ICD-10 and find that it does not meet the needs, what we are encouraging programs to then go to code maintenance to update because ICD-10 – ICD-9 had a decade or more of updates that evolved. ICD-10 does not have any of that code maintenance yet. Some of the programs I have found that codes have been collapsed that they have been tracking. They are going to have to go – I think ALS is one of them. They are going to have to go back out and have that split into code maintenance. But the programs themselves and the users need to pay particular attention to what that mapping does to what they are trying to track and work with Donna.
MS. PICKETT: Part of the issue is 10-CM up until a point, we had been updating it, incorporating things that were incorporated into ICD-9-CM. But of course, we have been in a partial freeze for the last four years. There are a number of concepts that are expected to come out next year, which represents almost four and a half years of delays and freezes. But for the most part, much of what was in 9-CM has found its way into 10-CM barring the last four years.
But also what has been incorporated into 10-CM has been some of the annual updates that WHO has done for ICD-10. But again, some of those things have also been warehoused for the last four years because of the partial freeze. We are actually getting input from multiple directions, but Denise is correct that as some of the public health partners are looking at their favorite codes, they are seeing that some things expanded and they are happy about that. But there are other areas where they have less information than they previously had. Denise was mentioning ALS. They have already put forward a proposal that was presented at the September coordination and maintenance committee to expand on the ALS codes. But, again, that is part of what is being considered for the October 1, 2016 update.
But we are encouraging people now that 10-CM and PCS are actually implemented to take a hard look at what is there to see if there are additional improvements that might be useful from a variety of purposes, not just the reimbursement purpose, but for surveillance, research, epidemiology, population health. Again, when we are updating ICD-10-CM, we are not looking solely at claims and reimbursement. We never have.
But, again, until I think for some entities until 10-CM and PCS went live, they really had not hunkered down to actually look at the codes. And now that it is live, I think we will probably see more proposals coming through the door, not that we hadn’t seen proposals over the last four years because we have had. But I think those entities that were still cautious about whether or not it would be implemented and how much work they needed to put in advance of an effective – will now likely start sending forward more proposals. We have already had some inquiries since October 1. I am expecting there will be more.
DR. KLOSS: Thank you, Donna. I am sorry. We had slow service at lunch so I missed the first part of your presentation.
It occurs to me in thinking about this update process that given what we have just been through, it might be good for CMS and for your agency to start communicating that. The industry should be prepared for a pretty extensive annual update on October 1, 2016 because of this freeze that we have had and a protracted freeze.
There will be just some pushback or back lash, if you will, and we have just been through this. This indicates that all these things were wrong when that is not the case. This is just the cumulative update, the annual update times four plus. I don’t know. I am just thinking from a communication standpoint getting out early on that message might be useful.
DR. SUAREZ: This particular first round could be significant because of the cumulative number of changes. As Donna and I were talking about during the lunch break, many – all these changes come from all the different specialties. Each one wants their change to be adopted and implemented quickly so they can continue to or start using the better code. This first round is going to mean basically a significant change. I think advising people, announcing it and mentioning it is going to be important.
Any other comments or questions? Hearing none, thank you so much, Donna. We look forward to February when we are going to have —
MS. PICKETT: Did you want to mention anything about what we might be able to bring forward to the February meeting related to ICD-11?
DR. SUAREZ: I just want to say it would be great to have a panel presentation, a review basically of the conceptual structure, the framework of ICD-11, the timeline because I think it is not anymore 2017. It is actually 2018 now. We are seeing it by the time we as a country adopt it, it is going to be in the 20 plus. But it will be helpful to have the framework about ICD-11 and the understanding and how some of the areas of comparison between 10 and 11 and those kinds of things.
MS. PICKETT: Certainly we can work with the committee to bring forward a panel for the February meeting that talks about it at a high level and what the status of ICD-11 is. And WHO has just posted a week ago an updated newsletter regarding the status of ICD-11. Yes, the new proposed date is 2018, but for those of you who remember presentations from Chris Chute of several years ago, it was ICD-11 in 2011. Then it was ICD-11 in 2013. Then it was 2015. Then it was 2017. And now we are at ICD-11 at 2018. It is fluid. There is a lot of parts that are trying to come together to make that Rubik’s Cube look really pretty, but a lot more work to be done. I think probably having a panel in February would at least provide a high-level overview of the status of the work and be able to provide input directly in terms of what things might be taken under consideration that perhaps may not have been considered during the review process. I can also send a link to staff to include in any further emails for the newsletter that is now posted.
DR. SUAREZ: Thank you so much again. We are going to turn it to Bill and Bruce for population health update.
DR. STEAD: Thank you. What we are going to do is to start reviewing what we learned at the workshop yesterday. We will pause when Dr. DeSalvo gets here to hear her remarks and have conversation with her. We will then resume. Once we are done with the discussion of what we have learned at the workshop and next steps, we will then take some time to discuss our current view of the subcommittee work plan for 2016, largely reflecting what we think we have learned yesterday in the workshop.
First, I wanted to thank Denise and Dr. DeSalvo when she gets here. The synergy that occurred between the National Committee and its convening authority and the Office of the Assistant Secretary and the action ability that that puts behind what we are trying to do has truly been awesome over the period of the last three or so months and I think contributed significantly to having the right people in the room. We had order of magnitude 100 people. And you see that they came from both health-related and non-health-related organizations. We did have people from different sectors in the room in a conversation that as far as we know has not taken place before. We also had deep experts who had been thinking about this for 25 years. This really was pretty remarkable.
First, we will walk through the points of consensus that appeared to emerge in the conversation. The first is a much more clearer statement of the purpose of what we are trying to do, namely to improve the community well-being. You notice we have really shifted from health care to health to now to well-being through support for multi-sector collaboration at the neighborhood level.
There is I think clear agreement on the value of a core set of cross cutting domains. Much less agreement on what those domains ought to be as we will come to in a second. But the clear need because they would provide a common language. They would help communities asses where they are by being able to compare to other communities. Within an area, they would help the different sectors see how to focus their effort for collective impact.
Everybody agreed that there was a critical need for sub-county data. If there was a single clarion call that we have to figure out how to address, that is it. Opportunities such as providing better tools to access the ACS, making better use of vitals, other approaches to doing that.
Clearly an opportunity for much greater collaboration across the federal agencies and programs. Charlie is clearly willing to convene his counterparts across the statistical leads across each of the agencies.
And agreement that we needed an environmental scan to understand how other sectors are approaching care domains.
The challenges. How do we achieve parsimony, which I think everybody believes we need to do while including key sectors? That is a challenge.
How do we meet other sectors where they are? We have done a pretty good environmental scan of what of this work has been done in the health-related spaces. We have attempted to make sure that we are paying attention to transportation, et cetera within that limb. But transportation has its own view of core domains. We may bridge more easily if we actually reach out and see if we could almost begin with core domains from another space as a way to just show how serious we are about the bridge.
And then how we support this combination of assessment of where people are, which takes comparative data with data that is really much more local and focused on the support of local action.
Vickie, do you want to come speak to this table because we have been doing just in time data-driven analysis of the various flip charts that people put out?
PARTICIPANT: With that, I will give my scientific caveat that this was done by me in the back of the room this morning in about an hour with very low-tech tool of an Excel spreadsheet. There were ten tables and you are going to hear some reflection of what Bill went over in coming out with individual recommendations from the tables.
Seven of the ten recommended identifying or inventorying what data and domains are already available, both health and non-health, and at what level of granularity.
Then about half, five said revise domains. There is a whole list of recommendations within that recommendation to revise, including making a conscious decision if the domains are going to focus on clinical outcomes versus root causes, consider methodologic issues such as weighting, feasibility, data quality. The clarion call came back from several tables. Need more small area estimates, micro, or community-level neighborhood data. Include measures of community policies and actions, not just the assessment, but what are communities doing about those issues. And consider indices versus individual measures like the environmental justice index.
And then next there was – half the tables had a recommendation that before the domains are finalized that you actually need to convene and seek inputs from communities and the people that are going to be using the domains. Half said conduct pilots, community testing, gather case studies, which are really related to the one before.
Be more clear on the purpose and the utility of the domains. Three, make data available in one place, i.e. a data portal with tools such as visualization tools. There were also recommendations for meta-data and very precise definitions. Make the Census ACS data more accessible and usable. And then finally, encourage cross agency at both the federal and state level collaboration on developing the domains and on accessing data.
DR. STEAD: Thank you. At high level next steps, we need to develop a report of the workshop. Our thought is that we should have that done in time to go to the Executive Committee for February 4 in conjunction with the Review Committee draft so that we could bring that forward. That report would not need to be treated as an action item at the February meeting as we did last time. What we would do is get whatever input people felt needed to have for it to be revised and then mounted as a report. But it is not a letter or recommendation. It would include themes of recommendations, not the individual ones of them.
We need to work with Denise and Dr. DeSalvo in whatever way they want us to in the meantime to provide feedback to them as they continue to act in the short term because they are trying to get something done in the near term. We could provide that feedback.
Revise a roadmap of longer term steps. We will presumably have initial revision of that in the draft report that we were bringing forward in February.
Then we would develop the more detailed recommendations to the secretary and the letter to the secretary probably for the – definitely by the June meeting if in fact we end up with an electronic committee activity before then. Our thought is that by the time we come out of the report, we would be close enough to this that we might could go on and do that in that way.
I will hand it to Bruce to talk through some early draft ideas of what some recommendations might look like.
DR. COHEN: Thanks. I will do that and also I see lots of folks in this room were here yesterday too. I would love to get feedback from folks who were in attendance.
I am going to do my David Letterman impression. My top ten list. It is actually going to be a top six list. This is very preliminary take-a-ways or thoughts I had about some potential ideas. I divided them into essentially two buckets. The first three are related to content. These are ideas moving forward. And the next three are related to methods, some of which Vickie and Bill already talked about.
Number one is performing this environmental scan to compile a comprehensive overview of these domain and indicator data sets being used in all federal agencies and programs. It is really important to consider asset-based indicators and community resilience indicators as part of this. There are so many of these indicator data sets that folks talked about. We need to almost do a meta-analysis, not only within HHS, but really reach out to the other folks, transportation, HUD are doing phenomenal work. As we expand what our view of population health is, we need to really pull this all together in one place so that we can move forward here. I think that would add enormously.
Second is as part of this ongoing process is really after the meta-analysis, figure out how we can develop and recommend a set of multi-sectorial indicators that can be used for a variety of purposes and how wonderful would it be if we could get consensus across federal agencies to have some kind of collaborative set of indicators that different agencies could use. Of course, different agencies have different objectives. They might want to drill down more deeply in terms of indicators and their particular domains. But if we all started with a constant set of indicators or domains that would be phenomenal.
Do you want me to break now for Dr. DeSalvo? I just have two more minutes. I am doing my David Letterman top ten list from yesterday.
The third substantive idea is when we develop this integrated set of multi-sectorial domains, we should consider orienting healthy people to focus on this simpler and broader content set of multi-sectorial domains with a menu of metrics that folks who have specific purposes and communities that have specific priorities can use within these domains. Those are the three basic content take-a-ways from me for yesterday.
The three methodological foci. One is we really need to review existing data sets that are available at small geographic levels and make them much more accessible and usable for communities. We talked about ACS. We talked about vitals. There are a bunch of other federal agencies that actually have data that are available at the zip level or Census track level, but there are communities that are not really aware of how to access and use these data. We need to do a lot more work in that area.
The idea of creating these easy-to-use data portals that provide access to these small area data is the second methodological take-a-way for me.
Finally, we need to task NCHS, Census, and other statistical agencies to develop easy-to-use guidance and resources for communities so that they can implement their own community surveys so that they can do their own – so they have the tools to do simple data analysis and actually I think even more complex data analysis because there are more and more ability at smaller levels to do such things as small area estimates.
These are the kinds of things as we move forward. Some are short-term. Some are longer-term that we are going to be considering as we develop our work plan. I am done.
DR. SUAREZ: Thank you so much, Bruce.
DR. COHEN: Folks, maybe I can take one or two quick questions before we get to Dr. DeSalvo or any comments from folks who were there yesterday. Any thoughts?
DR. SUAREZ: We can do that after because there are a number of comments. I think a number of us are going to have. Very exciting meeting yesterday. Thank you, Bruce.
It is a great pleasure and honor to really welcome Dr. Karen DeSalvo to the National Committee on Vital and Health Statistics. All of you know Dr. DeSalvo as our national coordinator for Health Information Technology and of course the acting assistant secretary for Health. We want to certainly express and extend our very warm welcome to you, Dr. DeSalvo. Thank you for joining us.
DR. DESALVO: Thank you, Walter. Again, thank you guys for accommodating some time on the schedule so we could have a discussion about some things that have been on our mind. I know you are keenly aware of them. Thanks to Denise for being so engaged with this.
As I understand it, what would be helpful today is if I gave you all a high-level overview of what we are looking at and thinking about and wanting some partnership with in the work of improving health generally. And then hopefully have some dialogue and discussion. I have had a little bit of a snapshot of what you all have been talking about for the past couple of days, but I certainly look forward to hearing more.
Before I begin to make remarks, I am going to say that I am pretty sure I am preaching to the choice as we say in the South. Forgive me if I am saying things that you guys know, but I want to make sure I get through the thinking.
We are at an incredibly exciting moment in the history of health in America for a variety of reasons. One is that the Affordable Care Act gave us this really great gift of expanding coverage, taking away one of the significant barriers to better health and access to health care that we have had in this country for many decades, more than that really, and has now though not finished created I think an open doorway for us to start thinking about what happens when people enter that health care system. We have been quite focused at HHS on improving that care system to see that it is more efficient and effective and person centered. Even if we get that 100 percent right and that is necessary. It is not going to be sufficient to get us to health in this country. Community after community, not only in the US, but across the globe would recount the same story.
And the reason for that we know is from what we believe we understand about the determinants of health that health care is some small portion of it in the neighborhood of 10 to 20 percent. And the rest of it are other determinants of health, very often largely driven by the conditions in which people live, learn, work and play, their zip code more than their genetic code. Though all of these things together interplay and come out the other end with somebody’s health. If we don’t as a country move beyond our dependency on health care as the solution for improving health, I think we are doing a disservice to the people that we are here to serve.
Please don’t misunderstand me because we have been serving people well. There has been tremendous work, but this opportunity has created a lot of hope for people like me and I suspect people like you all.
The other things that have changed are that because of the Affordable Care Act, public health as an infrastructure in this country is being freed from being the provider of last resort for many vulnerable populations and communities. I would love to argue with you all about that. But I have a particular bias about the opportunity for public health to move back into a role of primacy, a convener, a stature and accountability to everybody in their community in a way that their accountability to their patient population is not a distraction from that broader accountability.
Data has changed the landscape. We are swimming in data, sometimes in information, and have I think an opportunity to leverage it. It is not only for some of the more traditional ways that we have been leveraging it in areas like surveillance, but big data, analytics, and opportunity for big computing and tools that are available at the fingertips of every elementary school kid in this country like GIS are changing the way we visualize and think about information. The country’s movement towards open data and thinking about this is being a democratizing opportunity to share information and really reflect on how we are doing as a community more in real time and not relying on data that sometimes can get stale particularly at the local level.
There are probably a lot more reasons that we are at this really nice inflection point. But it does I think call us to action in a way to think again about how we are defining health in this country and what are the levers we will use to advance that and think about our responsibility to have a way to define a true north and to be able to point us in the direction.
In the collective impact model, which is probably as old as mankind, but well defined now in new ways of thinking about how communities can move forward for action and public health. It is a terrific model, but it does require having something that you can measure and monitor so you can set clear goals so you can find your true north and know what you are working towards as a collective.
As we have been thinking about what is this next chapter, how do we get to health as a country, it turns out, as you all know, to be an awful lot thornier to pick what is that measure. What is that index? What is that way that we are going to know that we got there?
I can tell you we talked a lot about it at HHS. I think we are running into the problems that I understand you all have been talking about, which is very much of what we measure right now in a systematic way, especially in the US government, is individual-level data. We don’t have a lot of community-level indicators.
We are still heavily dependent upon indicators that are dependent upon the health care system as a measure of success and I think are having a hard time not only as the US government, but as a country, conceptualizing how to measure and monitor and improve health. I don’t think it is so much of a measurement problem probably at the end of the day as it is a responsibility problem because it really is a truly shared indicator when you begin to think about health-related quality of life as an example. It isn’t only the public health system or health care system. It is really transportation. It is really every person in a community. I think the cultural shift that we have to make about that shared responsibility that we have to each other as a community in that community sense of the word is a place we are going to also have to get. It is one thing to measure. It is another to hold ourselves accountable to and say this is how we are going to improve.
I believe that one of the major changes that we will have to make structurally to help us get to the other side is just strengthen public health. That is not the reason I am here today to talk about that. But without a stronger public health infrastructure in this country, one that is accountable to everybody legally, morally, has that kind of responsibility to see that we are moving these health indicators. It is going to be quite hard to keep the movement going on the ground. It is not really clearly the responsibility for any other entity in a community.
But as part of that work, as we are thinking about modernizing and supporting public health in this new chapter of public health that we are calling public health 3.0 – public health ready and strong to work across sectors to address the multiple determinants of health and to work towards a set of shared measures. We need those measures. We are not going to be able to even think about – we can think about, but act on the recommendations that have been laid out so many times before and see that we can move forward on them in this really unique special time in history.
I will put to the IOM as an example. Just recently in 2012 our report about things that we should do to strengthen public health. Even embedded with that is this request that we develop better measures at HHS and beyond so that we know what our true north is and how to get there.
I wish I had the answer for you guys. I don’t exactly. I am pretty sure that you all have the answer. I am counting on you to get it in the next 430 days. I have an app on my phone that reminds me. Not a whole lot of time and I want to put a really big wedge in the door. That door is the door to HHS. I know that the frontier on the ground. There is a lot of experimentation by public health, by health care, by communities about how to measure success in their communities. I know there is frustration. They need to know that they are making progress and they are relying, for example, on the county health rankings, which is a great beginning tool, but it is not the kind of tool that as a local health commissioner or mayor that you can count on. You cannot build policy and then a year later when I understand if you made a difference in your community if the data is blended data that is already two years old when you look at it. The world just doesn’t want to work that way anymore.
We need to work much more quickly and have a more rapid cycle if we are going to really bring quality improvement to policy action on the ground, which is what communities are doing. They are tapping into additional data sources. They are looking at purchasing patterns in big box stores, but even small stores. They are looking at ways people are using transportation or bike share to try to understand what is happening in their communities and we need to help them. We need to put some structure on that. What they have told me and what they don’t want and what I did not want when I was there on the ground is a thousand ways to measure this. I need to compare myself to other communities.
While we are thinking about this at the national level, we need to be able to compare ourselves to other nations so we can understand if we are making progress, if we are getting return on the investment that we are making as a country. If you want to get down to brass tacks, it gets to be kind of a financial discussion. People want to know they are getting a return on their investment.
Public health. I don’t think ought to have to have a business case, but it does. I don’t think that business case comes from how well health care indicators look. I think it comes from how healthy a community is and how healthy it remains. If we are going to see that we are going to be able to continue making investments, not just in the public health infrastructure, but in all of the parts of that collective impact model, we are going to have to be able to show that we are making progress.
I am a lumper, not a splitter. When I was doing my research part of my life, I was a person who did work on single item measure of self-rated health. I might have told this group. I feel like I have told you this story before. In general, how would you rate your health? Excellent, very good, good, fair, poor is a terrific way to ask a person or a community about their health because it is not only a level setter and an opportunity to stratify or risk adjust, but it is also predictive. It gives a sense of future vitality for a person. There are a lot of domains that go into single-item measure of self-rated health. There are lots of ways you can ask the question. Many options for response. Trust me, I did a lot of noodling on that. I even tried Rasch Analysis for a while, which is way beyond my capabilities to describe to anyone.
But at the end of the day, people’s brains are really good at telling us how they are doing. They are a super computer. They are going to roll up their access to transportation and economic opportunity and their physical health, their emotional health and they also have a trajectory. They have a sense of where they are going.
I am not saying that is the measure, but what I am saying to you all is that we need to first of all trust people and whatever we decide to do, I would like for us to include a self-rated measure of health because for communities and for people, it is powerful, predictive, and not only state-based, but also trait-based. We need to respect the people that we are working for and with and this is a way that their voice gets really heard.
There is clearly I think in addition a need to stay. The reason I mention this single measure of parsimonious. There will always be lump or split or fight in a world of measurement. But we need to make whatever we end up with, if it is a dozen or some number therein. It has to be straightforward enough that anybody would understand it. That it would speak about health and that it would meet all the other expectations of measurement. But I think we get ourselves in trouble with a lot of complexity.
Yes, there is a lot of sophisticated ways we can do analytics. It is not accessible to many communities. And whatever we do in this world of building this true north, it has to be something that is accessible to even the smallest county health department with a couple of staff that they would be able to pull it from someplace. Let’s also be thinking about every person, meaning every infrastructure in the country.
My last piece about this is maybe two things. One, I mentioned the number of days. We have a very strong sense of urgency about what we can and should get done. I think the window, the door or whatever it is opened again. It is going to stay open for a little while, but I do feel a convergence of opportunity of people’s willingness to tackle this problem again. Get some shared language. Come up with this true north so we can really get to work on what the key elements to move forward on building well, healthy, whatever we are going to call it, communities that are sustainable and not just part of a special project.
I want to partner with you all wearing either of my hats or both and commit to you guys that we want to do – when we sort out what this looks like and what are the ways that we can make a difference at HHS, those within my control or those where I can influence, I am committed to doing that because I think it is the right thing to do for the people of this country. I think as soon as we can move beyond just thinking about health care as the way to improve health and respect and recognize what the people already know, which is that it is much more than just their health care experience and find a way to measure and mark that so we will know if we are making progress and we will know where we need to keep investing. I believe that in a few years hence we are going to be really proud of having to have the chance to do that and have done that.
DR. SUAREZ: Thank you. Thank you for those remarks. You have found certainly partner in the National Committee. We work in at least four different spaces. We look at standards. Mostly one of the big sources of data, which is standards related to administrative transactions, the claims and all the data and in the administrative world that it is used quite a bit in defining and setting policy in public health and even health policy in general. We work in privacy and security. We work in population health and that is what really makes it a very strong connection with what we are doing. We work in finding ways in which the data that the federal agencies have can be used and can be accessed in a more usable and useful way. All of those areas really touch on this work.
We have an incredible experience yesterday with the workshop that we held. It was extremely well attended. The diversity of perspectives and participation was incredible. We have the big fortune of connecting. I am not sure who made that connection, but it was a very good connection with Denise Koo, who came to us and expressed that interest in saying we are looking at this need. It couldn’t have come at a better time. Our Population Heath Subcommittee certainly engaged. We are now in a pathway in a roadmap, a process or pathway to help define those kinds of concepts that you are looking at.
We were discussing yesterday how we have good information at the national level, good information at the state level and then we have good information at the individual level and sort of in between at the community level if some of the elements start to break because of the lack of enough granularity to come to that level. I think that is one of the interests in trying to help define those types of data and data needs and data elements of importance to the communities.
One thing I think we came out with as a message at least personally and for me it was very significant having worked in public health so much was the real move from looking at diseases and sickness and disparities and all these areas in trying to move towards looking at health and wellness and well-being and equity. I think that was to me a really important message that came through and came across pretty much all the discussions really sort of transitioning and going into that direction. But I think there were so many messages. I am glad that when you came in that Bruce was describing his top six. I have my top ten actually too. I think we all have it. It was very incredible and exciting time.
We have now a process in terms of the next steps laid out. We very much look forward to continued to work with Denise and with your office. It has been just an incredible opportunity to partner in as many ways as we can to help advise the secretary and you on this issue. We will certainly be looking forward to doing that. Thank you so much.
I am going to open it for questions or comments from people from the committee.
DR. COHEN: I don’t know whether, Denise, you want to say anything. Denise was a phenomenal collaborator and partner. Again, I am not exactly sure how we made the connection. It was Rebecca who cannot be here today.
PARTICIPANT: It started with Vickie. I was having a discussion with Vickie Boothe. Then I called NCVHS and said who should I talk to at NCHS? I then was connected to Rebecca.
DR. COHEN: It was phenomenal synchronicity. One thing, Dr. DeSalvo, that I think is really central to this discussion is it is changing the culture. It is changing the culture of the federal government particularly HHS around defining what health is and that leads to changing the culture around what is important for collecting data.
The feds have done a phenomenal job historically, I used to be a fed and I worked at the state, generating national visionary information. Sometimes the focus on community got lost. I agree with you. This is a wonderful chance to change the culture to refocus the commitment of the federal government on supporting change at the basic – I consider neighborhood the basic building block level. We have all drunk the Kool Aid I think. I think you are right. This is an incredible opportunity to move us forward in this area.
The other take home message for me from yesterday was how excited the Department of Justice folks were, EPA was. The gathering of like-minded folks who have been separated by federal agency designations. Charlie Rothwell cannot be here today because he is at a meeting of statistical agency folks from other agencies. He said he is going to talk with them about what happened yesterday and how important it is breaking down and crossing over those barriers. Having HUD and Transportation develop their own set of indicators and having HHS develop their own as a waste of time when we are really talking about the same thing. How great would it be – just before you came in I said if the federal government could operate from a common set of domains and then each agency could drill down depending upon on their specific needs and priorities so that we are all working with communities, the same communities in a common kind of pathway.
DR. DESALVO: Bruce, thank you. The culture piece. We had a little bit of a pathway in our conversations in OASH about identifying a measure of culture change. Barbara Johnson has been trying to figure this out for quite a while.
I will just tell you a little story to give you hope, which is that back when you all know from New Orleans, there was this thing that happened, this storm. It was catastrophic and 1800 people died. I don’t mean to make light of it. On the other hand, the stories about CMS. The then administrator of CMS said to me that this was in 2005 that there was this guy named Tom Farley who was in New Orleans who was telling CMS that they ought to – when they rebuild New Orleans, not just focus on rebuilding hospitals, but rebuild communities. The person said to me we pay for hospital beds. We don’t pay for bike lanes.
If you think about now just ten years what CMS through their Medicaid program in particular, but is also thinking about more broadly is willing to pay for, it is a really big cultural change. It gives me a lot of hope and excitement that in a short period of time how quickly we can emerge. Wait until that data starts rolling in about how it really is making a difference.
Even just thinking about data collection, I know that is a little out of your purview, but in the administrative data space, we are going to have to have some kinds of ways to be able to understand from an accountable standpoint for dollars going out in programs like CMS to know if we are making a difference in some of these other domains of health.
The piece about the broad domains for government. It is exciting and interesting. I heard a little snippet about that from Denise. It would be interesting to conceive of how that could be done, how there could be a dashboard that had economic vitality or whatever we thought was the – or happiness, whatever is the key indicator. And then you could make your own outcome predicated on your own analytic model for it. I would be very interested and open to that.
DR. KLOSS: Thank you. It is great to have this chance to talk so soon after yesterday. One of the themes I heard that perhaps was maybe not yet captured or fully discussed was the softer side, the need not just for data and metrics and so forth, but for community building. I wrote down are communities competent to take the data and act on it. One of the participants said we have to balance the speed to action because I think there was a lot of sense of speed to action with the need for community building and to build the competence and confidence of communities to take action. I think that might not necessarily an NCVHS sweet spot, but something that will take some more collective thinking on how best to do that.
DR. DESALVO: I am glad you raised it because it gets to this idea of how we define community. Is it a neighborhood? What is the unit of measure? I have a lot of faith and confidence in communities. I was just in Johnson City, Tennessee, which is apparently closer to Canada than Nashville, as they shared when I was there. And this – factoid, the data group. I have not verified. I trust that, but I have not verified that fact.
This community does not have a public health department. They have regional health. They had discovered that they needed to do something about diabetes, which led them to obesity, which led them to nutrition and physical activity and as a community. Faith-based, schools, city council, whoever else had essentially implemented health in all policies. They did not have a checklist. They did not get a grant. They just figured it out as a community and they were using data. They are using data to understand what their trajectory looks like. They are small enough. The 60,000-person community and most everybody that works for the city who is willing to give some information. They have been able to track data.
They are interested in broader notions, third-grade reading level, and the number of biking trails and walking trails they have. The more lift we could give them to give them more data I would see it accelerating. But there are other communities that they are either due to size or due to distractions aren’t even quite that far.
I share their story to say I think sometimes we make it more complicated than we need to. It is about will. The more lift that we can give them by a clear set of measures that we think make a difference.
But there is this predictive modeling piece that I don’t know if you are getting to or not, but it is of great interest to me, which is that back to the bike lanes and the beds conversation. If you knew, as a community, that you wanted to – I will pick an individual level indicator like life expectancy or another like reduce infant mortality, a population indicator. And you knew that you could build an analytic model to say where are the places we should invest our resources. It is in better third-grade education or it is in smoking cessation. It is in better primary care. Whatever that is. Then they would know how to allocate their limited resources. That is a slightly different take on this data piece. But as we get more sophisticated, I believe it is going to help us allocate resources more thoughtfully and more impactfully even before we can grow the pie.
DR. MAYS: I am glad that you are here. Yes, we all drank the Kool Aid. We are going to see what we can do to really try and achieve your goals in those 400 and something days.
There were two things that emerged yesterday that for me were striking. The first one was the topic of well-being. I was struck by how many community groups had their own idea of what well-being was that they were measuring. But if we come back into our health domain, we are still struggling about it because we are very disease focused. We are very individually oriented even though for Healthy People 2020 we had well-being.
One of the things that I think really was cutting across all these agencies, which could be one of the uniting factors is to talk about well-being and to talk about where we want communities to be, to go because it seemed to be that is what they wanted is to come up with how to be a healthy community, what is a healthy community. I think that is one of the spaces for us to really think about with the other federal partners that can really create some momentum.
The second thing that came up is the focus on individual versus a community. With the community or neighborhood or whatever, we are not focusing on the extent to which mobilizing a group impacts the health of the individual. We keep putting blame on the individual for behavior change. We keep putting the blame on the individual for their status of health. But then we come up here with social determinants. The environment is bad and this and that. But we are not doing community responsibility for health. We are not doing community resiliency to change health. We are not doing community engagement. For me, the aha was that issue of groups have a lot of influence on individual’s behavior. They set the tone. They can be stigmatizing. They set the social norms. We know this in terms of things like smoking and drinking, but we are not doing it in terms of good health to some extent. For me, those were two things that I would actually put out there.
DR. DESALVO: Those are great. This is sort of a notion to me about the shared responsibility piece and this culture change. Until we can say this is about the whole community, it is not about one person’s choice in a community. It changes the conversation and the levers and actions that we want to use. Even though I think we know intellectually and scientifically that it is about systems environmental and policy-level change, we are not really applying our resources in that way.
Back to Johnson City, that is one of the reasons I was so excited to meet these folks is they are thinking like that. They are thinking when we pave over the new sewer line, we are going to put a bike path there. And a public works department that of their own volition. They were not instructed to or told to. They were just thinking in how are we going to help our community to improve. We have to have a way to know that it is improving. I think that reinforcement cycle is part of this measurement piece that is missing for folks. It takes a little bit long for it to get there.
Something else you said, which may or may not have been inherent was what does well-being mean. That lumper or splitter issue. It is such a big generic term. There has to be an amazing amount of literature and we could do a lot of fun meta-analysis on what it means to have well-being, what are the domains. But at the end of the day, it is intuitive. I have used a slightly different word, but it is something that we would understand that would matter to us as a community that we would come together around. Defining it perfectly, probably doesn’t matter I don’t think. I think you sort of know it when you get it.
On the other hand, we would know that there are some components that we would have to address to make sure that it made sense. It is going to vary by community. It is not going to be the same in every place.
DR. COUSSOULE: You mentioned before – I am trying to remember the exact term you used, but basically we are at a bit of an inflection point now. You mentioned that we are at a place where we are at a bit of an inflection point now where there is an impetus to change. And then you just used the term reinforcement cycle. How do we in fact create that reinforcement cycle? I am trying to understand what you think the inflection point is that caused the change and how does that become sustainable. How does that drive change over a long period of time, not just the next 14 months?
DR. DESALVO: Yes. This is not a 14-month plan. I have to go back out there and live. I want to live in a community that is really healthy and that it has a positive frame and not a negative frame. I agree with that. I love it.
The inflection point. We have tried different times to move forward in this notion of social determinants and broad determinants and there are good examples where it works. I don’t think this is a brand new idea.
On the other hand, the fact that the priority for a major player in this like HHS around coverage expansion as an example is still a priority for us. In the course of the next few years, if things continue on this trajectory, insurance coverage will be a given for people in this country. That focus and the priority of getting people into the health care system starts to – it just gives you intellectual bandwidth and resource bandwidth. And that same pattern will happen at the state level and the local level.
Then similarly if we continue on this trajectory of move into this more person-centered pathway of care, we have set out some goals in HHS to get to alternative payment models to be 50 percent of Medicare by 2018, doing that in a longer term glide path with the private sector such that it is not a 14-month objective. It is really something that gets medicine to be able to practice the way it wants.
If it continues going in the way that it is going and we are going to get things right and wrong, again, though there is less of that intellectual need to think about how we make a better care system and the way we are pushing the payment system is that people have to have a better health system to stay out of it. We are changing the rewards such that communities need to help. You see this behavior in health systems. They are now wanting to have not just population health, but some of them even more advanced when they have community health portfolios and working more and more with public health and other sectors. Our payment stuff is pushing the health care system to want to be in this space and there are many other reasons.
I really would not discount data. I say it is democratizing. I don’t know if that is really the right word, but it is completely changing the way we see and think about the world. The transparency opportunity. It was that even information like in BRFSS was so hard to get for so long and it is getting easier and easier. The more you all help push that and we push that and make data more available, it helps to generate hypotheses. It helps to see success. There are going to be mistakes made if we are not doing a hypothesis-driven question making, but it is a game changer. I don’t mean to use a kitschy phrase, but you are seeing this in public health, but also in other community efforts. And what it does is that – when you have data and visuals, it helps to create better conversations between business and transportation and others. Those are a couple of reasons.
I think at the end of the day some of this is about being able to see better, where are our opportunities are and what are successes that we are acting on. That is the data piece and then having the chance to have the time to see it because health care isn’t the thing that we as focused on. But we are going to have to do a lot of work to push us off of health care as the solution to stuff in this country. I am a doctor. I come from that. I get it. The awakening, the culture shift. We have to push as hard as we can as possible; otherwise, we are going to keep every year spending more and more of our money on health care, which is less and less of our money in education or other important parts of the development of the people of our community.
DR. PHILLIPS: I think you just headed where I wanted to go. Thank you, Karen. Thank you again for bringing Denise into this. I came yesterday with my IOM, my NQF, a whole bunch of things open because I was so concerned that we were only going to talk about it from the public health side and then Denise walked in and I went oh good because she is monitoring all of this. It was really incredibly helpful to have her here.
I think you were just alluding to the incredible building pressure on physicians to be a source of data about social determinants of health. It is going to be so hard. Looking at the NQF and the IOM recommendations, it is going to be hard for physicians to collect additional data, but particularly data where you have to look at a patient and say tell me how much money you make. That is a non-starter conversation. But they can collect data. We need to figure out what can they collect that will have utility for them.
As you said, alternative payment models in macro are going to push this very quickly because we need to figure out how do we work on a population and community health basis to reduce cost.
Having said that, what is happening on the public health side is incredibly important too. I helped write that section of the IOM report on integrating public health and primary care because we need shared data models and we need shared data contributions. We both need to be contributing. We both need to be working from the same aims and off the same measures and towards the same common goal. I would just encourage you to keep thinking like you are. We need to keep moving on the clinical side and the public health side in shepherding them together. I am here because I want to try and figure out how we can advise you and how to get there. Please keep working on both sides of the equation.
DR. DESALVO: I know that you guys are doing a lot of really great work leveraging simple information about somebody’s address and helping to populate and inform the decision making we make as clinicians. Sadly, doctors don’t pay a lot of attention to that stuff. We should. We should contextualize people’s health or else it is likely a medical error. Dr. Saul Weiner has done a lot of thoughtful work in that space. That is one way that we can help us to be thinking about in a structured way about the social determinants.
The general comment about the health care and public health piece of it. I know you agree with this, but I want to underscore it because it came up with what Bruce and others were talking about with the multi-sectoral. Primary care and public health are the two poorest sisters in this conversation. I might be wrong. If you want to include social services, I might give them that. It is an important relationship, but we cannot stop there. Again, I know you guys agree with this. But it is just simply not fair to say that they are going to solve this. It has got to be – we have to dig into the coffers a lot deeper to see that we are fine in a way to leverage all of the resources that we have. Public health, I think, is to me the natural leader in this. It has accountability, the responsibility, morally, legally, otherwise to everybody in the community. Strengthening public health in this equation, giving them better access to data and better ability to act on it, but also making sure public health is community capacity conversation ready. Public health is working to ready itself. I think accreditation is one of the great ways that that happens.
On the other hand, this is not work for you all, but it is going to be the work that we want to take on. What does a public health leader look like in this new public health 3.0 when we move to this new version? What are the skill sets that you need on the ground? How do we build that into the incumbent workforce because we cannot start from scratch nor do we want to? We want to retain the talent and the expertise because there is public health that we want to keep the work we are already doing and the gains we have made. We certainly don’t want to lose any, but we need to be able to add to it.
But there is also I think a need for public health to have some of its own culture change and that is just like medicine is undergoing. Medicine is rethinking being paid differently, being asked different questions. Public health is too. Vickie’s comment about well-being.
The other nuance to that for me and Walter brought it up too is it is not going to be perfectly curated data. I am going to have to just deal with it and move on. It is not like I am doing contact tracing for your syphilis. That has to be perfect. But on the other hand, if I am doing community-level data, it has to be close enough that we can take some action and see some improvement. I think for public health as a practice, that is an uncomfortable place because we tend to want to be really sure. That is a place that I think if you all give some thought to. Where does perfect become the enemy of good with data and where are we willing to take a little bit of a risk if it is going to be at population or community level? That would be some helpful guidance.
DR. RIPPEN: I drank the Kool Aid. I have been drinking it for quite some time. Again, I want to reiterate this notion of well-being that goes beyond just the traditional health and how well are you doing physically and mentally. Also, do you feel safe? Do you have a job? All the things that actually roll up. It is a really critical thing because I would say that a lot of the different departments that serve this nation including not only at the national level, the different agencies, but also at the local levels all really have a significant role to play.
One of the things I learned a long time ago when they were doing a World Bank assessment of the cost effectiveness of developing water supply systems in developing countries. They found out that it was not cost effective and that it would be better to just give oral rehydration as opposed to put in the water systems. Part of it was because it was artificially fractured to only include the health sector whereas we know that water systems also impact dramatically business sector or the economy and things like that. Again, making sure that we think about it in total as opposed to artificially dividing things.
DR. DESALVO: That is a great, great, great story. If you think of it, could you help me find that report?
DR. RIPPEN: I was kind of really upset about it because I was trying to actually say that is incorrect. I will try. It has been a while because I am so young.
The other thing again that really – and that requires leadership. It is easy to do stove piping. I got my own thing.
The other thing just knowing from preventive medicine, I have a lot of colleagues that actually go to the Department of Transportation, go to the Department of Energy because all have implications in health care and actually some of the major advances in our safety in the Department of Transportation is thinking about from a public health perspective. And you have to understand. These are experts and this is what they do all the time. They do understand health components of whatever their field is. You just have to find them. Now we think about policies that intersect. When you think about who is going to pay for it, it is a question of saying where do we get the biggest bang for the buck from a positive outcomes perspective because we all serve the public. Really important.
It kind of brings to another story, as I just moved to South Carolina, about someone talking to someone about walking and physical activity. Basically, someone saying well walking kills. Why is that? Because there are no sidewalks and there are 50-mile an hour rule roads. If you walked on there, it would not be good. So again really important.
The other thing is even thinking about cross collaboration. I am pretty amazed. Some of the leadership in South Carolina where we have cross entity collaboration around health issues where everyone came together, employers, health care systems, public health departments, universities to talk about what are the biggest issues of the state. Unfortunately, from a health indicator status, it is not that great.
One of the big issues is health equity. It was interesting because health equity – you would think only a certain group would care about. Everyone cares about it, but with regards to who has the action. Anyway, you had a lot of the employers and universities think beyond that by saying what are we promoting. Are we actually providing jobs? Are we giving people opportunities? Everyone actually felt they owned a piece of it, but not in the traditional sense. Again, thinking a little differently about joint ownership and how everyone can do something toward the goal. You can move the needle.
DR. DESALVO: You can. One of the things that – I am going to extrapolate from what you said to this kind of health in all policies frame. Every community is going to be a little different. I mentioned Johnson City. One of the ways that we experimented with health in all policies in New Orleans – we tried a couple of different models, but one was I actually funded the salary of a bicycle engineer to work in the Department of Transportation in the city. She was already there. She was losing her funding for a grant so we found a way to pay her. She is just tremendously successful in getting safe bike lanes and public safety around that going. She is not even in the health department. But you are right. We have to be willing also to think creatively. That is also letting go of credit. When you have shared ownership, you also have shared credit. It is just a place that we are all going to have to get.
DR. SUAREZ: I just wanted to make sure if there are any questions from the phone. Do we have anybody on the phone before we go to Denise?
DR. CORNELIUS: This is Lee Cornelius. It has been a wonderful, wonderful set of presentations and discussions this afternoon. I keep coming back to the preaching to the choir issue. How do we – action vortex that – it is wonderful synergy, yet how do we get all the people at the table that are not singing the song we are singing?
DR. DESALVO: I love that question. Do you have the answer?
DR. CORNELIUS: It is funny you – I did a presentation where we take the equity issue, for example. The issue becomes how we present the question in a way that people on both sets of the sides of the aisle have the response – whether someone is a conservative or progressive, you still – the question is and get people the wherewithal to get –- what it is is that we are sitting in a room with all of us. We are all – hearts and spirits on that, but how do we deal with someone who is in the market place and framing this in a different issue like no jobs, for example. I don’t need to worry about health care because I am – we have to keep the goal in front of us, but think about how to frame the dialogue and rename it so that someone could see it within their own perspective.
DR. DESALVO: I am really glad that you raised that. I have some ideas. A year from now I will tell you all if I think that they worked. My idea is that if you take this idea of a collective impact model as the approach and say we want to get a shared vision, which – I actually interpret that as a shared language. We have to know if we want it to be well-being then let’s settle on it and let’s decide we are going to go there and then let’s talk about what that means for our community.
One of the problems for the choir is that we are not all singing from the same song book just to stick with that. We are using different language when we talk to other sectors. Even public health does that. I think we do ourselves a disservice insomuch that we don’t have – we are not coming with a common set of ideas and vocabulary and approach.
This is where primary care I believe made a lot of inroads to use that analogy with the patient-center medical home model when the joint statement came out between the various primary care societies. They were able to take that language up on the Hill and to other policymakers and to payers and say this is what good primary care is. These are the components to it. This is what success looks like. This is what your investment will bring you. It has certainly not been as rapid as some primary care folks like I would like, but it has made a big difference in the past now 13 years that that language has been part of our lexicon. You even see recent results that we have at stiff old organization like CMS that realizing the value of investing in primary care. I know that we are going to have more work to do there. I can certainly speak for Andy Slavitt, the acting administrator. He understands that a good medical home really matters.
If we take that kind of a model, get ourselves squared on what we are talking about, how we are going to talk about, we get further. I think we have natural allies that we have not tapped into in this space. Let me begin by saying that wanting your neighbor to be healthy and your neighbor’s kids to have all the opportunities that your kids have is a bipartisan idea. I have yet to ever meet anybody on either side of the aisle in any community in this country I have had the joy to visit that doesn’t believe that. The pathway to get there and how we divvy up the pie might vary somewhat, but everybody will look at their neighbor and say they want them to have the kind of well-being or vitality they want for their own family. That is why I think the community piece of this, the local piece of this is so incredibly important.
With that said, the natural partner in this – I am not going to say what I was going to say. I think one of our natural partners – okay, I am going to say it. Health care is not really a natural partner in this as health care business models stand today. Their business model, our business model is predicated on sickness. It is a little bit of a struggle. Until we through our delivery system reform work, keep pushing to reward better outcomes in health. Business is to me a natural partner in this space. The elected officials, especially local elected are a very natural partner. Everybody wants a healthy community. Businesses want their employees and their employees’ families to live in a healthy community. It meets everybody’s needs. Our strategy, my strategy is to work with those groups in addition to health care. I will work with health care. Don’t misunderstand. But I think it is harder right now for them.
I believe part of our challenge in the past is that we have not really been open to working truly outside of traditional partnerships and sectors. I think we are going to find quite a lot of common ground. Though we will have to leave some of our assumptions aside about who should lead, who should follow, what matters because the business sector may have some slightly different ideas, but we should be open to listening to that. They also have a lot data by the way. That could be good partners in that.
MS. LOVE: This isn’t even really a question, but I struggle with this. I was bringing up the data. We know that big data has big value and it is growing. I worked with communities and states, building the data commons. It is a tough sell to sell the public utility model of shared data because who pays. The return on investment is two or three years down the road from the time I can get a state law or the initiative of building the data as we know in some of those states. The value of the data accrues to across many partners, but nobody wants to pay for it. I think the SIM grants have been great.
What I hear from the states is the fear that when they go away they are afraid to build anything because when they are gone, they will have to pay for it. How can we find the data commons and have shared funding, both private, public, state, federal, and have some sort of formula that meshes or maps to the utility to the doctors, to the public health, and to the private sector? Believe me. Everybody wants an all payer claims database, but nobody wants to pay for it or they want to pay for it in the private sector and then sell it. I don’t even know if you can respond, but that is a heavy burden that I carry.
DR. DESALVO: That is a great segue to what I wanted to make sure I mentioned about the Office of the National Coordinator and some work there. So you mentioned public utility and public good. Helga talked about water. I am not saying that information is water, but in the economy that we have and in the needs that we have to advance health in our country, we are going to have to reconsider the way we have been paying for and managing the basics. Information is probably a basic. Even if you just think about what public health and preparedness needs to have, it is a basic.
Some states are using a public utility model to see that their health information can be exchanged and be interoperable. They are still working through what that looks like. I do think the question for our nation – this is a question for individuals and communities, but this is a national question. Are we going to find a way to make that a part of what we pay for just like we do roads and water and power? I believe that we should because I believe that even though there might be a mixed business model for it, to Lee’s point, the equity issue. You cannot pay to play for data. I believe we get ourselves into some real trouble especially in disaster.
There is discussion about it. I kind of put that in a governance piece of the work. The Office of the National Coordinator has some opportunity to deal with governance. We are pushing that. Who owns, controls, uses the data? How does it move? The business model on top of an all payer claims is a business model as opposed to just having the data available. Those are two different things. We have been conflating them I think as a country. The information exchange that the – the health information exchange is the utility, the analytics that you do on top and resell or that a community needs to do is a different part of that equation and sometimes the more expensive piece.
The particular thing I wanted to just make sure that this group was thinking about as you are considering sources of data to do analytics or measurement is that we did require in our 2015 certification rule – I am getting in the weeds here for you all. The Office of the National Coordinator has a responsibility or the opportunity to certify electronic health records and other health IT. We have been linked with the meaningful use program, which is one of the Medicare payment program to incentivize the use of electronic health records and technology. But we have been evolving to a place where we are just requiring certified technology that could be useful in a variety of settings, not just with one payment program.
In our recent rule, we moved away from a model where data could remain proprietary and trapped in electronic health records to a model that would make it accessible and require by 2018 that all electronic health records have to have a generic publicly facing, public code available, API or doorway to the data such that your electronic health information or your patients – you would be required to open those doorways to the data, the consent, appropriate security expectations. That means we don’t have to have the point-to-point connections for that information, but could theoretically if we keep doing this right allow fundamental health information and other sociodemographics to flow. That means it has to go somewhere. That means there has to be a way for a longitudinal health record to be created for a person or a community. But that opportunity now because of the rule that we have put forth does exist.
If we continue in this pathway of innovation and we think about how we might want to keep that equitable, it does create a new world of clinical information. It is not the story of a person, but it is a story of their health care, at least some of it. I think that you all ought to be thinking about that as a way to –- we have done some other things like require people to move to specified standards to narrow the amount of proprietary standards. A lot of work to be done there.
I didn’t want to not be here and not mention that we are really trying to push open data, not just from surveys, but also in the space of people have asked us. Consumers have said we want our electronic health information free. We want to control where it goes. We want to give consumers that opportunity to see that their electronic health information can be shared when and where it matters to them and they can share it where they want.
DR. SUAREZ: Thank you so much. As I said at the beginning, you certainly have here a very willing and committed and dedicated partner to work with you. Again, we are so excited to have made a connection with Denise. We are going to continue to work through her and with her on all these issues. Thank you for taking the time to stop by and talk to us.
DR. DESALVO: Thank you, guys. It was a great conversation. I appreciate it.
DR. SUAREZ: I think we are going to take a break now and we will come back in 15 minutes at 3:45.
DR. SUAREZ: I am going to turn it back to Bill and Bruce to continue our discussion on population health. First, I want to say that it was quite incredible to really have the opportunity to have Karen be here in person, but it really goes to show her commitment to reach out to us and certainly the work that Denise Koo has done in connecting us to the Department in this area. I am very pleased and excited about the work that Population Health did yesterday and this opportunity to connect with Karen. Bill and Bruce.
DR. COHEN: Let’s get some feedback from folks about their thoughts on yesterday or what we talked about this morning before Dr. DeSalvo came or other insights you want to share.
DR. LANDEN: I have to admit after yesterday’s workshop, which was just overwhelmingly informative and stimulating that I walked away with a lot of cobwebs in trying to figure out who is trying to do what for whom and tries as I might to think through it. I always came to the conclusion that many people are trying to do many things for many. I think Dr. DeSalvo’s comments today helped distill some of that. She has a very good list of what the priorities are. I am hearing multiple priorities, but done and organized in such a way that they are not necessarily mutually exclusive. I think from her presentation, I am going to be able to go back tonight and think through more of what I experienced yesterday in terms of the domains. Yesterday they seemed to be pretty plastic, pretty flexible, not mutually exclusive. I was not clear on whether we were trying to provide a toolkit for communities to diagnose or quantify their health status level.
Other times it seemed we were assuming they already knew their health status level and we were trying to help them do something about getting funding for the interventions that would remediate their shortcomings. I am a lot clearer today. I am not sure that there is consensus achieved yet, but at least I have a better frame of reference to think through all the issues that were brought out yesterday. There were some really good issues.
DR. COHEN: Great. Bill is going to talk a little bit about our work plan and our short-term, our goals over the coming year around following up based on what happened yesterday and I think the direction that Dr. DeSalvo pointed to today. If that does not fit into what your mental model is, please let us know because we are all in this journey together to figure out how to tweak this to get to an actionable spot or spots.
DR. PHILLIPS: What I took away from yesterday because I agree. A lot of it was about what is purpose. What I saw as the most common denominator was an interest in understanding outcomes whether that was life expectancy or well-being or some grouping of that. That seemed to be the most consistent thing.
Then there was a set of factors that connote risk and those varied some. And then there were a set of factors that were things you could take action on. Those seemed to be different purposes. But as you got closer and closer to outcomes, what I got was a sense that the consistency got stronger.
What I was trying to convey yesterday and I think Marissa Levine and I were very close because this is what she is doing in Virginia is actually saying what are those factors that connote risk and how can you actually assess them against outcomes to figure out which ones are the most important not only in terms of their contribution to the outcomes, but how important is it to get them and get them right because she has created the health outcome or health opportunity index. It is very similar to what the UK and New Zealand are using to allocate resources.
What I was pushing for and Marissa had a long conversation afterwards is not just to be able to say this set of factors is 10 or 12 are predictive of these outcomes, but to say then to go back to the outcomes and say for community A and community B that look identical for those factors, are their outcomes different? If they are different, that gives you a way to prioritize the one that is worse than the one that is better. It gives you an opportunity to go to the one that is better and say what is working here that is reducing the predicted risk based on the factors here. And then maybe you come over and say what can we take action on in order to bring other communities above their predicted risk because we can take action on these things that ameliorate the impact of these things that we are measuring that are risk based. That has been a goal of mine for a long time and that is what folks in New Zealand are working on right now. I actually have them trying to write a paper for the US context about why we should be going here. I just want to get that on the table again.
DR. COHEN: Certainly. Welcome to the Population Health Subcommittee. You will make some outstanding contributions. It is all yours. I think I had never seen the Virginia stuff before and it is certainly worth pursuing as a potential model. Ultimately, I guess to me what was said – the perfect is really the enemy of the good whether we have 12 domains or 14 domains. It does not really matter. For me, relating risk to outcomes is the byproduct or the result of providing data at the level so communities can do that. My focus is more on creating the building blocks so that communities can engage into that process. The purpose is so communities can give them the tools so they can do this work and decide what is important for themselves.
DR. PHILLIPS: Can I give you a for example? I am completely with you. In the social deprivation index, we created for the US based on the primary care service areas. There is about 6400 of those. What we found is poverty – this is pretty expected. Poverty explains about 40 percent of risk. Unemployment, non-employment is the next big chunk. And then as you go down the line to single parent household to high proportion rental, no car, all of them have a meaningful, independent contribution, but it gets smaller and smaller and smaller. If we go from county down to Census track down to Census block group, which ones of those drop out and how much of your predictive value does your model lose? If you have to go to this community and say we think the ideal model has these 13, but for the area you are looking, we only have six, but we can predict 80 percent of risk. Is that good enough? It is actually getting associations of how much does each piece contribute. If you lose them, you know what you are losing.
DR. COHEN: That understanding and approach will really help us figure out what we can do in this space over the next year and what an appropriate goal would be for the National Committee and using the bully pulpit and marshaling resources and hopefully keeping OASH involved and maybe using some other resources at CDC and at ASPE to do some of this work.
DR. KLOSS: I had the great good fortune to be on the – to ride the train last evening with Melissa from Virginia. We really had a chance to follow up. I did get more insight into the kind of leadership that she has brought to that. I guess it just reinforces my comment to the assistant secretary about the need for community building. It would be useful to get more detail on the case study there. She had shared some of the work she is doing just to stand up the data governance process and to break down silos throughout the agency and across agencies and things like that that have been really important to helping to shape the culture and to get everybody on the same page.
As we look at standing up recommendations, we do need to talk about the leadership, change leadership, infrastructure pieces of this in addition to the data.
DR. COHEN: I totally agree with you and I am trying to see what is in our sweet spot. I think there are other organizations that focus on community building.
DR. KLOSS: I don’t think we need to do it. I just think as we frame a recommendation to the secretary that to the extent that HHS can leverage or work on case studies or some community leadership development, I don’t think NCVHS — but I think it is a dimension of the whole picture of what would make these communities successful when they have the data and the metrics.
DR. O’GRADY: Just a couple of points of what I wanted to support along the lines here. I think there is a danger that we have seen in the past with indicator stuff. It becomes kind of univariate and there is not this notion of taking it to the next level that is actually actionable of being able to do the kind of modeling that would tell you the contribution of this factor is a 13 percent change versus this one, which is a 25 sort of the way Robert was laying it out like that. It is a little bit of – I would encourage us to keep in mind that that sort of policy modeling of what are the factors we could actually – we want a well-specified model that explains a lot of the variation and then we want to know quite clearly what are those things you could actually develop policy to change versus those things that you are just not going to be able to change because they are whatever, who somebody married, their genetic markers and things like that versus some of the things we can actually step in with.
The other thing that I think is sort of a dilemma for us because it is not necessarily our portfolio of issues, but – in the past, people certainly have wanted neighborhood-level data, et cetera. We have the Census tracks and part of that is a sampling frame and things like that. But how to fund it has always tripped people up. I don’t know that we want to go into there, but we could build a perfectly specified really great set of domains. If they don’t actually get put into operation, where do we go on this? At least some thinking in terms of – the typical fight is and you certainly understand it is the states come to the feds and say you should pay for it and the feds go we don’t have any more money than you. We just have bigger credit cards. You have to balance your budget. We don’t. And we are terribly in debt. The feds push back and the states push back and nobody ends up paying for it. I don’t know quite what we do on that.
But I don’t know whether there is a business case for why every community should be willing to share some in the collection of this data and maybe poorer communities do get subsidized by the feds or the state. I don’t know what there is there. But I would just hate to see such an exciting effort go forward to have something that is mostly theoretical at the end, not actually makes it into practice.
DR. COHEN: This is a much longer conversation than we will have at Population Health Subcommittees. My belief is that it is not a question of more money for resources. It is the federal commitment and responsibility for providing support at that level. The past world view has been –
DR. O’GRADY: You are a state guy. Of course.
DR. COHEN: I worked for the feds before I worked for the state. Way back when 35 years ago when I worked at NCHS, there were programs, statistical notes for health planners. There was a cooperative health statistics system. Gib mentioned some assessment initiatives that targeted the development and provision of community-level data and indicators. I think it is really just repurposing existing resources and rethinking how to do use the incredible expertise and experience that the feds have to help support communities to do their own work.
Steven Cohen, who many of us know. His thesis was on small-area estimation. Before he went to AHRQ, he was working on figuring out how to provide information to communities based on existing levels of data. I think we have the resources without huge other additional expenditures to provide the level of information that could be actionable at the community level. That is to be discussed.
PARTICIPANT: I want to have some discussion of the work plan before we run out of time.
DR. MAYS: First, I just want to congratulate you all. It was a lot of work. I think the staff, the whole group – because it was a very successful hearing and those things are not easy to do.
A couple of things. One is your slides that were up there before. You were using the word neighborhood and I want to encourage you not to use neighborhood and instead to talk about community. Neighborhood has very specific meaning and it may not be the unit. I would say sub-county and talk about communities. Some neighborhoods are in such a feud that you just don’t want to do that.
But the other issue, which is probably a lot less popular in terms of what I am about to say is I am wondering whether we need to be doing such a deep dive in domain and instead doing a much deeper dive of making data that is usable, accessible, and represents what people want available and to be able to link it. Rather than us trying to predetermine what a community’s issue would be and being able to do all this prediction and stuff, let the academics do that. Many of us do that.
But instead it is like really beginning to say where is the data on violence. Where is the data on police stops? We need the race ethnicity stuff. And then being able to say in terms of that data’s availability, how it can be linked across the agencies. If we could get transportation and HHS and education alone to share, let the community decide exactly how they want to look at it. But I think as the data stewards that our job is to really try and get the data to people on all these different topics and make it usable.
DR. COHEN: Great segue into Bill’s discussion about what our thoughts are about how we proceed.
DR. STEAD: We have described sort of the nuts and bolts of the fact that we need to create a report that distills out what we learned yesterday in a way that more people have access to it and that identifies the themes of likely recommendations and we are going to work our way through that in time to have it discussed and get input, but in essence be approved in February.
That will then flow into refining those recommendations and generating a letter either in June or before. Probably in January we would like to begin to figure out or by January I guess, we would like to really figure out what are the possible resources that could do the multi-sector scan. Is it Healthy People 20X? Is it ASPE? Where might that work be done? Because we need to begin to – we would like to set a goal of actually getting that work done, which NCVHS won’t do. All we can is advocate for it and convene and pull for it.
But we would like to get that work done in time to set up a repeat of yesterday in conjunction with the November meeting a year from now. And the thought would be – and it plays into I think what you were saying, Vickie, you need to test this. If we are going to other sectors and we are pulling out their domain models. We are not trying to create one. We are pulling them out as a series of established reference models, if you will. And then if we are identifying or the people doing the survey are identifying the accessible metrics that are being used in other sectors in those domains, I think that would get at part of what you are saying.
Because we are thinking that we would discover and correct me if I am getting this wrong, but we will discuss three types of things that are available and accessible, some that generally available. Some might be some of the crime rates kind of thing that you mentioned. Others that are available in certain communities because they have figured out how to collect them. That at least means there would be a model of how you might do it. Others of which are estimable in a useful fashion. We might find them in those three categories.
Then we could really roll into – that could be presented and linked in a useful way that would actually presumably establish a more robust set of core domains because it had been obtained in a different way and in a way that meant that we already knew some of the menu of metrics that were available in those pieces. Then you could define or lay out the roadmap by which academia or HHS or whatever could begin to populate metrics where there were gaps.
For those of you that haven’t yet figured it out and I apologize to the degree I was too action oriented before lunch, I am action oriented. We have a long list of things that are topics for population health. My sense is we need to double down and really get this to the next stage where hopefully it is well enough defined in enough pieces that are sort of pulled together that it can carry on. We will need to pay attention to it, but we won’t need to be fully devoted to it. We can then begin to free up our bandwidth in the pop health space to go after some of these other questions be they how do we work with ICD-10 and both trends and in how you frame questions or do we want to knowing the domains and metrics are going on to begin to build the diagnostic examples or advocate for the kind of diagnostic examples that I heard Bob suggesting. I would like us to have a work plan that recognizes our limited bandwidth, but tries to really bring this to a substantive step forward over the course of the next year if we elect to double down on it.
Our other alternative is to say we have made progress. We surely are a long way ahead of where we were a year ago. We could set it aside now. I think Bruce, what is in my gut is we should try to carry it through the next iteration.
But at high level, that is sort of what we are thinking about as a work plan or approach to the work plan for the year. We need to know if that was comfortable for people. Again, for those that are new with us, all of our plans are nothing but something that we have currently drafted to give us enough of a notion of how to go forward. They are all subject to revision at the next committee call.
DR. COHEN: I think that is great. I think that is where we hope to be a year from now.
DR. SUAREZ: Have you identified sort of your priority topics? We have this work stream identified with the work with Denise and the department. Have you identified the other topic, the other domains that are part of the work plan or that could be part of the work plan priority to look at prioritizing and all that?
DR. STEAD: I think our gut is that if we are going to get this meaningfully to the next step, it is going to require all of our bandwidth. We have a list leftover from last year. We have identified three more new topics to date, all of which I would love to do. But realistically, I think we don’t have the bandwidth. We have gotten traction here. I think our gut is we ought to executive on that traction and see if we cannot really make a difference. The work won’t be done a year from now, but it might be far enough along that it is passed the tipping point or to the tipping point.
DR. KLOSS: I think you have also created some great expectations at yesterday’s meeting. It suggests that all that enthusiasm would be dissipated if you did not go forward as you are suggesting.
DR. STEAD: And that is the reason I think we ought to take the email list from yesterday and we should have a next step email out to them on Monday so that they know that – we did not say anything about next steps at the meeting – our oversight. I think it is very important that we connect back to them electronically and then we will be able to engage them to review our iterations as we go along. We won’t be having to reconstruct a group. We spent three months constructing that group.
PARTICIPANT: And they want the link to the toolkit.
PARTICIPANT: That would be an extra surcharge.
DR. O’GRADY: I guess I just wanted to think logistically for a second here because part of the nice thing that I enjoyed quite a bit was I was very pleasantly surprised by EPA’s participation, justice, number of people. They were willing to talk our language about that this was sort of the dependent variable here was health at a community level and things like that. Although we know that they probably – if you are justice, you are probably trying to look at predicting violence levels. You may switch what is the dependent variable there.
The one thing I was going to say is we are an animal of HHS. When you talked about this idea of moving across the agencies and it was very nice just the way it works operationally is the HHS kind of statistical leaders can ask for these things, but it would just be an accommodation colleague to colleague. We could certainly put it in a letter to the secretary and hope the secretary at the secretarial level would set that up.
The third thing that is not particularly in the public view so much is that this is sort of what OMB is supposed to do. We have a chief statistician of the United States. That is the premier position among the statistical leaders. And that different people might be brought in – agriculture was absent and we know food stamps and other things like that are very important in terms of thinking about these things. That would be again another pathway. Is it a letter to the secretary? Maybe still, but something that asks OMB to make this a priority so that you get – most statistical leaders are civil servants. We will go through a transition whether we transition parties or not. But I would hate to see much of this sort of build up some momentum that then just dissipates when Karen is no longer there and things like that.
DR. COHEN: Great point. It is wonderful that we have new energy on the committee who has these perspectives. I think whatever we do we need to cast a wide net in terms of options about how to move this agenda forward. It would include stuff like that. I don’t know that we can talk directly to OMB. I don’t know the politics of whether NCVHS can write a letter to the director of OMB.
DR. O’GRADY: Are there parallel groups? Is there the equivalent of NCHS at Agriculture and Justice?
DR. COHEN: The reason Charlie Rothwell could not be here this afternoon is he is meeting with the statistical heads of other agencies. He said he was excited about –
DR. O’GRADY: I was just wondering whether there was an advisory committee that we could – in proper protocol reach out to our counterpart.
DR. COHEN: I don’t know whether they have FACA set ups like we do. We can certainly look about how to – your idea of exploring multiple pathways to get this message across HHS is really I think right on target and we will need to figure that out.
DR. RIPPEN: And just building on that, actually given the data.gov initiative, I don’t know if that is OMB or not, but it requires all the agencies because that is the presidential executive level to actually asking all the agencies and departments to make their data available. There are already some hooks I think to your point. If not OMB, there is always GAO, which always makes the recommendations too. But I think that there are a lot of ways to leverage to your point. A lot of different venues.
DR. STEAD: Let’s turn the time over to Alix and Ob.
MS. GOSS: Early today we did talk Review Committee. This afternoon we are going to talk Standards Subcommittee. I don’t know about you guys, but sometimes this gets confusing. We are hopefully going to set some context here. Maybe we should have started here, but we will get there. We are going to talk a little bit of some historical information to put some things into context. We are going to talk about some of our plans that are in the pipelines, especially those related to the February activity. We have a hearing coming up.
We are going to tip toe into the waters of the mission, vision, and objectives framework, which is really the main part of an agenda item that Walter will be leading tomorrow. But just in the way things worked, we don’t have a standard section after tomorrow. Walter and I coordinated and thought it would be okay tip toe into those waters. It is going to be another very collaborative conversation this afternoon.
Ob, did you see the revised slide deck in email? I don’t know if you are online. I am sorry, Raj. I could not hear you. Are you able to get to look at the slides online?
DR. CHANDERRAJ: Yes, I am.
MS. GOSS: Great. The Standards Subcommittee has some focus areas. These are really driven by our legislative obligations. I apologize. When we converted these from Power Point into Adobe, they got kind of a little bit skewed in the spacing.
We have some legislative drivers for the Standards Subcommittee and our responsibilities related to administrative simplification. Please do not consider this slide to be the end-all, be-all. It is just a general discussion framework. But from an administrative simplification perspective, the Standards Subcommittee has obligations related to health care transactions, identifiers, code sets. We do a report to Congress. Privacy, Confidentiality, and Security Subcommittee also has a part of that. But we report to Congress on a regular basis typically about every two years to give them the state of the union of the HIPAA administrative simplification world.
We also have legislative drivers in the form of the Affordable Care Act specifically related to the operating rules since they came about after administrative simplification HIPAA provisions. That is where we got the responsibility for the Review Committee. Terri covered the responsibilities of the Review Committee in the earlier session today.
Any questions so far?
There were a lot of other things that are happening in the world of standards and especially as it relates to how standards plays at the full NCVHS table. The concept of convergence is something that has been a part of the vernacular since I showed up here as a committee member. From a Standards Subcommittee perspective, it is about how we get that administrative messaging payload to actually keep pace with what we need in health and health care.
We also look at convergence as an opportunity for the world of HITECH and HIPAA. When we look at the administrative financial transactions that were adopted under HIPAA, we see what meaningful use and the HIT policy and standards committee, the FACAs to ONC are addressing, and there are some linkages between those two worlds when you look at the patients, the providers, the payers, et cetera.
There are a variety of topics that have been emerging on our work plate. Public health data standards is an area that we would like to invest some time in. All payers claims database. You have heard that come up a couple of times today, but that is also an area of focus for us. It supports the transparencies, objectives, getting more global data.
There is the population health benefit and there is also pay for performance. These are all things that are influencing us or things that we need to take a look at to advance the support that we provide from a standards perspective.
Some of you may have seen this graphic before. It is an attempt to put together a life cycle approach. If you think about the health care, the National Committee eon Vital and Health Statistics, we have our strategic agenda. We have a very specific health care industry and strategic shifting that is going on especially around population and public health. It is another way for me to represent the information on the last slide. We have business needs that are emerging and we have evolving standards, code sets, and identifiers that need to be addressed.
We have things that have not been adopted yet like attachments and ACKs, which are short for acknowledgements. We have additional operating rules that need to be addressed. We have ongoing privacy and security concerns. We have the data work that we are also interested in.
If you tie in a lot of these efforts, we look at the national agenda, our standards obligation, our review committee. It keeps us looking at historically as well as into the future as to what we need and how do we need to keep pace with those.
MR. SOONTHORNSIMA: Since our role has shifted towards the additional – or Review Committee responsibility – if you think about the overall lifestyle goal of the Standards Committee, we complement as a National Committee very well with context of – when we look at the strategic and convergence within the industry and – life cycle of – how code sets and identifiers that evolve over time and then we get into the development and the implementation – provides us with a new opportunity – take a little snapshot of how things are going with these adopted standards, but what could we supplant in our future thinking as the standards evolve. We have an opportunity to provide guidance and influence and recommendations, which shape the future. With – we have really closed that loop.
We are hoping to use the first – set of recommendations, guidance and what not to align our thinking with the future recommendations from the standards. This slide really speaks well as to – life cycle, but more importantly – importance of how the National Committee overall sort of aligns itself and shape the future of health care.
MS. GOSS: To put a little bit finer point on the Standards Subcommittee focus area, we have on the right hand side of this eye chart the transactional flow related to the nine transactions that Walter mentioned earlier. But you have to also look at it from a business process perspective. On the left hand side, think about patient admission, registration, some of the activities related to the insurance processes for prior authorization, services being actually rendered, then the coding and billing that translates into claims intake and claims editing and adjudication and then remittance advice. There is also an end-to-end business process that we are trying to support and that is how the original nine transactions were intended to be used.
But, however, there are lots of other things that have emerged from the data use needs and the transactions. There are also aspects that we find that really have not been effectively integrated. We really heard that back in June from the long-term care and the mental health communities. There are lots of different data needs. The market is changing and so their data needs are changing on how they want the analytics related to population health, public health, health and health care even though there probably should be a pretty common set of underpinning data elements. We need to make sure that the data that we need is mapped all the way back into the standards that we have and so that we can have the right infrastructure to move forward. Any commentary on that, Ob?
MR. SOONTHORNSIMA: No. If you look at this – is where we bring in long-term care perspective, mental health perspective. Those areas that Alix pointed out are really some opportunities and gaps. While we spend a lot of time on HIPAA standards, operating rules, when we bring these other areas to the table, other stakeholders, we find that there is tremendous opportunity, not only just the fact that they are not really involved or have yet to adopt the standards, but the opportunities that – may not necessarily require the HIPAA standards alone. Maybe some other – of getting it there. Because this whole transaction and secondary use. We talked about population health. There we have payer data, pharmacy data, clinical data. There are a lot of data sets that you can see on this slide that are absent from the whole discussion thus far.
DR. RIPPEN: Quick question just so I understand context. Health care transactions imply billing. That is the collection of data and the concept of minimum necessary just because for a variety of reasons. That is one bucket.
The second use of that is this is what data we have. How can we use it? But we also know that there are underlying trends, meaning use, EHRs, data standards that allow investigators and others to use data for other purposes. Is the implication here that what the attempt is is to expand the transaction data set to include a broader thing so it could be used for different purposes or not?
MS. GOSS: There are multiple ways to look at this and I will give you my take on it and maybe Ob wants to chime in as well. I am thinking of the secondary use, not so much from like an IRB-type perspective, but more about we are starting to use the data in other ways and starting to realize how we need to harness it. I don’t necessarily think we want to go back and undo the data framework or the structure that we have already in place today. But I think if my secondary use – in that category, more about the Privacy, Security and Confidentiality Committee, the Population Health Committee like how does all of this stuff fit together. It is how I am looking at it, but I am not sure that is how Ob meant it when he wrote that title.
MR. SOONTHORNSIMA: I completely agree with what Alix said. The other thing – while we have payer database, while we have clinical data from EHRs and so forth, there are a lot of data that we can get to aggregate and harness. For example, home health and – things like that. That can really help – from the analytical perspective and the population health perspective.
And sitting in on yesterday’s conversation, I could even expand it even further. In the population health summit yesterday, there is well over 50 percent of the types of information that are so fragmented and could not be harnessed today effectively because they exist locally. Those are the things even – strategic standpoint – begin to look at.
The context here is – while the committee focuses on admin simplification and the operating rules – the convergence between clinical and administrative data and these other sets of data that we have yet really put our arms around and provide the guidance or direction. I think that is where the National Committee as a whole really comes together as a single entity. It is not just the Subcommittee on Standards or Privacy or Population Health alone.
DR. GOSS: Is this helping, Helga?
DR. RIPPEN: Yes. Again, I just really want to emphasize the importance of separating out the concept of transactional data standard set and other data standards that might be helpful to put together this concept of population health because we have to remember what the purpose of these transaction sets are and some of the major privacy potential privacy issues associated with it. Given a lot of data too and population health is kind of my thing, I just want to make sure that we are very careful about separating out something that has a certain connotation and expanding it. I understand why, but the secondary use and things like that.
Standards. Yes. We need the standards for all of it. We need the mechanisms to have access to the data when appropriate.
DR. GOSS: They are already taking it and using it for secondary use. Better for us to guide that and help prevent some of those concerns and address blending all of those different perspectives.
MS. DEUTSCH: I don’t know if I am going to be putting another twist to it, but in the Review Committee, there were comments quite a few that there was more data content needed for a lot of the transactions, for example, with eligibility about co-payments and other factors. I thought that that was something that you were looking to see. That would be things that we would look at in the recommendations from the Review Committee.
And now in the standards, we are talking about the standards that have been adopted. I will be talking about the Phase 4 operating rules that are being proposed.
It is this line that we put two hats on. One is looking at what has been adopted and are they meeting the needs and what needs to be added to it and what can we recommend. And then the other side is what about those transactions, standards and operating rules that have not been adopted yet and are they meeting the needs.
DR. RIPPEN: I think that this kind of reinforces something that you said earlier, which is if we are talking about expanding information and especially when we start talking about determinants of health and other kinds of things, the balance and for whom is this available and again making sure that we have significant patient involvement with regards to what seems reasonable for what the intent is and also from a clinician’s perspective because obviously they are collecting the data to take care of patients and they have an obligation to ensure some privacy, which I know needs to be addressed. But I just throw it out because I do think it is always nice to have more data. It is just a question of for our purpose, where is the balance.
MS. DEUTSCH: Right and there is always the question what belongs on a claim. I come from payment policy so I do know that.
MS. GOSS: I would like to bring it back up a level since I think it was just a poor word selection on the title. But I think it was a really good point to clarify.
I think, Nick, you are up next and then Robert and then Walter.
DR. COUSSOULE: I will be quick. But I am trying to reconcile some of this. When I look at the detailed transaction and bits and pieces, it is about moving data from one place to another with a purpose. I still come back to the purpose side. I always like to think with that in mind. You hit on this a little bit just a second ago, Terri, about understanding the business need that drives the use of the transaction, but then drives the implementation of the transaction and all the things we can do to help facilitate that. This is my own ignorance generally on what the committee has done and has not done before. I am by no means casting any aspersions anywhere. But I am trying to make sure I understand what the end game is that we are trying to then facilitate information for.
If I am thinking about the secondary use and the transactions, the specific data flow on how it mechanically works is it means to the end. The end needs to be what I am trying to do differently. Then I need to get that data. It is really an editorial comment. I am trying to make sure I understand that part of it first and I don’t know all of that yet. I don’t know how much of that is built in or how much – committee works through as part of the exercise.
MR. SOONTHORNSIMA: I think there was a slide two back where we were talking about the full life cycle. What the committee has really – a subset – part of the overall National Committee where we have the national agenda and we anchor around population health. I think Walter can probably chime in better than I can. But – how we have done our work, our body work has shifted from admin simplification to think about how data and standards can help enable those capabilities from the population health perspective. That is really partly –
MS. GOSS: Does that help, Nick? Less foggy.
DR. COUSSOULE: It is almost as much thinking out loud to make sure I get a better understanding of what is happening.
MS. GOSS: Part of the purpose here is to get us all in the same page.
DR. PHILLIPS: Helga triggered a newbie question for me and that is the working group on access. Is that cross cutting? Does that work across these?
MS. GOSS: I think Vickie is going to give us probably the best answer on that one. The working group and how it fits in with the larger picture.
DR. MAYS: We are actually going to go through all the charges and I can tell you. I think that in terms of access and use —
DR. COUSSOULE: I struggle with a little bit of the segregation of the groups because it is like concentric circles to me. There is a lot of overlap in what happens. I understand the point that you raise very early on about the need to work kind of across the different things. I understand the focus, but there is a whole lot of overlap I see.
MS. GOSS: Robert and I had a little conversation about that earlier today. This committee has gone through an evolution that they started even before I came on in 2012, which was shifting from this siloed work effort to being more of a global thinking work and then enabling more in the weeds discussion and work efforts within the committee, subcommittee or the Review Committee or working group perspective. For instance, the earlier conversation on the Review Committee recommendations/report/work product is maybe initially being led and shepherded by the Review Committee members. But it is really a product of the whole that has to get the blessing from NCVHS. We just use those structural approaches to incrementally break the work down. It always has to start and end I would think within the Full Committee. Do you want to chime in here, Walter?
DR. SUAREZ: Sure. First, I think on the transactions and the standards, we have been very much focused on the specific transactions that have been named in HIPAA legislation. There are nine of them and there are a few additional ones that we are looking at.
Shana this morning mentioned Medicaid processes, 4.6 million transactions a day. That is 53 transactions every second. That volume of transactions is nowhere near the type of transactions that we deal with in the clinical world when it comes to external referrals and clinical transfers and lab results and all that. We are going to get there probably.
The claim itself as the core of all those transactions and some of the other transactions are eligibility, enrollment, premium payment, all these other administrative process, but the claim being the main one, the daily transaction have been used to capture a lot of other data beyond what is normally used or normally needed for a claim process. I will give you one example. Race and ethnicity. I don’t need to know the race or the ethnicity of a person to pay a claim necessarily. But it is being seen as a valuable data element for purposes of additional operational functions. Remember, under HIPAA, there is this thing called TPO, treatment, payment and operations, where people can exchange data without stopping the process and asking for consumer consent every time in order to achieve treatment payment and operations. A lot of the data that is collected in a claim is used for payment purposes, but also for certain operation-like quality assessment and utilization review and other things. There is a lot of that. I think it is great to be thinking back about some of those.
The other point that Helga mentioned about minimum necessary and the implications of that into some of the data elements that are reported in transactions like this. All those are elements that we have certainly considered throughout the discussions.
I think we are seeing a lot more convergence around the various groups because a lot of these transactions of course support a lot of the functions of population health and population health management and public health. A lot of these transactions have to do with privacy and security. They certainly have to do with use and access.
There is also in the data use and access world, the need to consider standards that are not these ones, but are standards of the databases that the federal government calls such as meta-data or data dictionaries or certain things like that. The word standards apply to many things. The word population – the term population health applies to many things. That is why the convergence is starting to happen more and more. We are starting to see a lot more of that even when we discuss very detailed transactions in the HIPAA sense of the term. I think that is the benefit really of seeing this type of convergence happening so much.
MS. GOSS: I am going to do two things. I am going to change the direction that we are going to end in today. And I going then turn over to Terri. I had thought we would have time to get into the mission, vision and objectives. I think it would be distracting to do that this afternoon. I think it would be more important to turn it over to Vicki for her to dive into some of her work group stuff, but I think it is important that we set some context for the committee about things that are coming up at the February hearing. Terri is going to talk about our Phase 4 activities and operating rules and then Walter is going to give us some introduction to some of the claims attachment activities.
MS. DEUTSCH: Before lunch, we focused on the Review Committee and the Review Committee focused on those standards, operating rules, identifiers and code sets that have already been adopted. That was the Review Committee hat.
For the Standards Subcommittee, we are looking at those standards, operating rules, code sets, and identifiers that have not been adopted. In February, we are doing what is called Phase 4 operating rules. We received an official request by CORE that is the operating rule authoring entity or ORAE to give you some acronyms and to review the Phase 4 operating rules that have gone through their vetting process and are already now for us to make recommendations. Phase 4 of the operating rules consist of health care claims, enrollment, dis-enrollment, and premium payment and prior authorization.
In the Review Committee, those standards have already been adopted. When we do our recommendations and discussions in the report for the Review Committee, we will not have any comments for the operating rules for these standards because they have not been adopted yet.
In the proposed operating rules, we had a hearing about a year ago, almost a year ago on the proposed operating rules. We had CORE do a presentation and we had a hearing and got feedback and then provided the feedback back to CORE about some of the concerns that were raised at the hearing.
When we got the official ones to evaluate, we looked at those questions that we had asked the testifiers including CORE to respond to so that we would have a focused hearing.
In the questions that we are proposing to provide to the testifiers, it will be questions that we covered in the original proposed. It also is questions that we acquired information from the hearing. Our goal is to have hopefully in the very near future the same questions that are proposed for those that are being proposed for us to recommend adoption that we would use that same criteria to evaluate them in the Review Committee to see if they have been accomplished.
In the Standards Subcommittee when we are looking at the proposed standards, operating rules, code sets and identifiers, we would say does this, would it, will it. And then in the Review Committee, we would look at the same criterion and say did it do that so that we would have the same criteria across both ends.
To give you some idea of some of the questions that we are looking to have testifiers provide would be looking at the business function and use, which we talked about earlier today. If it is efficient, cost effectiveness. Does it adopt to the changes in technology and in health care delivery models, et cetera? Those same questions will be proposed for the testifiers to provide their information.
Because we are going to have only one day, we will have the morning and part of the afternoon dedicated to the proposed operating rules and then we will have a couple of hours dedicated to the attachments. At this point, the attachments have not gone out for us to be evaluated. It has not been finalized, but we are hoping that it may happen.
But I am going to turn it over to Walter. He apparently has some information on when and what is happening with HL7.
MS. GOSS: Before we do that, I want to add just for some people I know are very interested in understanding what the process will be around the Phase 4 and Terri to talk about the questions, the development that we have had. We will be finalizing those questions very soon. We will be distributing them and asking people to provide us with their written testimony and then those for the half day, a time opportunity that we have in February. People will be given the five minutes to give us their highlights. But what it will enable is people to submit that written feedback on the Phase 4 operating rules in advance of that hearing or at the hearing so that we can then have the five minutes of key points coupled with a review of the written testimony.
MS. DEUTSCH: I am sorry. I was remiss in not going into more detail because I was looking at the clock and the time. But what we did for the hearing was and it was very effective. We got very good feedback – was to limit discussion to five minutes and to ask the testifiers to provide any additional information in written testimony. As I have discussed earlier, they all submitted written testimony.
We also asked some of the entities to provide us only with written testimony because we did not have enough time to have everyone provide the oral testimony. We will do the same thing for the proposed operating rules so we get a wide representation. We learned that there were covered entities that were not represented all along and that we got a lot of valuable information of what was missing and what was needed for them. We are hoping to capture that with the proposed operating rules as well. We will open it up also for the industry to be able to provide written testimony. Since the operating rules are posted on the CORE website, it is available for anyone to evaluate and look at.
DR. SUAREZ: I do want to make an emphasis on that because I have been receiving quite a bit of inquiries about that specific point. This time around we are going to – has been described – announced, if you will, that people are going to be specifically asked to submit comments. We are not going to do a formal comment period process or anything like that. But we are going to be posting the questions and the topics and we are going to be asking the industry to prepare and submit those comments in advance of the hearing. There will be a number of weeks actually to do that. I am very pleased about that process because I think it is going to be very helpful.
With respect to attachments, that is the other big standard, the other big transaction for which we are being asked by the secretary on the standards to be adopted. As is pointed out in the slide, we have already done quite a bit of work on attachments. Attachments are one of the original transactions named under HIPAA. There are only two transactions for which we have not yet adopted national standards. One is attachments. And the other one – anybody can think of the name of that one? The other one is something called First Report of Injury, which is using workers compensation. We have not truly adopted a national standard even though the standard generally that is used in First Report of Injury associated with the claim transaction.
Attachments are one of the most significant transactions for a number of reasons. But the most important one is that it is the electronic vehicle to transmit clinical information in support of a claim. When I send a claim and the help line requires that I send medical documentation to support that claim in order to adjudicate the claim, I need to use an attachment. I need to send an attachment. I need to send electronic documentation of transaction called attachment.
This transaction is one of the ones that will really bring in many ways together in real life the two worlds: the clinical world where we have a lot of this data and administrative world. We have made recommendations around the adoption of the standard. As was discussed in the earlier process, the standards have been recommended in the exact same standard that is used in electronic health record transactions, the one that are mandated under meaningful use. It is the same standard. It is only constrained to include data that support the attachment.
The development process, the standard development organization or organizations that have developed this transaction standard are primarily three major groups. One is X12 that developed this standard itself for the content portion, the payload, if you will, in the transaction. X12 developed the so-called wrapper or the envelope, if you will, to carry the information. HL7 developed the standard for the content or the payload. And then we have some codification standards, code standards of something called LOINC that identifies through the code the type of attachment transaction that is needed to be sent.
We had already made recommendations about all this, but the standard for the payload, the one that HL7 developed, was not a standard that could be — as you remember Shana mentioning, one of the expectations is that the standards have to be enforceable, meaning the criteria and the standard content itself had to be actionable. And the developed standard by HL7 may not have contained what is known as conformance criteria, criteria that actually says thou shalt do this, thou shalt do that.
The HL7 attachment work group has developed a new version of the same implementation guide or classification that we recommended, but now it includes the conformance criteria so that it can be adopted. It is being validated and is going through the validating process at HL7 right now, very open and well known process. It will be by the time we come back to the hearing, it will have gone through the validating process and we will be able to hear from HL7 directly the status of that and the recommendations.
X12, we will also hear at the hearing the status of the envelope standard, if you will, and which specific version they would recommend that we consider adopting. We will also hear from LOINC about the standards for coding that exists and whether there have been some changes or updates.
I think at the hearing, it is not going to be a lengthy hearing. It is going to be a hearing that will give us an opportunity update these considerations. We will hear also from the industry about the standards themselves. We have heard throughout several hearings about attachments from the industry how important this transaction is to be adopted and to be used. Again, I expect that we will be hearing similar support for the adoption. Hopefully, at the end of the hearing, we will have the opportunity to work on a recommendation to the secretary about the adoption of the standards. That is the attachment standard.
MS. GOSS: So the agenda for the Phase 4 and for the attachments, drafts are being developed that we discussed with the Standards Subcommittee members. And the hearing will be the day before.
MS. DEUTSCH: Tuesday, February 16.
MS. GOSS: Split between Phase 4 and attachments.
DR. SUAREZ: Are you giving up your last three minutes.
MS. GOSS: Yes. I think that we don’t have enough time to get into the rest of it. I am not seeing any cards raised. We will turn it over to Vickie to talk about the work group.
DR. MAYS: Probably what would help is they are going to put up one thing on the screen, but what would help is if you pull out three documents. One is called the NCVHS work group charges and capacity 2015. In your packet, there is our agenda. It should be right behind the agenda that you have. And then the third thing to pull out is each of the work groups has their charge. We have one in which you are going to see the changes that we wanted to make to our charge. Those are the three things that I want to do. I am going to talk while people find – maybe if I just show and tell.
This is in your work group package. You need this. You need the agenda. And then they have given you this document. I am going to get started because I know I am between you and phone calls and everything before we go to dinner. But let me start by thanking Alix and the Standards group because they gave us some extra time so that we could actually be able to give you some background about the working group.
First, let me talk about what the work group is and it is listed as the working group. That is part of what we want to change. It is a little different than the way that the subcommittee operates. First and foremost, when you think about the work group, the work group is really designed in order to promote and to increase access to data and its use. Part of that increase was really predicated on the fact that the secretary in HHS wants to be able to get the data out. It is what we have been talking about for the last several days, but they are looking for people from the outside who may be entrepreneurs, people who work in the space of technology to be able to move nimbly and quickly to just do simple things like sometimes just give advice.
As you have seen in terms of our processes here for subcommittees, we are already talking about having a hearing from something and months before, we are actually able to give advice. In most instances, we are not giving advice to the secretary. In most instances, the work group is giving advice to an entity within HHS. I will give you an example.
We are tasked with looking at the website for SAMHSA and really having a sense of is there a way that SAMHSA can get the data out better, faster. Can we look at this data at the website and talk about whether or not SAMHSA’s data is available for whom? Is it available and easy and usable by data entrepreneurs? Is it available and easily used by researchers? Is it available and easily used by communities or consumers?
Part of what often is requested of the work group is to give advice about how to make the data more accessible, how to use formats such as social media, for example. In doing that, we are typically just meeting with that particular entity. We are able to do things like quick look, give some examples. And then we may determine after we have done that that for HHS websites in general, there should be some guidance or a philosophy about how to put data up or to be tweeting and finding out, to put things in some other particular format like an infographic. If we reach the level where we want to give general advice like that then we probably are looking at a report, letter, et cetera that might go to the secretary.
In those instances where we are talking about then going to the secretary, what we are talking about is that comes back to the Full Committee and that actually goes from the Full Committee. But simple advice is typically we are to move nimbly.
The members of the work group are consultants. They are not the same as you who sit here on the FACA committee. They are consultants. Other than being utilized for their particular expertise, we don’t pay them. They are volunteers. They come and go. Many of them are in spaces where they are pretty busy and pretty impactful in what they do. Often what they are looking for is to solve problems. Sometimes when we want them to come to our meetings and sit in hearings and stuff like that, they don’t often do that stuff. But if we give them a problem, that is what they love and they want to solve a problem and benefit HHS by making things move better or by creating a better widget or by actually bringing principles to bear that will liberate data. We have a lot of people who I think believe in liberating data. It is a good fit.
DR. PHILLIPS: I am just a little bit stunned. For a sector of the economy, it is almost 18 percent of our economy, the most consistent, economic engine our economy has, it is one of the most data rich pieces of our economy. Can you imagine going to the Council of Economic Advisors and saying can you please look at our website and tell us how we could get data out more easily? I think they would laugh. That is not to belittle the committee or the advisors. What a task to ask volunteers to do. Do we ever rise to a higher level of saying this is a task you really need to have a focused set of paid advisors who can come in and tell you that you are not meeting a standard of data sharing that is common in other industries. It is amazing.
DR. MAYS: I think you shouldn’t think this is the only thing that HHS does. I think if Suzie was still here, Suzie could come to the table and tell you within HHS that there are many times at which they issue contracts. There are many data developers that they work with. There are also some other parts. These are the people that we work with. For example, there is what is known as the IDEA Lab. Damon Davis, who is one of the staff to us, runs the IDEA Lab. And the IDEA Lab, which is an entity within HHS, is really designed to do this on a much broader level. He is the person who is acting also with many of the agencies. He comes to us with problems where sometimes he does not have a complement of people with every skill set that we might have. And then he would ask us. I have this issue. I have this problem. We have just put something up. Can you also look at it for us? I think there are contractual arrangements that go on within HHS. I think there is the IDEA Lab.
There is also – the White House has the presidential fellow innovation program where those fellows are often assigned, for example, to HHS offices. We are not the only ones. We are the kind of quick. We are the kind where it can take months to get a contract out. Once people really get a sense of what it is that we are doing, you can ask us a question. If we have the bandwidth, we then can answer that question for you. Believe me, I think that we have a lot to do, but we are not the be all and end all, but I think we are an important voice because of where we sit relative to NCVHS. I hope that clears that up so that you are not still stuck.
DR. O’GRADY: Can I ask a follow up question? But this looks like you are trying to separate yourself from NCHS. You don’t want to go through us anymore. This is a FACA committee. This is concerning to me that you have people who are volunteers and that is fine, but they don’t really speak for HHS unless they come through something like a FACA committee.
PARTICIPANT: Everything comes back through this committee.
DR. O’GRADY: Not according to –
PARTICIPANT: — the recommendations.
DR. O’GRADY: But they will be presented to us. They won’t be approved by us.
DR. MAYS: If they are recommendations that are going at the level of the secretary, they would come here. But for us to be able to of assistance to somebody who is simply asking us about websites, we meet four times a year.
DR. O’GRADY: You are speaking for HHS in that case.
DR. MAYS: No.
DR. SUAREZ: It is important to understand the context of this. There is some input, let’s call it that way, input that is being requested from the work group that can be processed and quickly shared in an informal way. Anything that has to be written as in a letter or a document that is provided to an agency as advice is a function that has to be an activity that NCVHS takes on. But there is less formal direct input that the work group is asked to provide. What we are distinguishing is that. Is that level of less formal input and advice, if you will, to an agency can be done? That is why we carefully were trying to make sure that it is not that the work group is not anymore reporting to work during the recommendations that have to be written and put into a document I have to sign as the chair have to be processed. That will continue and that will happen.
But it is also allowing the work group to interact more efficiently, more quickly and provide feedback more efficiently to agencies that request that in an informal way. There are those two areas. Informal, quicker the work group can do it directly to the agency. More formal, written, a document that I have to sign of the chair of the National Committee, that has to come to the National Committee and everybody has to –
PARTICIPANT: Because you do have these volunteers and that is great in one sense, but they are advising the government, the agencies that I would just be surprised if the HHS attorneys are comfortable with because it is implying – it is allowing a certain group of people to have access to agencies that not everybody else has access to. It is to help them. I understand the goal.
DR. SUAREZ: That is why this from a FACA and from a – this is called a work group. A subcommittee by FACA statute and by structure has to be formed only by members of the committee. But a work group can be expanded and opened to invite others outside of the members of the committee. That is actually written. In fact, I was a member of the Health IT Standards Committee of ONC, Karen DeSalvo’s advisory committee on standards. The committee itself had members, but we had work groups in which we were able to bring in others, not members of the Standards Committee, but experts in industry on things like I was chairing the standards, the security and privacy work group. We called it work group very carefully, not subcommittee or anything like that because it allows that. That is the other reason.
There are two main reasons why this is a work group. One is opening it up so that others – we can bring and engage others outside of the members of the National Committee. Two, it allows the work group to interact faster and more efficiently with agencies. But still it is connected to the National Committee and still whenever there is a formal recommendation then it comes to the National Committee.
PARTICIPANT: I also thought that in fact that you had a notion of a work group did not make recommendations. Is that correct?
DR. COHEN: Understanding a little bit more about the context historically I think would help. About five years ago, Jim Scanlon came to us and said he wanted a group who had a different kind of expertise. They were young data entrepreneurs or not necessarily young, a variety of folks who engaged data in a very different way than has been doing in the past and who could help him maybe deal with some emerging issues around blogging, tweeting, mash ups, stuff like that. As HHS was getting more involved in data.gov, be able to comment on some of these emerging data kinds of issues.
He thought the National Committed would be a good home to cite this group, but not interested in expanding or having them go through the processes that create a FACA or have them involved in the more formal aspects of the kinds of activities that we have been talking about the last couple of days.
He identified some folks who were willing to do this in this volunteer capacity. That is essentially the level of their involvement. There are issues that emerged that ASPE is interested in or that HealthData.gov is interested in or a variety of ways to think about how to get data out in different kinds of fashions. This group has these particular expertises. They meet sort of in conjunction at the time that we meet, but their role is very different and not as formal as what we do.
DR. MAYS: Also, let me just add one more thing. It is good. I think the other thing is the ability to rotate people in and out based on how technology changes. For us, we sit and we are here for long periods of time. The next thing you know we started out. We have a person who is really good in GIS and then we don’t really need that, but we need something else. The ability to be able to respond to the various needs that HHS has allows us to rotate these consultants in based on what the needs are that we are being asked to answer.
DR. STEAD: I totally get the idea of the flexibility of the membership and so forth. I think I have watched enough to have a good idea for what the work group is trying to do and can do. I am concerned about the edits to the charge because I think they – what in essence the edits do is take a set of bullets that are by definition summative, thoughtful, the kind of things in truth that NCVHS does. They are not quick advice. If you just looked at them, there is almost nothing in these bullets that can be handled as quick advice.
I think where we may be tripping up is we may want to leave that part of the work group when it provides that kind of advice, reporting through the Full Committee. We may want to have a paragraph somewhere that there is a different type of rapid advice that isn’t – it is not a recommendation. It is not summative. It is a response to a question that can be answered quickly, which none of these bullets can. It may be appropriate for those to have a direct connection. I think we would like to make sure that whatever that language is was reviewed by the lawyers so that we don’t get in trouble. But I think this edit does not work for me.
DR. KLOSS: I would just add that I am on the Privacy and Security work group now for HIT Policy Committee. All of our thought leadership output goes to the Policy Committee. There isn’t any other advice.
DR. MAYS: I want to go back to what Bruce said because I think that is the essence of this. It was not that this is something that we created. This is something that HHS created and wants us to have the ability to be able to respond to them without each thing having to – look at our agendas now – without us having for everything. For example, if we review the portfolio, which is – let’s just work through one. Let’s just go to charge one. Part of what we are trying to do is to really go through and outline what the charges are, how big they are, what expertise we have and what expertise we need. If we are reviewing a portfolio, for example, to look at what public health data we have and that is where we are asked to do by one of the agencies, if it is just to say, here is a list or here is what we have, I am trying to understand the necessity that then goes through a full report where they don’t get something for us from several months.
This is one that maybe we need to table when Jim is here. I did not create this. I am responding to how it is that we worked and the agreements that we have made and this is to respond to what HHS wants. This is not me. All my actions have gone through in discussions with Jim.
DR. COHEN: I think it is a good idea maybe to get Jim to —
DR. SUAREZ: I have talked to Jim and we were talking about that. Certainly, that is an important perspective. My understanding from his point of view was two things. One was no issue with respect to input that is provided interactively while we are with representatives from different groups like Damon comes and asks us. We are organizing a session at the next datapalooza and here are some ideas and we provide input at that meeting. Those are things that we provide. There is no reason why we would have to create a formal process. There are a number of examples like that.
And then there is the formal letters to HHS. It is to the secretary or someone that is inside the agency. For example, one of the products of the work group was a letter about use, usability, and usefulness and utility of the DHHS data resources. We spent months developing that letter, literally almost a year to develop that letter to craft it very carefully. Those are the kind of letters that have formal recommendations that go through the process of a National Committee.
I had my own concerns and I expressed those to Vickie as well about some of the changes because it gives the impression we are decoupling quite too much to data access and use work group from NCVHS and only tying it in some very constrained ways. My sense is the reverse. Many things can be brought through the National Committee and some specific things can be done with the interactive approach.
I prefer to think that we can explore and experience some of this new engagement with the work group as we go along in 2016 and see in which instances we believe that this creates a problem so that we can refine it better. I think the larger issues, the more specific, the more formal ways of providing input to the agency they have to come through the National Committee. But the less formal, more interactive type of input can go through the work group.
DR. MAYS: That is my understanding of the majority of what we are being asked to do. For example, I don’t anticipate that we are going to do a lot of letters. I think that Justine did one and I think that the individuals that we have don’t work in that space in that way. That is just one of the other issues in terms of how they expect to work, which is hit and run. You asked me this question. I am responding. Here, I have designed it for you and you have moved on. For example, when we talked about the marketing plan. If you look at our agenda, there are things like the marketing plan for your privacy tool. It is like I don’t think that is something that we would take anywhere. We would just give you some advice.
DR. KLOSS: It did not need to be approved. It was just a discussion.
DR. MAYS: Right. But that is what I am saying. If you look on here, for example, we are giving feedback on the framework. That, to me, is we just give feedback in terms of how the technology aspects of this works.
DR. SUAREZ: This is feedback to the National Committee. That is a different feedback. We are talking about feedback outside of the National Committee.
DR. MAYS: Then let’s take the blog. For example, one of the things that we will be talking about is the issue of a blog. We talked about this last time. We did go and find out information about what is the rules for an HHS blog and what is the ability to just blog about different issues. That is what we will present. If you want us to do an HHS blog, here is what we need to do and here are the rules. I am assuming then you would say okay. That comes through you. But in terms of blogging about activities that are relevant to the different advice that we give that individuals want to do on their own, that was totally different. We talked about that in the meeting last time as a way to get information out.
Several of the people that are in our group actually have their own blogs. They are experts at these things. And what they want to do is to be able to get things out. That is not considered the committee. That is considered putting things in within the network of HHS data. Here is an idea. I found this. This is what I did to solve this problem of finding the data dictionary. It is things like that. That, for example, would be an individual. That wouldn’t be it was done by a committee member as on behalf of the committee.
DR. SUAREZ: I am sure that with the appropriate disclaimers about this is an opinion about this person or this person’s opinion does not really reflect it. Work group consensus, opinion or the National Committee. All those are appropriate disclaimers. I would expect that there would not be any issues. Certainly, that is something that —
DR. MAYS: But that was just giving you an idea of when we talk about being outside the space and how it functions. When we want people to utilize our data and we come up with an idea, it will be over a year before we can probably get a report out about that because we have talked about doing a guidance or some kind of framework about ways in which HHS as an entity should think about responding in terms of data use. But this would be allowing a person who is an expert to make a comment on a blog somewhere about an easier way to use HHS data. They are not saying it on behalf of the committee. But we happen to know as part of the committee that that is an issue. That is why I am trying to give examples when you are saying we are going in terms of those things that are outside. That is an example of what we would talk about and talked about before.
We have, for example, the website, review that we have been asked to do. We are asking the work group to come up with what they want to see in terms of a review and discussing that. And then it would be that we will try and see if that meets the request from Damon and from Jim about the needs they have for us to review a website. We would review the website. If it is quick and dirty, we just give it to the person. After we have done a few of these, our thinking was that we would then come back with guidance on HHS websites in general. That is the kind of thing that comes through the committee. But if somebody asks us to look at their website, we informally tell them what we think and that is it. I am not sure exactly where you want to go with this.
DR. SUAREZ: I think Bill was suggesting that we bring back the statement on the third paragraph and then add a statement afterwards to just clarify the ability for providing informal interactive input. That is basically it. Because I think all these bullets are —
DR. MAYS: Those are the charges and we did not –
DR. SUAREZ: By eliminating this, I think Bill’s point – by eliminating this and I think I mentioned this to you too. It creates a sense that the work group on its own to perform all those functions and advise to HHS. It will assist and advise HHS. I think returning this text.
Again, my sense is if we start looking at concrete examples and find that we are getting into trouble, we can address those. I am concerned that we are addressing something that has not become yet an issue concretely.
My suggestion just following Bill’s comment is let’s just return that particular statement.
DR. MAYS: That is right before the charges. So that I don’t think is a problem. If it is looking like by saying that we are not addressing the charges then understood.
DR. SUAREZ: And then in the second page and before management, there could be a short paragraph introduced that describes that the work group will be able to provide informal, interactive-type input. That will open up that door to the ability of the work group to provide that type of input.
I think that is what Bill was recommending. I am just paraphrasing what he said and reporting it too.
DR. MAYS: Let me take these last two and try to get us out of here. Lilly will be here tomorrow so then we can make some changes. I have no staff here.
DR. COUSSOULE: How did these requests get made and how do we decide whether to take them and just position them and whether they go to a committee kind of structure or the work group kind of structure? I am just trying to think more of the practical nature and how that happens.
DR. MAYS: They come from Jim and Damon. So far, those are our customers within HHS. He runs the – I don’t know what he runs. Damon does the IDEA Lab and then Jim. Typically, that has been it.
DR. COUSSOULE: From a day-to-day practical standpoint, they send an email? They make a phone call?
DR. MAYS: Usually what happens is that we are in the meeting and they both do updates for the meeting if you see on the agenda. And what Damon will do is say here are some things that I need. Jim will say here are some things that I need. There is a third way that we get them and that is from the committee itself. We will get asked sometimes by the committee or we will volunteer and say we could help with that. Typically, it is in our meeting.
MS. BEBEE: For instance, to talk about the review of the website, which came from Jim Scanlon as a suggestion that possibly websites within HHS could be looked at. Then we look at the resources and working with Vickie. We have Lilly Bradley, who will be here tomorrow. She has been supporting this work group. Some of the people that are on the work group have volunteered to take on a certain project. In this case, it was a work group member who offered up some resources from his university to look at a particular website. We decided that with limited resources that we would look at one, HHS website, which is going to be SAMHSA. We have been working through a down and dirty kind of process at the request of Jim Scanlon to work through data access and use types of issues with this website. That is the background for that particular type of request that is coming from and within the committee.
DR. LANDEN: Looking it over, it sounds like the changes are making what is now known as the working group sometimes independent of the Full Committee and sometimes not. I wonder about the implications of that. I guess I have to leave it to others as a newbie and directionally, I see no objections to that.
But on the second page, the one line that was added, any recommendations or advisement specifically for the secretary of HHS will be presented to the Full Committee. I have two concerns with that. One is presented to the Full Committee leaves it very ambiguous as to whether that is for information purposes or for approval of the committee. It could be either one or both.
Second, all prior references in the draft talk about HHS and only HHS. This sentence specifically differentiates between recommendations, advisements, and I presume guidances that go to HHS versus to the secretary of HHS. I don’t understand the nuances there. What is the difference between something going to HHS and something going to the secretary?
DR. SUAREZ: If I may just very quickly, by reinstating the sentence on the previous page, which eliminates the need to have that sentence in my view. I think the sentence in the previous page covers everything we need and we don’t need to add that sentence. I think the reason that the sentence was added was precisely because we had taken out the sentence in the first page, in the first page in the third paragraph where it says through the Full Committee and recommendations. But by reinstating that text, it eliminated the need to have that last sentence in the second page.
DR. MAYS: The goal there was when you say HHS that is really big. If we are going to be able to informally respond to HRSA or SAMHSA or somebody that asks us to do something, which still is a part of HHS. I don’t think we can predict exactly who or what in HHS because typically Jim and Damon come in and make requests to us or the committee makes requests to us. That is why HHS was left in. And then we put in the things specifically. It was because when on the Executive Committee, Walter raised it. I wanted to make sure that it was very clear. Anything that is going to the secretary is going through the Full Committee. He has to sign off as the chair anyway so that comes in.
The other thing maybe that isn’t clear is that there is a representative from every subcommittee that is also a part of this. It is not just me and the consultants. It is actually you have representation. In the past, the representations have been the chairs. We were raising whether or not if you started having committee members and you want them to come and represent you, which is fine. The information is always there for someone to say we should take this back or we think that this is something that is at a level that the Full Committee needs to do. There is representation there from the subcommittees.
DR. O’GRADY: I certainly still have these kinds of FACA concerns in terms of if nothing else the spirit of FACA and the representation. I just have two clarifying questions. The friendly amendment I heard from Walter was to take out that third paragraph prior to the bullets. Reinstate it. And then the one in orange on the next page that talks about any recommendations presented and goes away.
Can you just talk a little bit about in terms of – I appreciate the idea of a certain flexibility that allows the agencies of HHS be able to get this outside opinion without jumping through a lot of hoops and having a lot of contracts and stuff like that.
The current language you have in the charge. In what ways does that limit you from being able to do that now? Is it a feeling that you have to bring everything back to us for a more formal advice? You have some great consultants on this. There is no doubt about that. If I am sitting at CMS and I am trying to figure out something of how to do whatever and I would like to be able to call those guys. I think to a certain degree if they know them, they call them probably anyway. I like very much the goal here.
I am concerned about – as we know, being able to give the government advice often – hundreds of millions of dollars are spend every year on people trying to give the government advice. We need to be very careful that we don’t cross any lines there.
How tough is it for me and my – it is not Bluetooth. But CMS – blue button. On those sorts of things, you do seem to have the kind of people you would want to talk to if you were trying to design something. What is the stumbling block from – it is not a formal recommendation. It is not something going in a letter. Right now the way the current charge is, are you prohibited from just having that conversation with them?
DR. MAYS: There were a couple of reasons to clean up the charge from my perspective. One is the initial set of documents that I had, which were slides and stuff from the previous chair, talked about the work group. And then when we put it on the NCVHS website, it seemed like it was a working group. Walter says that is what it was the whole time, but Justine’s slides always said the work group. I assume there were some other earlier iterations.
And also there is a description of what a work group is relative to a subcommittee. It fits along with understanding the FACA issues. Work group is something that is official. Lilly could not find anything about that. We were trying to clean that up so that exactly what you are saying is we are under the right auspices of what we are supposed to be in terms of the legislation. We are a work group.
The second thing was in our own group, there has not been clarity as to what it is that we do in terms of moving forward. For example, I think something came up. Was this supposed to come back through the Executive Committee? That kind of advisement really wasn’t. We had already been working specifically with Jim’s office on things. It was not unknown. Part of this cleaning up is also to make sure that the committee understands the ways in which we can move.
I think that part of what we are hitting is this sensitivity of exactly when are we nimble and when are we not. I landed on based on – again, Lilly did some background research and what have you. When we are acting in this informal capacity, when you are just coming to ask us to tell you something, we are fine. When it starts talking about it being a written guidance document, et cetera, we always come back.
What I was actually trying to do is make it clear about that that we have the capacity to be able to do that because I don’t think it is clear among us. We are just getting at the stage where – typically, I only have about 15 minutes to usually present. This is about the longest space I have had to present. Again, having the time as a work group to make sure that we are intersecting with the committee, the committee understands what we are doing, that is really just starting. I think we are having a bumpy road a little bit because of that because we have not really been integrating in that way where we come in and say it.
We usually have 15 minutes and I tell you real quick. We are going to do this. We are going to do that. But now that we are really working on this convergence model, it really is trying to make sure you understand and that you ask us for things that we might be able to help with. Our next goal in our meeting is to really say here is what the charges are. Here is where we have a bandwidth to do it in terms of the expertise we have. But what are the priorities that are coming from HHS to us, the request, and do we need to add some more bandwidth in order to be able to answer that? We are trying to design our work products going forward, have a rationale for when we put somebody on. Our people are only on for a year so they can all rotate off in August. We can get different people on. That is also a different kind of flexibility. I am hoping that a lot of this is more helpful in terms of how we are working.
DR. O’GRADY: I applaud your goals. I am not sure that this is the mechanism to do that at least not without talking to Jim Scanlon about have we crossed T’s and dotted I’s with these FACA concerns just to make sure. It sounds like he came to you with a goal that is laudable. You are trying to make a mechanism to actually operationalize it and make it work and make it work efficiently and quickly. That is laudable too. I just want to make sure we are not stepping in it in terms of some of these other concerns.
DR. MAYS: As I said, I am happy to send it through. We did have Lilly go and check FACA rules and what have you to make sure that we are in that space when we were doing this. If you want to run it up the lawyer flag pole or whatever the flag pole is that needs to go up, I have no problems with it. I just want the understanding here as to the ability to work so that we can work. I think some of this came up with these issues. It is in response to some earlier issues about what mechanisms we go through for even little simple things. I was trying to get clarity on that.
DR. SUAREZ: I think reinstating that statement in the first place and eliminating the second statement on the second page would take us to a place where we can start this new process. If you prefer to add a statement before management administration around this point that Bill was mentioning that clarifies the opportunity to provide informal, interactive feedback to agencies during meetings and things like that and through other mechanisms and leave it like that without saying blogs and that is kind of the goal, we can have that.
DR. MAYS: When Lilly is here tomorrow, why don’t we clean this up and then if you can find some – I don’t know what time Lilly gets here. I think she is here late. And then if we can find some time to give it back out or to send it via email, it is whatever as long as we can work tomorrow.
DR. SUAREZ: And then you can present it to the work group in the afternoon.
DR. MAYS: Thank you people. Bumpy way to start, but welcome to NCVHS’ work group.
DR. COHEN: I think it is really helpful to have new eyes look at stuff. We are doing things a certain way and it is great to have different perspectives. It will make the work group ultimately —
DR. MAYS: I appreciate the comments. We just want to work. I am happy especially for some of you who – you know the lawyers at HHS. I don’t want to meet them.
DR. SUAREZ: A couple of logistics. Thank you very much, Vickie. Thanks everyone for this wonderful second day of the National Committee and first day of the Full Committee meeting. We have a logistics. The dinner arrangements. I don’t know if Debbie you want to say something about them.
PARTICIPANT: I got the count. For those of you who are going back to the hotel, we did indicate 6:30.
DR. SUAREZ: So 6:30 at the restaurant. Tomorrow we start at 8:15. We start bright and early tomorrow. Then the last thing we have actually before adjourning public comments. I know most of our public has left and I apologize for that. We will certainly have public comments tomorrow definitely. Anybody on the phone at this point? Probably gone by now. We will consider the meeting adjourned for today. Thank you very much.
(The meeting adjourned.)