[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics (NCVHS)

February 17, 2016

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


P R O C E E D I N G S (8:40 a.m.)

Agenda Item: Welcome

DR. SUAREZ: Good morning everyone. I think we are going to get started. I want to call to order the meeting of the National Committee on Vital and Health Statistics, our February quarterly in-person meeting, and welcome everyone. My name is Walter Suarez; I am the Chair of the national committee and work for Kaiser Permanente.

We are going to go first through introductions and then we’ll make some introductory remarks and review the Agenda. So let’s start with the introductions, to my left. If you’re a member of the committee, please mention your possible conflicts or no conflicts. Thank you.

DR. STEAD: Bill Stead. I’m from Vanderbilt University. I’m a member of the full committee and Co-Chair of Pop Health and a member of the Review Committee. I have no conflicts.

DR. COHEN: Bruce Cohen, member of the full committee, Co-Chair the Population Health and am on the Data Workgroup, Massachusetts Department of Public Health, and no conflicts.

DR. O’GRADY: I’m Michael O’Grady. I’m a member of the committee; I have no conflicts. I’m a senior fellow at the National Opinion Research Center at University of Chicago.

DR. SUAREZ: Mike, just real quick. Have you selected your subcommittee yet?

DR. O’GRADY: Yes. I think Pop Health would be very nice.

DR. SUAREZ: Excellent.

DR. RIPPEN: Helga Rippen, Health Sciences South Carolina, but also Clemson University and University of South Carolina. I have no conflicts and am a member of the Subcommittee for Population Health and also the Data Committee working group.

MR. COUSSOULE: Nick Coussoule with Blue Cross/Blue Shield of Tennessee. I’m a member of the full committee and member of the Privacy Subcommittee and the Standards Subcommittee, and I have no conflicts.

MR. LANDEN: Rich Landen. I’m with QuadraMed and a member of the full committee, member of the Review Committee, no conflicts.

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

MS. GOSS: Good morning, this is Alix Goss. I’m the Executive Director of the Pennsylvania eHealth Partnership Authority. I am a member of the full committee, Co-Chair of the Standards Subcommittee with Ob Soonthornsima, as well as the Review Committee, and I have no conflicts. I plan framework efforts with Population Health as well.

DR. MAYS: Vickie Mays, University of California Los Angeles. I’m a professor there. I chair the Data Workgroup and I’m a member of the Review Committee and Pop Health.

DR. HINES: Rebecca Hines, Executive Secretary with NCHS CDC.

DR. SUAREZ: Are any members of the committee on the phone?

DR. SOONTHORNSIMA: Yes, good morning. This is Ob Soonthornsima with CVS Health, member of the full committee, Chair of the Subcommittee on Standards and on the Review Committee. No conflict.

MS. MILAM: Good morning, this is Sallie Milam. I’m in West Virginia with the West Virginia Healthcare Authority. I’m a member of the full committee and a member of the Privacy, Security and Confidentiality Subcommittee and I have no conflicts.

DR. CORNELIUS: Good morning, this is Lee Cornelius. I’m at the University of Georgia. I’m a member of the full committee and the Population Health Subcommittee, and I have no conflicts.

DR. SUAREZ: Any other members of the committee on the phone?

DR. EVANS: Yes. This is Barbara Evans of University of Houston Law Center. I’m a member of the committee and a member of the Privacy Subcommittee. I have no conflicts, but I note and disclose the relationship that I serve on the privacy panel for the Food and Drug Administration’s sentinel system and the planning board for its national medical device evaluation system.

DR. SUAREZ: Thank you, Barbara. Any other committee members on the phone? Let’s go around with staff and members of the public.

(Introductions of staff and members of the public.)

DR. SUAREZ: We are waiting for Jim Scanlon from ASPE to come in, but we’re going to move ahead. I wanted to mention that this is certainly a very important meeting of the committee. We have several very significant topics to cover in the Agenda.

For a quick review of the agenda, we’re going to have two major actions for the committee at this time. One is the Review Committee Letter of Recommendations from the June 2015 hearing, and the other action item is the report summary from the November 2015 workshop of the Population Health Subcommittee. Those are the two actions, and we’ll have a chance to review and discuss them.

We will also discuss three other significant topics. One is ICD 10-CM. We’ll certainly hear about the status of that from the administrative perspective, but also hear about the development and the process on ICD 10, and also about ICD 11. We want to begin to think about that next version of the Code.

The other major topic we’ll hear and talk about is the all-payer claims databases, the so-called APCDs. We’ll hear about it as well, and we’ll have a chance to talk about opportunities for NCVHS to play a role in those.

Then we will hear an update on the recently-released proposed regulations, Notice of Proposed Rule, published by SAMHSA, the Substance Abuse and Mental Health Services Administration, on the confidentiality of substance abuse and substance use disorder records — part of what is known as 42 CFR, Part 2, the federal code that governs this set of records. So those are three very important topics.

Also, we will be discussing the workplace for 2016 for the subcommittees and the work group, and the overall national committee work plan for 2016. We’ll talk about those and get a sense, at least a map, if you will, of topics and actions and meetings and hearings and workshops that we would be looking for in 2016 on the various topics.

This morning we will hear updates from the federal agency partners including ASPE, CMS and ONC, and then tomorrow morning we will hear updates from our federal partners on the privacy side, Office for Civil Rights and ONC as well. Tomorrow afternoon we will adjourn and then convene the Workgroup on Data Access and Use for the afternoon meeting.

That is our agenda. Any questions, additions, suggestions for the agenda? All right. I hear none.

I wanted to pause a minute and also a mention a few words about our Linda, Linda Kloss.

As you all know, her husband, John, passed away a few days ago and I just wanted to let Linda know in spirit and in our hearts that our thoughts and prayers are with her. She is going to be taking off some time in the next few weeks. She is intending to come back, certainly, to our National Committee activities later in the month of March. I just wanted to let her know that our thoughts and prayers are with her. And thank you for all your messages and your thoughts on her loss.

With that, I think we want to move on. I’m not sure where Jim Scanlon is, but in the meantime, we’re going to move on and hear updates from the other two federal partners. We’re going to start with CMS, Shana Olshan, and then we’ll go to Jon White on the phone from ONC.

Agenda Item: Updates from the Department

MS. OLSHAN: Thank you, Dr. Suarez. Good morning to the committee. As always, it’s a pleasure to be with you here today. I really want to recognize the Standards Subcommittee’s handling of yesterday’s icy morning. It was able to compress the really important hearing into a much shorter day and I thought it was truly successful. So thank you for all your hard work yesterday.

I know that meaningful use continues to be a topic of great interest to this committee and to the healthcare community at large. Therefore, as I commonly do, I’m going to turn the first portion of these remarks over to Elizabeth Holland in our Center for Clinical Standards and Quality who is on the phone with us today. Elizabeth, the floor is yours.

MS. HOLLAND: Thank you, Shana. The Medicare and Medicaid electronic health record incentive programs have paid over 483,000 healthcare providers over $31.8 billion in incentive payments since 2011. In October, we finalized the definition of meaningful use for 2015 through 2017 and the Stage 3 definition of meaningful use.

We are currently accepting attestations from eligible professionals, eligible hospitals and critical access hospitals for the electronic health record reporting period in 2015. Last week, we extended the attestation deadline from February 29, 2016 to March 11. However, we do not recommend waiting until the last minute and we urge providers to attest now. Providers need to attest for an EHR reporting period in 2015 or they will be stuck to the Medicare payment adjustment in 2017.

If providers are unable to successfully attest, they may apply for a hardship exception. Although the hardship exceptions were included in the HITECH Act, the Patient Access and Medicare Protection Act of 2015, or PAMPA, has resulted in a new streamlined hardship application process, and the applications we have currently posted on the CMS EHR Incentive Program website. Under PAMPA, the deadline for submission of hardship exceptions is March 15th for eligible professionals and April 1st, 2016 for eligible hospitals.

This streamlined application does not require the submission of documentation. We ask people not to submit any documentation; just complete the application and submit it on time.

While the Medicaid electronic health record incentive program will continue to pay incentives through reporting periods in 2021, the last year that the Medicare incentive program will pay incentives will be for reporting periods in 2016. However, meaningful use doesn’t just go away. There are provisions in the Medicare Access and CHIP Reauthorization Act that provide for the creation of a merit-based incentive payment system, or MIPS, and meaningful use will be 25 percent of the initial MIPS payment.

In his January 19th blog with the National Coordinator for Health Information Technology, Karen DiSalvo, CMS Administrator Andy Slavitt stated that we will be looking at meaningful use with the following guiding principles: Rewarding providers for outcomes-based technology that will help them achieve better outcomes for their patients; allowing providers the flexibility to customize health IT to their individual practice needs; leveling the playing field to promote innovation; and prioritizing interoperability. So look forward to the MIPS’ proposed rule coming out later this year.

That’s all I have for my update. Thanks, Shana.

MS. OLSHAN: Are there any questions for Elizabeth while we still have her on the phone?

DR. O’GRADY: As you went through and talked about the weighting of kind of coming out of the new act and how that will — I think you had a total of four criteria. There was quality, some sort of terminology that I interpreted as cost savings, innovation and interoperability. The weights are sort of equal — .25 across all four criteria?

MS. HOLLAND: No. The weights are actually in the law.

DR. O’GRADY: Oh, the weights are in the law, okay. But that’s what it is? It’s sort of a quarter, a quarter, a quarter, a quarter?

MS. HOLLAND: I don’t know the breakout, but I think there might be somebody talking about that later, the meaningful use percentage.

MR. LANDEN: Since we are over halfway through the out-of-station period for meaningful use, any preliminary observations about both the quantity of submissions and are they meeting expectations, and also the quality? Are we seeing any issues with pass/fail?

MS. HOLLAND: I think we’re pretty happy with the way they’re coming in. This is the first time we’ve had hospitals and eligible professionals all coming in at the same time, so the system capacity is there. We’re averaging around 7,000 providers coming in a day, so the numbers are looking fairly good.

There was some concern that because the Reg did come out later in October that we wouldn’t be able achieve meaningful use, but I think with the modifications that we’ve made lowering a lot of the thresholds, I’m confident that we’ll finish really strong and have really good numbers.

DR. SUAREZ: Elizabeth, I’m just wondering with all the discussions around meaningful use lately, and certainly the very helpful blog from Administrator Slavitt and Assistant Secretary DiSalvo on meaningful use, what do you see meaningful use being after Stage 3 starts to be implemented? I know there is the migration path of some of the quality aspects of it to MIPS and all that discussion and the upcoming regulations that will describe that. But beyond that, what do you see the meaningful use program being after Stage 3 is started and completed? How does that evolution continue?

MS. HOLLAND: I think we want to continue on with the progress that we’ve made. The thing with MIPS is that it brings a lot more providers under the umbrella, so people who were not eligible for the EHR incentive program will be part of MIPS. We have a lot of work to do to try to help those providers convert to electronic records.

Although we did finalize the definition of meaningful use, that definition was subject to comment, so we did get a fair amount of comments and we’re looking at those comments as we develop our proposal for MIPS. So it’s very possible that we’ll be keeping some of the things that we did finalize in Stage 3 through MIPS.

DR. SUAREZ: Thank you. Any other questions for Elizabeth? Thank you, Elizabeth, for joining us.

MS. OLSHAN: Before I move on to the administrative simplification portion of my remarks, I want to briefly mention some other important DMS initiative that may be of interest to the committee.

Elizabeth already mentioned MACRA, the Medicare Access and CHIP Reauthorization Act of 2015, which was signed into law this past April. In MACRA, it permanently repeals the sustainable growth rate formula for determining Medicare payments for clinicians’ services. It establishes a new framework for rewarding clinicians for value over volume and streamlines the other existing quality reporting programs into one new system.

Implementation of MACRA is a major opportunity to put a broad range of healthcare providers on the path to value through the new merit-based incentive payment system, or MIPS, as Elizabeth just mentioned, and incentive payments for participation in certain alternative payment models, or APMs.

MACRA sunsets the payment adjustments associated with the physician quality reporting system, the value-based payment modifier, and the Medicare EHR incentive program for eligible professionals. MIPS combines these efforts into a single consolidated program with four weighted performance categories upon which the eligible professionals will be assessed, and those four are quality, resource use, clinical practice improvement activities and meaningful use of certified EHR technology.

MIPS requires the Secretary to develop and provide clinicians with a composite performance score that incorporates MIPS eligible professional performance on each of those four categories, and, based on this score, eligible professionals may receive an upward, downward or no payment adjustment. MIPS offers an opportunity for eligible professionals to achieve significant financial incentives for providing healthcare that advances the goals of a better, smarter and healthier system.

MACRA also provides incentives for participation in certain alternative payment models, or APMs, as I said. Qualifying APM participants will not be subject to MIPS adjustments and will receive a lump sum incentive payment equal to 5 percent of the prior year’s estimated aggregate expenditures under the fee schedule. The 5 percent incentive payment is available from 2019 through 2024, but beginning in 2026, the fee schedule growth rate will be higher for qualifying APM participants than for other practitioners.

MACRA also encourages expansion of the APM options available to physicians, especially specialists, through physician-focused payment models — and you may see that referred to as PFPMs. The law requires the establishment of a technical advisory committee that will assess these new payment model proposals submitted by stakeholders and make recommendations to the Secretary about which models to consider testing. This is a valuable opportunity for stakeholders to participate in delivery system reform by developing and submitting their ideas for APMs.

CMS issued a request for information about MIPS and APM in late September, and while that comment period has closed, as Elizabeth mentioned, CMS intends to implement these MACRA provisions through future notice and comment rulemaking.

The MIPS payment adjustments and the APM incentive payments will begin in 2019 based on performance or APM participation, respectively, in a prior performance period.

CMS is actively working on another major initiative required under Section 501 of MACRA. CMS, along with impacted partnering federal agencies, has begun the process for removing social security numbers, or SSNs, from Medicare cards. A major objective is to effectively modify more than 75 existing systems that currently use the SSN-based identification system, changing over to a randomly generated Medicare beneficiary identifier, or MBI, in a cost-efficient way.

CMS will solicit input from stakeholders at various points throughout the project to ensure a smooth transition that maintains beneficiaries’ access to care while avoiding disruptions to the payment process. In 2018 and 2019, an intensive outreach and education program will take place for beneficiaries, providers, private insurers, clearinghouses, Medicare contractors, state Medicaid agencies and other impacted stakeholders.

Now, on to administration simplification. Last month, our Acting Administrator, Andy Slavitt, described the ICD 10 implementation as, and I quote, “…the biggest event that no one heard about.” This relatively smooth transition is a testament to what can happen when the federal government partners with industry. The ICD 10 implementation required individuals from across healthcare to work together, thereby joining the expertise of clinicians, administrative staff and information technology experts.

Within the next week or so, CMS will be releasing additional information about the ICD 10 implementation, and once that has happened, I will make sure that members of this committee are provided with all of those materials.

We have heard repeatedly from stakeholders and in press reports that the success of the ICD 10 implementation was due largely to two things. First, unprecedented collaboration across the healthcare industry and, two, extensive educational resources including the CMS offerings available on CMS.gov/ICD10 and roadtoten.org.

Moving forward, I want to capitalize upon this experience to transform the way we approach evaluating, adopting and implementing administrative simplification standards and operating rules. I have laid out an ambitious agenda for the National Standards Group for this year, which is appropriate, as Dr. Suarez mentioned, for this HIPAA 20th anniversary year.

Now that the ICD 10 implementation is largely in our rear window, we can give the rest of our administrative simplification responsibilities our full attention. I think the committee will be pleased to see over this coming year that CMS, on behalf of the Department, will be responding to many of the past recommendations you have made to the Secretary and will respond in a more timely fashion to the recommendations that you submit in the future. We will highlight a few items today.

Last time I was here, I briefly described the evaluation framework that we’re developing. As a reminder, the four principles we will be using in the framework are to determine, first, does the proposed solution solve a problem; secondly, does the solution lead to administrative simplification across the healthcare ecosystem in the long term; third, can the solution accommodate changes in technology or changes in the healthcare industry and not stifle innovation, and, lastly, is the solution enforceable.

We plan to provide an opportunity for the public to comment on this framework in the very near future. Such input from interested parties will allow us to strengthen our proposed approach and implement something that will be understood and well received by the covered entity community.

In the unified regulations agenda that OMB published on reginfo.gov, we included language stating that we plan to publish a second notice of proposed rulemaking on certification of compliance in April of this year. We have used the comments on the earlier NPRM on this topic and the responses to last year’s Health Plan Identifier Request for Information in our development of this new NPRM. I’m not sure whether we will make the April date but we are working hard on this proposed rule.

In another regulation planned for this year, we will include the Department response to the NCVHS June 2013 recommendations regarding NCPDP standard for pharmacy claims enhancement to the NCPDP Telecommunications Implementation Guide version D.0.

As we continue to explore the options regarding the Health Plan Identifier, HPID, we will be applying this new evaluation framework. The information provided in the various NCVHS recommendations and the Request for Information was comprehensive and will be central to this evaluation.

Addressing the issue of claims attachment is high on my list of priorities for 2016. As you all know, it’s one of the claims transactions described both in HIPAA and the Affordable Care Act for which the Department still has not adopted a standard. With the information provided at yesterday’s hearing — and I understand it was the seventh on the topic — the many past NCVHS recommendations, the extensive work by HL-7 and the HL-7 WIDI X12 attachments collaborative, and the application of our new evaluation framework, I believe that 2016 may finally be the year for action.

I’m excited to hear today’s discussion on the recommendations from the Review Committee. I was impressed by the hearings last summer. The degree of engagement by the healthcare industry was rather phenomenal. The criteria used by the Review Committee are quite similar to the evaluation framework that we plan to use as well, so the timing of the recommendations will be excellent.

This first review of all adopted standards and operating rules was an important step on the road to ensuring that the Department will be a force for good in the world of administration simplification and will not create unintended obstacles to increasing efficiency and effectiveness in the healthcare ecosystem.

The time has come again for us to solicit feedback from NCVHS and the Office of the National Coordinator’s committees on opportunities to improve standardization and uniformity in new financial and administrative activities, as required by Section 10109 of the Affordable Care Act. We will be coordinating with you, Dr. Suarez, as the NCVHS Chair at least through September, and my colleagues at ONC to determine how best to proceed with this activity this year.

There continues to be a perception that there are no consequences to not being in compliance with the adopted standards and operating rules, so my group is developing a comprehensive compliance strategy that will challenge that perception. I already mentioned certification of compliance. We will also be enhancing the compliant-based enforcement including the upcoming deployment of an updated tool to report complaints.

The Affordable Care Act made clear our audit authority, and we have developed an audit strategy to implement this authority. Later this year, we will be sharing this strategy with the public prior to implementing it.

Finally, I want to speak about education and outreach. Covered entities are unlikely to be in compliance if they do not understand the adopted standards and operating rules. As recently as September 2013, this committee recommended to then Secretary Sebelius that there needs to be increased education, outreach and guidance about administrative simplification requirements. The ICD 10 implementation also confirms that providing excellent education improves and facilitates compliance.

We will be leveraging the lessons we learned about education from our ICD 10 work to increase and improve the available information about each of the adopted standards and operating rules. This important work will not be successful unless we partner across the industry — another lesson from ICD 10. Partnerships will enable the messages to reach the broad spectrum of covered entities large and small. With more comprehensive education and outreach, compliance should increase and the healthcare industry will see greater efficiencies and less clerical burden. The ultimate winners will be all of us, both as taxpayers and as patients.

Thank you for your time today, and I’m happy to answer your questions.

DR. SUAREZ: Thank you so much, Shana, this was a great update. Let’s open it up for questions from the members of the committee. Anyone on the phone with questions?

MS. GOSS: Thank you for that update. It sounds like you have a lot in the hopper, and at some point it would be great if we could maybe get a visual once your strategies are worked out and your key priority areas, to see from the collaboration that you’re doing with Walter and also with ONC, for us to just have an actual sketch-out of what’s in your queue and where you’re focused. It would be very helpful for us to understand how our process will then fit in with your cycles.

MS. OLSHAN: Absolutely. I think that’s an excellent idea, Alix.

DR. STEAD: If I could just build on that, it would be worth its weight in gold if we could have a graphic that would let us know when each of the things you mentioned — MIPS, the accountable payment model, the change from SSN to the random ID — when implementation will be required to be complete, in essence and, for things that are around payment, what the measurement period is that precedes that. So then we can really begin to see what the implementation time line looks like, what the measurement time line looks like, and when they actually affect payment. That would be helpful. I haven’t found that.

MS. OLSHAN: I will pass that along to my MIPS, APM and social security number removal initiative colleagues. I’m not working on either of those, but I will definitely make the case that you just did, that putting it all in one place will help everybody.

DR. STEAD: And include the things like the change from SSN to random ID, because we’ll have to align all of this.

MS. GOSS: I think, Bill, you make a really good point, if I can just add on to your add-on. We have heard from our discussions and strong commentary from the industry that we need a roadmap. In order for us to think about all the pieces that have to come together and be mindful in what we recommend and balancing the burden with the progress, that kind of graphic and tool will help us be better at advising.

DR. SUAREZ: If I may add on to all the add-ons, we will be seeing, in the next several months, recommendations about new standards, new versions of standards, and particularly I expect that at some point later in 2017, not this year necessarily, we will begin to know about the next version of all the HIPAA transactions and the timeline for adopting those.

So I think it would be helpful to begin to sketch, as Alix said, and it was mentioned by Gail Coker and others who testified yesterday, the importance of really now building what we’ve been thinking and saying we would build, which is this sort of roadmap and sketching of all these different elements including the ones that Bill mentioned and certainly all these transactions.

I’ll pass it to Michael and then Rich and then Bill.

DR. O’GRADY: Back on the payment model innovation you’re trying to do, one thing I would say — and it was brought up by Bill’s comment — I’ve seen the agency stumble, even with all the best intentions, in the past because they didn’t have really good baseline data. It’s one thing when you’re talking about an entire health plan where you’re sort of saying what is your per member, per month and things like that.

But as you try to move into things like bundling of certain services or however you want — and it sounds like you want to be able to explore a whole range of capitated, incentivized payment reforms and have other people come to you. It’s just heartbreaking when you get to the end of something and you’re trying to do the evaluation and you’ve done a great job on measuring what happened during the demo, and then your legs are cut out from under you because you have no good baseline data on what all these services actually cost. And the claims can get you so far, but all of a sudden you’re realizing that that sort of — and now it’s three years later and you’re stuck.

So I guess it’s just an encouragement that, as you go into these things, especially if it’s being suggested to you from the outside and some of these other innovative ways you want to do it, it’s really important to have very rigorous baseline data so that you get the proper picture of exactly what savings are there, if there are any.

MS. OLSHAN: I think that’s an excellent point. As I mentioned, I’m not working on this project and I will pass your recommendation along to them.

But I do know that our Office of Enterprise Data Analytics has been looking very closely at all of the Medicare data that’s out there and hopefully is creating good baseline metrics that this can work upon. But I do not know that. I will pass it along.

MR. LANDEN: I have two questions. I was intrigued with the four criteria in your framework for evaluating proposals, and I’m looking forward to a lot of conversation so we can flesh that out and understand it.

Specifically, I was thinking about how different the draft letter that we’ve got on the table for today might look if we ran that through the discipline that your four criteria say, so that we could actually start culling out from all the testimony some of the things your staff would be looking for as they apply these criteria. So I look forward to more dialogue on that.

My second comment is would you also, in your thinking and your planning, consider one of the topics that came up repeatedly from many of the testifiers yesterday which was a desire for predictability of a maintenance cycle. Now that ICD 10 is behind us, we hope, can we think about terms of predictability of the cycles, and particularly I’ve got standards in mind but I’m sure it would apply to other things as well.

MS. OLSHAN: I think predictability is always a challenge in the world of government. There are many forces that are beyond us. But I think the idea of predictability fits in well with the idea of a roadmap. I think a lot of your comments all are coming to the same point, and we will definitely take that back and see what we can do with it.


DR. STEAD: I just want to flesh out one more piece of the idea of the roadmap. Nirvana for me would be that we had the roadmap, and whenever we have a new thing that met your fourth criteria — and I would love to see those criteria also applied to payment models — that we would, in essence, be able to insert it in the roadmap, and we would be able to sum down the column of a particular year of the roadmap and know what the implementation burden would be to the industry in the different pieces.

If we had that kind of a tool the different parts of HHS could use it in coordinating plans, but providers would also be able to use it to sum up their decisions on which of these things to participate in and which not. So, in essence, if we could make the roadmap actionable at that level, it would lead to great coordination.

MS. OLSHAN: So, sort of a map that also has multiple levels that one could drill down depending on your interest.

DR. STEAD: And sum up impact — yes. You could think of it as a map that was a slice of Swiss cheese and you could actually sum up what the impact in a year would be from different combinations. That could be used at the government level as it’s deciding what to adopt, and at the provider and other pieces of the industry level, at which points we’re going to implement where those choices are optional because we’re trying to sum it up net effect.

MR. SOONTHORNSIMA: Can I chime in real quick to that comment? Dovetailing to what you just talked about, I can visualize it, and I think it’s important for us, as part of this roadmap, if you can call out the capability that you’re looking for from the data perspective as well as standards. We anticipate lots of changes coming down the pike. However, we wonder if some of these standard changes and changes to operating rules that we’re thinking about applying here would add any value if at all to some of the business needs that are coming down the pike.

So I think if you can drill down what capabilities, what dependencies you see over the next two to three years.

MS. OLSHAN: On this roadmap idea, Ob just mentioned two to three years. What timeframe are you all thinking about if we do go down this road — five years?


DR. STEAD: You would want five years, and the detail would be greater in year one than in year three than in year five, so it would be a rolling five-year roadmap.

MS. OLSHAN: That makes sense to me. Thank you.

DR. SUAREZ: Any other questions from the phone? Denise?

MS. LOVE: I don’t know if this is a question or just an editorial comment, but I’m a little struck by going away from the SSN to the random ID, and I think that has ripple effects through a lot of our health data community. You’ll replace it with a randomly assigned ID in Medicare, but I’m thinking of all the state data systems and others that rely on some form of social security number, and without a global or national patient ID I sense chaos in the data world.

MS. OLSHAN: As I mentioned, we are having to look to update about 75 systems and that includes what do the state Medicaid agencies have to worry about, for just the issues that you raised.

MS. LOVE: Yes. You have state Medicaid but then you’ve got hospital discharge data reporting and you’ve got vital records. There are ripple effects throughout the whole system. But I don’t hold out any hope that we’ll have a national unique patient ID. So it’s not really a comment or question; my brain is sort of scrambled here.

DR. SUAREZ: Good comment. I will mention later on something that’s evolving. You might have heard about some efforts around a patient identification system — let’s just it call that — rather than a national patient ID. I think it’s important that there is movement in the industry.

I received literally this week, a letter from CHIME to me as the Chair of the national committee — CHIME is the executives in health information management. CHIME and HIMS have joined to actually put out a $1 million challenge grant to help develop systems, patient identification systems, let’s call them that way, that will improve the patient matching ability.

And I think we have heard from Congress now calls for considering this issue in general, the patient identification and matching mechanisms, because it has been recognized and acknowledged as one of the bigger challenges around interoperability itself, among many other things. Not just interoperability of being able to match data in the data analytic world, but it’s more significantly being able to match data in the clinical delivery of care way.

MS. LOVE: And evaluation of ACOs and payment models. It just has this ripple effect. There aren’t a lot of MPI activities at the state level, so I don’t know what that impact is.

DR. SUAREZ: We have just received this request as a national committee to begin to perhaps begin considering a role to facilitate the industry discussion of patient identification systems, or patient matching systems, to use our ability to convene the industry to discuss this. We’ll talk more about it. I just wanted to mention it because I think it’s a very timely and relevant topic.

MS. LOVE: I just wanted to ring an alarm bell because it went over my head.

DR. SUAREZ: You did, thank you.

DR. COHEN: Can I just follow up on that alarm? Thanks for doing that, Denise. I know a variety of other organizations, including NCHS for the National Death Index work, relies on social security number to link files within HHS. What is the impact of going to a random ID to replace SSN on those kinds of activities? Is that part of the ongoing discussion?

MS. OLSHAN: I actually don’t know the answer to your question but I can try and get an answer for you.

DR. SUAREZ: Any other questions? I do have two questions. First of all, yes, a very ambitious agenda and we are certainly partnered to work through those agenda points.

I wanted to clarify one comment that you made with respect to compliance certification regulations and attempting to get this out by April, but you mentioned a proposed rule. I thought the proposed rule was what got published last year. Is it going to be the final rule?

MS. OLSHAN: We published a proposed rule two years ago. What we put in the Unified Regulations Agenda is saying that we’re going to a new, a second, NPRM on the topic.

DR. SUAREZ: All Right. Thank you for that.

I’m very excited that you mentioned 10109. Probably not a lot of you know what 10109 is, but it is very important. In the Affordable Care Act, it’s a provision that called for NCVHS to look beyond the current HIPAA transactions into other administrative processes, and we did have a hearing already once and identified priority areas, and we made some recommendations. It’s very exciting because there are new developments in the standards development world with respect to — and it’s really not a new development but more maturity of the standards for conducting some of these types of transactions.

I’ll give you one example. Provider enrollment — the enrollment of a provider in a health plan network, including Medicare. Medicare uses a form, I think it’s 855. We discussed the ability to improve the efficiency of enrolling providers in networks, and there is a standard actually that does that. There are a number of other opportunities and I’m very much looking forward to the discussions around the 10109.

The last point I want to make — and this is just highlighting your introductory comments about your intent to really move forward with a number of the existing recommendations that we have made and certainly reacting and acting more expediently on the new ones — is acknowledgments.

Acknowledgments is one of those transactions that, even though it was not named under HIPAA as a specific transaction for which standards should be adopted, it is a transaction that everybody in the industry would really like to see, and we have made recommendations. I just wanted to mention that this is one of those exciting transactions that I think we’ll have a chance to consider more and look forward to perhaps on standardization.

MS. OLSHAN: I did see it in the Review Committee draft letter, so I’m prepared.

DR. SUAREZ: Great. Thank you so much, Shana, again. It was great to have you here. Denise, do you want to introduce yourself?

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

DR. SUAREZ: Do we have any other members on the line? Okay. Jim.

MR. SCANLON: Thank you Walter. Good morning, everyone. This is Jim Scanlon; I am the Executive Staff Director for the full committee and I’m the Deputy Assistant Secretary for Planning and Evaluation here at ASPE and HHS. First of all, let me welcome everyone and thank all of the current members, continuing members and all the new members for serving on the committee and agreeing to serve in the future.

Fortunately, the Secretary signed the renewed, or the same charter for the NCVHS in January, so we’re good for another two years with a solid charter. We may have even included it in the briefing books.

I’m going to talk a little bit about where we are with the overall budget, some policy and programmatic initiatives, and then data and statistical policy and some research projects that we’re undertaking in HHS.

First of all, I’m happy to say that we actually are in the second quarter of the fiscal year 2016 budget, and we actually have a full year budget earlier than we normally do, so we’re in the process of implementing that budget. You saw last week that the President sent up the President’s 2017 budget request. Hearings have already started on the 2017 budget and we’re looking at that as well.

For the reference of our new members and a reminder for the continuing members, we have our strategic plan which was updated last year posted on the HHS website. It covers the period 2014 through 2018, so it’s basically the strategic plan in effect now. Four overall goals and 21 objectives, and there are metrics and strategies for each of the objectives. We also just in December of last year released our revised overall government plan.

In addition to the overall plan, I should mention also that probably one of the best two guides to what HHS does and how it all fits together is the overall Strategic Plan, which was sort of a 20-30 thousand foot level, and then our budget, and particularly our budget in brief, which was about a 70-page summary of the various responsibilities and initiatives that HHS is responsible for across all of the agencies and some of the new proposals as well.

In addition to the Strategic Plan, which is an umbrella plan, there are plans for initiatives underway in a number of other areas. I won’t mention them all but you’ve heard about the Precision Medicine Initiative. We have initiatives dealing with combatting antibiotic resistance, emerging infectious diseases. Now you’ve seen the new Zika virus. It’s amazing that you don’t know what it will be but there will be some emerging infectious disease almost — probably two a year now.

And we’ve mentioned prevention of morbidity and mortality associated with the misuse of opioids, a number of initiatives there. And delivery system reform, which Shana talked about, but it’s a more across-system set of initiatives with metrics as well.

I might also mention that HHS was called upon to take the lead for coordinating the federal response to the water and environmental problem in Flint, Michigan. Nicki Lurie, who is our Assistant Secretary for Preparedness and Response, is spearheading that effort. This is a coordination effort as well as specific agency efforts.

Dr. Laurie is spending a fair amount of time up in Flint, and the Secretary is due to be up there tomorrow to talk to the governor. The governor sent in a Medicaid waiver. You saw that request announced publicly yesterday. The waiver involves covering all of the folks who were exposed to lead in the water up to age 21.

All of our agencies, I have to say, we have a call every Monday morning, but HHS has always had, in the overall federal response and national response to emergencies and so on, the strategy and the concept of operations, at least the HHS largely, sort of the medical, healthcare and public health kind of a response, along with some social services. We don’t do housing, we don’t do trailers and that sort of thing; that’s homeland security and HUD and others. But we advise on the science of what’s occurring. We advise on what the impact of elevated blood levels in the blood mean, what the treatment is and so on, and we provide — all of our agencies are weighing in in various ways to try to help.

I think I heard everyone say yesterday on our call that this is a marathon, not a sprint. It’s not going to be over in a couple days or a couple weeks; it’s going to be a continuing kind of effort. But again, all of our agencies are helping.

Interestingly, in the data area, it’s amazing the questions that come up about the demographics of Genesee County and Flint, and who gets health insurance there and who doesn’t. So there are a number of other issues, a lot of prevalence of various other health issues including behavioral health and other areas as well. At any rate, we’re moving there as well.

I wanted to say a little bit about health reform. We’ve just completed the open enrollment period, the third one, at the end of January, and obviously this continues as a major priority. It looks like the data we have from the Health Interview Survey for the three quarters for the last calendar year, we’re really looking at probably the lowest uninsured rates in about four decades, probably since we started asking the questions on the Health Interview Survey when we were all in kindergarten I think in 1957. At any rate, the downward trend continues.

I might say that in terms of monitoring the impact of affordable healthcare and health systems functioning and performance generally, I’ve said previously that our strategy has at least two dimensions, three dimensions really. What can we learn from administrative data; what can we learn from our survey of population measures, and then from special research studies and modeling that we’re able to do as well. We’re using the administrative data from the healthcare.gov website.

This is the enrollment information. We have it for those on the federally administered website and we’re able to analyze and publish the information at the close of these enrollment periods from the simplified application that’s available on the website. Remember, that also includes some vulnerable population information — race and ethnicity. It also includes primary language. Couldn’t quite get a question on — well, there is a question on disability. It’s sort of a program participation kind of measure.

On the survey side, we have, as I said, made a number of enhancements and continue to do so to most of our major surveys to be able to monitor the implementation and the impact of health reform — the Health Interview Survey, the MEPS, a couple of different components of the MEPS, the National Ambulatory Medical Care Survey. We have a survey at CDC, the Behavioral Risk Factors Surveillance System, and we work with Census on these areas as well.

Many of those enhancements we’ve posted a summary of on our HHS Data Council website, and I’ll say a little bit in a minute about some attempts now to kind of align the kinds of questions we’re asking for health insurance coverage, a topic which I know is dear to Mike O’Grady’s heart. And I think we have actually made a lot of progress.

As I said, to try to get the data quicker than in the past, particularly from the Health Interview Survey, ASPE provided funds to NCHS last year and this year to speed up their early release program. Remember the early release program was publishing quarterly data more or less at a six-month interval after the quarter closed. So, with some funding to HHS and working closely with them, we’ve been able to close the gap now, and we released through the third quarter of calendar 2015 earlier this month. So we’re moving it closer and we’ll have the next release probably in April.

A couple of other things on the statistical policy side. I think I mentioned on the analytic side that, in addition to having access to CMS’ administrative claims data through various means, through seats to the virtual research data center and some other means, we’re looking at some other analytic resources. We’ve established here at the Humphrey Building a research data center for NCHS, so this is available to HHS but it’s also available to CBO and JAO analysts who don’t want to go over to Hyattsville. They have been pretty good customers. This is access to the data that is more detailed than public use files, so it provides more detail and it can only be used in kind of a restricted access setting where nobody gets access to any identifiable data and it’s fairly highly controlled.

A little bit about statistical policy. I think I told the committee previously that our HHS Data Council was asked to look at how we can get better use of our investments in data collection, and one of the overall approaches was the concept of alignment and convergence, if not integration, where — just as the committee is thinking about this — we try to think of administrative data, electronic health record data and our surveys and surveillance data as all related and all part of the resource and portfolio to provide data to help us, not just for whatever program function they’re serving but also to help us more broadly with helping understand and analyze and monitor the health system and the human services system.

So, with that overall umbrella, we’re taking a number of steps. We provided guidance to our agencies to look at — this is administrative data systems now — some standard demographic data collection. This is just to be sure that we have at least the core of age, sex, race, ethnicity and federal poverty level, and we even give guidance on insurance questions. So that on administrative data we would have a core where everyone is using the same — for grantees and so on — was using the same items so we could relate the two and cross reference and get better use out of all of them.

Within that area, as I mentioned previously, there’s always an interest in, well, yes, health reform is fine and everybody is getting health insurance coverage and so on, but what exactly happens to, as a result of getting access to health insurance, access to care? We talked about network adequacy earlier and other barriers to care. Even with health insurance coverage, do people have enough?

There are economic issues about being able to buy prescriptions, to use prescriptions and so on. So we used the HHS and some of the other surveys to look at the impact of health systems change on those areas as well.

And there has always been a worry that even when the majority of the population is doing well, there are always vulnerable populations — getting access to these services and so on. And there, I mentioned previously race and ethnicity. We provided more detailed standards than OMB, and all of our surveys have already made those changes or are in the process of making them. So these are more granular standards relating to race and ethnicity, standard questions relating to sex, standard questions relating to language, primary language, and standard questions relating to disability.

The goal here, again, is to have all of our major population surveys where there is a self-report dimension all use these standard questions now for comparability purposes across the surveys.

One of the other areas in the vulnerable population area that we looked at was we’ve added questions on LGBT populations — sex orientation and gender identity. Sexual orientation we’ve added to the Health Interview Survey, so we now have national data on how that population is faring in terms of healthcare and access and insurance coverage and so on. And to the CDC survey, the BRFSS, we’ve added a module on both sexual orientation and gender identity. Again, we’re trying to beef up those areas as well.

Let me say a couple of words about another alignment effort in terms of our surveys. We were asked by HHS leadership a few months ago to look at how can we better align our survey questions and survey data in certain areas, pretty high priority areas. We were asked to look at four areas — health insurance questions and measurement and data, behavioral health — mental health and substance abuse — measurement and data, LGBT data, and tobacco-related data because of all of the initiatives on tobacco control and the new FDA role in terms of regulating.

We were looking at, number one, the HHS portfolio surveys. What questions are we asking in these areas? What is the degree to which these questions and the data itself are aligned, are similar or not similar? What did we learn from previous reviews in these areas? Can we explain what the differences are due to when we have differences? And then some recommendations for moving forward.

We’re still in the middle of this effort. We established four working groups across HHS in the areas, took a nice look at all of our surveys and what kind of measures we were using and what kind of data estimates we were making in these areas. Now the working groups have come forward with some recommendations that we can proceed with. Some of them are consensus, some of them are not.

It’s hard to get agreement on some of these areas. Everyone likes the way they‘ve been asking the questions, and whenever you suggest changes they’re worried about a time series interruption. But there are often ways to get around that with a little imagination. At any rate, we’re moving forward on those, and hopefully, by our next meeting, I can at least describe where we are.

But we have really made a fair amount of progress in terms of health insurance measurement. I would say we’ve made the most progress there. When folks looked at what they were collecting and analyzing, they actually found some areas that would make some better improvements across adn that make our data more consistent and actually more accurate as well. There, there was almost no disagreement, so I think people are doing that now.

Tobacco control — this is one of those health behaviors where everyone has very fine distinctions about what they ask, so we’re trying to find a way. We clearly have some recommendations for how to measure that, but we have to resolve some of the differences.

LGBT, as I said, we are probably recommending a question for sexual orientation that everybody should use. And gender identity we’re probably going to recommend. There’s no agreement there; that’s a very tough area, very small prevalence, and there doesn’t seem to be any consensus emerging on one single question. There are two major approaches that the survey experts in that community have identified, so the agencies that are planning to collect this data would at least start with those and then ask for some advice. At any rate, we’re moving along there as well.

A couple other vulnerable population initiatives and then I’ll stop for questions.

In addition to the 4302 data standards that I mentioned that all of our surveys are using in the LGBT data, we’re looking at an area that has been very tough to develop data capacity, and that’s data on tribes, American Indian tribes. It has just been very difficult. Normally, the folks living on reservations are not included in our surveys. When we tried a while back — some of you will remember we tried a MEPS on tribal populations in America and Alaska native populations, and it was very difficult to do. To the credit of the agency, they carried it out but it was extremely difficult to do.

There are just a lot of issues dealing with tribes and how do you get a sample out of all of these areas. Many of the tribes want to do it their own way. We’re trying to find if maybe there are toolkits we could use. Maybe there are some grants we could use to try to get better data there not only on the populations on the reservations, but American Indian and Alaskan native populations more generally.

We’ve also been asked to look at adding to our health surveys questions which you’ve seen discussed more recently. It’s a group called the justice-involved populations. These are folks who have had some interaction — I would say negative interaction — with the justice system, either been incarcerated or otherwise been involved. We don’t normally include that kind of information on our health surveys but there’s great interest now in the health and wellbeing of that population and program participation.

We are in the early stages of — and we were asked to do this by the Secretary and leadership — to provide some guidance to our agencies — this is largely internal to HHS — to make administrative data more available at least so much as it can be, and easier to use and easier to identify and easier to share. We’re just in the early stages. There’s great interest there on a number of different sides of HHS. This is a focus more on, as a first step, can we look at how do we share data within HHS.

And associated with that are some linkage questions about — We’ve actually had a lot of experience linking administrative data to surveys and research studies. In fact, the NCVHS, in a workshop, made a number of very positive recommendations, and we’re looking kind of at second generation, where are we now, and so forth.

Let me stop there and see if there are any questions.

DR. SUAREZ: Thank you so much, Jim. This has been a journey, really. Thank you. We have a number of questions here, and if you have questions on the phone we’ll get to you in a minute. Michael, Bruce and Bill.

DR. O’GRADY: Jim, this is all very good, all very encouraging. I do have one question for you on not just the breadth of the data but the quality of the data.

I, unfortunately, a number of years ago was the author of a report that almost slammed CMS tremendously, having to do with low-income Medicare beneficiaries and not serving them until I luckily got a call from a colleague to colleague, because I was working on the Hill at that point, who explained to me that I would be very unwise to rely on that income data to actually project eligibility for low-income programs. And luckily, I did not put my name on a report to Congress that said, you know, everybody is screwing up. They’re only covering 17 percent of the people they get.

Now, we know that in the past there have been these — I won’t put words in your mouth, but — that Census was much stronger at collecting income data. HHS was much stronger at collecting health insurance data. Some of the HHS surveys — there were recommendations made for how they could improve that.

When you talk about the ACA coverage, who is eligible, who’s picking it up, who is not, is that data any better than it was a decade ago?

MR. SCANLON: Well, that data is from Census and from the Health Interview Survey.

DR. O’GRADY: Oh, I see. That’s not MEPS data looking again —

MR. SCANLON: Well, MEPS’ strength is the full year, 18 months’ utilization and expenditures and insurance. We always have that to look at. We always have it, and I think that’s the gold standard.

I think for insurance coverage, healthcare use and expenditures, MEPS is the gold standard. It has to be a necessity later that a full year is completed. I think it’s right. I think MEPS is probably the gold standard for measuring that.

But if you’re looking at sort of recently, the past six months or so, really it’s HIS. We did have — ASPE put a fair amount of resources into looking at the way income was collected and the validity of income across federal surveys, and, clearly, Census was much better at this than our agencies. And then our agencies decided to start using — and it was really ASPE that kind of pushed this — the kind of approaches that Census was using.

DR. O’GRADY: Good.

MR. SCANLON: So it’s better, and in some cases, Mike, all we could do was like on administrative data, sometimes — who knows what income they’re getting. The income question is considered one of the most sensitive questions, even more than sexual behavior or religion. So it’s usually at the end of the survey so that if the respondent says I’m not going to answer that, you haven’t lost them.

What we have the agencies trying to do, for example, is to at least give us categories that correspond to the federal poverty levels. So, even if you’re not precisely at the income, we try to be able to place you poor, near poor — relating to that federal poverty level — so we can tell who is eligible. And we’re using the ACA federal poverty level thresholds. Hopefully, it’s a little better and we don’t have false prediction there.

DR. O’GRADY: Yes. I’m just saying there are big policy implications. For the decision makers to think there’s another five million people out there who would be eligible but they have just not enrolled them — you would hate to have that just be an artifact of under-counts in income data.

MR. SCANLON: And we do de-compose the under-insured population. We try to de-compose it into what their situation is. A fair amount of it is undocumented, and they won’t be eligible for ACA at any rate, so that’s a big part of it.

It’s very interesting, who are the long-term uninsured, a year or more without insurance, and who were the uninsured. It’s fascinating. There are about five different groups. It used to be the young immortals — remember. Now their parents are picking them up, but there is still some of that. There are other folks who can’t afford it even with the subsidies, or don’t know about it. There are others who are pre-retirement and they’ve lost their jobs and they’re in between. Now, ACA should help them. And there are others who just feel — maybe it’s income. That’s not the highest priority. They have rent to pay and food. And we’re not the only ones who are finding this. So there are a lot of different populations.

And the other area is the nature of the job you have. If it’s seasonal or something like that, you may not be getting — So, each one of those — you’re right. I think we’ve reached the uninsured pool now that is fairly hard to continue to make large inroads. But I think having everybody look at it helps.

DR. COHEN: I could ask 14 questions but I’ll hold myself to one question and one comment. First, the comment.

Jim, when I hear you talk about data for preparedness, whether it’s Zika, opioids or lead poisoning, that reminds me that we, as the national committee, should really be strengthening our work in looking at the timeliness of vitals, and I want to make sure when we talk about strategic planning that we go back to some of our roots around what we can do to improve the timeliness.

And looking at births for congenital anomalies, deaths for early detection of opioids. It’s a huge issue at the state and community level getting good data on these things, and I think we can play a really critical role weighing in with recommendations to the Secretary about improving the timeliness and helping support NCHS and the states’ vital statistics enterprises. So I really hope we can put that on our agenda. That’s my comment.

My question was do you have any updates on what the Census is thinking about potential changes to the collection of race and ethnicity data?

MR. SCANLON: Yes. They are looking at some changes they would make — we should probably get a briefing on it for the committee — for the decennial. They’re doing some research. I don’t know that OMB would necessarily — You remember that the standard for race/ethnicity that we’re all using now is an old piece, the statistical policy directive that came out of the 1970s educational statistics. But OMB went through a process almost like a regulation of adopting that, and then we updated it. So I think OMB would have to go through a process like that again.

But there clearly are some changes not everybody is happy with because some people feel that you may lose perceived accuracy from one group to another — American Indians, for example. But there is an interagency group on what to do with this. Maybe we should schedule a briefing, because they’re —

DR. COHEN: Yes. It would be really important, if Census does make changes for consistency, to see how those changes affect the data collection throughout HHS and all agencies.


DR. STEAD: I have a question in follow-up to the discussion about the different categories of uninsured.

In just causal contact, I think there may be an undercurrent that is a change in how people value insurance that may actually be in the direction that we were not hoping for. I have come across this with the lineals, young school teachers that are actually using the cheapest insurance they can get, not on the Exchange, and they’re not accepting subsidies that they’re eligible for because colleagues have gotten caught as their incomes changed and ended up being penalized. Everybody was being honest. So that’s one end of the spectrum that surprised me. These were educated people.

On the other end, well-to-do Medicare Advantage folks who were unable to continue with their provider because of the change in plan in essence are hoping nothing goes wrong because if they need to go where they want to go they’re going to do it and pay for it.

I just wonder the degree to which we have measures that are beginning to inform us about those kinds of trends, because they, in essence, could be sea change trends that make people go around the system in an uberized health and wellbeing instead of healthcare world. And if we don’t get some early lens — I don’t know if that’s an area NCVHS could help with in some way. I just put it out there.

MR. SCANLON: Certainly, the surveys are looking at reasons for not having insurance, and then we’re doing some really more market research, things like that, about these attitudes and how each group reacts. We have some grants and some of the foundations are doing this kind of research as well.

But I think you’re right. There’s just a different view. If you have very little income, even with the subsidy it can be pretty expensive, although the subsidy helps a lot.

We’re finding in the Health Interview Survey and others where we’ve asked people about it — in the past month, have you had to forego — we don’t ask it in that way — your prescriptions? Were you unable to see the doctor when you thought you should? Were you unable to buy the prescription that you thought you should have? And there are various reasons why, and income is still one. It’s very realistic.

Some of the foundations have found the same thing. It’s more in-depth discussions with these various populations. It really should come as no surprise. This is all very complicated and you’re dealing with a family on an income or an individual, and there are a lot of other demands on the person, and income and resources.

So, again, it’s thinking how do you resolve those, how do you get at those. There are incentive programs. There are subsidies and so on to try to help with that.

DR. MAYS: Thank you, as usual, for a very interesting update. Like Bruce, I’m going to try and contain myself because there are a ton of questions.

But I want to start with the issue of alignment. Often when alignment is talked about it’s talked about as questions that are asked in various surveys and whether those questions can be the same. One of the discussions at a couple of the meetings I have been to is talking about alignment a little differently.

Can we have coverage across populations, like, for example, in behavioral health it’s often talked about we’ll measure depression in the 18 to 40-something year olds and then not also make sure that we do it from a life course perspective of getting it in the elderly, catching it earlier in the younger population. So that’s kind of the first thing — can we think about the issue of coverage when we talk about alignment and take a life course perspective.

The other question has to do with developing a cohort for Flint. One of the things we’ve learned in terms of disasters is that it usually costs us a lot more money to keep funding people to keep going in and finding everybody, particularly in terms of how people move and disperse and all that. We’re having this issue right now even in L.A. where there has been a pipeline and people have moved and they’re trying to bring them back.

But the issue of the federal government thinking very quickly in a disaster to put a cohort together and being able to enroll them right away, and even as they move and disperse you’re able to follow them. So this has come up around this issue of lead in particular because they want to see what’s going to happen long term to kids’ cognitive development. I haven’t heard Nicki Lurie talk about that. That hasn’t come up. But that’s a big disaster lesson that we’ve learned.

Last is the VA. I sit on the IOM board in which what has come up is that they want to work with HHS about putting in better veterans’ questions. Right now, there are a lot of veterans that they can’t service because they’re not coming into the VA. But, typically, in many surveys there will be one question, are you a veteran, and it’s like they need more detail.

I can tell you they’re preparing something, so they really want to work with HHS and potentially fund and talk about what would be — they want to hold a hearing on what would be a best practice set of questions for the various issues that they have to cover. I’ll stop there.

MR. SCANLON: Those are all good points. I will agree with you. The behavioral and mental area is just about the most difficult area for measurement, and our surveys — you could argue that there are some mental health disorders that we’re probably not going to pick up in a household survey anyway. We have a group at the National Academy of Sciences at the moment, looking at how do we improve our measures largely for behavioral and mental health. For children and for adults, what are the best measures, and how could they fit into our surveys. So we’ll see what ideas come there.

And then we looked at it as well in our alignment group. But the idea there is to try to align what we can now, and we have some developmental activities as well.

I agree with you on the preparedness area. Going back to Hurricane Katrina. After that, Mike will remember, ASPE actually did the evaluation and the daily analysis on what was occurring then, and then we made recommendations and everybody else did. And that really kind of led to a much bigger and more organized approach to preparedness and response, and really what’s the doctrine about how you do these things.

Nicki’s office actually has — this was an issue I think we talked about in the workgroup on data access — a map. It’s a GIS-based analytical map and tool that shows all the — really, for the whole United States you could drill down to the county and to the city. It has population measures. Maybe we should have a briefing on that. It also has all the health facilities in the area.

I think the problem — you’re right. Everyone seems to start with creating a new cohort for the long-term follow-up and it’s usually a grant from CDC or from NIH, and it sort of follows that mechanism. We learned a lot after Katrina. We sponsored some follow-up studies. There are some studies now that follow up from the World Trade Center. There’s a whole medical program there for the first responders and so on from the twin towers.

But it would be good to be able to have kind of — not to just react to it, as you say, and what do we do now, but to have a more formal, organized way to do this. I have to look to see what we’re doing there.

DR. MAYS: Do you think it would be worthwhile for us to consider having a hearing about what should be kind of a standard for data collection? Some of this is like linkages to records — like, right now, in terms of lead, kids have been screened by their pediatrician. There could be some best practices that we could come up with, because each time it’s kind of knee-jerk and then you have to depend on NIH to give you money.

But it should be that when HHS goes, it also goes with the notion of what should we be putting into place around data collection and accessing records, et cetera, in order to be able to have a comprehensive response. It may be us who could hold a hearing on this.

MR. SCANLON: Yes. I think there could be. Each one is so different. On the environmental area, for example, we have a whole agency that sponsors studies, follow-up studies and so on and investigations. These are Superfund toxic sites and so on. But it doesn’t necessarily work for lead. That was a drinking water issue.

There are some general protocols, sort of how do you handle these emergency responses across the agencies. There are some scenarios that deal with these sorts of things, but the data part of it is sort of always — well, many times it’s an afterthought, and you’re sort of scrambling to see what kind of data could you put together. Some of it is community data, but it’s not what the community has necessarily. It could be that, but it’s usually what Census has or what someone else has about what does Genesee County in Michigan look like demographically and health insurance coverage-wise and income-wise, and that’s probably going to be Census.

It probably would be worth at least a look at what’s the capacity now, and are there ideas that could be followed.

DR. SUAREZ: I think we will bring that up and consider it.

DR. RIPPEN: I was just going to build on what was said. I think there are some nuances because, again, if you do a cohort, what’s the cohort for? Is it a research question, is it a public health issue? And is it associated with benefits, and how is it affected? The different measures.

And the core component obviously is the unfortunate participants in the event, the patients and the consumers and the individuals. And the question of consent and their role in the process, because depending on what it is, as you pointed out, Jim, it becomes a little different. So, again, just some of the nuances that make our lives interesting.

DR. SUAREZ: I think we’re going to go ahead and finish up. We’re only about 30 minutes off schedule. We are going to go to Jon, who has been patiently waiting on the phone. Jon, we have your slides on the screen.

DR. WHITE: Okay. I will do my best to be as focused as I can and try to get you all through. I hate being between you and a break.

I’m happy to be addressing you all, esteemed colleagues. I’m sorry that I’m not there but I’ll try to stop by tomorrow. I just finished a year as the Chair of the Health IT Standards Committee, so I have new, starry-eyed appreciation for everything that you all do, so thank you. It’s great to hear from all my colleagues there. Helga, it looks like we have a new chapter to our thick book.

It was actually really helpful for me to be listening to the discussion. I do want to offer a tip of my hat to my CMS colleagues. As one of the people who was in the room at the Eisenhower Executive Office Building in 2008 when they decided to move ahead with the ICD 10 regulation, it’s nice to see it come across the finish line. That has been a lot of fun.

I won’t speak much about it, but I appreciate your engagement with Elizabeth on the meaningful use incentive program. It’s exciting for us to watch the evolution of the incentive program into a new place.

You all mentioned things like Wnt and Zika. I just want to add that one of the stories that I’ve appreciated coming out of Flint is that the pediatrician in Flint who picked up on the pattern of the elevated lead used her EHR to do it, and that speaks very highly of her ability to do population analysis, using that data at her fingertips. There are a lot of concerns coming out of the area, but some pass-forward as well. I will reserve comment on Zika unless you guys really want to talk about it.

I’m briefly going to run through for you the near-term health IT strategy. We’ve talked to you all before about the interoperable roadmap. I do want to mention the interoperability commitments, which is a significant initiative for us that I’ll just make you aware of. I want to highlight some of our work with standards development organizations and talk quickly through our Fiscal 2017 budget request, which includes some requests for new authorities. That’s what I’m going to try to cover for you today.

We have some guiding policy documents that I’ve mentioned. This was given to us by Secretary Burwell in the administration, and it really helps us see a clear path forward to a lot of the things that we want to do. You all heard about the Better, Smarter, Healthier, and our focus area is improving how we pay providers, deliver care and distribute information.

Obviously, we at ONC are significantly focused on the last aspect. As I said at the end of last year to the Health IT Standards Committee, it’s really a sea change. We’re all caught up in the moment of whatever thing it is that we’re dealing with right then and there, but if you stop and look back across the past eight years at the difference in the use of information systems in healthcare, it’s unbelievable. We’ve come a long way. It helps me to take a moment to stop and appreciate that.

And then I’ll come back to focusing on the near term, which is what I’ve got to do. We have three strategies focused on the near term. One is making sure information is usable and accessible and easily transferable and used by patients, providers, payers, scientists and others.

The second focus for us is better technology through a better market, which is making the technology easier to use by encouraging market transparency and competition, driving usability improvements and the availability of real-world testing, and helping providers get the most out of their health IT.

And then, finally, reducing regulatory burden and aligning measures; providing flexibility and meaningful use rule compliance; aligning quality measures across programs, agencies and the private sector, and simplifying the overall recording burden. We say those words and they kind of roll off my tongue. You certainly heard from Elizabeth of some of the flexibility that we’re trying to provide for incentive programs.

If you’ve been paying attention to the news as well, you heard the announcement this week from CMS and the National Quality Forum on aligning quality measures across different kinds of payment programs in the private sector. And we’re looking forward to continuing to work with our colleagues in the private sector to simplify the overall reporting burden. We think it’s important to do this right, and we’ve heard loud and clear from the provider community that they want to do this, and they need our help in being able to do it. Part of the paying providers, delivering care and distributing information gets us to the focus of incentives, care delivery and better information.

Was it Bill who asked for a roadmap from CMS? Bill, be careful what you ask for, because I’ve got a roadmap. The Health IT Strategic Plan is about 30 pages, but the Interoperability Roadmap is longer; it’s about 160-some pages and there’s a lot of substance that underlies those 160 pages that can be elaborated on.

But I think probably what I want to do here is just say I’m not going to go through the different principles involved and the time lines and stuff like that but just suffice it to say that we have a roadmap. If you want to ask questions about that and how we’re looking ahead to getting better interoperability, I’m happy to discuss that more.

I want to talk about commitments and calls to action. Of course, we do regulations. ONC is responsible for the certification of health IT regulation, as CMS is responsible for the incentive program. We work literally hand in glove with our colleagues at CMS to make sure that those programs are aligned up, but we also work with other colleagues, whether in the private sector or in the federal government, to make sure that we’re aligning what we’re doing with health IT with their programs.

A great example is the Precision Medicine Initiative. That has been quite the ride for me over the past year. I’ve been fairly deeply involved with that. We’ve taken it as our partnership responsibility to help the initiative leverage the power of these widely deployed certified health IT systems and the standards upon which those systems are based as they gather their information for that initiative. Other colleagues, including the DA, have expressed interest in some other kinds of initiatives. I think that’s one of the examples of not just the regulatory power but the coordination power of what we can do at ONC.

In the roadmap, it’s very clear that we can’t do this by ourselves, nor would I ever imagine that we could, but we have got to do it in partnership with the private sector. People like to worry about things like payment rules, for good reasons, and we think that there’s kind of an aspirational aspect to what we do, as you know, the power of making commitments publicly.

There are several calls to action captured in the Interoperability Roadmap. These three are particular ones where we have been reaching out quite actively to our colleagues in the private sector. Actually, Bill, if you wouldn’t mind, Kevin Johnson asked me about these, and this is a good jog to my memory that I need to send these to him.

We have been asking our colleagues in the private sector to make these three commitments. First, that consumers can easily and securely access their electronic health information and direct it to any desired location; second, that those making commitments will share individuals’ health information for care with other providers and their patients as much as permitted by law and refrain from blocking access to that electronic health information; and, finally, to implement federally-recognized national interoperability standards, policies, guidance and practices for electronic health information and adopt best practices including those related to privacy and security.

Again, I’m not going to dive too deeply into specific meaning, but I want you all, as my fellow data geeks, to know that we take that federally recognized, comma, national interoperability standards language very seriously, and that has figured prominently in some of the discussions with folks that we have in the private sector.

We’re looking forward to talking a fair amount about these commitments and the very strong response we’ve had from the private sector at the HIMS meeting coming up here end of February, beginning of March.

I’ll briefly talk about some of our work with standards development organizations. We love them and they love us. We are looking to better align the standards development process in the private sector with our regulatory and other guidance, improving the testing of newly developed standards, and making the process more straightforward and consistent. We have been looking to convene a meeting with many representatives from a variety of different standards development organizations, happening in March. And we’re reaching out to them now, individually, to create feedback loops by which SDOs can get information from implementers about challenges experienced when they’re using their standards or specifications.

What we’re finding is that there’s a fair amount of variation across standard development organizations about how this information is gathered and brought back to SDOs. This is all part of the Interoperability Roadmap work. Again, I wasn’t going to delve into details there, but I want you to know that this is a significant part of the detail and what we think needs to happen to get to more widespread interoperability.

We do have specific cooperative agreements with HL-7 and NCPDP and are looking to review their respective portfolios to assess available or potential testing infrastructure as well as their ability to measure the adoption and use of the published standards in the field.

That’s what we’re doing with SDOs.

Jim mentioned the 2017 budget. This is your quick look at ONC. The details that I probably want to call out to you here are that the President is requesting additional funding for ONC as part of the 2017 budget request. The purpose of this funding is to get to a better place — which is what we’re all looking for — to both increase interoperability, which has been a significant focus for us in our discussions with our colleagues and the administration on the Hill and the private sector, but also to further care transformation.

The additional funding will be providing interoperability by building consensus around the federal Health IT Strategic Plan; transitioning to a governance approach for health information exchange; demonstrating best practices and scalability of innovations to address emerging health IT issues with information-blocking; integrating prescription drug monitoring programs with health IT — this is relevant to the Department’s opioid strategy; looking to inspire trust and confidence in health IT through ensuring the privacy and security of patient data; and ensuring that consumers are able to exercise control over their health information.

And we’re looking to continue to develop a Health IT safety collaborative. We continue to think that’s an important aspect of what we and our colleagues need to do. And, finally, to establish consensus around standards development activities and policies related to health information exchange, precision medicine and MACRA, and support a way of optimizing health IT in support of new value-based payment models of improved care delivery.

In addition to the usual budget, which actually is a really good read — I know it’s probably not what you guys do on the plane back home, but the thorough budget I found, as Jim said, is a very good description of what we do across the government if you take the time to look at the details. There are four legislative proposals contained in our budget request, and there are four requests for new authorities.

In the process of doing our work and interacting with our colleagues in the Department and in the private sector or on the Hill, we’ve determined that in order to achieve the goals that we all say we want, we think there are specific authorities that would be helpful to us to be able to do that. Those are to establish health IT governance certification, to prohibit information-block and associated business practices, and to require health IT transparency and to establish a health IT safety collaborative. Again, in the interest of time, I won’t bother you with details unless you have questions about those.

And that finishes my presentation. I really appreciate your attention. I hope you didn’t mind me kind of rollicking through that, but, again, I want to be able to let you all take your bio breaks. So thank you for your attention, and, Walter and colleagues, the floor is yours.

MS. HINES: Thank you, Jon. Walter had to step out. We really appreciate you hanging on and filling us in on an incredible array of initiatives. Any questions from the committee on the phone? In the room? Rich.

MR. LANDEN: Thanks for the report. I really don’t have any questions. I just want to thank you for highlighting the safety initiatives you talked about and the expanded authority, and I look forward to meeting with you and your staff at HIMS coming up in a couple of weeks and drilling down on a lot of these areas. Thank you.

DR. WHITE: Absolutely. We appreciate that. Honestly, Rich, we really appreciate the significant effort that you’ve put into that. It has meant a lot to us, and it has meant a lot to the country, so thank you for that.

Actually, that spurred something in my mind. In the preceding discussion you all had also mentioned patient identifiers. Walter had mentioned the outreach from CHIME. One of the fun things about being around the government for long enough is that when you see change happen it sticks with you. So the fact that I can say patient identifier is so gratifying —


We are actually really excited about the CHIME initiative. I had a meeting with some of our colleagues over there and we think that’s a great example of the private sector stepping up to work with us and the public sector to advance what is a pretty important issue both for safety, for interoperability, for a number of the things that we all care about. So we’re looking forward to seeing that come to fruition.

DR. SUAREZ: Any other questions for Jon?

MS. GOSS: This is Alix. I have a bunch of questions but I think it’s really good for us to move into the RC letter because it really sets the framework of the things I think we need to be sitting down and talking with Jon and Shana about — the roadmap perspective.


DR. WHITE: Alix, I’ll try to swing by tomorrow morning before the meeting if you want to try and peg me then.

DR. SUAREZ: Thank you. Thank you so much, Jon, for the update. We’re always very appreciative of all the work that you and ONC are doing and we’re looking forward to continue to work with you on that.

I did want to mention — I mentioned this earlier — this new topic around patient matching — it’s not a new topic but it’s coming back again — and patient identification systems, and the possible window or opening of the door perhaps around the discussion that we can have and the opportunity we have to convene perhaps the industry as a facilitator to discuss this topic.

As a reminder, most people know that there is a rider that’s put every year in the budget that says the federal government is prohibited from developing — and there’s very carefully crafted language, but it’s — developing and adopting a standard for —

DR. WHITE: And implementing —

DR. SUAREZ: Yes. It seems that the people actually that voted on it, which was in 1998, 1999, apparently like 90 percent of the people there are not anymore in Congress, and most people don’t even know what it means or where it came from. The person who leads this is Senator Rand Paul, and at some point someone asked him and he said, well, the only reason I’m doing it is because my father did it. His father was actually the person who originally put this in the rider back in 1999.

In any case, I think there are calls now in Congress to begin to look at this need for discussion on patient identification systems and patient matching because it’s one of the most significant barriers to interoperability, as has been debated and discussed in many forums.

So I wanted to get your brief perspective on it — I know it’s not a brief topic, but your sense about it, and then any possible work that ONC might be planning to do on this topic. Because we just received a letter, and you are aware of the CHIME and HIMS initiatives to pursue improvements in patient matching. We received a letter calling for NCVHS to perhaps facilitate industry discussions and debates around this particular topic. So I just wanted to alert you about that and then ask if you have any thoughts about this and any plans for the ONC to work on this.

DR. WHITE: Thank you, Walter. I can be brief and to the point. We think it’s a wonderful discussion and we think it’s a great idea. If you guys want to have hearings about it I would fully support that, and we would look forward to participating in it.

I will qualify your statement to say that the rider prohibits us from spending any funds on implementing a national patient identifier, which is how we kind of got over that hump to being able to actually say the words. We have also been interacting with CHIME and Russ Prindell and colleagues. Karen actually got the opportunity to have some comments at the kick-off event, and we’re very excited to see what’s going to transpire there.

DR. SUAREZ: Great, excellent. Thanks so much, Jon. We really appreciate that.

MS. LOVE: I just want to go on record and say, for those discussions, be sure that the states are involved because we —

DR. SUAREZ: Well, this will be us, so you can bring that up.

MS. LOVE: Okay. Because a lot of MPI activity is going on and it’s a big deal in the states.

DR. RIPPEN: Just a really quick comment. I think the question of social security use as an identifier in healthcare and the challenges that we have been hearing about with medical fraud, identity theft, and some of the challenges as it negatively impacts patients more than in other business models — again, as we discuss the approaches we should cover the entire spectrum.

DR. SUAREZ: This is a great point because it is my expectation that this will be, as we think about it, an undertaking of the entire committee. This is not just the Standards Subcommittee or the Privacy Subcommittee or even the Population Health Subcommittee. This is truly a national committee activity that involves all those aspects.

MR. LANDEN: Just quickly, I’d like to call out WIDI as a possible collaborator on this. They have got the ID PAG that has a lot of institutional experience in the industry and working with CMS on the provider ID, the payer ID and, more recently, the health plan ID. And there are lots of good lessons learned, both positive and negative, about approaching ID subjects.

MR. SCANLON: I will just raise my usual due diligence issue, that before the committee gets too far down the line, let us check for due diligence with the lawyers and the budget folks to see that everybody is reading this the same.

DR. SUAREZ: Absolutely, again, the intent is to be very careful in terms of the purpose and what it covers. This is a different world and we have an opportunity to begin those discussions.

PARTICIPANT: And it’s not necessarily a number.

DR. SUAREZ: No, exactly.

DR. O’GRADY: Having seen other things like this where a methodology evolves, I’m thinking of cost effectiveness. Methodology is developed and it’s nice; they fine tune it, they get it very rigorous, and they don’t think about the broader population that’s liable to have, in that case, a very negative response to what they have come up with. And then, all of a sudden, it’s a ban put in a piece of legislation — in this case, the ACA, which was I think a surprise to people because it was from the Right to Life people.

So, if we’re going to do this, and you were talking before about the broad tent of something like ICD 10, it has got to go beyond the technical experts. It has got to be to a broader consensus and a broader community that you may have to hold your nose a little bit about things, but the idea that grandma loses her identity when she goes to the dentist because she has to give this guy with a lousy system her social security number — you know. The public outreach on this one has got to be really big.

DR. SUAREZ: It’s interesting. What you just said is something that happens all the time today. Grandmothers lose their identity because people have lousy systems; they use things like social security numbers. Today, that’s a problem.

Great comments, great discussion. We are going to now take a break. We will take a 15-minute break and come back at 10:55.


Agenda Item: ACA Review Committee – Action: Review Committee Letter of Recommendations from June 16-17, 2015 Hearing

MS. HINES: We’re going to start again. We would like to take this next period for Ob and Alix and Terri to review the Review Committee letter, which was distributed in advance to the full committee as well as posted on the website for folks to take a look at and give us some public comment.

MS. GOSS: With Ob remote and Terri and I here, this is how we’re going to run the session. Ob is going to walk us through the slide deck to set some context. When we get to the slides on findings and recommendations, then Terri and I are going to tag team on managing feedback from the committee members, and then likely we’ll have public comment.

We are going to approach this today to get an understanding of your suggested changes, but we’re not going to spend the committee’s time today wordsmithing. Terri and I will take on that task in finalizing whatever version may or may not need to be produced based on today’s hopefully robust and highly supportive conversation.

The other thing I want to highlight is that this is the first of two work products. Terri is going to talk a little bit more about this later, but this is the letter to the Secretary on actions that we believe should be undertaken in accordance with ACA, and this letter will be supplemented by a more extensive report that will be produced.

With that set-up, I’m going to advance slides on Ob’s cue and then we’ll turn it over to Terri to help us walk through the detailed recommendations.

MR. SOONTHORNSIMA: Thank you, Alix, for that tee-up. We will go through this overview very quickly. We’ll talk a little bit about background.

We are required statutorily to evaluate and review adopted standards — the operative word here is “adopted” standards and operating rules — and make recommendations of any changes and improvements. By the way, the second bullet point there is misspelled. The hearings — We are required by the ACA to review, to conduct a review committee, every other year, so it’s biennially, not biannually. Every two years, not every six months. That’s misspelled.

The process that we went through is we determined whether or not existing standards and operating rules meet the business needs, and we gathered recommendations and suggestions through the public hearing that we had back in July. The testifiers are asked to respond to explain whether not the current status of HIPAA transactions meet their business needs, and the degree to which the standards identify operating rules, how they are impacted at business operations. And we also look for the implementation — if there are any discrepancies in efficiency or effectiveness, if there are any limitations to these standards and operating rules, especially whether the standards and operating rules would need new or emergent technologies to meet business needs.

The idea there, again, is while these are adopted standards, we look for opportunities more strategically whether or not these standards and operating rules could provide future capabilities as the industry evolves, and whether changes are needed for the current standards and operating rules.

For the findings we will have two letters, one that we’re going through with you today to the Secretary, and then we’ll have a separate report that’s a lot more detailed for standards development organizations and entities offering operating rules and code sets for the healthcare industry overall.

The hearing was conducted on June 16th and 17th, and we had testimony, written and verbal, from folks. There were 77 overall. Again, just to remind everybody, the transactions that we went through are health plan enrollment, disenrollment and premium payment authorization, health plan eligibility, benefits inquiry and response, healthcare claim and equivalent encounters, healthcare claim status, EFT and ERA, and COB, coordination of benefits.

I’m going to turn this over to Alix.

MS. GOSS: Thank you, Ob. Hopefully, that brief update puts everybody on the same page. I’m going to have Terri walk us through the actual letter itself. Hopefully everybody has a copy of it.

What we would like to do is go through each section one at a time and get feedback. We’ll start with general findings and then get into the eight specific recommendations. We’ll pause at each section so that we can take your questions and any commentary and identify areas for change. We’ll make some notes on that. I’m going to put up a version of the document so that we can reflect areas of agreement and change so people can track what we’re doing.

MS. DEUTSCH: Good morning, everyone. Just to reiterate, the Review Committee members have gone over this letter and we spent a great deal of time going over it. We hope you all think our letter is good, and we think it is, but we do want to have your feedback.

We start out the letter in the beginning with background information that Ob has gone over. Then we start on page 46 in your packet and start with the general findings and recommendations. As Alix had stated, I’m going to assume there is no comment on the background information that’s on page 45 and on the top of page 46.

Then we go to page 46 where we have the general findings and recommendations, and we start out giving a little more of a picture of the healthcare industry and the entities that are involved with the standards and operating rules, code sets and identifiers, and that’s in the first paragraph. In the second paragraph we go through the significant findings.

Does anybody have any comments or questions on the first two paragraphs on page 46? Okay.

On page 47, we talk about another significant factor that’s a continuation from the other page. Then, we have the reasons for the two issues identified by testifiers, and we talked about what these issues were, and we highlighted the fact that they were level of complexity of the adopted standards, the concerns about the adopted standards not meeting the business needs, and then some additional ones. So that’s the kind of global theme that we heard from the testifiers.

Then we have a paragraph that talks about the fact that compounding these concerns are the rapid advancement in healthcare and in technology. Any comments on those?

MR. COUSSOULE: In the general findings and recommendations it talks about the current focus and future focus. Do you want to put any kind of timeframes around those? The reason is it’s kind of vague. Do we say the focus for the next couple of years? By definition, if you say future focus you mean don’t pay any attention to that now, and do we want to put a timeframe in there?

MS. DEUTSCH: I think, again, when we go to — This is the letter that gives the recommendations for the Secretary and the statute requires a 90-day implementation, so we have these that are able to comply with that requirement. The report will have more information, and then we’ll go into more depth as it involves the other entities in addition to HHS.

If there are no other questions, we’ll go on. On page 47, we indicated here the criteria that we used. We said that we reviewed testimony and formulated the recommendations using the criteria, and we listed five criteria. In addition to that, we looked at other factors such as completeness and efficiency, and we listed all those different factors.

Then, based on these criteria and factors, we developed numerous questions that we asked the testifiers to respond to so we could have the information to focus on objective criteria to the degree of objectivity that we could have. And that’s how the recommendations were developed. Are there any comments on the criteria and the different things we outlined here on page 47 and continuing on to page 48?

Now we go to Recommendation 1.

MS. LOVE: The paragraph underneath talks about new paradigms. I guess that’s the term we want for payment or administrative and billing processes. I was looking for a sense of transition. It’s not all new, and I don’t know if I’m —

MS. DEUTSCH: I’m not sure which paragraph you’re in.

MS. LOVE: The one on page 47, the third. As we go into new paradigms, but we also have — I was looking for the word transition, but we aren’t going to wordsmith.

MS. DEUTSCH: But there’s a suggestion and you think there’s something about a transition period.

MS. LOVE: Yes. It’s not all new. We’re still in the old way as we emerge with some new paradigms, so I think we have to accommodate both. I just didn’t want to lose the fact that these new payment models are great, or we’re transitioning to them, but we still have the existing infrastructures and transactions in place.

MS. DEUTSCH: That will be added in. That’s a good catch, thank you.

MR. SOONTHORNSIMA: So where do we add that new paradigm — as we transition?

MS. DEUTSCH: It’s going to be in that sentence where it talks about new paradigms. It’s also going to be talking about transitioning from the existing healthcare delivery into the new paradigms, so you’re dealing with the existing and you’re dealing with what’s going to happen in the future, because we don’t erase one to go to the other. You phase in from one to the other.

Recommendation 1 — we gave some background information and we gave an example, and then we indicated what HHS should do. Under Recommendation 1 we have two sub-recommendations. I’m not going to read them out. Are there any comments on Recommendation 1? Okay.

On page 49 we have Recommendation 2.

MS. LOVE: I just want to pause for a second. Is everybody tracking with this? You’re all really quiet and that’s not normal so I just want to make sure that we’re okay and you’ve had a chance to read this.

It’s just a stylistic thing on the recommendation. I started reading the front matter, and the recommendations are 1.1 and 1.2.

MS. DEUTSCH: Yes. The way we do this — and you’ll see that they’re numbered consecutively, too — there’s a background, an explanation, and then the actual ones.

On page 49 we have Recommendation 2. Again, we summarize what the testifiers agreed upon and then we had three recommendations under Recommendation 2. Are there any comments or questions on Recommendation 2?

At any point if I’m going too fast, please tell me to slow down.

Okay. Recommendation 3, we again talk about what the testifiers discussed and we have four recommendations under number 3, and continues on to page 50.

Even though I had indicated this is an HHS letter, if you will note, they also include that HHS would interact or partner with the industry and the SDOs and the ORAE, so it’s not just unilateral. But because the focus is on HHS, it’s the letter that goes to the Secretary.

If there are no comments on number 3 we’ll go to number 4.

DR. RIPPEN: This is actually not specifically to one recommendation or the other, but Denise and I were talking — and again, it may be a style guide kind of issue, but a lot of times when you’re quickly perusing this, you lose sight of what the focus is that you have bolded. I don’t know if there’s a way maybe in the Recommendation 2 where you have this colon to basically say education.

MS. GOSS: It’s interesting. We went back and forth on that one and I very much commiserate with your perspective. I’m even thinking right now we should have been giving a short title to each recommendation as we’re introducing them to make it a little bit easier. So education or collaboration or roadmap or something.

I think the other thing that may be easier is we could create a cheat sheet that summarizes all —

MR. SOONTHORNSIMA: Alix, if someone could advance the slide, we attempted to do that a little bit.

MS. GOSS: I’m thinking I’m in just plain Word and you’re looking at the PowerPoint.

MR. SOONTHORNSIMA: I’m doing both. That might help frame up the context for each recommendation.

MS. GOSS: We originally were going to run through this overview and then go through the letter, but because of time constraints today we decided to not double dip and try to be a little more efficient and I think that might be backfiring.

DR. RIPPEN: No. The letter is fine.

MS. DEUTSCH: I will try, just in the interest of time, to summarize some of them beforehand as we go ahead. Again, we are trying to beat the clock. If this is not going the way you need I’ll be happy to do it any way.

MS. GOSS: I think there’s agreement that we need a short title for recommendations just to make it crisp.

DR. O’GRADY: I was going to hold on this until the end because it’s not substance; it’s form. After this point, you want this to go to the Secretary. We already have the Deputy Assistant Secretary here. Everybody who is going to see this above him has been confirmed by the Senate. So this, as a communications document, is not working. They’re not going to wait until page 3 to get to your first recommendation. They’re going to say, Jim, tell me what this says. I’ve got a meeting in five minutes.

And this is written as almost all of us who were trained as researchers, etc. You’ve laid out your background and you’ve done that. It’s just not for this audience. You can either do a one-page sort of executive summary that gets — include the background of who we are and why we’re talking to them, but not on page 1. You’re burying your lead. Nobody is going to read this.

MS. GOSS: I hear you, but also we’re following kind of a prescriptive approach that has been done historically. I’m with you, so I —

DR. O’GRADY: Then dump the prescriptive historic, because —

MS. GOSS: I think what you’re bringing up is that this needs to be reflected in an overall change in how we do our letters. I’m agreeing with you.

DR. O’GRADY: I’m just telling you —

DR. SUAREZ: We don’t have to follow whatever traditional standard form. We have had in the past this type of letter sent. The way it works really is the Secretary doesn’t even read the first page. She doesn’t. There is someone who briefs her on, well, they wrote us a 50-page letter; here is the two-minute elevator speech. No matter how we write it, even if it’s everything in one page in the first paragraph and only that, she’s not going to read it.

My suggestion is, yes, we do have — and the people who are going to read it are actually here, including CMS, because this is specifically going to CMS as the agency that will implement a lot of it. They know.

DR. O’GRADY: All I’m saying is right now the way this is written, the only version that’s going to go forward is Jim’s verbal synopsis. If that’s fine with you, that’s fine. There are going to be people between Jim and the Secretary, not that Jim isn’t a right hand man to the Secretary, but there will be a few people between them like his assistant secretary. And having been that assistant secretary and gotten these kinds of letters, I’m telling you, if they don’t get to the point by the second paragraph, you move on to the next thing.

If you only want Jim’s synopsis, his elevator speech, then this is fine. If you want actually a little bit more than Jim’s version — not that Jim wouldn’t give a straight version, but if you would like this to move up the line and actually be read, don’t write like this is for graduate seminar 265. It’s just not going to fly.

DR. RIPPEN: I think the letter is necessary just for documentation, and I think a lot of work has been put into it. And I do think, though, by summarizing the recommendations, capsulizing them, then you could put those bullets at the very front and then track for each recommendation, and I think you would get both the bottom line plus the letter.

I’m doing one of these for another state where you just capsulize the recommendation and then put the documentation underneath. I think you can get it there pretty easily, and I do think the letter is for historical purposes if nothing else.

MS. GOSS: I also think some of this background could be put as an attachment, because at this point, if the Secretary doesn’t know who we are, then, oh, my gosh.

DR. O’GRADY: Or just later in the piece. I’m saying just don’t bury the loot. Get your points right up front.

MR. SCANLON: The other thing is, it’s like the debates, Mike — These letters have to serve multiple audiences as you know. They do get circulated. The Secretary doesn’t look at something until it has been vetted by everybody and she gets a better sense.

But I do think it would be good here to indicate maybe in a first paragraph, really what is the significance of what we’re doing. Not the process, that we were named, but maybe that administrative simplification holds tremendous potential to reduce the costs in the healthcare system, and a number of efforts are underway to do this. HIPAA was one of those efforts, and we’re now in the stage of HIPAA where the implementation has taken place. This is sort of, there are additional interests and issues associated with moving forward. Just so she knows where this fits in. It’s meant to streamline the healthcare system.

Everybody is familiar with the general concept of cost savings through the administrative side, so just remind her of that, and everyone who reads it. Then it will go into specifically what’s recommended.

MS. GOSS: I heard two things specifically, because we’re going to add a short name to our recommendations, we can just bulletize those up front, and maybe just transition some of the opening remarks to just link it to the larger roadmap conversation.

MR. SOONTHORNSIMA: I’m trying to follow here. Are we talking about a summary section or a cover page?

MS. DEUTSCH: It’s all in one letter. There’s no cover page, there’s no summarization. We don’t want to make it longer than it is. It’s just a matter of giving the meaning of it upfront and then, at each of the recommendations, just giving a high level what is the recommendation. We can leave out the historical part.

DR. SUAREZ: I do think we have a challenge, though, because there are eight recommendations. Each recommendation has two or three items, so there’s 24 probably items. To try to summarize them in a small paragraph on the first page before we even say national committee is going to be very difficult.

PARTICIPANT: But education is one, and —

MS. GOSS: I think I’ve got an idea, having done some stuff like this before. I think what we can do is we could actually take the larger picture linkages and say here are six areas or eight areas that we’re going to look at for specific recommendations. Just whet the appetite and then move on to the rest of the content.

MS. DEUTSCH: Yes. I think we just have to be a little bit cautious how we write this because, as Jim has mentioned, there are a number of different areas that will be looking at it, and the content is important for some of those areas. As much as you want to summarize, they need to respond and react to the content, and that’s why each of the recommendations had at least identified what the topic was and that’s why it’s bolded. As we go on later on, there are a number of these sub-things. If we start looking and making these introductory, we may, in trying to be brief, lose some of the nuances that are important.

I’ll try to see if I can make the bulleted part have a few more words in it, but knowing the different audiences that are going to be looking at it, I just want to make sure that we’re not going to have a letter that is not what people are accustomed to seeing and the information that they need in order to be able to make whatever decisions they have to make.

Jim is shaking his head yes.

DR. O’GRADY: All I was going to say is, at this point, you have got a long line of unread letters, so I don’t think you want to stick with what you have done in the past. The fact that people other than the decision-makers would like to take a look at this and read it is fine, but they’re not the primary audience, as I understand it.

So you don’t have to write a front end. You have to simply make your recommendation, then give a paragraph or two about background and who we talked to and different things like that so that the reader can read it if they want. But a decision-maker can go through this and say there are seven main recommendations, 1.a, 1.b., boom. If they want more, you’ve given them more. I’m just talking about reordering it in a way that actually makes it have a fighting chance of being read.

DR. SUAREZ: I must say, though, we have written many letters before and they don’t all follow exactly the same format. In many letters we actually had very bolded Recommendation 1 with exact words and then a description of it, and then very bold and big. We have never had a problem with the communication of that, mostly because, as I mentioned, generally, what leadership like a secretary will do is say who is this going to. CMS, okay. Here is what you need.

And then we hear, like this morning from Shana, who is the person that ultimately is going to come down to respond to this letter. So we have that level of communication. As Jim said, this is a larger audience communication, not just directly to the Secretary, and directly going to the Secretary.

So I’m trying to avoid specifically perhaps addressing a situation that has not, at least in our past — and Terri and Alix and others could provide testimony on this — but has not been a major issue in terms of our communication style. I don’t know if anybody has complained that these letters are 15 pages long and nobody reads them or, on the contrary, actually people have been very much reacting positively because the letter provides not just the specifics about the recommendations but the background and decision-making process and the supporting materials about why the recommendation was made.

Have you heard of any issues that have been raised by any of these letters in the format that we have?

MS. GOSS: I haven’t, although I have to agree with Michael that you want to get to your power punch up front to capture someone’s attention, and I think there is an easy way to address this. I think if there’s a larger issue with the way our letters are written and whether or not they are being left unread and why, I think that’s a separate discussion than the Review Committee letter, at this point in time.

MS. LOVE: Is this posted on online?

MS. GOSS: It is posted online. It’s available for public comment.

MS. LOVE: People do read those things that we don’t even know about.

MS. DEUTSCH: I just want to remind everyone that these are the first Review Committee recommendations that were made for all of the standards and operating rules that have been adopted. Because they are recommendations that may have impact, there needs to be some supporting information about why these were recommended and to give some information so that they can be enacted.

The report is going to be more detailed than this is for that very reason. I think how detailed — That’s why there’s a recommendation summary and then there are sub-recommendations. If somebody just wants to read the recommendation and not the sub-recommendations, they can move on. I’ll just see if I can try to do something with it, but I think it’s important that it’s done in a way that the different entities that are going to be looking at it are pretty much accustomed to seeing it and that it conveys the information it needs to convey.

MS. GOSS: I would like to go ahead and move on to Bill because he has been very patient.

DR. STEAD: I want to second Michael’s point. I think for us to get a one paragraph elevator speech, that we want the first thing that comes out of everybody’s mouth would be a major upgrade to all of our communication, and particularly this.

Second, I would like to advocate that in this case we make it clear that we think there’s a significant opportunity for increase in value by focusing, coordinating, educating and enforcing.

MS. GOSS: Say that again. That was good.

DR. STEAD: A significant opportunity to increase the value we’re obtaining from administrative simplification by focusing, coordinating, educating and enforcing — really at that level, and not try to restate the recommendations.

MS. GOSS: I like it, thank you. You may have just given us our start on that one.

So we’re going to go back to the recommendations.

DR. RIPPEN: For 3 — and I guess this might be more the language because some of the recommendations are not very specific — consider requiring operating rules be consolidated. What are the implications of that?

MS. GOSS: I think you will notice that some of the text in here is specifically broad. That sounds contra-intuitive, but we also need to be respectful of the ACA requirements to implement these recommendations in 90 days, and there has been notable concern from within the federal processes as to what we recommend and what’s feasible. That’s why we’re doing a two-part process of first a letter to the Secretary and a second larger, more expansive report.

DR. RIPPEN: Okay. And then 3.2, respond — Is there a recommended response or is it just say yes or no?

MS. DEUTSCH: This had a history behind it.

DR. RIPPEN: I’m sure it did.

MS. DEUTSCH: We’re recommending again that there be a response to the request that had been made numerous times in the past. It came out in the Review Committee but it had also been in the past.

DR. RIPPEN: Because then 3.3 and 3.4 are also very vague.

MS. DEUTSCH: I think the important thing to understand is what can be accomplished in 90 days.

DR. RIPPEN: I totally understand. That’s why if you think about 3.3, to measure the degree to which each of the transactions, standards and operating rules are to be implemented in a consistent manner — that’s the big line, potentially. These are recommendations but they seem not very — there are a lot of implications wrapped up in each one of these, as I know you are very aware of. I was just commenting that some of them are not very clear, maybe for obvious reasons. Some it will have potentially very significant levels of effort associated with them and have implications across all the business sectors and —

MS. GOSS: And you just answered part of your own concern. How can we ask the Secretary to take something on that’s bigger than a bread box, probably bigger than a tractor trailer, and be prescriptive in this letter when they’ve got to act and respond? And part of this journey goes back to the collaboration efforts, and they have to convene and pull people together to address some of this stuff.

DR. RIPPEN: Yes, but if I was being asked this, I would need to know — I wouldn’t necessarily know how big the bread box is, so that’s my only concern. Some of these, it’s like really big. If you’re writing to the Secretary to recommend things and there’s no kind of nuance about the potential level of effort —

MS. DEUTSCH: The information that has to do with 3.3 is going to be explained pretty deeply in the report, so the detailing — Right now, this is just to be able to say that there needs to be a dialogue between the SDOs and the industry about these transaction standards and operating rules that are not consistently being implemented, and during the Review Committee that came up numerous times.

So it’s just saying to start to work with them; it’s not saying there’s an end product in this letter.

DR. RIPPEN: So maybe instead of “work with” it may be more nuanced as far as — begin discussions —

MS. DEUTSCH: We can change the words to begin discussions. That’s fine.

MS. GOSS: What I’m thinking is also that we may need to link to the fact that we want to expand upon this in the report, and that’s part of what’s missing here. We need you to start working on this; we’re going to give you more and be a partner in it.

DR. RIPPEN: Yes. And again, if you’re giving this to a decision-maker, what are the things they need to know about, like how big is the bread box, any nuances and things they need to be aware of, how much is it going to cost and what’s the level of effort. If the report has it, that’s fine.

MR. SOONTHORNSIMA: I wonder, like 3.2 is much more actionable and it’s something that they can do immediately. Now that you mention it, we can swap 3.1 and 3.2, because everything else is more of a path, and more collaborative action is needed, perhaps a framework. But for sure, 3.2 we need immediate action on.

MS. GOSS: I’m thinking actually we can take — Terri, maybe you and I can talk later and we can look at 3.3 and 3.4 —

MS. DEUTSCH: Switching and reordering we can do offline.

I just want to bring your attention to page 46 where we say above the general findings and recommendations, NCVHS will also be developing a separate report that will include observations, themes, issues and NCVHS recommendations for the entire healthcare industry. So the fact that there’s going to be a report is prefaced here.

I think for a lot of these, if you read them, they do require more information and more detail that would be for the other entities besides HHS which would be reflected in the report. We did the letter before the report, and that was because we had a statutory requirement that this letter had to go out within a certain period of time, or a report, so we’re trying to meet the statutory requirement and maybe putting the cart before the horse.

But the fact is that this is at least a starting point. It gives HHS a knowledge and understanding of the depth and the areas that are going to be addressed in the recommendations and the fact that there’s going to be a report to follow. I do concede that the wording in many places is vague, but it’s intentionally vague.

MS. LOVE: Just for those 3.1s, just as an example of what I’m thinking because I think we’re close, I really do, but I labeled Recommendation 3 — I grouped them as short-term focal areas or priorities for action because really that’s kind of what they have in common even though there are some different recommendations. But I grouped really the immediate focal areas for action or consideration. I’ll give you my notes.

MS. DEUTSCH: Perhaps the way to get around this that might be easier is to take 3.2 and make it a separate recommendation and then leave the others as they are, because the others have to do more with considering and beginning work; whereas, 3.2 is a separate action. Would that resolve your concerns?

DR. SUAREZ: I don’t know that we need that. I think it’s fine the way it is. Just move it up.

MS. DEUTSCH: Okay. Any other comments on 3 before I got to 4?

DR. SUAREZ: 3.4 — I think there’s something about it that might need to be added. It says consider that additional efficiencies can be realized through common understanding of something by the healthcare industry —

MS. GOSS: If I could interrupt, Walter, I have struggled with this, what 3.4 really says, so when I’m working with Terri later I think 3.3 and 3.4, within the context of the other things we discussed, can be sort of merged together to give a little bit of clarity. I think what we’re trying to get at in 3.4 is really making sure that we’ve done our due diligence and understand the realities and the boots on the ground and what it takes to do implementation and how to benefit from those conversations.

DR. SUAREZ: All right.

MS. LOVE: Okay. Recommendation 4, are there any comments?

On page 51, Recommendation 5, we heard a lot about acknowledgments so we, once again, are recommending that acknowledgments be adopted. Any comments?

PARTICIPANT: We’re saying it should be adopted. It’s kind of buried in there.

MR. LANDEN: That’s my comment as well. We need to make the recommendation, which is the very last sentence of the fourth paragraph. We need to have that stand out as a bullet or something.

MS. LOVE: Adopt acknowledgment standards, and then the rest of it would support that.

DR. SUAREZ: So the comment is basically the statements in Recommendation 5. There isn’t a place that explicitly says we recommend again that the Secretary adopt acknowledgements. It’s buried in the last statement in the paragraph at the very end, before Recommendation 6.

I think Rich is suggesting highlighting that one. Maybe that is the first statement.

MS. DEUTSCH: We can’t adopt it in 90 days, so that’s why part of the wording —

DR. SUAREZ: Again, initiate the adoption, whatever we need to say.

MS. DEUTSCH: If I understand, the two paragraphs that give the background and history will not lead into why that recommendation is being done. We’re going to take the recommendation and put it up front and then follow with the background information.

DR. SUAREZ: Yes, just that paragraph that says HHS should pursue adoption. We’re not saying implement in 90 days; we’re saying pursue adoption.

MR. SOONTHORNSIMA: I think that would work. You can talk about pursuing adoption of standard operating rules for the acknowledgment transaction, and then we can follow with the background. I think that will work.

MS. GOSS: And I think I heard another piece in this conversation but I’m not sure I heard it right. Are you questioning why this is number 5? All right.

MS. DEUTSCH: Number 6, we did have a comment from Blue Cross and it’s just some wording. It’s not going to change the content; it’s adding a couple of words. We’re going to do that offline but we’re not going to wordsmith now. We’ve spoken to them and will get the information.

Any other comments on 6?

On page 53, we start with transaction-specific findings and recommendations and gave a little bit of a background on that. So, when we get to the health plan enrollment, disenrollment and health plan premium payment, we give a background of what led up to it, and then we say, and, therefore, NCVHS recommends — and then we give the recommendation there. Any comments on Recommendation 7?

Recommendation 8 has to do with prior authorization. Again, there’s some explanation and background and there are two sub-recommendations. Are there any comments?

Are there any other comments or questions pertaining to this letter?

MS. LOVE: I’m having trouble with what that recommendation is. I’m having trouble with what we’re actually recommending — to evaluate the value.

MS. DEUTSCH: On the first one, we’re evaluating the value of the current prior authorization transaction and the adopted standard. Remember that we did not have operating rules; this was only looking at the standards. Yesterday, we had the operating rules proposed, so that’s all we’re looking at, is the current standard. So that’s the recommendation for 8.1

Then for 8.2, this is another one that has a background that was mentioned yesterday by Margaret about the script standard, and it’s just reiterating that HHS respond to that request.

MR. SOONTHORNSIMA: So for 8.1, you may recall that there were a lot of comments and feedback around the use of websites, portals and so forth. That’s why we wanted to really call this out, to make sure that we understand why these portals seem to be more effective in delivering information, and if there are any gaps or opportunities for a future version to include this additional information. And we call out attachments transaction here as well. So that dovetails pretty well with what we talked about yesterday when we discussed 278.

DR. SUAREZ: This’s one of those transactions that there’s a lot of opportunity for improvement in value and AMA, AHA, everybody testified was very valuable. So one of the thoughts was we could convene a workshop devoted to prior authorization to see these kinds of issues. Why is it not currently providing value, and what can be done.

This is sort of setting the stage for that possible action that we can, as a national committee, convene.

MS. LOVE: And it’s not indicating that there shouldn’t be use of the Web portals. It’s understanding why they’re allegedly preferred over the electronic and see if there’s a way that that will be incorporated or worked into the standards and operating rules.

MS. DEUTSCH: Any other comments?

MR. SOONTHORNSIMA: Can we summarize changes that we are planning to do?

MS. GOSS: Terri, do you want to make notes and I’ll just make sure I’ve got the electronic version to track with that.

MS. DEUTSCH: What we’re going to do on page 45 is we’re going to eliminate the first paragraph about the background and instead focus on what is the significance about it — no?

DR. SUAREZ: No, we’re not eliminating. We’re just adding —

MS. DEUTSCH: We’re going to add in front of that paragraph the significance of why this is important and what’s important with administrative simplification, and then the fact that we have to focus on coordination, education and enforcement.

MR. SCANLON: At the end of that first paragraph, last sentence, why don’t we just say that you, the Secretary, designated the NCVHS as the review committee last year.

MS. HINES: You also mentioned that it’s important to refer to the report that’s forthcoming.

MS. GOSS: It’s actually down below. Should we move it up?

MS. HINES: I’m just wondering whether that should go in that nice crisp opening paragraph that basically says what Bill laid out — significant opportunity for increasing value; here’s our initial set, report forthcoming with details and so forth.

MS. DEUTSCH: And the next thing would be on page 47 where it talks about paradigms, some language will be added about transitioning from current into new paradigms.

On page 50, do some switching so that 3.2 becomes 3.1, and 3.3 should start with, “Begin discussions” and I’ll combine 3.3 and 3.4, just play around with the wording.

Also, in the beginning of each of the recommendations there will be a bold sentence — I’m sorry?

DR. O’GRADY: The way I’m hearing you lay this out, you’ve really added Jim’s paragraph which is good, but otherwise you’ve changed nothing in terms of moving things forward.

MS. DEUTSCH: I just was starting that conversation.

DR. O’GRADY: Right. The paragraph at the start is great, but I’ll just say it one more time and then I’ll be quiet and you can do what you want. But if you just put a paragraph at the front and then go on with all this —

MS. GOSS: I don’t think that’s what we said. I thought we were going to update the paragraph.

DR. O’GRADY: Well, that’s not what she just said when she summarized what the change was going to be.

MS. DEUTSCH: I was just starting the conversation. I was just going to say that at the beginning of each of the recommendations we’ll summarize what the recommendation is.

DR. O’GRADY: Right. And my suggestion is you move the recommendations right up, so that as you turn that first page — all the general findings and discussion there is just put in the background behind it. You’re just waiting too long to get to the point. The fact that it has been done that way in the past is not persuasive to me.

DR. SUAREZ: We’ll draft something and we’ll bring it back.

MR. SOONTHORNSIMA: Are we saying that we’re just going to summarize the recommendation in the first couple of pages?

DR. SUAREZ: We’re going to find a way to begin the first page to include a description of the recommendation as a highlight. We cannot bring all the recommendations. We’re bringing a summary of the recommendations —

MS. DEUTSCH: I understand. I think I know a way to do it so it will be a compromise and we’ll be able to have the information and still be able to follow the flow. I think I have an idea. I’ll be happy to share that with you, Michael, so that you can see if it satisfies you.

MS. GOSS: Okay. Terri and I are going to work on some updates and then we’ll bring it back. For managing expectations, Walter, we are going to vote on this tomorrow at 10:00 a.m.

DR. SUAREZ: I don’t know how much you want to include this in the discussion this afternoon at 4:15.

MS. GOSS: We have a very full agenda this afternoon with the work plan discussions. We also have the themes from yesterday’s operating rules and attachments hearing. Ob has put together a slide deck so I thought we would look at that. And I think we only have about an hour and 15 minutes. It also depends on what we can get done this afternoon.

MR. SOONTHORNSIMA: We can work offline tonight.

DR. SUAREZ: I do want to thank everyone. It has been especially challenging. We have, as I said, done many letters, some 15 pages or longer and some very detailed. I remember the biggest one we had I think was 22 recommendations specifically. So we have done those. This has been especially challenging because it’s a very complex, large scope issue.

It is, as Terri mentioned, an issue that has to be carefully drafted because the law says that the Secretary must act within 90 days of the recommendations, and it said, must act. In other instances, it says the Secretary can consider recommendations from the national committee. In this case, it’s one step higher in terms of the expectations. So we have to be careful crafting the language.

Thank you everyone. I know this has been like a six-month process since June of last year when we had the hearing. Thanks also to the audience and the public that provided feedback on the draft as well.

We have another topic. It’s 11:55 so we’re only about 30 minutes off schedule. We can take this topic right now or we can take lunch and come back and start the afternoon with this topic. Do it now? All right.

Agenda Item: ICD 10-CM and ICD 11

MS. PICKETT: Good morning. Thank you for the invitation to provide the committee with an update on ICD 11. This feels rather strange since I’ve been talking to you for years about ICD 10-CM, but I’m very happy to be talking about 10-CM implemented as opposed to we’re still talking about it. And thank you very much to the committee for having supported that transition and working through all the ongoing delays and such.

ICD 11. I have a number of slides but I’m going to go through them pretty quickly so that we can get through within the allotted time period, but I also want to leave time for questions just in case there are any. I know, again, a lot of people are just kind of getting through the exhaling from 10-CM, but I know there’s a lot of curiosity about what’s happening with ICD 11.

I’ll give you a little bit of a history but I think pretty much everybody in the room has a good understanding of what the ICD is and its long and rich history, so I’m not going to dwell on that. I will provide an update on what work WHO is doing in the creation of ICD 11, and also describe some of the tools that are available and on the WHO website. So what I’m showing you is not a mystery, it’s not hidden. There is transparency with this. For those of you who have an exquisite amount of free time, you can actually go up and look at it yourself. Kidding.

History; We all know it has been around for a while. To take the mystery out of things, I know there has been a lot of supposition and guessing about what is the date for ICD 11. Again, mystery gone. The current date is 2018. And we heard several years ago it was ICD 11 in 2011, and then it was 2014, then it was 2015, and now we’re up to 2018.

The change to 2018 I won’t go into a lot of detail on, but there’s an expert panel report that was commissioned by WHO to look at implementation and other steps that were needed to actually move forward the work to create ICD 11, and to move it to the World Health Assembly for approval. Again, those documents are available on the website so I won’t try to go through all of that.

The revision goal for ICD 11 was to ensure that ICD 11, unlike ICD 10 and its predecessors, will work in an electronic environment. It will have logical operational rules, something we’re all familiar with, and actually lay out the construct as it relates to the electronic healthcare world.

It will be a multipurpose, coherent classification. Not only will it now cover mortality, which has always been its primary focus, but it will now be looking at morbidity which has become equally important and, in some countries, actually more important than mortality.

It will also be looking at some of the other use cases that have been identified for ICD, which include primary care, clinical care, research and public health. Again, many countries, including the U.S., have been using it for these purposes, but in WHO undertaking this work there is a key focus on looking at those other use cases and making sure that the business cases for those issues are actually incorporated into this revision.

It’s an international classification. WHO does have six primary languages, but we also know that there are other countries that also translate the ICD, and the platform that WHO is using will help generate some of those other international versions.

As part of the development process, WHO gathered together topic advisory groups. Those were primarily groups focusing on specific chapters within the ICD. You have mental health, pediatrics and a number of issues that have been raised over the use of ICD 10. And again, in the U.S., we’re sort of new to it, we’re the new kids on the block; however, other countries have been using ICD 10 since 1995-1996, so they’ve established a baseline for what they’re looking for in terms of the use but also to look at some of the content issues.

ICD 10 was approved by the World Health Assembly in 1989. So, yes, a lot of things have happened in the world of medicine and healthcare since it was approved. And even though WHO has an annual updating process, it certainly, within the structure of ICD 10, has been a challenge for them to add new information to the classification.

WHO, for the first time, is also looking at definitions for the concepts within ICD 11, and also looking at content parameters. I’ll go a little bit more into that as I go along.

Structure — We’re looking at linearization and what does that mean. Again, there’s a linearization for mortality but it will be different than it would be for morbidity or for primary care and for some of the other use cases. Recently, a task force was formed, the Joint Linearization Mortality-Morbidity classification group. Basically, it’s a subset of some of the topic advisory groups and some of the crosscutting tags, and I’ll go into a description of what I mean by crosscutting.

This is the current organization for the ICD 11 revision work. Obviously, this is a WHO classification, but it’s ably supported by the ICD collaborating centers, of which the North American collaborating center for Canada and the U.S. is housed at NCHS. And we also have regional offices and others involved in the ICD work that are part of the work.

As you can see in the green boxes, those are the subject matter expert tags, so, internal medicine, dermatology, mental health, musculoskeletal, neoplasms, et cetera. The internal medicine group has a number of smaller working groups that assist in the review and content development for some of those chapters.

On the left side of the screen you have what are called crosscutting tags. Basically, they’re looking at the uses across the board of the entire classification and not just looking at a specific chapter like endocrinology, for instance. So there’s a mortality tag, which again was the historical use of the ICD. There is a morbidity tag, a functioning tag which is looking at the relationship between ICD and ICF, the functioning and disability classification. There’s a quality and patient safety tag, which again is looking at the broad view on how the classification is used in quality indicator work and benchmarking, et cetera. Then there’s a primary care task force. So, as you can see, there’s a lot of effort going into this revision process.

For those of you who are interested in how the U.S. specifically is involved in this process, the collaborating center, North American collaborating center, is a member of the Revision Steering Group and also sits as part of the small executive group and also sits as part of the overall task force.

For the mortality tag, that tag is co-chaired by the U.S. mortality representative, Robert Anderson, from the National Center for Health Statistics. The morbidity tag I am co-chair and also sit on the quality and patient safety tag.

Getting down in a little more of a deep dive, ICD will have definitions. Again, definitions are to help everybody understand what is in that bucket, what is in that concept. It’s not to be used for how you code something or how do you take the documentation within a healthcare record, be it hard copy or electronic, and assign a diagnosis. It’s just to give everybody a clear understanding of what is in that bucket.

Within the classification in the printed version and in the online version, you’ll have what they call a limited definition of 100 words or less. In the online version they actually will have some of the more detailed, very descriptive definitions. The definitions will be generalizable across the entire classification, so not just for this particular chapter will you have this set of definitions. There will be diagnostic criteria, again, just to set the understanding, not for a specific use, and documentation by the provider.

This slide gets used frequently because it keeps being updated. There’s a proposal platform that WHO has set up, and this just gives you an idea of the amount of work that is going into modifying the content that already exists in ICD 11.

The main activities — This just describes for the beta version that is now available on the WHO website some of the work that’s going on, looking at some of the historical things that have risen to the top needing attention in ICD 11 because they have proven to be a challenge or a major need for update in terms of the chapter content in ICD 11.

MS. LOVE: Donna, what is shorelining?

MS. PICKETT: We use shorelining to describe where the cutoff is behind adding very exquisite detail versus what’s absolutely necessary for morbidity and mortality work. For those of you familiar with the classification, you can think of things that are on the shore as basically your three-character or four-character codes in ICD 10. Anything further out is being considered for what’s called post-coordination, so it’s additional detail, very important additional detail that other countries have identified as being necessary to capture the complete clinical picture but not necessarily needing what is a three-character or four-character level concept. I’ll be describing some other terms that will be new to you because we have introduced some things

Again, as you can see in the slide, anything beyond the shoreline gets grouped into its own category or may appear in something that we call extension codes. I’ll go into a little more detail on what extension codes are.

With the shoreline, again, it’s figuring out what the breaking point is as the waves come over the shore, to figure out how much content detail do you need for the different linearizations. Obviously, for primary care you may need less, but for a clinical modification such as the one used in the U.S., but other countries also have their own national clinical modifications.

Where do you place things? WHO is looking at use by the various countries to kind of make that decision. Again, there’s a slide in here for those who want to do a deeper dive in terms of what the shorelining is.

This is an example of hierarchy for the endocrine chapter. We’re looking at a slightly different hierarchy, but also how you lay that out in terms of whether you’re using it for mortality, which would basically be your three-character, four-character codes, but what you would do with it in terms of more detail in a clinical modification. You see example of a code, but how do you arrange them? Do you arrange them sequentially, as you do now, or do you use it as a string? Decisions are still being made about the best way to represent this and, also, from a country-specific viewpoint, what works with their data system, because again, this will have a lot of impact on data systems and changes in how things are organized.

There are now 26 chapters in ICD 11 as currently proposed. There are five new chapters — diseases of blood and blood-forming organs, immune systems, sexual health, sleep/weight disorders, and traditional medicine, and then the extension codes. For Chapters 3, 4 and 6, those concepts were in ICD 10 but they were organized within existing chapters. Sometimes things like sexual health could have ended up in the genitourinary; it could have ended up in mental health. Again, they created a new chapter to pull all of those things together.

Here are some of the terminology differences in terms of how we have always described ICD 10. What we have now is something called the foundation, and the translation of foundation is it’s everything that’s in ICD. What is an entity? Well, it’s the thing that is in the foundation. Linearization is what we call a classification. It’s viewed that we will have primary care linearization, a mortality linearization, morbidity, and others are also being discussed.

Stem code — It’s basically your three-digit or four-digit category as you know it in ICD 10. Extension code is additional information, and I’ll show you a table that kinds of lays that out. And there’s parenting, multiple parenting of the concepts in ICD 11.

There’s a numbering difference. It’s alphanumeric, seven character, so at least for the U.S. we are already familiar with how to handle an alphanumeric seven-character. They’re changing to Arabic numbers, not Roman. The coding scheme is now a minimum of four characters with two levels of subcategories beneath that.

No I’s or L’s and small i’s and o’s and zeroes to make things very confusing. That’s something that everybody always complained about in ICD 10; however, that’s what ICD 10 had, so for 10-CM we worked with it. And the first character is always going to tell you where you are within the structure of the classification.

Standardization — It used to be you had a number of ways of describing relationship due to. The preferred term will now be “due to” and it will be used consistently across the classification. Other expressions — indicating a coincidence that this and this are together, there’s going to be a standard way of doing that as well.

Extensions are intended to be additional information used with the stem codes. There has been a lot of discussion about the level of granularity you include in a code. Do you pre-coordinate everything? Do you post-coordinate everything? And where is the middle ground? Basically, within the extensions, if a data system is able to capture that additional information you’ll have a diagnosis timing indicator which basically equates to “present on admission.” Again, it wouldn’t be added to the actual diagnosis code; it would be an additional code to enhance the information about the diagnosis code.

Severity scale measure, dimensions of injury. Laterality is included as one of the dimensions. Histopathology, consciousness, which basically equates to the Glasgow Coma Scale that we have in ICD 10-CM. So a lot more information to be included in the extension chapter with a lot of very good information. But, again, countries will be able to decide how much information they can actually use and how that should be captured. Some countries may not use some of the extensions because they have identified other ways to capture the information.

Again, the extension codes, you have Type 1, which basically in the rules will tell you that this is something that always has to be used if your stem code doesn’t have all of the required detail. Main condition — We all struggle with is this a ruled out condition; is it still being worked up; is it possible, is it probable, is it provisional, is it an admitting diagnosis. So there will be ways to capture that information as an add-on code in ICD 11.

Also, the Type 3. Again, family history, a personal history — those will also be added as extension codes.

So we have a content model with definitions.

ICD 11 tools. On the WHO website, there’s a coding tool to help you figure out, okay, if I said this in ICD 10 what does that look like in ICD 11. There’s a browser so you can actually look up your favorite diagnosis code and see how that translates into ICD 11. There are downloadable versions. There are frozen versions, frozen versions being people found it very hard to deal with the fact that WHO almost on a daily basis is updating the coding system. Very hard to do an analysis when you go to the system today and you come up with all of these findings and results that you want to report out and then you go back to it the next day and it has totally changed. So they have frozen versions updated basically every six months, so that if a group wanted to actually compare, there’s a way to do that.

There’s a proposal tool, as I mentioned earlier, where someone interested in modifying what a concept is in the classification can actually submit a formal proposal. There is a review tool. There’s a translation tool, so if you want to translate something into Russian or Slovakian, et cetera, the tool will help you do that. And then there’s a mapping tool to show you what concept existed in 10 and where it exists in 11.

A lot of online information. There’s video, there’s FAQs. They have now added a feature for quarterly newsletters so that you get a quarterly update of the work that has been done since the previous newsletter. Also a segment on how do you become involved. There’s a registration site and you can actually work through the things and look at your favorite chapter.

If you have an interest in rheumatology, et cetera, you can actually look at that level of detail and submit a proposal if you find something isn’t exactly to your liking. It’s amazing how many perspectives physicians have based on the subject matter experts on how something should be handled. They can have four ways to split something. Some are lumpers, some are splitters, and that becomes rather interesting as well.

The beta phase — there will be testing of the classification through WHO. Participants can make comments, they can make coding proposals, they can participate in field testing. I think we have a little ways to go but they’re already setting the stage for the field testing. And assisting and actually translating the ICD to other languages. And, again, looking at whether there is scientific accuracy and is the concept complete. Is there internal consistency. The relevance of each unit to the whole. And then field trials. And again, there’s a lot of information on the website for field trials and assessments.

Some of you asked previously so I thought this would be a good opportunity — Is there a concern about the development of what is in 11 and how that relates to ICD 10-CM? This is just a quick snapshot that we had done about a year or so ago showing that some of the concepts that are new to ICD 11, not necessarily in 10, are already in 10-CM. But again, we have an updating process. We will try to keep pace with what WHO is doing.

But all of this is supposed to work together, so the fact that ICD 11, in terms of some of the concepts, may be different, some of it may be based on what we already have but also some of it we will be modeling based on what is in 11 once 11 is approved. We’re not going to try to model anything while it’s still a moving target.

Some of these issues are things that were relevant in other clinical modifications as well. What WHO did is they took a look not only at the use of ICD 10 and its updating process, but they also did a review of what other countries that had their own clinical modifications were doing such that the German modification, Canada, Australia — there’s at least 15 or so countries that have their own clinical modifications. So WHO just did a sweep of the landscape to see what did countries add that was considered important for their particular country and took a look at adding that into ICD 11. So you’ll see that a lot of the concepts that others have added as well as the U.S. are resident in ICD 11.

Again, some of the issues may be captured in other ways outside of the classification. For instance, the “present on admission” indicator.

Somebody said, when do you think ICD 11 will be implemented, and this was for an international audience. This was my slide to say this is the history of how long it took us to get to ICD 10-CM, and you’ll notice I stopped with the final rule of 2012. We all know that there were some additional final rules that came after that. I would hope that any transition in the future — I will be retired — won’t take this long, but I think in any country where things are regulated and have to go through that process, the fact that WHO hopes to have World Health Assembly approval in 2018 is, for most countries, the start of the race. It’s not the end of the race.

With that, I will stop and turn it back over to Walter.

DR. SUAREZ: Thank you so much, Donna, this is very helpful. And thank you for helping us recoup some of the time. Any questions?

DR. COHEN: You hit on a great summary, Donna, thanks. Is ICD 11 going to replace — will there be a CM, or is it intended to replace a clinical modification?

MS. PICKETT: When WHO started out, the intent was that no country would have a need for its own national modification. However, I think there are still discussions among those countries that do have their own national modification as to how that would work, particularly since, for instance, in the U.S. we update at least once a year but have the ability to update twice a year, and whether or not the WHO process could actually keep pace with the U.S. needs or Germany or France or any of the other 13, 14 countries that have their own national modifications, and how quickly would that work. So there are ongoing discussions on that, Bruce. No decisions made.

But I know that countries are concerned that their systems would now be held to an updating process over which they don’t have control, and there is concern about that.

DR. COHEN: We’re a ways away but at some point, probably there would be a fertile discussion for the NCVHS to have on how the dissonance between adoption of ICD and ICD-CM versions creates chaos in this country, and it would be wonderful if we could move towards unification.

MR. LANDEN: Actually, that first question was my first question. My second question is have any look-sees been done into what this would mean for the business adoptions for providers for health plans? Like ICD 10 was such an issue because it impacted so many of the billing systems, not just the library, the data and the research capability of it. Have we looked at who uses ICD, for what, and how the changes to 11 might be easier to swallow than 10 or more difficult or just different?

MS. PICKETT: Each country is going to have to look at that for itself because each country actually uses the ICD very differently. I think for the U.S., Rich, it’s going to be an interesting discussion because, by far, we use the classification in multiple ways that most countries don’t. In most countries ICD diagnosis codes are used if they have a case mix system. It may be used in inpatient settings only. Some countries are now moving into outpatient, but slowly. We are, by far, the only country that uses it for all diagnosis purposes across the board — inpatient, outpatient, rehab, home health.

The business use case in the U.S. is something that U.S. will have to look at specifically. But since the content is not yet set, it’s not clear when to start that discussion. Do you wait until the World Health Assembly has actually finalized and adopted ICD 11 as a replacement to the WHO ICD 10, or when you think it’s pretty much there? Is that when countries start their discussions? I think we’ll need to have more discussions through the national committee on what that correct timing is and how to kind of figure out what the push points are in terms of the use.

But yes, those discussions, while they’ve been touched on at the international level, the use cases are so different it will likely go back to the countries.

MR. LANDEN: If I can follow up, is there a point in the process for the North American group where this business scenario, the business impacts, can be introduced and discussed prior to the World Health Assembly approval?

MS. PICKETT: Yes. I have already worked outreach to a number of groups basically on the content, because, again, it’s the content that will drive whether any country believes that this is the best replacement and should move forward from using ICD 10. But the content, as you can see on one of the other slides, there are still a lot of content issues that need to be worked out. I think once the content is set, then you can start talking about what the potential business impact is.

We have involved not just a collaborating center itself. Other subject matter specialty groups have been involved in the process as well. So you do have, like for the pediatric topic advisory group, there’s a group that chairs that, and one of the chairs is from the U.S. So there is input, and in neurology and pediatrics. So there have been a number of the content groups that have U.S. participation.

MR. SCANLON: Very nice overview, Donna. Can I ask, for the mental health chapter, are they thinking of DSM? It’s a different process outside of WHO.

MS. PICKETT: The American Psychiatric Association has had consultations with WHO and the mental health tag specifically to try to harmonize. But again, at the end of the day, this is still WHO, so they’re looking at this from an international perspective. And there are some decisions that are going to have to be made about representation of various concepts and how that plays out. I know the APA has worked closely with the mental health tag, but it won’t be an overlay of DSM-V into the mental health chapter is my current understanding. There will be a harmonization.

DR. SUAREZ: My question is about the other terminology, SNOMED. My understanding was that ICD 11 would be much better aligned or harmonized with SNOMED, but there have been some concerns or issues around mapping of ICD 10 to SNOMED. Some of them are proprietary, intellectual or property related, but I’m not getting into those issues.

What is your sense of the relationship between ICD 11 and SNOMED?

MS. PICKETT: Well, ICD 11 and SNOMED are to be harmonized. WHO has a working agreement with IHTSDO. That information is available on the WHO website and I believe it also is still on the IHTSDO website. There was agreement from the beginning, and most of the definitions that are in ICD 11 are based on SNOMED terminology, so there is a harmonization there as well. Again, looking at usefulness in the electronic health record was key, and everyone is more than aware that SNOMED is being used in the electronic health record.

Again, on the WHO website — I went through this very quickly, so forgive me that I glossed over that, but there is work underway to do that. One of the tags is a terminology IT tag, and IHTSDO staff are part of that tag along with others from Stanford and WHO.

DR. MAYS: One of the things that happened is that the behavioral health community kind of had a difficult time in this transition. You had DSM-V come out at the same time this transition happened, and there were probably about 300 new mental health codes that needed to be developed. I sit on List Serves where people are constantly sending emails asking is it this or is it that. So there’s an issue.

And let me just add one more piece because this really goes to Jim’s point. American Psychiatric Association wants it to be DSM-V. The American Psychological Association is not necessarily in the same place but has also issued for its members booklets and tutorials and all this other stuff to help in the transition.

The question I have is about the quality of what’s going on right now and whether or not any of that is being monitored. There are a lot of errors, there’s a lot of lack of understanding of what code is to us. You also have in this process something that’s going to be lost which is an integrated care. You also have people billing that are billing under not, for example, the mental health provider but they’re billing, for example, under the physician because it’s an integrated care model. There are a lot of issues that are floating around. And I know also Jeff Reid, who used to be psychologist at WHO, retired.

The issue really is whether or not WHO or some group is monitoring whether or not the way in which this is being rolled out is in any way deficit or not in enough detail to make sure that mental health data is going to be of the quality that we want it to be.

MS. PICKETT: Let me start at the top. As some of you know, ICD 10-CM has been in a partial code freeze for the last four years. So, yes, there are concepts that are in DSM-V that don’t exist in ICD 10-CM. The American Psychiatric Association did bring forward a number of proposals during the freeze to harmonize 10-CM with DSM-V. Those proposals, however, because they came through during the freeze, were put on hold, so we’re looking to bring those new codes where appropriate to ICD 10-CM effective October 1, 2016.

Interestingly, again, because this process has taken so very long, ICD 10-CM was originally harmonized with DSM-IV, and many of you who sat through our previous presentations know that we did a lot of work to harmonize. But because of delays in implementing 10-CM, the world kept turning and we didn’t. There were delays after delays, and then APA worked on DSM-V and got it implemented, so now there is a disconnect.

With the next update to 10-CM we hope that will kind of smooth out some of the wrinkles for some of the concepts that aren’t currently in 10-CM so they can be harmonized with DSM-V.

You mentioned books and things of that nature. That really is sort of out of scope for us to address because we’re not the publishers of those books. And for the maps and other things that people have put in those books, that was their independent use case work, so we have not looked at it. I’ve heard that there are issues, but that would have to be handled through the APA or others who have made those modifications, because some of them are missing ICD 10-CM codes.

So it’s not just that concepts are missing; there are valid ICD 10-CM codes that exist now that are not in any of the mappings that people have pointed out to me. But again, it’s for them to have to update that material because it’s outside of our purview to do that.

DR. MAYS: But what about WHO? Is WHO not concerned about the problems that are being experienced in terms of the coding and what it is that we’re losing and the errors that are current in how people are getting their diagnosis?

MS. PICKETT: Well, ICD 10-CM is more consistent with the WHO version. What’s in DSM-V, that one I can’t handle because it really is out of scope for us, but I know that’s why APA works closely with my office to try to make sure that concepts that they have in DSM-V that are missing from 10-CM are brought forward. They have done this for years.

Again, that four-year partial freeze really had an impact, but there’s always a way to code something in ICD 10-CM — you know, the other code .8. Again, is it ideal? No. But at least there’s a way to capture the information. Then, going forward, we hopefully will be able to catch up and smooth out some of the wrinkles that occurred because of the delays and the partial freeze.

But I know WHO, for the mental health chapter in ICD 11, have already started looking at doing field testing and such. However, other countries tend to use that chapter a little bit differently than we do in the U.S. And other countries don’t necessarily use DMS-V either. So the fact that we have two classifications kind of working side by side — But again, the HIPAA-approved, adopted classification is ICD 10-CM, and we don’t have clinical criteria in ICD 10-CM so there shouldn’t be a disconnect at least in that regard.

DR. SUAREZ: Thanks. We have a question from the phone.

MS. MTUI: Have there been any discussions among U.S. parties involved in developing ICD 11 PCS and ICD 11-CM about how they might improve their processes to reduce the amount of time between the release of codes and U.S. adoption?

MS. PICKETT: Again, U.S. adoption is totally related to our regulatory process, so not much can be said other than it goes through the regulatory process because it’s a HIPAA-adopted code set. For anything in the future to replace ICD 10-CM as the diagnosis code set, it really kind of comes back to the national committee, to the Secretary and everyone else that’s involved in the process. We would all love it if we could just flip a switch, but we all know it doesn’t really work that way.

What I didn’t cover here is there’s also work going on at WHO to create an international procedure coding system. It’s called ITCHI, the International Classification of Health Interventions. That work is ongoing. Again, many countries, as some of you know, Volume 3, ICD 9-CM, the procedure codes, were adopted and adapted by many countries, so there were many countries that were quite upset with the U.S. when we went to PCS and we took away Volume 3. Somehow, some countries thought we were going to continue to maintain Volume 3, which was sort of not exactly in the cards.

But there is international work going on related to a classification for surgical procedures and interventions. That’s on a separate track but there is information on the WHO website on that as well. I didn’t cover it because they are further behind in terms of the timetables when you compare it to the work that’s going on for the diagnosis codes.

DR. SUAREZ: Okay. Any other questions from the phone or from any members of the committee?

Well, thank you so much again, Donna. Let’s come back at 1:30 and just take a 50-minute lunch break and we will restart with our agenda. Thank you.

(Lunch break)


DR. SUAREZ: We are going to start. We’re going to hear from Denise everything you ever wanted to know about all-payer claims databases and you were afraid to ask. Important to consider, as you are listening, is what kind of roles and opportunities and services would NCVHS be able to provide.

And just as a reference, I think this was distributed to the group. We received already a letter from the industry calling for some areas where NCVHS could help the industry with respect to all-payer claims databases. I don’t know if Denise will be addressing them but we’ll talk about that.

MS. LOVE: I have not seen the letter but I’m guessing it’s around standardization.

DR. SUAREZ: It is, in part. We can bring it up.

So, without any further ado, Denise, the floor is yours.

Agenda Item: All Payer Claims Data Base: Overview, Challenges and Opportunities

MS. LOVE: First off, thank you for the committee’s interest in all-payer claims databases. They have become a bigger part of my life than I ever thought.

NAHDO and I, in particular, have been involved with hospital discharge database development for 31 years, working with states. In 1990, it was a radical idea. It was not standardized; people were resisting, providers were up in arms. Now, 48 states have inpatient, emergency department and AMSURG just rolling in just routinely.

Now we’re propelled into a new kind of dataset, level set here with you because some of you have heard this presentation and I apologize, and others have not, so I’ll describe the dataset that we’re talking about.

All payer claims databases — I feel like I’m thrown back into the 1990s again. We’re back to not standardization across states. It seems like a radical undertaking in some states, and other states are rolling very well with it and I’ll try to tell that story. I won’t get down into the weeds too much to leave time for discussion. I will hit the high spots and I’m prepared to go down to the low spots with all of you.

There may be some of my council folks on the line so I want to give a shout-out to the APCD Council. The APCD Council is a collaboration between the University of New Hampshire’s Institute for Health Policy and Practice and NAHDO, National Association of Health Data Organizations, and it really is bringing together what started in the Northeast in 2003 with the Northeast states with all payer claims databases and then, as other states were taking up APCDs, many of them NAHDO members, they said what about us. We need a learning collaborative; we need this through NAHDO. So we re-branded as the APCD Council, and we have been that way since 2007 or 2008.

What we do on an almost daily basis is provide technical assistance to states. We support a learning network, and part of the learning network is also payers and other stakeholders, and there are many and I’ll touch on those. We really are trying to unify states to achieve their common goals, and that’s a story in itself.

What are APCDs? Every one of you probably has a different thought about it. We have come up with this definition as a working definition. They are usually mandated by a state, and the data are medical, pharmacy and dental claims with eligibility and provider files, in most states, from private and public payers in a state. They are large-scale databases. They are complex, and they bring together pretty much all the stakeholders in a locale.

APCDs typically start out bringing in the commercial claims from the commercial payers in a state. Then the state will normalize those. Then the next dataset they usually migrate to is Medicaid, and you can see this in the slide. All states intend to bring in Medicare; many of them already have, but it’s on the drawing board in other states. We have worked closely with CMS, and I want to give a shout-out to Nile Brennan and his crew who really worked out a streamlined process for requesting state research abstracts for those states with all payer claims databases.

The nut we have not cracked is Tricare, VA, IHS, and federal employees’ health benefits plans. We have had some talks with those folks and I’m hopeful, but it really will require probably another year or two of delicate negotiations and discussion.

So, where were we in September 2015? The dark blue states are in full implementation. The medium blue states are in early implementation. The light blue states are in the planning and exploration phases. I think this map is old; it changes every time I look at it. The really light blue state, Wisconsin, is a voluntary collaborative called the Wisconsin Health Information Organization. They are collecting claims on a voluntary basis. The majority of these states will have a mandated collection.

The interesting part about all payer claims databases is it’s a foundational circular development cycle. It begins with stakeholder engagement, and that is the most important component. The data stuff, the privacy stuff, the technical stuff — there are solutions and they’re complex and I don’t want to minimize those, but you can’t get to any solution if you don’t have broad, inclusive stakeholder engagement. And that is so important because you’re really building a community database. The data get everyone around the table and you have different sectors talking to each other, and it’s really important, and we work with these states to build a transparent, inclusive process. If anyone is excluded — say a payer that doesn’t want this to happen or a consumer group — it’s bound to fail at some point or trip up.

So we spend a lot of time with the stakeholder engagement which leads to then governance, and I’ll talk a little bit about that later. How will this system be governed? And then how will it be paid for, which is a huge issue.

Technical build seems to go pretty quickly. Once they have made those decisions, the other decisions are pretty smooth because there are some vendors in the space that are very good. But, also, we have quite a bit of documentation and state lessons learned through the learning network, so that tends to go relatively smoothly once the big decisions are made.

And then states are just emerging now an analysis and application development and it’s exciting to see these systems mature to the point where they’re actually generating information that informs the various stakeholders. And it’s a continuous process. It doesn’t go away when the system is built.

These are just examples of the various stakeholders. A policymaker may be a champion for the program, and they are looking for policy, payment, healthcare reform information. Payers are the data suppliers, so they are key to the success of any initiative, and they provide the technical and content expertise. Providers are concerned with how the data will be used and need to be at the table to be sure that the community comes up with the policies and regulations that meet those concerns.

Employers are mostly at the table — and we’ll talk a little bit about that later. There are employers who are looking for tools and information and transparency information. State agencies, again, are concerned with the governance issues — Medicaid applications and leveraging existing infrastructure. So, what does the state already collect; what infrastructure is in place analytically and IT-wise that can be built on? Or even Medicaid.

Consumers are interested in most areas. Of course, we need pricing data and informed choices, but as one state said, to build this exclusively as a consumer database is not really the way to go. That’s one of the applications. Really, policymakers are the number one users of the data and we need to be mindful of that. Researchers, of course, are interested in the data.

And some states are figuring out how they work with their HIE and HIX, because some of those clinical data and directories may have some import for the APCD.

So, state approaches to governance — The majority are, obviously, state led where a state will have the legislative authorization to collect the data. We’re seeing some public-private models emerge. Colorado, Virginia, Arkansas, Washington (in implementation and in law) where they have to have a public-private partnership where the state has the authority and will delegate the oversight and management of the APCD to an external agency.

And again, we have some private voluntary reporting initiatives that are regional in focus or in Wisconsin state.

Walter wanted me to hit on some of the lessons learned so I’m hitting on some of the use cases. I think I’ll just do a quick show and tell. I’ve left out all the technical build, what data elements are collected. We know what’s in a claim. It’s pretty much what is in a claim.

I don’t think my standard slides are in here but I’ll talk a little bit about that because I’m sure AHIP did mention that in the letter. Their concern is that each state does their own thing and builds their own all payer claims database and their own format and their own definitions, and the burden for a multi-state insurer is onerous to respond to all those state extracts.

So, in 2010 — I don’t have my notes so forgive me if I’m a year off, and Walter was involved in this, too — we met in the AHIP offices and the National Governors Association offices and we took four state APCD extracts and mapped them and harmonized them across the four states. Then we went to the payers and spent about six or eight months going through, field by field, and getting some agreement that the payer systems could support that data element. There were certain data elements that states wanted like race/ethnicity, premiums and other things that just are not in a claim, so we were able to kind of sort those things out.

That information is on the USHIK site and I can give you the URL — United States Health Information Knowledgebase. There’s an APCD module and it lists the state formats, the 837 formats, and the APCD core is what we came up with with AHIP. So that’s a rough standard, not perfect. It needs to be updated.

My colleague, Amy Costello from UNH and the APCD Council, monitors and participates in X12N and NPCDC to build the reporting guide, so we have a post-adjudicated claim reporting guide that has been promulgated through X12N that’s aligned with the core standard. We have the NCPD pharmacy standard for state reporting of pharmacy claims, and they’re working on now some eligibility.

So, again, we’re trying to play in the standards arena but it’s difficult because getting funding for developing standards and for promulgating standards is quite difficult. I think we’re kind of stuck on how do we get to the next level of standardization across the states, so we can talk a little more about that.

I’ll talk about how the states are using the information gaps, and I just wanted to mention some court cases that have some implications for all payer claims databases.

We’re seeing states now use their all payer claims databases to look at total cost of care, and there are some multi-state efforts going on to uniformly measure the total cost of care, and understanding the categorical costs. Consumer tools — I’ll show you some websites — Main, New Hampshire and Massachusetts. Intrastate cost variation is of huge interest to the states and it’s tremendous, so it begs the question of where are the improvements.

Purchasers are using the data for benchmarks. Medical home evaluation is particularly of interest in Vermont and New Hampshire but other states as well. And accountable care and regional profiles.

I just put together some of the examples from the APCD showcase. All of our states, when they release a report or website, we post it up on the APCDCouncil.org showcase, and there are portals for consumers, employers, providers and researchers.

This is an example of Virginia’s portal for healthcare prices, and they have a purchaser, a preventive health portal, an emergency portal, maternity. Their APC is one of the newer ones and they’re providing some price comparisons in Virginia.

Colorado — This is too small to see but this is the hip joint replacement, the Denver private insurance, and they’re showing the distance from the zip code that you enter in — it’s a query system — and the estimated price and the patient complexity for comparison of prices of the hip replacement. There’s quite a bit of variation there from $35,000 to $21,000 when adjusted. So that’s a queryable site for medical prices in Colorado.

The New Hampshire health cost site is also supporting portals for insured and uninsured, and this is important for the uninsured to get some information about various procedures and the costs.

The newest site is CompareMaine, so I did a query when I was presenting this to another state. I put in a procedure and I think I put in arthroscopy of knee. I guess my knee hurt that day, so I queried this. And it’s really cool because it brought up a map in Maine to show the various providers providing the service and their pricing. It really does vary and you can see that on the pop-ups when you go into the site. You can also see it in tabular format, which is not here.

Colorado, total cost of care reporting — this is by service category. They take a physician group, professional cost per member per month, inpatient cost, outpatient cost, ER cost, pharmacy, and they do that with the raw, the adjust statewide and the PCP group price. Again, the concept that they’re starting to get down to the physician level and looking at comparative statistics. And that’s not trivial because these databases, even if we standardize the demographic and other data elements, the provider ID is a real mess.

States are working hard to get the coding of the provider identifier cleaned up. I know in one state that I looked at their output, half of their submissions were missing provider ID and the other half had one medical group, one major medical group. Just IMG, and everybody was IMG. So we had no idea what that physician — how to attribute.

States are working hard. Once they get the data in and see what’s under the hood they have to work with their health plans to work with their provider directories and align those provider directories, align the coding. And then the next level is attribution, how do you attribute the patient to that particular provider. It’s a messy business. Some of the vendors are getting pretty good at it. In states like Colorado, after a couple years of working on this, they were able to get down to that clinic level.

This is just an example of employers contracted with the University of New Hampshire on an accountable care project to get benchmarks on regional benchmarks and per member, per month metrics. They’re too small to see, but it’s a Web system for employers to look at their experience against the region and other commercial insurers.

Minnesota has done some work on preventable healthcare events, and this is one of the reports. I’ve got some statistics from this report but I won’t go over them yet. Massachusetts is using their APCD for healthcare enrollment trends.

In Minnesota, this is an example of pain management services and how many CRNAs are providing those services in that state. The colored bars are the percent of CRNAs, 4.7 on the left hand side, but the percent of procedures, two to five procedures, 64 percent are being provided by that group. So it really sheds some light on who is providing care and for what. These all payer claims databases are providing information that the state previously did not have outside of Medicaid. The states don’t have outpatient services, pharmacy and others on a system-wide basis. I would like to say it’s really a broad view or a broad lens on the healthcare system.

Some people say, well, it’s claims data and it doesn’t say a lot about the patient, but I say the patient is the healthcare system. The healthcare system is broken, so this really provides a view of the healthcare system and how it’s operating and where the opportunities are to improve.

This is Colorado Emergency Department, and, using their APCD and the claims in the APCD, they say that if Colorado could just reduce their preventable emergency department utilization they would save an average of $1,150 per visit, which would equate to over $800 million per year in annual savings if patients used a clinic or doctor’s office for emergent care. So this just draws out with real claims and data the opportunities for reducing costs.

This is Bennington Dashboard in Vermont, a regional dashboard, and they’re using their all payer claims databases to look at their medical homes. This one lists the practice sites and it has a whole dashboard on number of Bennington blueprint encounters by discipline, the readmissions on the bottom line, and then their total expenditures by per capita ED visits, 30-day readmissions, outpatient visits for a whole health service region. They have tabs here — adult practice profiles, et cetera. So they’re really using this to hold the health system accountable and to measure progress.

Again, this is Vermont and they’re looking at the actual blood pressure — hypertension with blood pressure in control, so they’re actually merging with some clinical data in their health information exchange to add a dimension of clinical data with the claims data and looking at the members with hypertension whose last recorded blood pressure measurement in the clinical database was in control.

Maryland Insurance Dashboard is, again, looking at professional services by month across the system.

I emphasized the uses here, but the lessons learned so far by the states are the importance of the multi-stakeholder approach, forming provider relationships and payer relationships early on and throughout the whole process, transparency, documentation, managing expectations that after spending two years of building a claims database you don’t want the stakeholders to think it’s going to answer all the problems or be the single source of data for everything. I mentioned this morning about the identifiers.

Seizing integration and linkage opportunities are going to be critical to the success and enhancement of all payer claims databases. We have a lot of public datasets that states collect, and each one is built for a certain purpose. No one dataset is going to answer everyone’s needs or questions, but strategic linkages with hospital discharge data or vital records are going to be how we get down to some of these questions without spending a gazillion dollars to collect a universe of data that we can mine. So, really thinking about strategic linkages.

Again, I mentioned these use cases and I breezed over them. There are many more. States are starting to get their — I guess realize their return on investment, which is a big deal, because one of the first things that legislators and others say is how are we going to pay for this system-wide data collection, and what’s the return. Is this just a database that will put out some graphs for some people, or is it going to save the state some money?

I think we’re just on the cusp of answering some of those questions. Because the databases are so new, we can’t say that they have saved the state of Utah $8 million. We’re not there, and maybe we never will be there, but the ROI and answering some of the questions, reducing variation and targeting improvements I think are some of the early ROIs that we are seeing.

We’re working with states to stage reporting to match APCD capabilities. For instance, if a state brings up an all payer claims database, say, next year — and there are a few of them that we hope do — and they promise that they’re going to go into consumer price transparency that first year, it ain’t gonna happen. The provider identifiers aren’t there. The data quality is unknown. But they can do a decent job on regional comparisons of variation and looking at the data globally as they figure out what’s under the hood and what that data quality looks like.

I left a lot of time for discussion. I skipped all the standards because they weren’t in my slide deck. Do you want me to talk about SCOTUS and the ERISA?

DR. SUAREZ: I was going to ask about that.

MS. LOVE: How many of you have heard about Gobel versus Liberty Mutual? I think the implications for this are well beyond all payer claims database. This is a state data policy issue, at least this is Demise Love saying that.

The case is really challenging Vermont’s requirements for ERISA self-funded plans to submit claims data under the state law. The second circuit court overturned previous rulings exempting ERISA from Vermont’s collection, in effect. NAHDO and the Joint Public Health Informatics Task Force, the Colorado Improving Value in Healthcare, AMA, probably AHA, and a whole host of various amicus briefs were filed, and it’s on the SCOTUS website and they are really fun to read.

It was a remarkable experience at least for me to work with these top lawyers to build this petition to the court. I learned a lot about how the SCOTUS works and the process. It was argued on December 2nd. The argument was for SCOTUS to reverse the second circuit court decision on the premise that really this is state domain, to regulate the healthcare market. It’s not regulating ERISA plans and telling them what they have to cover and what they don’t have to cover; it really is state domain, and these databases are designed to help consumers, policymakers, providers and payers make decisions to improve care and lower costs.

So, fast forward to this week. Recent events just astound me because we were feeling pretty optimistic. The people that were there for the arguments said they couldn’t get a read. Some say it could go either way, but there was more favorable feeling about it without knowing anything, just listening to the questions and arguments and reading the transcript.

But now with the recent events in the court, the big fear is that when they vote in June, if it’s a deadlock, that remands it back to the second circuit and exempts the ERISAs. I’m not sure that — There would just be different work-arounds then for those self-funded plans for states. But I think it has implications for states because employers are part of the healthcare system, at least last time I checked, and they are a big part of it.

Then there was an antitrust document we have out, because that usually comes up in a group, what about antitrust. So these websites in the states are producing median and average prices and paid amounts, and the data are old. They’re not usable in real time for negotiating your contracts. If you’re using those you’re in big trouble anyway.

So the non-binding legal ruling in Colorado — and we have the paper out on the APDC Council site — advised that if it’s averages and medians and the data are over three months old, it’s not breaking any antitrust laws. That really has not been an issue except it comes up, so that was a paper, an opinion that was written.

I think that’s all I’ll say on the legal end. We need standards. We need a hearing probably on the states and with AHIP and with payers to engage again, and where we go from here with the standards.

DR. SUAREZ: Thank you so much, Denise. I think it was a great overview. I’m opening it up for questions.

DR. COHEN: Denise, what do you think? If you had to design a workshop or hearing for the national committee, what would the focus and intent be and who should be involved?

MS. LOVE: Well, definitely the states and the health plans providing the data. We laid the groundwork for those discussions with AHIP in 2010, I believe. We met about a year off and on and again went through the core of what data are being collected by the states. Have that conversation revisited because the needs are shifting now in the states. In 2010, we were looking at the claim and the enrollment as administrative data and what the payers could provide given the variation in the payer systems. There is not one uniform payer standard either.

But now the needs are shifting. We need back-end settlements, premium amount and capitation that doesn’t come from the claim, so there may be a supplemental feed. And states are looking at that right now — what a supplemental, maybe a quarterly feed, from the payers would look like that then could be backfilled into some of those missing data elements. But to have those conversations with the payers in a community discussion I think would be well advised.

DR. COHEN: Would the goal be to have the feds recommend a standard dataset that should be a minimum dataset, like vitals — you know, for instance? Is that the model?

MS. LOVE: Maybe I’m Pollyanna, but I do remember when I was getting started in this data business the uniform hospital discharge dataset that the national committee endorsed. There were no teeth to it; it wasn’t a mandate, but it really informed states like Utah — and I worked for nine years building the hospital reporting systems in Utah, and the uniform hospital discharge dataset informed a lot of our decisions we made in our Regs and our submission guides, so it gave us a starting place.

My fear is where if a state say three or four years down the road decides to build an all payer claims database and is not connected to the standard or the learning network, or there’s no core out there, they could pick all sorts of data elements off — who knows what they could come up with — and not look at all like the other states. It would really upset the payers because where does that data come from? Where should race/ethnicity come from? Ideally it would come from the enrollment but it’s not there.

So a core and some discussion around what a core might look like I think would be a useful conversation.

DR. SUAREZ: I just want to briefly mention I sent you all a copy of the letter that we got from AHIP with respect to this, soliciting actually our role in facilitating some standardization. I gathered from the letter plus my own experience that there are standardization opportunities in several places. One of them is really defining a core data element set. What’s interesting is there are differences in what data is being collected and captured by the different APCDs. There’s also the methodology by which it’s collected, the electronic standards.

So here, for example, we, the industry, are developing a national standard called PACDR, post-adjudicated claim data reporting standard. That standard is in place, exists. It’s sort of a combination of — for those in the standards world — of A37 and the A35, because it includes the claim and it includes the payment portion of the claim which is part of what the state APCDs collect. But I don’t know that any state has started using it, and they need to pass a law in every state to adopt that as a standard, and there needs to be a process for that. But there’s standardization in that area.

There’s standardization in the analytic part, also, in analytic capabilities and those kinds of things. So there are a number of opportunities where the national committee could play a role, and I just wanted to mention that that is part of what the AHIP letter submitted to the NCVHS required.

Let me ask if there is someone on the phone that has a question.

MR. SOONTHORNSIMA: Yes, I do have a question. Thank you, Denise. This was extremely helpful. After you went through the use cases for model states, I had two questions.

One is, because everything is driven by the state, how are they ensuring sustainability in terms of the cost? It does take a couple of years. How do they ensure the sustainability, because the data, like you said, is somewhat old. But to do the type of reporting of use cases like you just showed us, in the commercial world you at least have to have a minimum of a monthly upload of the data, and in some cases, the attribution as I recall is quarterly. Even a quarterly upload was not sufficient, and on the commercial side they started thinking about how can we get that closer to monthly, to get to that level of actionable population management, health management, or even cost management.

Those are really two questions — sustainability and then the governance around how some of these data are actually being aggregated to the point that the data becomes actionable.

MS. LOVE: The sustainability is unknown because the start-up costs are one thing, and states typically have used general appropriations. To get these started in Colorado there was a foundation that supported the start-up, and it’s really hard to talk about sustainability until you have the data, so it’s a chicken and egg sort of thing.

We are working with states, and states are now diversifying their funding sources quite a bit. The trick is getting the data and the funding to get the data. Once the database is built, it’s easier to get other sources of funding, be it grants — and there are two things that states are now really taking advantage of. One is Medicaid Match, and that’s useful and it will be key to sustainability if the state data agency and Medicaid work in partnership together. This is a beneficial database for Medicaid, and Medicaid benefits from it and some of the states have done very well in receiving that Medicaid match.

The SIM grants have stimulated some of the states in their planning and the implementation of their all payer claims databases. It would not be a sustainable, ongoing source of funding but it has been important to many of the states to get to that establishment phase.

States that have developed their data and have done a fairly decent job of packaging and communicating what’s in the data and have good data release policies baked in — not as an afterthought but at the front with those stakeholders — that, to me, is a crucial key to sustainability. What do your stakeholders need out of the data? They need to identify that up front. What are those use cases? Then, that drives the requirements; that then drives some of the data products and releases on the back end. Then, data sales and partnerships are supporting some of the states, and that’s the key to sustainability.

If it’s a dataset that just sits in a state agency for a few bureaucrats to crunch, that’s not going to be sustained necessarily. But when the community starts using it and seeing the value in it, then those partnerships, be it analytic partnerships with academics, data sales and data subscriptions, those will be key to sustainability, and I also say Medicaid Match. This is a database that benefits Medicaid and the Medicaid population in states that use it for benchmarking population prevalence. They’re on Medicaid today but they may not be on Medicaid tomorrow. What’s happening in between?

And this is a database that — I skipped a lot of pieces, but it really does connect the dots in a state. That gets back to the linkage and the patient fields. But what’s happening to patients as they come on and off Medicaid? The questions and analytics are exciting to see. But sustainability is related to its use, and it will be interesting to see.

With hospital discharge data, that’s the only thing I can look back far enough to say. We had the same questions with hospital discharge data, and there were some predictions in my agency in Utah that we would have like a three-year run until our first sunset review and then the funding would dry up. It is a core dataset in the state of Utah today, in a state that is fairly conservative and has a tight budget. I don’t think the stakeholders would allow that dataset to go away, so it has been, since 1991, a continuous source of population-based morbidity data.

I don’t know for sure; my hope is that we are five, ten years out in saying that a bare bones APCD is a core dataset for states to look at the performance of their healthcare delivery system, because I don’t know what else there is out there.

The second question is a little tougher. The provider directories — States and vendors are working with the plans to upload those provider files. I know that some of them are doing that quarterly, refreshing quarterly.

There is attribution methodology being developed. We will have some conversations next month with some vendors who have worked out some solutions for the attribution that could be replicated and used across states. There’s a great deal of interest in it. It is very difficult to do. This also is not a real time negotiated data base use like industry uses it. I look at it more as a population-based retrospective dataset that’s cleaned, validated.

This gets back to the argument of timeliness. What’s the purpose of the data and what are we trying to do? If it’s to look at the health of the healthcare system, look at the variation, look at improvements and evaluate programs, I want cleaner data and I’ll sacrifice timeliness.

The states, most of them. if they’re doing the technical build the way that we write about — We have a manual, West Health put a manual on APCDCouncil.org. We were funded by West Health to sort of compile all of the lessons learned on the technical build, the analytics, the stakeholder engagement, and we have worksheets. It’s a manual and a guide for states developing an all payer claims database.

If they’re doing this right, they’re not just taking data in and spewing it out. They’re going back — and this is where the payers probably don’t like it very much, but they’re looking at the data feeds and they’re giving carrier feedback reports and leaning on the carriers. This is a compliance issue. So, working with carriers to come into compliance on fields that are missing or dirty. It’s a tedious process but an important one that then, when the data are released and reported on like some of the examples I used, data quality is not the key issue. They are not fighting over data quality; they’re fighting over maybe the results and other things. But data quality should not be the primary argument.

So, timeliness and data quality are trade-offs, to be honest. It depends on the purpose of what the dataset is being used for.

MR. SOONTHORNSIMA: The point is the use cases have to be defined appropriate to the fact that the data is going to be stale.

MS. LOVE: Yes.

MR. SOONTHORNSIMA: So I assume that each state has a set of use cases, and how effectively they will use the data for that type of consumption is really my question.

MS. LOVE: Again, they will tier it for the early years to be regional reports, regional variation, Dartmouth type views of the data, population-based views of the data, prevalence in publicly versus privately and the chronically ill. Chronically ill, I have some statistics out of a Minnesota report, are astoundingly the most expensive. You know, those with chronic conditions, and looking at where they’re enrolled and their care profiles. So it will be used in a more global way.

When you get down to pricing and clinic levels, it takes a level of sophistication and having that attribution down, and you still aren’t using it for negotiating contracts or looking at real time —

MR. SOONTHORNSIMA: They should already have their own data to do that. They don’t need any —

MS. LOVE: Right. This is really a system-wide view. It’s a wide angle lens on the system, to put it bluntly.

DR. SUAREZ: We’re past the time now by 15 minutes so I’m going to ask you to be very concise. We do have five or six more people with questions. We’re going to start with Alix, then Helga, then Vickie, then to Mike and then Nick.

MS. GOSS: I’m going to change my question to punt to this afternoon — to make you all really excited — and the conversation about the Standards Subcommittee work plan because I think we have to make some choices about where does APCD fall in the realm. We have had public health standards and vital standards as being something we want to look at. APCDs we also want to look at. So I think we need to have a big discussion about that this afternoon so we have both sides of the coin so we can figure out how to prioritize our workload. That was my one comment.

The other point that I will also punt on, but I do want to talk about claims isn’t good enough. I realize we just want to get to the point where we can use claims to get to something of good data quality, and I think health information exchanges can really help you with the attribute issue that you noted, but I think we have to start looking at how does clinical data fit into this big mix of claims data.

MS. LOVE: That’s something the committee can really help the states with.

MS. GOSS: Yes. I’m hoping you can, too.

DR. RIPPEN: I have one comment and a question with regard to some of the all payer claims databases. The challenge sometimes is around outpatient care, also, because it tends to be a lot more expensive to get.

But I guess in the backdrop of Bill’s talk about time lines and where everything fits, and we think about accountable care organizations, different payment models, so now, when you start thinking about the concept of an all payer claims database and claims that may change with regards to what data gets collected, where does that fit in? If you’re talking about a 10-year horizon, where does that overlap with a different way of paying for something, and what does that mean? And there’s a difference between true cost or cost-plus and a charge. So I think there are a lot of different nuances.

Also in the backdrop of things like PCORnet, all these data warehouses that are popping up left and right for all these different things, HIEs that are now looking at sustainability and what does that mean about data. There are a lot of interesting questions.

MS. LOVE: I just want to clarify because I didn’t have the slide that showed the data elements. What makes the all payer claims database unique from the hospital discharge databases and similar databases is we do have the paid amounts charged, allowed and paid, which is unique, and for the outpatient. It provides a broader view and the financial.

DR. MAYS: There are a couple of comments I just want to build on. I think that part of what we need to struggle with is educating the states, for example, about what they can do. We’re almost jumping to what is perfect, and I think at this point things like how to deal with some of the privacy issues about why data can’t be released down to certain levels and why it can’t be linked and used, some of it is outdated or there are overly protective privacy rules.

I think when we start thinking about some of the other issues about for what use — and I agree with what Alix said about people want the clinical. Claims okay, but they want some of the clinical because that’s what people see as really helping them.

So I think the committee — Going back to what Bruce said like what would you want to see in a hearing, I think there are some things that we could help to just jump start the states with by introducing them to what’s going on and how to use data warehouses and what have you. I think we really have to have a very involved discussion about where we would want to go with this, but in the interim, I think it’s to put information out there to help some states who do have the resources to move ahead and be able to do that.

DR. O’GRADY: A couple of points or questions. In terms of thinking of this from the Secretary’s point of view, you talked about a CMS role in terms of providing data to the states. What is the best business case for CMS in terms of what would they get out of this? Is there a chance for basically a national database at some point that they could use for managing Medicare?

MS. LOVE: We tried that. This gets into a philosophy and probably a debate which we don’t have time for. Yes, CMS has an interest in the state all payer claims databases because the states could be giving back more to CMS because we have the under-65 populations, and the states can start saying this is what we’re seeing; this is what’s hitting you, Medicare, in two or three years. So, some analytics and algorithms, predictive analytics. I think CMS could benefit greatly to see what is out there in the states. That’s one thing that we could do which probably we aren’t doing

And then the CMS physician-level data releases have been huge as a boon for states, because if they can follow that template for the all payer, then we have a broader view and it gives CMS some cover, too, so they aren’t just the only people out there reporting physician-level experience but the states are as well, so, harmonizing some of that. With Medicaid populations there’s quite a bit for a Medicaid partnership with the state data agency with the authority to collect system-wide data.

DR. O’GRADY: But at this point they’re providers of data; they’re not clients of data at this point.

MS. LOVE: In many states they are both. Medicaid is a provider of the data. Medicaid also is a contractor for analytics —

DR. O’GRADY: I meant CMS in terms of federal CMS, where you’re talking about federal data policy —

MS. LOVE: I think Nile has tweaked me a few times on that, that we could be giving back more to him, so that would be great. That would be a vision that we should work towards.

DR. O’GRADY: I was thinking in terms of our portfolio of issues to work on, if there is something like that.

MS. LOVE: It would be important I think for Medicare to see at least the prevalence of the 55 to 65-year olds.

DR. O’GRADY: Yes. One other point just in terms of thinking about this, again, from what should the Secretary be thinking about. When you brought it up before about the Supreme Court and the ERISA preemptions and what not, I can sort of see how the employers would say I don’t know that we want to — even if we have no problem with you on data, this may be a Rubicon we’re not ready to cross.

But the other aspect — when you’re talking to lawyers — is part of this has to do with federal preemption over a state law, so the idea is ERISA is federal legislation. Should the Secretary be talking to the Secretary of Labor and say how about you promulgate Regs about data sharing for ERISA-covered plans? Or is there need for legislation? You know, start that sort of process.

In effect, if their main point is we don’t want to start paying state premium taxes or get benefits mandated, which they certainly have an argument for, is this just another way around to get something less controversial like their data? They get something out of that, too. Whereas, in the other two examples they really get nothing out of it except having to pay more taxes.

MS. LOVE: A lot of states are getting ERISA data, so it’s just — Liberty Mutual seemed to take it all the way. But it is an important conversation and I think Department of Labor did write a letter in support. I don’t know if second circuit — But I think it is an important issue because, again, if we have employers paying for and responsible for a big chunk and a growing chunk of our population, to segment that out of our information systems makes no sense to me from a policy standpoint. But in a lot of states employers are not making an issue of it, so it’s a mixed bag.

DR. O’GRADY: Right. Have you worked with — there’s the organization that Kaiser and United and CCI — how do you coordinate with them? Is that usable or not?

MS. LOVE: It depends, again. What are you going to use it for? If it’s national benchmarks and some national statistics, they have a lot of covered lives and a lot of data. But if you’re working in the state of New Mexico or Utah or others, I don’t know what their percent of coverage of sample would be — less than 2 percent? That’s one thing, is the sample size. They are for-payers.

DR. O’GRADY: Right, but aren’t they for the five largest payers in the country?

MS. LOVE: If you’re in Utah you have Blue Cross and IHC. That’s one issue. And these are, again, philosophy issues that are very deep and I have been in conversations with states for hours on this.

Data are collected locally, improved locally and used locally, so when the stakeholders have ownership of that dataset — This is our community dataset that is transparent; they understand it, and they see huge variations like in Colorado with orthopedic procedures in Summit County that are like four times what they are in Denver. It creates some heartfelt discussions that are local. So local data is important to that discussion.

Again, it gets back to what the purpose of the data system is being designed for.

MR. COUSSOULE: I happen to be on the Tennessee Health Information Committee which is the governing body for the state all payer claims database and have been since it started a number of years ago. I do think this is a ripe topic for the Secretary to take up for several different reasons. I think Michael hit on a few of them.

If you look at this from a payer perspective first — We operate in Tennessee primarily but we get calls from every other state that has an all payer claims database because some of our members have received services in other states. So, every single payer could now be dealing with 50 or more different variants of this, all different kinds of datasets for different use cases meaning different kinds of data, different timing requirements, et cetera. So the sheer magnitude of trying to make this work on a national scale is pretty daunting.

And then each state has defined different rules and regulations for what they’re going to collect, how they’re going to collect it and how the data is going to be used which creates a different regulatory burden on the payer side. I think the ability to take what I assume is all very well intentioned by each state trying to do certain things that make sense for them, and trying to do this 50 different ways at different times and different paths is really going to be pretty difficult for anybody to live up to.

MS. LOVE: Nick, if it’s any consolation, you’ve got three or four of us on the front line trying to keep that from happening, but it’s just three or four of us on the front line. We work really hard to try and align those formats when they go into data submission guides and rules, but, again, I’m asking if we can get more support and more help that will just help you.

MR. COUSSOULE: But if we talk about things like we were talking earlier, even from the administrative simplification process, how do you create some standards that can be leveraged and utilized? This is the exact same issue. It’s just done 50 different ways by design and not necessarily just kind of grown up once.

So I think it is an opportunity. Whether the timing is right or whether it fits into the priorities is a different question, but I do think it’s a topic that the Secretary could certainly weigh in on.

MS. LOVE: Yes. And I honestly thought in 2003, 2004, 2005, 2006 that these would go away, and I’m here in 2016 and I’ve got three or four more states in the gate. It’s both daunting and exciting. Again, I appreciate all the help that the committee can bring to the conversation.

DR. SUAREZ: Thank you so much, Denise. This was a very good and very important topic, as will be the next topic that we have.

We want to hear about the proposed changes to the rules governing the confidentiality of substance use disorder. We saw a formal publication of a proposed rule to modify the current regulations around handling of substance use disorder records, so the floor is all yours, Kate.

Agenda Item: Update on Proposed Changes to the Rules Governing the Confidentiality of Substance Use Disorder Records

MS. TIPPING: Thanks so much. As you mentioned, SAMHSA did publish a Notice of Proposed Rulemaking in the Federal Register last Tuesday. I’m just going to give some background on the current regulations and then I can give an overview of some of the high level proposed changes that we’re including in the proposed rule.

The confidentiality of alcohol and drug abuse patient records regulations, 42 CFR Part 2, implements the federal drug and alcohol confidentiality law, which states that it protects the confidentiality of the identity, diagnosis, prognosis or treatment of any patient records maintained in connection with the performance of any federally-assisted program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation or research.

The law and regulations were written during a time when there was great concern about the potential use of someone’s substance use disorder information against the individual. And the purpose of the regulations is to ensure that a patient that goes to receive treatment for a substance use disorder in a Part 2 program is not made more vulnerable than an individual with a substance use disorder who does not seek treatment.

The current regulations apply to any federally-assisted alcohol and drug abuse program, and in the current regulations, both federally-assisted and program are defined terms. The general rule is that patient consent must be obtained before sharing this Part 2 information from a covered program. Also included is a prohibition on re-disclosure, so once this information has been disclosed, no re-disclosure is permitted without the patient’s express consent.

There are a number of exceptions with 42 CFR Part 2 including — and this is an exception meaning that you would not need to obtain patient consent in these circumstances — for medical emergencies, for research purposes, audit or evaluation, child abuse reporting, crimes on the program premises or against program personnel, if there’s a court order or communications with a qualified service organization, which is similar to a business associate under HIPAA.

Why is SAMHSA looking to revise the regulations now? The regulations were first promulgated when the law was enacted in 1975 but they were last substantively updated in 1987, and since that time, as you know, there have been significant changes that have impacted the way healthcare is delivered. There are new models of integrated care that rely on information-sharing to support the coordination of patient care, an electronic infrastructure and a new focus on performance measurement. Also, the way research has been carried out. There are a number of issues with the current regulations.

The Part 2 regulations are more stringent than the HIPAA privacy rules, and there are a number of reasons why there are these extra protections for the Part 2 information. Even though the current regulations themselves are outdated, there is still a need for them. A breach can still lead to civil and criminal consequences for the patient, including if their information was breached it could lead to loss of employment, housing, child custody, discrimination by medical professionals, there could be arrests or prosecution and sometimes incarceration. So SAMHSA’s goal in revising the regulations was to try to modernize the regulations and make them more understandable and less burdensome.

When we started the process of trying to analyze the regulations and trying to modernize them to fit within today’s healthcare system, we initially held a public listening session back in June of 2014 and we highlighted a number of areas where we were actually proposing to make some changes to in the NPRM. In that listening session we received over 700 comments.

In addition to reviewing all the comments we had received from the public listening session we also collaborated with our federal partners in developing the NPRM. As I mentioned, it was published last Tuesday. The public comment period is open for 60 days. Comments must be received by April 11, 2016.

I’m just going to give an overview of the highlights or major provisions of what we’re proposing changes to. The goal, again, is to modernize the Part 2 regulations to try to facilitate information exchange of substance abuse disorder information and also balance that with protecting the privacy of individuals with substance abuse disorders.

The first provision is the applicable, so who does 42 CFR Part 2 apply to. For this proposed change, we revised the definition of program within the regulations so that it does not apply to either general medical facilities or general medical practices in certain circumstances.

Currently, the definition of program includes three prongs. The first prong is an individual or entity other than a general medical facility that holds itself out as providing and provides substance abuse disorder diagnosis, treatment or referral for treatment. The second prong would be a unit within a general medical facility that holds itself out as providing and provides substance use disorder diagnosis, treatment or referral for treatment. And the third prong is medical personnel within a general medical facility whose primary function is for the provision of substance abuse disorder diagnosis, treatment or referral for treatment.

So, in the current regulations it just refers to either the inclusion or the exclusion of general medical facilities, and the proposed change was basically to include both general medical facilities and general medical practices.

The next change is with regard to the consent requirements. We’re proposing to allow in certain circumstances a patient to include a general designation in the “to whom” section of the consent form. Currently, the “to whom” section of the consent is very specific where you really need to list the provider’s name or the name of the organization. We know a number of the HIEs and ACOs are having issues with complying with this specific provision so we proposed to allow for a general designation where someone could list New York HIE and all their treating providers. But with that there needs to be an established treating provider relationship between the provider and the patient.

We are also seeking comments on an alternative approach in which we are not proposing to change the language in the “to whom” section but to seek comment on how the term organization could be defined.

To balance the increased flexibility that we’re proposing to allow for, in the consent requirements we propose to add a requirement that the patients, upon their request, could request to have a list of the entities to whom their information was disclosed if they used the general designation, and we’re calling that section the list of disclosures.

The next provision with regard to changes is we tried to address some of the issues folks have been having with the research provision. Currently, under the research provision it’s only the Part 2 program director that has the authority to release Part 2 data for scientific research purposes. What we’re proposing is to allow for any lawful holder of Part 2 information to disclose the information to researchers for scientific research purposes as long as they meet other certain requirements for existing protections for human subject research. So, if they’re a HIPAA-covered entity, if they meet the requirements under HIPAA, or if they’re subject to the common rule, if they meet the requirements under the common rule.

Also, within the research section we’re proposing to address data linkages to enable researchers that hold Part 2 data to link to datasets from other federal data repositories. In the proposal we limit it to federal data repositories, but because we are aware of the requirements that some of the federal repositories need to comply with, we’re also seeking public comment on expanding the data linkages section to datasets from non-federal data repositories, so we ask a number of questions in that area.

The next one is on audit and evaluation. We’re proposing to allow for an auditor evaluation necessary to meet the requirements of a CMS-regulated accountable care organization or similar CMS-regulator organizations to disclose information in order for these auditor evaluations that are required by CMS to occur and to include the Part 2 information.

Here is just the information for when public comments are due. It’s open for 60 days, due April 11th.

That’s just kind of a high-level overview of what we’re proposing but the actual rule itself is 144 pages, so more complex than that.

DR. SUAREZ: Thank you, Kate. I know there are a lot of organizations actively reviewing this. I have been engaged in a number of those. Normally, I think the national committee as an advisory committee does not really provide comments on regulations. I don’t think we have done that necessarily in the past. I might be forgetting maybe one or two occasions that we did that but generally we don’t. But we do have the ability. We have done that? Okay.

So this is something — Rachel is here from the Office for Civil Rights and the lead of our Privacy and Security Subcommittee which will be meeting tomorrow morning, and we will have a chance to discuss this in terms of interest in developing comments. If we were to do that, we would certainly have to move quickly to allow us to comment on this and review and develop a letter and get it approved, and the national committee will have some discussion about it, of course, so it will be a bit of a challenging sequence of activities if we were to do it. But we certainly can, and we will have a chance to talk more about tomorrow. We can say a few things about that today if we want to.

I want to see if there are any questions for Kate with respect to the proposed changes. Let’s start with Denise.

MS. LOVE: Thank you for that overview. That was very good. I think my association, the National Association of Health Data Organizations, will submit comments. Maybe I missed it when I perused the Regs, but there was no mention of state agencies that are now collecting data and secondary administrative datasets. I just didn’t see that piece of it at all addressed, and maybe on purpose. I don’t know.

MS. TIPPING: You are right; we did not address that. We have heard a number of comments and that would definitely be something for consideration we would take as we review comments.

MS. LOVE: Okay, good. I’m just curious, on ACOs and HIEs, is it true they will not be able to access the data or the records unless the patient signs a consent? Is that correct?

MS. TIPPING: Yes. Unless they were able to fall within one of the exceptions a patient would need to consent to include their information within the HIE or the ACO.

MS. LOVE: The only concern I have is its impact on care coordination. That might be a problem but I would let probably the ACOs talk to that. But it seems to me that could leave some gaps.

DR. MAYS: Thanks for the presentation. It’s an area that many of us have been concerned about. I’m wondering if you could just say a little bit more about the research side and what some of the struggles are.

One of the things I know about that researchers have been concerned about is the ban on Medicare substance use data, particularly in terms of right now we’re struggling with this whole opioid epidemic. Can you talk a little about that and how that would be addressed?

MS. TIPPING: Sure. Some of the concerns, as you mentioned, were related to CMS not being able to release the Part 2-related information, the patient identifying information that was covered under Part 2. Part of the reason is because today, the current regulations state that it’s limited to the Part 2 program director who may release that data for those purposes. Given that CMS is not a Part 2 program or a Part 2 program director, they wouldn’t have authority to do so.

So, in our efforts in the proposed rule, we tried to it that so that any lawful holder of the information could release the information to qualified personnel for scientific research purposes if the researcher had met a number of requirements. That would give CMS the authority to release the data as long as the researcher met certain other requirements. That would, hopefully, address that part of the research challenge that has been going on.

DR. MAYS: As long as this doesn’t turn out to be an access — the ability to do it has to be in a data-secure center, et cetera, because right now, in terms of the opioid epidemic, people really need this data, and there are a couple of congressional people who I’m sure you’re very aware of who are demanding that.

Hopefully, in terms of what criteria have to be met, it will be kind of consistent with other ways we access Medicare data.

DR. SUAREZ: Are there any questions on the phone?

MS. MILAM: This is Sally Milam. Has the de- identification standard changed with the proposed regulations?

MS. TIPPING: No. The Part 2 regulations did not change any of the de-identification standards. In fact, the Part 2 regulations only apply to patient-identifiable data. So any information that would either directly or indirectly disclose that someone is a substance use disorder patient —

MS. MILAM: Right. There was some Part 2 and HIE guidance issued a couple years ago, so I didn’t know if you all brought that within the reg.

MS. TIPPING: You mean the frequently asked questions? Yes. The guidance will have to be updated, so for some of the FAQs that we had released we did add some more guidance into the preamble for the proposed rule, but then there are parts of it that may have changed. But the de-identification part we didn’t address in the proposed rule.

MS. MILAM: Okay, thank you.

DR. SUAREZ: Since we don’t have any other questions, thank you, Kate, again for joining us. Like I said, we will be looking into this topic tomorrow during our discussion with the Subcommittee on Privacy, Confidentiality and Security to determine if we would pursue reviewing and commenting on this, because we would have to put a schedule together and all that.

In the meantime, if you would like to call in to listen to that part, we start at 8:15 tomorrow morning and we’ll have until 10:00 for this meeting of the Subcommittee on Standards. You are welcome to join us as well, Kate. Thank you.

We’re going to take a break. If we can take a 10-minute break to try to catch up with our agenda and we’ll come back at 3:15 and we’ll start our Subcommittee on Population Health at 3:15.


Agenda Item: Subcommittee on Population Health – Action: Report Summary of November 17, 2015 Workshop

DR. SUAREZ: So we are going to start this Subcommittee on Population portion of our meeting. I remind people that this is still a full national committee meeting. This portion of the national committee meeting will be led by the Subcommittee on Populations. We are not – this is the way we are proceeding now. For a few of these meetings, we have done this. We are not adjourning as a full committee and moving into subcommittee meetings. We are continuing as a full committee. I am going to turn things to our two co-chairs of the Subcommittee on Population Health, Bill and Bruce. Thank you.

DR. STEAD: Thank you. We are going to tag team. Before we start, we want to share the fact that Kate Brett has joined us as our lead staff, probably the most important – maybe second most important – would you say a bit about yourself, Kate?

MS. BRETT: Sure. I am at the Office of Analysis and Epidemiology in NCHS. I actually started there quite a while ago as an epidemic intelligence service officer. In my spare time between hurricanes – actually, I was this close from having to go to Flint tonight, but I sent somebody else instead.

I have been working on indicator – on data dissemination indicators at NCHS for quite a while, starting with the Healthy Women, which morphed into Quick Data Online I think it is called now that is sponsored here by the Office on Women’s Health. I went to several others, ended up in the Health Data Interactive at NCHS. I am working on the Health Indicators Warehouse also at NCHS. I have been thinking about indicators and data dissemination for over 15 years.

DR. STEAD: Thank you. What we hope to do is briefly discuss the workshop report, which is on the agenda tomorrow for action. Then to spend the bulk of this block – get Parrish on the phone going over the environmental scan and close with an overview of our work plan for the year.

Just to refresh your memory about the report, which has been on your table here – it is also page 55 in the agenda book. It is a report of the event that took place in November. It is a summary of the event, itself, and the key discussion. It importantly does not include recommendations to the Secretary. All we are trying to do is get an accurate summary of what took place and key themes and next steps.

It went out – an earlier draft went out to both this full committee and to every participant at the meeting. We received back a few comments. The version that you had in the agenda packet reflects those comments. We hope it is essentially ready to go. This is a chance to raise any concerns or suggestions you would like to see corrected before we bring it back for the approval vote in the morning.

While you are getting your head together around that idea, I was going to walk you through the last page of the report, which is the roadmap. We were going to do this on the projection, but technology has intervened. You can look at the last page and what you have. It, in essence, reflects what we feel we learned in the process and the next steps that we are trying to move through.

Walk through the roadmap. The November workshop was the point at which we checked whether we had consensus with the core domains that were drafted as part of the process that Denise did. We came out with a yellow on our stoplight sign in that there was a clear consensus that we needed such a set of domains and that – it was, in fact, doable and would be actionable.

We needed to, first, as you see in the roadmap, do an environmental scan, then revise the draft framework, develop a draft menu of potential metrics that were accessible, estimable, or collectable at the sub-community level, then frame those or present that revision from different perspectives, a determinants perspective, a health equities perspective, a life course perspective. Then reconvene individuals from across federal sectors, many of whom – and the experts, many of whom were in the September event and see if we have consensus at that juncture. We are proposing to do that in September.

If we do have consensus at that juncture, in essence, you see in the roadmap that the National Committee begins to hand this process off to HHS and other federal agencies and public/private partnership as appropriate to carry out the next stages of this journey. That is, in essence, where we are.

At that point, I will stop. Any questions about that, in particular, if there are things you still feel need to be changed in the draft that you want to bring to our attention so that we can edit tonight before we bring it back in the morning? We hope we have already gotten that. That is the purpose of this slide.

DR. SUAREZ: Is there any comments or additions? Any questions for anyone?

MR. SCANLON: So Denise Koo worked closely with us. She has obviously seen this.

DR. COHEN: Yes, she has seen and reviewed copies of this – of the workshop report. She contributed edits. She has also been involved in the next activity, which I am going to describe, which is the environmental scan.

Gib, are you on the phone?

DR. PARRISH: Yes, I am here. Can you hear me?

DR. COHEN: Good. I am just going to introduce the environmental scan. It is up. Kate will advance the slides in a minute or two. First of all, I want to certainly acknowledge Susan, who did a phenomenal job putting this population health summary workshop report together. After the workshop, I didn’t have any idea how it would all come together. It was such a diffuse and overwhelming workshop. She did a phenomenal job. Thank you very much.

One of the key findings of the workshop was we needed more information. We needed to do a more thorough review of the indicator datasets and domains and variables and indices, particularly those available outside of the traditional health realm. We are very fortunate to get Gib Parrish to agree to do this environmental scan for us. The goal of the scan really is to provide us a firmer basis for the activities that Bill described and to build on Dr. Denise Koo’s work and move us forward for the fall workshop.

I have – after Gib’s presentation, I have several copies of the current draft of the environmental scan. I would like to collect all of these because we haven’t finalized these, but I would like to just pass them around so folks get a real feel for the tremendous breadth of work that Gib has done. Without further ado, Gib, I am turning it over to you.

Agenda Item: Subcommittee Update: Environmental Scan on Community-Level Measurement

DR. PARRISH: Thanks so much, Bruce. Thank you, Bill, also, for your introductory remark. Could you go to slide four please?

So I was asked by the population subcommittee to conduct an environmental scan. This slide is the two main purposes for that scan. One was to identify existing measurement frameworks or domains, indicators, and indicator datasets and as Bruce said, primary in the non-health sector. Secondarily, to the extent possible, to try to identify data sources for sub-county level measurement.

I just wanted to briefly go through my method. Basically, at the workshop in November, there were several suggestions. These are contained in appendix five of the draft report that Bill discussed. There were several suggestions of frameworks and indices that people thought should be followed up on and reviewed in the course of this project. I started with those. They were quite good, a very worthwhile place to start. They in turn led me to other indices and rankings. I discovered others completely out of the blue as I was proceeding. I was also asked in the course of my work to specifically identify any poverty and depravation indices and indicators, which I did. Finally, to look for at least some sector-specific indices and rankings to get a sense of what those might contribute to this effort.

Once I had compiled this mass of material, I then looked through it and was able to essentially group what I had identified – I found essentially 40 or so different kinds of indices, rankings, and indicator systems. I grouped those into these categories listed here: community and neighborhood indicators systems, well-being indices, poverty depravation and inequality indices, visibility metrics, health sector indices, and then non-health sector specific indices. I also categorized the domains that are used in these different indicator systems and indices using a subset of the most frequently used domains and what I found. This will become clear in a second when I show you some of the findings. Finally, I did also compile a list of sources of sub-county level data that I had identified during the course of my scan.

This is the beginning of what I found. There is a section in the briefing book that has four different lists that I am going to show you. I am not sure what page that is because I don’t have the briefing book in front of me. Bruce, could you direct people to the appropriate place in the briefing book?

DR. COHEN: 89.

DR. PARRISH: Great. Thank you. I am going to go through this actually quite quickly. These are essentially the names of the indicator systems and indices that I found. I located and reviewed in detail 10 community and neighborhood indicator systems. Suffice it to say that there are literally tens if not hundreds more of these kinds of systems. This list of ten is simply sort of a representative sample of those.

I located a number of well-being indices and selected these four as, again, representatives of that group. I identified nine poverty, depravation, or inequality indices. These are listed here. A number of these come from the United Nations development program. I have indicated that. Those are actually quite brief indices consisting usually of only two or three domains.

There is a short continuation here of the poverty indices. There are five visibility metrics, indices, and rankings listed here, the last three of which are essentially on the internet as sort of either private or non-profit ventures. These may be familiar to some of you if you have ever looked for a place you want to move to in the United States. The best places to live, for example, is an example of that.

I also looked at two sector-specific indices. One is the leading economic index. This is essentially a candid leading economic indicators that people are familiar with, also the environmental quality index, which the EPA maintains.

Although not in my original charge, Bruce, Bill, Rebecca, and Kate suggested that it would be useful if I also compiled a list of health sector indices. Those are listed here. Several of these – not all of them, but several of these were, in fact, reviewed by Denise when she put together her list that was reviewed during the November meeting.

The next thing I did is with all of those, roughly, again, 40 of those indicator systems and indices, I then within each of those sort of broad categories, I put together a set of summary tables that listed the particular indicator system and my extract of either the domains or whatever they are called, sort of the categories that were used to organize the particular indicator system, index, or ranking. This slide here gives an idea of what that particular effort was like. I have – there are five other tables that summarize these materials for each of those areas. I won’t read through these, but you can see that there is a variety of different domain names that have been used. Many of them are very similar, although slightly different in their wording. We will get to that in just a minute. Again, I did this kind of a summary table for all of the different systems that I identified.

Then I took all of those domain names, if you will, and compiled those into a single list. That is actually contained in the briefing book as table number three. Again, I don’t know the exact page. This is just the top of that table that is on – in the briefing book. Particular domain names that were mentioned most frequently, actually twice or more, are highlighted in light green here. They are also highlighted in the material in your briefing book. That gives you a sense of sort of the different domain – at least domain names that have been used in these various indicator systems, indices, and rankings.

This brief table simply pulls out of that last table that I showed you those domain names that were used four or more times. You can see here there are roughly 15 or 16 of those. Some of these were used quite frequently, for example, education, environment, health, housing were very commonly used as domains for these different systems.

Having done all of that, I then – this is, again, in the briefing book, table number four – I then took those most commonly seen domains that I showed you on the left and tried to array under each of those names, other domain names that are used in the different systems and indices. For example, here, I will mention one example here. Arts and culture, it was referred to as arts and leisure in one, arts, culture, and recreation, arts, recreation, and cultural life.

In the third column of this particular table, I have just raised a number of issues or questions in terms of what is the most appropriate name that might be used for one of these domains, do some of these domains make sense as free standing domains to use. Basically one of the things I found is that the breadth of domains is actually in the non-health sectors, far greater than the breadth that was discussed during the November meeting. They really cover the waterfront, if you will. A number of the issues and questions relate to how broad should things be? At what level should we be looking at domains, et cetera?

Then finally, in terms of background work that I did, for each one of the indicator systems, indices, or rankings, I again used the list of sort of common domain names, which is on the left hand column here. I tried to indicate as best I could for each of the individual systems whether or not they had domains that corresponded to those on the left. I used subjective judgment in this regard. Again, this is just one of five tables that shows particular systems and sort of how they are aligned. For example, these particular community indicator systems actually cover a lot of those domains on the left. Although if you look down towards the bottom, relatively few covered both capital and cohesion or social service, by way of example.

Next I just wanted to sort of summarize some of my observations. First of all, in terms of the development of these particular systems or indices, it varied a lot. Some of them were actually grassroots efforts coming from communities or local organizations versus many which are sort of national in scope from expert panels, universities, or national or international organizations. I think that is an important distinction. You have a group which are really locally based coming out of typically local needs versus much more large-scale efforts, typically national, which are used actually fundamentally for different purposes, I would say, than most of the local efforts are.

Next, the input, who participated in developing these. There often were experts that were the principle groups that put a particular system together versus community members were either involved in roundtables, focus groups, or in some cases there were community-wide surveys to get their input on what they thought might make the most sense in terms of a particular system.

I wanted to highlight some pivotal work that has been done by the National Neighborhood Indicators Partnership, which is part of the Urban Institute. They started work back in the mid-1990s, working with what is now roughly 30-35 different urban areas and trying to support those groups in terms of putting together information systems and indicator systems that could be used locally for various kinds of purposes. They have a number of very helpful materials on their website, things that have been published in the course of their work. They have also done some interesting surveys of their participating urban areas in terms of what datasets are used for local indicators, many of which are at the sub-county level.

I also want to mention the community indicators consortium. Many of you may be familiar with this. It is basically almost a clearinghouse, which gets lists of community indicator systems. These number in the hundreds. They try to at least make these available so other people can look at them. There is typically an annual conference that is held where people can get together working on these systems to exchange ideas, best practices, et cetera.

In a recent collaboration between EPA, HUD, and DOT on livability principles – and they have published a set of those, which are listed in my – in the draft report so far. It might be interesting to see how HHS could possibly collaborate with those groups on some of this work.

The next thing and I alluded to this briefly as I was talking a bit about what I had found, terminology is a bit of an issue here. We have tended to use the word domain, but there are a number of other words used for that, including category, domain, topic, sector, dimension, component, theme, area, and priority. I tried my best to pull out the things that seemed reasonable in terms of domains and put them together. Just be aware that in some cases, the actual systems or indices on which I based this did not use the word domain to describe what I have listed as a domain. Finally, a lot of these systems also have – at a lower level, typically, of something that can be quantified, indicators, benchmarks, measures, metrics, variables. Again, the terminology differs in terms of what they call a particular thing.

Another thing, in terms of the conceptual level domains, these sort of range from the global to specific, all the way from something like a domain might be well-being all the way down to something like receipt of means-tested benefit. I want to compare and contrast sort of what was reviewed during the November meeting, which I would consider to be at a lower, more specific level in terms of a set of domains, than I would say most of what I found, particularly as I looked at the non-health sector domain, which tended to be at a higher level, I would say, in terms of a more general, less granular, less specific.

The next thing is that in a number of the different indicator systems or indices, the same indicator – I am saying indicator here, not domain – but the same indicator might actually be included under more than one domain. For example, percent of population with a high school diploma in one particular indicator system might be listed both under education, under demographics domain, as well as under workforce and economy domain. That is – just be aware of that. People sometimes put them in more than one place. You may see the same indicator utilized more than once in a given system.

Finally, this is to contrast what I found in terms of the use of these particular systems and indices. Many of these were developed to produce essentially a single numeric value, in other words and index or a ranking for a particular, mainly geographic area or type of jurisdiction. If you will, they were generating a summary measure. Whereas, most of the community and neighborhood indicator systems do not do that. They actually are using individual indicators within their domain to track specific items within the urban area or whatever. That is, again, a contrast between some of these indices versus some of the indicator systems.

Just quickly, this is a list of some of these sub-county level data that were identified in the course of my work. Some of this came from publications by the Urban Institute. I have also listed the American Community Survey and, of course, the Decennial Census, which are frequently used by local areas and communities for their work. You can see there is a variety of different kinds of local data systems that communities have tapped into to get data to track various aspects of their community life.

I list here the American Community Survey because, again, it is probably the one national-level data system which is used most frequently by systems that provide community and sub-county level data. This is actually a listing of the main, if you will, topic areas in the 2015 survey. It really covers a lot of material. I think it should be very seriously considered in the course of the deliberations of the subcommittee and committee as certainly a principle data source that can be used for domains and indicators.

That is essentially what I found. This is a brief list of the next steps that we hope to accomplish to complete the environmental scan. We want to compile and compare methods for calculating some of the selected indices and rankings, including any weighting schemes. Again, this was requested by some of the people who wrote in for suggestions with what the environmental scan should accomplish. We will try to identify some additional sources of sub-county level data if possible.

Once we have done all of this work and based on the work that has been done, we hope to develop a revised set of domains with examples of indicators and metrics and data sources for each of those domains for consideration by all of you. That is the end of my presentation. I am trying to make this relatively quick so there is time for some discussion.

DR. COHEN: Thanks, Gib. That was great. Questions or comments for Gib? I hope all of you have had a brief chance to look at his full draft report. It is a pretty astounding document. After we work on it to complete the tasks, it will be ready for, I think, final release and sharing in mid-March, I believe. That is our goal.

The question is, for us, where do we go from here? Given the initial workshop and Gib’s work, I think our goals are really to build on this existing work to make recommendations to the Secretary to support HHS’s role in data collection activities and collaboration with other federal agencies to promote the use of these domains and indicator datasets by communities. Gib talked briefly about what that process will look like, doing a little more work around getting more consensus about the domains, figuring out some examples or exemplars of indicators and metrics that populate these domains, and then really thinking about the issue of measurability at the community level, at the small geographic level or the population subgroup level. That is where we see us moving over the next six months in order to prepare for the workshop in the fall.

Do either of you two want to add before I turn it over to general discussion? Vicki?

DR. MAYS: Gib has done an incredible job. What I am trying to understand is what is the committee’s space in this? Some of this we have seen. HHS has actually had IOM hearings or committees on coming up with indicators. There is a lot of indicator work that is out there.

Part of what I am – I can tell you what some of the criticism of the indicator work is from the perspective of communities of color. They have been that these are very standard ways of looking at their lives that don’t fit. When I was looking through, I was trying to find some of the gendered issues here. I was trying to find like – if you took something like right now, Black Lives Matter or you took something like the Occupation, the Wall Street Occupation, those things aren’t here. They are not there well enough I should say. They are not really kind of there as kind of like how are we going to do this differently, what is the cutting edge issue.

For example, HHS is really in the social determinants perspective. It is like then the indicators should really fit the social determinants perspective. I think the question is what is new or what is the committee’s space in this? I can see the collection. What I can’t see is like are we going to take like a life course perspective and make sure that we are cutting across and we are thinking about the elderly as much as we are thinking about the children? We have all the ACEs study that is out now. That, to me, is the kind of newer stuff that people are really trying to put onto these indicators as opposed to here are the indicators and here is the measurement. It really is the quality of life of the person. It is the things that the person brings that are unique that cause them not to have a productive life. I don’t see that perspective. I see kind of our traditional indicators perspective.

DR. COHEN: So what do you see the role of the committee doing to promote what needs to be done by HHS?

DR. MAYS: I guess what I was saying is that to me this seems like the traditional approach. The question is – I can tell you some of the work that is going on in this area where people are asking about using indicators and having a life course perspective, especially as a result of the ACEs study, the Adversity and Childhood Experiences Study.

The other thing that people are talking about is whether or not there are gendered, racial, sexual orientation, and class ways that you can have an indicator, but do they really capture that diversity so that it really reflects the variability of how that indicator works in the community. What would be the data point around social inclusion? The social inclusion data point in some communities would really have to be about all of these justice issues and how people are incarcerated and policies that end up taking away a person’s ability to vote. I think it is thinking a little differently about these. It is not just the HHS data, but will HHS, in order to look at health, bring some of these other things into the picture in order to really look at the quality of life?

DR. COHEN: This is like a six beer conversation. Since I don’t even have one — I guess Vicki, if you get a chance to look more thoroughly at some of what Gib did, he did review a lot of the depravation indices and some of the indices focused on some of the specific issues that you raised. I guess my feeling is we have to crawl before we walk before we run and just highlighting the notion that HHS needs to be in a broader space than looking at health care delivery systems and looking at indicators in the broader sense of quality of life is the place to begin before we can tackle some of those issues that you are raising.

DR. MAYS: I think Bill is so good at models and stuff. That is what we need. We need another kind of model.

DR. STEAD: I will point you sort of back to the roadmap a second. What we are hoping we can do is get a balanced set of domains that are at the right level. We did not feel that what we had in November was that. Gib’s work has brought to the fore deep information about things that were not included in the work that led up to November that I think covers the space you are talking about. I may or may not be right, but I believe so in terms of sources.

Now, the trick here is that we need to be able to show how each community could pick the set of metrics, maybe one from each domain – however works for what they are trying to do – to tackle things that they want to do from their perch, which we are going to explicitly take as the work that Gib has given us to pull from to be able to show what the – if you picked – how those domains and metrics look from a determinants perspective, a health equity perspective, and a life course perspective. We are actually going to try to show how you could use them to paint a picture from each of those perspectives.

We think – what we hope will be different – we are not trying to develop another set of indices. We are trying to draw from what exists, to give community tools to work with it, and in particular, our job is to identify the gaps in metrics, presentations, or tools that HHS could address in a way that would draw or align the work of multiple sectors to achieving HHS’ mission. In essence, that is what we are trying to do. You need to help us do that. What you are asking is right on target with where we are trying to go.

DR. MAYS: She just pointed out number seven on here. I just don’t understand.

DR. COHEN: To be continued.

DR. TIPPEN: Great job, just glancing at it. I want my copy. I am going back though and saying then, ultimately, going back to what is the purpose, if we are talking about data for communities to use, to address some of the health challenges, how does that crosswalk to determinants of health, and then the question of availability, too. Then if you start thinking about indices, one thing I have learned about indices is they are created by somebody for a purpose. Indices tend to have many different measures associated with them that may be perfectly calculated for one purpose and may not be for another.

Also, if you want to impact an index, how do you know which one has a bigger effect? Unfortunately, I don’t think we understand – we are not wise enough and don’t have enough experience to understand which measure or which thing may have a bigger impact on health than something else. When you have indices, there is a challenge.

I guess my only request really is that we look at indices in buckets and see what is available, yes, but we don’t start bundling things de facto. The question of what are the measures available, what can people use, and then maybe leverage indices as groupings – kind of what are the buckets and who has it. I have just seen indices that work in one state and don’t work in another state because of, to your point, some of the demographics and some of the nuances.

That is kind of my only request. Don’t forget what we are doing. What about availability? And an indices versus a measure until we are wise enough to know what it is that we need.

DR. COHEN: Thanks, Helga. That is a great point. We did talk about waiting on the domains, but we are nowhere near having the ability to do that. I don’t know whether – again, it was important to look, I think, at the entire scope of activities. Indices are one approach to measurement that we wanted to include.

DR. O’GRADY: When I think of this and the advantages it could provide, I am mostly focusing on kind of answering hard policy questions at HHS versus kind of academic pursuits. I guess one of the questions that came up with kind of your discussion about Black Lives Matter – so a good decade ago, we saw this thing about life expectancy and that it was lower among certain communities than it was in the general. Now, much of the debate that went on there was there were other things contributing. It was drunk driving. It was gun violence. It was things like that. HHS was pretty much ready to build more emergency rooms. It was sort of like I know that is the horse you ride, but that is not – you are not reducing gun violence. You are just making survivability of gun violence a little –

I guess in terms of this, I tend to think of this as an old kind of modeler in the econometrics – you are giving me variables so I can understand why a particular community or set of communities has more or less something. Some of those factors I can’t do anything about. I can’t do – northern Europeans are more vulnerable to Type I diabetes than almost anybody else. We are not going to tell northern Europeans to not be – or of northern European descent – we are not going to tell them they have to intermarry with other ethnic groups to reduce their Type I diabetes risk. There are these other things. That is going to explain a good part of the variation in Type I diabetes rates in different communities, et cetera, et cetera.

Some of that other stuff about diet and exercise and some of these things like gun violence and those sorts of things, are we helping these policymakers to be able to see a complete picture? I remember when we had that meeting, boy, the EPA was there. They were excited. I think even Justice was there. All of those guys, candidly, bless their heart, but the Justice guys are going to be there thinking gang taskforces. The EPA guys are going to be thinking super funds. That is the set of tools they have. I think you are headed towards that of this sort of practical ability to diagnose, whether it is at the community level or state level or the federal level and sort of say we need to bring a different mix of tools from the toolbox. Cleveland has a different problem than Buffalo. They look kind of alike. They are on the same lake. Otherwise, they are just different. I think you are providing that tool. I just wanted to check with you.

DR. STEAD: I think we are hoping to. This particular effort is really focused on what can be done from the perch of this committee, by HHS, to mobilize multisector action at the local level. There are different problems we have to tackle when we think about assembling the data to support decisions about HHS on national level policies. It is different than national level policies about what they need to do to help make sure we have the data for local action. That is one piece.

A second piece – I think we are going to have to figure out – it is little bit like we have – we are really going to have to develop a scenario that shows people how these domains look, feel, and are actionable from equity determinant, life course perspectives. That is one thing we actually have to do.

Second thing we have to do is to – we have to show how these domains work for Justice or Transportation for their priorities in a way that sums together for collective impact on health. They are not going to do them if it doesn’t first hit their own view from their own priorities. You have to help us with this.

DR. COHEN: I agree. I think the analogy you were using around tools – I think we are trying to help HHS develop toolkits for communities. That is really our goal here. Each community is going to define its building project differently. Some people are going to use screwdrivers and hammers. Other folks are going to use drills. As long as they see what is available in the toolbox, they will be able to build the project that they want. HHS has the resources to help create this toolbox for communities. I think that is what we are trying to do.

DR. PARRISH: Some interesting ideas have been put forward. Clearly important in terms of purpose of the project. I just want to highlight one thing that I mentioned before, which is the contrast with some of these systems that I have found between those which essentially started in communities – they are community-based – versus ones which are developed more at a national level, again, usually with very different purposes in mind. It is quite interesting if you go to that group of the community and neighborhood indicator systems – again, that is just a few of many of them out there – and you look at them carefully, it is like someone just said Cleveland is different than Buffalo. In fact, you get a sense of different communities and what they have come up with, given their own particular issues and problems, and they are often somewhat tailored to the different kinds of people in those communities.

Some of these locally-based systems are really quite interesting and quite – cover a lot of different things. They also have put – some of them have put together websites, which, in fact, allow individual community members to go in and look at different neighborhoods in the urban area, for example, and to really get a sense of the distribution within that urban area of different issues. They can look at this in terms of racial breakdowns, age breakdowns, and in some cases also socioeconomic breakdowns. I think it is worth looking at – as we proceed, looking at some of these in detail because I think they can provide good examples of what is possible out there.

DR. CORNELIUS: I would like to make a couple comments when you get the chance.

DR. COHEN: Please go ahead, Lee.

DR. CORNELIUS: I am just going to run through some quick comments. This is a very wonderful and rich discussion that we are having. I will just make three comments. One, there was a conversation – one of the comments was, for example, if we have EPA at the table and we are thinking about the issues of health, in essence, it sounds like we would be informing them regarding utility – I wrote down the phrase bidirectional. It really ends up being a two-way conversation. While we are talking about our knowledge-base, if those agencies are adapters of those indicators, then we have to do that dovetail. That is one comment.

The second issue gets into the piece of the variation of what happens in communities and use of information. One of the things we deal with is when we work with communities around them setting their priorities, they could use some similar indicators, but they may come up with their own set of priorities. Hence, you are not going to have uniformity across communities if you are really building from the community up in terms of their ownership.

The last comment deals with our discussions about indicators and not reinventing the wheel. Looking to the comments when Vickie was talking about the issue of social inclusion, just to say on the international level with the Afrobarometer and the Eurobarometer, they have indicators on there that look at some of these broader issues of inclusion, community participation and ownership. Our challenge will be to make sure that when we are talking about this within HHS that we still have our ear to the ground in terms, well, maybe there are these indicators that are really speaking to these things. They may not have been developed in the U.S. and are used in other countries.

DR. COHEN: Thanks, Lee. Gib did include – when we have a chance to circulate the full document for you to see, you will see some examples of some of the international indicators that he looked at. A variety of these kind of civic cohesion/social cohesion network measures do emerge.

MS. HINES: Because I think some people haven’t been involved in the day to day, I just want to emphasize that clearly there are, as Gib has demonstrated, hundreds of these efforts already out there. What is the role – what is the space for the committee?

We know, of course, that the federal role, in certain ways like automobile safety standards, can make a big difference. What I have gotten from the subcommittee leadership is so much of health happens actually on the ground in the community. What we have learned from talking to communities is they don’t have the data they need. They are winging it to some degree.

We know that the Health in All Policies approach, the social determinants, is the way to go. If there aren’t any sidewalks, which is obviously not HHS’ purview, is a big deal. We are trying to find a way to frame this so that it supports a multi-sectoral approach to health in a community. In order to do that, we have to say, well, what do the communities need? Well our role is to advise the Secretary. Clearly there are things in listening to communities that HHS and other federal departments aren’t doing what we could do. I think, in the end, that is what we are trying to identify.

We don’t need to come up with another indicator set just for this. There is a million of them out there or thousands. What we need to do is figure out from this intensive analysis, where are the gaps where the federal sector could really help out. What are the tools that we could provide so that communities with limited resources could actually – some of them already are, like through the Urban Institute, coming up with frameworks to do their own assessment, set their own priorities, and so forth.

Having been in federal data for a couple decades, I really do appreciate what is trying to be done here and see if we can identify – San Diego couldn’t believe they couldn’t get certain – I won’t name the agency, but all of this money is coming into their community from this particular HHS agency and they can’t find out how much and where. They had to do their own study. That seemed crazy. That, I think, is a lot of what this is about is to help inform HHS around what you, in partnership with other federal departments, can do to fill those gaps and tools to help communities so that when they are doing this work, which they already are, clearly, they don’t have to work so hard.

DR. MAYS: I just want to make two suggestions. Rebecca actually started kind of in one of the spaces that I wanted to talk about. That is whether or not we are ready to make comments about the kinds of things that HHS should do. For example, if we just talk about violence data, the National Death and Violence Reporting System, it doesn’t even cover the entire U.S. It is very political where it isn’t. Things like, for example, NIH puts money in communities all the time. Communities can’t find us half the time to say do you have these data, which we often could give them, the epidemiologic data.

There are things that I think we should be prepared. It is whether or not we want to do that that are sometimes not major changes, but simple changes or recommendations that would help give the community the kind of data it wants. That is one thing.

The second is what I think you also could benefit from in terms of this environmental scan, is the mashup data. Right now, the way in which coders come into cities and they work with the Department of Health and they mash data up in ways in which it really benefits the community. I will give you just one example. In San Francisco, the coders came in and they helped the Department of Public Health by actually putting where it is – they worked with Yelp. They got Yelp, for example, to put onto their site when it was that people had – well, for us, it is As and Bs. I don’t know what they have there. It is like restaurant ratings, reports of problems in terms of restaurants, food borne illness dropped like 20 something percent after Yelp started – after they mashed this data up and it was in Yelp. Restaurants were really clear that this stuff was now in Yelp. They were really good about keeping their ratings up and having less food-borne illnesses.

There is a lot of stuff in the mashup data that if you also could have kind of some environmental scan about that, coders will go and do it free. Coders of America come into cities and they help. They are given internships. They can actually help some of these cities to better utilize the data that they have with some of the social media stuff.

DR. COHEN: That is a great source that we haven’t really tapped. Maybe we can get with you later and get some suggestions about where we can begin looking for those kinds of data. That would be really helpful.

A couple more comments and then we have maybe three minutes to go through our work plan. Is that okay Walter?

DR. RIPPEN: Just a comment, as you kind of summarize the indices, it might be helpful to summarize the context, as far as how they were used and any insight into effectiveness if at all possible. If you are ready to do the survey, try to glean some outcomes with it.

DR. O’GRADY: I will just say it strikes me that in some of this, if you are successful, there will be this nice resources available to communities to analyze. I think we know that all communities are not equally capable. The one thing that is maybe outside our traditional purview, but there is certainly – and I don’t think you should sort of fine tune things and get the Department into a big – but an agency like AHRQ could develop a series of sort of whatever, 20 analyses that would cover most of the questions an area might have. They could be available to sort of say, all right, Bethlehem, PA, they don’t have analysts on staff. AHRQ kind of matches it up and says here are ten other cities that have your kind of matchup and similar characteristics in terms of income and racial/ethnic mix and things like that.

You can see kind of how you stand up next to them. If you have a question about how Syracuse handled it, then you can call Syracuse. The feds aren’t going to do that for you. I think you may – if this is going to be successful, we may have to build that second step into it that there is at least a first round analytic product that is also produced if especially the poorer cities are going to get any value.

DR. COHEN: Great point. We really do need to keep our eye on the prize. 35 years ago, when I worked for NCHS, I was involved in a series of publications called Statistical Notes for Health Planners, which was essentially taking the data from NCHS surveys and vital statistics and showing communities how to use the data in different situations. I think if we are going to be recommending data collection for any of these indicators than we really need to provide basic resources and cookbooks about how communities can do this. I don’t know whether we can get all of that done initially, but that certainly – I see that as a part of the solution.

We have three minutes to go through our work plan.

DR. STEAD: This shouldn’t surprise you, given what we have said so far. Basically, this sort of lays it out by quarter. We are now going to finish the environmental scan in the next little bit. We are then going to do a process, which Kate is going to lead for us, around how we draw from Gib’s work a next draft of what the domains might look like, how we assemble a first level menu of metrics that are examples so that we can test whether they could maybe work the way we are talking about, and we are going to line up the participants for the September workshop. That is going to be our major focus between now and June. In the June meeting, we hope to be able to go through an iteration of this with this committee.

We then will do a variety of vetting activities between June and say late August in which we try to get refinements in another iteration so that in the workshop that will be the day before the fall committee meeting in September, we will hopefully get a greenlight on the consensus lightbulb this time. That will then position us to draft the report of that and to develop recommendations for the Secretary that we would then deal with in the winter moving forward.

We are basically saying that we are going to focus the activity of the Population Health Workgroup on trying to bring this work to the point that NCVHS can hand it off to HHS and the appropriate other partners. At that point, we will be in a position to move forward to other priorities. That is what we are proposing as the work plan.

DR. SUAREZ: So we identify the process steps. We identify the products, such as the report. We identify the activities, such as workshops. I appreciate that. Thank you.

MR. LANDEN: I would just like to confirm my understanding that what the product of this is is going to be recommendations to the Secretary as distinct and opposed to actually building a toolkit for communities. If it is the latter, I am not sure we have enough steps in the work plan.

DR. STEAD: Absolutely. If you look at the roadmap again – so I draw your attention to that. What our product we hope will be is a revised draft and a representative menu of metrics and some communication scenarios about how this works from different perspectives, plus the specific recommendations to the Secretary as the actions HHS needs to take to do what it can do directly and in partnership to carry this forward for community action.

If you look at the roadmap, two-thirds or three-quarters of the roadmap is after our handoff.

MS. HINES: So if you look at the roadmap, this committee is saying up through nine. If we can get that consensus in September, then you see – it didn’t come out will, but at the top, it says public/private collaboration. Now we hand it over to HHS to work with all of these organizations to then take it from step 10 through onward.

DR. COHEN: My only additional comment is this is all very fluid and dynamic process. That is the end of this particular phase. That doesn’t mean we can’t be involved, I think, in making future recommendations about what that toolkit would look like. That is not included in our shorter-term scenarios for our work plan.

DR. MAYS: Are you going to include – we should be thinking about recommendations that are things HHS could do, not at the community level, but in terms of its own data?

DR. COHEN: Yes. I think it will be a combination of how it could strengthen – yes, obviously the data that it generates now and the data that it might be able to generate in the future.

Agenda Item: Subcommittee on Standards – 2016 Subcommittee Work Plan

MS. GOSS: So for the standards subcommittee meeting this afternoon, we had a couple objectives. The first one was to make sure we cover the work plan for the upcoming year. We also wanted to talk about Operating Rules Phase IV and attachments hearing. I think it would probably make a lot of sense for us to start with the overview.

Ob, I really appreciate you putting together a framework of themes and thoughts from yesterday. I propose that you could run us through that. That will hopefully inform some subsequent discussions on our work plan, including the APCD presentation from Denise.

MR. SOONTHORNSIMA: Thank you. In the interest of time, I am not going to give too much of a background of the operating rules. I think we talked about this in the fall last year, why we are doing this and the critical timeframe that we have to get the recommendation out.

In terms of what we are looking at, there are four transactions – four operating rules that we have to consider – enrollment/disenrollment 834, premium payment, health care claims, and lastly, prior authorization. At the end of the day yesterday, we also had a panel discussing attachment, which is another standard that has yet to be adopted. That number is 275. Over the next few slides, I am going to walk through what we covered during the operating rules discussion.

This came from CORE, CAQH CORE. It is a really nice slide that gives kind of the overall scope and the changes that would apply if we were to make the recommendations to proceed with these operating rules. Again, prior auth, claims, disenrollment/enrollment, and premium payment.

First of all, there are two key areas of the operating rules. The operating rules aren’t really focusing on content, but there has been a general consensus among the industry and stakeholders that CORE appropriately is focusing on – has been focusing on infrastructure and also connectivity. If you look at on the left hand side, there are different rows, in terms of process mode batch versus real-time, acknowledgement, and then connectivity and system availability and so forth.

You can read this on your own. The operating rules do not focus on content. I don’t think I need to get into details here. That just gives everybody the scope. Are there any questions before we jump?

MS. GOSS: People seem to be tracking with you.

DR. SOONTHORNSIMA: Let’s keep going. It is always great to be late in the day because you guys are ready to get out. I’m kidding.

So after yesterday’s hearing, we thought about what are some of the salient points that we heard? These may not be the only points. I would love for my colleagues in the room or on the call that participated yesterday – can chime in and see their or any other observation. One thing we heard is that there is a general agreement on the fact that acknowledgement is needed for all transactions. That reflects also in our review committee letter, one of the recommendations. They also agree that it is a good focus – that CORE is focusing on infrastructure – that is a good thing – and not content. In many regards, content is not ready to be discussed yet.

The second observation is that there is general opposition on using X.509, which is a certificate for an activity. Notably, Phase I, II, and III of the operating rules did not call for it. There was – for Phase I, II, and III, there was more flexibility. For Phase IV, there is a requirement for a certificate. General feedback was that this would create lots of additional costs. If this was to be built, it may not be used. The burden falls on the health plans and entities that have to implement 509. The option to use this remains open. In other words, if the trading partners are using the current method of user id/password and what not, they will continue to use that. There is a safe harbor rule built in.

I will pause here. Are there any other observations or comments? Alex, do you have any thoughts?

MS. GOSS: I think at this point, I need to go back through my notes. My head is so in the review committee letter I can’t – I am having a hard time remembering the eight hours on the WebEx yesterday. I will certainly go back through my notes. I am not seeing any disagreement from those who might have been in attendance yesterday. I know we can certainly evolve this after we have the chance to review the written testimony and get some –

MR. SOONTHORNSIMA: You’re right. Let’s keep going to your point. Let’s go to the next slide.

Specific to the various transactions – operating rules I should say – for claim and payment, there is general consensus that Standard 837 is widely adopted. Folks will question the value of the Operating Rule, whether this would add additional value, whether this would close any additional gap if there are any.

820 – I didn’t say it here – is not adopted generally. However, it is used for health insurance exchange – that is what HIX stands for – especially for the federal facilitated exchange. Going back to the second bullet point, enrollment 834 has low adoption among small groups. It is mostly used for large employer groups – health-insured groups. It is highly customized or the industry commercial plans tend to use an intermediary or third party to facilitate that 834 bid exchange. I might note that also 834 or HIX also vary among the states as well. There is a FFE, federally facilitated exchange, 834 with its own companion guide. Many states have their own companion guides as well.

Any other comments or other observations?

MR. COUSSOULE: Just one comment. I had forgotten about this yesterday. In the enrollment, some of the other bodies that are using it are state Medicaid agencies that are actually using it to feed information to the MCOs. I know that happens in Tennessee. It is happening in two other states that we are working with already. Not just the federal exchange.

DR. STEAD: This is Bill. In all the language I learned from the review committee, do you mean implementation in place of adoption on these slides?

MR. SOONTHORNSIMA: Yes. Bill, good job. Can you spell 837?

DR. STEAD: Not yet.

MR. SOONTHORNSIMA: Prior authorization – there is another general agreement that 278 is not adopted – or is not implemented or used widely. There is also a question of whether or not an operating rule would impact any adoption at all. The fact that there is no content rule generally, which is fine – so right now, if the OR is to be adopted, it is only going to be for infrastructure, connectivity, and acknowledgement. What value would that bring for the usage or wide adoption of 278?

The other point about prior auth is – this is consistent. This is in our recommendation for the Review Committee as well. We should approve recommendations already made in 2014 to use NCPDP Script Prior Authorization. That is prior authorization between the prescriber and PBM. Overwhelmingly, everybody agreed that the opportunity may be in the attachment standard, which is 275. I will pause here for any other comments.

MS. GOSS: I am not seeing any.

MR. SOONTHORNSIMA: You guys are really ready to get out of here.

Attachment, now we move on to the last part of the day yesterday. There was great collaboration – conversations across the panel and participants. There is general agreement that it is time to adopt – in fact, we are thinking about calling it something to do with the Suarez Standard. I don’t know.

We are thinking that this is time. Everybody said this is time. 275, as you all know, is not for claim alone – post-adjudication, quality data exchanges and what not. This specific call out to – since HL7 and X12 have collaborated, and LOINC – so there is already an alignment between the standards organization. More importantly, there is a good alignment with the meaningful use and the providers already adopting the EHR and so forth.

The way you can go about using 275 standard is when you align 277, which is a request for additional information for claim processing and 275, which is the attachment. Of course, it can also assist the 278, which is the prior authorization, as I talked about in a previous slide.

However, we also heard that there will be a significant learning curve for payers and providers, especially for the payers who are not very familiar with – who are not familiar with HL7 today. They don’t really use HL7 or LOINC. The providers also have some learning curves because there are some process changes that have to be accommodated to begin to leverage the attachment, extract the data from EHR, go through that process, and creating a 275.

There are some – I am not sure what I heard exactly, how many years. I put a timeline of three plus years for conceptually working this into the process. According to the feedback that we heard yesterday that 275 would work well with 6020 and 7030 – it is almost agnostic. I am not sure I heard that exactly. If others heard differently, I would love to hear your feedback.

MS. GOSS: It was really clear that there should be not any issue with moving forward with a 6020 version of a 275 or a 277 as it would work with version 7030. I specifically asked a question about would there be a cost because we now are suing different base versions of the standard. We are trying to address burden. What was this going to mean? They basically assured me there was no impact and it would be minimalistic challenges – costs depending upon how the provider had purchased any translator they may be using or would actually be embedded into the vendor costs.

MR. SOONTHORNSIMA: Another recommendation – the group feels that the sooner we adopt this – that way it will give a signal for the industry to prepare the vendor community and so forth.

As I listened yesterday, I started reflecting on one of our recommendations. I am going to shift gear for a little bit. When you look at our review committee recommendations, there was a recommendation 3.1 that states consider requiring operating rules, for example connectivity, be consolidated across transactions, including combining all phases in a single document to alleviate the need for industry to keep four different versions of a similar rule for different transactions. I wonder if now that we heard yesterday that there is lack of support for 509, lack of support for 278, lukewarm for 834, which is enrollment/disenrollment – this caused me to sort of rethink that a little bit.

MS. GOSS: He went from attachments back into Phase IV.

MR. SOONTHORNSIMA: Back to the review committee. Sorry guys, I can’t help – we have to make – we are trying to finalize our recommendations for tomorrow. That is why I am bringing that back since we are talking about the operating rule.

DR. SUAREZ: I think we are going to have to look at each of these transactions and look at each of the type of operating rules identified, then review the testimony to really get into generally which were agreeable and acceptable in terms of the value they provide and the appropriateness and all of those things. Then look at which ones people raised strong concerns or questions and make the determination. This would be part of the challenge, as a national committee, to really begin to evaluate this type of operating rules in a packet, but then unlocking the packet, if you will, and having to consider making recommendations of specific operating rules.

I think the point I wanted to make is really I think we heard strong concerns about the connectivity rule, which is the fifth row that says safe harbor connectivity and security. We heard strong concerns about that one. We heard some concerns about a couple of the other ones.

MS. GOSS: I think we also heard a philosophical difference of some people wanting to solidify some basic infrastructure rules and have those be able to be built upon versus other ones saying, yes, it actually is going to cause – people aren’t widely implementing these. It is going to add extra cost. It is really not necessarily going to give us the value we may be looking for. We did hear both sides of that coin yesterday about is it better to take a small bite at this and advance it incrementally starting with infrastructure before we get to maybe more business operating rules and content downstream or is it better to let things stabilize –

DR. SUAREZ: But all of these are infrastructure.

MS. GOSS: All of these are infrastructure, but there was pushback from a number of organizations saying we don’t need this right now. This is not going to really help. Those are the two different perspectives.

MR. SOONTHORNSIMA: That is exactly right. That is why I am bringing up the point for 3.1 – it is almost like we are advising the Secretary to consider the entire – all of these operating rules.

MS. GOSS: Ob, I am not tracking. When you say 3.1, what am I missing?

MR. SOONTHORNSIMA: I am sorry. I am going back to the review committee recommendation – the letter, itself. I am simply bringing this up because I see that might be in conflict with what we heard yesterday. That is all.

MS. GOSS: So I think that there is a lot of testimony that was given yesterday. Hopefully, we will be getting all of the written testimony. One of the things that I would ask is somebody who was not here yesterday, if I could actually obtain that written testimony, it would be very helpful. I am not sure – I am thinking Ob will need it as well.

DR. SUAREZ: Yes. We need all of the testimony.

MS. GOSS: Yes, but those who weren’t here in the room yesterday didn’t get all of the written testimony. That is my point.

DR. SUAREZ: Absolutely. All of the material that we got yesterday, we have to post them.

MS. LOHSE: I just wanted to make sure – I don’t know who is in the room. I apologize I am not there in person. There were over 100 entities that voted affirmatively on the entire Phase IV package. As the managing director for CORE, I would be remised to not represent them. These entities represent a large percent of the commercially insured. There is over 75 percent of the commercially insured, a number of federal agencies that voted to support this, a number of state-based Medicaid, as well as a wide range of vendors, providers, and clearinghouses. I know we heard from some associations yesterday, some individual companies, but there are actually quite a lot of entities that did support it. I just want to make sure that is clear. I am going to follow up. It is my job to – they put a lot of time and energy into voting. When you have 90 percent participation in a voting and 88 percent approval, if I didn’t say anything based on what I am hearing, I wouldn’t be doing them any favors after they put in all that work.

MS. GOSS: I appreciate that input. We know that yesterday you gave us a lot of those statistics. We know there was a lot of time and effort, as has been done in a lot of the standards development one. I think that is all factors that we will consider when we look at the whole testimony. That is why I was making the point about getting the written testimony and I think Walter was making the point about incremental – looking at each one of them and thinking through the process. If there is additional content from yesterday’s hearing, love to hear it, but would like to be able to move on to the work plan topic.

MS. LOHSE: I appreciate it. I just wanted to make sure you all knew about those that were there, which is a large majority of people. Thank you.

MS. GOSS: You’re welcome. Any other comments on yesterday’s hearing before we move onto the work plan?

MR. LANDEN: One observation is that there were a lot of grey areas, different assumptions being made, different testifiers wanting to use the outcome as leverage for or against something else that is not really directly related to the operating rules or the attachments. There are going to be some interesting policy decisions in here.

One of the things that we kind of touched on as Ob and Alex went through the presentation is there is one school of thought that says if we mandate it, it will start the process of accretion and building to meaningful implementation. Whereas, if we don’t mandate it, if HHS doesn’t mandate it, it is never going to start and we are never going to get there. The other argument that you also heard Ob and Alex described is why – if we mandate it, it is going to force different entities to build something that either will not ever be utilized or may not be well utilized for many years or many periods to come.

There are a lot of tradeoffs in here. I don’t see a clear outcome one way or the other. It is going to be a challenge, but something we have to do is to go through all of the testimony and then sort out and then make some hard choices for our recommendations.

MS. GOSS: Anything else on that before we move on? I think that is the right one. Hopefully, the folks on the phone can see the Draft Standard Subcommittee Review Committee Work Plan for 2016. I believe this is a PDF. Is that what we are looking at?

This is not the first time we have seen the work plan presented. I think I actually walked folks through a very early version last fall that had not had any vetting. I think it was in the September meeting. It was a very strawman at that point. Since that time, we have evolved a number of our thoughts from a whole NCVHS full committee perspective, but also from learning from our review committee and our standards subcommittee efforts.

What you see up on the screen is what we are proposing as a discussion tool for today so that we could come to an agreement on our priorities. Hopefully, this is going to hit the mark fairly closely. I suspect from earlier conversation today, we may want to talk specifically about the APCD timing.

What I thought would make sense was to walk through each of the quarters and see if there is any feedback on it, in particular the activities and workshops. We are already in Q1 in the review committee letter. We are morphing. We will bring an updated version tomorrow. Then we will have – this is our effort today to advance our specific work topics.

Moving into Q2, we had topics including public health standards and vital records. We are starting to work on any DSMO updates and planning for Q3. We also think that we will be, at this point, still advancing our review committee report, which will supplement the review committee letter that we will hopefully approve tomorrow. Also in Q2, we would advance a Phase IV operating rule recommendation and letter, as well as an Attachment Standard recommendation and letter. I think those are pretty high priorities for us to come to consensus on and get a letter into the full committee’s hands for approval.

Q3 would have us continuing a number of our efforts, but is where we would really step into doing the APCD work initially. Possibly if we have had some workshop in the prior quarter on public health, we would be able to advance some kind of a recommendation letter to the Secretary. As we have heard in the past, the need for standardization for public health data exchanges and vital records is pretty important.

Q4, wrapping up with our review committee efforts. Starting to look at what is in 2017. Possibly a workshop for additional administrative processes, such as provider enrollment. Maybe the output of that would be the APCD workshop, possibly a draft HIPAA report, which won’t be just this time a standards subcommittee activity, but because it includes so much privacy and security and confidentiality, it will be more of an overarching work product. In the past, Terri, as the staff lead, has done tremendous work on that. I would envision that we probably would leverage her depth of experience in producing our next congressional HIPAA report.

That is an overview of the four quarters. I am going to open it up for feedback and thoughts on how people would like to see this morph. Bruce.

DR. COHEN: I am very interested in pursuing public health standards, working on vital statistics. Not exactly – I think the best way to approach this is really get together with NAPSIS, Kelly Baker, I would say, and Trish Poterboski(phonetic) and with maybe Dalton and Charlie to sit down and talk with them. NAPSIS represents the jurisdictional point of view. Dalton and Charlie represent the NCHS point of view. They have ongoing meetings on several committees. One is called, Good to Great, which is focused on improving vital statistics enterprise. I think we should talk with them about what would be helpful from their perspectives, in terms of us trying to mobilize some activity to support, whether it is increasing timeliness or setting standards for the future for vital statistics or other issues around interjurisdictional exchange. I think that would be the way to begin trying to figure out where this committee could reinvigorate its focus on vitals.

MS. GOSS: I was picking up on some of the commentary we heard from Michelle Williamson at prior NCVHS meetings. I think some of that work has already been vetted. I think it may be worthwhile to circle – because it has been about a year. Has it been that long since we heard from Michelle? Maybe we do need to do some advance homework, set the stage, sort of like Denise did today for APCDs. Am I tracking correctly?

I am going to make a leap from what you said to proposing that we would look at advancing APCD in Q2 and push public health to Q3.

DR. COHEN: I think we are more ready to focus on APCD than vitals at this point. We shouldn’t ignore vitals. It’s not on the backburner. It is on the simmer.

MS. GOSS: We are only talking about one quarter kind of punting on here. It gives us some time to line it up. Denise, from your perspective, I would – based on our prior conversations, my sense is that you could have a team that could kind of hit the ground running with a really in-depth sort of workshop very easily. We need to frame up the questions we want to ask others to provide their perspectives.

MR. SOONTHORNSIMA: What did we envision at that workshop again?

MS. GOSS: I don’t think we have had a collaborative group –

MS. LOVE: We would probably bring in the states and the payers, HIE, HIX, and AHIP, to have a conversation. Offline, several emails have come in already. What are the problems? Where are the opportunities? Really the standards are at a grassroots level. How do we elevate them to more endorsed standards? We can hear the baseline, where things are, and then move the conversation to – ultimately, I would love to see like a uniform dataset endorsed by everybody in the workshop. That might be post-workshop. The sub-issues of provider ID and attribution, those are kind of drilldowns.

MR. SOONTHORNSIMA: We have enough to start in Q2 to really get it off the ground.

MS. LOVE: We have already got the CORE dataset mapped. We have the USHIK. We have the PACDR, the Post-Adjudicated Claims Data Reporting. We have these components.

MS. GOSS: But we have to somehow put it together so that we know who are the players that we want to come in to get a diverse set of perspectives. It sounds like we could do some working sessions with you offline to advance that. Maybe at the same time then we could be looking at how to start some of those conversation, Rebecca and Terri, with maybe the public health folks, starting queuing them up for the next – we can keep the review committee report moving. We can start to queue up the APCD. We can then start to reach out to the public health and vitals folks, which should be fairly easy, and start to queue that up. I am trying to kind of get some balls rolling because I know sometimes it takes time.

One of the things I want to be mindful of is that we have Terri really busy with the review letter. I want to be mindful of being able to put things on our work plan that we can actually accomplish. I am feeling like we were getting overloaded by trying to take on finishing up the review committee, doing the APCD, and doing all the vitals, public health.

DR. STEAD: I am wondering whether we are trying to run too fast. I would be more comfortable if before we were trying to put something as an actual convening session that we were going to hold in the second quarter, which is two to three months from now, if we had a rough statement of purpose and activity plan so that we can make sure – no disrespect to Denise, but you come into this with a perspective. NCVHS has other perspectives. You are building out this one. This event needs to reflect yours and others. I am enough of a generalist, I don’t even know what some of the others are. I am not sure I didn’t get some instinct from Nick’s comments and others – you can speak for yourself. We need to know – I think we need to have some framing of it before we actually drop it in the water when it is quite this close.

MS. GOSS: I think that what you two may not understand is that Denise and I have already been having some conversations. We had this at the last meeting. She actually had a framework. We just need to put pen to paper.

DR. STEAD: I would love to see that come before either the subcommittee or us for discussion, ideally before we lock in the –

MS. GOSS: What you have just done though is you have punched that out. That is okay. That means we discuss it in May or actually June. We don’t have a meeting in May. We have a meeting in June. That means the earliest we could have a hearing or workshop would be September.

MS. HINES: Just to let everybody know, in terms of context, and then you can get back onto our thing – our line of thought, we already have a standalone two-day hearing for privacy in May. We have a June privacy meeting tacked on to the June meeting. We have a population health workshop tacked on to the September. Anything you do here would have to be standalone.

DR. GOSS: Which actually is not a bad thing. So we could bring it forward in June. Vet it. Make sure everyone is in agreement and then move from there.

DR. STEAD: The other two things I heard today and it seems to me we have got to figure out relative urgency around were if we are going to begin to participate in this discussion of a system for patient matching, where will that fit in? Will it take priority? Then at least for me, it was a bombshell that we are going to move forward with random Medicare ID number. What kind of discussions we need to be having early on – I mean if we are going to have any effect on that train, which sounds like it may have left the station, then we may need to figure out the right kind of hearing to at least make sure they are bringing the right people into that discussion early enough to be helpful.

DR. SUAREZ: We are mixing things. There are some topics that are committee-wide topics and some topics that are standards subcommittee topics. I have four more. It is important to highlight them. I am not saying that we are going to do them all this year. I am just saying that we should identify them and list them because throughout the day today we heard four major additional topics.

DR. STEAD: It would be nice then for standards to develop a critical path.

DR. SUAREZ: It might not be Standards. This may be a larger-scope topic.

DR. STEAD: I would be very comfortable with a list of things in a priority group. I am concerned we are trying to earmark Q2.

DR. STEAD: What I am concerned about is we are throwing everything out, doing the Standards subcommittee topics, in some ways because not everything is about Standards subcommittee. We are just focusing on what are the kind of things that –

MR. SOONTHORNSIMA: One more deliverable that I totally forgot to mention. That is the Review Committee report. That should be included in Q2.

DR. SUAREZ: I thought you were going to say the HIPAA report to congress, which is a separate product.

MS. GOSS: So I would like to have clarity on the patient matching issue. It is full NCVHS, not Standards?

DR. SUAREZ: I think it is full NCVHS.

MS. GOSS: I am okay with that. I think it is a big issue. I think we need to be talking about it. It has a lot of implications in a lot of ways. We thought Y2K got people all – this, to me, is worse.

DR. SUAREZ: Just to be clear, this is not a June thing or a September thing. We need to wait until Jim comes back with a feedback from within the Department to make sure that this is appropriate for us to address. We started talking about it. Yes, there definitely needs to be some clearing of the pathway for us to be able to engage. The good news is I think there is a lot more interest. As you point out, there are already things going on like – it was news to me, too, this change in the Medicare program, which is going to affect 60 million people or more, maybe 75 million people.

There are a lot of topics. I wanted to mention specific to Standards, two other topics. We mentioned prior authorization workshop. Again, this is not for like just do it this year. This is a topic that has been mentioned as a great opportunity. This is one of the most significant transactions where we don’t do the right things and we are stopping – we heard stories, personal stories, yesterday at the hearing from testifiers within the industry, experts that know how to navigate theoretically, and they still have issues with prior authorization. Prior authorization is a big opportunity. I wanted to just remind us that this is a topic.

The other one is the – well, we have heard it, ACA 10109 provision. The 10109 provision is the provision within ACA, the Affordable Care Act, that says NCVHS should look at other opportunities for simplification of administrative processes. We started looking at this two years ago.

MS. GOSS: I’m trying to figure out if it is duplicative.

DR. SUAREZ: I was looking at that. It seems like that is the topic. That is one. Maybe it is a workshop already listed there. Yes, that is, indeed, the 10109 section. That is good.

Anyway those were two that I think will be important for the Standards subcommittee to consider. I think the idea was to really try to plot and look into the 2017 quarters one and two and begin to really map out a little longer –

MS. GOSS: Yes, I think that we would do that.

DR. SUAREZ: Thank you.

MR. SOONTHORNSIMA: Walter, we have a question mark on the HIPAA report. Considering the review committee letter this year and then the final review committee report, I wonder if we shouldn’t push the HIPAA report to the National Committee report in the middle of next year. That will sort of supplement, if you will – we have review committee that we did last year. In the middle of 2017, we could have a draft of the full committee.

DR. SUAREZ: I think that is a good thing to consider. I think we don’t want to overwhelm Terri. We don’t want to overwhelm the subcommittee.

MS. GOSS: Did you propose mid-2017 or something like that?

DR. SUAREZ: Yes. I think that would be probably a good –

MR. SOONTHORNSIMA: We kind of talked about this before, but we really never landed on it. That way it gives – again, I think we all agree it is not really HIPAA report anymore. It is really the state of affairs, if you will, of the National Committee and all the changes that have taken place and all the changes that we anticipate coming.

DR. RIPPEN: I don’t know where it falls, but we talked about it earlier, is the whole question of data models. That has implications that are not only for research and kind of the investment for grants and everyone creating their own, which is not the most cost effective, but then also as it ranks into death registries and actually how do you construct data so that you can actually do the population health activities that we are talking about. There is a lot of interesting touch points that would be of interest, I think, to DHHS. I don’t know where it falls.

MS. GOSS: I think we should probably talk about that and where data models fall and whether that is a Standards work. Is that a pop work? Is that a full committee work? Is that sort of the framework effort kind of bubbling back up again?

We are talking about data models. We are trying to get an idea of where it fits and whether it is something that Standards should look at, Pop should look at, Frameworks should look at. Is that Vickie’s group? Is that full?

DR. SUAREZ: Is it a public health – population health data model?

DR. RIPPEN: Actually, it touches everything now, right? If you look at PCORnet, CDM Version 3 – you talk about the PMI, everyone has their own. Everyone has camps. That is for research. Then you start talking about population health from a healthcare systems perspective and the question of actually then marrying it to other datasets, such as death registries, Endpoint. Again, as you start thinking about the importance of this infrastructure for everything from health to population health to research. I don’t know what role NCVHS plays in the discussion because it is timely right now. Money is being invested.

DR. SUAREZ: Absolutely. There are many trains that have left the station in probably different directions. The good thing is there is some coalescence around – people call it different ways, a common data model, a common dataset, a minimum common data – clinical dataset. ONC, actually, through the work that they have done in various projects, including actually Meaningful Use certification programs where they define, actually, what is a common dataset, and then applying that to other projects, including PMI. PMI is actually building a little bit from that. It is a question of is it the exact same? Is it expanding? Is it different?

DR. RIPPEN: It is timely. It has a significant impact in many things. It is just a question of does this committee play a role.

DR. SUAREZ: I certainly want to say we do play a role in it. It is a matter of priority. It is a matter of whether this is something we can fit within this structure and how much we can work with other bodies, including ONC again and their Standards committee.

MS. GOSS: I also think this kind of gets back to two things I heard earlier in regards to other project activities. Could we scope it out? Is it within our legitimate due diligence? I think we can get a lot of nods about data modeling. A discussion would be good. I think we need to put some definition about what it looks like and maybe you could help with that. I think that would be the best way for us to get it in front of folks. I think it is probably something of the whole, not a committee.

DR. SUAREZ: Great point. Your expertise, particularly, is incredibly important in this area. Not that we want to create a new committee on data models, but I think bringing your perspective into the other committees is very applicable to that. Perhaps one of the things we can do is begin to think of some of this work can be done in smaller groups that don’t necessarily have to be subcommittees. It could be two or three of the members that can flesh out a concept document that can be brought back. Maybe if you don’t mind helping develop something like that that we can discuss.

What this is pointing to is really – we meet every three months. We are meeting every month almost or trying to look at ways in which we can meet more often. As a full committee we are meeting really every month. We haven’t really set up a conference call for full committee meetings. We only do that whenever we really need major decisions to be made. We meet as executive committee a little more often. Certainly, there is the subcommittee work that is done a lot more frequently. We want to balance the workload. The last few months I have been – many of you have been in many different conference calls.

If we can think of approaches where we can take two or three people – even one person who is willing to flesh out a simple document that describes an important topic like this, I think it will be very helpful, very valuable.

MS. HINES: Does the committee have – like what Shana outlined this morning – four questions? If we have ten things that were raised today, we can’t do all ten. Maybe we can spread them out, but in two years, some of them may be irrelevant. It is almost like we need a framework of like three questions to ask in order to get to here is what we are going to do in the next 12-18 months. It almost seems like we need to come up with something that is actually quite simple.

DR. SUAREZ: You mean the questions like evaluation, timely, relevant –

MS. HINES: Exactly. How critical is it? Will the recommendations be actionable by the Department? Just things like that. How important is it that it gets done in the next 12 months? Just a list of quick questions. You have a list here for tomorrow that we could all work full-time now.

MS. DEUTSCH: One thing you may want to consider is if you have the list of ten, see which ones are dependent upon others or build upon each other so that you can then use it as a roadmap. That kind of helps you to start figuring out where the pieces begin, which is more appropriate for the full committee, which can go into different committees based on what their priorities are and what they have on their list. I think, listening to it, some of them seem to feed into some other things that you have all talked about. Everyone has indicated that we should have a roadmap. I think it is a perfect opportunity.

DR. SUAREZ: There is another important activity, the roadmap, itself.

MS. GOSS: I think it is also having that master list may help us know where we need to link arms with our other counterparts inside the federal government to try to advance something more effectively.

MR. LANDEN: My add on to the pile as we heard this morning from Elizabeth Holland and CMS, we are going to have new MACRA MIPS proposed rules. I am suspecting there will be something in there that will affect Standards. My question is do we need a placeholder on the work plan for the Standards group? Would that be something we will just wait and see and wrestle with as a full committee?

MS. GOSS: Great question. I don’t have a clear answer to it.

DR. COHEN: Since we don’t know the timing and we don’t know the content, it is kind of hard to put a placeholder.

MS. GOSS: Is this also part of maybe the opportunity when we are going to be – Walter, I think I have heard you mention several times you are going to be talking with Shauna and other – John White, other folks, doing some coordination on behalf of NCVHS with the other federal partners. Maybe this is also – can we find out some intel there? I don’t want to be behind the curve, to your point, Rebecca, about if we don’t do something on an activity for 12 months, is it irrelevant because it is too late.

MR. LANDEN: My recommendation would be put as a placeholder for the Standards committee in the second quarter. It may or may not happen. It may not be a big deal. It may be a big deal.

MS. GOSS: Ob, what do you think of that?


MS. GOSS: So we will go ahead and put that in for Q2 as sort of a placeholder.

DR. O’GRADY: I just have a quick comment. You brought up a good point here. We are trying to do this sort of roadmap and triage and think about how we do that. It is important to kind of work back from – there are points where if like CMS or one of the other agencies is moving forward on a rule, to have us come out with something, especially if we disagree with them like the week after that closes or what not – Secretaries are often interested very much in second opinion. The idea that – I wouldn’t worry about weighing in on certain areas if HRSA or CMS has already decided this is what we want to do. The Secretary will decide, not them.

I wouldn’t worry about that so much, but I would not give them any ugly surprises if we are going to disagree with them or if we agree with them. Let them know and kind of fit that timeline. It is not just what are our priorities, how do we fit. It is working backwards from there is a process that is going to close in May of 2017. We need to be done with our work by April of 2017. That kind of thing. It is whatever the topics happen to be, if we want to be helpful to the Department and not just tick off the agencies unnecessarily – if we have to and if it is necessary, more than happy to. Let’s just think about what that whole flow is and work backward from it.

MS. GOSS: Thank you. At this point, I am going to recap what I have heard. If I have missed anything, let me know. We are going to present at the June meeting a framework of purpose objectives and some questions about APCD. We will work with Denise on that to hopefully get everyone in agreement and support a possible standalone workshop on the topic, maybe the August timeframe. We are going to advance planning on public health and vital records standards. I am going to probably put some of that advanced work at least into the Q2 or Q3.

DR. COHEN: I will volunteer to move some of that forward if that is helpful.

MS. GOSS: It absolutely is. Thank you. In the MACRA MIPS rule placeholder in Q2, to just do a check-in point on that. We are looking at data models – I don’t know that I am putting in here yet, but I am thinking it might come up. It is not for us right now. Prior authorization workshop needs to be added in somewhere. That is also a part of developing some of our 2017 body of work that we need to tackle. I think we also said we were going to push the draft HIPAA report into mid-2017.

MS. DEUTSCH: I thought there was discussion and agreement that there needs to be a roadmap and prioritization. I wondered when you plan to have that discussion. I would think that at that time, once you have prioritized, then you can determine which quarters, and you can fill them all in.

MS. GOSS: We are going to start that tomorrow morning. There is time on the agenda tomorrow morning. Walter said he is going to lay out something for us to all look at. We have this. We have Pop Health. We have the Privacy work plan. They are all in different formats. There are all the new things, the SAMHSA rule. We have to kind of look at the whole pot and kind of turn it into something that we would actually want to eat.

MS. DEUTSCH: I would just suggest maybe just hold off with figuring out exactly what is going to go into each of the quarters at this time. You can have a tentative list. Getting them all together might make it something –

MS. GOSS: We are doing that. I just wanted to capture, if I heard what input I got today – so I agree we may tweak it as we go along, Terri, but at this point I am – the last change that I have to make is just to reference the ACA 10109 – I hope I got that right – that Walter noted. With that said, I would like to propose that we are two minutes – three minutes ahead of schedule.

MS. HINES: So Walter is back.

MS. GOSS: I should have made sure that Ob had nothing else to say before I did that. I apologize, co-chair.

MR. SOONTHORNSIMA: I second your motion.

DR. SUAREZ: We are ready for public comment. If there is any public comment here or in the room, please.

Agenda Item: Public Comment

MR. LAZARUS: I am Steve Lazarus, president of Boundary Information Group, longtime observer of this committee, a former chair of WEDI, HIPAA Summit co-chair. I have been in this business for a very long time.

I want to piggyback on something Rich Landon said about the operating rules at the end of the comment period among the committee. The committee should deliberate very thoughtfully as it decides how it is going to proceed with the comments it heard versus the testimony provided by the authoring entity for the operating rules.

I remind the committee this is not the first time that there has been industry pushback on implementing standards in this space. The first major event occurred in 2001 when there was significant pushback on implementing the 4010. That was resolved by an industry consensus process that resulted in an act of congress that delayed the implementation for one year. I know some of you probably weren’t born when that happened, but that is what went on. More recently, you are all familiar with what happened with ICD10 and the long delay and the thrashing and mashing that went on before we finally got it done. This is not the first time.

You should, in your deliberations, think about what is the leadership role of this committee. In this case, I urge you to take a leadership role like you did with ICD10 and be very proactive and thoughtful about how you move forward with these operating rules.

DR. SUAREZ: Thank you for that. We really appreciate that. Any other public comments in the room or on the phone?

Hearing none, I just want to conclude the day by saying this has been really another terrific day. I really appreciate all of the input and the participation. We understand and know how important this time commitment you make to the committee is. Certainly your expertise and knowledge and participation is so valuable.

We have seen and heard how important also is the advice that the national committee provides to the Secretary. We are called upon in many instances to provide that advice in different places and from different perspectives. Just so that you know, you might have heard about the 21st Century Cures legislation that was passed last October by the House unanimously or overwhelmingly passed. There is actually a little provision that says the National Committee shall provide advice to the Secretary on the standards that are being adopted, along and in partnership with Health IT Policy and Standards Committee.

In the most recent bill from the senate – the Senate Health Committee just introduced health IT legislation. Again, we are highlighted. At some point, the intent was actually to merge the Health IT Policy and Standards committee into a new Health IT Advisory committee and then work in partnership with NCVHS. It is clear that NCVHS is a committee upon which congress and others look after and certainly the Secretary, most importantly, look after as well.

All of the topics that we discussed and that we highlighted are really important and critical. I think it is going to be a matter of us tomorrow to begin to pare down from the list. I will try to bring a simple picture that can fit into one page that can highlight the various topics and have a discussion about prioritization.

In any case, I wanted to say really thank you. It has been a terrific day. It has been really great input. We will start tomorrow at 8:10 with a call to order and start at 8:15 with our privacy and security workgroup. We will have Lucia Savage from ONC, the Chief Privacy Officer of the United States, of ONC, and then Rachel Seeger from OCR presenting to us and updating us on privacy and security. There are a lot of developments around that area, itself. And then have a discussion about the work plan of the subcommittee on privacy and security and then look for action time at around 10 A.M. from both the ACA review committee letter and the population health workshop report. Then we will spend the rest of the morning in this discussion about – well, we will hear from the workgroup on Data Access and Use, of course, and then we will spend the remainder of the morning on the work plan.

Thank you so much again.

(Whereupon, the meeting adjourned at 5:35 P.M.)