[This Transcript is Unedited]


Meeting of:
National Committee on Vital and Health Statistics

November 30, 2016

National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782

Proceedings by:
CASET Associates, Ltd.


P R O C E E D I N G S (8:35 a.m.)

Agenda Item: Welcome

DR. STEAD: We’ll start with introductions of the Committee members.


Agenda Item: Review Draft Work Plan from Day 1

DR. STEAD: Thank you all. What I will do is take a few minutes and try to provide an overview summary of the plan as it evolved or as it came out of our discussion yesterday as a basis to set up the feedback discussions from HHS agencies.

So basically, just for the layout, we have tried to develop a coordinated set of work streams for the four quarters of Calendar 2017, then for Calendar 2018, Calendar 2019, and beyond. So that’s the layout of the plan, as we understand it. And I thought I would just talk it through at high level in the order in which we think we can produce deliverables.

So the first deliverable probably will be the Measurement Framework, we’ll get an update on that in a bit for the Pop Health has been developing for community health and well-being. I think we will find that is in a form in which it can have final review at the February Committee meeting and probably action at that meeting.

De-identification is probably going to be next with review of a final draft at the February meeting and possibly action at that meeting also.

The Report to Congress, we’ve decided produce it with a scope as a communication piece to the new Congress. So we will basically pull key points out of the work over the past 3 years and make a succinct statement of the value of administrative simplification to the industry and then four or five key points pulled from the Review Committee and our other activities so that we will be able to review a final draft in February, possibly approve it in February, more likely make edits after the February meeting, and approve it as part of a teleconference or telecall in April.

The HealthData.gov Next Generation, we plan to have a draft to review and comment on at the February meeting. It’s possible it could be ready for action at that point, or it may need subsequent editing, at which point, it would have action in April.

All-Payer Claims Database, the Standards Subcommittee has agreed to take that work under its wing working with Denise, and we’ll be discussing it this morning, but we’ll then have a draft in February, and it could either be approved in February or in April, depending on if it needs further editing. Actually I have here in my notes it would be action in April or June. So I think actually having it ready for February is unlikely. Maybe we will discover differently as we go through the morning.

Now, the Review Committee hearing, we have had extensive discussion and we’ve decided that its focus will be narrow. It will include an update on the statistics of the implementation and rate of use on one hand, trying to make that part of the Review Committee process standard and reproducible.

We will then do a deep dive, if you will, into end-to-end prior auth, trying to work out what is needed in terms of modifications to implementation guide, education, attachments, clinical content, to make prior auth work.

I’ve made a note after yesterday’s conversation that it might also include something about the accuracy of ICD 10 coding, not implication on analytics, but impact on coding. If we can get the staff support to move this, we would then be able to have the Review Committee hearing in June. So that would basically be our target.

On ACA 10109, we decided to limit the scope there to clean claims and audit and enforcement because we will be dealing with the prior auth component as part of the Review Committee, and the thought is we would have a second hearing in June, probably the whole thing back-to-back is a 4-day marathon of a Full Committee meeting plus two hearings, and we’ll want to look at penciling that into our calendars today if that still seems like a good plan when we come out of the end of the day.

Those are all activities that are either in flight or legislative mandates.

We’re then beginning to open up a couple of additional major activities that we will begin in Calendar 2017, but we’ll carry on into calendar 2018 and beyond. The first of those is Beyond HIPAA. And in labeling this Beyond HIPAA, we are trying to clarify that we’re not thinking about or talking about changing HIPAA.

We’re assuming HIPAA will roughly stay as it is, and what we’re talking about are the other policy and governance levers we need to accommodate the changing landscape that is taking place, ranging from things such as cybersecurity and mobile to things such as pay for quality and programs.

And we’re thinking of tackling Beyond HIPAA on two planes. On one plane, the Committee will develop a vision statement, and the first piece of that vision statement would be a policy framework for thinking about how one would manage in this environment.

On a second plane, we will be doing the most urgent detailed work. De-identification is viewed as one of those pieces that happens to already be underway.

The Predictability Roadmap is another piece of the detailed work that will relate to that, and we are planning to have, if we can work out the right support, we’re planning to be ready to have a workshop on the Predictability Roadmap in Q3 of Calendar 2017, and then a hearing on what we come out of that with either in Q4 of 2017, or possibly in Q1 of 2018.

Another of the detailed pieces that would fit under the broad umbrella of Beyond HIPAA, are the implications and privacy components around wearables and mobility.

The next big thing we’re going to begin to open up is terminology and classifications. We’re talking about starting with a fairly narrowly scoped effort around approaches to support for iterative addition of concepts and terms and the roadmap to ICD-11. We may also want to get into the analytic impact of ICD-10 as part of that work.

Of the scoping documents we reviewed yesterday, we decided to let the future of health surveys be worked at the level of the Pop Health Subcommittee because we feel considerable additional scanning is needed before we would really shape up something that we would want to focus on as a Full Committee.

This set of work, if we can get it done in 2017 and 2018, will then position us for the 2019 Report to Congress, which would then be able to include things like the Predictability Roadmap, the policy framework for Beyond HIPAA, and the first steps of the terminology work. It would also prepare us for the 2019 Review Committee, which presumably would repeat the statistical data uptake, but might have a broader look at transactions.

There are a number of sort of targeted updates we want to bring, but at high level, that’s, as I got up this morning and sort of thought about it, what the plan feels like to me. We’ve got a lot more detail on the post that’s around it. So I’ll answer questions about that or seek clarifications from Committee members, to the degree that I got it wrong.

DR. COHEN: Hi, Bill. This is Bruce. I’m sorry I wasn’t able to participate yesterday afternoon. I didn’t hear Vitals.

DR. STEAD: That was an oversight on my part. We’re landing the Vitals hearing in Q3, probably August-ish I think was the timing because Delton felt there were a number of inputs that would be available by then. That’s an oversight on my part.

DR. COHEN: Thanks.

DR. STEAD: Other questions or clarifications?

MS. KLOSS: This is Linda. Just to reiterate that while we talked about the Beyond HIPAA on two planes, we didn’t flesh out what the detailed work sequence might be for kind of nail that down beyond the things that were sort of conveniently already on our plate. So I think that is something we would return to as we started working on a vision statement. So we left place holders for other detailed dives into issues that will feed into Beyond HIPAA vision, but we didn’t specify those.

DR. STEAD: Well, and I’ve not really talked about how we are going to change how we use our face-to-face time to deal with the compression into three meetings after we come out of this fiscal year, but we’re hoping to possibly free up a half of a day in each of the meetings to actually let us work something like Beyond HIPAA at fair detail just as part of our Full Committee meeting, and we’ll have to flesh that out a bit.

That would really begin to take hold I think primarily in the June meeting probably. We may get a little bit of it in February, but I think all of us feel that we’re under a tidal wave to get through the February and April work, which in essence is landing the stuff we’ve got in flight as we’re beginning to start up the key stuff around the Review Committee, et cetera. And if we’re not able to work out the right staff support to make that happen, then this whole thing will shift.

So this is a planning radar screen, it’s how we think we can work our way through it. It’s not a prescription. And we’re going to all be comfortable tuning it as we learn more. But I think that just tries to lay the big picture out so that we can then get feedback from the people from HHS that are here to help us understand, to know, the degree to which this works from their perch as a preliminary draft or the degree to which they would like to suggest that we consider other things or other sequencing. We’re having gotten this together, so we think we know how to work with it. We’re all ears from my perch.

So are we ready to start the feedback piece? A bird just whispered in my ear that Jim Scanlon is on the phone to do the update. Are you here, Jim? Are you on mute, Jim?

(No response)

DR. STEAD: While we’re seeing what’s going on, Alix had her tent up and I was not observant enough to pick that up.


MS. GOSS: Good morning. It’s all good. We probably all need some more coffee this morning. I think you did a phenomenal job recapping all of that, and I was there yesterday, and I greatly appreciate hearing it all put back together again.

There is one little nuance I just want to call out, and not to change what you said, but just to do an acknowledgement that when we talk about the Predictability Roadmap, and we did talk about it being nestled in sort of in this Beyond HIPAA, but we have mindful that it is all about HIPAA, it’s about the predictability in the HIPAA process, just a slight nuance, but I think that we are trying to work as a committee as a whole on a number of topics, especially complex things like that. So I think it makes sense in Beyond HIPAA, sort of have the structure, but didn’t want anyone to be confused that we understood that there was an implication potentially, but we don’t know what it will be yet.

DR. STEAD: Understood. Thank you for the clarification.

I didn’t hear Jim.

PARTICIPANT: I didn’t hear him either, but I know he’s on.

DR. STEAD: Then, Rashida, since Jim is not – we think he’s on, but we’re not hearing him. Would you like to make any comments about what we’ve described from the perspective of ASPE? Well, first actually introduce yourself.

Agenda Item: HHS Feedback

DR. DORSEY: Good morning. My name is Rashida Dorsey. I am the Director of the Division of Data Policy in ASPE. I was serving as Jim’s alternate here as the Executive Director, but with his retiring, I’ll be moving into that position to support the Committee. I’m really pleased to do that.

I actually would like, if I can, I would like to hold on giving some feedback because I would like to hear a little bit more because I did miss some of yesterday for reasons related to retirement. But I’m excited that the Committee is planning a full year and probably a half of activities that will support the Department. And I would like to pause and circle back if that’s okay.

DR. STEAD: That’s fine. Then that will take us to Cora Tracy.

MS. TRACY: Good morning. Cora Tracy. I am the Deputy Director for the Office of Enterprise Information at CMS. I’m also wearing two hats. So currently I was named the Acting Director for the National Standards Group. So that will be my position in the foreseeable future.

I’m really excited to be here this morning to reflect on the Committee’s visioning conversations from yesterday. However, I was not here yesterday. There is some transition work that we’re doing, so Denesecia Green, who is the Deputy for NSG, will share some of her highlights. And I understand it was a fruitful and productive day.

I did have a chance to look over the strategic planning documents. As expected, there was much interest by CMS and NSG in particular. As NCVHS embarks on the 12th Report Congress on HIPAA, you should be proud of the milestones you’ve achieved and will report on for the last 3 years, including the successful implementation of ICD-10.

Looking ahead to initiatives planned for 2017, I support the idea of the Predictability Roadmap. There is much to gain from developing opportunities for efficiencies to enable greater predictability in updating HIPAA transaction standards and operating rules to accommodate the changing landscape.

With regards to the status of administrative simplification scoping, I was glad to see the discussion of the Review Committee activities as well as the ACA 10109 requirements for solicitation of feedback. These are two areas where I think NCVHS can really support CMS in 2017.

These are just a few initial reactions from looking over the scoping documents. As Denesecia attended the visioning sessions yesterday, she may have additional feedback to relay during her remarks this morning.

So in closing, I want to reiterate that NCVHS plays a vital role in shaping our administrative simplification agenda, and we will continue to look to you for insights and guidance as we head into the new year.

I look forward to our continued collaboration and the accomplishments to come. Thank you.

DR. STEAD: Thank you very much.

MS. GREEN: Good morning, everyone. My name is Denesecia Green, and I am the Deputy Director of the National Standards Group. It’s a pleasure to be here this morning.

Cora, I couldn’t have said it better. We are delighted by the discussions yesterday, and I thought it was a very planful discussion. I think the work that you all do here has lasting effects on the communities that we serve: patients, providers, health plans, technologists, and researchers. So I think this is important work, I think we can make a difference together, and very committed to doing so.

Just a few things I wanted to go over. Overall, I think there was great alignment with some of the priorities that we’ve been looking at as well. I applaud this group for your interest in gathering metrics around some of the key topic areas as you all are developing your recommendations and your hearings and research.

Also, on the topic of ICD-10, we are certainly open to taking a look at that and ask that this Committee allows for a full set of data to come in before making a recommendation, but we’re certainly supportive of any feedback that you all have so that we could work to help to normalize that data.

The HIPAA Beyond topic was very much of interest to our group here, and we ask that you continue to engage us in those discussions. Where there may be some synergies across the board in terms of our HIPAA policy, we want to make sure that we are aligning going into the future. We see the possibility of sort of HIPAA reinventing itself and may show in some of the HIPAA Beyond topic areas. So we would be interested in your thoughts on that.

Thank you very much.

DR. STEAD: Thank you. Are there any questions from the Committee? Good to go. Okay. Then is Elise Anthony on the phone?

MS. ANTHONY: I am. Good morning, everyone. I actually am speaking on behalf of myself as well as Lucia. Lucia Savage, our Chief Privacy Officer, actually had to drop for a standing commitment at 9:00, so she sends her apologies but did send some feedback over to me as well to share with you.

So Jon White joined yesterday, as did Lucia Savage, so I was able to talk with them as well as kind of look through the materials that you provided. And I wanted to thank the Committee for really their thoughtful look at this upcoming year and the activities that surround the health information landscape.

So one I wanted to note, our continued interest in working with you on a number of these topics. At ONC, we think a lot about interoperability, we think a lot about standards, of course, and vocabulary. So we look forward to working with you and to identify synergies that might exist between the work that we are taking up and continuing through our Interoperability Roadmap and through the Federal Health IT Strategic Plan, and bringing those into the landscape that you will be examining as well.

On the area of health terminologies and vocabularies, we were interested in that particularly given our work in the interoperability space, and though some of the players may be different, we look forward to working with you and as you think about how terminology and vocabulary can continue to help advance the electronic health information environment. So please continue to keep us apprised and in the loop on that one, and we will do the same in some of our activities.

And you know, we’re moving into I guess the next phase or the continued phase for our Interoperability Roadmap, which focuses on interoperability, but not only in the space of electronic health records, but really across the care continuum to really advance care and make sure that information is where it needs to be, how it needs to be, and for the benefit of the patient.

I wanted to touch on some of the things that Lucia mentioned to me, and I’ll share with you as well, and those were in the HIPAA space, of course, given that that is where she focuses a fair amount of time.

So, one, in thinking about HIPAA going forward, she mentioned that one area that would be helpful may be to also think about the challenges of sharing data between health care and social service agencies, especially if those agencies are not government affiliated. So that was one note.

She said even in consideration of that, that one area that might be interesting is to think about coordinating regarding the scope in terms of with ONC for coordination around innovation and the some of the work we’re doing, but also in terms of genomics and precision medicine, which would really be an NIH base.

But altogether, we are really looking forward to the opportunity to work with you in these areas and to think about alignment between the different activities that we are engaging in.

So I think generally that’s where we are in terms of the feedback, but really we’re excited to see the work that’s happening, and I think the biggest takeaway that we would have is we’re excited to work with you as you embark on the new year.

DR. STEAD: Thank you. And from my perch, as this plan evolves, and as your FACA develops, the similar plan, and as we all get input from the new administration, it will be very helpful probably to review the plans at that level and see where the best opportunities for alignment are because that would be very helpful to us.

MS. ANTHONY: Yes, absolutely, we agree. And I think with the new administration coming in, that’s also something that we’ll be thinking about. In addition, if legislation should pass, Cures should pass, there will also be – there are some new focus areas for our FACA, and I think all of that we can work together and think about how to make sure that there is alignment and synergies between the two works, the work of the two FACAs.

DR. STEAD: Thank you. Are there questions?

(No response)

DR. STEAD: So we’re good. Well, thank you for joining us.

MS. ANTHONY: Our pleasure.

DR. STEAD: Should we now move on to Rachel? Because Lucia is not going to – Rachel would you like to introduce yourself and take over?

MS. SEEGER: Sure. I’m Rachel Seeger. I’m the senior adviser for Public Affairs and Outreach at the HHS Office for Civil Rights. I listened to your session all day yesterday, via phone, all day with my little earphones on. Very thoughtful discussion and I applaud you for your work. OCR is looking forward to working with all of you especially on de-identification today as we move this important work forward; also working with NCVHS on priority setting for policy enforcement and the outreach efforts in 2017 and beyond.

With respect to HIPAA moving forward, OCR continues our vigorous support of the Precision Medicine Initiative. This is a real priority for our office, and ensuring that health care providers understand their obligations with respect to privacy and security under the HIPAA rules for research as well as for patient access. And to this end, OCR has in the works another training module via Medscape. If you recall, this is our free online provider education program that offers continuing medical education and continuing education credits for health care providers as well as allied health care professionals.

This module will focus on patient’s right to access. With respect to patients, we are launching our Powerful Medicine Campaign, Part 2. This is the campaign that we ran as a pilot, as you might recall in 2013, targeting young African American men who have sex with men who are HIV-positive with messages about how to use their health information and their right to access to be more involved in their care.

We will be picking up on that campaign, working with the Precision Medicine Initiative to target women of color, of low education, and low income in their role as both patient and as caregiver. We’re really excited about that, targeting both of these projects to be complete by spring, early spring. So hard at work on that.

I also brought some updates for you in addition to our feedback. Would you like to hear those now, or we can wait? Or we could just table those slides for another time.

DR. STEAD: What’s the Committee’s preference? We’ve got time. Would you like to go ahead? Okay. That’s fine.

MS. SEEGER: For once I have time. So I wanted to provide you with some highlights on our enforcement efforts. OCR has issued our 2013 and 2014 Reports to Congress. These are two reports that are required under HITECH. One is on Compliance and Enforcement, and the other is on Breach Notification. Concurrently, we also posted our 2015 annual numbers.

And this data all highlights our work. And folks will see that our work continues to focus on the investigation of breach reports, especially those affecting individuals, the 500 or more individuals, affected by a breach, as well as other reports of systemic noncompliance with HIPAA.

You may recall we also spoke the last time we were together about OCR’s efforts to look at small breaches affecting fewer than 500 individuals and to open up compliance reviews based on those reports. We will continue to do that moving forward in 2017.

We also, as you may know, have in 2015 and 2016 entered into a record number of settlement agreements. We’ve been very, very busy, and we’ll continue to focus our enforcement efforts on those cases that send a strong message to the industry about noncompliance and where corrective action impacts the largest number of individuals. Whenever we make these announcements, we tailor our press releases very carefully to send a strong message, an educational message, to the industry, and also hope that these resolution agreements, the details, provide a template to our covered entities and business associates about proactive steps and best practices that they could be taking to ensure compliance with our rules.

And let’s talk a little bit about those recent actions. Just a few weeks ago, or last week, we announced a settlement with the University of Massachusetts at Amherst. This is to settle potential violations of the privacy and security rules. The settlement is $650,000, and it’s reflective of the fact that the university operated at a financial loss in 2015, so we took that into consideration. It also has a robust corrective action plan.

So just a little bit about the details of this particular case. It was a result of a malware infection that resulted in an impermissible disclosure of ePHI affecting over 1,600 individuals. This was really the result of the fact that UMass had not put a firewall in place at their Center for Language, Speech, and Hearing.

When we started to investigate this case a little further, we found that UMass had failed to designate all of its health care components when hybridizing, and this resulted in the fact that there was patchwork compliance throughout the organization.

We also found that UMass had not conducted a thorough risk analysis until September 2015, after the incident had happened.

So there are really two messages here: one, the importance of a comprehensive risk analysis, as well as the importance of correctly hybridizing your organization so that the entire environment and operation is addressed. This is critical for protecting patient data.

On October 18th of this year, we also entered into a settlement agreement with St. Joseph Hospital. This resulted in a payment of over $2 million and the adoption of a corrective action plan.

St. Joseph Health, this system, was working on their meaningful use implementation, and they had a certain number of files that were part of this program that became accessible via Google and possibly other Internet search engines. They had set up a file-sharing application and had not amended the default settings from what was initially set up coming out of the box from the vendor, and as a result, all of these files were publicly accessible with unrestricted access to all the PDFs for almost 32,000 people, quite a lot of people.

So the investigation also uncovered a lack of an enterprise-wide risk analysis. We’ve talked about this before, where we’re seeing a risk analysis that’s just being conducted on the EHR system to comply with meaningful use credits, and a lack of systemwide, enterprise-wide, risk analysis that’s looking at laptops, that’s looking at mobile devices, that’s looking at other systems.

So moving forward to some policy updates, as promised to all of you, we have finally released our cloud computing guidance in October of this year. This new guidance is important in explaining to not only covered entities but also to cloud service providers about their obligations under the HIPAA rules.

The guidance is presented in a question-and-answer format, and it specifies that when a cloud service provider is creating, receiving, maintaining, or transmitting electronic protected health information on behalf of their health care clients, that these organizations are business associates under our rules.

All of this guidance can be found on our website. And again we have some special FAQs on this topic that are also available on the Business Associate section under our FAQ guidance.

We also have worked with our friends at the FTC on issuing joint guidance that reminds HIPAA-covered entities that they must also comply with the Federal Trade Commission Act. So it’s not enough that you’re just looking at HIPAA. Organizations must also look at their obligations under the FTC Act to make sure that their disclosure statements are not deceptive. We have posted this guidance on our website, and it’s also over on the FTC’s website.

Since we last spoke, we’ve issued two cybersecurity newsletters. This is part a new series that OCR is doing every month. We release these to our security LISTSERV, and we also post them on our website.

So in October, the title was Mining More Than Gold. And this particular newsletter alerted HIPAA-covered entities of a particular malware variant, and reminded covered entities of some best practices, such as limiting user access, performing regular self-audits, and checks for unauthorized equipment, looking at their network traffic, and keeping their anti-virus and anti-malware software up to date.

In November, we issued a newsletter on authentication titled, “What Type of Authentication is Right for You?” Again, we tried to provide as many best practices and recommendations as possible, but this focused on how the risk analysis can be used to assist covered entities in preventing cybersecurity attacks and how single-factor and multi-factor authentication can also work as a too.

Well, what’s to come? We are working now on guidance on text messaging. Hopefully that will be out soon.

Social media guidance, this is looking at the use of social media by employees within a covered entity. There has been a lot in the news about employees within nursing homes who have been using applications like Snapchat to take photos of patients who are in compromised or other positions, and this is not acceptable under HIPAA in any way.

And the guidance will provide some best practices for organizations also on training.

We continue to work, as I mentioned earlier, on supporting the Precision Medicine Initiative and research authorizations. There will be guidance on that coming.

And a longer term item is our continued work on an Advance Notice of Proposed Rulemaking on ways in which an individual who is harmed under HIPAA may receive a percentage of any CMPs or monetary settlements that we collect.

So audit. On Monday, we began sending out document request packages to HIPAA business associates as we continue moving forward with our Phase 2 audit efforts. So there is an email coming out to all of these organizations asking them to participate in an opening meeting via webinar on December 6th from 11:00 until 1:00. This is closed to the public but focused on these auditees to make sure that they understand what is to be expected of them.

We also post our Phase 2 audit protocol and all announcements and frequently asked questions on our website for complete and full transparency. So to this end, we have issued a LISTSERV announcement that generated quite a bit of press coverage earlier this week. We had a very eager vendor who decided to take the letter that we have that’s directed to auditees on HHS letterhead, and under the signature of our director, Jocelyn Samuels, and used this as a phishing email.

He embedded links within this letter to a mock government website that alerted individuals to the fact that they had – the phishing hook was that they had been selected for an audit, and when they went out and looked at this website, it said, “You’re out of HIPAA compliance because you don’t have a firewall in place and your employees are taking the bait here off of their email.”

So we have been working on a response to that and trying again to have complete transparency to our regulated industry that the way they hear from us is through our official email and website. And it also sends an important message about phishing in general and the importance to have risk management policies and procedures in place to prevent these types of things from happening.

So I think that is the end of my update. But, again, looking forward to staying with you today to work with you further. And, as always, we look forward to working with you moving forward into 2017 and beyond on HIPAA.

DR. STEAD: Okay. Thank you. Questions?

(No response)

DR. STEAD: Then my bias, since we’re a smidgeon early, but my nickel is a couple of these topics may take more than the allotted time. I’m in favor of going on and switching our hats and starting the discussion of the de-identification letter if the Committee is amenable to that.

First, though, I think Rebecca wanted me to do one logistical task related to the hearings that are beginning to pop up potentially in June. Currently, we have a Full Committee meeting scheduled June 20 and 21, which is a Tuesday-Wednesday.

It seems to me that it’s probably best from a logistical point of view to have the ACA 10109 hearing one day, the Review Committee hearing the next day, and then the Full Committee hearing the next 2 days because that would mean that the people on the Full Committee that are part of the Review Committee but don’t want to participate in ACA 109 would – I cannot imagine that anybody would not want to do that, but it’s just possible from a logistical point of view, and by putting them in advance of the Full Committee meeting, we could then do follow-up. We could somehow incorporate follow-up planning into the Full Committee meeting.

So it seems to me that sequence is probably the best sequence. Am I processing that right?

PARTICIPANT: I think you want to look at that way.

MS. KLOSS: I think one adjustment might be to try to start that at noon on Monday because you would have to travel Sunday on Father’s Day.

DR. STEAD: That would be a challenge.

MS. GOSS: And we also did receive feedback yesterday from some staff that didn’t think that we needed a full 2 days for that. So I think that works on a day and a half.

DR. STEAD: Noon on Monday would solve the Sunday travel problem and not create a Friday travel problem if we think that we can do both hearings in a day, and if we think that’s realistic. We would have the Full Committee as a follow-up block.

So then what I’m hearing is Monday at noon.

PARTICIPANT: Or 1:00 or 1:30 or something. 1:00?

MS. KLOSS: We just have to look at flights. It may not be possible to –

DR. STEAD: Okay. We’ll figure out what the right timing is, and if flights make it be a little late, we may have to go into the evening.

MS. GOSS: I am not impacted, I drive, so I think I need to defer to my teammates.

DR. STEAD: No, I know. All I’m saying is if we want to make so – I think the idea that we want people to be home on Father’s Day is a good general principle. All I’m saying is the float we’ve got is the evening. So do we lock that in as our tentative schedule, and we’ll work on the specific time?

MS. HINES: If we do that, it just means that the dates we currently have for the June meeting would shift from the 20th and 21st to the 21st and 22nd.

DR. STEAD: Correct.

MS. HINES: So we just wanted to make sure if that –

MR. COUSSOULE: I think we need to put a little bit of noodling into, can we get it all done in a day or not? I don’t think we need 2 full days. We’ve talked about whether we need more than a day for the hearing.

PARTICIPANT: A day and a half.

DR. STEAD: It’s inconceivable to me that we don’t need more than a day, given the way we’ve now – the Review Committee’s scope, it’s narrow, but it’s nontrivial.


DR. STEAD: Unless I have less of an idea of how many hearing blocks one would need around the ACA 109, 1-0 whatever it is. I can’t keep the numbers straight. Be that as it may. Well, we can –

PARTICIPANT: But I think if we target before the meeting, and the Committee meeting –

DR. STEAD: Well, let’s try to work that. You can be working – we can find out about schedules. You can be working what you think the hearings need to look like, and collectively we’ll get smarter and we’ll tune it. But let’s make that what we’re doing.

MS. HINES: Okay. So that means we’ll shift the June meeting for the Full Committee just by a day, so it’s the 21st and 22nd. So I just want to make sure everybody has got that from a support standpoint.

DR. STEAD: But that still fits within the block of days you’ve been holding in the facilities, I believe, if I’m understanding –

MS. HINES: Yes. That’s a yes.

DR. STEAD: Okay. So we’re working within our footprint.

MS. HINES: Okay. And then I would like to ask those involved with the Predictability Roadmap, right now we have a workshop in Q3, if you want to give us as much lead time on – it sounds like we wanted to –

DR. STEAD: Well, and the Vitals hearing.

MS. HINES: Right, which will start.

DR. STEAD: And so we’ll need both, so we’ll need to figure out, will either of those be linked to the September meeting or not?

MS. HINES: Right.

MS. GOSS: I believe yesterday, I don’t remember exactly how, but we put the workshop for the selected participants from the industry for August. I think that’s confetti in the air right now. We need to do some coordination with our partners at NSG and figure out room availability and that kind of stuff. So I don’t know that I can really give you any sense on that one.

MS. HINES: Okay.

MS. GOSS: But August/September, sure, that will work.

DR. STEAD: And the other one will be landing in that same framework as Vitals. So we’ll –

MS. GOSS: I thought we purposely – Delton is here, or was here. I thought we were looking squarely at no earlier than September because he was waiting for some reports, so we didn’t – we weren’t – were you trying to co-locate them or am I just –

MS. HINES: Well, I think Vitals makes sense, but I’m thinking given the smaller meeting and the suggestion that maybe we can schedule it at CMS’s headquarters might mean it’s a different issue.

DR. STEAD: So Predictability Roadmap might be standalone.


DR. STEAD: And we might try to co-locate Vitals with the September Full Committee meeting. And we might at look then which day, which we might pencil that date in based on –

MS. HINES: Right. So we’ve moved the September meeting to be the 13th and the 14th –

DR. STEAD: Which day of the week?

MS. HINES: – so if you happen to have your calendar, that is a Wednesday and Thursday. So Delton is not in the room at this particular moment, but it would look like Tuesday, September 12th, would be a good candidate date for the next-gen Vitals hearing.

DR. COHEN: Yes, I think September is better than August. The state Vitals meetings, NAPSIS meetings, are in June, so a lot of energy is put into preparation for those and follow-up. So always fall makes more sense than August per input from a lot of those folks.

DR. STEAD: So let’s pencil it in for September 12, and then we’ll work out – yes.

MS. GOSS: Is there a budgetary consideration we should be having, Rebecca, as it relates to wanting to – because we’re going to have to travel members in for a separate – for an August workshop, and I just want to make sure that we were being mindful and not forgetting the budget.

MS. HINES: No, we’re good.

MS. GOSS: Okay.

MS. HINES: We’re good through September.

DR. STEAD: Because we’ll have three of them aligned, one – okay, good question, but I think we’re good. Okay. So we’ve got a tentative plan, and you’ll work with NGS to figure out – NSG, excuse me.

MS. HINES: Yes. Thank you.

DR. STEAD: Okay. So that’s a piece of logistics. Why don’t we now start with –

DR. MAYS: Bill.

DR. STEAD: Yes, Vickie.

DR. MAYS: Are we adding anything on in February?

DR. STEAD: Not that I’m aware of.

DR. MAYS: Oh, okay. So our work, it is just purely we can get it done in those 2 days.

DR. STEAD: Yes. Our direction is that our extra activities are limited to four events in the fiscal year, and we’ve now identified what those four events are, and we’ve landed them. So by definition, we’re going to have to scope our work to fit within those 2 days or telephonic visits, which we’re thinking there will be one – we’ll need a good telephonic visit in April-ish to finish up some things from February.

DR. MAYS: Thank you.

DR. STEAD: Okay. Then I think we want to switch. Linda, do you want to begin to start? And I think we don’t need to finish before our 10:00 break. We can go as far as we can go, take the break, and then complete it if we need to because – let me actually check –

MS. KLOSS: So we want to stick with our break time of 10:00 and then we’ll see where we’re at.

DR. STEAD: I think sticking with a break time of 10:00 is best for people, and we can let the block go across the break.

MS. KLOSS: Okay. Good.

Agenda Item: Privacy, Security, and Confidentiality Subcommittee: Themes for De-Identification Letter

MS. KLOSS: Well, I am going to ask you to either follow along with the slides or turn to page – does someone know what page that is in the –

PARTICIPANT: It looks like it’s page 38.

MS. KLOSS: Page 38, there’s a slide deck in the e-book if you are following along remotely or here.

The purpose of our discussion is to try to accelerate the thinking on the Privacy, Security, and Confidentiality Subcommittee’s next major lift, preparing the letter to the Secretary on de-identification and HIPAA. And as you know, we held a hearing on May 24th and 25th.

I want to acknowledge Rachel Seeger, who was then on detail to ASPE and was a catalyst for helping organize that important hearing. And so it’s great to have you here, Rachel, to help with this discussion. And Maya is listening in and helping to take notes with us on this discussion.

So our purpose is two things, to both reorient the Committee to the content of that hearing and the issues that we heard. And secondly, engage your help in helping us frame practical areas for recommendation. We obviously don’t have a draft letter to present today, we have some outline, but if we can come away from this discussion with some consensus around areas that we want to certainly highlight in the letter and highlight in recommendations, that will help us immensely because, as you know from yesterday’s discussion, our goal is to have a draft letter for review first by the Executive Committee in January, and then the end of January probably, and then by the Full Committee in February. We’re pretty committed to moving this one along.

And I think we’re also pretty committed to taking the same general course that we took with the minimum necessary letter where we tried to be pragmatic and focused in our recommendations. Like minimum necessary standard, well, even more so than minimum necessary, this de-identification topic is huge. And so scoping it is an important challenge, yet we need to – you know, we certainly want to develop very substantive and useful recommendations.

So I’m going to just walk us through a few framing slides, and then we’re going to tee up some discussion questions. Just to remind you that our objectives for this hearing, as we laid them out and presented them, were to increase awareness of current and anticipated practices involving protected health information – what are the environmental changes that raise the stakes on this topic? – to understand HIPAA’s de-identification requirement in light of these evolving practices, and identify areas where outreach education, technical assistance, policy change, or guidance may be useful. So number three kind of frames kind of the nature of the focus for our recommendations because these are recommendations primarily to the Secretary, thought I think, like any of our letters, they can help be instructive to the industry as a whole.

Thanks to Rachel’s great help in digging and Maya’s Rolodex and the terrific work of staff, we had an amazing set of expert testimony, which I’ve reread in preparation for these slides. And I won’t review the names, but I just want to remind you that we really had academicians and attorneys and practitioners and researchers. We really felt like we scanned this industry very well for our expert testimony. And rereading them reminds us that there is just publishable materials in that testimony, it was so rich and deep.

So when we came out of the hearing, we did a first cut of what the themes were, and these have evolved some over the months, but the current iteration is that there were six major themes, and what we’ll do in the next few minutes is step through each of those with kind of subthemes. And I think what we’re asking you to do is punch hard at critiquing these and help us sharpen them and set priorities for where something is important or where it’s not on the mark or where we may have missed something.

DR. STEAD: Just to sharpen the focus of everybody around the room and on the phone, what we are trying to do here is both help the Subcommittee move forward, but we’re trying to do it in a way that means that each of us understands and is on board with these things. We don’t want to get to where we’re discussing action on a letter and have questions come up about the basic framing.

So as you engage in this, ask whatever questions are going to be necessary so that, in addition to helping Linda and the Subcommittee figure out how to frame this, we’re making sure that when it comes back framed that way, we’re all going to be comfortable going ahead and supporting the recommendations. So I want to really encourage people to engage in this review with that lens.

MS. KLOSS: Yes, it will help a lot come February if we’ve had that kind of substantive discussion here.

So I won’t review the six items here. We’ll come back to them later and look at the package. I think maybe the most important thing is to do kind of the drill-down and then come back to these. At least that’s the way my mind works.

So the first theme is – we heard this several times – that we have this privacy and data public policy collision playing out. And I tried to extract a quote from the testimony just to kind of underscore these points, but we heard this from several who gave testimony, and they used this phrase, and that de-identification figures centrally in this because the assumption is that once we de-identify, then we’re off the hook, everything is okay.

So the subpoints under that is that de-identification, we have to be more nuanced on this, the challenges vary by data set and by use. So it isn’t as simple as saying there is Method A or Method B and it works uniformly for all data sets. And we need to consider re-identification as part of a spectrum of disclosure limitations, techniques, and tools; again, I think a really important sort of way to think about this. And that there’s a tradeoff between utility and the extent of de-identification. The more data elements you strip out, the less useful the data set and so forth. But you’ve got this continual risk-balance tradeoff, and we’ll focus on the risk issue more in one of the other themes.

Promoting public use data. That’s our stand, our position, our policy position, but at this point, it carries no restriction on re-identification. Right? That’s kind of part of the collision.

And no one is kind of responsible for certifications when multiple data sets are integrated. And overarching public policy issues that individuals want greater control over access and use.

So all of these themes sort of merge, but these were things that seemed to be indicative of the collision.


MR. COUSSOULE: Sorry, just one other comment. I remember that came up at the hearing was the – typically we will talk about the needs for a certain data set for a very specific use, and one of the topics that came up was that the need for more information to be able to utilize for a use that may not be anticipated when the data set was asked for.

And I think it’s a bit of a nuance, but it’s something we may want to think about how we frame that because several members or the testifiers at least talked about the opportunity if not the specific need for a broader set of data because I may not know exactly what I’m looking for now, but I want to do some R&D almost – right? – or some “what if” modeling. So instead of saying I need this specific data to solve this problem, I may need a broader set of data because I’m not sure what other problems I might solve, and from a policy perspective, that gets kind of fuzzy today.

MS. KLOSS: Because that’s the mining question, and I think that does come up, but it’s a good point to underscore.

DR. COHEN: Linda, I also wanted to raise a point around public use data sets. I guess in a variety of contexts around data release, we’ve always struggled with a completely open public use data set that’s available, let’s say, via the web, where there are no restrictions on access, and sort of a research public use data set where we think there is minimal ability for re-identification and general use, but we want to collect information about people who are using these data so that we can essentially know how the data are being used and maybe monitor that.

So I don’t know whether that’s an issue that was discussed, but it’s something that we’re grappling with around data. What is public data? What is a public data set?

MS. KLOSS: Okay. Thank you.

DR. STEAD: Denise, then Lee, then Helga.

MS. LOVE: In this report – and please refresh me – is this around the federal data or any data?

MS. KLOSS: Any data covered by HIPAA.

MS. LOVE: Okay. So state data may not be in there if it’s exempt from HIPAA, because they carry restrictions on their public use files on re-identification because it’s a combination of technical de-identification and management controls. So if they sign –

MS. KLOSS: And who issues those restrictions?

MS. LOVE: The states.

MS. KLOSS: Each state?

MS. LOVE: Each state –

MS. KLOSS: So are they different?

MS. LOVE: – will have the releases of public use microdata file, they will sign a data use agreement that prohibits certain things, like re-identification, reuse, re-distribution. They’re pretty extensive. So I just wanted to –

MS. KLOSS: There are models.

MS. LOVE: Oh, yes. Oh, yes.

MS. KLOSS: IRB and states.

MS. LOVE: IRB and the de-identification management controls.


DR. CORNELIUS: Part of what appears to be going on is a paradigm shift. A paradigm shift is the willingness of the field to accept whatever the notion of de-identified is no longer a reality, because in the world of metadata and large data sets, analytically we are fastly approaching that zone. So one of the issues both for the panel and the field is really to ask fundamentally, is there a paradigm shift? If the paradigm shift is that we are capable of identifying folks, then that represents something both for us and the field. So that’s one point.

Second, thanks for sharing the list of the folks. I kept thinking like an NIH consensus panel, that you have all this testimony about the state of the science. Is there a way to get that information out to the field about the state of the science?

And then the third issue is always the gap between science and practice, and how do we, as a committee, help bridge that gap between the wonderful information we have access to versus what the public would need to learn to increase their uptake?

MS. KLOSS: Thank you. I think you’ll see that those points did come out in testimony, and perhaps I’ll see if I’ve captured them.


DR. RIPPEN: I guess as we started talking about this as far as data access, the question of the pile that’s open, and then there is the pile for research, for research use, and there’s a pile that’s for business specific, and then the question of, and then is there one for delivery of a service? So I would say either identified, re-identified, or de-identified targeted. So three possible things to consider.

Then there are the mechanisms that may be in place to provide protection or to consider a way to manage. So we already know for research you have the IRB. You write it generally. Now, if you get the access to data, it’s a pain, you have to pay for it sometimes. There seem to be state requirements that provide the guidance. As far as allowable use or not, that whole business associate agreement. And then what’s an allowable use?

So there are a lot of nuances and a lot of ways to slice and dice it because they’re not all equal and they’re not all the same. Some have mechanisms in place potentially while others may not. Just something to consider.

DR. MAYS: Bruce raised something that I think we also want to think about, and that’s data on the data. One of the things that the workgroup had talked about was ways in which to improve the use and access of the data by knowing something about the user.

So what’s increasingly happening is that there are all these algorithms, machine-learning formulas, that we can actually use, which will include things like, for example, your IP address. It doesn’t tell us you, but it tells us a lot of where you are.

And I think people more want to be able to identify who the user is. So I think you may want to think about also whether or not you need some kind of guidance. IRBs do look at that, and we’re allowed to negotiate it through in terms of the ways in which we can protect individuals’ information.

DR. STEAD: As I listen to the conversation, I would encourage us to try to get a clear statement of scope pretty quickly because we’re trying to close down a process that is based on findings from the hearing and recommendations we want to make.

As we try to do that, one of the things that after the last Subcommittee meeting around this, at our last meeting, I read the NIST white paper that was evolving, and I believe that – I don’t know where that stands, but I presume it’s either now done – it was draft I think when I read it then – I think that provides a very good base of beyond HHS, the industry’s understanding of de-ID and the different approaches that you can take, et cetera.

And although many of the people we’ve had in the panel have the talent, the knowledge set, to weigh into that as our Committee, we don’t really have that expertise.

I think the thing we’ve got to try to do is summarizing the findings from the hearing, which is an important thing to do, hopefully, referring, incorporating, and then leveraging the NIST as the source to the real detail, then what we’re trying to do is come up with a few actionable recommendations for HHS in the near term that will begin to move the ball in the right direction because right now there is a big gap between how we’re approaching this and where we need to go.

And so as we think through this, I would encourage us to try to begin to narrow the conversation down in that way, if that’s helpful.

MS. KLOSS: I would also remind the Committee that the author of the NIST report was our lead-off testifier, so knowing that report was coming was something that was introduced into testimony. And I agree, it’s very relevant, and if the Committee would like us to circulate that, we can. It’s good reading. Okay, good.

Rachel, do you have anything to add to the approach we’re taking?

MS. SEEGER: So with respect to NIST’s work, the scope is much broader than health care, and they continue to work on developing a set of recommendations for federal agencies on this topic. HHS has done the most work in this space, which is why NIST has looked at HIPAA for direction, but I think Dr. Stead is right, that we want to continue to laser focus on HIPAA, the practice of de-identification by covered entities and their business associates.

MS. KLOSS: Yes, right. So the next theme area then kind of summarizes what we learned about the current science of de-identification, and I think there was a recurring theme that what we know – the science is ahead of practice, not surprisingly, and the techniques, they’re not useless, they’re still valid, they’re still useful techniques, but there are other techniques that are being developed and have been shown to be workable. So the suite of techniques is actually growing, and there is good research going on, things like field swapping, the addition of noise to data sets, use of synthetic data sets. These techniques are certainly being well used in the hands of experts.

I think the bottom line for me, the takeaway, was that the pool of experts is limited and that deeper training is needed on the part of those who do the de-identification, both practitioners and in academia, and we need to continue robust research. And it was pointed out that there are special difficulties with de-identification in the areas of narrative and unstructured data, which are very important to health care data sets.

So I think our learning was that Safe Harbor is convenient, still useful. Expert determination is very useful. It’s less frequently used. It’s more expensive. There’s a shortage of experts. And, as we also learned, there is kind of no agreed-upon standard for that, and it can be a bit of a black box. So I think there are some observations we can offer on that.

I don’t know if there is anything that pops out there as a question or an observation.

(No response)

MS. KLOSS: So we’ve got two kind of general themes. One is that we do have a policy collision course. De-identification figures sort of at the nexus of this. And that the science is ahead of current practice.

DR. STEAD: And I think Lee’s way of framing that was, if we can capture it off the transcript after this, was actually quite helpful.

MS. KLOSS: Paradigm shift.

DR. STEAD: Well, it really had three components.

MS. KLOSS: Yes, between the science.

MS. LOVE: Linda, on the other techniques, I’m assuming the report will have the pros and cons of those, because that is not generally accepted in the state data – you know, my world – because it introduces noise, and when you’re doing comparisons of facilities and other things, it just is complicated. Though it is acceptable in some cases, it’s not in others, but I suppose we would have that and discuss that –

MS. KLOSS: I don’t know how much detail we’ll go into in techniques.

DR. STEAD: We don’t know have a prayer of going to that in detail. And that’s where I’m hoping that – a lot of the detail is in the NIST report. If we can basically say given these shifts, given that as a reference for us, what does this mean to HHS and HIPAA now? I think we’ve almost – I mean, we’ve got to have that kind of lens if we’re going to deliver something in a letter form in February. Otherwise – and as with minimum necessary, I think it’s okay for us to have a paragraph in our letter that talks about future work.

MS. LOVE: I was just taking your advice to heart, to air things now and not later.

DR. STEAD: No, I want you to –

MS. LOVE: Setting expectations.

DR. STEAD: – and so I am glad for the question. I’m just trying to provide an answer.

MS. KLOSS: And I think one of what we heard over and over is that every technique has benefits –

MS. LOVE: Tradeoffs.

MS. KLOSS: – and tradeoffs.

MS. LOVE: Definitely.

MS. KLOSS: And going back to that earlier point that every data set has different de-identification needs.

MS. LOVE: Yes.

MS. KLOSS: So there is no new silver bullet, and we did hear that very directly.


DR. MAYS: On the bullet where you’re talking about the training, I think the real audience for some of this is the IRB, at least in terms of academia because we really don’t take courses and stuff. And there’s a group called PRIM&R, and that’s what they do, is they put out a lot of advice and train the IRBs. So I think we want to go for them.

MS. KLOSS: Would you want a break now or should I do one more?

DR. STEAD: Let’s break now because it’s only going to be a 15-minute break. We’ll be back at 10:15, and we’ll caucus about how much more time we can spend on this because we’ve used a 1/2 hour, and we’ve got an hour and 45 minutes for finishing this and two more topics.

MS. KLOSS: Well, and I would like to spend more time on the potential recommendation areas.

DR. STEAD: Right.

MS. KLOSS: I can probably go through these last three quickly.

DR. STEAD: Right. Okay. So let’s regroup at 10:15.


DR. STEAD: Colleagues, if we could reconnect.

MS. KLOSS: Thank you. Let’s go through the three remaining theme areas and then focus on –

DR. STEAD: And for scoping, let’s try to contain this and have it done by 10:30.

MS. KLOSS: Okay. Turbo. So to the point made earlier by Lee, the de-identification does not stay, de-identificated data doesn’t stay de-identified, and we just have to understand that – I think the quote was data that appears correctly de-identified today might be identifiable tomorrow based on future data release, so that we need to address in the letter the issue of re-identification, how to define it, and on context for re-identification.

Four, we had some wonderful discussion, and we keep coming back to de-identification practice, and really over break we had this discussion again. De-identification practice, like security practice, requires a deep understanding of risk assessment and mitigation, and I think that was an important theme. And there was agreement that risk means something different to everyone, and we don’t have good risk assessment tools, methods, and it requires a lot more training.

Five, this theme came out several ways, but it stuck with me because I work in the area of data management and governance. And one of the areas for recommendation is that we need to look at certainly de-identification methods, but we need to go back and look at policies and procedures for managing de-identified data and managing data in the process of being de-identified.

And so through the life cycle, if you will, sound policies and procedures are as important as methods and technology. As in security practice, sound process is key. And that we need better education about lifecycle data stewardship of de-identified data, including IRB education, as Vickie pointed out earlier. And just the lack of resources to kind of audit de-identification certainly came out.

And the final area was certainly guidance and regulations need some tweaking for a more complex information ecosystem. And we heard recommendations that once again we can look to fair information principles as a set of levers that can be modulated to help with the balance between de-identification and this collision, the privacy data collision.

So just going back, do these themes seem to the group to be sound? Would you collapse? Revise? I mean, some of this will be clear when we start writing what works, so maybe there is four and maybe some things get collapsed, but do you think we’ve captured the essence? Good starting point. You’re comfortable, those who were at the hearing and weren’t.

Rachel, are you okay?

MS. SEEGER: Good to me.

DR. STEAD: Good with me.

MS. KLOSS: Okay.

MS. BERNSTEIN: This is Maya. Could I ask something here?

MS. KLOSS: Maya, please.

MS. BERNSTEIN: Can you guys hear me? Can you hear me okay?

MS. KLOSS: Yes, we can.

MS. BERNSTEIN: So the one thing that occurred to me from the nice summary that you guys have been providing is that there are sort of two different kinds of de-identification, and I’m not sure that we captured it precisely.

One is the de-identification that comes from intentional work with de-identified data sets, which people talked about in the hearing might be dealt with by contract or by some kind of agreement, you agree not to try to de-identify.

And the other is the de-identification that comes from the time. Whether the ability over time where other data sets are relieved and new technologies become available and so forth. And I don’t know that we’ve differentiated between those two different kinds of de-identification –

MS. KLOSS: Are you talking about re-identification?

MS. BERNSTEIN: I’m sorry, re-identification, yes. Yes, that’s right. Two different kinds of re-identification, one that sort of deals with purposeful intent and policies or procedures to deal with that, and one that deals with the ability to re-identify out there in the – even though intentional, but may come from less nefarious maybe purposes –

MS. KLOSS: Right.

MS. BERNSTEIN: I don’t want to call them nefarious because there are people who are doing it for the purpose of science and so forth, but things that come from the release of other data sets or for new techniques and so forth that were not available or inadequate at the time we went through the data. And I want to make sure both of those ideas are captured.

MS. KLOSS: Okay, thanks. And we did say we need to define re-identification, that that probably is something that needs to be part of the letter, and so we’ll address both of those because it did come out that even though we think we’ve safely nailed everything down, we don’t know that re-identification won’t happen at some later point because a new data set is released that unlocks the gold.

So areas for recommendation for HHS OCR – and these are just starting point areas – that we certainly need to continue support for de-identification and re-identification research. There’s a lot being learned, and I think that there was a suggestion that that research be brought to light and translated into practical guidance, lessons learned from the research.

Secondly, providing practical guidance and tools on how to assess risk of re-identification as a starting point for the importance of getting into a risk assessment mindset.

Reinforce that de-identification is one approach to data protection that needs to be bolstered by other mechanisms.

And establish some form of oversight for de-identified data holders and consider legal penalties for unauthorized re-identification. I think that did come out, and that is one of the recommendations that I think we could consider, some consequence for intentional re-identification.


DR. STEAD: I’ve lost my tent card.

PARTICIPANT: It’s right in front of you.

PARTICIPANT: You don’t need a tent.

DR. STEAD: I’m in trouble. One question that would fit with this that I recollect from the hearing was the idea of periodically testing how well the Safe Harbor, et cetera, was working. So instead of simply – well, the idea that there would need to be a gradual increase in the floor, if not – so I don’t know if that would be part of – could be part of a recommendation or not. That was the thing that I remember.

MS. KLOSS: There were three more on the second page. Establish a clearinghouse for de-identification best practices. I don’t think that’s “gnomic” data sharing. Cute little Nordic. Policy for genomic data sharing. And that may be something we – you know, I don’t know if that’s going to be in scope or if – remember when we dealt with the minimum necessary standard, we just decided that that needed a whole big – could we say a need for policy instead of a policy? I mean, that’s going to evolve.

PARTICIPANT: Yes. I guess it’s a question of, do you put it all in a bucket –


PARTICIPANT: – or do you – is it such a big –

DR. STEAD: My gut is that would be in a bucket of more work that’s needed.


MS. KLOSS: As we handled it with minimum necessary.


DR. MAYS: If it’s the genomic one –

MS. KLOSS: It is genomic. It’s not gnomes.

DR. MAYS: – NIH is currently doing that, and I just sent a thing out to the workgroup about the request that they have for people to comment, and they were hoping that even if we could help them with that work. But they’re actually doing that as we speak.

DR. STEAD: I think just from a point of view of trying to bring a first letter to closure, if you err on the side of putting things in a future work bucket –


DR. STEAD: – then as we see the letter and we see how actionable the set of recommendations are, we can always pull one forward into the current, but I think it will be easier to tackle it that way than having to continually push things out.

MS. KLOSS: Okay. And last but not least, education. And for covered entities, we heard strengthening the data release and data-sharing policies and processes, strengthening accountability for vendors and business associates. And I think now I would add a third regarding the data management process and the risk assessment and data management process.

DR. COHEN: Linda, I think it’s also important to remember that even though these specifically target HIPAA-covered entities, they will establish the playing field for mixed and non-covered entities as well. And that context is huge with respect to a lot of de-identification practices. And I really don’t want that to be lost because the secondary impacts of whatever we do on this network of mixed and non-covered entities could be enormous.

MS. KLOSS: Should it be covered entities and data holders?

DR. COHEN: I think so. I don’t want to wordsmith now –

MS. KLOSS: Right.

DR. COHEN: – but I think we need to recognize the implications. Even though the focus here is on HIPAA-covered entities, it will establish the playing field for anyone – for other organizations as well. We can talk later about –

MS. KLOSS: Thank you.


DR. MAYS: First, well, let me comment on Bruce, and then I wanted to go to the first three that you had. I think we have to be careful about trying to lump everybody together because I think that the HIPAA-covered entities have a specific set of responsibilities, and others will really push back about having to do exactly the same thing.

But on the first three – can you go to the slide before? I kind of thought that one and two were too general. They’re like mom and apple pie in the sense that, yes, we want to do that, but I think in order to get someone to do something, it’s like a little more teeth in terms of exactly what you want and what kind of tools, for example, you would want.

MS. KLOSS: Okay. I’m not sure we know, but that’s a good suggestion. Okay, more specific.

DR. RIPPEN: Just from a scoping perspective again, I think if we leave it to the HIPAA and their business associates and vendors, that it might be a future thing for a broader expansion. I think it’s an important point, but again I’m just trying to limit the scope so that we can move it out and to a next bucket list potentially.

MS. KLOSS: Okay. Richard? Rich?

MR. LANDEN: Yes, I’m trying to keep in mind the instructions from our Chair earlier. And one of the things that struck me is I would suggest we be very clear that we come down on the side that we recognize that data disclosure and the risk of re-identification is something to be managed, but so many of both federal and state policy purposes are dependent on better access to data, we have to clearly state that we don’t believe that access to data should be restricted, rather, that the controls need to be on the re-identification/re-disclosure end of the equation.

Second, I don’t see how this is limited, can be limited, just to HIPAA-covered entities because they’re not – it’s just not enough of the universe there. So I think we have to put this somehow into the Beyond HIPAA realm as well.

Third, another aspect of this gets into the clinical side, that we, the nation, is wrestling with, in that for clinical uses, we still have some clinical issues around individual patient treatment, not population level. For patient treatment purposes, we still have challenges linking accurately and successfully patient records in different clinical databases. So re-identification techniques is really something – successful re-identification techniques is something we are really looking for as a positive thing on the patient treatment side. I’m not sure how that fits into this, but it’s just something for us to keep in mind as background in that, yes, we also have a need for better re-identification. I guess that’s it. Thank you.

MS. KLOSS: Thank you.

Rachel, any last comments?

DR. STEAD: And Nick has –

MS. KLOSS: Oh, I’m sorry, Nick.

MR. COUSSOULE: Just one comment. I think it’s a bit of a combination of a couple items you have when you talk about item three, and then the training or education, item seven.

One question is there is a bunch of well-versed experts and people steeped in this during the hearings, et cetera, but do we have an opportunity to educate more broadly in regards to not just de-identification as a method, but more on the front-end side of understanding that the data protection model is bigger than that and de-identification is part of that?

I’m just trying to think if that – I mean, that theme came out a little bit during the discussion, so I’m just trying to think if we have a way to ask for more of a generalized education process in regards to data protection, of which de-identification is a part. I don’t want to lose sight of its – you get kind of caught up in the de-identification part and you lose sight a little bit of a larger risk management process.

So you’ve got some of it there in three and some of it in the education. I’m just not sure if there is a way to frame that up.

MS. KLOSS: Well, it may be one of the foundational frames for the letter. That may be the way it needs to be positioned. Okay. I think that’s a really good comment. Thanks. All of the comments have been very helpful.

DR. STEAD: Very helpful discussion. So we will continue work on this within the Subcommittee and try to have a draft that can be gone through with the Full Committee in February. Does that still seem like a target?


DR. STEAD: Very good. Then, Bruce and Kate, do you want to take over for the measurement framework for community health and well-being and the report of the workshop?

Agenda Item: Population Health Subcommittee: Measurement Framework; Themes for Recommendations

DR. COHEN: Sure. Kate, I will talk and if you could advance the slides for me, that would be great. And feel free to comment if I misspeak or if you want to add anything. Okay?

DR. BRETT: Will do. All right. You’re on the title slide.

DR. COHEN: Oh, here we are now. Okay. Great. So what I’m going to do this morning is just update everyone on the progress we’ve made since the November workshop, lay out a timeline for our activities, and let you know about some homework that we’re going to be asking the Full Committee to do, and get initial feedback from the broad themes, like Bill mentioned, so that when we are ready to prepare the final report or the letter to the Secretary, there will be no surprises in the themes. So that’s what I’ll try to do today.

And I just want to recognize that we’re at the closing stages on a 5- to 6-year journey focusing on community health data. That doesn’t mean that we won’t continue the journey at some level, but certainly this phase is over. And I have a couple slides at the end. I think it’s also really important to celebrate this journey and the accomplishments the National Committee has made in its focus on community health data.

Next slide, Kate. Oh, here we go. There’s a little lapse between your advance and the WebEx here.

So where we are now – and, again, we processed a framework that we went into the workshop with and have drafted the next version that’s in the e-book, and I’ll talk a little bit more about that in a second.

We created and launched the beginnings of a nongovernmental organization group to continue the framework and community measurement activity. This was I think a key emerging accomplishment. Certainly, we don’t have the bandwidth or the expertise to do the detailed work that’s required, and there seemed to be enormous interest among some of our non-government organization partners to continue with this work.

We’ve built momentum, and we continue to plan for federal interagency focus on community indicators. The framework was designed in a way so that executive agencies can really see themselves and their work. And at the workshop, there was enormous interest from our colleagues and other executive agencies about how they see themselves fitting into this work.

Next, there will be continuing HHS activities – oh, I’m sorry, Kate, still – not quite – next bullet on the last slide.

There will be continuing activity in HHS. The role that we have – the National Committee role is unclear yet, but certainly Public Health 3.0, Healthy People, CDC and HRSA projects will be influenced by this activity, and we might help facilitate some of those discussions.

There are two independent products, actually three. One is the report of the workshop. Another is the framework itself, which has evolved into a standalone document. And the third is the recommendations.

Next slide, Kate.

So where we’re at now is I have to really give a huge thanks to Kate, who has done an incredible job on the framework as it has evolved. I’ll talk a little bit more about that in a second. But we’re all now on Version 4.

The initial handoff of some activities has occurred, and our NGO partners are trying to develop an organizational structure to continue this work. We have no timetable for interagency work set as of yet. And it remains to be seen internally, HHS, how it will continue to be involved.

The first draft – you folks have seen the next draft of the framework. We need to discuss in the Subcommittee I think and get feedback about when we consider the framework activity finalized from our perspective so that we can do the official handoff. There will be a draft of the workshop report coming to the Subcommittee first and then circulated to the participants and Executive Committee and then to the Full Committee, and hopefully we’ll have all this in place by the end of January so that in February we will be able to review and approve the report by our February meeting, or if not then, very soon thereafter. We haven’t decided whether the detailed recommendations will be part of that report or not as of yet.

Next slide, please.

So this is where we’re at. Did you all have the detailed framework document as part of your agenda book?

DR. BRETT: Yes, yes, we do.

DR. COHEN: Okay. I’m not going to go through everything in detail, but essentially we’ve achieved I think, consensus on the domains, and there were some updates on the subdomains, which might be tweaked as well. One I think enormous conceptual breakthrough that we made at the workshop was to think about the measures in two buckets: one, a parsimonious set of core measures that would be within each subdomain, and this could be incredibly useful for policy development and comparison; and the second is a larger expanded set of measures that would meet a variety of different community needs. So this is the kind of activity and work that we hope that the NGO workgroup will carry forward as well as maybe some of the folks at HHS, considering this framework as useful for their activity, particularly the core measures in the subdomains.

If you haven’t had a chance to look at the framework document, it’s really a wonderful standalone document, not only describing the body of the framework and its context, Appendix 2 really describes the evolution of how we reached this current set of domains and subdomains. And Appendix 3 provides I think a historic context for this whole activity. Appendix 4 begins to provide some example measures that we found are available at the subcounty level, and those that aren’t available currently where new data collection or other techniques might be needed. And Appendix 5 begins to explore some of the sources of data.

And we see this as a living document, but we’re really very –

DR. STEAD: You’re fading, Bruce.

DR. COHEN: Oh, I’m sorry. We see this as a living document, but we’re really comfortable with where it’s at.

Next slide.

DR. STEAD: One comment on that slide. NCVHS doesn’t make recommendations around funding, so we’ll need to be careful about how that’s worded. It will be fine for us to make comments to share findings about the effect of a lack of funding. So we need to be careful of how it was framed. We’re trying to surface the kind of thing that needs to be done without being prescriptive around funding.

DR. COHEN: Okay. I am sorry. I am a little disconnected from the specific general recommendations and how that comment fits in, Bill. I’ll get back to that in a second.

Kate, can you go just to the last two slides first? And then I’ll go back to review the recommendations.

DR. BRETT: We’re on the second to last slide.

DR. COHEN: Okay. So I just want to – I think it’s really important that we do celebrate the enormous amount of work that we’ve put into this effort over the last 5 or 6 years. And the National Committee should be really proud of this body of work. And I think I would like to talk in the future about how we can create all these – put all these documents together somehow – next slide, too, Kate – to show the extensive amount of I think really foundational work we’ve done in advancing the issues around community health data.

So if we could go back to the first recommendation, federal themes.

DR. BRETT: You got it.

DR. COHEN: Okay. So these are the broad themes, and I welcome general input.

DR. STEAD: We’ve got tents up. We’ve got tents up from Linda and Helga, if you would like their comments.

DR. COHEN: Sure. Let me just – in ten seconds. So these two themes. First, everybody recognizes that community data and federal data need to be more expansive than health services delivery data, and that needs to be reinforced. And there are a bunch of folks throughout HHS who are in this space, and we want to make sure it’s coordinated.


DR. BRETT: Linda, why don’t you go first.

MS. KLOSS: I think Helga was first.

DR. BRETT: Oh, okay.

DR. RIPPEN: I guess two questions. With regards to identify a home for community level data within HHS, so are we talking about data that the federal government has, or are you suggesting that there is an HHS home that all local and states can send their data to? I guess I’m just trying to do a scoping question. What’s the answer to that?

DR. COHEN: I think here we are thinking about federal initiatives and federal data collection that support community level data rather than data outside the federal sector, and here outside of HHS.

DR. RIPPEN: Yes, you may want to make that specific because it reads like the government is going to be a data set.

DR. COHEN: Thanks. We will. I’m more interested in finding a home to coordinate all the activities that touch community data rather than thinking about this as a repository for the data.


DR. COHEN: We heard time and again that different people are doing different pieces of this and don’t know about each other’s activities.

DR. RIPPEN: Right.

DR. COHEN: So this could be virtual or it could be real, but there just needs to be some more coordination around community data activities in HHS.

DR. RIPPEN: Yes, no, I think that’s great. I just wanted to make sure that was clear because it didn’t seem to be.

The other one is, as you know, there are some efforts to start collecting determinants of health, social determinants of health, that actually cross some of these themes as it relates to the first recommendation. And so what I don’t know is how much of an acknowledgement you may want to provide or discuss with regard to coordination of efforts and how this might be beneficial to HHS not only for supporting this kind of activity, but then also for some of the other goals and objectives.

DR. COHEN: Yes. Clearly, our intention is not to reinvent the wheel or create duplicative wheels, we just want to make sure everybody knows what’s going on and how we can achieve some economies of scale here with these activities.

DR. RIPPEN: Great.

DR. STEAD: Linda, and then Vickie had her tent up.

MS. KLOSS: Thank you, Bruce. I would like to suggest that when you assemble this body of work, that the stewardship framework letter to the Secretary and the toolkit be included in that body of work because both of those were privacy dimensions of the community initiative.

DR. BRETT: Right.

DR. COHEN: I apologize for that omission on the Celebrate Success, but clearly they’re part of this journey. Thanks for the reminder.

DR. BRETT: Right.

MS. KLOSS: And then this is perhaps just food for thought. It seems to me that on the framework, you might think about how it gets packaged. I think it needs a title. I think it needs something that –

DR. BRETT: Context.

MS. KLOSS: – makes it less just an outline of terms so that anybody who picks it up kind of gets that explanation. So I would put some effort into packaging that.

DR. STEAD: Can I make a related comment? I think given the power of the table that shows the evolution of the four versions, that it would be very helpful for a few of us to co-conspirator and write a short health affairs paper that actually outlines what this is and how people should use it, and have that be the thing which tries to really get it in the way people that haven’t lived through the process can grasp, and then link the full thing to it.

I think the first page of the framework is actually a pretty good description that has evolved, but I really would love for us to figure out how to find the bandwidth to write the paper. We would do that as individuals, not as NCVHS, but I think it needs to be done.


MS. KLOSS: We could still package it in a way that it looks like the substance that – yes.

DR. BRETT: Thank you.

DR. COHEN: Can you speak up, please, Linda?

MS. KLOSS: I concur with Bill’s thought about a health affairs piece, but I would still say then that as it gets linked to, just to have it packaged in a way that –

DR. COHEN: Yes, no, I totally agree with you. The framework is sort of in organic evolution. I don’t think we had initially seen it as a standalone piece, but Kate has done such a remarkable job pulling things together that it sort of has evolved to where it is, but I think without a lot of enormous amount of additional effort, we can make it a really nice piece.

And, Bill, I’m happy to work with you on our off-hours to try to come up with a succinct little paper here that might help promote this.

DR. STEAD: Awesome.


DR. MAYS: One of the things about this being the federal – the recommendation themes being federal, is it would be great to think about how to have something of this recommendation include the Data Council because if you’re really wanting the feds to do this, the Data Council is where all the people come together.

The other thing that we can think about as we do HealthData.gov is to see if we can pick up one of the themes that you have as well and follow through. But without the Data Council, it’s like you got it out there, but you don’t have a group that really will carry the water for you. So I’m not sure what it would be, but that’s just a suggestion.

MS. HINES: I just want to remind folks who weren’t involved in the day-to-day of this that at the workshop an organization volunteered to take the outcome, which is this package of one-page description, the framework, and the history, and our charter says we should do that. We have the vision and then we can work with the private sector and let them move it forward. And they are delighted to be inclusive, so it’s not just their organization, it would be them as a coordinating entity.

So I think along with the idea of the paper and the fact that the private sector is now willing to take this, and I don’t want to steal your thunder, Bruce, but there is going to be a federal recommendation that the feds have complementary federal (indiscernible) that would then work with this private sector, I think this thing is going to grow legs and move.

MS. GOSS: So does that mean that maybe the NGO – I was there and I can’t remember the name of the organization that stepped up –

MS. HINES: Institute for Health Care Improvement 100 Million Healthier Lives.

MS. GOSS: Thank you. There was tremendous agreement around that during the meeting. Are they a part of the health affairs paper?

DR. STEAD: Since it’s not written yet, anybody can be. The more the merrier.

MS. GOSS: Absolutely. Collaboration.

DR. COHEN: Other duties as assigned, as my boss would say.

DR. STEAD: Okay, Bruce, have you gotten the input you need?

DR. BRETT: We have at least one more federal –

DR. COHEN: There are just a couple almost, Bill.

The next slide, quickly.

DR. BRETT: Got it.

DR. COHEN: I don’t think we need to go through it, but this is just a little more discussion, and, Vickie, certainly the Data Council should be here when we talk about this as well. But I will expand this in more detail.

And then just the third recommendation slide that focuses on not federal. We discussed this transition activities, the framework to NGO. One thing that came up clearly in the workshop is we need to get more community reaction to the framework and more community input. And ultimately we will be trying, as Rebecca just said, to coordinate federal activities with any non-federal, non-NGO activities in this area.

And so these are the broad themes that we’re going to try to hone in on as we prepare these recommendations. And as I said before, we still haven’t decided whether it makes sense to try to finalize these recommendations for the report in February or whether we’ll need some more discussions to try to get these done I think in a conference call, Executive Committee, or Full Committee meeting sometime later in the spring.

MS. HINES: Bruce, can I just echo on that? That the workshop report probably should just be a standalone report-out of what occurred at the workshop, and any emerging themes that came out can be reflected in that workshop report, but I think the letter from the Committee would have the actual recommendations in a concise, clear set of messages.

DR. COHEN: Yes, I agree. I don’t know whether we can have both of those done by February. I think we should target the workshop report to be finalized by then, and the letter soon thereafter. That would be my recommendations now.

DR. STEAD: Vickie has her tent up.

DR. MAYS: Can you go back to the – Kate, can you go back to the one before this?

DR. BRETT: Sure. This one?

DR. MAYS: Yes. I just want to say we need to go through these because this is a lot. Like develop methods and assist state development of web-based query systems, provide local data. Some of it – I just think some of this has to have a little bit more discussion. That’s a very expensive undertaking, and I’m not sure exactly who should be doing that.

Collaborate with NGO efforts to spur community metric-centric well-being efforts. To me, that has to be a lot more specific, how you do that, who the NGOs are.

So some of these I think we need to work on just a little more.

DR. COHEN: Thank you for volunteering to help us, Vickie.

DR. MAYS: I’m on the Committee. I have no problem.

DR. COHEN: That will be great.

DR. STEAD: So basically your work, as a Subcommittee, to narrow that list.

DR. MAYS: Yes.

DR. COHEN: Yes. This is Population Health Subcommittee. And if there are folks who aren’t on the Population Health Subcommittee, technically who want to be involved in refining some of these recommendations, just please let us know. Your input would certainly be welcome.

DR. STEAD: Well, thank you, Bruce. All the tents are down at this end, so we will shift to the all-payer claims database if that’s okay with you.

DR. COHEN: Thank you all.

DR. STEAD: And we’ll free you up for your afternoon. Thank you so much for joining us.

DR. COHEN: Okay. Bye-bye.

DR. STEAD: So we are now to where we can spend the rest of our time before lunch on the all-payer claims database discussion. Are you going to lead off, Denise?

MS. LOVE: I am. I am. Thank you. I’m multitasking here.

Agenda Item: APCD Hearing Follow-up: Themes for Recommendations

MS. LOVE: Thank you everybody who was involved with the hearing. I want to thank Walter in particular and Rebecca for putting this together on – even the staff. It was put together I think fairly rapidly, and we had a day-long hearing. And I thank the Subcommittee, including Alix and a few others, I can’t even remember who was on, to help –

PARTICIPANT: Sorry to interrupt, but I can hardly hear you, Denise.

MS. LOVE: Okay. I’m doing my thank-yous – to help guide the response. As you recall, we had a draft letter come to the Committee when we met last in September, and we had a discussion and we opted to go back to make sure that we’re on the same page regarding the themes and the recommendations before we proceed into a draft letter, which I think will be early next year.

PARTICIPANT: As in one month.

MS. LOVE: Yes. Okay. So the purpose of the hearing was really engagement of stakeholders and the Committee on key issues related to claims-based databases and identified priority areas and opportunities to recommend to the Secretary of HHS and the industry where appropriate.

The objectives of the hearing was to – and I’m refreshing so we can then get into the themes, and you can put your memories in gear to remember the discussions, but the objectives of the hearing was to get an update on the status of claims-based databases, APCDs, what’s driving the development, and some of the challenges that states and agencies must address as they go down this journey.

We wanted to hear about the public benefits and concerns for consumers and policymakers, research, and population health programs; business model benefits and concerns for providers, payers, and state and federal programs; review of the technical challenges, of which there are many; and the role of claims-based databases, including APCDs, in a reformed health care system, as we know that we’re migrating to, albeit slowly.

I won’t go through a list, but these were the presenters. They represented states, some industry repositories and warehouses, and payers, and employers.

These are the themes, and the themes from the hearing, and in reviewing the materials, we heard repeatedly there’s a need for standardization and interoperability between claims-based data reporting initiatives.

Another theme was there needs to be a mechanism for sustaining a process of maintaining reporting standards.

Incentives will facilitate the adoption of state-based APCD standards.

We need or we suggested that federal and intra- and interagency collaboration is essential for filling important data gaps, and I’ll cover those in a little bit.

And patient and provider identification solutions are essential for analytic needs and so on.

So those were the themes that rose to the surface. Do we want to take a minute and –

DR. STEAD: Yes. So let’s pause just for a second. Would these be findings from the hearing? Are these things that were –

PARTICIPANT: When you say “findings,” do you equate that to recommendations?

DR. STEAD: No. I am trying to distinguish between findings which are the themes that we heard during the hearing, and they would be based on and reflected in a transcript of the hearing and –

MS. LOVE: I think the only one that might be weak would be incentives.

DR. STEAD: Okay, but what –

MS. LOVE: Oh, okay.

DR. STEAD: I think of recommendations as things which we, as a committee, agree to recommend to the Secretary, and they presumably reflect our response to the findings, but they are in fact from us, not necessarily from the hearing.

So I’m just trying, as we talk through this, I think one thing we need to do is be pretty careful about what are the themes that we’re viewing as findings, which we would presume if there was any question about, we could track it back to the transcript, and what are recommendations, which are a different animal.

MS. KLOSS: Could I put another question on the table? I don’t think we decide it now, but maybe when we get to recommendations. Does the Committee have a position on this or do we need to discuss the Committee’s position?

MS. GOSS: I think that’s sort of also where Bill is getting, if I can jump in here, Linda, and since the – we just inherited this yesterday afternoon, so we’ve done no direct coordination, you know, myself and Nick and Denise, however, I’ve been engaged in the APCD discussion and also attended the meeting.

My recollection is that at the end of the extensive day of testimony, we captured a number of thoughts, and that those thoughts were then distilled down into themes or findings. And I’m looking to Rebecca because I know she was involved in this.

MS. HINES: It’s all written up.

MS. GOSS: It is all written up. So there should be a thread, to Bill’s initial point. And I think to Linda’s point, we are now at the point – we’ve come to the point where Denise is going to present some thoughts, and then we, as now the Subcommittee on Standards, needs to hear the feedback from the Full Committee’s discussion today to take it back so that we can do further work.

My understanding is also that the industry has expressed some concerns and that information is just coming in. So we need to step back and think about the larger set of implications and considerations that will come from today’s discussion, so it’s just a launch-off point because I think we do really need to dip our toe into the water of what do recommendations look like, do some noodling on it. And so I suspect even getting a letter to February may be challenging when we look at the other priorities that we have related to the 12th Report to Congress, the statutory obligations that we have related to ACA 109 and RC.

DR. STEAD: And, therefore, when I was sketching out – you know, I basically said action on this was likely to be in the April to June window, not in the February to April window for that very reason. Obviously, if things turn out to go quickly, fine. I would like to keep the themes to where they’re things that would fit in the category of findings.

MS. GOSS: I think that’s a standard approach. I think I shouldn’t say that, but that’s how –

DR. STEAD: Okay. Then based on Denise’s comments, do we keep as a theme incentives will facilitate the adoption of standards? Was that something through which we heard –


MS. GOSS: Yes. We heard even from the feds, we talked about it.

MS. LOVE: We heard CMS talk about the Medicaid match as a sustainability –

DR. STEAD: Okay. That’s fine.

MS. GOSS: They did a lot of encouragement to tap into creative strategies that leveraged –

MS. LOVE: And since that hearing, we have had several states avail themselves of CMS’s presentation at that hearing, so I think –

DR. STEAD: So one thing may be that incentives are available to facilitate? I’m just trying – I’m just –

MS. LOVE: Well, but this is where it’s a little weak because incentives are and will facilitate the adoption of APCDs, but there is no hook –

MS. GOSS: There’s no maintenance.

MS. LOVE: Well, or requirement, and I think that is where it’s unclear, and that’s where I wanted to say it’s a little weak, because they didn’t say if you adopt a standard APCD format, you’re eligible for Medicaid Match, because there is no standard APCD format, so they can’t require it. So we could reword that, though. We could reword that.

MS. GOSS: I think you’re also introducing an additional distinction –

MS. LOVE: Yes.

MS. GOSS: – but I really do want to defer to Nick. I think he has some comments.

MS. LOVE: Okay.

MR. COUSSOULE: No, I’m trying to understand Linda’s question on a base level, sorry, about, do we have a position? A position on what? A position on recommendations? on the agreement of the findings? on the –

MS. KLOSS: Well, I guess I’m – I missed the meeting where the commitment to hold the hearing was launched, so I’ve been a step behind or maybe several steps behind on this topic since the beginning. But I think what triggered my question was specifically number three. And my concern that we have an opportunity to talk about, what is our position on promoting APCDs, and how does that fit with our charge? I don’t know, maybe I’m just obtuse, and I’m sorry about that, but –

MR. COUSSOULE: No, I think that’s a fair question. To Bill’s point, if we can get into, was this what we heard at the meeting, and does this concisely represent that? And then we can talk about, is it something we think that’s even in our purview to progress or not, right?

MS. LOVE: And I think the way that Walter framed it was – I mean, for 10 years this has been happening at the states, and it’s accelerating. And I think we’ll talk about later whether the NCVHS engages or not, it’s still happening. So that’s a committee – I think what my goal was, to engage, just what we’re doing. And how we engage is not determined.

MS. GOSS: And to add to that, the one linkage I can see, Linda, is that if we are anticipating that – let me rephrase that. If we know that we have a need for standardization and we know that this is based upon claims and we know that the source data that leads into is the 837, there’s a linkage there.

MS. KLOSS: That I get. That I get, yes.

MS. GOSS: But the question is, just how far should we go?

MS. KLOSS: Yes, that’s a different scope.

MS. GOSS: It is a different scope. Yes. But if you want to promote standardization, why would we reinvent the wheel with the investments the industry has already made? We should help promote leveraging the data in a thoughtful and useful, meaningful way.

MS. KLOSS: And that’s a different way to frame this issue.

DR. MAYS: And that was actually my question to some extent, is that, is this in really the standards bucket, and that that’s part of what we’re actually talking about, is framing from that perspective?

And then my other question was you said something about already getting feedback from the industry.

MS. LOVE: Mm-hmm.

DR. MAYS: Can you talk about that a little bit? Is that coming as a standards thing or is that – I’m just trying to get the framing.

MS. LOVE: What I was going to do is mention after the presentation we did – I think Jim just got one from Anthem, and there’s been an AHIP letter. And I can go over some of their points. Some of them are not resolved, and they won’t be resolved in short order, like provider ID.

DR. STEAD: Right. So it seems to me that as we’re working our way through to a clear understanding of findings and developing a position on recommendations, we can receive and pay attention to the input we receive along the way, and it will be an iterative process.

MS. LOVE: Yes. So what I’m hearing is reframe these as findings instead of themes, or does that –

DR. STEAD: All I would do is have one list of – and I don’t care whether you call them – I would have one list that are things that – I like the word “finding,” frankly, and another that is recommendations. But they can both be themes.

MS. GOSS: But I think it’s important is that I don’t know that we have any specific recommendations at this point.

PARTICIPANT: There are a few that I know have put out.

MS. GOSS: There is some fodder for us to start thinking about, but we haven’t gone that far, and I think part of the reason is we know that there has been some background noise about the topic and things seem to still be bubbling in a multitude of ways. And the second thing is, is it in our wheelhouse? And where does it fit in the prioritization?

DR. STEAD: Right. Because one alternative could be that we write a report on the hearing, and all of the recommendations could be in the category of future work, not in – I mean, if you play back the things like – we may not have recommendations out of this at this time, or we may.

MS. GOSS: So let’s dive into the themes and see where we land.

MS. LOVE: Yes, yes. So on the journey of engagement, the next – so I expanded these themes out. We heard just about every presenter cited the need for standards and uniformity. I think that was like my biggest takeaway from that whole day.

There is state-to-state variation. It exists. It is burdensome, we heard, for the multistate carriers, who may have to respond to – I mean, there are up to 20 states now who are at some stage of implementation, and I expect that will increase over the next year.

We did develop in 2010, with AHIP and AHRQ and NGA, a core, Version 1, just a list of data elements that we reviewed, and it just sat there, and some of the states were using that as a guidepost.

And so we had a little thing happen called ERISA, the ERISA ruling with the SCOTUS, and that changed a lot of things. One of them was it stimulated a fabulous energy and response around state interest in harmonizing across states. I’ve been doing data, state data, policy since 1991, and this is the first time that states actually came together and voluntarily said, “We will standardize, harmonize, across our data sets if that is a concern for getting the ERISA data,” and we can talk more about that.

So everything is lemons and lemonade when you do data policy, so we took that lemon and turned it into what I think is pretty good lemonade. I figured this morning just NAHDO and the APCD Council alone have put in two full-time FTE efforts without funding to corral 14 states since last spring, and it’s not finalized.

MS. GOSS: That’s additional commentary that I think is important, but I think we need to stay very focused on themes –

MS. LOVE: Okay. Thank you, Alix.

We are developing the CDL, which was mentioned in the hearing, but it was not ready for prime time or review at that point, so we did not get play. But the process is open to all states. Payers are participating. It’s open. No dues or membership requirements. We are now working with PACDR and X12 for guidance and harmonization across those implementation guides.

So the recommendation in bold –

MS. GOSS: Can you explain PACDR term?

MS. LOVE: Oh. The Post-Adjudicated Claim Data Reporting, which was developed I think in response to not only state APCD developments, but also Medicare and Medicaid encounter data and the anticipation that as capitation and other forms of reimbursement come about, that they needed an alternative.

MS. GOSS: So one additional translation is that it also aligns with the HIPAA-adopted claims transactions.

MS. LOVE: Only one state has implemented the actual transaction, with much pushback from the payers, who are not prepared to send an 837 outbound to states. That has been clear.

So we are there. And the bold recommendation for your discussion review is NCVHS should engage with the issues related to APCD initiatives. That’s kind of a soft recommendation. It leaves it wide open.

The second theme, a mechanism for sustaining a process for maintenance and content reporting standards. Really, state reporting initiatives have no official SDO, or standards development organization, for content development.

I was thinking this morning, I mean, Vital Records has NAPSIS, the cancer registries have NACR, and both of those are support by CDC. This has no federal partner. So NAHDO and the Council are really filling the void because there is no place to go. So that is a flaw or a hole, I guess, in the process.

But as we move to Alternate Payment Models, how will this information be collected? And I think that is a Committee concern. Do we want a systematic upfront design for data collection or are we going to go with the six states who are actively working to fill those gaps on their own?

This is I think a larger question from a policy standpoint because states will move, they must move, but they’re moving maybe a little different direction. We’re trying to corral that. That’s just an open question there. And then if CMS is moving in that direction with Medicare, will there be harmonization between what the states are working on right now and what CMS moves towards with APM and MACRA MIPS?

So does there – I guess this is – you know, and my thinking on the recommendation, does there need to be an SDO designated for addressing federal-state reporting initiatives and not payment transactions? I’m just saying.

This is that incentives will facilitate the adoption of APCD standards. And maybe this is a little aspirational. I will just say that as I thought through this, we are seeing Medicaid Matching funds coming into, and a lot of SIM investment into some of the state APCD developments. But there is no real hook or requirement for adopting a uniform standard, if one ever exists. So in the future, I just think that would be ideal.

The states in the planning stages are seeking guidance around APCD reporting formats, and eagerly looking for a common core. So once we have a common core, I think the development of analytic tools and methods based on these common core standards are just going to be a natural outflow.

One of the models that I’ve worked with over decades is Healthcare Cost and Utilization Project, or HCUP, where we now have quality measures off a standard hospital discharge data format.

So that is looking down the road a little bit. I think standardization is the first step if we’re going to get common measures.

So I’m suggesting maybe NCVHS can support federal incentives for aligning state-based reporting initiatives or not, but that would be an HHS ask, if I were to put in a letter, to put a requirement for standards if accepting federal dollars.

MR. COUSSOULE: Sorry, Bill, you made a comment – oh, sorry, not to interrupt – you made a comment earlier about that NCVHS cannot reference funding. How does that play in? I guess I don’t understand that well enough to know what the do’s and don’ts are for that from an NCVHS standpoint.

DR. STEAD: Well, I’m not the expert, but we’ve been very careful not to say, Fund X. We can make statements like, Incentives might help, as long as we don’t say necessarily where they come from. So we’re trying to provide policy guidance, not a prescriptive, implement it this way, in general.

MS. LOVE: And I think I’m referring to the money already flowing.

MS. GOSS: And I think that what I heard you also say, Denise, is that if you’re going to promote APCDs or strategies related to them, then as a state body, then you should really tie an expectation to that funding about using base standards because it’s really also not just about what one discrete state does, but it’s about how the data across the states and the public initiatives all need to have interoperability to really harness the value of the data. So I think there is sort of a larger picture.

DR. STEAD: Well, and it might be that we can identify a set of best practices that at this juncture we could annunciate. That would be one step back from saying, Do X. I mean, I can see as we really figure out where we are in this landscape, we can figure out what is ready for prime time now is the real question versus what would be a next step.

MS. GOSS: Well, reference is either other models, like either HCUP or Vital Records or others as a model that could be looked at for these developmental databases because I do think that they fit almost closer to those models than some other data initiatives do.

MS. LOVE: So we heard at the hearing from the states and from SAMHSA, OPM – we did not hear from Labor – that collaboration across federal agencies will be essential, and states really are concerned about gaps in the data. SAMHSA data and substance abuse data is at risk of going away, and APCDs right now in many states it’s the only source of statewide substance abuse data, and several states have done opioid studies off the pharmacy and the claims databases, and it’s critical. OPM is in communication with us, and states, and I’m optimistic that that will open up.

DealWell, we don’t have time to go in, but the states have submitted comments to Department of Labor. It closes December 5th, so we won’t know how this will play out, but it does not preempt other ERISA-covered, it’s only the self-funded, not the fully ensured, the self-insured only.

So the states are proceeding with – we are reaching out to employers. We won’t get into that, but there are some good things happening in the states in regards to the employer-based self-funded plans.

We also have to be aware that we have APMs – Med Advantage is another one that we want to watch closely because the states are getting Med Advantage data, and I did not know that CMS does not. So that’s another gap that might need to be looked at.

But the soft recommendation here is really federal-state collaboration engagement is needed to fill these gaps, the states can’t do it alone.

We all agree – I think the letters came in from AHIP as well, that patient and provider identification solutions are essential and needed. The NPI continues to be a problem, needed for population health, evaluation, on and on, you can see the slide.

This may not have come out as clearly at the hearing, so I wanted to be clear about that, but patient matching guidance has been requested. We have states approaching it different ways, and it would be nice, in the spirit of uniformity, to maybe corral that.

But fixing NPPES would be – I think everyone would agree, industry and states, and it will be crucial to APMs, and that will require federal-state collaboration, and industry.

So I think that covers it. Now, on the letters, we did receive some, and I just wanted to be clear that the common data layout, as we’re referencing, is in process or in progress, it is not finalized, and we welcome all people that want to join our calls and develop that.

The other, I think the provider –

DR. STEAD: Again, to keep our different hats, you are making that statement in your day job role –

MS. LOVE: Yes.

DR. STEAD: – not in your NCVHS Committee –

MS. LOVE: Right, right. I’m sorry. I’m sorry. It’s a good point.

DR. STEAD: – and I’m just trying to keep –

MS. LOVE: Yes. But it is not finalized, still has some work to be done.

The other, I think the – and how do you want to approach the letters? Do we write or do you write a formal response to the AHIP letter on the –

PARTICIPANT: We’ve gotten more than just an AHIP letter.

MS. LOVE: And there’s Anthem. But they’re very similar. Anthem and AHIP are sort of similar.

DR. STEAD: We have now got – I simply – all I did –

MS. HINES: You’ve looked at them.

MS. LOVE: Yes, right.

MS. HINES: So a lot of us need to – I think from a – if –

DR. STEAD: I think they need to – so let’s – well, I replied to the AHIP letter saying I appreciate the input and –

PARTICIPANT: It was addressed –

MS. HINES: Okay. Okay.

DR. STEAD: – so I was basically acknowledging receipt and feeding it into our process so that we can deal with it. My inclination is to do the same thing with the Anthem letter, to basically acknowledge that I have received it.

MS. HINES: The Anthem letter was sent to Jim Scanlon.

DR. STEAD: And to me I think.

MS. HINES: It was CC’ed to you.

PARTICIPANT: CC’ed to you.

DR. STEAD: Okay, CC’ed. Then Jim – well, whatever. Then maybe Jim replies or maybe Rashida replies. From my perch, we’ve agreed on the following process modification going forward. Denise had been working with Walter in managing this as a Full Committee activity without it in fact having a home in a subcommittee.

I think as a general practice, I think it’s important for each of our activities to have a home either in the workgroup or in one of the subcommittees because that’s how it gets connected to the Executive Committee and lots of other pieces.

So I think that Alix and Nick will sit down with Denise and work out a process through which we will move from today’s discussion to something that will come back to us and to some way of dealing within what we receive, et cetera.

MS. HINES: I did want to say that there was at the hearing a post-discussion on, since it didn’t have a home, of a small group not specific to a committee group of members who agreed to shepherd it. So I don’t know if we want to go back to that group of people who were at the hearing and had at the time said they would or whether you would like to go with this new process of giving it a home.

DR. STEAD: I think it’s very important that it have a home, and I think Standards is a logical home.


DR. STEAD: I think that as we do to the degree there are people that are not part of Standards that are interested in helping move this forward, they will be very welcome on the Standards calls that address this.

PARTICIPANT: Come on over.

PARTICIPANT: That’s fine.

DR. STEAD: It may or may not, but I think it’s important to fit this within a process that – and I think while I’m Chair, I will try to make sure that any initiative we launch does have a home, even if, as we did up there, most of them are being worked as a full committee. They still have a home and they’re being facilitated and driven by that home. So it’s just a good process I think from a management of bandwidth and everything else.

Alix has a –

MS. GOSS: From a process perspective, I think the first thing we need to do, since we’ve been getting documents in on the fly this week, we need to make sure that we get those out to – because I noticed like Terri wasn’t on the distribution list. We’ve got to get them to Terri, we’ve got to get them to the Standards Subcommittee members, and we’ve got to schedule some time to – once we’ve all been able to digest that, to actually talk about this and figure out where we want to go and how we might want to distill down the themes and findings into recommendations or not, or where we want to go.

But I also question, because I can’t remember because this was in June, was there anybody that’s in the Standards Subcommittee that wasn’t at the hearing, APCD hearing, in June?

(Show of hands)

MS. GOSS: Oh, that’s right, Rich. Okay. So we may want to then make sure that we start with a recap, Denise, to level-set everybody on sort of – and I think we can go back to some of that subgroup work or ad hoc group work that Rebecca referenced where after the meeting we did a round-robin, did a whole bunch of flipcharts, and then distilled that down into sort of core thoughts, and we can make sure to level-set everybody.

DR. STEAD: And from a process point of view before we go to Rich’s tent that’s up, I would suggest that you consider, based on where the maturity of this is, whether you want to have a report of the hearing that in essence captures that background and information, much as we’ve done with some of the Pop Health pieces.

And if you can get that where it’s then accessible both to the Committee and beyond the Committee, you could then have a separate, much more focused task around, are there specific recommendations that you would recommend the Committee making that are ready for prime time now?

And that you could then put those two together as a letter with specific recommendations and the report attached. That’s a fairly useful way to tackle it when we’re exploring what to the Committee is a new space. So I just put that out as one possible way to manage bandwidth.


MR. LANDEN: A couple of quick comments. One, again, I point out the parallel when we’re talking about the use of this data for APM and alternate payment models. It’s a parallel track to similar data that’s flowing, has to flow, across the APMs on a clinical side.

So I think what we should take some time and look at and whatever product we come up with is just making sure we look at the clinical flows versus the post-adjudication flows and see what there is that may change our perspective. I’m not expecting much, but I think due diligence, we need to look at that.

Harking back to some of the earlier comments on this, I think the presentation today starts from the assumption that the APCDs are something that need to happen, and we have a roll in that.

I think what we need to do, again in whatever drafting we do, is to fully articulate why that assumption is true and bring it out and why it rises to the level that it needs action or at least analysis from NCVHS. I don’t have any doubt that it’s there, but I think we start from that assumption. I think we have to take a step back and make it very clear why we’re engaging.

MS. HINES: I would just say that this is a good case study of when you don’t have a home for a project. We’ve sort of circled backwards a little bit, I think, and thank you, Bill, for having a policy now that’s explicit that everything we do going forward has a home because I think this project has suffered from not having a regular subcommittee or place that can keep it moving forward.

DR. STEAD: Yes. Is there other discussion or input that would be helpful to you, to the three of you, or whatever the group is, as we try to carry this forward, or has this served its purpose?

MS. LOVE: Yes, I feel fine.

MS. GOSS: Can buy off in this corner.

DR. STEAD: Okay. Then we are 17 minutes ahead of schedule.

MS. KLOSS: You’re setting a heck of a precedence for your running a meeting.

DR. STEAD: Do we want to break for lunch a smidgeon early? And then maybe get back a smidgeon early or let it go – or let people – we’re going to walk out to lunch, I presume.

Absolutely hard start at 1:00, but we get a little bit longer chance to get out and get back. Thanks, everybody.



Agenda Item: Full Committee Strategic Discussion: Next Steps

DR. STEAD: Colleagues, I think we will begin to regroup. Let me put a draft of what we might do on the table and see if it works for people. I would like to take a few minutes and just find out if there are changes people would like to suggest in the plan as we left it last night to reflect your thinking while we slept and in various and sundry sidebar conversations or whether that still seems like a pretty good working plan. I thought we might take some time and do that together.

If we still like it or if we modify it a bit and then have a piece we like then what I would suggest we do is break up into smaller groups, possibly one around standards and one around privacy and confidentiality. I think pop health has a pretty clear path forward right now. We might work the plan from now to the February meeting. The thought would be in essence to try to let us work in small groups so that you did not leave here and then need to begin to regroup as a subcommittee about how we respond. I was just thinking that that might be the best way to let us effectively walk out of here with the big plan and with the immediate work plan, if you will, from the perch of what I see as the two most weighted subcommittees. I think we do not need to do anything in that regard about the report to Congress. That has been yours and my court. Plus we are going to get the input from people. That is how I am proposing that we use the afternoon. Welcome to any other suggestion as to how to do it.

We would break in the middle at two at a time that Jim could call in so that we could formally cite his accomplishments and thank him for the guidance he has given us as a committee and then we would continue to work after that.

Would that be the most effective use of time or is there another approach? Are there specific topics? Does that work?

Let’s start with the big plan. I did omit – I actually had typed out a one page. Should you just maybe send to the whole group what I sent to you this morning? Even maybe just project it. It is a way to look at the big ticket plan and we can see if we want to jiggle it or not.

While we are waiting, are there reflections? The meeting dates have changed. That is the current agenda.

MS. HINES: I was thinking, Vickie, that shortly after we adjourn sometime in the next day or early next week, I will send an email with the whole logistical update and everything revised so that you can get your calendar straightened out ASAP.

DR. STEAD: Before we look at back at what I wrote out before this morning, which had a couple of things that I forgot to mention that were correctly picked up by Alix and Bruce, does it high level where were yesterday still work for people? Or on reflection, were we having second thoughts? I know we still have to know – get the plan to know if it is doable, but I do not know if people simply —

MS. KLOSS: One other thing I thought – this is more on committee operations, but we will have to go through an orientation process for new members.

DR. STEAD: I hope that we will have an opportunity to go through the orientation process.

MS. GOSS: Considering the workload we have, it would be phenomenal if we could have those appointments done this calendar year. That would be great. Whatever powers that be might be listening, please.

DR. STEAD: It is a compact view and it may be helpful if we can get it brought up.

(Technical Problems)

DR. STEAD: What I did was to be as brief as I could and to create a table at the top of it that had the major projects, then a column for Full Committee review or hearing or workshop and then action or subsequent action based on what something was. Does everybody now have it?

Let’s come down from the top. Measurement framework. What I am now hearing is that pop health is actually thinking about the recommendations being subsequent to the report. If so that that may make it after February. It seems to me that is tight enough. It would be really helpful if pop health could actually bring it in on this way.

MS. HINES: I would say that what we have here is the measurement framework and a workshop report could be done by February. The measurement framework is done now in a sense. Basically, what this should say is the workshop report and then the letter – we will work on it and see if it is also available. I think it actually could be done by February. I am not sure what Bruce’s hesitation was, but we will just see how it goes. We certainly have pop health subcommittee meeting set up. It is just a question of will we be ready by the time of the February.

DR. STEAD: In many ways, I would just advocate trying to bring that to closure to free up our bandwidth because the committee is going to be very busy in both the April call and in June. And now she has it up for people that do not have computers. Thank you, Janine. These are just listed in the order of what I thought action would take place. So then the DID and the target there is actually to get the action in February. Report to Congress. The Full Committee review of a pretty final draft and action either at that meeting or on an April call. Rebecca and I are owning that. We are asking each of the people to identify points and get those to us in the next two to three weeks. But we are trying to keep the report to Congress off the critical path of the subcommittees. Do people agree? You will need to edit it. We are trying to keep this short. I think it is easier for us to do it and the subcommittees to fix it than for the subcommittees to do it and us to assemble it.

MS. GOSS: It sounds great. I think we just need to make sure we get you the kind of input you are looking for in the next couple of weeks, which is something that we need to figure out.

DR. STEAD: Then healthdata.gov. I think we are on course for February and then either a February or April action. APCD. We had additional sidebar conversations over the course of lunch. Rebecca has emailed a summary that had been put together back in the summer and an outline of what might be a short summary.

MS. HINES: And I emailed it to the people who were on the list who said yes I will help work on it. That was Helga, Vickie, Linda, Bob, Alix, and a few others.

DR. STEAD: My gut tells us we should try to limit what we are trying to do to a short hearing summary, which would in essence be compatible with what we were doing. This hearing was our initial fore into the space. We were surveying the landscape. If we can summarize what we learned from that in a way that helps us and the industry then we could then decide, as we look at our downstream plan, do we want to work some piece of this in more depth or not and come back with whatever the right approach to doing that would be as we had bandwidth? We would not try to go further than we can based on the one-day hearing that we have. That is a gut reaction. Leave that to Alix and Nick and the subcommittee process to handle as they see fit. But that is one possible way to contain it. If so, this material that Rebecca sent might be a way to get to a first draft. Just putting that out as a possibility.

But at the moment what we are doing is leaving it as Full Committee review in February with action four to six. It seems to me maybe what you are really going to do in February is update us on the approach and timeline and maybe we take – wouldn’t that be more realistic?

MS. GOSS: I think everything you have said is reasonable. I think that we need some time to digest all of these in concert with one another with lead staff, staff, whoever is designated to support us as in subcommittee members because we have a lot of heavy sequencing over the next two to three months to get to some very critical milestones in the June and August timeframe. For me right now, I am still trying to put my brain around it.

DR. STEAD: What I am trying to do is help with that by basically saying, one, and limit scope. Two is from my perch and I think we need to know whether we agree on it, finishing whatever we do in this version of APCD is less important than us setting up the other things that you are trying to do to get us ready for June. As we have to tune the critical path, I would rather begin to move this out rather than overloading you.

When I wrote this this morning before we had today’s discussion, it seemed to me we might actually have something for real review in February. I think what we might now have for February is how are we going to bring this closure and in what timeline. That would be whenever that was.

PARTICIPANT: What we are having for February then is a work plan?

DR. STEAD: Approach and work plan. And then I will just simply kill the action block.

Then Review Committee targeting hearings 2017 with action on something in November. It probably still would be nice to have a different way to title this if we could. It is what we are doing. It would be nice to have a name as we did when we went to admin simp, but admin simp was bigger. We need to consider whether there is another name?

PARTICIPANT: Do you mean the Review Committee?

DR. STEAD: Yes. That would be a neutral name that would do the scope as we have defined it and meet the charter – same for ACA 10109. We now have two topics we are going to deal with there.

MS. GOSS: We have a sexy title for that. Edits, audits and enforcement.

MS. HINES: What is it called?

MS. GOSS: Edits, audits and enforcement.

DR. STEAD: Do you have something as sexy for the Review Committee.


DR. STEAD: Keep it in mind. Then vitals. We are now changing that hearing to September.

MS. HINES: We actually have a date, which is September 12.

DR. STEAD: We also have dates for –

MS. HINES: For the pri auth end to end it is the 20th and for edits, audits and enforcement, it is for the 19th of June.

DR. STEAD: Then predictability roadmap workshop in August and then hearing either in Q4 or Q1. Whatever it is it will be one of our four hearings in the subsequent fiscal year.

DR. GOSS: I would like to tie this back to a comment that was made yesterday. I think, Denise, you might have made it. I think that as we were trying to be efficient in our co-locating of topics from the testifier’s perspective and our budgetary aspect, it may be that the predictability roadmap conversation ties into the next DSMO change request brought forward and did not want to lose the linkage with that outlier activity that might be in 2018.

DR. STEAD: You lost Rebecca and me. Let’s unpack that.

MS. GREEN: I think you are right. We were talking about 7030 and some things to come.

MS. GOSS: HIPAA upgrade is going to happen. Maybe the time to actually have a hearing relates to a HIPAA upgrade is also the same appropriate timing to try to talk about predictability roadmap opportunities.

DR. STEAD: This would be hearing Q4 or Q5 and might include 7030. Does that capture it?

Then beyond HIPAA, the first real step of that will be a draft framework of principles, which we will try to do over the course of this calendar year led by privacy and confidentiality. That could set us up for a hearing of some ilk and 2018.

MS. HINES: And what we have on right now on the chart and obviously this can all be amended and revised is to carve out time at 2017 meetings to queue you up for that.

DR. STEAD: To queue us up for that and to queue us up for terminology and coding. Both of them are going to have to have queued up work beyond HIPAA first. Terminology and coding might be Q4. We have a hearing in 2018.

PARTICIPANT: But we had some pre-work on the board here. We had something up there.

DR. MAYS: What is the queue up meeting date? June?

MS. HINES: No, for queuing these up, we were going to just make sure there was time allotted at the February, June, and/or September meeting.

DR. STEAD: One of the things that Rebecca and I will bring to the executive committee probably in our December call will be a draft suggestion of how to use the half day blocks in February, June and September. We only have those three. We will not have November. Let’s put that on a tickler list for you and me for the December exec call.

Those are the pieces. It seems to me what that does if we can achieve that will really set us up for the 2019 report to Congress and the 2019 Review Committee. I like the cadence. We are beginning to get to it.

Then I tried to put key points under scope. I did not try to rewrite everything we did, but report to Congress. We clearly need a statement of the importance and value of admin simp in addition to four to five key points. We are going to mine those over the next two or three weeks or we can wait.

Then what we are saying we are going to do in the whatever we rename it is update implementation use statistics, do prior auth end to end and maybe do something about ICD-10 coding accuracy.

MS. HINES: Right now is our working name for that, Alix, prior auth end to end. Is that reasonable? Nick. Yes.

DR. STEAD: I do not yet have a better name than review committee unfortunately. We are basically going to – we want to get updated usage statistics on the named HIPAA transactions. We want to actually get a – whatever happens we are going to need a way of tracking our progress. The industry is going to need a way of tracking our progress. That is one – we would like to do an end to end, which will be an important deep dive. That is prior auth. I do not have an idea yet.

Then we renaming – beyond HIPAA, we have the high-level framework principles. The high-level framework is plane one. Detail is plane two. We had mentioned – we were going to dual count DID as an example there. I think dual counting predictability roadmap there works less well. I take that out. Is that what you were advocating for?

PARTICIPANT: I am sorry. I missed that, Linda.

MS. KLOSS: I do not think predictability roadmap works as a detail beyond HIPAA.

PARTICIPANT: We are in beyond HIPAA under scope.

DR. STEAD: Then is improving patient authorization process appropriate there as a detail item?

MS. HINES: Not really.

DR. STEAD: That is fine. Is wearables and mobility an appropriate detail issue there? Is there another that should be added or are those two all that we need to do at the detail level this year?

MS. KLOSS: I would like to see us think about incorporating the value payment.



DR. STEAD: These are kinds of things we might do in our four-year blocks. So QPP. Is that now feeling right?

Then terminology and classification. We have narrowed the scope to approaches to support iterative additions to concepts and terms and roadmap to ICD-11 plus or minus ICD-10 analytic impact.

MS. HINES: Is this terminology and classification or we use the term vocabulary or does it not matter?

DR. STEAD: I think terminology and classification. Don’t you think?

MS. HINES: I just want to make sure we are consistent.

PARTICIPANT: Terminology and vocabulary.

DR. STEAD: You prefer that? Terminology and vocabulary. And then future of health survey. We basically said it is going to be scanned in pop health. People are comfortable that that is high level and how we are scoping these tasks.

And then priorities for committee briefings, commission on evidence-based policy, SSN replacement were the first two in the list. I was not trying to keep going beyond that.

That is an attempt to summarize the high-level plan. We have the detail. I think Rebecca will be turning it into Walter’s form or a modernized version of Walter’s form that is project based.

Is this what we are walking out saying basically that is our current draft?

Then how do we want to break up and begin to work? What are the right groups to work the path to February? Will it be helpful to have a standard’s huddle, and if so, who should be in it?

MS. GOSS: The challenge is that we have lovely people like Linda who sit on multiple committees.

DR. STEAD: Linda is going to have to deal with the privacy and security. We are not going to be trying to work a pop health one. We thought that some of the pop health people could help Linda work privacy and confidentiality. Who do you need to work to be productive?

MS. GOSS: There is a difference between need and want. I think that quite frankly I think Terry needs to be a critical part of this as does Rich, Denise.

DR. STEAD: — work it as a whole. Now that we know the big piece if we are really trying to lay out now to February, would you like to work that with us all here and then we would do the same thing around privacy and confidentiality?

MS. HINES: Why don’t we just do that? We have time.

DR. STEAD: We have time to try to help — I am just trying to get to where you do not walk out of here and need to —

MS. GOSS: I think from my perspective all of us having a deep appreciation of what we need to do between now and then is good because we are all going to probably lose a little bit of this in our brain capacity between now and February. It is probably better if we all stay together.

DR. STEAD: Then we are getting a butcher board. White board for those that do not like butchers. Do you want to do a quick one on report to Congress?

PARTICIPANT: Will you do a standard kind of format that you want? That would probably help.

PARTICIPANT: (off mic)

DR. STEAD: We need to determine if Susan –

MS. GOSS: But I do think there is an aspect of who are the resources that are going to get involved whether it is committee member —

DR. STEAD: We can take credit for the things you do in the next 24 hours because what we are really looking for is writing support.

PARTICIPANT: What we basically need are all the pieces that we then put into a basket and hand to Susan.

DR. STEAD: And my thought is once we have the key points, I will work with Debbie to pull them into the basket and then we will hand them to Susan to make it intelligible.

PARTICIPANT: Who is going to go to the Review Committee report and pull out —

MS. KLOSS: When I was thinking about how I would do that, I thought I would go to Debbie’s – look through those work products and say what needs to be highlighted versus what can be just listed in an appendix.

PARTICIPANT: Would you like to take a lead on that for us?

MS. KLOSS: I thought we were all going to do that. I am just saying that was going to be my work process.

DR. STEAD: What she is doing is suggesting a work process, which makes a lot of sense because we had Debbie pull out the list of letters and reports —

MS. KLOSS: But we are just going to highlight the things that really need to be underscored.

DR. STEAD: Which means in this thing you would be pulling forward this topic. It would not be the whole thing.

MS. KLOSS: Correct.

MS. HINES: Identify a work product to highlight.

MS. GOSS: I think I am really confused. I thought that we were going to create a report to Congress that had several sections of information upfront and that each subcommittee that had an applicable part of the report was to come up with the key things that they felt were the three to five really essential items we wanted to tout and that there would be an appendix with all the stuff listed. Am I still on the same page?

MS. KLOSS: But that was just going to get to my three to five by going through the work we have done over these three years.

PARTICIPANT: You guys are just going at it from different angles.

DR. STEAD: I think you are both saying the same thing. What Linda is saying is the way she is going to focus in on the top X things is to look at the list of deliverables that we have developed over the past three years and say what item in that deliverable should be brought forward.

MS. KLOSS: Given the context of the time we are in.

MS. HINES: We also were going to draft a transmittal letter.

DR. STEAD: We are going to draft a transmittal letter because we think that is actually in a way is important as a report. We want as the executive committee as looking at the draft and the full committee is looking at the draft. We actually want them looking at the transmittal letter also. It is going to be the one pager.

PARTICIPANT: Define to me a transmittal letter.

MS. HINES: Dear Madam Secretary. Dear Dr. Price.

DR. STEAD: Except this is Honorable X. This is to Congress. We are talking about — that is going to be the most concise place that we can actually – the one most important message probably will be on that page or should be on that page.

Then we basically – we will have a chance to see where we are on this on the December executive committee call and we will have another – we may have an early draft for the January executive committee call. Does that gives us enough of a frame of how to tackle the report to Congress?

MS. KLOSS: We do not yet have the date for the December executive call.

DR. STEAD: One of the to-dos as we leave – one of the to-dos will be to identify the date for the December and January executive committee call.

PARTICIPANT: If we are missing too many people –

DR. STEAD: We are not going to try and do it today.

MS. KLOSS: We may want the deadline for the key points input to be before then.

DR. STEAD: If that is practical. My sense is we are going to want that call to be closer to – we are going to want that call to be before the winter holiday, but as close to the winter holiday as we can get.

PARTICIPANT: — yesterday Bill was spot on that we need to schedule those out in advance.

DR. STEAD: One of the things Rebecca will work with Beth to do is to get them scheduled monthly from now through June. An hour and a half work for people – two hours. We moved mountains in an hour and a half the last time. Let’s get the discipline to make it work an hour and a half.

MS. HINES: Does this make sense to folks? We have basically an outline. I will obviously start adding dates to it. But basically we will get the request out to you all to get us your key points. We will get a writer in place. We will gather the key points and identify the key work products that we want to highlight in the report while at the same time be drafting a transmittal letter and then have the executive subcommittee help us with that. We will have the contractor actually weave together the building blocks and put a draft together. We will have the executive subcommittee take a first crack at it and anyone else who wants to be involved and then we will get a draft distributed to the full committee with any luck by February 1. And then we have the full committee.

DR. STEAD: And if we are fortunate enough to get Susan to do this – Susan, for those of you that have not worked with her, does an extraordinarily good job of doing a first draft that is trying to get the flow and so forth down without actually having everything and getting us to agree on that, which would be the first call, and then it will be more populated shortly thereafter.

PARTICIPANT: What do you want to do next?

DR. STEAD: I think we want to do whatever – let’s do either – for our purpose, let’s call it the review committee because that is what it is. We will figure out how to rename it later.

MS. HINES: What is our end point for the review committee? Tell me again.

DR. STEAD: There are a set of end points. We have a hearing in June and that is June 22 maybe or something like that. We have in advance of that in May the update on the – the end point from the industry on usage.

MS. HINES: What we discussed yesterday was having a – but what we discussed was to back into that was to have a very brief one-page description of what the plan for the review committee is and why we are asking for these utilization rate statistics. In December, we would draft that request to industry. I do not know if there is a formal way of doing an RFI, whether the committee does that, whether we get CMS’ help with that. I do not know. I guess we will figure that out. Is that something we do? Can we do an RFI?

MS. LOVE: How long does it take to issue an RFI?

MS. HINES: Federal register notices do not take that long. If we could get the language together. I just do not know if there is an official formal way to do that.

DR. DORSEY: I know that we can do request for information. I would have to check to see if we could do one on behalf of a FACA. I do not think it would be an issue. That is one thing I can ask about, but I know we can certainly do it —

MS. GOSS: I think there are a couple of different approaches here. We have a number of entities who have been testifiers under the review committee 2015. They gave us some metrics. I think we have a group that we can go back to specifically to send a request.

I think secondarily we probably want to say if anybody else wants to submit statistics, here is what we need, when we need it by, put that on our website. I think the due diligence is to go the distance and maybe put it in the Federal Register so other people know that we are trying to capture that information and to make this an every two year kind of benchmarking of our adoption and use.

MS. LOVE: But an RFI depends on who responds. You could have a very low response rate.

MS. GOSS: I suspect that those who testified at RC 2015 will be very interested in doing this. I do not think we will have a problem getting responses.

DR. STEAD: I like the title of benchmark of –

MS. GOSS: Adoption and use.

DR. STEAD: Is it adoption and use or implementation and use?

MS. GOSS: I would say implementation.

PARTICIPANT: Adoption is a little more formal.

DR. STEAD: Basically, we are using adoption for what HHS does. Implementation is what the industry does. Let’s make this for – benchmark of implementation and use of HIPAA named transactions. Is that right?

MR. LANDEN: Just to be clear, we are going to do an RFI in the Federal Register and we are going to separately contact the usual suspects, those that are in our records that have contributed testimony.

MS. GOSS: I was actually proposing we started – what I was avoiding saying was the usual suspects. I was not trying to preclude RFI in the Federal Register based upon the processes and the rules we may not understand. We know who we want to ask.

MR. LANDEN: For them I am saying we need to reach out directly so that they do not miss it, but to cover the general public, anybody else wants to contribute to the conversation, welcome.

MS. GOSS: That is also why we should put on our website.

MR. COUSSOULE: I am struggling a little bit. It is not an RFI in the classic sense – somebody presents something that we might buy. It is not about that.

DR. STEAD: We need to know what the right terms are.

MR. COUSSOULE: I do not know if we are getting caught up in a term that does not have the same meaning.

MS. HINES: What do you want to call usual suspects? Industry? Is it industry groups? What is it?

MS. KLOSS: Stakeholders.

MS. HINES: Thank you.

DR. STEAD: But it seems to me this request – whatever it is. That actually does not have to – the thing that is going to the Federal Registry does not have to have the description of what we plan to do at the review committee hearing. This is actually something we plan to do every couple of years to update the benchmark.

MS. GOSS: If the process for an RFI is extensive, complicated, et cetera, are you okay if – and we are not obligated to do it in the Federal Register, are you okay if we take the approach with the website and the known stakeholders just from an efficiency perspective?

DR. STEAD: Absolutely.

MS. HINES: Marietta and Rashida and I can figure out the logistics because we do FRNs all the time to let everybody know about these meetings. It is really not complicated. It is a question of whether we want to do that.

DR. DORSEY: What I will look into is you are interested in getting the feedback and is an RFI through an FRN. Is that the best way and most appropriate way? I will just check into that. We will figure out what the best way to do it.

MS. HINES: I guess my sense is we can do what Alix suggested, but in the name of being completely transparent. That way we reach out to the usual suspects, the stakeholders, and then let anyone else who wants to send us that data they can as well.

DR. STEAD: And what we are trying to do is be sensitive to the stress we put the industry under last time and give them three months to reply.

MS. HINES: So we are going to say do April 30.

DR. STEAD: If we get it done in January than have February, March, and April to submit it and we have it a month and a half before the hearing. I would make this something that – this definitely does not need to be tied to the review committee. It is something we need to do. We will do it under the auspices of the review committee. This one actually can be divorced from the paragraph. The more I think about it this can be divorced from the paragraph. That gives you running room on defining the paragraph, which I think would be good. It gets it out of this time period.

MS. KLOSS: I have a little concern about calling this a request for benchmark because I think benchmark conveys some value, some best practice. I think we want metrics. And then from that we may derive a benchmark.

MR. COUSSOULE: There is no benchmark.

MS. HINES: So now it is a draft request for utilization rate metrics for HIPAA adopted transactions.

MS. GOSS: Do we need to be a little bit more – I am just trying to figure if we are only talking transactions. We are not going to operating rules or anything else. I just wanted to make sure we were in agreement on how narrow this was. We are talking about the X12 and NCPDP transactions.

DR. STEAD: Isn’t that what we really got?

MS. GOSS: I think it is. Semantics are important.

DR. RIPPEN: What is important for us to get?

MS. GOSS: I think right now my initial thought is focus on the X12 and NCPDP transactions as a starting place to see how far we get and see how we can extend it.

DR. STEAD: Do we want to narrow it –

MS. GOSS: Leave it at transactions. We are fine.

MR. LANDEN: Would it be of interest to know which of those are using the operating rules and which not or how many are and how many are not.

MS. GOSS: I can see some benefit on that.

DR. STEAD: I would advocate keeping this as narrow as we could as we try to begin to get a first more systematic measure and then I would try to build out. This is the end point. If they are not doing this, they are not using an operating rule. If they are not using the transaction, they are not using the operating rule. It seems to me that the narrowest scope would be whether the people are using the transaction.

MR. LANDEN: I would almost go the other way. The people who are going to provide us the data on the transaction usage are one group. But I am thinking that the ORAE would be the likely group that would answer the other question and that is not duplicative. I do not know if they have that information. If they do, that is fine. We can at some future point decide if we have enough to incorporate that into our report or not.

MS. GOSS: I am trying to think back what people reported on.

PARTICIPANT: Let’s not go too deep.

DR. STEAD: We have to keep moving.

MS. HINES: I guess my question is we know we are going to get these utilization rate metrics and we know we want to have a hearing in June.

DR. STEAD: It seems to me in February, we need a – in February, it would be nice to have a draft approach to the hearing.

MS. HINES: Why don’t we do that in January to draft it so it is done in February?

MR. COUSSOULE: I know Terry had already laid out the sequence of the events to the hearing to the documentation and that kind of thing. There are already steps built in. I think the idea is if it started in January, we need to make sure it lines up well enough —

DR. STEAD: But you also have to define scope. Scope – that will tune the template. So the question is when it would be useful to have – if we are going to have the hearing in June, would it be useful to have a first draft of that at the February meeting?

PARTICIPANT: Draft of the agenda?

DR. STEAD: No, draft of the –

PARTICIPANT: Trying to remember the sequencing exactly.

MS. GOSS: Typically, we have a topic selection. We then the build the questions. The key thing would be we need to have the questions defined and the materials, the things that we would need for that hearing as a first fore. I am a little bit confused because sometimes what we have done in the past is that gets developed by the applicable subcommittee and has not always bubbled back up to the full committee, but may in this case. I am just trying to think through the process and what we have done as a benchmark for moving forward. We have to send it out in advance to the testifiers to give them enough time to get their communities to give feedback so that they can develop their testimony. I do not remember how much lee time we need for going out. I would defer to our lead staff on that.

DR. STEAD: Do you have that off the top of your head, Terry?

MS. HINES: So the testifiers need two months’ notice. If the hearing is June, it means we need to get them going by April 1.

PARTICIPANT: (off mic)

MS. HINES: Basically, between January, February and March, we need a hearing agenda and questions.

PARTICIPANT: (off mic)

MS. GOSS: I think you are on target then if you want to try to have something for the February meeting if that is what you are getting at.

DR. STEAD: At least for pop health. It has been helpful to talk through an early draft with the committee in time to get some general input before you are really trying – I like the idea of a discussion and then you all finalize it after that and get it out.

MR. LANDEN: I am getting a little tripped up here. Our RFI responses are not due until April 30.

DR. STEAD: That is a parallel track because we are doing that in advance of the hearing. Last year, we got the statistics as part of the testimony for the hearing. We are actually talking about pulling that forward, giving the industry longer and getting that data to us in advance of the narrowly focused hearing because that is sampling the full set of transactions. The hearing is going to focus in on 278. We have decoupled them. Does that work for you, Rich, or not?

PARTICIPANT: I am digesting.

DR. STEAD: It is intentional. Whether it is correct or not is another issue. I think that is helpful.

PARTICIPANT: We sort of backed our way from the hearing all the way to –

DR. STEAD: I think that is as far as we are going to go. We are going to just keep trucking and we will pause when Jim comes in and then come back to trucking.

MS. KLOSS: DID. This will be easier because it is a letter. I was just reflecting on how we tackle the minimum necessary. Here is what I would suggest. We start with our goal, which is a letter for approval at the February meeting. What I think I need to do is bring my co-chair up to speed next week and then produce a rough draft. Just frame this letter, rough it out. That is the kind of thing one person needs to do. I will do that. This is what we did with minimum necessary.

Then we had a call. We made section assignments. And then we had those pulled together and we did a draft 2 and a draft 3. Dates. Next week I will regroup and talk to Barbara and refine the themes and the document we went through this morning.

Schedule a conference call for the week of December 12 to review rough drafts so toward the end of that week and make section assignments. Have those due the week of January 5 or actually on January 5.

PARTICIPANT: Will they go to you? Will they go to Rachel?

MS. KLOSS: They go to me. We can change that as we go along.

DR. STEAD: Just a question. From a work life balance point of view, do you want to have them do at the end of that week — that is the end of the week. People will be back before then.

MS. KLOSS: And the reason I was looking at the fifth is then we turn around draft 2. We have to have a call at the end of the following week. The 12th. And then we have to turn around draft 3 in time for whenever the exec call is in January. We will not do this fewer than three rounds. I know that from the last experience. It was maybe more like five or six. We will try to be smart.

DR. STEAD: It seems to me we want the January exec call fairly late in January – basically a month off.

MS. KLOSS: That will give us a chance to do a draft 4 and it polished before the middle of February.

PARTICIPANT: This next one was called edits, audits and enforcement. Do you want to do that next?

DR. STEAD: Or healthdata.gov. Is healthdata.gov sufficiently contained to your operation –

DR. MAYS: That is what I was working through. I can kind of tell you what I am thinking and then see if this work. The first thing I need to do is meet with Rebecca and Jim. I think we will try and do that this week to hammer out the final things that we need to do to give Erica kind of what her workload will be.

I want to have a call the week of – to let her work a bit more and then have a call the week of December 11.

PARTICIPANT: A call with Erica?

DR. MAYS: A call with the whole work group. We are going to work online I think more because we are actually drafting. But we will have a call.

And then one on the 15th because I am expecting a draft that we then want to tighten up on the 15th. And then a draft that goes to them the 22nd.

PARTICIPANT: Another draft?

DR. MAYS: Yes. And then we should be ready for a solid draft then to go to the executive committee the last week of January. I think that is when we are meeting. The week of January?

DR. STEAD: Third or fourth week in January.

DR. MAYS: Just let us know. Now the question that I wanted to put on the table is it should come to the whole group at some point in time to let them look at. Do you want that before it goes to the executive committee or after?

DR. STEAD: We generally go to the executive committee and then post executive – ditto based on the executive committee. And then it goes to the full committee before the – part of the agenda book or whatever for the February meeting.

DR. MAYS: I would like to come to the full group before to make sure that any input they want to have and areas that we have it early so that we are not trying to do it in the February meeting. Maybe in early January to say this is what we are thinking. Have we missed any areas? Is there anything that you have problems with?

DR. STEAD: I am just trying to deal with the bandwidth of the full group.

PARTICIPANT: But how about make it optional.

DR. STEAD: I think the key is to make sure we have it in the executive committee bandwidth pipeline. You do it as –

DR. MAYS: I feel comfortable doing that.

MS. KLOSS: We tried that with the minimum necessary standard letter. Remember. We sent it to everybody. I do not know if that was productive.

PARTICIPANT: I do not think one person responded.

MS. KLOSS: We just hoped it would move the understanding of everybody along, but I think our discussion this morning.

DR. STEAD: We are trying to get these discussions iterative, which I think makes it better. You look at the number of parallel tracks. The more stuff we can keep out of people’s in boxes, the better off —

MS. HINES: We just –

PARTICIPANT: We will just be risk takers.

DR. STEAD: We will risk it.

DR. MAYS: Yes.

DR. STEAD: Edits, audits, and enforcement. The end game is still a hearing in June.

MR. COUSSOULE: I think process-wise, it is very similar to what we were just talking about as far as getting the agenda put together, the questions that are going to be asked, and the topics. I think that Terry’s point before. It is a couple of months plus notice. I think it is the same sequence of events. If the hearing is targeted virtually the same time in June then you really have the same schedule.

DR. STEAD: Do we in essence line it up with the review committee with the exception of the fact it does not have a metrics phase?

MR. COUSSOULE: The review committee hearing would line up with this.

DR. STEAD: We would basically replicate it. Is that practical from a subcommittee bandwidth point of view?

MR. COUSSUOLE: I have to ask our lead staff that too. The question Bill has was – line up for two hearings in the June timeframe. Is it practical to do that at the same time between now and then?

DR. STEAD: In essence, can we draft agendas, questions for both at once in essence?

PARTICIPANT: For the record, yes, it can be.

MS. HINES: The timeline would be the same by the February full committee, we would have a draft agenda and questions ready for the committee to discuss. Is that right? And then by March 30 have the request out to the testifiers.

DR. STEAD: We have a game plan. Then do we want to say anything further about APCD – or do we let that sit – within standards – worked at that level for a while.

MR. COUSSOULE: We could huddle up and then talk about it at the Executive Committee meeting.

DR. STEAD: — February as bandwidth permits. Then we are not trying to do vitals right now. Do we want to do any next steps around predictability roadmap or do we let you work that at standards and bring that plan back of how you doing –

PARTICIPANT: I think we need to talk about it here.

PARTICIPANT: Do you want to talk about it here?

DR. STEAD: Predictability roadmap.

MS GOSS: I just want to make sure we are on the same page as part of the goal here because I think that there is some substantial work to do and I want to make sure we have everybody’s best thinking on it.

We were shooting for an August workshop hopefully physically located near the Security Boulevard location of CMS to maximize participation. We have talked about having a preliminary — a pre-workshop call with the participants so that we could do a collaborative approach of education and firming up the actual agenda to garner more buy in and effectiveness in that workshop. It is benchmark step before that. We need to do some work in advance of that to – I think there is subcommittee work that needs to happen on ensuring that we understand what the baseline reference material is across the standards development organizations, operating rule, authoring entities. The advisory rule is like DSMO, WEDI, and NCVHS and then the federal process with some consideration of implementation but not thinking that we are going to have too much in that realm.

MS. KLOSS: I think we should also go back and look at prior testimony on the importance of a roadmap because remember we have had hearings where this was – we had a whole hearing on this topic. I think it would be good to go back and refresh our memory.

PARTICIPANT: When was that?

MS. KLOSS: I will find it.

PARTICIPANT: You talked about a lot of different points in the last couple of years, but I never thought we gave one focus. Was it a February meeting? Do you know what it was, Terry?

MS. KLOSS: I really think some of the observations are still going to be relevant.

MS. GOSS: And some of those have been captured in the 10th and 11th report to Congress. I think it is a wise idea to look back at the actual testimony because we might get a little bit more details. I need you to add operating rules to the SDO because they are two totally different things.

PARTICIPANT: When did you want to have this call because that needs to get scheduled?

MS. GOSS: I do not want to have the call scheduled until we know what the scope is going to be. We can send out an invitation to that call with some kind of expectations and laying out what we are trying to achieve.

PARTICIPANT: Do you have a month –

PARTICIPANT: If the workshop is in August, let’s back up from August.

PARTICIPANT: Let’s say early August since we know people go on vacation.

MS. GOSS: Somewhere in the month of August we are going to have it. We are going to be getting ready for the review committee hearing in June. There is going to be a lot going on. But maybe we will have a little lull. Maybe we have it in May.

MS. HINES: If everything for the review committee is done by March 30, which is what we have said that the request is out to the testifiers with the agenda, the questions and everything that they need to know, April would be a really good time I would think.

MS. GOSS: But we have work we have to do. We only have so many bodies to do all this other stuff. I was trying to figure out how to stretch it a little bit.

DR. STEAD: If you had this call mid-May, would that be far enough ahead of August to do what you are trying to do or not?

MS. GOSS: I think it is too far almost, but maybe not. It gives them enough time to go out and talk to their stakeholders.

DR. STEAD: I am trying to understand how much time you need between the call and the workshop. How is the call going to change what you do at the workshop?

MS. GOSS: I think it is about how the participants – what they need to do. Maybe they need to go out and talk to their communities.

DR. STEAD: Let me see if I am understanding. I am the process person. So maybe what you do is you get the scope and plan for the workshop including the participants and you issue the invention and the first thing they do is have the call. Is that the right – we would get that out. Then there would be time and then there would be a call and then there would be time for them to do work and then there would be a workshop. Is that the sequence?

MS. GOSS: Yes, that works for me. How do other people feel about that?

PARTICIPANT: Do you want to say you have that done by May 1?

DR. STEAD: What I am hearing is scope, plan – let’s put that as May 1. That would give April to do that. And then let’s say the call would be June 15. That would be six to eight weeks before the workshop.

MS. GOSS: I think the two months to give because we do not know what they are going to do with it and who they need to talk to.

PARTICIPANT: Is this the call with the participants?

MS. GOSS: Yes.

DR. STEAD: Just put two months in advance of workshop. It is just a draft. Does that look like a reasonable —

MS. GOSS: I do think that there is a lot of work within those but I think it is the high level. I think we are fine from my perspective.

MS. HINES: There is a lot of subbing out in here. Tons. This is probably 15 steps or something, but these are the big rocks. So is there anything big that happens between the call and June and the workshop? Is there anything big that has to happen?

MS. GOSS: We probably need to finalize our facilitation approach, documentation, that kind of stuff. We have some really deep dive content review and thinking that we need to do to make sure that we are setting up the workshop correctly. But I also think we have some logistics, some project management activities that need to happen.

And then I think we will need to then have some plan for someone to do a recap out of that August workshop, as a validation point with the participants so that we then have something that we then take forward to get further industry feedback or weave into a DSMO change request hearing or something.

DR. STEAD: Which would be steps from this to the next hearing. Once we do this, you do a recap. Then you are setting up the next hearing.

MS. HINES: You mentioned taking the results of the workshop and putting it out for public feedback. That is what you said.

MS. GOSS: I am not sure how we are going to do that. There have been a number of ideas about that.

MS. HINES: When is hearing we talked about?

DR. STEAD: It will either be Q4 or Q1. Jim is going to be calling in at 2:30. What I would like to try to do is let’s see if before Jim calls in, we can actually pretty much finish up our work. And then we could have the conversation with Jim and then we could do public comment and head to our various and appointed airplanes.

MS. HINES: Are we done with this part?

DR. STEAD: Is there anything else that in nine minutes we need to – I think we have done a really good job of getting our plan to February and beyond. We have over performed. You are truly an unbelievable group of colleagues. Are we all good?

DR. MAYS: One of the things that I would suggest is that after Rebecca gets this all out that we then decide when we want updates and things that we do them key to these dates so that we really can just have the best of people coming and we have something to say to them and they have something that they could actually impact to make a difference.

MS. HINES: We need a good timeline. I have put in one final request for smart sheet. If powers that be don’t give it to us then I will do it by hand in Excel or Word. But I am hoping I can get the software that I need from the powers that be and then you push buttons. You can see everything lined up and everyone can see it and so forth. But if they do not give us approval for the software then we will just jerry rig it.

DR. STEAD: In the time we have left, does anybody of our staff team want any comments on what we have done or are we good?

MS. KLOSS: We did get a public comment by email. If you just jump on to your email, you will see it went to Alix and Bill and myself.

MS. GOSS: Shall I read it? Thank you, Steve Lazarus, for providing us with a comment, which reads there is a significant difference between implementation, ready to use, and adoption, actual use. I recommend that adoption and actual use is what will be most useful to the industry. I think this goes back to the discussion we were having yesterday, Linda, about what was the right term. The CAQH index annual includes the transaction volumes for all HIPAA transactions as of 2017 publication. There is a multi-year trending possible for most of them. Most of the other stakeholder testifiers did not report statistics. Some did hurried surveys that at best had data on the number of implementers/users, but no transaction volume data. It seems to me that you will need to screen the testifiers to those that have statistics and give guidance to those that will do surveys to focus on transaction statistics. No point in hearing from the others if they have no statistics.

Looking forward to the prior auth end to end. You might want to kick the session off with an overview of what prior auth end to end is from the provider, payer, and patient views. I think really good feedback. I know yesterday I had a conversation with Denise about the CAQH index and some statistics and what could be useful there.

These are the suggestions from Steve, not from CAQH CORE. I had to put that disclaimer in there.

MR. COUSSOULE: Maybe this is my own ignorance, but I thought the term adoption had a specific use in the federal process of actually adopting recommended rules and standards. Depending on how we use the terminology, we could really get into a semantic bind. We may just have to clarify that. I do not know. Does that make sense? I just want to make sure we do not get caught up into using something that is interpretable by half the people one way and half the people another way. We are going to have to get to some level of consistency to how we use the semantics.

DR. RIPPEN: I think if we have a definition, which will reinforce it.

DR. STEAD: Why don’t we then start public comments? We will pause when Jim comes in. Do we have public comments from the room first? Do we have public comments from the phone?

DR. CHANDERRAJ: I have no comments.

DR. STEAD: I hope you have been able to make some sense of us. I think we are done with public comments.

Jim, thank you for joining us in time to let us publicly thank you for your service and to also hear any parting shots you may have to give us guidance from your perch. But first let me just make a few comments as much as I did at dinner last night.

Jim had a 48-year career of federal service. This is simply outstanding. Since 1996, he has served as the deputy assistant secretary for Science and Policy in the Office of the Assistant Secretary for Planning and Evaluation.

In this role, in the time around ’96 as HIPAA was just taking over or beginning, Jim was instrumental in the formation of the HHS Data Council. That is the principal internal advisory body to the secretary on data policy. He has been an advocate for the National Committee and our role in supporting the department and others in health data information policy and statistics.

In my four years on the committee, not as long as others, he has provided a perfect balance between healthy skepticism, restraint and optimism. That has really served to help us pick the path in which we can be most helpful.

The other thing that amazes me is his ability to find a way to do what we really need to do, both of which – we are in great debt to you, Jim. I just wanted to put those comments formally into the record.

Do others have comments they want to add to that or does that communicate the sense of the group? There are lots of smiles around the table, Jim.

MR. SCANLON: Thank you for all those kind words, Bill, and I really enjoyed having dinner with the group last night. I was telling my folks here – I was at a meeting with NIH and FDA about a year ago. A couple of people were surprised to see me. They said, are you still here. We thought you retired a year ago. They were as old as me. I do not know why they were complaining. Despite many requests to the contrary, I was still working. But I am pleased.

I am finishing up 48 years here at HHS. It really has been a joy working at HHS and working with the committee. I continue to be amazed at what you can get done when you get smart people in a room to put their heads together about solving an issue or finding a way. It really remains impressive to me even after all this time.

I will stay active professionally, but I want to take some time off and enjoy myself, my family and some of my hobbies. But I plan to stay active professionally in public health and data policy and health IT, but it will be on a part-time basis. I do not really want to work full time anymore.

But the committee has really been – it really has been a pleasure working with the committee. It is true. We expanded the previous NCVHS as HIPAA required back in 1996. I think the committee is sometimes a victim of its own success. Every time the committee makes a good recommendation or accomplishment, finds a way to do something and address a problem, the committee gets named in another bill, another law to do more work. I would not be surprised if that happens again.

What the committee gave us in terms of advice on data standards, administrative simplification, I really do not think we could have done that, the department. I think CMS, Terry, will agree and some of the folks who originally worked on HIPAA. I do not think it was even possible to do without the committee’s advice and the committee’s ability to get the industry together in a setting where it was a very open and a very objective setting. The committee was always – some of other advisory committees. Everyone knows they would get a chance to present their views. We could always rely on the committee for where – the consensus if any and then what was the way to move forward.

And really it was always the best data and information and thought so we did not have to worry, which was really our job to be honest. It is to provide the best thinking and the best recommendations. Anything less than that is just not helpful to anyone.

The committee has a wonderful record. I know you will do well. The names for three vacancies on the committee are now undergoing vetting here at HHS. There is a pretty good chance that those persons will be announced as well. We will almost have all of the vacancies filled on the committee. I just want to wish you the best going forward.

In terms of advice, it is kind of like what our agencies are doing here. We only have one president at a time. The current president and administration is here until January 20. I think the focus here and in all the other agencies is to get things in the best shape that you would want to leave them for the people who are here now.

And then after that just to be – again, take the same perspective. It is a good reputation as an honest broker in the future.

The only thing is it is a time – as we are doing here. It is a time to reflect on what we have accomplished and where things stand. It is not necessarily a time to start anything new for a variety of reasons, but to think of – and not to take big steps, but commit time and resources without knowing where the parameters may lead us.

But by January and by February, I think the committee’s meeting, and then by later, I think the smoke will begin to clear. In many ways, the committee’s work is pretty much enduring. It is like public health. Things change, but the issues do not go away. It is just different views of how to solve the problems.

As I was going through some of my old files here, I was looking back even down into the ’70s. The public health service published – plans for health. What was said in those plans in terms of research and policy and health insurance, public health, regulation and protection for public health. Most of those ideas and many of the specific recommendations actually foreshadowed things that we take for granted now. I think it is constantly evolving.

I think the best thing would be for the committee to keep a lot of flexibility for the next six months. We just do not know what will happen. I think the committee itself has a great reputation for objectivity. It is not seen as a political body. I think the issues that the committee deals with are really – they were bipartisan to begin with. I hope that remains.

It has been a pleasure working with all of you. I may be one of those folks who writes to the Secretary later or comes to some of your meetings, but it has been a pleasure.


DR. STEAD: Jim, we would always like a comment from our new citizen member. We hope that from time to time you will find your way to some of our social dinners as Marjorie and others have done. You have a special place in our hearts and minds. Thank you.

DR. SCANLON: Great to see everyone last night.

DR. STEAD: Take care. Are people good with adjournment or do you want to run around the table? I hear movement to adjourn. Thank you. You have been awesome.

(Whereupon, at 2:45 p.m., the meeting adjourned.)