[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS

November 20, 2009

National Center for Health Statistics
3311 Toledo Road
Hyattsville, Maryland

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030

P R O C E E D I N G S (8:05 a.m.)

DR. WARREN: I would like to call to order the meeting of the Standards Subcommittee of NCVHS for our breakout session on November 20, 2009.

With that, we will start introductions. I am Judy Warren, University of Kansas School of Nursing, and I have no conflicts.

MR. BLAIR: This is Jeff Blair, co-chair of the Standards Subcommittee, Lovelace Clinic Foundation, and I am always conflicted.

MS. DOO: This is Lorraine Doo, lead staff of the subcommittee. I am from the Office of e-Health Standards and Services with CMS.

DR. OVERHAGE: Good morning. Marc Overhage from the Regenstrief Institute and the Indiana Health Information Exchange, and I have no conflicts.

MS. WILLIAMSON: Good morning. Michelle Williamson, CDC, National Center for Health Statistics, and staff to Standards.

DR. WARREN: Oh, you’re going to be staff now to us? That’s great.

MR. BIRNBAUM: Adam Birnbaum, Blue Cross-Blue Shield Association.

MS. CHRISTIANI: Jeannine Christiani, contractor for the committee.

DR. WARREN: Why don’t we do a quick agenda check, because we really only have about 70 minutes for our meeting and quite a bit that I want to have discussion about.

We need to bring you up to date on where we are with the hearings on 5010, ICD 10. Lorraine and I will give a report on the status of our work on the Ninth Annual HIPAA report. Then I met with Populations yesterday, and they have some requests of our time. Then, finally, I would like to start talking about the presentation that our subcommittee has to give at the 60th anniversary.

Walter, if you want to introduce yourself real quick.

DR. SUAREZ: Yes. Good morning. I’m Walter Suarez with Kaiser Permanente. I am a member of the subcommittee and I don’t have any conflicts. Sorry I’m a few minutes late.

DR. WARREN: So we just added two things to the agenda at the bottom. One, the Population Subcommittee is putting together a report called “Enhancing Health,” and I can’t remember the next of it, “Health Statistics for the 21st Century.” They want some input from our subcommittee on writing that. Then we need to begin to think about what our presentation at the 60th anniversary is going to be like.

So with that, Jeff, do you have any opening remarks you want to make?

MR. BLAIR: No. It’s kind of nice after all of these years to have a co-chair who is now taking the reins. Thank you.

DR. WARREN: All right.

In December we are having a hearing on the implementation of 5010 and ICD-10. Our customer for this hearing is Tony Trenkle from CMS. In August Tony called Jeff and me and set up a meeting to begin to talk to us about some of his concerns of the implementation time line and where people are and was hoping that we would pull together hearings to see about readiness, what people were doing to get ready, the training, business cases, et cetera.

So from that time Lorraine and I began to work with Tony, and also we brought Harry into it. Because of his day job, he has been very influential in trying to put these things together.

We had quite a full set of stakeholders that we needed to hear from, and so that’s why we decided to deviate from our normal pattern and make it two full days of hearings instead of a day and a half.

The result that Lorraine has gotten from calling the people that Tony wanted to hear from, that Harry thought would be good, and then that Jeff and I knew we needed to bring in to hear from, and then Lorraine had a few people that she knew were essential, Lorraine still has received numerous phone calls, emails, et cetera, to be added onto the testifier list. I know Walter has emailed, “do we have room for,” and we are just packed to the gills, because we made the decision that was very important that we keep enough time for our own subcommittee to ask questions and for discussion. So I have protected that jealously.

DR. OVERHAGE: One thing that I wonder if we could do, though, is I think, given the importance of this, whether we could certainly offer to people the option to submit written testimony, because I think there are a lot of thoughts about this, and I would hate to give short shrift.

DR. WARREN: Yes.

DR. OVERHAGE: The other thing, and the AE has probably talked about this, but I would be curious, is that, at least on the list I see here, I don’t see a lot about the clinicians’ readiness to use ICD-10. At the end of the day, the benefits that we hope to get are heavily dependent on whether the clinicians are going to do anything differently or not. Unfortunately, I think they are not, and I actually think our data is going to get worse.

DR. WARREN: And I have started talking to faculty, medical as well as nurse practitioner faculty, and they haven’t even thought about it.

MR. BLAIR: Right. It’s not on their radar. They don’t even know what it is.

DR. WARREN: Right.

MR. BLAIR: They don’t know what those numbers on their superbill now are.

DR. WARREN: Yes.

You actually led in beautifully to one of the things that I had on my list to talk about. What I wanted us to do during the hearing, since we deliberatively chose kind of the business people and stuff first, is for us to listen and determine what voices were absent. Certainly at the hearings we are going to put a call out for verbal testimony. We’ll put a notice up in our minutes and everything that people can do that.

MR. BLAIR: You’re going to put a call out for verbal testimony?

DR. WARREN: I mean written testimony, I’m sorry.

Then I think we need to determine on day two of the hearings whether or not we want to request another set of hearings on this, and also talk to Tony, since he is our customer for the hearings, and see where he thinks we are in putting this together.

I am just concerned that as I look at all —

MR. BLAIR: You missed the back, so that helps a little.

DR. WARREN: Oh, does it? Day two?

MR. BLAIR: Yes.

DR. WARREN: But I’m still concerned. The research community has not been engaged, and we are beginning to see a lot of people doing recruitment by ICD code, and so if they’re not seeing a need for this, the education community needs to be engaged, start getting the upstream part ready. Then, as Marc pointed out, we still don’t have that many clinicians represented here, and so looking at their groups.

Then, Lorraine, were there any other kinds of people that have called you that wanted to testify?

MS. DOO: No other types. The vendor community actually has been fairly interested, particularly for both the software, the practice management systems, and the testing. So I think we’ve had some additional interest from them. I think the education piece for the clinicians and the people who are doing the coding are probably going to be good for next time.

DR. WARREN: Okay. Yes, Walter?

DR. SUAREZ: I think it’s important to consider the idea of a future hearing. I think there’s a number of voices that I would argue also would be helpful to hear. You mentioned clinical or clinicians, the research community. I think the public health community itself, population health, how it’s going to be affected and how ready it will be to handle both the 5010 as well as the ICD-10.

I think a couple of others would be some of the ancillary services beyond the physician and the clinics, the other types of groups. I mentioned dental as one of them, but there’s a number of them, chiropractors and a whole host of them.

DR. WARREN: We’ve also looked at home care and long-term care but didn’t have — we do have one long term?

MS. DOO: I think the long-term care is going to be able to, Barbara Maynard.

DR. WARREN: Great.

DR. SUAREZ: Okay. And then I think rural and small providers would be one subset of some of the larger groups that are represented. Of course, American Hospital Association, American Medical Association, HBMA, these groups include small providers, but there are specific groups that represent more directly small and rural providers that it will be helpful hear from.

DR. WARREN: Probably the American College of Family Physicians.

MR. BLAIR: American Academy.

DR. WARREN: American Academy, okay. That’s one of those C words.

MR. BLAIR: AAFP.

DR. WARREN: I should know that. They’re in Kansas City.

DR. SUAREZ: The other thing that I think is going to be good, and this is an important aspect of a future hearing, and this relates to the clinician readiness, is the relationship of this transition to the meaningful use requirements that are going to be published later this year in federal regulations. So I think understanding better the meaningful use requirements, the expectation of moving the HRs into a more granular vocabulary standard like SNOMED and LOINC is what is really going to create a question in the minds of clinicians of how this — I’m doing SNOMED and LOINC in my HRs and I’m doing ICD-10 in my claim standards, and so making sure that we have very good understanding of the issues and implications around that will be very helpful.

But again, that will be very good into a future event once we have, I think, the proposed rules and other kinds of rules out.

DR. WARREN: Jeff and I had talked earlier in the year, way before meaningful use, about what was happening with these new terminologies coming out, so revisiting the ones from HIPAA, which would be RxNorm, LOINC, and SNOMED has evolved. LOINC and SNOMED now are having meetings to interdigitate and to find out where they’re working.

DR. OVERHAGE: It’s going very well, and I won’t say it’s done is it’s well along the way.

DR. WARREN: So that those might be future hearings as we go through.

I know Tony’s concern was that we already have regulation 5010 and ICD-10, but everybody was beginning to pay attention to meaningful use. So once those regs come out, maybe the next set of hearings could pick up some of that and then start about how do the regs for ICD-10 and the regs for meaningful use go together, and hopefully they would help inform each other on implementation.

DR. OVERHAGE: I think that one of the issues that Walter raised, though, is really important to highlight, and, Jeff, you might have guidance here, but it seems as if the clinical applications are getting nudged very strongly in the direction of SNOMED, and so we’re actually creating again a divide between our billing processes and our clinical processes.

One area we might want to explore a little bit more is that translation and mapping part of the world, because if we’re asking people to report two separate things in two separate coding systems, A, it’s inefficient, but B, it’s not going to get well-recorded, because, just as it is today, the claims recording will be viewed as not important and superficial.

DR. WARREN: And I can tell you, because I do sit on IHTSDO’s quality assurance — so I should probably say there might be a potential conflict here — some of the maps have started between ICD-10 and SNOMED, and they’re differing by country, which is causing a lot of concern internationally.

I don’t know the status of the U.S. translation, but I know that Betsy Humphrey’s shop is trying to spearhead and coordinate that. So we probably need to have Betsy and Vivian Auld in to discuss some of those things.

Do you think Clem needs to come in as well? McDonald.

DR. BLAIR: Yes, for Lloyd?

DR. WARREN: For Lloyd.

DR. OVERHAGE: Actually, he has a broader perspective than just Lloyd. Yes.

MS. GREENBERG: Sorry to be a few minutes late. I’m Marjorie Greenberg from NCHS/CDC and executive secretary to the committee.

Mark, do you want to introduce yourself?

MR. HORNBROOK: Mark Hornbrook, Kaiser Permanente, member of the committee. No conflicts.

MS. GREENBERG: One reason that the maps are probably different is because countries have different clinical modifications. There is no way to avoid that as long as there are different clinical modifications, although we’ve made efforts to harmonize among the clinical modifications, and they are not wildly different, but they certainly — Australia, Canada, the U.S. all have clinical modifications.

DR. WARREN: So let me modify my statement. In SNOMED there is a mapping workgroup. Within that group, as they’re laying out the rules and the approaches for developing the maps, there’s great concern that there’s difference.

MS. GREENBERG: Right.

DR. WARREN: Now, for them, one concept could be enough to make them concerned about a difference.

MS. GREENBERG: I understand that, and actually, a member of my staff is on those mapping groups. But it is my understanding that they’re focusing, the IHTSDO is really focusing on, right now, the SNOMED CT to ICD-10 map.

DR. WARREN: Yes.

MS. GREENBERG: And there should not be — if there are differing maps between SNOMED CT and ICD-10, the only one that should be official should be the one that IHTSDO and WHO agree to, 10.

Now, when it comes to the clinical modifications, of course, there is going to be some country variation.

DR. OVERHAGE: That was the clarification I was just going to add. So ICD-10 does not have clinical modifications, right?

MS. GREENBERG: What? No, ICD-10 does have clinical modifications.

DR. OVERHAGE: Okay.

DR. WARREN: Isn’t there a pure ICD-10?

MS. GREENBERG: No. There’s ICD-10, and that is what is used in mortality classification around the world and by many countries for morbidity classification. Some countries — U.S., Canada, Australia, principally, but also Germany and others — have developed clinical modifications of ICD-10 which they use for morbidity. Nobody is supposed to use a clinical modification for mortality classification. We’ve heard of a few countries that are using ICD-10-AM, the Australian one.

In the development of ICD-11, there is a hope that there will be much more harmonization on the morbidity side. But the problem is not just — for example, in the U.S., Congress requires us to update now 9-CM, and it will be the same for 10-CM, at least once a year. There is actually a requirement that there be two updates a year if they meet certain criteria. Fortunately, that hasn’t happened yet. So there is no way we’re going to be able to avoid clinical modifications anytime into the future.

Countries that say they use ICD-10 for morbidity are not English-speaking. When they translate it into their language, little changes come up also. So on the morbidity side, there are some differences.

Although I recognize the purists’ concerns, for the most part they’re not dramatic, though in some crucial areas like diabetes or something, they might be, because there have been different solutions to the clinical problems.

I think mapping SNOMED-CT to as detailed a version of ICD-10 as is in use is a good thing because you’re already going to lose a lot a granularity going from a very granular terminology to a classification, and then to map it to a less granular classification doesn’t give you — you lose more. So it’s kind of an issue.

But there isn’t actually that much international morbidity data right now anyway. Most of the international data that’s compared is mortality data.

MR. BLAIR: Maybe I can help Judy get back on the agenda.

MS. GREENBERG: I’m sorry. I came in late and then tried to steal the show.

DR. WARREN: What we were trying to do is lay out a future series of hearings, because this one doesn’t cover everything we need to hear.

MS. GREENBERG: Well, I must say I was thinking about that this morning. I had a few thoughts on that as well.

DR. WARREN: I was trying to look at what would be next. Walter had already submitted a list of people, some of whom we could accommodate and some of whom we could not. Marc had a few voices that still needed to be heard, and so we have those. Then Walter brought us back to some of the concerns that are happening in HIT standards once the regs come out, or the NPRM comes out for meaningful use, then there needs to be a harmonization, or could be — maybe harmonization is not the right word. But then you need to consider the regs for both 5010 and ICD-10 and meaningful use.

So even a more future set of hearings might talk about how those should go together and how to help people get themselves organized to meet all of these deadlines that are going to be coming up.

Does anybody else have any other stakeholders that you don’t see on here or think about?

MS. GREENBERG: On where?

DR. WARREN: On our agenda before —

MS. GREENBERG: This agenda?

DR. WARREN: Yes. It’s front and back.

MR. BLAIR: I don’t have any more. I would make a suggestion. One of the things that I would suggest is that we tentatively figure that there will be another hearing with respect to 5010 and ICD-10 implementation issues. It sounds like there’s already a nucleus of half a dozen growing to a dozen testifiers that are really important, and I think that will grow, especially with the diversity of clinician testimony that we’re going to need to receive.

Marc knows where my heart is in terms of mapping, but I think that that should be possibly — if you cannot fit that into a January or February separate standards session for ICD-10 and 5010, can that be a little bit later? I think that the mapping pieces are multi, so one is the SNOMED to ICD-10, but the ICD-9 to ICD-10 mapping is also an issue.

The other pieces are that — well, now I’m broaching into an area of mapping that we want to make sure that we don’t cross over with the HIT Policy Committee and Standards Committee, because I think this is on their agenda as well — for health information exchanges, they’re looking at an awful lot of different mappings to be able to facilitate interoperability, and maybe we ought to confer with them to see which of the mapping areas they want to focus on for meaningful use, and then maybe there will be a number of others that they’re not focusing on which are also very important that we could cover.

DR. WARREN: Marjorie?

MS. GREENBERG: I wanted to say something, but first, you just mentioned something else about the mappings between — I guess you mean 9-CM and 10-CM and probably 9 CM Volume 3 and 10 PCS.

MR. BLAIR: Yes.

MS. GREENBERG: There are official general equivalence maps that have been developed by CMS and CHS in conjunction with 3M. Those are posted and those are being updated every time we update the classifications. So I just wondered what the issues were that you’ve heard about that.

MR. BLAIR: Oh, thank you, Marjorie, and that’s fine. I think there’s a number of issues. Number one, if there’s some evaluations of those mappings, if there’s some testimony from folks that have engines to enable and facilitate those to find out where they would be used and implemented, can they be available at no cost? Because just having the mappings without the software engines to enable that sometimes doesn’t cover all of the issues.

MS. GREENBERG: Okay, thanks. That’s helpful.

But speaking of stakeholders, and Walter may have said this before I came, but this all seems basically to be about implementation, which of course is very important, but what I sort of see missing, and maybe I’m wrong, and maybe this would be for another hearing or something, but how can we sort of maximize the benefits of moving to these more modern and up-to-date, granular, whatever, classifications both from a population health and a healthcare perspective?

I know that at least some of the health reform legislation talks in terms of completing the suite of HIPAA standards, one of which is the claims attachment. I think AHIMA has — I don’t know if there’s anyone here from AHIMA this morning —

DR. WARREN: Not yet.

MS. GREENBERG: — kind of had a position that with the greater granularity of 10-CM and 10-PCS, you might not need some of the attachments.

DR. WARREN: That’s one of the panels.

MS. GREENBERG: That’s the last panel?

MR. BLAIR: And that kind of brings up one other thought. We’ve tended to look a lot of the mappings as one-to-one mappings. I think that if we could maybe have for this next year on the agenda — and Jeff Blair will be gone by that time, so I won’t have to implement it —

MS. GREENBERG: No, but you can present.

MR. BLAIR: One of the things I think is either this subcommittee or some other entity needs to look at the total impact on healthcare providers of migrating from ICD 9 to ICD-10 at the same time that they’re preparing for all of the meaningful use and doing LOINC and SNOMED and RxNorm, and see if there is some way that we could look for synergies or things where one part of that evolution could be used or reused to help them with others, or if there is some way that we from — now I’m thinking of the we as the federal government — can maybe do some little things that could accommodate and take some of the burden off of the parallel transformations.

DR. WARREN: Right.

I’m going to need to call an end to this discussion because we’ve got other things on the agenda. So if anybody thinks of anything else, because it sounds like we’re pretty much set for these hearings. We know to listen for what is not there to find out if there are other people we want to hear from, and then just wait until the new meaningful use information comes out so we can see where harmony is.

So anything else that occurs to you during this meeting, let me know or whatever. Walter?

DR. SUAREZ: Yes, one quick comment — two very quick comments. One is on the standards, Health IT Standards Committee, I think it’s important that the group knows the Standards Committee has formed a vocabulary work group specifically to focus on vocabulary issues. So I think that’s going to be a place for a lot of these discussions to happen.

I certainly would encourage a lot of opportunities to work together, of course, with the Standards Committee and perhaps even consider having some sort of a joint hearing that could benefit various committees at that same time, I guess, at least those two committees, because I think it will be quite beneficial.

I guess that was it.

MS. GREENBERG: I think that’s a good idea.

DR. WARREN: I think it’s a great idea. So it looks like you and I, Walter, will follow up on that. That will be our to-do to continue and try to coordinate.

Marc?

DR. OVERHAGE: This is a question for Marjorie. Do you ever coordinate with AHRQ on research on taxonomy changes? The question here would be, as we change from this taxonomy, the 9-CM to 10-CM, are there — obviously, there should be benefits — but are there particular population subgroups or disease groups that somehow are being overlooked? Do you care about the —

MS. GREENBERG: That are overlooked in the classification?

DR. OVERHAGE: In the sense that, say, there’s a set of diseases for American Indians in the Papago Indian tribe reservation that is deemed to be too trivial to break out, so they get lumped. But it is important for the Indian tribes that break those diseases out because they have different treatment technologies, and yet the world that be, such as it is, doesn’t care about one Indian tribe. I just wondered whether there are disparities issues and whether anybody has suggested research ideas on the implications of classification for under- and overrepresenting diseases that —

DR. WARREN: So you’re asking whether NCVHS identifies researchable questions and tells people to fund those.

DR. OVERHAGE: Or coordinates with NCHSR to figure out ways to —

MS. GREENBERG: NCHSR? Now that —

DR. OVERHAGE: AHRQ, excuse me. I’m going way back.

MS. GREENBERG: You’re going way back to when I first met you.

DR. OVERHAGE: Yes.

MS. GREENBERG: We certainly do work with AHRQ, but I think you’re asking — well, you’re asking a really interesting question that certainly could be explored. This starts, ICD starts, at the international level, and there have always been certain professional groups, I would say, who have been more active in that process than others. If you looked at ICD-10, it is probably much richer in eye diseases than it might be in some other diseases. So like anything else that’s scientific, it can get a little political.

There are debates over where certain conditions should sit, and there are advocacy groups and all of that. The rare diseases tend not to get picked up in a classification because you’re talking about lumping rather than splitting for the most part. But you’re asking some interesting questions. And actually, I would have to say that as ICD-11 now is being developed, and in a very different way, by mid-2010, I think, there will be platform that anybody can contribute to ideas for ICD-10 on the WHO Web site.

I really would like the NCVHS — it got started actually out of a recommendation of the WHO that there should be national committees dealing with ICD and other vital and health statistics issues to look at how should the American, how should the U.S. community, stakeholders, really participate in this process? We have official participation, obviously, and my staff are very involved. We have a long history of working with any group that wants to work with us or is interested and that we can seek out to try to make sure that the classification meets the needs of all the stakeholders.

But we really haven’t figured out — and I could really use the help of the National Committee in that area — how do we want to reach out? Do we want to hold some hearings when the alpha draft of ICD-11 is published? The problem is to even talk about ICD-11 when we’re trying to implement ICD-10-CM is certainly a mixed experience.

But I will just say two things about that and then I’ll end, but this is something I really could use the committee’s help on and this subcommittee in particular.

First of all, 10-CM is one of the foundations for ICD-11. So we’re not at conflict here. And recommendations for 11 could be, because we’re trying to use the same alphanumeric structure, et cetera, could be fed into 10-CM before 11 ever is available internationally.

So I think we have to sell it that way. Hopefully, we are past the point of saying why are we going to 10-CM, why don’t we just wait for 11? But, nonetheless, I could really use your help as to how can we maximize U.S. participation and input and to make the classification as useful as possible and also as useful with SNOMED and the clinical data.

DR. OVERHAGE: I mean the question for me, for example, is: Is Rock 1 and Rock 2 a disease?

DR. WARREN: Make it really fast because three-fourths of the agenda has not been covered yet. I’m sorry.

MS. GREENBERG: We can talk about this off-line. But you did get something on your agenda, right?

DR. WARREN: Right. It’s right here on my agenda.

MS. GREENBERG: Good, good.

DR. WARREN: It’s there.

The next big pressing piece we have is our annual HIPAA report, which in this instance we missed one year so we’re bundling both 2008 and 2009 together in one report. So Lorraine and Suzie Burke-Bebee and I have been working for the last about 2 months in trying to outline the strategy to bring a report, an outline report, to this meeting. So I wanted people to take a look at what we were doing and to tell you a little bit of the thinking behind putting this report together.

It’s different from the eighth annual report.

MS. GREENBERG: Good.

DR. WARREN: Yes. One of the things that has happened in reports one through seven was they were straight reports of all HIPAA-related activities with NCVHS. In the eighth report, there was also information brought in on other activities that NCVHS did that complemented HIPAA work but was not directly attributable to HIPAA.

So in picking up the 2008 and 2009, which now will be known as the ninth report, we are going back to the formal purpose again of only reporting those things that have happened on HIPAA in those two years.

So with that, we’ve had Suzie going through all of the letters and recommendations that the committee has made to the Secretary. We actually also decided we had to go back through the transcripts of our meetings to see if there was anything, any other discussions that came out. Suzie has gone through all the reports. She’s about halfway through the transcripts, and we should have that analysis done shortly.

Lorraine and I have then taken a look at the format of the letter and have worked with that and have realized that the format of the letters as they have progressed is a pretty straightforward format. So we chose not to do creative writing but to come right on in with the previous formats.

So pretty much some of the background and stuff is really a copy/paste of what has been in previous reports, and you can see that evolution should you want to go back in there.

MS. GREENBERG: When you say the letter, you mean the report.

DR. WARREN: The report. I’m sorry.

DR. SUAREZ: What will be the source for the information for, say, status of security standards and implementation or privacy or any of those?

DR. WARREN: These are things that — we take a look at what NCVHS has actually had hearings on, what the letters to the secretary have been. We have also gotten Maya to help us with pulling in the privacy. Lorraine has talked with OCR. They’re going to be taking a look at the read to make sure that we have all of the privacy and security issues correctly summarized within the letter, and you will notice those pieces are missing.

We will also take this to Karen to have her look for a CMS perspective. Tony has said that he will also take a look at it for us to make sure, and those are the two main bodies in HHS that are rolling out HIPAA. So that’s how we’re doing it. And then it will come to

this –

DR. SUAREZ: We’re not collecting any new data to assess how people are implementing —

DR. WARREN: No. This is retrospective report on what’s happened.

DR. SUAREZ: But I mean how people are, like if we were to do a picture of where is HIPAA security today, do a survey of HIPAA information officers, information security officers, and then assess — we’re not doing any of that, we’re just using —

DR. WARREN: No, nothing. We’re not collecting new information.

DR. SUAREZ: Good, fine.

DR. WARREN: Marc?

DR. OVERHAGE: I was actually along the same thread, since this is supposed to be — and I am not suggesting it for this year, but I’m wondering if we should be looking forward, if we’re supposed to describe the status of implementation. That is different than the status of what this committee has done.

DR. WARREN: That probably is really terrific to start us looking at getting the ninth report done.

DR. OVERHAGE: Looking forward.

MR. BLAIR: Or the tenth report maybe.

DR. WARREN: What Marc is suggesting is that for the next report we be proactive instead of realizing we lost a year and be retroactive on writing up the report.

You said you had another comment?

MR. BLAIR: Yes, and I don’t know if you can do this. This is just a thought to consider. If I was a member of Congress or if I’m in the administration and I see this report, if it’s just going to be a list of the topics and recommendations that we made, the value of it to me is pretty limited.

On the other hand, if it winds up saying, Here’s where we made recommendations; of those recommendations, here’s the ones that have been adopted and have either flowed into meaningful use or flowed into other adoption areas. Then I would also maybe ask us to consider the other areas that either were not adopted or that need to be done, so that both Congress and the administration can look at it and say, Here’s what NCVHS was able to do these last two years with the funding we allocated to them. They accomplished certain things. There were other things they could not accomplish, maybe because there wasn’t quite enough funding for NCVHS, and then there’s other areas that they have highlighted and identified that need to be done where, again, maybe we need to fund them to get these things done,

DR. WARREN: Go ahead, Marjorie.

MS. GREENBERG: I do think that this report should include — let Harry talk first.

MR. REYNOLDS: No, I’m just making sure —

DR. WARREN: He’s next.

MR. REYNOLDS: I was making sure I was in line.

MS. GREENBERG: Oh, okay.

MR. REYNOLDS: I’m just trying to get in line.

MS. GREENBERG: Should include some observations, at least, by the committee as to where there seems to have been success or progress, et cetera, and where work is still needed and what some of the challenges are and some of the issues.

I would agree that this is no time for holding hearings or independent research, because we want to get this report, which is already two years’ report, done.

I will say this and then I can withdraw it, but yesterday we had a discussion in the committee regarding the issue of matching patients with their records. Harry stated very clearly where we are on that, and we’re not going anywhere else. But it is one of the HIPAA standards, and it is appropriate to say this issue is coming up more and more as we’re trying to move towards meaningful use, electronic health records, all these things, and does require solutions or something, because it’s Congress who has actually told the committee and the Department not to do anything about it. So I think you can make just an objective statement even in that area.

So I would agree that just a description is not going to be of interest to anybody.

DR. WARREN: Okay. So our plan, if you noticed the very last page of the letter, it says, “Conclusions to be written.” Once we get all the information in there, then we’ll need to come together, and Harry has offered for us to have a conference call so that we can talk about the kinds of observations and recommendations we want in those conclusions.

Lorraine and Suzie felt that writing this was our task, and putting all the background in there, the status of everything, laying it out within the way that HIPAA does it so that people could read it and know which part of HIPAA was being discussed.

There are some changes, and the OCR now has much more responsibility for different issues than what they’ve had before.

So that is kind of our strategy. Certainly we are not — I don’t mean this is a passive report. It is just that we’re not to the point where we can do those things.

Harry?

MR. REYNOLDS: A little bit along Marc’s lines, I think one thing I would like to see mentioned in here is kind of some of the things that NCPDP has done. Remember, we’ve been screaming streamline, streamline, streamline, and they’ve done a heck of a job in moving their standard forward. I think that should be noted, because all you hear is it takes too long, it’s too burdensome, da, da, da, and they’ve kept coming in here, and we have moved that forward and that has happened quickly.

The second thing is — and I chair one of these groups so I’ll put that on the table and then the committee can decide — the industry is picking up operating rules and moving things forward, and you see that in some of the new bills, where it belongs or doesn’t belong — we won’t argue that — but the point is that’s enhancing what’s out there. That’s enhancing what’s out there and making it bigger returns.

Meaningful use and some of the other things like that where it is being considered now in meaningful use, now in some of the other things that are going on, making these part of the standard process, are being considered.

Now, we are not recommending that it stays or goes. It’s in the draft bill, so once it’s in the draft bill, it is being considered. So you’re not telling somebody to move it, you’re not telling somebody — but those are the kinds of things that are showing that HIPAA is now becoming part of the mainstream, and its discussion is becoming part of the mainstream.

Then Marc’s comment, “But we still aren’t there yet in getting all the adoption we need and getting everybody using it to the fullest extent,” so that’s kind of the rest of the picture to me, is that there are some things that are going on out there where one of the hopes was that industry would pick it up; one of the hopes was that some of the organizations would figure a way to move along within the structure. I just think those are some thoughts.

DR. WARREN: What I’m trying to figure out is where they belong in the report. So we have a section on specific progress of the HIPAA standards implementation. So would it go under there or would it go at the end where are observations are —

MR. REYNOLDS: I think that’s a good place because it’s just some considerations, and again, however we would or wouldn’t want to do that, and obviously we’ve got to check with our partners in CMS and others.

MR. BLAIR: Let’s be clear what we’re winding up saying. It isn’t just that we made the recommendations. We also want to note in that section which of those recommendations have been implemented in one way or another, whether they’ve been adopted as a regulation within HHS or whether they’ve moved into the meaningful use or —

DR. WARREN: Or MMA.

MR. REYNOLDS: I’m completely past that, Jeff. You’re doing a tally. I’m good with that. I’m talking about discussing outside of that standard process what else is going on and how has the industry stepped up or not stepped up in appropriate ways.

DR. WARREN: Walter?

DR. SUAREZ: I think there are three parts to this report. One is what happened with HIPAA up until now. Number two, what’s coming with HIPAA, which is primarily 5010 and ICD-10. Number three is a whole host of additional elements that have been introduced and are in place; for example, breach notification, privacy, and a whole bunch of other things from the Recovery Act related to privacy and security, as well as things that are looking like they will go, which is —

DR. WARREN: Hold there just a minute. So what I need clarification on, and I need it from you, Harry, is in this report, do we then go on and talk about MMA and ARA, or is this just a HIPAA report?

MR. REYNOLDS: We’re not talking about them specifically. We’re making a number of comments that show outside of the score — Jeff is going through a score: Here’s what we said, here’s what happened, here’s what it did. I’m going through how is the industry around HIPAA reacting, and that’s what Walter mentioned. So this gets added, that gets added, this is going on and that’s going on, to show that, because otherwise, to me, if I was reading this, I would go, “Big whoop.”

I want something going up there that’s saying — it’s almost saying in many ways people are trying to make this happen, ladies and gentlemen, and they’re working real hard to do that, and they’re working within the structure you set up, and things are getting picked up as they move along, and groups are handling them in different ways and enhancing this and doing that and so on. I think that’s a good story.

Now, I didn’t say six pages. But it’s not bad to just tell — whether it’s a paragraph, whether it’s two paragraphs, it tells a story, that everybody’s not sitting there going, Okay, I’ll implement this standard and now I sit and wait for you, for somebody to come up with some magic next one. It’s getting enhanced.

Are we where we need to be? Absolutely not? Is all the adoption there? No. But the energy is actually, in my opinion, probably two to three times more than it was when HIPAA came out.

Walter, do you agree?

DR. SUAREZ: Absolutely. I think the Recovery Act is HIPAA. Health reform is HIPAA also.

MR. REYNOLDS: That’s what I mean.

DR. SUAREZ: So it is nice sequence to test — this is what happened and where we are with 4010. We’re getting ready with 5010, and we have a number of other things related to HIPAA that are being already implemented from the Recovery Act, that are being discussed under the health reform, that are being incorporated into meaningful use. So it tells a much more complete story and much more, I guess, future thinking rather than back into 4010.

MR. REYNOLDS: And again, just a short part. In other words, if you make it too big, then — no. Just to stay, in the past we’ve been talking to you about what’s going on because we’re trying to get it going. It’s going, guys, and it’s really going well philosophically. People are still pushing up front. There are things happening. So let’s keep it going. That’s kind of like, it’s almost like let’s keep it going, let’s get more people using it, let’s do what we do because it’s there.

Lorraine, I can’t tell what you’re thinking over there.

So, Judy, do you need help?

DR. WARREN: Yes.

MR. REYNOLDS: We’ll help you.

DR. WARREN: I was going to say, right now, let Lorraine and Suzie and I finish getting the materials together. When we get to this end of where it’s fleshed out, that’s when we’re going to need help.

MR. REYNOLDS: Yes, but I just want to make sure — I can’t read — I don’t know Lorraine well enough yet, I can’t read her face. I want to make sure that she doesn’t think this is a bad idea.

MS. DOO: I don’t think it’s a bad idea. I think that as we’re putting it together and looking at the past reports, it is what has this committee’s impact been on this progress? And so, yes, you’ve made recommendations, things have happened. And what I think I hear you saying is bigger things have happened than just the implementation of —

MR. REYNOLDS: For example, I mentioned NCPDP. That’s a huge impact. With the way they’re moving and we’re doing the backward-compatible, that’s a huge impact.

Now, you could say that has been accepted, but if you just say it that way, that’s about streamlining. That’s about the industry moving forward in the right way. That’s not about whether — we sent something up and the Secretary checked it off. That’s a different story. I am trying to tell stories around what we did.

DR. WARREN: So I think what has us confused, because we’ve talked about it amongst ourselves when we’ve met, is this is a HIPAA report. A lot of what we did was NCPDP, was with MMA, under that, did build on some of the standards of HIPAA. We now have ARA coming out with healthcare reform. It is certainly building on HIPAA.

So it is trying to craft this report that is supposed to be about HIPAA and then pulling in these other things.

MR. REYNOLDS: We’ll start talking about HIPAA and say, “As a byproduct of that, here are other things that the committee and others have been involved in.”

DR. WARREN: So we’ll work on that and see where we go, so there will be things that will be coming back to people to take a look at and —

MR. REYNOLDS: They might throw it all out. The point is, let’s think about it.

DR. WARREN: That’s okay, yes.

It was Mark and then Marjorie.

MR. HORNBROOK: Are we supposed to be talking about the impact of HIPAA on our ability to generate national health statistics, the effects on response rates, the effects on people’s willingness to give us the data you need?

PARTICIPANT: Care statistics?

MS. GREENBERG: No, I don’t think so.

MR. HORNBROOK: That’s not what this report is about.

DR. WARREN: This is about administrative simplification. There were certain things we were asked to report on and their status. And so when you look at the outline that we’ve given there, we have a list of things that were in the bill, and each one of those will be addressed. That’s under number 3.

MR. HORNBROOK: And you’re not supposed to be dealing with impact of HIPAA on research generally?

MS. GREENBERG: No.

MR. HORNBROOK: Okay.

DR. WARREN: No. Wish we could, but no.

DR. SUAREZ: Well, on the privacy side, if there’s something so gigantic that affects privacy, then yes, in that sense I think it’s part of the impact.

DR. WARREN: Maya may decide to add something about that, I don’t know. We haven’t gotten her piece yet.

Marjorie?

MS. GREENBERG: Just two things. I’ll try to be brief. I don’t have the legislation in front of me here, but it is my understanding that the committee was asked not so much to report to Congress annually on what it has done but on what has happened with HIPAA. So I do think that that is actually what the committee was asked to do.

Of course, we feed into that what we’ve done, we report on what the Department has done, to the extent we have information we report on what the industry has done. So I do think our mandate was much broader than just what did NCHS do. And we all agree on that?

DR. WARREN: Yes. And what you need to know is Suzie wrote the seventh report, Maya wrote the eighth report. They are both involved in writing this report.

MS. GREENBERG: Okay.

DR. WARREN: So we have a history of all —

MR. REYNOLDS: And history is good and it can be restrictive. So I just want to make sure that we talk a little bit —

DR. SUAREZ: The title is about implementation, though.

MS. GREENBERG: It’s about implementation, yes, but let me say one other thing. For a long time implementation just was getting the regs out and everything, but we have sort of passed that, although not completely.

The other thing I wanted to say is, at the same time that this HIPAA report is being written — and, of course, there will be presumably a 2010 HIPAA report too — we are writing, updating the 50-year history of the National Committee, which is a solid document. We’re not changing that document, but we’re doing an update for the 60thanniversary, which will focus on the last 10 years that aren’t included in the 50th and will also focus even more on the last few years because we have not done an annual report of the National Committee. We do the HIPAA report and then we do the annual report of the National Committee, and then it was a biennial report, and we haven’t done it I think since 2006, maybe, because we’ve had these other things going on and we were anticipating this big report with the 60th.

So some of the things that you’re talking about, Harry, or that you’re talking about, Mark, that may be a little out of scope for this HIPAA report could be in scope for the committee’s report.

DR. WARREN: So one of those that I could think of that, as you were talking, went off in my head is the HISPC group that Braylor start out with the states — I know Jeff was one of the states and we were — that was looking at security and confidentiality. We actually found out that one of the major barriers we had was HIPAA, for all the reasons you’re talking about, because it stopped research, it stopped the sharing of data, it stopped a lot of other things because people didn’t understand it and they used it as an excuse.

Things like that, should that go in this report? That was a major national initiative coming out of HHS.

DR. SUAREZ: That’s part of the ONC initiatives that just ended in July. But in whatever respect the NCHS was involved, that will be —

MS. GREENBERG: That could go in the HIPAA report, it seems to me, if you’re talking about HIPAA. Absolutely. But I’m thinking some of the MMA stuff, some of the other stuff, should get into the 10-year report.

DR. SUAREZ: If there was something big in the last 10 years, there should be even a chapter maybe on this new book, updated, which is 10 years of HIPAA, because that has been 70 percent of what NCHS has been doing.

MS. GREENBERG: But I will tell you that Susan Kenaan, who is writing this one, needs your help.

DR. WARREN: Or we may need hers.

MS. GREENBERG: She will need your help on at least topics, okay?

DR. WARREN: Okay. Harry?

MR. REYNOLDS: Jeff, you made a comment earlier about what NCVHS did and what was accepted. I would be comfortable — I want to be careful having it too black and white that we’re saying here’s what we told the Secretary to do and here’s what he or she did.

MS. GREENBERG: Of course, we report on that annually.

MR. REYNOLDS: I know that, but I want to make sure we just do that in a way that it’s not in somebody’s face, and I know you well enough that’s not the case. I’m just using that as — because maybe not all of our suggestions are — may not be worth —

MS. GREENBERG: Actually, it’s amazing how many were.

MR. REYNOLDS: And I’m not being ugly. You know, it’s called a recommendation.

DR. OVERHAGE: It was a previous Secretary.

MR. REYNOLDS: So keeping score — well, but keeping score, I want to be —

MS. GREENBERG: GAO requires us to keep score, but we have been amazed, Debbie Jackson and I, in this GAO report we have to do every year, how because — in good part because of HIPAA, how many of the recommendations really have seen the light of day, or at least are in the process of being addressed.

DR. SUAREZ: Or are addressed in other ways, that’s good.

MS. GREENBERG: Yes. So it’s a pretty story, actually. Ten years ago, it wouldn’t have been nearly as pretty, or 15 years ago.

DR. WARREN: Okay, so we’re right at 9 o’clock, which is when the full committee is supposed to start.

DR. SUAREZ: Nine-fifteen. You have 15 minutes.

(Simultaneous discussion.)

MS. GREENBERG: The full committee is not meeting until 9:30.

DR. WARREN: Okay. Jeff?

MR. BLAIR: You had just wound up pointing out about HSPC and that, at the same time that there has been a lot accomplished and a lot achieved, there have been some issues and problems because some things were not done completely or comprehensively or we didn’t think of the side effects.

There is an issue here, and I don’t know whether you want to have it in this letter because, Harry, you pointed out the sensitivities.

But one of the things was that when privacy was passed as part of HIPAA, there was a decision that we were not going to preempt state laws with respect to privacy, and right now we’ve been making progress on so many different fronts in terms of interoperability and health information exchange. What appears to be emerging as a major gridlock is simply the fact that although we worked for years with HSPC to try to see if there are some ways to resolve these issues, to share information between states, the ability of us to do so technologically or with policy is coming to an end.

If Congress doesn’t relook at this issue of trying to preempt state laws with respect to privacy, I think that we may cripple so many of the things we’re trying to do with meaningful use and interoperability and the NHIN. I think we need to say that that may have been the right decision 10 years ago to not preempt state laws, but we’re in a different place right now and we’re running out of ways to resolve the issue of sharing information between states.

MR. REYNOLDS: In my opinion, that would need to be through a committee, through hearings, that would need to be a letter to the Secretary, not just quietly thrown out in an annual HIPAA report, because if we make a recommendation like that, we’re going to have to make sure we’ve heard from enough people.

MR. BLAIR: All right.

MR. REYNOLDS: I don’t mind the situation, but I want to make that that’s done through the regular channels, not over the Secretary’s head to Congress. I don’t want to go there. I don’t play in that world.

MS. GREENBERG: Amen again.

DR. WARREN: Marc?

DR. OVERHAGE: Another quick non-controversial question, and that is — oh, I think — health plan identifiers are on the forward-looking radar screen, it looks like in the report, and I am just ignorant where that is and what’s going on. Is that actually —

DR. SUAREZ: It’s incorporated into the health reform bills. I don’t know if HHS has done any — I am almost certain that HHS has done nothing yet about the implementation of it, the drafting of rules or anything like that. But it is called for to be completed, just like a few other things, like claim attachments, in the proposed health reform bills.

MR. REYNOLDS: Two different sets of dates. The House has one set of dates, the Senate has another sets of dates.

DR. SUAREZ: Yes, the time frame is a little different.

DR. WARREN: Lorraine?

MS. DOO: Just for — everyone knows this, probably. It was in the original rule for HIPAA. We were already required to do it. We don’t need health reform to tell us to do it.

DR. WARREN: It’s at the bottom of page 4.

MS. DOO: Right. But, hopefully, that will help stimulate it. A proposed rule was drafted but never published.

DR. WARREN: I am going to go through the actual outline of the meeting today, just so that all of you are aware.

We started out with an executive summary which just states why we’re doing this and that we’ve been designated to do it by the HIPAA legislation. Then in that will be a summary of the report that follows, and then our recommendations will come at the bottom of that page which is on 2.

On 3, a lot of this is just updating the dates and pretty much boilerplate of an introduction to the report, the background of listing — we wanted to develop a listing of the regulations that have already been published, and we’re working on that list.

Then on to part 3, which is the specific progress. So we’ll be giving an update on transactions and code set standards, privacy standards, employer identifier standards, security standards for protection of PHI, the national provider identifier standard, the dissemination policy of NPI; various enforcement issues such as the enforcement of transaction security and privacy; and then we felt we needed to add a section in here of realignment of functional responsibilities between CMS and OCR, because that has happened.

That’s where we’ll come in and talk about the national health plan identifier and then make a statement about the unique personal identifier and where we are. Then we have a section that will be talking about claims attachments, and that’s where we wanted to talk about 5010 D.0 and 3.0. So we do have NCPDP stuff in there. I had forgotten about that.

MR. REYNOLDS: Yes, but I am not —

DR. WARREN: You’re talking about the story of the —

MR. REYNOLDS: I am more interested in the story of the things that are happening different than the way HIPAA was originally envisioned and how the industry and others are using it in the appropriate ways to move things faster. That’s asked for.

DR. WARREN: Okay. Then to follow that one will be the ICD-10, some discussion about the publication of the final rules and where that time line is, compliance reviews, and then the private sector input about HIPAA administrative simplification, some of the things that we’ve done with them.

We wanted to put a summary of the DSMO and how they’ve participated in this. Now, we didn’t know whether or not we wanted a placeholder after the DSMOs about the data stewardship work that has gone on. So that’s a question to this committee and not only to the subcommittee but to the full committee as well.

So, Harry?

MR. REYNOLDS: I think it is from the fact that a lot of what — when we were talking, Jeff made the impassioned statement about being able to match records and get across state lines and everything. The thing I like about continually putting up stewardship is a lot of that is the stewardship of people’s data and whether or not it’s put together the right way and whether or not it travels — so it’s not a bad umbrella to continue to put up every time you talk about what are the things that are happening and how do they get impacted and what does it mean. So I think that’s a good subject, because it’s a safe subject to talk about difficult issues.

DR. WARREN: To follow that, Lorraine and I both thought it was very important. HHS has done a lot of outreach to get some of these HIPAA regulations out there, and we wanted to note their work, both CMS and OCR in their work to get information out and to provide guidelines, et cetera.

MR. HORNBROOK: Judy?

DR. WARREN: Well, just let me finish because we’re almost done here.

And then we wanted to phrase that in addition NCVHS has had a prominent role in the monitoring of the implementation and what our role was. Then we’ll have conclusions, so we’ll go back to our format of observations and then recommendations, and then those will be pushed back into the executive summary as well.

Okay, I think it was Mark and then Mike.

MR. HORNBROOK: This is just a question, Judy. Is there any place in here for some kind of summary of major security breaks?

MR. REYNOLDS: Major what?

MR. HORNBROOK: Security breaks, like the VA. I’m assuming that most of the violations of HIPAA have been largely accidental, but some of them have been huge in the sense of the numbers of people affected. Is there any part of that in here, or is that just the wrong flavor?

DR. WARREN: I don’t think so. It has never been reported in the others as we looked through those. So I have to —

MR. REYNOLDS: I would not want to report anything we haven’t had a hearing on, we don’t understand, and we would just be kind of — in other words, that would be something I would assume OCR or somebody else would be reporting to Congress on, not necessarily us, I think.

DR. WARREN: Unless OCR would ask for it to be in.

MS. DOO: And remember, for 2008 and most of 2009, OCR was not responsible for security, CMS was.

MR. REYNOLDS: Well, whomever. I would want them to be the ones reporting to Congress, because again I just think that’s —

DR. WARREN: Right. Mike and then Walter?

DR. FITZMAURICE: Probably it’s not thin ice, but in talking about data stewardship related to HIPAA, HIPAA has always been concerned with things in motion, not with maintaining a database and responsibilities for a database.

But saying that and saying there’s a caution with it, with our maintaining a large database, I think that it’s good to put it in here, because as we move down the road toward health reform, toward other things, we might have to be having repositories under HIPAA repositories, health plan provider system. We do have a national provider system.

So starting to tell people NCVHS is concerned with the ethics, with the moral behavior of handling data and has developed some principles and guidelines, I think is a good thing. So with the caveat that, yes, it gets into what do you do about data at risk and does this really move us beyond HIPAA, it foreshadows the fact that HIPAA may get involved more and more with maintaining repositories of data, just with all the functions of HIPAA.

DR. WARREN: Are you talking about this data stewardship issue?

DR. FITZMAURICE: Yes. That’s what I meant.

DR. WARREN: Just trying to keep up, Mike.

DR. SUAREZ: Just a couple of comments, I guess. One, before the conclusion there is this shaded area about the prominent role of monitoring implementation of HIPAA. I think that in my mind is one of the anchor elements at the beginning of the report, that that is really our role, or part of our role is to monitor and to report on the implementation. So I think it would be great to highlight it. I haven’t read the introduction yet, but I guess it would be helpful to bring that more prominently at the beginning. Just a suggestion.

Then the other thing is, on page 4, the list of the specific progress, and I wasn’t sure if like Roman numeral III meant that that’s a big section or — I’m not sure if this is sort of like it outline form, but the wording in which this is presented, these items, I think it will be a good idea to group them a little differently, like privacy and security together and identifiers together and transactions and code sets together, just a way of organizing them.

DR. WARREN: All right.

DR. SUAREZ: So it might be helpful to have or create a report outline, if you will, kind of like a table of contents.

DR. WARREN: That’s what this is.

DR. SUAREZ: Well, I mean actually a table of contents that shows the sections and their various aspects. Or it’s only three sections?

DR. WARREN: Right.

DR. SUAREZ: Okay. Well, maybe a detailed outline. I’m trying to understand what the overall picture of the report, not just the first, the high-level four sections, you know, introduction, background, specifics, conclusions, but a little bit more detailed outline so that — to me it is always helpful to start with that and see how the report is organized and what sections are there and how is the order and all that. That’s just a suggestion.

MS. WILLIAMSON: I think he’s saying in the specific progress in HIPAA standards implementation section that those topics that you have outlined can be groups differently and —

DR. WARREN: Right.

DR. SUAREZ: What I mean is just —

DR. WARREN: Once we get the report written, then we’ll go back and take a look and see what needs to be on this front page.

DR. SUAREZ: All right. Well, before we get the report written, my suggestion was to create the outline of the report and table of contents.

DR. WARREN: That’s what this is.

DR. SUAREZ: The table of contents?

DR. WARREN: No. Harry asked me to pull together and present at this meeting an outline of the report with as much detail as we could pull together by today. So a description of what would be in the sections. And so that’s what this is.

DR. SUAREZ: Okay.

MS. GREENBERG: The six pages?

DR. WARREN: Yes. The six pages is an outline.

DR. SUAREZ: Okay. The way I would think of an outline is more of a table of contents of the report that shows section 1, subsection 1.1, et cetera, so that it shows really how the report is structured.

I think this is a great way to describe the various elements of the content, but for example on page 4 there are things that are part of section 3 as specific implementation items, and then the national health plan identifier shows up at the bottom, which is not an implementation part, it’s more like planning, so it’s more like a section 4, Roman numeral number IV.

DR. WARREN: What we did on this, believe it or not, Walter, is we took the exact same sequence of items from the eighth report, and that’s where we started. That’s the way it was structured in the eighth report. So we have now put in that writing that we already had, that we had finished, and put it in the sections. You don’t see all of the writing that we’ve done because I edited out quite a bit of that, but I wanted to leave enough to let people know what was going to go in those pieces.

So probably the only thing that we did was we gave you too much to look at.

(Laughter)

But that’s helpful. As you think of those things, please let Lorraine or me know so that we can start folding them into the report.

Mike?

DR. FITZMAURICE: On the reassignment of certain functional responsibilities, CMS and OCR, I guess I would put that either under security standards, above, or under enforcement. I wouldn’t make it a big deal as a separate product.

DR. WARREN: Right. Right now, those are just notes to us that that needs to be addressed, and that’s why we put them in the Italics.

DR. FITZMAURICE: I think it’s fine. You don’t have to include it in an outline. You don’t have to give it the Roman numeral or the As, the Bs, or the Cs. Walter might want to see that, though, but I’m happy with it the way it is.

DR. WARREN: We worried about getting stuff to you, not about format.

MS. GREENBERG: I think you should proceed the way you’re proceeding. But we’re pointing towards approval at the February meeting, right?

DR. WARREN: Yes.

MS. GREENBERG: That means that there’s going to have to be a full draft in January that the subcommittee can look at and then maybe do some tweaking, and then you said a conference call maybe for the conclusions part.

DR. WARREN: I think we need some input from the Executive Committee as to the recommendations and conclusions.

MS. GREENBERG: Yes, that would be good. You might want to have a conference call first, and then we can have a conference call of the Executive Committee, subcommittee, and then at the meeting — we would want to get this to — we want to give the full committee — we don’t want them to get this the day before or something. The full committee is meeting the 10th and 11th, so that’s kind of early. So we’ve got a lot to do by mid-January or whatever.

DR. WARREN: We’re working as fast as we can.

MS. GREENBERG: I know. I didn’t mean to be like a schoolmarm, but I’m just talking out loud here.

DR. WARREN: Yes. Lorraine and I are well aware of what our things are.

MS. GREENBERG: Forget Christmas, right?

DR. WARREN: Yes. Mark?

MR. HORNBROOK: Another question from way out in left field. Is there going to be a section about future challenges? I’m thinking, for example, that in the future at least NIH hopes there’s going to be a lot of bio-libraries out there with tissue repositories linked to individual identifiers.

DR. WARREN: As Harry said, we’ve not held hearings on that, so that would be something —

MR. HORNBROOK: Are we going to say anything about what we should thinking about into the future or not?

DR. WARREN: What I would rather do is you think about the things that we need to do about the future and we start planning them in in what we’re doing in 2010, so it can be part of our 2010 report.

MR. HORNBROOK: Okay.

MS. GREENBERG: But if these things are not so much HIPAA but more generally health information, I think there definitely will be a future section in this 10-year report that I was describing, and some of those things might fit in there better. Again, we’ll need full discussion.

MR. REYNOLDS: Talking about subjects in a report is fine. Directing debate that we haven’t had is where I want to make sure — in other words, if we haven’t had any debate on it, we haven’t had any forums on it, we haven’t had anything else, then I sure don’t want to even allude that we would be making — I mean opinion on it.

DR. WARREN: Right.

MR. REYNOLDS: We can talk about them as subjects, we can talk about things we ought to consider; in other words, we maybe ought to consider to deal with the future that’s coming up, I think that’s a fair statement, but I wouldn’t want to allude that it’s good, bad, or indifferent. It’s opportunities.

MS. GREENBERG: With that said, you will have — and actually it will be good because you will have both of them, the committee will have both of them — you will have in February this 10-year report as well, and we might want to set aside some real time for committee discussion about any kind of future thinking that will go into that report.

MR. REYNOLDS: I think that’s right.

MS. GREENBERG: We shouldn’t load up the February meeting with too many other things to do, not to mention the — oh my. Okay.

DR. WARREN: I need to bring closure to this topic. It looks like we’re going to be having some conference calls, so some of the agenda I’ll put off to those.

But I do want to let everyone know that under tab 4 of your agenda book is a report from the consultants to the Population Committee on meeting health information needs for the 21st century. What the Population Subcommittee decided to do last evening is they’re reframing the questions under that, so much like we’re reorganizing the way we’re going to be presenting this report, they’re going to reorganize those questions.

Once they come out from that, one of the things that they would like this subcommittee to do is to take a look at those questions and to start identifying whether or not there are standards in place to implement or to answer those questions. They need to have their report done for the June meeting. So there is going to be some fast work being done through emails, conference calls, to pull all that together.

What I thought was going to be kind of a nice, sleepy beginning of the year is turning out to be much more packed with that.

MS. GREENBERG: Right. It’s cold in January anyway.

DR. WARREN: So I don’t know much more than that. Right now they’re very busy. They’ve got three people who are coming together to reframe those questions. As soon as they get them reframed, they’re going to be sending them out to the rest of that subcommittee and they’ll send them to me and then I will disperse them out to this subcommittee and we can start looking at how we want to add our portion. What they’re seeing is they want from this subcommittee what are the standards that are in place that can support the work that they’re going to lay out, and then where are the gaps.

Marc?

DR. OVERHAGE: I always struggle — whenever I hear the question, “Do we have standards for?” I get this visceral response. But I think you addressed — so I think I would just like us to be careful as we think about that to say it’s not are there standards in place in most cases. There might be a gap, as you say, but I think they will be few and far between, but rather, as Mark described, what are the things that directionally need to be done in terminologies or what are the things that — because this reflex “We need another standard” just drives me nuts.

DR. WARREN: It may the piece of should there be modifications, is it an implementation issue? Because they’re still trying to figure out —

DR. OVERHAGE: Which, of course, is where 95 percent of it is.

DR. WARREN: Yes, right. And so all of those would be things that they’re going to expect our committee to make comments on. It’s not create new standards, Marc.

MR. REYNOLDS: We’ve got to cut this.

DR. WARREN: Okay. We’re done. Harry just adjourned the meeting. Thank you, everybody.

(Whereupon, at 9:25 a.m., the meeting was concluded.)