[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS

September 23, 2009

Washington Marriott Hotel
1221 22nd Street, NW
Washington, D.C.

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266-8402

Table of Contents


P R O C E E D I N G S (8:05 a.m.)

DR. WARREN: We don't seem to have a whole lot of people here. We now have a quorum with you Jeff.

MR. BLAIR: Okay, sometimes quality time is –

DR. WARREN: With that we would like to go around the room and identify who is here.

I am Judy Warren, University of Kansas School of Nursing. I am co-chair of the Standard Subcommittee, member of the Full Committee and I have no conflicts.

MR. BLAIR: This is Jeff Blair, co-chair of the committee. I am with Lovelace Clinic Foundation. To my knowledge, I have no conflicts of interest.

MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield North Carolina. No conflicts. Member of the subcommittee and Jeff's brother.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Restriction Quality. Liaison to the Full Committee. The only conflict I have is that I am a FOJ, which is a friend of Jeff.

DR. SUAZREZ: Good morning, I am Walt Suarez. I am a member of the subcommittee and I don't have any conflicts.

DR. HORNBROOK: Mark Hornbrook, member of the Full Committee, Kaiser Permanente, no conflict.

(Introductions around the room)

MS. DOO: Lorraine Doo, CMS, Office of E-Health Standards and Health Services. Lead staff to the Standards Subcommittee.

DR. WARREN: Just for the record, Jeff and I want to acknowledge that this is Loraine's first meeting with us and welcome.

MR. BLAIR: Welcome, Lorraine.

DR. WARREN: Before we start on the agenda, is there anything anybody else wants to add to our agenda?

(No response)

DR. WARREN: I have one thing to add and we will add it to the end, in that we need to be talking about our 2009 HIPAA Report that will be due by the end of the year.

I would also like to give a brief report, I attended the Population Subcommittee yesterday and we had some interesting kind of proposals that will be coming out to the Full Committee later this morning.

Agenda Item: Plan hearings on the readiness to implement 5010 and ICD-10

With that, what I would like to do is kind of open this up for discussion about hearings in December. Let me give you some preface with that, and then if Jeff or Harry have anything to add, they will do that.

We have been asked by Tony Trenkle, who is one of our customers, who is very concerned about the implementation of 5010 and ICD-10 and it's nearing deadlines. What he would like to see is for us to hold hearings to see what people are planning to do. So not really looking at implementations yet, as it is a little premature, but there is concern that with all of the effort around Meaningful Use and some of the other things that are happening right now in health care, that 5010 and ICD-10 are not really being worked on.

I personally have concerns because we heard very clearly in our hearings that people needed enough lead time to get ready for these two requirements. We have given them pretty much the lead time that the industry said that they needed, so now we want to look and make sure that the evidence is there that they are beginning to plan for that.

Jeff, you want to add anything to that?

MR. BLAIR: No, that is just fine.

DR. WARREN: Harry, you want to add anything right now?

MR. REYNOLDS: (Nods no)

DR. WARREN: So, with that Karen Trudel, Lorraine Doo, Harry Reynolds, Tony Trenkle and I, had a phone call about two or three weeks ago to see what kinds of things we wanted to have on this hearing. What I thought I would do is talk to you about how we see this playing out and then get some ideas from the committee about how we might put these panels together and begin to craft the set of hearings.

We began to derive a list of testifier groups. At this point, it is far many more people than I think we have time for. Right now we were looking at providers coming in, quality improvement people, various vendors – and these are EHR vendors, as well as both in-patient and ambulatory, clearinghouses, hospitals and clinic groups, billing services, health plans, CMS, WEDI. That is my list. I don't know if you have any more on your list or not, Loraine?

MS. DOO: The additional vendors would be the practice management and software vendors, so not just the electronic records but those that are actually conducting the transactions on behalf of the providers and plans.

MR. REYNOLDS: Did you mention the training companies that do training?

DR. WARREN: No.

MR. REYNOLDS: That is training based on the code sets and the possible process implications that ICD-10 creates. I know I said for example, in my own company, we are going to have to train more than 2000 people on some facet or some degree of ICD-10, especially. Your normal process of training is not going to play out nicely when you take numbers where you are used to doing 20 at a time, and you start talking about those kinds of numbers.

DR. WARREN: You were also talking about business processes and helping people understand what those might mean.

MR. REYNOLDS: I think some of those will come up in the questions and Loraine's got the copy of it. Remember you had assigned Karen and I and Lorraine to work on the questions – so we can go over those whenever you want to.

DR. WARREN: I thought we would try to get down people first and then questions.

Mark, and then Mike.

DR. HORNBROOK: Just a question, I did not hear the words fiscal intermediaries or carriers, which are Medicare concepts, and I did not know whether you did that on purpose because you had a broader – but it seems to me that Medicare is going to be the bell weather here if we don't have Medicare –

DR. WARREN: We had CMS.

MS. DOO: CMS would incorporate the intermediaries and carriers because that is how the work gets done.

DR. HORNBROOK: Similarly, for the states that have Medicaid claims processing contracts – at least the largest states; New York, Pennsylvania, Texas, California.

DR. WARREN: Okay.

DR. FITZMAURICE: Judy, you might have included this, those who provide billing services. That is physicians say, here is the paperwork on the people that came in. Turn it into something I can get paid for.

DR. WARREN: Right. Dan, you had a question?

MR. RODE: Dan Rode, AHIMA. You may also want to also consider the vendors that are coming up with new products in the area of coding and potentially the groups that will be working on N-coders because there is a new set of vendors that will come into the equation.

I would also suggest that you consider looking at some of the smaller Medicaid's organizations because I would be concerned that they may have more problems than the larger ones.

DR. WARREN: I am surprised that you are not suggesting AHIMA.

MR. RODE: I figured we were all ready on your list.

MS. DOO: You are on mine.

MR. REYNOLDS: As we have worked this out, the purpose of the hearing is not to require people to come in and put them in a position that they may not be moving fast enough or may not be considering things. The purpose that we worked on was to get a sense of how people are approaching it, put down some lessons learned, put down some other things, so that our communication and/or what CMS could use from our situation, could be sent out to the industry to move people.

This was not a readiness – I mean this is not a readiness hearing. This is more how are people approaching this? What are the things they are running into? And we will go through that list in a little bit. So, Dan, in that fact the reason I am answering it that way is the thing you don't want to do, especially with ICD-10, you don't want to necessarily make people feel that they are being judged this early in. We are trying to build a body of work so that people will be able to pick it up and use it whenever they do have the right time.

We are trying not to be over draconian at this point, in scoring people when – some of them could say, well, I am not starting ICD-10 till now. That is a request we had.

DR. WARREN: You said it much better than I did.

MR. REYNOLDS: We are really trying to make sure that we are not going somewhere that we should not go.

MR. RODE: Thank you, Harry. My concern is we have some of the same concerns that you do and what I am actually more concerned with right now than ICD-10 is the 5010 transition because I have encountered in trying to find out where we stand, a lot of folks who have never been through a HIPAA transaction upgrade. We were not there for the first one and I think your idea is great and I definitely like that, but I also think it is also important that I think there are some folks out there that may be blowing in the wind right now because they don't know what to do.

DR. WARREN: I think that is why we had the trainers and companies like. The other note that I had here is what we were trying to produce is a set of ah-ha's for how to think about planning implementation training and transition into using these.

I have Walter, Mark and Mike.

DR. SUAREZ: Thank you. I don't know if I heard or not, including Medicaid representatives.

DR. WARREN: Yes.

DR. SUAREZ: I think that would be an important group. Also, on the provider category there are a large group of a variety of providers – so in-patient and out-patient. In-patient there is a whole group of entities from the traditional hospitals to long-term care and others. Then on the ambulatory side, beside the medical clinic, there are other important groups that are going to be affected like dental clinics and ancillary services, which will be important to consider their way of transitioning.

The other one to consider perhaps, more as a reference point, is the DSMO's and the standard development of organizations.

DR. WARREN: Thank you. You had a rebuttal?

MS. VIOLA: Allison Viola, AHIMA. Just something you might want to consider as you are trying to build a body of work to serve as best practices or something similar to that is those countries that have gone through this implementation, Australia, Canada, that could perhaps share their lessons learned and some of the challenges that they encountered and how they overcame those.

DR. SUAREZ: You talking about ICD-10, specifically?

MS. VIOLA: Yes.

DR. HORNBROOK: Help me understand here, we are not trying to do an expose of how unprepared the country is. We are trying to do an educational lesson about where the people are who are doing it right and can serve as leadership examples and teaching examples for the rest of the world who is following along? If that is the case, I think the burden on us is to find those diamonds somewhere out there and get them identified and verified.

DR. WARREN: So, if you know of any?

MR. REYNOLDS: Yes, when we took on this assignment we realized that real early.

DR. WARREN: I think what we are going to find is some are better at some phase of the process than others, so it behooves us to try and put together a network there.

Mike.

DR. FITZMAURICE: I took some lessons from what Harry was saying. We may want to learn from them what is your baseline? What are you planning to do? What kind of timeline do you think should be done? Then maybe synthesis that into, here is what we have heard about how to plan for it. There are different ideas out there. Not so much a cookbook, since we don't do this, but learn from the people who have to develop their own cookbooks and ask them what the barriers are, the clichés. Maybe it is having sufficiently trained personnel to actually do this. And where are you going to find them – nowhere, you may have to train your own people Just lessons like that that help people get started.

We might have to hear from Blue Cross, from Kaiser Permanente, from WEB-MD, the people who have large operations that have to do this.

MR. REYNOLDS: As we go through this, in 5010, for everybody who has done the HIPAA before, 5010 is kind of the ramp-up to ICD-10, it is not a dramatic change, however the fact that we are changing the code sets forces other people who have not been at the table. Anyway we can help.

Judy, the other thing I was going to say is I would not be restricted by the fact that we could not talk to everybody. I would even consider whether or not we do 2.5 days. The point is we are in the front-end of a huge launch, in the midst of everything else we talked about yesterday with the Meaningful Uses and everything else. If we needed to do two full days, two and a half, I am willing to talk about that because once we do this and then we put this body of work together – and let us say we do it in December, and we have it out sometime in January, you are into ‘10. 5010 is due at end of '11, and you better be running full speed not too long after that on ICD-10.

That would be kind of the industries main shot in an open public forum. CMS and others are doing a lot of outreach, but our ability to make sure that we touch all the right things and all the right people, I don't want to be restricted. I would rather look at what you and Jeff, and others, think who we should talk to. Not necessarily the fact that we just have got a day and a half and we want to leave these people out because this thing sweeps up a whole lot of other people we never had before. It sweeps up a whole lot of thinking we never had before. If we are going to be the launch-point of really pulling this together in this kind of an environment, a little bit like we did Meaningful Use, then let's make sure we have the appropriate list and then we will talk about whether that is a day, day and a half, two days. Does that make sense?

DR. WARREN: Jeff and I have talked before in planning meetings, and came up with a couple of alternatives that I think are worthy to consider as we engage the dialogue. One of them is to have two full days and not a day and a half, and see where people are in trying to get back out of town with that.

The other one is, what we have done a lot of times in the past, is ask for written testimony. So that is kind of the second half of the dialogue that I want to have is what kinds of questions – because we need to start inviting people like within the next week or two. So we really need to kind of hone down our questions that we want these people to answer in testimony.

So with that, Walter and then Mark.

DR. SUAREZ: I just wanted to ask this. I think we are sort of jumping from identifying organizations to kind what kind of questions to what is the purpose to how long it should be. So we are kind of jumping into different topics and maybe it would be helpful to sort of go in order to understand what is the purpose first and then what sort of questions are going to ask.

In the purpose, like I agree, it should not be an expose, but it should allow us to understand what is the level of readiness in the industry. Not to expose issues with readiness, but more to understand where are the pressing points and what are people doing to alleviate those pressing points.

Whenever we are ready to go into the discussion about the purpose and the question is –

DR. WARREN: Pretty much, I think, Harry captured the purpose. Remember we are being asked to do this by Tony Trenkle. Harry, do you want to clarify this?

MR. REYNOLDS: I don't even want to just say Tony. It is important to the industry and CMS that there be a view as to how things are going. Tony talked to us but this is really kind of – because one thing I can say about CMS in general in this one, they are out front quite significantly on ICD-10 and I commend them for that. So making sure that we get the right people in here.

Again, Walter, where I might push back a little bit is having people declare this early on rather than declare how they are approaching it and which will help us understand where they are and where we need to shore them up. There is a lot of concern that a lot of people won't come in here and/or you can create a fire storm that people are not going to get there.

DR. SUAREZ: This time it is different – the implementation process. This is not a deadline by which we have to comply.

MR. REYNOLDS: There is clearly – 5010 is '11 and ICD-10 is '13, so there are clear dates. But people are – again, this is the first thing out of the shoot. If you are talking to me in the middle of '10, then a readiness discussion may be much more serious from an NCVHS standpoint. We have not been asked nor do I think this far ahead – and again, most of the discussion in my opinion, is going to end up on 10. There are people who are coming in who will be talking about what they are doing on nine – the big groups are able to do that.

Now, who do we need to pick up and what does or doesn't it do and what does it create on some things. Again, working with a partner and a customer, I don't want us – it is going to be easy for people to come in here and start talking about the dates. It is going to be easy for people to come in here and start talking about I've got too much to do. We are looking at the landscape, the dates are set, nobody is talking about anything other – those dates are going to happen. That is all – we are trying not to send a signal that if you come in and you are not far enough along, then you will be identified as not far enough along, and that is all.

So we are trying to gather from everybody how are you approaching this? What are doing? You will hear the list of questions. We made a huge list of questions all ready and subjects. So that is all I am saying. I am trying to not create some kind of an issue here – we are launching this. This hasn't been launched in any open public environment to this point, as to how it is going, how are people approaching it, or anything else. So, best practices are not on the table, except CMS has done a great job with their own work and are passing this out, but not necessarily hearing from the entire industry.

DR. WARREN: Just to follow up on that, we are still crafting the words for the purpose. I don't think we are quite ready to do that. When those words get crafted they will come out to the Committee for viewing.

MR. BLAIR: Harry just mentioned that you have crafted questions. As I was listening to Harry, and Harry tell me if this is echoing back the overall guidance you are giving us. It sounded to me like we wanted to know what each of the testifiers felt were the major challenges, and what are they doing to address and overcome those challenges?

MR. REYNOLDS: Yes, that is fair. Again, when we go through this category of questions, not the specific questions, this category of questions that we all met on yesterday getting prepared for today, and then anybody else will add areas, I think you will see that it will bring the things to the table – those that are doing it will be able to explain how they are doing it and why they are doing it and what it means. Those that are not doing it, would be able to hear from these questions, even from the people that are doing it, what are some of the things that they have run into that are different than the other implementations and so on, so that that could be a body of work used.

I would say this to you, it might not be kind of bad to have not done some of these other things. If you have this hearing and we get the things done that are listed here, you might be able to jumpstart yourself without sitting in your own environment worrying about what I should do. If we get some of these things accomplished, it would be almost like a consultant coming in and saying, here are the things you ought to worry about. Here are the things you ought to do, and oh, by the way, get going on it. Versus right now, that is kind of hard to get going.

As you know, my day job is implementing these so I feel the pain clearly, but I also feel the positives. That is why we are doing this and that is why I think we can be of great service to a lot of people to do it as initially a helper, and almost the primer, visionary, that kind of thing. Then, I am sure that starting in '10, we do have a responsibility to help understand the status of the implementation and what does that mean.

DR. WARREN: Is that all, Jeff, or can we go on?

MR. BLAIR: It just reminded me, did we have WEDI on the list because I know that they have come up with a roadmap?

DR. WARREN: Yes.

MR. BLAIR: For one of the folks that would testify – I think that the WEDI roadmap might be helpful.

DR. WARREN: We have that on the list.

MR. BLAIR: Okay.

DR. HORNBROOK: In thinking about the big building blocks, this conversion is for ICD-9/ICD-10, is a scientific technical and cultural turnover. It seems to me that if I were going to craft these day and half/two days, I would want to start off with a very brief concise statement of any differences in principles and differences in the major conversions issues. What blocks of the code are essentially mapped over one to one? What blocks of the code are totally turned on their head? What are the new codes and what are the condensed codes? Sort of a meta-classification of the mapping, the cross-mapping, to give you a sense of the theory and the principles that the 10 developers are trying to get to.

I would not spend hours on this. I would just try and do it – hit the tops of the mountains but to set the foundation for what the technical problem is and a little bit of what the principles were that the developers of 10 were thinking about.

Then there is the question of whether it is – I think it is going to actually happen - but what are the implications of taking existing 9 data and running it through a 10 grouper. Somebody out there is going to have a 10 grouper that will take 9 data and run it. Of course those of us in research really need that because we are going to need to have our data in consistent fashion from 9 into 10, when we have our data systems going across these years. Some of the systems will do that.

Again, can anybody speak to the implications of that as being a sub-optimal but feasible way of getting through because they have to send in 10 data that will get through the utilization review mechanisms?

Then the final third leg would be talking to the folks who actually have to do the coding. So they are looking at the text language of the diagnosis and the reason for visit or reason for services, whatever, and they are putting the number in. That is going to be the medical records people in the hospitals, it is going to be the physicians in the electronic medical records, and it is going to be perhaps, billing clerks inside physician offices.

Of course some of those are going to have access to major consulting – able to come in and help them do it. And they are going to have a huge roll-out and a training program. They are going to have self-training within the organizations. A lot of physician practices are going to be left on their own.

Somewhere in that spectrum you want to come down and give an optimistic perspective on how to get through this, rather than simply saying we are out to get you if you don't do it right.

DR. WARREN: I agree. I have Mike and then Dan.

DR. FITZMAURICE: In the questioning, one of the things that come to mind is are you doing 5010 and ICD-10 in tandem or sequentially? It is laid out time sequentially, but what tasks are common to both and more efficiently when done together rather than separately. This would get into areas of training, software modification, personnel hiring, linking with providers with others who feed information into your system, and what software do you find helpful in making this transition? To what extent are they combining 5010 and ICD-10?

MR. RODE: Thank you. Dan Rode, AHIMA. I just mention that some of this discussion has just occurred at the coordination in the Maintenance Committee Meeting mid-September. Those decisions are still within the CMS. While I think the questions are excellent, I think it may be a little premature to try and get that detailed at this point. I think in looking at what people are laying out as their roadmap to I-10, they may be able to make some comment on it. But because the roadmap is two years longer, you may not be able to get all those answers quite at this point. There will be some other decisions coming out of Coordination and Maintenance that will impact some of those questions.

DR. WARREN: Are you talking about both 5010 and ICD-10?

MR. RODE: No, just the ICD-10. Among those are the freezing of the code sets, which was a major part of the discussion in September, and when that might take place, which will impact what some of the approaches will be.

DR. SUAREZ: I just wanted to comment on the structure itself and the type of questions. I think we do need to separate – and as much as I like Mike's idea of bringing together also ICD-10, I think basically trying to meld together the two, I think we need to ask a series of questions – and I have them grouped in my own way – but I am sure we will hear from –

DR. WARREN: Yes, I want to start with –

DR. SUAREZ: So I will wait for that but my suggestion was we need to separate and talk about 5010 first and have a series of questions on issues about 5010. Then have specific questions on issues about ICD-10. Most of the people that are going to testify will be able to talk about both. I suppose pretty much everyone that is listed will have in one way or another, going to deal with both, but I think it would be important to address the specific transitional issues of 5010 and understand how things are going to be transitioning because as I said, even though there is a deadline, there is a different transition process this time. The transition itself, from 4010 to 5010 is not going to a major change from what we had, which was from zero to 4010. I think it would be helpful to separate the two and try and address topics on each of the two.

DR. FITZMAURICE: I agree with Walter and everything is laid out the same sequentially, so one does come before the other. My contribution was let us find out from them are they planning to do some things together and save time and money by saying here is 5010, and you have got ICD-9 in here now, be aware that ICD-10 will come in and replace this segment of the training we are giving you today. Or may they would say, we are not even thinking about ICD-10, we are swamped with 5010. Just information we don't have.

DR. WARREN: Okay. Jeff, do you have anymore comments about the kinds of people that we should bring in and gather testimony from?

MR. BLAIR: I have no additional thoughts at this time.

DR. WARREN: With that, I would like to turn it over to Harry and have him talk about the categories of questions that we have all ready started putting together.

MR. REYNOLDS: Again, this was an assignment that I had as a member of the Committee not as the Chair. Playing off of Walter's comment, I think I would maybe amend it just a little in the fact that I think one of the messages we need to hear from people that come in is can you do 5010 and ICD-10 separately? Shouldn't you be thinking about ICD-10 in everything that you do in 5010? So that is one question. I did not say I have the answer – I know how we are doing it at our place, but that is a question because many people that are doing it right now feel that it is one effort. The reason is you better build the platform the right way to – but we will leave that to the testifiers. That allows them. It is two separate efforts in some cases, but in other cases it strategically –

DR. FITZMAURICE: Find out what they are doing?

MR. REYNOLDS: Yes, that is a good question. So one of our other things is bringing in some of the people in early that have done these things before; what are the surprises? I know for example, I can list numerous surprises. Having done all this before we can list numerous surprises as to what we needed to think about, not the issues – so are there any surprises.

Are there industries and adequacies versus previous implementations? So for example, are their truly a whole lot of people that can help you out there that have done it? If not, what does that mean? If not, where would you seek help? If not, then what does it mean?

Again, we are trying to build something so that somebody would know where to go and somebody would know how to think about getting help. We are not chastising or applauding, we are making sure that that is on the table. Those things are issues. They are issues for discussion.

Areas of focus. What are the things you need to do? Mark you mentioned a couple of them and I put that under ICD-10 codes. The codes themselves – now that you understand the basis of the code, does that make a difference or not? So there are things like that. Those are areas of focus.

Best practices. I know CMS has got some best practices. I know other people in the industry that all ready have some best practices as to how to start. I did not say how to finish – nobody has finished this yet, ever. I know the other countries have done it, but the other countries have not really done it to pay and the other countries have not really used this in an extensive code set. So I think there are variations there that we need to – so best practices. Again, if we can get best practices on the table by February of '10, that starts giving the world a whole lot better – again, ours is to gather up the whole flock and bring it forward, not to necessarily prove who the leaders are.

What is going on in the states? I know for example in North Carolina, we all ready have committee that is going full speed on how should everybody in the state think about doing it and outreach and everything else. Are there other states that are doing similar things? If so, have them come in, testify, talk about what is going on, so you also know how to group up within your environment because we all have to get where we are going.

The next thing is ICD-10, the codes, their translations and things to consider, because this idea of how are you going to use them. And then one thing that I know is on everybody's mind is how are people going to pay on those and what does that mean and some of those things, and whether or not those get added.

DR. HORNBROOK: Harry, you just mentioned, is there a link here for birth and death certificates for ICD-10? Is it on the same timeframe or is it a whole different timeframe?

MR. REYNOLDS: I don't know.

DR. SUAREZ: Electronic birth certificates?

DR. HORNBROOK: Yes.

DR. SUAREZ: The use of ICD-10 codes in the birth certificate system – is that what you are asking?

DR. HORNBROOK: yes.

DR. SUAREZ: I think that is expected to be done before that but I am not exactly clear. I think it is October of 2013.

DR. HORNBROOK: You get less lead lag lessons from vital statistics or not? If not, then just forget the question.

MR. REYNOLDS: It is a good question. I will let someone else figure that one out.

The next one is strategic opportunities. As the industry goes through this, what are the strategic opportunities that any groups, segments, individual companies have come up with that are strategic opportunities that this affords. Just the more detail on the code itself starts to give you ways to do things differently. Again, listing those up front by anybody that has come up with any.

The next one is lessons learned. I would say to you, CMS being probably number one, has spent an awful lot of time and effort looking this. So what are some of the lessons learned?

The next thing is outreach. This Committee has heard numerous testimony, and we will go back to NPI and you can pull up the testimony where there was a significant problem finding everyone that would be affected by NPI, well, a number of you have stated there may be some new players in 5010 and ICD-10 that have not been at the table before in the same way that they are. Much of the industry is depicting this to be 5010 is 80 percent system and 20 percent business. These are just philosophies. ICD-10 is 20 percent systems and 80 percent business. We have not had any of the HIPAA stuff or anything that we have done up until now, that had anywhere near those kinds of percentages as it related to business versus systems. So that is another key discussion.

Let me finish the list and then Judy has got the ball. We made a list of all the things that we have. We did not say it was complete. We were asked to bring something in to start the discussion today – period. Then I am going to stop talking about it.

The outreach - the testing. The testing on some of this will possibly create that entities – and I know if we were testifying, there are dramatic differences on how you are going to test this and what you might or might not have in place with your current testing environment to be able to do these things as you go forward. That is another one.

Training – we all ready talked about that some as a group. What not to do? I was in a meeting the other day – great example, I was in a meeting the other day where somebody said, I am starting to get contracts from people that are committing that they will be ICD-10 compliant. So we may talk about some of the things that are out there now and what might that mean because there are going to be a lot of people running around looking for help and maybe there is some discussion about what they might not think to do.

With that, to the Chair, I have submitted our list for consideration.

DR. HORNBROOK: This is a check on the level of detail you want to go. If you are a hospital, ICD-10 are going to have to go into the DRGs. Do you want to talk about how in the world CMS – or do you want them to talk about how they are going to convert to an ICD-10 based DRG system? Then for HMOs, they are getting paid by APCC and the risk adjustment mechanism underlies APCC, when is the ICD-10 diagnosis going to be put into that and will it change the payment co-efficiency? Medicare fee schedule – if you have to submit a bill with the diagnosis on it, what kind of affect is it going to have on your payment if your diagnosis is illegal? Is it any different than the current system?

That gets you into utilization review and compliance issue. Is CMS going to have a period of grace here? Are they going to be draconian and throw everything back that doesn't need the screening criteria for strong teaching position? I don't know how far you want to go down this in the space of two days?

MR. REYNOLDS: The initial discussion that we have had, and again just to put it on the table, this is not to come out with everything they might or might not have to happen in not putting CMS ahead of where they are or anybody else. This is talking about the people that are having to start thinking about -- your list of questions is a great set of questions for us to come out of this with to say if you are doing this, these are things that you are going to have to make sure that are straight. And when they are available, you know that you had the question.

The most important thing I think we are trying to come up with, how do you give all the people that are doing this – how do you learn from the ones that are all ready moving and how do you give the ones that are moving and are not moving, the other set of questions? That as they go back home and try to make something happen and we put this out as a print – however we put it out – it allows the water level in the industry to rise because if you give somebody the questions that they did not even know, you dramatically affect their ability to make a difference with it.

I think that is how NCVHS, working with CMS in this case, can get in front of this because we are doing it in an open forum, we are doing it in a way we are asking people to come in and talk about it and we are doing it in a way that then it can be filtered into everything that CMS is doing, everything that the rest of the industry is doing, everything the states are doing. So that is our purpose in doing this.

So rather than getting those answers because those answers will come out whenever the individual entity that is being discussed with, would be ready to answer that. Having that list of questions is – we have been working on this a long time and I did not have this list of questions. I love those questions - I would take them out of here and use them.

That is where we are going. It is not to say, tell us right now how you are going to do something. It is to say, what are the questions you better have so that when they come out you have at least thought about and you better be going.

DR. WARREN: Right.

MS. DOO: I actually have a couple. All of your questions are very operational like what is CMS going to do? Which is a little bit different than what we were originally planning for this forum, which is what is the industry preparing? What are they thinking about?

These are great questions for me to take back. I know they are working on them but it is a whole other area of CMS, and very valid, and maybe it makes sense to have something for us to think about, because we have not talked about it, is a grounding of here is where CMS is. Here is where Medicare is. Then we want to hear more from the industry and then we will come out probably, with a whole compendium of questions.

That is part of a preliminary response because I need to think about it a little more because they are great issues.

The other thing I wanted to mention to complicate things a little bit is we talk about 5010, there is also D.0, which is the pharmacy transaction. And there is 3.0, which is the Medicaid subrogation, which has never been done in a standard that everybody has to comply with before. So that is a new standard between Medicaid's and health plans and we need to address that as well, and it is something we should think about including in this as well.

DR. WARREN: Is that the NCPDDP 3.0?

MS. DOO: yes.

DR. FITZMAURICE: What is subrogation? Is that where Medicaid pays and then comes and gets the money back from Medicare?

MS. DOO: Yes, it is not Medicare, it is from private health plans. It is the pay and chase's philosophy of oops, we paid this. We should not have. You actually owe it. Now there is actually a standard for it that we have adopted and everyone calls it 5010, but it really three new changes that have to happen.

DR. FITZMAURICE: I suppose it would not be – why not let the private companies do the pay and chase? Chase Medicaid – that is a policy issue that we don't need to get into.

DR. WARREN: No. Thank you. Walter.

DR. SUAREZ: I have three comments. The first one, the pharmacy should be a specific segment of the industry that we should look into to understand better their work. That is another sort of category of people to come. The other one I thought of which is something that came up from Harry's comment is where are states. There are state groups in the nation that are helping in the state the industry to proceed. I always try to give the state where I feel I belong to, which is Minnesota – in Minnesota there is a specific group that is an industry group called the "Administration for Vacation Uniform" – and administration uniform committee, which is the group that is leading in industry the transition development. They discuss all the issues about 5010. It is sort of the group that meets every month to address and review and they have workgroups to look at specifics. I think it would be great to have – there are probably a group like that in several states.

The second comment is I tend to think in a more structured way so I try to organize the groups of questions that we would try to ask. I found that there might be too many categories. We want to ask a few overall questions. We want to ask a question about preparedness. We want to ask a question about coordination, transitioning – which an important part of this is the transitioning. This is the first time that we are going to have two standards acceptable during a period of time; 4010 and 5010.

So even though we have a deadline of January of 2012, there is a period of time where 5010 and 4010 are going to be available and permissible. So transitioning will be another category.

Testing, remediation, implementation and allocation. Those are the categories of questions I was thinking we could ask. They are just my categories. I can send them to you via e mail.

Then the last comment I want to make – this is a very critical opportunity. I have been involved in some of the discussions that have been happening at state level preparing for 5010. There are a number of issues that are specific to the transition. For example, NPI. How NPI is going to be done 5010 is going to be a little different. There is some transitioning of the NPI approach. NPI is one type of issue.

I have companion guide, which is another interesting aspect of the transition. Paper transactions, of course, we always have to think about. The qualification of things like the insured versus the subscriber versus the member – major issues on 5010. They totally revamped 270-271.

I have a whole host of more detail issues. Even when you think about it, there are specific issues about each of the nine transactions that we are going to be transitioning. Even though are thinking more overarching, it will be helpful to ask people what are your three or four issues – five issues – for the various transactions. A-37's, the A-35, the coordination of benefits. The 270-271, it is a mess – not a mess but it is a very challenging one because it is a major transition. So there are specifics.

Those are some details that we can throw into the mix.

DR. WARREN: Let me ask for clarification so that I understand what you are saying. We sort of talked about or a comment had been made during our meeting that one of the ways we might want to start out the hearings is to have an overview of what the changes were in 5010.

So all of the stuff that you just talked about, if that were included in this overview, do you think that would be helpful? Also, to illicit some of the questions that we need people to start asking.

DR. SUAREZ: I do think that would be helpful. I do think it would be helpful to ask people to specifically identify in their testimony issues related to some specific priority topics, if you will, that the industry has all ready identifying.

To dive a little more into the specifics about what other things that need to be done between now and 2012, it would be helpful.

The last comment, I think, and Lorraine you clearly hit it too, I think there is a major distinction – I have always highlighted that, a major distinction between CMS, the regulator CMS in Medicare implementation. So when we say go to CMS, we do need to think that CMS could do also some of the overview – kind of the 5 minute overview, 10 minute overview, on what the regulations are, the timelines, and the specifics. And then Medicare, itself, can be a testifier for different groups.

DR. WARREN: Mark, Mike, and then Harry.

DR. HORNBROOK: Just a random thought here. We need to ask ourselves at some point, whether it is really bad or good to ask the trade associations, the AHA, AHIP, AMA, MGMA, State Medical Society, Society of Actuaries, whether they have something to add or they just get up and preach at us. Some of them have huge memberships and huge resources.

DR. WARREN: We would sort of lump those under provider and would tease those out because those were all examples of what we meant by providers when we were coming up with the initial list. So provider is this really huge bucket right now with lots of stuff in it.

MS. DOO: I think you are right. What we don't want from the associations is just a list of what the issues are but some real representation from real providers talking about what they are doing, what their practice vendors are doing, because we have heard all of that. So we are really trying to get some substance.

DR. WARREN: Okay, Mike.

DR. FITZMAURICE: One area we should probably look at is the quality improvement activities. That gets into what changes we have to make in your screening software, in your quality measures, in your performance measures, because if anything, because of the move from 4010 to 5010, and certainly because of the move from ICD-9 to ICD-10.

They might also comment on their meaningful use performance measures. So maybe Harry might want to touch base back with ONC to see are there any questions you would like to have us ask about these quality improvement measures that get into performance measures. That maybe they would reveal to us before some other testimony before the other FACA committees, what issues they have with a meaningful use performance measures? Is there clear enough guidance as they move from 2011, 2013, 2015, enough guidance from ONC that they know exactly what they have to report and what the codes are that they have to report? Or will this throw them for a loop?

DR. WARREN: Again, let me ask a clarification question, and this is for Lorraine and Marjorie, as well. Currently CMS requires the reporting of certain events, which are also some of the quality metrics that are in meaningful use. When we do that, is it ONC we should talk to or can CMS, the regulator, speak to that?

MS. DOO: CMS should be able to speak to that.

DR. FITZMAURICE: Both. Or maybe it is CMS. CMS, also, for the meaningful use measures?

MS. DOO: Right.

DR. FITZMAURICE: Since CMS has to receive them. You are right. Good clarification, Judy.

MS. GREENBERG: I just wanted to echo what Mike said because as I think back on the cost-benefit analysis that this committee commissioned for the transition to 10-CM and 10-PCS – of course they go together with the 5010. All the benefits had to be kind of estimated because it was to some degree, hypothetical. It is a hard thing to do but they were very much focused on being able to do better disease management, better quality monitoring, and all of that.

Again, I think it is an opportunity that we really want to encourage. Kind of like what somebody was saying yesterday about the whole HIT and EHR revolution, that there is a lot of potential but it is very possible we won't realize it. I think that is a role that we should really play.

DR. CARR: Mike, that really peaked my interest what you said because a couple of years probably after the ROI was done, the patient safety indicators were developed through AHRQ and they are very ICD-9 dependent and they are embedded into a current screening and P for P and all of that.

Would AHRQ reconvene a group to do the cross-walk from ICD-9 to ICD-10?

DR. FITZMAURICE: We should ask AHRQ that. I don't know but a good question.

DR. CARR: That is big.

DR. FITZMAURICE: I know the place where that work would be done. I don't know that it is going on.

DR. CARR: I think that is a very important one. That is a great example because there is strictly built off the ICD-9's.

Right now, a couple of years ago, we made these patient safety indicators. So who is doing the cross-walk of those?

MS. GREENBERG: That is being done by CMS and NCHS. There is a contract with 3M-HIS.

DR. CARR: I understand that but there are really two parts to it. Because these are coded interpretations we find year over year, even with the existing ones, that there were nuances that were not anticipated. I would say it was a two-step thing; one is that you do the actual cross walk, but the other is to go back and say, when I look at the universe of these things have I included people in the population that I did not mean to or have I excluded ones that should be in?

So there is really a quality analysis that goes with the patient safety indicator.

MS. DOO: Right. CMS is doing the cross-walk from ICD-9 to ICD-10. But there is work, whether it is AHRQ or any organization has done based on ICD-9, you are absolutely right, everybody has got to redo their work and now using ICD-10.

DR. FITZMAURICE: I think what Judy and Lorraine are talking about, and please correct me if I am wrong, is that it is an issue of the validity of these patient safety indictors; are they still valid and do we still know to what they apply?

MS. GREENBERG: You might want to get some testimony on that.

DR. CARR: I think that is really important.

DR. WARREN: Let me clarify that. So get some testimony on once we take these indicators and switch them from ICD-9 to ICD-10, are they still valid for the purpose for which they were –

DR. CARR: Right, because most likely it is going to be a one to many relationship. So then as you look at the many, do you want to include them or not?

MS. GREENBERG: 3M is not only doing the cross-walks, but they are also doing the mapping to the MS DRGs. So there is that work too, that will inform the process. They should be posted on the CMS website from ICD-9 CM Coordination and Maintenance Committee meeting, a very comprehensive report or set of Powerpoint slides, by Rhonda Butler from 3M, about not only the actual mapping of the two classifications, but then the mapping to the MS DRGs. I think that would refer you to that.

DR. WARREN: Let me ask a question and then Justine you can reply and then it is Harry. When I am thinking about the purpose of these hearings and what we are doing, this seems to be something that we would want to investigate after we have the first set of hearings. This would be a follow-on, because this is more implications. Where what we are trying to do at the hearings is to identify best practices for people getting to do the implementation of 5010 and ICD-10.

So does that kind of fit with what you are thinking, Justine?

DR. CARR: That logic makes perfect sense but in the meantime, I mean, maybe you will be bringing that back to AHRQ.

DR. WARREN: It may be something that Standards and Quality want to take a look at doing there as we go down this path to adopting ICD-10 and so what are the issues in quality metrics, et cetera, that your subcommittee – your other subcommittee – chair is looking at.

DR. CARR: In a way it is a follow-on to the hearing that we had probably three years ago, about administrative data as part of quality, and being in this hybrid world. Because the other thing that could change, if we are looking ahead to 2012, is that as EHR data becomes more available – even independent of 5010, would we be looking at a greater reliance on EHR data and a lesser reliance on administrative data? So it is a very interesting -

MR. REYNOLDS: I think if we could take all of these things that we have heard about, make sure that they come up with subjects, there is an entire ecosystem out there. It is a little bit like how do we train the village to go help everybody rather than it takes a village to do something.

We just talked about other NCVHS hearings, we just talked about something that AHRQ could pick up, we just talked about referencing a document that is all ready out there from what somebody is doing. There is conference, after conference, after conference, going to happen on this. If we can build a body of work out of this hearing – not every answer – the body of work as to what the questions are, what the issues are and the other things, then as you look at all these conferences that are going to go on, hopefully that will be what they will use to pick up and go that next level. We are talking about two, two and half days.

I know, as I said, in my day job, I can bring enough questions in here to keep you busy for two and a half days – as far as that is concerned. I think if we can build that body of work, build things to look at and things to do. If we decide as NCVHS out of this, Quality could pick this up. If Mike came in and said, that is something I know that AHRQ is going to be working on. If we heard from other people in the audience – that is one of the things we will make sure is covered in our next conference.

Our point is to energize the entire industry – and industry being everybody, in that this is going on, that it is happening, what are people learning? We have not done some of this before, and oh, by the way, here is your check list. Here are your things to think about and here are the things to do. Oh, by the way, we are going to take these three and NCVHS will go deeper here, and then we hope the industry and others pick these others up. If not, then maybe we need to have another hearing to go deeper into that. We are going to be sitting here going, whoa, never thought of that one. Whoops, did not know somebody was running into that. That is the body of work that we are going to try and do in this first initial kick-off.

But for some of us that are ahead of the curve on that, that is not where we want to end up. That is for sure. We want to get a little further faster. But we got to bring this whole group together – and there are a lot of people out there that can't even have the discussion we have had today, let alone be talking about what they are going to do with it.

DR. CARR: Perhaps you covered this before I got here, but I think a key piece of this is how institution's budget for this. Is that something that we had talked about earlier in terms of what are the elements to think about and how do you anticipate and properly budget?

MR. REYNOLDS: For example, I just got our budget approved last week for all of 2010 on ICD-10 and 5010. Again, those are the lessons learned. Those are the things to tell people.

DR. CARR: I think the breakdown of here are the categories of workforce that you need, IT time, whatever it is, so that at least there is a roadmap for how to anticipate.

MS. DOO: I think – Harry, correct me because you would know it – the WEDI roadmap for project plan, I think has some of that in it. So when they actually do their presentation, assuming we are going to invite them, and Walter you would know as well, they try to anticipate some of that. But the industry is so huge and diverse – it can only be buckets.

MR. REYNOLDS: But I think if you took a panel and you had WEDI talking about the general roadmap and then you took some of the entities – say you took a state and a couple of entities that are all ready well into it so that they could play off of that, now you start saying, this is a great overall picture but oh, by the way, here is some of the things that are specific in there that maybe don't come out quite so easy.

So if you built that panel and they could look at the WEDI roadmap that was presented and then they could take it down and say, in these areas if you are this kind of group you have this issue. If you are this kind of group you have got this issue. That is the kind of thing that I think then starts.

Hopefully, whenever we finish, I wish I had had this before we started, somebody doing it could pick it up and start making a difference in their own shop and be much more educated than they could ever get meeting with a vendor, a person, a group. We can give them the subject and then we can help shepherd the subject between now and when they are all implemented. But boy, I think we could be a big service to the industry – the entire industry – and I mean people in industry that have not been in before.

DR. WARREN: I wanted to leave time for all us to take a quick break before the full meeting starts. We have got about five to ten minutes left of the meeting. For this topic on the agenda, are there any last comments or thoughts that people want to add to it?

Carol.

MS. BICKFORD: As you were talking about engaging the industry and helping flesh out the ICD-10 issues, you might think about e-Health Initiative in helping them organize strategic initiatives to focus on the actual practicalities of ICD-10.

DR. SUAREZ: Quick addition to the testifiers and a concept that I think is also – it used to be one of the big issues when 4010 was around, or its implementation was, the quote/unquote certification of a compliant transaction. There used to be this vendor priority and others, that would validate and help the industry – well, trading partners, confirm that this is truly something.

It might be helpful to understand what role that group or that type of services would play and to what extent it would be needed this time around, as well.

DR. WARREN: This is certification of the transaction before it goes to CMS?

DR. SUAREZ: If it is compliance confirmation, more than certification - the confirmation that the transaction is compliant with the standard.

MS. DOO: With the format and the content. This says you have got it right and not just to CMS.

MR. REYNOLDS: Many people have set up websites that were standard that can take the transaction, process it, and go back to – Why don't we have that category be testing/certification, because both of those really go hand in hand. You can test all you want to – if you are not certified then your testing is just your own joyous event rather than something that plays in the real world.

DR. HORNBROOK: This is getting into the level of micro-detail as we close down. But from the perspective of a Medicare Advantage contractor, these data conversions have very important compliance implications however CMS chooses to do this. All HMOs with Medicare Advantage contracts send pseudo claims data to CMS – even though none of us ever see it sitting there, it never gets used. I guess it gets used for setting the AAPCC for risk adjustment.

One of the questions of course is, how is CMS going to manage the transition process in the AAPCC from one system to the next and how many years is it going to use a mixed or weighted approach or is it?

Then there are a series of data reviews that the intermediaries and the carriers impose in the data pipeline – because we send data through the pipeline that the fee for service hospitals and providers use – and they use the same data screens as fee for service gets. So, HMOs are on the cusp or on deck for under and over reporting, both diagnoses, upcoding and undercoding and procedures, upcoding and undercoding.

So there are some issues here about whether business risks are going to change for the HMOs the Medicare Advantage contractors in this particular data transition because there seems to be some black holes in here that could end up with somebody getting a huge fine because they did not understand how CMS is going to interpret the compliance issue.

DR. WARREN: So, you are concerned about data integrity basically; are codes being put in appropriately? Will they be used appropriately? What changes in business does this change have? Whether anybody is going to get thumped with a big stick if they don't get it right?

DR. SUAREZ: Right.

DR. WARREN: Any last comments?

MS. DOO: I will just say this. All of the questions are really similar to what we went through in our CMS Gap Analysis, which is what every organization has to do. It is iterative. We just keep finding things under every office and every department and then there is the hand that gets raised three weeks later saying, wait, we just thought of something else. All the things you are bringing up we have been through and every organization is going to have to do.

DR. WARREN: Okay. So I am going to bring closure to this part of the agenda. We will be putting out a list of questions. Jeff, do you have anymore about this set of hearings?

MR. BLAIR: I do not at this time. I am very sorry I was not able to be with everyone. Thanks for allowing me to kind of tie in by phone. I look forward to seeing you in November.

DR. WARREN: Okay, but we are not quite done with the meeting yet. I just wanted to let people know too, that we are getting ready to write the HIPAA report that we are required by law to write. We will be putting together the 2008-2009 report. That will begin sometime soon, after Marjorie and I finish negotiating how that is going to happen.

Do you want to make any comments about that or is that enough?

MS. GREENBERG: I did talk to Dale Hitchcock yesterday and asked him to follow-up with Jim Scanlon. We have gotten some help from Jim's office, the Data Policy Office, in the past. I assuming this will be a joint venture – the writing of it – with CMS.

What I would encourage everyone to do is go back and look at the 2007 report. I don't think we have to repeat everything that was in that report but I think we can refer to it. It is on the website so people have easy access to it. Actually I think it could really enrich the 2008-2009 report, to include some information or findings whatever, from this hearing that you are going to have because this is exactly what I think, Congress would want the committee to be doing. Since the last report, two major regulations have come out. Of course, I guess NPI has been implemented since the last report.

I can think we can be pretty brief on the history and then focus on the major activities that have taken place. Hopefully we can – I think our goal would be to have a draft by the December meeting.

DR. WARREN: Do you mean November?

MS. GREENBERG: Your December meeting. Which would not include of course, anything from the hearing. I would think we would want to have it approved at the February 2010 meeting by the Full Committee.

DR. WARREN: I think that is realistic for us to take a look at even with the hearings coming in December. Justine is worried.

DR. CARR: Do we have an outline of what are the elements that we include year over year? It has been a while since I looked it up and I know it is the letter. Even abstracting from that, that every year the following ten elements are reported on, and do we go back and seek quantitative things? How many – the OCR things. They have looked at the CMS complaints?

DR. WARREN: I don't know. Do you know of anything like that other than to pull the old reports and look at them?

MS. GREENBERG: I know the first several years we just kept going over the same territory. Then I think it may be the 2007 report where we really tried to streamline it. I think if we look in the legislation – if you look at the hearings in the last report, again, I think that can be really brief, what are the standards? What are the ones that have all ready been implemented? Which ones are still in development? What progress has been made since the last report to congress? What activities has the National Committee been pursuing?

First it is kind of a review of what the Department has done because the committee is suppose to be monitoring that. Then specifically, what the National Committee has done and then what are the outstanding issues? By the time this actually comes for approval, it may be new responsibilities for the National Committee in health reform legislation. There would probably be some reflection on that, too.

Generally, I guess, we included a little bit about e-prescribing but that is more under the MMA. As I said, then actually the 2007 report included this lessons learned sort of reflecting on the 10th anniversary of HIPAA. As I said, I think the first place to start is to review this report – you can look at the legislation too, but I think it is very general. It is like a few sentences at most as to what the report should do, but it is always good to go back and look at that.

Then I think read this with fresh eyes. Most of us haven't probably looked at this in quite a while, and just see if you want to follow this within in the legislative constraint – follow this general structure or you want to do something different. I think this probably provides a good structure.

DR. CARR: My recollection is that it is qualitative. I am just making a plea for consideration of putting some quantitative things in.

MS. GREENBERG: Like what type of quantitative? Because certainly it does always talk about the specific standards with how many have been implemented, how many have not been implemented. Which ones are still outstanding? Where there needs to be more work.

What kind of quantitative –

DR. CARR: Let me take a look at it.

DR. WARREN: I can see – I really agree with Justine on some of the ways that you can use tables to clarify things. While you may want to describe those in paragraphs, it would really be nice to have it summarized at the end with here are the things that have been finished. Here are the open questions.

MS. GREENBERG: If you look at the Bacchus Bill, they sort of go through a review of what was passed, what was not. I think a table would be very nice.

DR. CARR: I remember Larry Green's first meeting, he was a little bit outspoken about certain questions people might want to know. So it might be of interest.

MS. GREENBERG: The other thing is I would definitely engage the Privacy Committee and ask them to actually take the lead on that section because it is part of HIPAA and they have done a huge amount – and again, we can just refer to things that will all ready be on the web. I think if Lorraine and ASPE could work on the whole standards part of it and they could do the privacy part and security.

DR. CARR: I think we have a good story to tell really. Looking at it, here is where we were, here are the hearings that we had, the recommendations that we made, here are the new changes is ARRA legislation. To kind of demonstrate a kind of journey.

MS. GREENBERG: A think a nice executive summary – we can use sort of nice meaty – because there is a lot to tell – one of the advantages of not doing it for a while – there is more to tell, but a nice executive summary. We could also use as part of the 60th Anniversary and outreach and all of that. That doesn't get written until after you have done the first of the report but I think we should think in terms of –

DR. WARREN: We should just blow our own horn is what you are saying, an executive summary and say –

MS. GREENBERG: It could even be like a little monogram.

MR. REYNOLDS: Also, I think if you add in there how we have been able to help streamline – something like the NCPDP. In the past everybody thought about standards being overly cumbersome, taking forever, we have been able with NCPDP, to move that along with the reverse –

MS. GREENBERG: I think something about the committee's effort to look at streamlining and the problems that are caused by this long regulatory process. I certainly think that is still relevant. We will see if maybe there is some remedies that come out.

DR. CARR: Even a timeline would be nice. We did that in the uses of data where we sort of said, historically these are the things that have happened. This is what we have done. This is where we are going. I think a timeline would be very interesting.

MS. GREENBERG: yes, and also visual aids would be good. It can be kind of a dry report but it is really important.

DR. WARREN: Okay. We have five minutes until the main meeting. Unless there is something pressing, I'd like to adjourn this meeting.

(Whereupon, the subcommittee meeting adjourned at 9:25 a.m.)