[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 505A
200 Independence Avenue, S.W.
Washington, DC 20201
Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda – Dr. Lumpkin
DR. LUMPKIN: Well we’ve had a lot of dramatic changes since the last time we’ve had our meeting. He’s back in California, I’ll be back, see you know it’s like the Terminator jokes just aren’t any fun anymore, now he’s Governor. Also of note Proposition 54 was defeated, so congratulations to you in California who engaged in that, well, it really as quite amazing, the polls in a period of about two or three weeks completely flipped, so that was -–
MR. BLAIR: Those of us who are California ignorant –-
DR. LUMPKIN: Proposition 54 was the proposition on the California ballot at the same time as the governor’s election that would prohibit the collection of race and ethnicity data in many officials businesses. While there may have been an out for health care there was some concern that this was a significant slippery slope. There was a large outpouring including in the final days the California Medical Society, a large coalition of groups who just thought now was not the time to pretend like we have a color blind society, which we don’t.
So having done that and seeing that we have as, still don’t have the internet, we’re going to just start off with the meeting, we’re going to start off with introductions. My name is John Lumpkin, I’m senior vice president of Robert W. Johnson Foundation and chair of the committee, and why don’t we start off with Marjorie.
MS. GREENBERG: I’m Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
DR. MAYS: Vickie Mays, University of California, Las Angeles, member of the committee.
MR. HUNGATE: Bob Hungate, Boston Massachusetts, Physician Patient Partnerships for Health, and member of the committee.
MS. BEREK: Judy Berek, liaison to the committee, from the Centers for Medicare and Medicaid Services.
DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, member of the committee.
DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City. I will need to recuse myself on any votes relative to ICD-10-PCS, LOINC or HL7.
MR. LOCALIO: I’m Russell Localio, University of Pennsylvania, committee member.
MS. SANCHEZ: Linda Sanchez, Office for Civil Rights.
MS. FRIEDMAN: Maria Friedman, CMS, and staff to the committee.
DR. SONDIK: Ed Sondik, director of the National Center for Health Statistics.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the committee and staff to the Subcommittee on Standards and Security.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, on the committee.
DR. ZUBELDIA: Kepa Zubeldia, Claredi Corporation, member of the committee.
DR. COHN: Simon Cohn, national director for health information policy for Kaiser Permanente, and I actually need to recuse myself if there are issues coming before the committee related to CPT. As you imagine Stan and I have a problem in being on the same subcommittee together since we can’t talk about anything.
MR. SCANLON: I’m Jim Scanlon from HHS, director of the Office of Science and Data Policy in ASPE and I’m the executive staff director for the full committee.
DR. LUMPKIN: We’re going to now have the introductions from the audience. I just wanted to say that we’re going to come back to the issue of conflicts, we already have two, but I just want to take some additional ones just to make sure that we don’t have others.
MR. BLAIR: Is the NCVHS able to make a recommendation to turn on the air conditioning?
DR. LUMPKIN: It would take an act of Congress to do that. Richard? Introduction?
DR. HARDING: Good morning, I’m Richard Harding, department of neuropsychiatry, University of South Carolina and a member of the committee. Conflicts –-
DR. LUMPKIN: We’ll get to the conflicts later.
MS. CANNON(?): I’m Susan Cannon, writer for the committee.
MR. EMORY: I’m Jack Emory with the American Medical Association.
MR. ALFANO(?): Bill Alfano, Blue Cross/Blue Shield Association.
DR. FANNING: John Fanning, Department of Health and Human Services.
MS. FYFFE: Kathleen Fyffe, Department of Health and Human Services, lead staff to the NCVHS Privacy Subcommittee.
MR. PEDACORD(?): Doug Pedacord for the Coalition for Health Information Policy.
DR. EDINGER: Stan Edinger, AHRQ.
MS. GOODMAN-LUKE(?): Marilyn Goodman-Luke, AAHP/NHIAA.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the Subcommittee on Standards and Security.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, and staff to the Subcommittee on Standards and Security.
MS. BLUM: Amy Blum, National Center for Health Statistics, CDC.
MS. FISHER: Beth Fisher, National Center for Health Statistics, CDC.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, committee staff.
MS. JONES: Katherine Jones, NCHS, staff to the executive subcommittee.
MS. BERNSTEIN: Amy Bernstein, NCHS.
MS. CLAUS(?): Linda Claus, American Health Information Management Association.
MR. RODEY(?): Dan Rodey, AHIMA.
MS. PROPHET-BOWMAN: Sue Prophet-Bowman, also AHIMA.
MS. LEON-CHISEN: Nellie Leon-Chisen, American Hospital Association.
DR. LUMPKIN: Okay, at this time let’s go through conflicts, Simon listed a conflict because of his membership on the CPT committee. Stan, if you could just sort of give us the background of your conflict.
DR. HUFF: In terms of ICD-10-PCS I’m an occasional, I’m an occasional consultant for 3M that originally produced the PCS as contract. With HL7 I’m a former chair or chair of the board of directors and currently a vocabulary technical committee co-chair. And with LOINC I’m a co-chair of the LOINC Committee.
DR. LUMPKIN: Did your consultancy with 3M involve PCS?
DR. HUFF: No.
MS. GREENBERG: That confuses me.
DR. HUFF: It said that in the letter that they sent me, they said, I mean those are all three things in the letter that came back to me from –-
DR. LUMPKIN: It certainly wouldn’t be my task to try to convince you to go against a letter from, even though the logic escapes me. Do we have any other conflicts? I just have a disclosure just because I’m still within that timeframe, I was on the board of HL7 for about two months, and then decided it was too conflicting to remain on that but I haven’t extended a year since I’ve left that so it’s just a matter of disclosure.
MR. BLAIR: This is a disclosure, I have never considered, at least I haven’t considered this a conflict of interest, but back in ’97 when I was with IBM there was a consulting engagement with SNOMED, the College of American Pathologists, but I’ve not had any relationships with CAP or SNOMED since that time.
DR. LUMPKIN: I think you’re outside the statute of limitations.
MR. BLAIR: I think so, too.
DR. LUMPKIN: These kind of things are not like kids where you’re conflicted your whole life since you had them.
Okay, we’re going to go to the updates from the Department. Jim?
Agenda Item: Update from the Department – Mr. Scanlon
MR. SCANLON: Thank you, John, good morning everyone. Well, let’s see, I think we met in late September so it’s only about six weeks ago since we met previously but there are a couple of short reports I want to update you on this morning.
First of all I think I mentioned previously that we have formed within the Department the Council on Application of Health Information Technology. As you can imagine in a department as large and as complex as HHS we often try to get coordination and improve management through councils, and the Council on the Application of Health Information Technology is the most recent of these councils. This was established at the Secretary’s request, we have the chair of NCVHS attending the meetings of the council as well so we can promote some cross fertilization as well. But the goal of the council, again this is an internal group, is to coordinate our own HHS activities in investments in health information technology and to ensure a coordinated approach across HHS and in our collaborative HHS work with the industry. All of the agencies in HHS are members and the council is co-chaired by my office, ASPE, and by the head of AHRQ. I might mention that John and I will be heading off this morning for a meeting of the steering group and they will be looking at the suite of CHI standards that have been recommended and kind of where they are and the committee itself, let me say a few words about CHI because I don’t think we’re going to get another report to the full committee on CHI.
You’ll remember that after the first set of five standards that were adopted by the Secretary, well, all federal agencies, last March, the CHI Working Group has been busy looking at additional standards in very specific domain areas in health care and the working group has already forwarded within HHS and DOD and VA a set of three additional candidates for standards dealing with an HL7 demographic, message lab tests and units of measurement, and more recently has proposed an additional set of candidate standards, particularly in the area of medications, which is probably the most complicated so far of the CHI standards. I think the Subcommittee on Standards and Security has been briefed on what the thinking was and has given us some reaction to those initial CHI standards. And now we’re going through the internal process of vetting and assessment of those standards to see which of those could be adopted for use in the federal health care enterprise.
So in addition we had a joint meeting of the HHS Data Council, which kind of focuses on the substantive data and statistics in NHII issues, as well as our CIO Council, in HHS, who are the folks that actually deal with the implementation of information technology and their systems, with the budgeting for information technology with strategic planning for information technology. Again, and the service of the program mission and so on, that was held last Friday and the group was briefed on the suite of CHI standards that is being considered for adoption, they were reacting to it, had a lot of interesting questions, but a pretty favorable reaction from the two groups. So in terms of the internal process of adopting CHI standards we’re actually moving along pretty well.
The questions on the CAHIT Information Technology Council, or the CHI, before they proceed to some of the other issues. On population based data and race ethnicity data we’ve actually had a couple of things moving along. You’ll recall that HHS is supporting a study at the National Academy of Sciences, this was a Congressionally mandated study, it is looking at the adequacy of race and ethnicity data in Health and Human Services data systems and activities. It’s not just focusing on HHS and I think we would be all disappointed if that’s all it focused on. A big part of the study is to see what the adequacy is, what the current practices are, what the policies and the barriers are in the private sector, in health plans and health care providers and so on, as well as in the public sector and sort of where we are and what are the needs and where are the gaps and what is the adequacy of these systems. And the full panel is expected to have a deliberative report and a set of recommendations, I think Vickie it’s probably sometime early in the next year, probably February, March, so on, it will have to go through the full Academy policy review as well.
But we did ask them to hold a workshop on the issues that, the issues in race ethnicity data in the non-public arena, in plans, in health care providers and hospitals and so on. They had a workshop and they have released the results of that workshop, which I think I have now, you’ve got this at your place as well, there are no recommendations as you know in workshops from the Academy but I think you’ll see there are actually some interesting issues that arose, including legal issues, potential legal exposure issues that some of the health plans and health care providers belief they’re facing when it comes to collecting race ethnicity data. So I think there’s a big job yet of kind of clarifying what the legal situation is, what the current practices are and so on. And there’s a discussion of HIPAA as well, but I think it’s a good start at looking at what are the issues in terms of private sector data collection as well.
In terms of public data collection we actually have a good start on that, we’ve got a lot of advice, we have policies and plans within HHS, I think in general we would know what we would want to do if we had the resources and in general it’s largely though not exclusively a resource issue.
So at any rate we’ll be looking forward to the full committee and we’re referring this in the meantime to the Populations Subcommittee.
I was hoping that I could report to you today that we had a budget for fiscal year 2004 but again I’m kind of doing a tap dance as I did, the fiscal year ’04 has started of course in October and we, HHS and many other federal agencies are on a continuing resolution, which means that we more or less are authorized to continue our spending at the level of the same period for last year, so we’re somewhat restricted in what we can do. We’re not generally permitted to undertake new activities or new large obligations as you can imagine. And we’ve just had a, the original continuing resolution was for the month of October and now we’ve had another one week continuing resolution which will take us through a week from Friday. I guess the hope is then that we would actually have an appropriation.
I will say that we’re hopeful that the final appropriation for ’04 will contain some of the data and NHII initiatives that I’ve mentioned to you previously and we have every hope to think that that will be the case. Recall that there were a number of very positive initiatives in HHS ’04 budget relating to the information technology and standards and NHII, $3 million dollars in ASPE, my own office, for NHII related activities, Department wide and working with states and communities and the private sector. Another $10 million dollars, this is a Department initiative in standards, this is a $10 million dollar initiative that ASPE and AHRQ put together for standards work, this would be to support some of the standards work. In fact it would relate quite directly to some of the CHI standards that are being considered now, particularly in the medications area.
And then at AHRQ a $50 million dollar research and demonstration program to focus on how improvements in hospital and health care patient safety through health information technology, $50 million dollars there, that would be a research and demo program. And in anticipation of the funding coming later the agency is preparing request for applications, which is the way you normally solicit such proposals and demonstrations.
So again, we’re all hopeful that we will get a final budget soon and that we can actually move off on these. The Secretary in those demonstrations by the way may give preference to smaller rural hospitals. And again, the focus is not on silo type technology but it’s on interoperable health information technology. The integration and interoperability and a look at common standards and approaches as well will be emphasized, not on niche type of applications and one of a kind type applications.
Two projects from the Data Council that we’re making progress on. An issue that has come up I think in the full committee as well as in the federal agencies is geocoding, to what extent do our data systems, our data holdings, include information on geographic level. This could be anything from an address to a zip code to a state or a nation or country, and we actually have some sort of data of this kind in virtually all of our data systems but there’s a movement across the federal government under the OMB auspices, a kind of a standardized look at what capabilities we do have in our major data systems and to look at best practices and to try to standardize around, there actually are a number of standards in this area as you can imagine, but there are a number of reasons why we generally don’t go below the national level or the regional level, confidentiality is one of them, sample size is another, and of course comparability is another. So we’re looking at, we’ve awarded a contract and we are now under the auspices of the Data Council taking a look at our metadirectory of data systems, these are our major workhorse, statistical and epidemiological and research and administration data systems to look at what do we have now in terms of geocodes, what are the best practices and how can we kind of describe that information and move forward.
The second project, we’re again starting with the HHS electronic gateway to statistics which I’ve described previously to you. We’re now expanding that and upgrading that to make it more user friendly and to organize the data a big better. You’ll recall that we had something like 2500 web pages from HHS agencies that included either the presentation of data or a description of the survey or the data system or policy or web pages that actually allowed you to do your own tabulations or to get access to the data in a secure and confidential manner. Generally it’s anonymized data. We’re now going to be expanding that to updating it and expanding it and providing some better user friendly features as well. I think this is an attempt to pull together at the front end, well, actually at the end back I guess I should say, at the dissemination end, the front end of integration is much harder, data integration, but at the back end where people are looking for data that we have an HHS on the web and we have extensive holdings as you all know, it’s quite extensive, this is to kind of organize that information and provide more or less a one-stop user friendly place to begin to look at, sort out the kind of data.
For those who are aficionados and know all of the data systems and know exactly what you’re looking for we have pretty much direct pathways. But for folks who are coming in and they’re kind of trying, browsing or trying to see what we may have on various topics we have a search engine and categories that actually make that a little easier as well. And that’s what we’ll be focusing on in the improvements.
So I will just quickly in terms of recommendations from the full committee, I’m looking at the last half a dozen or so, but going back to September, I think the Secretary or the Department have answered most of them, at least replied to most. There’s a set that was developed in September, two of them relating to population based data which I’ve seen drafts, not quite ready yet to go to the Secretary but probably in two weeks we should have some responses there. Again, dealing with increasing HHS presence on the federal networking R&D committees, I’ve seen a draft there, that needs a little more work, that should be coming to the Secretary soon. So at any rate those last four or so are being, letters are being drafted, I tried to track them down yesterday. One of them relates to the NCVHS concurrence with the last set of CHI standards that were being talked about and the Department’s already moving forward on that as well.
So let me stop there and see if there are any questions.
DR. LUMPKIN: Okay. Maria?
Agenda Item: Update from the Department – Ms. Friedman
MS. FRIEDMAN: Good morning everyone. Well, the last time we met it was right before the October 16th compliance date, which has come and gone in relative quiet, at least from our perspective. I guess it’s like that almost everywhere else the best we can tell. To date we have gotten seven complaints. Of those two are privacy, and of the remaining five one filed twice by the same person, so we’re trying to figure out how to count that.
DR. LUMPKIN: Were they from Chicago? Because then you can count it twice.
MS. FRIEDMAN: In any case, we have a process for people to file complaints, both on the web and by paper. We’re committed to not only talking to the people when they file a complaint because we want to make sure that they have complete information, but we get back to them in two weeks to give them a status update of how their complaint is going. And if they file electronically they can check on the website to see where they are, there’s a way to, electronic compliance tool that allows people to file their complaint and then check back later. So that’s pretty much where we are with compliance.
DR. LUMPKIN: Do those complaints have to be filed in a standardized format? Mike.
DR. FITZMAURICE: It seems like the train wreck that was forecast really hasn’t occurred, that people are working through their contingency plans. I know that some people are keeping track of what percentages of claims being filed are compliant with the HIPAA standards and is that moving up along the way. Do you have anything to present to us on the percentage of claims coming in to the Medicare program that are compliant with the HIPAA standards and does that seem to be moving up?
MS. FRIEDMAN: It’s moving up when last I checked, we get reporting every two weeks so as of last week it was about 30 percent, it’s moving up, and I believe that it’s that way everywhere. People are taking advantage of the contingency plans to work through some of these issues.
DR. FITZMAURICE: And there’s been no reports of big cash flow problems to date?
MS. FRIEDMAN: Not that we’ve heard.
DR. FITZMAURICE: That was a big industry concern.
MS. FRIEDMAN: I think the contingency plans have gone a long way to take care of it.
DR. LUMPKIN: Okay, any other questions? Jeff?
MR. BLAIR: I think maybe I’d like to see the NCVHS consider a commendation to HHS because this was a tremendously difficult thing to do and as Michael just referenced there was predictions of train wrecks, it was contentious, it was hard to move one seventh of our domestic economy to accommodating these HIPAA codes and transaction standards and I think the fact that there hasn’t been a train wreck we should recognize in some way. I’m not saying a full motion or anything but I’m just saying that I think that’s a real achievement that you were able to manage this tremendously complex difficult task as well as you did.
DR. LUMPKIN: I was all the way up with you Jeff until you said not a full motion. So I’m going to accept that –-
MR. BLAIR: Oh, you can do it.
DR. LUMPKIN: I’m going to accept that as a motion to commend the Department of Health and Human Services for forging ahead and taking a major step in the transformation of one seventh of the economy into an informatics automated environment.
DR. STEINWACHS: Second.
DR. LUMPKIN: Is there any further discussion?
MS. BEREK: Can I make a comment? Since Medicaid is now bigger then Medicare it might, could I just say we say HHS and our partners or something, to recognize that the states in fact played a major role in this? Just put it on the table.
DR. LUMPKIN: How about HHS taking a lead in working with its numerous partners? Okay, all those in favor say aye.
COMMITTEE: Aye.
DR. LUMPKIN: Opposed say nay. Great, we’ll put it up on some stationary and send it up to the Department. If it’s okay with the body then obviously there may need to be a little bit of wordsmithing once it gets to the paper. Okay, any other questions of CMS? Okay, Linda.
Agenda Item: Update from the Department – Ms. Sanchez
MS. SANCHEZ: Hi. I’m trying to imagine my work life if we have five complaints, that would be so great, like we ever just had five. At this point we’ve had a little over 2700 complaints, we’re averaging about 100 a week, and overall we’ve resolved and closed approximately 37 percent of those complaints.
The top issues in the complaints have remained fairly steady since the last time I was here. The biggest category would be impermissible uses and disclosures and then the related issues of safeguards and minimum necessary. Access continues to be a big concern with complainants as is notice, the failure to provide notice or an inadequate notice. We’re also seeing a number of cases involving authorizations and complaints about policies and procedures.
I was asked the last time I was here about types of covered entities that are subject to complaints and we’ve actually run some special reports to get that data. We’re seeing an incredibly wide range of covered entities being subject of complaints, just anything you can imagine we’ve gotten complaints about them. The top categories are private medical practices, general hospitals and pharmacies, and this does seem to make some sense as these are the entities that have the most direct contact with individuals. Those three types account for roughly 40 percent of recorded institution types and we’re still working with our data to get a better sense of what institutions have been subject to complaints.
I want to move on now to talk a little bit about outreach. At this point our joint OCR and CMS call center has handled over 15,000 calls regarding privacy. Over 8,000 calls have been handled by our regional offices and that includes calls referred from the hotline and calls we’ve gotten directly at the regional offices. Our call level has dropped to about a third of the initial influx, so we started out getting about, in the first week we got over 1300 calls, in the last week we got 380, which is about what we’ve gotten a month ago. And the most frequent topics handled by the call center at this point are questions regarding how and where to file a complaint, what rights are provided by the rule, and questions about the model authorization form that’s available on our website. We’ve also gotten lots of questions about what is the website and how to find it.
Since January our frequently asked questions on the web have been accessed over 1.4 million times, pretty popular site, and this week we’ve added several new questions regarding disclosures to family and to friends, and also some treatment related FAQs.
I’m happy to take questions.
DR. STEINWACHS: When you resolve a complaint, could you tell me a little bit about what that process is? The complaint resolution? Are you going back to the provider?
MS. SANCHEZ: Yes. Generally speaking the process for handling a complaint, we receive a complaint, we do an initial assessment to determine whether we even have jurisdiction. If we do have jurisdiction and we feel that there’s an issue at hand that we want to look into we will get back to the complainant and we’ll also send a notice letter to the covered entity letting them know that there’s a complaint against them, letting them know how to contact HHS and that we’ll be contact them as well. Generally our goal is to work with the covered entity to help them come into voluntary compliance, so that once they are aware of what the problem is they can figure out what they need to do to take appropriate steps.
DR. STEINWACHS: So the ones that are closed, are a fair number of those ones where you’ve actually gone through this process and providers have come into compliance? I know some are probably because you didn’t have jurisdiction.
MS. SANCHEZ: I would say there are, I didn’t bring the exact figures, there are some number that were closed through voluntary compliance efforts, I would say a large number at this point are still complaints that were not within our jurisdiction. But yes, we have certainly closed some through voluntary compliance efforts.
DR. STEINWACHS: So it’s working.
MS. SANCHEZ: Yes, it is working and I mean generally speaking covered entities work with us, we get a variety of responses to their receipt of the initial notice letter but once the shock has worn off normally they are quite willing and eager to work with us to come into compliance.
MR. HOUSTON: A couple of questions. For your calls, do you have some type of metrics or some type of commitment in terms of the responsiveness to when somebody actually calls into the hotline or to OCR, a question?
MS. SANCHEZ: We do, I don’t have those standards with me, but we do have metrics.
MS. FRIEDMAN: Yes. I’m the project officer on the hotline for both, so we do have metrics in terms of response to the individual and also for the transfers and that kind of thing. What happens after they transfer the calls, I don’t know if you have internal metrics on how you handle this.
MS. SANCHEZ: Our internal goals are to get back within a couple days –-
MR. HOUSTON: Do you differentiate between a consumer question to the hotline versus one from a covered entity?
MS. SANCHEZ: Not in HHS, I’m sorry, not within OCR, I don’t know if the joint hotline would, I can’t imagine –-
MS. FRIEDMAN: What was the question?
MS. SANCHEZ: Whether there’s a differentiation between calls from consumers versus covered entities.
MS. FRIEDMAN: No, they all just get sent over. It really depends, I mean the types of calls that OCR get are really more consumer oriented, the types of calls that we get are more provider oriented. The ones that the hotline can’t respond.
MR. HOUSTON: And I guess the other question I have is out of the posed calls do you have any metrics as to how many calls frankly there was no complaint, they called and there’s a beef, the patient who had the complaint really frankly there was no privacy issue underlying their complaint?
MS. SANCHEZ: I’m sorry, you’re talking about calls or the complaint –-
MR. HOUSTON: I think calls or I think there’s, I guess on the complaint side, I guess I’m more interested. So of all the complaints that are filed do you keep metrics on frankly how many of them just didn’t result in a violation of HIPAA or –-
MS. SANCHEZ: Well, of the ones we’ve closed so far roughly 60 percent were not within our jurisdiction, so that would generally mean that there was no HIPAA violation alleged, or it happened before the, the activity complained about happened before the compliance date. That’s why we’ve been able to close them so quickly. The open cases generally are ones where we do believe they are within our jurisdiction.
DR. HARDING: Just a point of information for me. I rode up this morning with a human resources Colonel from the Army and he was saying, I mentioned where I was going and he said funny, he was going to the Pentagon and that they were trying to come up with policies about notification of family members for active duty soldiers wounded, that they were having some difficulty with that. I had not thought that HIPAA was involved with active duty but was only with dependents and so forth and that kind of situation. Is that too much of a discussion to get into right now or is there a simple answer for that? Notification of wounded like in Iraq, who to notify, what permission to notify.
MS. SANCHEZ: I’m not sure it makes sense for me to get too deeply into this, I’m aware of the issue. The medical services provided by the Department of Defense are covered by HIPAA and there are special provisions in the privacy rule regarding the ability of those covered entities to provide information through the command structure to the military operations. It’s not clear to me who would be making these reports back regarding wounded. There are provisions in HIPAA for talking to family members.
DR. LUMPKIN: Well, we are now on the internet, I want to welcome all those of you who are listening for our patient as we worked through the technical difficulties of getting back on. Michael?
DR. FITZMAURICE: This has been April through November, so it’s been a good half of a year and been a lot of outreach, a lot of complaints, a lot of hearing what’s been going on, and a lot of resolution. Linda, has this been done without filing the first fine of $100 dollars or have we gotten into the fine business yet?
MS. SANCHEZ: We have not yet assessed any CMPs, no we have not.
DR. FITZMAURICE: That’s an amazing good working with the public.
DR. LUMPKIN: That’s a fine performance.
MR. HOUSTON: Has anything else been referred to DOJ? I know two you’d previously indicated, has anything else happened in that regard?
MS. SANCHEZ: There have been cases referred to DOJ, yes.
DR. LUMPKIN: One of the things, and I just wanted to again a note of appreciation to OCR about trying to get the message out, there was a recent series about two or three weeks ago in USA Today about the privacy rule and I think that while the headline was alarming what I saw in the article was the fact that there are providers who are, in that particular article they mentioned a particular ambulance service that was no longer able to go to Mrs. Jones’ house, and it was in a rural area where they didn’t really have good signage, because they thought that was a violation of privacy regulations and there was clarification from the Department that no, no, that was okay. But I think it really described the process of in some cases over reaction by the industry and the role of OCR and Department in clarifying and trying to get the system running in an environment in which we protect privacy but continue to take care of the business of caring for people who are sick and injured. So, well done.
DR. ORTIZ: Eduardo Ortiz from the Agency for Healthcare Research and Quality. Mine’s just a little bit of follow-up to the question asked earlier because I’m still trying to get a sense. Of the complaints that you’ve actually looked at, and I’m kind of, I don’t know if you can kind of let go of the jurisdiction because that’s sort of difficult for me to understand, but of all the ones that you’ve kind of looked at I’m just trying to see if you can give me a sense in terms of even a guesstimate percentage wise of how many of these complaints are kind of legitimate violations of HIPAA versus how many of them are just misunderstandings that can be resolved through just educating the complainant. Even if you’re looking at maybe the ones that maybe they are violations but they occurred before HIPAA, I’m just trying to get a sense for what the average is, what the percentages are there.
DR. LUMPKIN: Can I maybe rephrase the question, those complaints on the face of them have merit to continue as a potential violation versus those which on the face of them do not?
DR. ORTIZ: Right, that can be resolved probably just with maybe educating the complainant.
MS. SANCHEZ: I really can’t tell you of open cases what percentage are ones where we would be moving forward and how many we wouldn’t. Generally we’d try, if we get a case where we think there’s no merit at all, it doesn’t have anything to do with privacy, it’s a complaint about something that’s about disclosing information but it’s clearly permitted by the rule for instance, we try to close those very quickly. So there would be some number of those within our open caseload but hopefully not too many. I can’t really tell you, I’m discouraged from guessing in public –-
DR. LUMPKIN: And I thought that was a federal rule.
MS. SANCHEZ: As I said about 60 percent of the ones we’ve closed we felt that were non-jurisdictional meaning they didn’t have anything to do with privacy, or the complaint was against an entity that wasn’t a covered entity, things like that.
MS. FRIEDMAN: Can I jump in for just a second? As far as the hotline goes they get a lot of calls of people who think they have a privacy violation and one of the things the hotline does is walk people through some of the issues. For example, did it take place before the deadline, before the April 15th date and all of that. So of the calls from the hotline, the ones that get transferred to OCR because people didn’t think that, we either needed more information or they really wanted to go on and file a complaint, there’s only been a handful of calls that get transferred from the hotline over, so we do a lot of first line defense in helping educate the public as to who’s a covered entity, what are some of the issues involved with privacy and all of that and who can weigh in, so we do a lot of that at the front end.
MR. HOUSTON: Just a comment. The statistics sound, I work for a large system and very similar, a lot of people will come in with just a general beef and they throw HIPAA out because they think that’s going to get them some additional attention or whatever but there frankly is typically no privacy complaint. That’s why I was interested in finding out because again, I think they use this as a surrogate, HIPAA as a surrogate for getting somebody to listen to them or try to beef up what their issue is.
DR. LUMPKIN: I would like to thank the three of you for the updates and I’m going to turn it over to Simon to do the next part and I’ll be back in about an hour.
DR. COHN: We’ll see you at 11:00 or thereafter. Our next discussion is with our director of NCHS, Ed Sondik, obviously Ed we’re delighted to have you joining us and giving us a view of what’s been happening over the last year.
Agenda Item: Presentation by the NCHS Director – Dr. Sondik
DR. SONDIK: If you don’t mind I’ll stand up. Can you all see that? Okay, there are also some handouts, the slides, the handout approximately follows this, I’ve added a few slides here and there. I’m under strict instructions to be succinct so we have time for discussion so I’m going to go through these quickly.
What I’d like to talk about today is the progress that we’ve been making and what the challenges are, talk briefly about each of the major programs that we have. I want to focus a big on one aspect of dissemination that has to do with Health, US and Diane Makuc is here for the, I saw her a minute ago, she’s still here, if we want to have any discussion about Health, US. I guess part of the theme in my talking about the programs is really the reengineering that we’re going through on all of the aspects of the center. I want to talk about the budget briefly and just overall the challenges. I also promised to say something about summary measures of health, qualities, values, expected length of life, so I’ve just said it. No, I have a little bit at the end to talk about that, and I also want to talk about the new board of scientific counselors, in essence a committee parallel to this one and talk a bit about the first meeting that was held.
The programs, you’re all familiar with the programs so I won’t belabor it other then to say that lots of different activities within the Center. You can summarize them by the way I have on this slide as vital statistics, activities related to health status, activities related to the health system. There’s a terrific matrix, which I didn’t bring today but I think all of you have seen in the past, that outlines, I’d be happy to get you copies, that outlines in much more detail all of the, particularly the data collect efforts in the Center so it includes things like the National Survey on Family Growth, for example, which I’m not going to talk about, it includes SLATES(?), the National Immunization Survey and so forth and so on. I’m not going to talk on those today but of course I would be happy to cover any or all of those in detail.
I’m also not, I’m talking more about what I’m not going to talk about then what I’m going to talk about, but I’m not going to go into all of the data that was produced over the year other then to say that there were lots of, documented lots of lows of one sort, lots of highs, we had information on antibiotics and drugs that came out, a very, very wide range of things and one of the most surprising things that happened this year for me I think was the focus on size. We have been collecting information related to obesity as have many of our sister or brother agencies, of course this is, NHANES is critical to this because we’re actually getting clinical measurements of this, but it seems as if the tipping point came, and I’d like to know what caused the tipping point, but it seems as if it came this past year with just the appropriate focus on obesity, so I have this cartoon of the whale looking at the people looking at the whale and saying look at the size of those things, and somebody reading an article that says 65 percent of Americans are overweight. I’m not sure that’s the right figure but this is poetic license.
So let me talk about vital statistics. We’ve actually had a major change in the vital statistics community in the way that community views reengineering. By reengineering I mean really something actually very simple here, going from in some cases systems that are DOS based to a system that is web based. And in some cases it needs to go through Windows based before it actually gets to web based but that’s what we’re aiming for. And from I’d say a couple of years ago the thing we were hearing was well, you know, we all want to do this but every state is different and this is very complicated. We’re not hearing that anymore, we’re really hearing that the states feel that they’re very much alike, this was clear at the NAFSIS(?) meeting last May I think it occurred. They really feel that they are very much alike and want to be able to pool the resources and knowledge to do this, so there’s a great deal of effort been going on and sort of building a model system, at least on paper, and some states are actually taking off and doing this but the idea is to build something that would be highly compatible, could be implemented in different places by different vendors but the system would be highly compatible, so we really have some momentum here on the design side and in some states it’s more then that. And as part of this we of course have to look at security and transmission issues, it needs to be compatible with the other activities that are underway but in general I’d say the National Health Information Infrastructure and more specifically NEDS and the Public Health Information Network.
Funding is an issue here, we’re doing okay at this point, we’ve been able to find some funds to move along on the design phase. In particular we are enormously grateful to the Social Security Administration and having the information from a reengineered system is important to that Administration in a dollars and cents way, major dollars and cents way, to know about events when they occur. And they have been extremely helpful and generous in moving this effort along to this point and we’re looking for other national partners to continue this.
This is a table, I won’t go through all of the elements on it, EBRS is on the birth side, EDRS is on the death side, but it shows the different status of, I showed this actually last April although it didn’t say October, it said April, whatever it was, and we’ve updated it since then. And it’s actually quite something to see the number of states that are actually working with vendors at this point on this, 23 for birth and 11 for death, and even some that have found money but what they’re waiting for is the model so they can actually implement. So all of this I think is very positive but we still have 36 states, for example, which have not been able to take any action on the death side.
We’re currently collecting new data on race and ethnicity and data on education, and actually we’re expecting this data in 2004 and you can see on these maps more of the states giving us the information on death in 2004 then states giving us information on births but we’re making good progress.
A very important analytic activity that happened at the Center this year was working on bridged race categories, you’re all familiar of course with the new way of collecting race data with multiple choices and possible, so we needed a way to bridge from the current back to the old or from the old to the current, however you want to look at it, and some very, very nice work was done in the Center and we sort of took it on for Census so this is being used by us and Census and it’s on our website.
Now health care statistics, I’ll come to the major challenge in this at the end, but I think you know that we have a family of six different components to the health care statistics or the Health Care Survey, or surveys as we call it, the emergency department and ambulatory care, in Hospital Discharge Survey, long term care, home and hospice, I may have missed something. And all of these are really necessary to give us a picture. We don’t have all of them in the field at one point in time by any means but that does not stop us from making improvements in what we do have. In the ambulatory care there’s been a focus on emergency departments and pediatric services, we’re adding a supplement of rural and proprietary hospitals to the NHAMCS, and we actually have a very interesting activity underway, at least I think it’s going to be interesting when we actually see the results from it, on bioterrorism and as part of the NHAMCS, the National Hospital Ambulatory Medical Care Survey, we’re asking questions that relate to the preparedness of the hospital to deal with bioterrorism and mass casualties. And on this slide it shows some of the question is here, is does your emergency bioterror response plan specifically address each of the following types of incidence, biochemical, biological, chemical, nuclear radiologic, explosive/incendiary, national disaster, this sort of thing. So I’m pleased that we’re doing this as many of the things we do are a bit removed from bioterrorism. But I think certainly in our health care area we can do it and I’m sure there’s much more we can do, and this is in the field now in 2004, I mean 2003, I’m sorry, and we expect the results in 2004.
In the Hospital Discharge Survey we have new items on admission and type of service, creation of linked files including to the area resource file, and ongoing research to evaluate the collection of drug data. I’m really pleased on our redesign of the long term care component. Actually we did this and then we became later on in the activity partners with ASPE in doing this and we hope to be getting this into the field relatively soon.
Part of the activity in this is it says in the bottom bullet ongoing research to develop a typology of long term care facilities. I think I’ve mentioned here in the past this activity, not only on the typology but to do an inventory of inventories of long term care facilities, assisted care, but this is really one of the areas where it’s really critical that we come up to speed on understanding better the long term care situation in the U.S. We just don’t have the requisite amount of data to do this.
The principle issue with health care statistics is the maintenance of the complement of health care surveys. We simply don’t have the resources to do all of these at one point in time. We’re doing three, if we were able to do five I think we would be in better shape, but we’re doing is we’re carefully using the resources we do have and judiciously choosing the ones that are in the field.
Let me turn to HIS, the National Health Interview Survey. There’s a slide on the screen that shows children with public health insurance. I’m putting this up because it shows, well, it shows one of the measures that we are producing now on a quarterly basis. We’re able to produce information on the insured or the uninsured very rapidly. This reflects a real change in the HIS, it’s a change in how things are done and it’s also a change I think in the culture of the HIS, but it doesn’t reflect, the changes have not impact the rigor of the HIS, I think this is really possible. The emphasis is not on doing everything at once and when it’s ready then we publish it, but to do things on a more sequenced basis so that we can get the information out very rapidly. And to get information out within six months of the end of the year and then be able to do that on a quarterly basis for a survey this size is really quite an achievement. So I’ve given HIS my own commendation, but it really is quite a change.
Along with this has been the reengineering of the program, not the things that you actually see but it’s the way the program actually does its work and working on database technology and I won’t get into all of it, but it’s been really again quite a change, it sort of goes along with the culture change. Part of it is staff training because we’re using tools that people haven’t used before, database tools and that sort of thing, and we’re also changing the basic program that’s used by Census to collect the data, we’re going from cases to BLAISE, or BLAISE, however it’s pronounced, it’s Belgium, B L A I S E, I think it is, and it’s a very large, it’s a program that’s able to, Simon’s looking puzzled, you’ve never heard of it. It’s actually used, it’s a program that’s used in the CAPI, Computer Assisted Personal Interviews, and it’s able to handle much more effectively then certainly the prior program that was used, the very large survey like HIS, and the changes in it and supplements and this sort of thing. And it’s being used actually quite widely, and we made that decision I think well over a year ago in concert with Census and Census seems very pleased by it, at this point if I can speak for them. So this is also going to help us considerably.
Benefits of all of this are better data quality, timeliness, these early release estimates which we think are very important, and the fact that with these databases that we’re putting in we’ll have much better analytical capabilities within the program itself. Now what we’ve had to do in order to do all of this, and one thing I didn’t put on this was a challenge here is that we have to redesign the sample, this has nothing to do with the reengineering, it’s that every, the way the HIS sample is drawn it’s every ten years we draw a new sample and based on the most recent Census. And then that sample together with supplements over the time keeps us going throughout the year.
Drawing that sample is a costly enterprise, very costly enterprise, and in order to continue work on that, continue work on the reengineering, which I consider absolutely vital, what we’ve done is we’ve experimented with some sample size changes. Changes is a euphemism for cuts, and we’ve cut a few weeks and you can see what we’ve done here over 2002 and 2003, 2002 we had a total of five weeks, 2003 we’ve cut another five weeks, and we have a question number of weeks in 2004, which are dependent on the budget in part that Jim talked about that we don’t have yet at this point. I think in all likelihood we’ll probably continue to do this.
The question that we’re doing in this is number one, does it hurt the survey by making these cuts. Well, it certainly doesn’t help, there’s no question about that in terms of precision. But how much do we say by doing it? And it turns out that this is anything but a simple question because these surveys of 40,000 households, 100,000 people in the field all the time, in so many locations around the country are complex logistically. So if you cut one week you don’t cut two percent of the cost by any means. That would sort of be nice if it were true but it doesn’t work that way. And there’s question of the number of weeks in a row that you can cut and of course if you do too many of that then we get concerned about the nature of the sample because HIS is a representative sample of the U.S. every week, that’s how we can cut weeks is we, in a way that was sort of designed in from the word go.
So I want you to be aware that we are experimenting with in effect the fiscal impact of these sample size changes as well as the change impact on quality.
We’ve also done things like canceling the interviewer, retraining for January 2003, which probably is not the best idea and I don’t think we’ll do that again, and postpone as I mentioned of the implementation of the sample redesign from 2005 to 2007, which has implications for the quality of the sample. But we still feel we have enough in order to be able to keep this going.
Now these are the things that we’re doing based on the grand decision that we don’t want to take anything out of the field, we want all of the components, the components that give us health status, the vital statistics, and as much of the health care statistics as we can muster to be in the field at the same time. An alternative of course is to not have them in the field at the same time. Then that raises more logistical issues, for example, the cost of reprogramming everything to get it back in the field once it’s come out of the field. So we’re dealing with a lot of operations research in addition to statistics.
Let me talk about NHANES, it’s going great guns, we’ve also made some adjustments in NHANES as well, but NHANES kind of has a new schedule I guess you could say, new basic schedule. It views everything in terms of two year data sets although data can come out after a year, because as I mentioned to you I think at least twice before we changed the survey since 1999 so that it’s a representative sample every year. But since it’s only 5,000, 5,000 is not a lot, so we like to think of it in terms of sort of two year increments of 10,000, but there is data that is useful. For example the exposure data, environmental exposure data has been going into an annual report. That may not be annual in the future but it’s been going into that and we that with our colleagues in the National Center for Environmental Health. We also are able to produce annual figures on diet and nutrition, which is very important for our collaborators in USDA. The 2001-2002 NHANES release is going to be available in 2004.
Now repeated in a somewhat different fashion an exercise that we went through with NHANES back in ’97 I think it was in which we convened a forum, a large forum, of people both from outside the government and inside the government, the private sector, researchers, some people from foreign countries from that matter, on NHANES, and we’ve done that. We used a different process this time that people reacted to very positively, we call it an open technology process, but that’s sort of not here or there, people who were there really enjoyed it, everyone felt that they really were able to get their two cents in on ideas for NHANES in the future. And I was pretty taken by it and I think we’re going to try this with our other components as well as kind of a widespread net for ideas.
But the thing with NHANES is that a high proportion of it, well almost every proportion of it is done with a collaborator within the federal government, and the collaborators within the federal government also work with people outside the federal government, and NHANES is very intensive in terms of the methods that are used. But it’s not unlike what happens with our Children’s Supplement, or our supplement to HIS on children’s mental health for example, which is done with NIMH and a panel of outside experts.
In any case the forum was held just this past, I guess it was in August we did it, and there are proposals that are going to be submitted. We’re also in the process of contract competition for the conduct of NHANES, and that’s underway. Now a very, points that I’ve talked to you about in the past is Community HANES, or rather, you can see something I typed, it says Community NHANES, I should have typed Community HANES, I like it better that way. But in any case this is something in which we have a set of trailers that are self contained and the thought is that we can take the methods in NHANES and apply it to communities around the country, and either that we could or others could take these ideas and apply it.
And I’m really pleased to say that we now have an activity with New York City, this is not being done with the trailers but the way it’s being done is actually replacing the trailers with storefront clinics, but it’s happening in New York City and we’ve been very intimately involved with this, we’re very excited about it, we’re kind of consultants to New York, and it’s in a way an experiment to see how well this goes. But it will provide a very firm baseline on the health of New Yorkers and we’ll evaluate it in that sense.
We’ve received many, many inquiries about Community HANES and I’m hoping that we’ll find ways of doing this in the future. This is one of the community HANES trailers, which is self contained as opposed to the mobile exam centers which are four trailer trucks that become interconnected and then they need to be plugged in to all of the sort of services from sewage to electricity to water. These on the other hand can go anywhere and we have a variety of these it turns out so we actually are very well prepared to do this, we just need the right kind of invitation somehow, it’s like we’ve gone out and we’ve dressed, we’re ready for the party but no one’s invited us if you will. Well, people are talking to us but I guess we’re in the early stage of dating I guess you could say. I won’t push that analogy, I don’t think it’s going to go anywhere.
Let me mention the Board of Scientific Counselors, the charge to this board is to provide scientific guidance to review intramural research, which is becoming more and more important and part of what Dr. Julie Gerberding, the head of CDC, one of her emphases has been on extramural research and wanting to see a larger budget for CDC be able to fund extramural research. I’m a big proponent of that, I have been ever since I’ve been in this position, for us and for CDC. But in doing that it highlights what goes on in the institution’s intramural research and the review of intramural research falls to boards of scientific counselors or the equivalent. So I think it’s very important that we’ve started this activity at this point in time. It will assist in guiding extramural research and along with you and the community at large help us in providing guidance and setting priorities.
We held this organization meeting at our building and the content of the meeting really was an overview of programs and orientation. We’re currently even though we’ve just begun we’re now seeking four new members to join in April, which is part of the committee process of course, and the next meeting is on January 22nd, 2004, and of course like this meeting these meetings are open.
I view you and the BSC as very complementary. The BSC, it’s sole purpose is to give advice to NCHS on the statistical and science base of what it is we do. You advise the Secretary, the rest of HHS and of course us on data policy issues, but of course also get into these aspects of the science of what we do and the direction of that. And I see this as sort of coming at us if you will from two directions and I think we, it’s not added in for us, it sort of multiplies, so I see great benefit coming from this and Dr. Mays was there for this first meeting as a liaison.
I’m not going to talk about today our Office of Analysis and Epidemiology of Research and Methodology, technology in the center and international activities. Although I must say there’s a lot of action here in many different ways, particularly in the Office of Technology and Information Services as the department sort of reconfigures how it carries out its information activities in light of the President’s management agenda.
Briefly on dissemination, it’s a very important aspect of what we do of course, to collect it and keep it where would we be. The web continues to be more and more important to us, this is just a picture of the web page, but we have a number of tools on there to access data and when I look at this slide I was struck by the number of different tools and how many of them are named after peculiar animals, like data ferret, and whiskers, and I guess it’s only those two. And I say to myself this is great, but on the other hand would I love to have a kind of uniform entry, data system so that we could use it to still get everything and it would be more and more transparent to the user. And I hope that we head toward that in the future.
A brief word about the Research Data Center. Since we began this in 1998 to allow researchers closer access to data that cannot be given to the public because of confidentiality reasons, we’ve had, the number is here, 12,600 SAS programs have been used, we have had 82 government clients all the way down to ten private sector and 11 non-profit clients. I see this is more and more happening with this in the future and what I hope in the future is that we’re able to have a string of these data centers very close to the people who are actually using them. Using our remote entry we’re able to achieve a portion of that but there’s nothing like actually being there and holding onto the paper if you will even though we’re in an electronic age, there’s something about actually being there and being surrounded by it that I think is very positive.
One of the important dissemination efforts is in our support of Healthy People 2010, which is at the core of the President and the Secretary’s steps to a healthier U.S. In fact this afternoon at 1:00 we have one of our Healthy People reviews in which I present the data and there’s discussion internally on whether or not, to what extent we’re making progress in a particular area. And we have the role of being responsible for all of the data even if it’s data that we haven’t collected.
Now on the screen is a slide of Health, US, 2003, so while I’ve extolled all the virtues of the web there still is a use for, or maybe there isn’t, this is going to be up to you, as to whether or not we need something that’s in paper like Health, US. At the Board of Scientific Counselors meeting Diane Makuc, who’s in the back, who has overall responsibility for this as part of the Office of Analysis and Epidemiology, talked about Health, US and its release, it’s the one on my right here, and how it differs from past issues. And what we were planning in 2004, in 2004 a special feature on drug, pharmaceutical drug utilization. The question though, and I really thank Diane for raising this, was something that we should ask periodically which is what should be the directions for Health, US, how should we do this, how should we get input, and what aspects should we look at. Should we think about the audience, should we think about the content, and in particular should we think about the format. So perhaps in the time we have we could discuss that and Diane is here to help with that.
Let me talk briefly about budget, this is a graph of our budget from ’94 to 2004 and it’s got from about $80 million up to $125 million over that time. Since 2002 it’s been pretty much level. What doesn’t really show in the way I’ve drawn this is that it really wasn’t a smooth rise from about ’98 to 2001, it was relatively small amounts of money at the end of the year if you will. Now if you take our ’94 budget and adjust it for inflation our budget today would be about $152 million compared with $125 or $126 million that we have. So in order to deal with the minus 26 million we’ve had to make changes in the program. And we’ve made these changes and I’ve mentioned some of them we’ve also I think have a much more productive program then it’s been in the past. Part of that I think is technology but part of that is just doing things differently and adopting technology.
The money is distributed in this fashion over these different areas within the center. What doesn’t show up here in this picture is that on top of NHANES, the NHANES bar, we need to add so called reimbursable funds, which come to us from other agencies as part of the collaboration. And these are, these in effect are part of the NHANES budget but they’re not part of our appropriation and they’re solely for NHANES. So if you looked at just the major data collection components, HIS is 11 percent of the appropriation, the Health Care Survey is nine percent, Vital Statistics 20 percent, and NHANES 16 percent, but the NHANES budget is actually, itself is actually much larger then that. It’s also true to a degree for HIS, which gets a considerable amount of money from outside the NCHS.
Facilities, we have a brand new building, and I would love to have this committee come and meet in our facilities, it really is terrific and Marjorie I think would agree and I’m not asking her to agree, it’s incredible how positive everybody is about this building. It’s right next to where we were before but it’s really bright, light, airy and we have a great set of meeting rooms. I won’t go into, we actually moved in in the great blizzard of ’03, I won’t belabor that.
This is our building in North Carolina and this is a brand new building. Unfortunately we’re no longer in this building because we had an environmental problem in it. There was an odor that was there when we moved in and it got worse, so we’ve moved out, lock, stock, and barrel, and we’re just not connected with this anymore and we’re in the process of looking for space in that area. Just check your local papers for the ads. And that search is actively underway of course through the GSA. This is really too bad because this is a very nice building but it was one of those unusual situation.
I want to just take a minute to talk about the CDC Futures Initiative, you can find this on the CDC web page. This is something that Dr. Gerberding initiated and she did it for all of the goals that you see on the screen here, kind of small print, but she wants to ensure good solid improvement and really measurable improvements in the public’s health. And these goals all the way to being sure that the CDC workforce can handle all of this and that it’s state of the art if you will. So there’s a lot of activity underway, meeting with groups from outside of the government in the private sector on the future directions for CDC. We are full party to this, of this, with this, and what comes from this is going to be very important to us. We’ll see a variety of strategic themes established and I want to see this frankly as much in tune with the vision for health statistics for a 21st century and particularly the framework that we’ve outlined in that.
So if I could sum up where we are, there are a variety of challenges that we face in terms of reengineering, they are the things that other statistical agencies but we’ve been doing actually pretty well with. But part of our resources have been going into seeing to it that we are doing pretty well. But response rates are tough, they’re headed down for a variety of reasons but as I said we’re doing pretty well. It takes more and more resources to do that. Keeping our staff at a level of, the appropriate level of technology and with the depth that they also need in terms of their individual specialties is very important and it’s a continuing challenge. And the federal government is working differently then it did in the past. When NCHS as born people joined the Center and then they stayed for a career. Most of those people, not all, have retired, NCHS is 40 years old. But that’s not the way people work today and we need to find ways, as does the rest of the statistical system, of assuring that we have staff with the requisite knowledge and this can happen in a number of different ways but it also takes of course resources to do that.
In terms of how we’ve been meeting these challenges, I’ll just recapitulate in this fashion, in vital statistics we found ways to find the money to be able to make the changes. In HIS we’re experimenting with this reduced sample size. In NHANES we’ve made some changes in field procedures and staff. And in the health care surveys we’ve reduced the number of surveys in the field.
Now one thing I promised I would talk about is summary measures of health and I want to report very briefly on a workshop that we held this March. This was convened by an interagency workgroup across the departments, not solely NCHS by any means, many, many people from NIH and CDC and other agencies. The purpose was to identify priorities for moving this field forward -- summary measures of health. And what we did was we had the conference, from input that we had during this conference we identified seven themes, and these seven themes have to do with comparison of preference base versus non-preference base instruments, analyzing the properties of the instruments, you have this on the handout. And what I wanted to do was just show you the results.
The results from the input that we received and then voting by the various experts and attendees to this meeting came out with number one priority was to compare these various measures. Number two, which is very much related, is to look at the properties of these instruments. The point of both of these is that while these instruments are widely, some of them are widely used, for example SF36, and I would put into the mix, some of my colleagues might not, but qualies, dollies and so forth, exactly what the properties of these are is not clear. In particular qualies and dollies and expected length of life and so forth in their use in decision making was considered to be a priority, that got a rating here, ranking of 16.3 on a scale. And conceptual issues in the measures, research to improve the measures and improve data collection in general and training, these were the seven themes that came out of the recommendations.
What we hope to do, this was our purpose, was to turn these back into the decision making components of the Department and it turns out that Dr. Zerhouni of NIH actually kind of got, jumped the gun here if you will, and one of the pieces of the NIH roadmap, which is also on the web in case you want to look at it, has to do with a very significant aspect of this, particularly on the instruments such as the SF36 and so forth, building a better database for these.
So we’re pleased about that and that in a 35 minute nutshell is where we are. I’d be happy to take questions and of course Diane is here so that we might say, if we want to discuss HIS and I have a few copies and I’ll hand them out around the table. But I think most of you are familiar with HIS.
DR. COHN: Before we get into the general discussion, I see Vickie you are on the agenda here as comments regarding the role of scientific counselors, do you want to make some comments and then we’ll get into the general discussion?
DR. MAYS: Sure, I’ll keep it also brief because I think a discussion is important for Dr. Sondik. Dr. Sondik actually handed out to you just so that you know the list of who, the roster of who is on the new Board of Scientific Counselors as well as what the agenda for the meeting was. Having attended as the liaison from this group what I would say is that is that I was very pleased and impressed with the individuals on the board in the sense of their commitment, their diversity of expertise, so I think it will be a very good board.
They’re just starting so I think the issue of what the liaison role will be between the two of us, I think Dr. Sondik kind of laid out what he thought was the ways in which we can work together and I think the actual activities that will occur, I think we still probably will kind of field our way.
One of the things I think probably we will recommend is a presentation to the group about this committee so that they actually understand the range of activities that this particular committee engages in and also how we work with other agencies so that they have a sense of that. There was a suggestion, which I think, I don’t know if Dale Hitchcock is here but Dale had made a suggestion about the possibility of having an update from this group to the Board of Scientific Counselors at each of the meetings so that they would have a sense of the landscape of what we’ve dealt with. I think for us we’ll probably also think about those points at which we should cc them on letters that involve recommendations that are key to NCHS.
So I think that that’s pretty much kind of in a nutshell because it really was, they were just brought in with introduction to all the different data sets and activities and NCHS and so I think over time we’ll work out what I think will be a very complementary relationship.
DR. COHN: Great. Was it about this or something else?
DR. STEINWACHS: About the next –
DR. COHN: About the next, are there any other comments about the Board before we move on to just general discussion? Don, you have the floor.
DR. STEINWACHS: You got me stimulated Ed, I’ve got my little list here but I’m sure Simon will say stop, Don, stop. Your lead off showed the pieces in the press and elsewhere, is NCHS getting credit for this? Is it really apparent when people read the news articles and other things that this is NCHS data and if not are there things that we could do to try and make sure that American is aware that you are the resource?
DR. SONDIK: Well, you know we are one department, I mean the federal government is producing and, I’m being facetious, sometimes it says NCHS, sometimes it says CDC, the sort of the recorders of record know where it’s coming from and we have a very good staff, Sandy Smith is really, I don’t know how many of you know her but she really is a national treasure and I mean that because she actually is in effect the lead on this type of activity working with the media for the statistical agencies in general and people turn to her for her expertise on how to do this, not only in HHS but with the other departments as well and the other statistical agencies. So we make every effort to be sure that if we’re not mentioned specifically that CDC is mentioned.
DR. STEINWACHS: Just to add one another thing. Out of curiosity, do press releases really accompany any of these reports? Is there a metric to try and push this visibility? So when you talked about the uninsured, which we now can produce timely stuff, it’s not where most people go for the uninsured.
DR. SONDIK: We are working very actively to do that. We actually, one of the points that I think has become clear over the years is that, and actually the BSC discussed this as well, is that the value of the information that we produce is sometimes not immediately apparent and that we should be doing more to emphasize what the value is. I think it’s interesting that we have a number of, a few I should say, economists who are on the Board of Scientific Counselors and this is really important. Even though we don’t collect any economic data it’s in our, if you look at our legislation we’re mandated to if not collect it to report on it, so we will of course work with CMS, who is really the major fount of this information but AHRQ of course is very important in producing this as well through MEPS(?). But it was very interesting because the economist were vocal at this meeting and gave a perspective I think that was very useful.
So we have been working, in addition to that, we’ve been working with groups and the community in general to emphasize the importance of what it is we do, I think this also comes across in the vision document as well, so we’re trying to make this point. For many things we do there’s a press, we contact the press, we have very good relations with that. Some things it’s funny, though, some things really hit and some things don’t hit. For example we do this collaborative activity, it’s on my mind because we just discussed it two days ago, but we do a collaborative activity with the other agencies from Producing America’s Children. And we have a highly coordinated effort in terms of getting it out and working with the media doing that, very important, because all of us, it’s sort of a labor of love, Producing America’s Children, because we all feel it’s important that decision makers see the multiple dimensions of things that apply to kids, housing as well as health, criminal justice as well as education. And what we saw this year was that we got, we actually had very good television coverage but our print coverage was not as great as it had been in the past. So we’re looking at that and trying to figure out what it was about the timing, it turns out when it came out there was a lot of things going on, including issues, international issues, Iraq, so we do take interest in this.
DR. STEINWACHS: Let me ask you one other thing, and you had mentioned NHIS and I guess I wanted to discuss it, it’s still I guess not clear to me what the price is that we’re paying for not being able to update the sampling frame and it would help me to have a better understanding because what you’re saying I guess is that it’s less and less representative of America.
DR. SONDIK: Well, when the sampling frame was drawn we added a couple of years to it, not looking ahead to this but you never know, so it was longer if you will then it sort of needed to be. I’d like to be able to give you sort of a quantitative estimate of what it means in terms of the precision of what it is we’re getting. It probably says something in terms of the cost that goes into filling out the sample because there’s more that needs to be done in terms of new construction and that sort of thing. But I could try to get back, I would get back to you with as quantitative an estimate as I can but all of my advisors tell me that we’re still in good shape using it, but the fact is there is no more after I guess it is 2006.
DR. STEINWACHS: So you’ve got to do something no matter what.
DR. SONDIK: Yeah, we do, if we don’t do it we don’t do it because I mean it’s integral to doing the survey.
We’ve also asked the Census and our advisors to think about perhaps other ways of drawing the sample that are of a more dynamic nature, it’s always a little jarring to think that you lay out a sample ten years ahead, but it turns out that this is a reasonable thing to do in terms of doing these large surveys and the fact of the matter is that we’re in a continual update over time throughout the ten years but we lose the base in another year or so.
DR. MAYS: Like Don I think I’m stimulated with several questions. I’m actually going to pick up on this point about the NHIS. Has there been any work to look at what the loss is analytically? I mean we may have a representative sample but for some questions what happens is as it gets smaller and smaller we’re not really able to do certain kinds of multi-varied analysis, so is there any way to have a sense of what we might be losing analytically?
DR. SONDIK: In terms of the sample size reduction? Yeah, we can do that, there has been, and it’s pretty straightforward. It’s actually much more straightforward then the other question of as you get further away from the base census year what does this say in terms of the precision of your sample. And I’d be happy to have us get back to the committee on that.
DR. MAYS: Yeah, I think that could be important –-
DR. SONDIK: We feel comfortable, well, we feel, I can’t say we feel comfortable but we feel that it’s a loss that we can accept at this point. Now it’s fine of course for us to accept it but you’re the users, so the question really is can you accept it, so we would be happy to get back and perhaps we can do that at the next meeting, because this I think will be a continuing issue.
DR. MAYS: My other question has to do with the Data Centers. I actually looked, I was looking from 1998 the usage and I know one of the things that we’ve talked about in the Subcommittee on Populations and I think we’ve brought this up with Jennifer is that particularly for some of the smaller groups where one has to actually use the Data Center to be able to do analysis, that that’s a much needed activity. The problem is that we need more Data Centers in order to probably increase the use. One of the things we had raised was the possibility of NCHS actually sharing space with Census since Census has increased its Data Centers both relative to them being an academic environment as well as having some that are in, operated in community based organizations. Is there any progress on your ability to be able to do that in the face of these new guidelines about data sharing?
DR. SONDIK: Well, no and yes. I wouldn’t say there’s any direct progress, I think we’ve still got the Title 13 issue, but on the other hand it seems very reasonable for us to be able to somehow merge the space and to be able to appropriately partition it with respect to the data that’s actually being addressed. And I’d be happy to report back on that.
DR. STEINWACHS: Is this like a fire wall –-
DR. SONDIK: Well, we need something like a firewall, but I don’t think that the data sharing agreement helps us because Title 13 gets in the way of that, which is the law that controls how Census shares its data. But I can’t imagine that there isn’t, that there aren’t economies of scale and I’d be happy to eat those words, unhappy to eat those words if it turns out there aren’t but we should pursue that with the Census, I agree.
DR. MAYS: My last question is in terms of the Futures Initiative, is Dr. Gerberding herself actually being very involved in that initiative?
DR. SONDIK: She’s very involved in that, without a doubt. It’s impressive the amount of activity that is going into this, there are a number of groups, there have been subcommittees that have been formed, there are these focus groups that are going on with people that we all work with, customers so called round the country trying to identify the issues that you all see in these future directions. She’s very much involved and the person that is leading it under her is Kathy Cahill(?), who’s a special advisor in effect for looking at CDC in the future. But this is not a small activity and it’s, she’s from the beginning when she created this she’s put a lot of her personal time and effort and reputation into it.
DR. STEINWACHS: Simon, can I squeeze in one more?
DR. COHN: Is it a follow on, Don, or can we let Clem –-
DR. MCDONALD: Well I may not be able to actually be heard so it may be moot, excuse me for the voice. I had a question, I read your report, both this year and last year, and it’s very impressive, there’s really some good news in it about how well we’re doing in health care and public health, I mean in terms of the death rate, that reduction in heart disease in the last 30 years I guess. Recently the big drop off in death from AIDS, cancer reduction and death rate, I think the press doesn’t like good news so that’s maybe part of the problem because you hear everything bad that happens in health care. So the question was have you ever thought of engaging and trying to magnify the voice about this good news through the hospital associations, the medical professions, maybe the drug industry, because they can all take some credit for that.
DR. SONDIK: I think that’s a very interesting suggestion. I think we’ve strategized more related to America’s Children and the companion document on the elderly then we have with respect to the other reports that we do although we certainly actively consider it. We have actually gone to the Hill with this report, Health, US, in the past and had a briefing with Hill staffers, it’s been very well attended, the APHA was instrumental, critical actually, in setting that up. I think it would, what we don’t have is an address if you will, or is a document that says something sort of like this is the state of health of the American public. Now you certainly can get that out of this, this is aimed at that. But somehow it isn’t viewed as sort of the state of health document but that could be a matter of reorienting how it’s put together in the literature.
DR. MCDONALD: Well, the front section more or less does summarize some of this and they’re really pretty remarkable, like three years in a row longevity has increased, or four years in a row, and when you think about the little bitty itsy changes we can do with clinical trials and all the rest to show through the whole population, these are pretty remarkable improvements and no one is noticing it.
DR. SONDIK: Well, they are improvements but for example, we had a review the other day on children’s health and I’m always struck by infant mortality, how the figures on infant mortality continue to get better, it’s terrific, but the disparities persist. If anything on a percentage basis the disparity gets worse. Now we try to emphasize that but somehow when people look at it and some people see the glass as half full, some see it as half empty. I look at it and I see a persistent case of disparity in a measure that many people use to characterize an entire, a country’s entire health and it’s one of the major measures that we use to judge how well a country is doing.
And I’m struck by, and I don’t know exactly what to make of it, but I’m struck by the focus on obesity. The focus on obesity is really a health focus, it’s not one that’s concerned with how people look or dress or whatever, it really is a health focus, it’s a diabetes focus and so forth, it seems to me it is the right, it’s exactly the right kind of focus and I think it’s one thing that we should try to capitalize on at this point, understanding how it is that this has tipped so that we have this national, it’s become a national issue, and how we can relate the broader health, the more full health picture of American’s, and in particular the issue of disparities and whether we’ve been doing any better with respect to disparities, which we haven’t overall, over the last 20 years or so. They continue to persist and there have not really been major gains in reducing the disparities.
I’m willing to consider any and all suggestions, the thing I think it’s important for us to do as a statistical agency is for us to maintain the posture that we call it as we see it, we collect the data, we produce the data, I think it’s important though that those who then take it analyze it further, look at the implications of it, that they consider they import. And I think we’ve tried to strike that kind of balance in this document, sort of a workman like but very attractive, at least in my personal opinion, very attractive presentation, it’s very easy to read, very easy to get the salient points but without sort of standing up and saying okay, this is what we think the priority should be, I don’t think that’s our role, but it is our role to point out where there are problems.
DR. COHN: Do you have a quick question?
DR. STEINWACHS: I’ll make it quick, or maybe I’ll make a quick comment.
DR. COHN: Okay, why don’t you make a quick comment and then we need to wrap up on this one.
DR. STEINWACHS: Simon’s reigning me in. I like the efforts you’re making trying to focus more on health recognizing that looking at disease is a decrement we know in health. One of the concerns that I have and I think some of the things that we are discussing in the Populations Subcommittee is around the mental health piece because you infrequently die of an identified mental illness even though, for instance people with schizophrenia on average die ten to 12 years earlier then other people, and so it isn’t quite clear to me how mental health or even mental illness become more core to what you’re capturing and so when you talk about potentially in the future getting into dollies an disability and health you pick up more of those dimensions because disability, mental illness is a major contributor to disability but it doesn’t up on the mortality, it doesn’t show up on some other places. And I notice NHANES this next time around is likely to go without a mental health piece, so I think it would help, it doesn’t have to be now, but to get a sense of how you see moving mental health and mental illness into a more core position for health and illness.
DR. SONDIK: But I think you really put your finger on a question where you all can be very helpful in this, which is how best to represent health. We still continue to use pretty much the outline if you will, the sort of time honored outline of looking at mortality first and then we have some morbidity measures and so forth. I think there are major issues about how to combine the morbidity into a single measure and/or whether to combine it with health and we have some work going on in the Center on summary measures of health.
I personally would like to see much more research going on on summary measures, not necessarily to produce a single measure but on better understanding of how to represent health in a way, particularly in a way that’s understandable to the public and to decision makers so that we can move away from the disease of the month or the year type of thing and see a broader picture of health in the balance. My problem with dollies and qualies is that it boils it down to a single dimension and that’s only useful for comparing one thing --
DR. STEINWACHS: For cost effectiveness.
DR. SONDIK: Well, but also, I mean I’ve been approaching this really from a standpoint of whether we’re comparing counties or comparing countries, it’s making those kinds of comparisons. The problem is once you make the comparison and you say that country A has a higher ranking then country B that tells you essentially nothing, you need to pull it apart and understand what’s in it, and I think you can do that from the word go and present it in such a way so that you can see that. We have plenty of tools today that enable us to do that and at the minimum we can see in three dimensions. So there are ways to put this together that I think would better inform us.
And I think if we do that an emphasis on mental illness, emphasis on functioning, at this point we’re getting very little information related to functioning and we can adopt a whole different point of view that says we ought to look at things not in terms of disease, but in terms of functioning, and I think that would be an important dimension. But I think it would be very productive if we could sometime in the future, maybe in the Populations Subcommittee or elsewhere, focus in on this particular, exactly what you’re raising, how do we best represent this, and the way to do that might be to focus in on Health, US, and in particular the front part of Health, US.
DR. COHN: Actually Ed, and this is actually sort of a wrap up, the one issue that obviously Ed brought forward which was this questions for consideration on the health document, we obviously haven’t discussed it all. Vickie, is this something that you can work with them on in the subcommittee?
DR. MAYS: Yes, and we actually are considering mental health tomorrow morning.
DR. SONDIK: Well, I hope that Diane, I’m not sure what her schedule is but I hope that you can be there for that, because Diane’s given a lot of thought and many, many years of her life considering how best to do all of this.
DR. COHN: Well, Ed, I want to thank you very much, appreciate you coming and updating us on the state of the National Center. Obviously what we’ll do is take a, we’re running a little bit late here, we’ll only take a 15 minute break and then we’ll come back slightly after 11:15. Thanks.
[Brief break.]
DR. LUMPKIN: The next item on the agenda is the letter that’s at your position on ICD-10. I just want to call your attention, if you have not looked at Tab three it’s very important that we all understand how we got to this point. Were you going to talk about that Simon?
DR. COHN: No, actually I wasn’t, only at the briefest levels. Didn’t we talk about that at the last meeting?
DR. LUMPKIN: Yes, but I’m just wanting to call everybody’s attention that the first item on this timeline is 1990, and it is my hope that it’s been on the table that one way or another we can fish and cut bait on this issue and come to some decision at this meeting. So that’s just my plea as we move into this issue that I think it’s, there are some decisions that you make no decision until it’s time and I think it’s time. So Simon, go ahead.
Agenda Item: ICD-10-CM Letter – Dr. Cohn
DR. COHN: Well, John, thank you, I’m obviously pleased to bring you this letter as well as very pleased on this that you’re chairing the activity.
This is the first actually of three action that we’ll be discussing today from the Subcommittee on Standards and Security. First we’ll talk about ICD-10 and then after lunch we’ll talk about the PMRI core terminology recommendations and then from there we’ll go to the final letter which is the CHI recommendations and comments from the full committee.
Let me just talk about a couple of comments about this letter and about the process, I’m not going to go back to 1990 in terms of these comments, but just for, I mean I know many of you have been involved with much of this, at least since 1997, others have only been exposed to the discussion more from our last meeting and on today. First of all I think as you all know this is a very contentious and complex issue, and let me just sort of say that straight out. If this were simple we would have dealt with it long ago. Obviously while we’ve been discussing this issue, John mentions 1990, I tend to think of it really as starting around 1997 in terms of more serious conversations, and really having been a focus of the work of the subcommittee and full committee from time to time in the last two years. But once again it’s not something we’ve held one hearing on and solved the problem.
Indeed I think I would say one of the major pediments of this activity has been to raise the level of awareness of the issue by the industry. We have heard or received written input from over 80 organizations and individuals, some of them multiple times, and have had eight days of hearings on this, so it’s certainly an issue where the industry and health care community at large has had significant opportunity to provide input.
Now early on it became clear that there was lots of concern but very little data related to the costs and benefits of moving to ICD-10, and this really prevented the subcommittee from making much progress and knowing how to make recommendations on this subject. Clearly because of this as well as the requests from large segments of the industry the committee took the unusual step about a year ago of commission a cost/impact study which RAND Corporation did, and which we received a report on at the last meeting. Obviously you heard our presentation on that as well as a reactor panel, and there have subsequently been other reports related to independently developed data, one of which you have on your table from Blue Cross/Blue Shield, which you received a paper copy of today, but had heard an earlier report at the last meeting.
Since the full committee meeting last time you’ll remember we spent a number of hours talking about the issue and reactions and our cost/impact study. The subcommittee held additional hearings and discussed this issue, in fact actually last week for a full day. At the hearing we heard additional testimony from Blue Cross/Blue Shield, from CMS, and NAHDO, as well as heard other testifiers during an open session. We obviously spent much of the day trying to talk and identify next steps, which is what this letter is all about.
The subcommittee felt at the end that it was really our responsibility to synthesize the information and make a judgment about what is best for the country, recognizing once again that there was no industry consensus on this. The letter which I will read in just a minute attempts to provide an accurate summary of the issues we heard and tries to make reasonable recommendations on the next steps.
So with that any questions before we move into actually reading of the letter? Okay. I think the good news here is that sometimes as clarity increases brevity increases also, so we’re looking at a letter that’s only slightly over two pages.
DR. HARDING: I have a point of information, are we going to vote today or tomorrow?
DR. LUMPKIN: The usual process is that we would discuss today and vote tomorrow, unless there’s like an overwhelming desire to get it done today we usually, so I’m always willing to entertain a motion to vote if there is a reasonable sense of readiness of the committee on the first day.
DR. COHN: Well, let me read the letter and what I will do is to read the background, which takes, is basically the first page and then we’ll stop and take comments rather then going paragraph by paragraph if that’s okay by everyone since this is primarily background information.
Dear Secretary Thompson:
As part of its responsibilities under HIPAA the monitors the continued effectiveness of the health data standards adopted pursuant to the requirements of HIPAA’s administration simplification provisions.
During the past several years NCVHS’ Subcommittee on Standards and Security has focused consideration attention on the feasibility and desirability of replacing the current diagnosis and inpatient procedure classification system, ICD-9-CM, volumes 1, 2, and 3, with a newer and expanded version, ICD-10-CM and ICD-10-PCS. ICD-9-CM, volumes 1 and 2, was adopted as the HIPAA standard for diagnoses in all settings and ICD-9-CM, volume 3, as the standard for inpatient procedures reported by hospitals. At issue are the one-to-one replacement as HIPAA code sets of ICD-9-CM volumes 1 and 2, with ICD-10-CM for diagnoses in all settings, and ICD-9-CM volume 3, with ICD-10-PCS for inpatient procedures reported by hospitals. This would not affect the usage of other code sets under HIPAA, such as CPT-4 and Level II HCPCS.
The ICD-9-CM was developed in the 1970’s. Despite an annual update process ICD-9-CM volumes 1, 2, and 3 have structure and space limitations that increasingly constrain their ability to accommodate advances in medical knowledge and technology. ICD-10-CM is recognized as the logical successor code set to ICD-9-CM for diagnoses. In fact ICD-10 already has been used for mortality classification in the United States since 1999 and has been implemented for that purpose throughout much of the rest of the world since the mid-1990s. Many of these countries also have adopted ICD-10, or a clinical modification of it, for reporting diagnoses in health care settings. ICD-10-PCS was developed by the Centers for Medicare and Medicaid Services, CMS, as a successor to ICD-9-CM, volume 3.
More than eight days of hearings have been held by NCVHS since 1997, and letters and oral and written testimonies have been provided by more than 80 public and private sector groups representing the health care industry, the federal and state governments, the public health and research communities, insurers, and providers. A chronology of the development of ICD-10-CM and ICD-10-PCS and a synopsis of testimonies and letters are attached. Also attached is a complete listing of groups that have provided input.
Let me stop there.
DR. LUMPKIN: Any questions or comments on the first page introductory language? Clem?
DR. MCDONALD: Last week when we discussed the letter of support, since then I got a hold of the letter of support from the 55 organizations and I should say I’m a board member of the ACP so that’s why I became aware of that, and the tone of that letter was not supportive for any of it, it was just saying whatever you do don’t do this, and I would just like to get that in the record that it wasn’t saying do this half and don’t do that, it just said we hear you’re going to do this, don’t replace the procedure codes. They said it pretty strongly. So I just thought it was a little, the way I read it last week was they actually were supporting the other part and I thought it was a little misleading that it was presented that way until I saw the actual letter. I sent the letter to some of you –-
DR. LUMPKIN: I think we all received a copy of the letter from the medical specialty societies, I think the full committee did receive a copy of that.
DR. COHN: Obviously you’re commenting on the accuracy of the appendix, which is something that we’re going to have to be very careful of.
DR. MCDONALD: It’s just a shading but I wouldn’t call it supportive the way they wrote it.
DR. LUMPKIN: Other questions or comments on the first page of the letter? Okay, let’s forge on.
DR. COHN: Okay, page two.
The issues surrounding the migration to a replacement diagnosis and inpatient procedure classification system in the Untied States are complex. For example, there are concerns within the health care community that ICD-9-CM is an antiquated system that cannot meet the current and emerging needs of payers and providers in today’s fast-faced highly specialized, and technologically sophisticated environment. There also are concerns that ICD-9-CM is increasingly unable to address the needs for accurate data for health care billing, quality assurance, public health reporting, and health services research. This has been well documented in the testimonies and letters provided to the committee over the past several years.
At the same time, the committee has heard concerns from the health care community about the costs, potential benefits, and implementation issues associated with transitioning to ICD-10-CM and ICD-10-PCS. Given the widespread use of ICD-9-CM there could be significant implementation costs in terms of hardware and software changes, lost productivity, and training among others.
Benefits are harder to quantify but appear to outweigh the costs. They include improvements to the quality of care and patient safety, fewer rejected claims, improved information for disease management, and more accurate reimbursement rates for emerging technologies. These costs and benefits and related issues also have been substantially documented in testimony before the subcommittee as well as in a cost/benefit study by the RAND Corporation that was specially commissioned by the NCVHS. A copy of the RAND study is attached.
In addition, many in the public and private sectors are concerned about the additional administrative and resource burdens posed by this implementation since they would follow on the heels of HIPAA’s other mandated requirements. Along with testimony about the timing and cost concerns, the subcommittee received considerable input about the timeframes that would be needed to effect a successful transition to ICD-10-CM and ICD-10-PCS.
Let me stop there.
MR. HOUSTON: Just one minor point is in the second paragraph on the page, you talk about, the first line speaks to the committee has heard concerns and then in the next line you talk about the potential benefits, I think you should strike potential benefits because it’s described in the next paragraph down.
MR. BLAIR: I think that that’s a valid point, I think that what it meant to say there was concerns maybe about the accuracy or validity of the potential benefits, and I don’t know exactly the words to help there.
MR. HOUSTON: Could you put lack of potential benefits?
DR. LUMPKIN: I think the word maybe is magnitude.
MR. BLAIR: That’s good.
MR. HOUSTON: Because the way it’s written it seems like it’s out of place.
DR. COHN: John, thank you. Other comments? Okay, let me continue on.
While taking into account the diversity of input and lack of industry wide consensus, [it’s either a major of or the] NCVHS concludes it is in the best interests of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation in place of ICD-9-CM volumes 1, 2, and 3. As a result the committee recommends that the Department of Health and Human Services initiate the regulatory process for the concurrent adoption of ICD-10-CM and ICD-10-PCS. By issuing a NPRM the Department would provide a structured environment in which critical implementation issues may be addressed. We further recommend that the NPRM specifically invite comments on the key issues presented in testimonies and letters before the committee.
Now should I got into these bullets or stop there?
DR. LUMPKIN: Why don’t we stop there and then we’ll go into the bullets. I would just like to interject, I think that, at least as I remember, all of our work comes out as recommendations from the committee and it’s fully recognized that any number of people may choose to vote, opposed to something, but I think it’s confusing to say in this case the majority of.
DR. MCDONALD: I might have had a lapse, on be on benefits are hard to quantify yet? Or past it?
DR. LUMPKIN: We’re on the last full paragraph on page two, which starts out while taking into account diversity.
DR. MCDONALD: Can I still talk about that paragraph?
DR. LUMPKIN: If there is something you want to talk about and we’ve already gone over it we’ll be happy to go back, at least I’d be happy to go back, you’ll have to check with the rest of your colleagues.
DR. MCDONALD: I worry about, second sentence on the third major paragraph –-
DR. LUMPKIN: Okay, that’s the paragraph that says benefits are harder to quantify but appear to outweigh the costs?
DR. MCDONALD: Right, the second sentence after that. Specifically I have trouble perceiving how we code discharge diagnoses would change the quality of care in patient safety. I think one could say we’d have better understanding of the care process but how those would directly improve care or safety I think is a stretch, because the patient has already been cared for.
MS. GREENBERG: Future patients.
DR. LUMPKIN: Well, the issue is is that the quality improvement process is an iterative cycle, so if you know what happened in the past it can influence what you do in the future.
DR. MCDONALD: Well, they will teach us, I think they’d help us understand the care process, which could lead to those things, but I didn’t hear either testimony or do I know any papers that suggest changing your coding after the fact changes care quality.
DR. STEINDEL: John, I think this was specifically addressed in the RAND report from the point that Clem is bringing up and what the RAND report said was that people were saying that there are potentially improvements to the quality of care in patient safety by moving to the new coding systems, but that they could find no evidence that the coding systems themselves would yield any of these improvements. And that relates to what Clem is bringing up about there’s no direct evidence that the coding systems themselves could improve it, there is a suggestion that they could and I think that’s what the paragraph and the sentence says. That there appear to be benefits, some of these benefits include, so I think both sentences are accurate, and I think Clem’s point is accurate, too, I believe it is addressed in the RAND proposal, which we’ve attached.
DR. LUMPKIN: Now I’m a little bit confused, is there a suggestion to change the language, recommendation to change the language in these two sentences recognizing that what we’re talking about is the fact that there is, what we’re suggesting are potential improvements. Simon, did you?
DR. COHN: Well, I’m actually trying to figure out what Steve said, I think Steve is saying that this is okay –-
DR. STEINDEL: I’m saying this is okay.
DR. COHN: It’s a qualitative, possible qualitative benefit that was recognized in the RAND report. I think I would further state and I think this goes along with other people, the intent here was not an individuals quality of care concurrent with the delivery but more this general view of better understanding of best practices, the ability to understand what the best practice is so you can implement the best practices and all of that stuff and I think that was really the intent here, the statistical piece.
DR. SONDIK: Maybe it would be better, the first phrase at the end of the sentence rather then at the beginning. Because you sort of put the most tangible thing right at the beginning rather then at the end.
DR. LUMPKIN: I’m sorry, which end of which phrase?
DR. SONDIK: Rather then say they include improvements to the quality of care in patient safety say they include fewer rejected claims, improved information for disease management, more accurate reimbursement rates for emerging technologies, and improvements to the quality of care in patient safety.
MS. GREENBERG: It was that way and they changed it.
DR. COHN: I think we felt that care in patient safety, quality basically needed to come first as a leader on this one. I’m trying to think of how we wordsmith this to resolve it.
MR. HUNGATE: A suggestion, what difference would it make if we injected the word facilitating improvements, seems to me that deals with the real cause and help.
DR. LUMPKIN: Could you read that the way it would read?
MR. HUNGATE: They include facilitating improvements to the quality of care in patient safety, fewer rejected claims, and the rest of it.
DR. COHN: Is that okay? Okay.
DR. LUMPKIN: Thank you. Anything else? Kepa?
DR. ZUBELDIA: This may be just a very subtle point but it goes along with the point that Clem made on the letter from the medical specialty societies. The paragraph that begins, the recommendation paragraph begins while taking into account, the fourth lines says ICD-10-CM and ICD-10-PCS should be adopted as HIPAA standards for national implementation in place of ICD-9-CM, volumes 1, 2, and 3. Perhaps instead of just saying in place of we could be more specific and say as replacement for, and it goes along with not replacing HCPCS or not replacing CPT codes, we’re only replacing ICD-9 procedure codes.
DR. LUMPKIN: Does anyone have a problem with that? Okay. So that would read while taking into account the diversity of input of industry wide consensus the NCVHS concludes it’s in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation replacing ICD-9-CM volumes 1, 2, and 3. As replacement for.
DR. MCDONALD: This paragraph in recommendation, how does it reconcile with the first, the second major paragraph where we say it will not effect, because it seems not to have that qualification in these last paragraphs.
DR. LUMPKIN: Can you say that again?
DR. MCDONALD: The second paragraph of the whole document –-
DR. LUMPKIN: That’s on page one.
DR. MCDONALD: Yes, has a strong qualification on the scope of our recommendation, the last paragraph –-
DR. LUMPKIN: Can you read that qualification?
DR. MCDONALD: At issue are one-to-one replacement as HIPAA code sets of ICD-9-CM volumes 1 and 2 with ICD-10-CM for diagnoses in all settings, and ICD-9-CM volume 3 with ICD-10-PCS for inpatient procedures reported by hospitals, that’s the qualification, and it goes on to say further qualifying this does not affect the usage of other code sets under HIPAA such as CPT-4 and Level II HCPCS. What I’m worried about, I don’t see that same qualification in our final recommendations. I mean was it meant to comply –-
DR. ZUBELDIA: Clem, that’s by saying as a replacement for ICD-9 volume 1, 2, and 3, it’s replacement for current uses of ICD-9.
DR. MCDONALD: Well maybe we should say that, current uses, that would make it flow in this last sentence.
DR. LUMPKIN: Simon, can you read that the way it would –-
DR. COHN: So while taking into account the diversity of input and lack of industry wide consensus the NCVHS concludes it is in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation as replacements for current uses of ICD-9-CM volumes 1, 2, and 3.
Boy is that a long sentence.
MR. HOUSTON: You could actually take what Clem talked about on the first page, the sentence this would not affect, you could move it below that then.
DR. MCDONALD: I think it’s alright, you get the qualification here and you get the qualification –-
DR. LUMPKIN: Okay, anything else on that paragraph? Okay, dot points.
DR. COHN: Then basically, I’ll read this sentence and get into the bullets. It says we further recommend that the NPRM specifically invite comments on the key issues presented in testimonies and letters before the committee. One is what could be done to minimize the costs of a transition to ICD-10-CD and ICD-10-PCS? Two is what could be done to maximize the benefits of implementing ICD-10-CM and ICD-10-PCS? Three is what are potential unintended consequences of such a migration, and how could they be mitigated? Four is what timeframes would be adequate for implementation? And then in parentheses NCVHS heard in testimony that the industry would need a minimum of two years for implementation, however, such timing could be further clarified and refined through the regulatory process. Fifth is what additional steps would be required to ensure a realistic and smooth migration?
And then the final sentence is NCVHS wishes to thank you for the opportunity to submit these recommendations.
DR. LUMPKIN: Any comments on those dot points? Clem.
DR. MCDONALD: The second to the last bullet, rather then saying such timing could be further clarified and refined, why don’t we say such timing could be adjusted based on the response to the NPRM.
DR. LUMPKIN: Let me ask this question, it really is inconsistent with the structure of the rest of the dot points to even have that clause in there, and I just wonder what it adds.
DR. COHN: I think one of the things that we’ve heard, I actually was going to make it stronger rather then weaker here, I guess, you may be right, this somehow is hear, I think what we meant to say is the NCVHS heard in testimony that the industry needs a minimum of two years for implementation and agrees, I think, and then we want to say however, such timing could be further clarified.
DR. LUMPKIN: Then that should be moved I believe up into, as a sentence, in the paragraph that precedes it, which is the recommendation paragraph which would be the NCVHS would recommend that implementation would take a minimum of two years, however that should be adjusted based upon testimony heard in the process. The question should be –-
DR. COHN: Okay, so maybe it’s the next to last paragraph?
DR. LUMPKIN: No, in the last paragraph, which is bottom paragraph on page two, the NCVHS concludes it is in the best interest of the country as a whole that be adopted as standards and so and so. Okay, Marjorie suggested it goes in with the sentence on the testimony about timing, and so we could take that clause which says the NCVHS heard in testimony the industry would need a minimum of two years for implementation, however such timing could be further clarified and refined through the regulatory process. That paragraph reads in addition many in the public and private sectors are concerned about the additional administrative and resource burdens posed by this implementation since they would follow on the heels of HIPAA’s other mandated requirements. Along with testimony about the timing concerns the subcommittee received considerable input about the timeframes that would be needed to effect a successful transition to ICD-10-CM and ICD-10-PCS. The committee recommends that a minimum of two years be considered for this process with additional time based upon input from the regulatory process.
MS. GREENBERG: Actually if you’re going to make it a recommendation it probably does need to go in this paragraph. If you were going to just take the paragraph --
DR. FITZMAURICE: Could I suggest just separating the two? At the end of that paragraph put the statement about what NCVHS heard and then put the recommendation for the timing in the next paragraph.
DR. LUMPKIN: Okay.
MR. HUNGATE: Could you just replace the timeframes with a minimum of a two year period, rather then use the word timeframe?
DR. LUMPKIN: Well actually HIPAA already has a minimum of a two year timeframe does it not? Six months for code sets, okay. Steve?
DR. STEINDEL: We actually heard testimony on two issues concerning timeframes, one issue was the timeframe for implementation after the adoption of the regulation and the other was the time in which the process would start.
DR. LUMPKIN: Which process?
DR. STEINDEL: The implementation of the ICD-10 series. I mean you could have a regulatory process that we’ve seen can go five plus years, which would probably make the industry happy, but we could also see a regulatory process that might just take a year. And the industry was concerned about the actual time that the two year clock would start as well as the length of the two year clock and I think this bullet is meant to elicit comment in both areas, which is why the timeframes is plural, it’s not timeframe, it’s timeframes.
DR. LUMPKIN: I think that the statement that’s in the bullet would fit at the end of the sentence in that fourth paragraph as a statement about the regulatory process. I’d like to suggest we move that sentence and then we take as a separate issue whether or not we put timeframes in our recommendation. So if it’s agreeable we’ll move that sentence in the parentheses up to being the last sentence in the fourth paragraph on page two.
DR. HUFF: My sense of the subcommittee was that we did want to recommend that it not be any shorter then two years so I would say we’d put that as a new sentence into the last paragraph on page two.
DR. LUMPKIN: After the recommendation and before by issuing we could say as a committee the committee recommends that the Department initiate regulatory process for the concurrent adoption of ICD-10-CM, ICD-10-PCS. Further the committee recommends that this adoption occur with a minimum of two year, over a minimum two year period, with an implementation period of at least two years.
MR. BLAIR: That’s the implementation period after the final rule is issues.
DR. LUMPKIN: That’s correct.
MR. BLAIR: Yes, and I think you and I understand that, I’m not sure that everyone does. We may want to add a little phrase –-
DR. LUMPKIN: With an implementation after the adoption of the final rule, the committee recommends that after the adoption of the final rule that the implementation would be a minimum of two years.
MS. GREENBERG: There were many people who spoke about two years and even some who said less then two years, I think one or two who said more then two years, so I’m sort of questioning the emphasis here from the committee on a minimum of two years.
MR. BLAIR: I think it’s just the sense of the committee that we all seem to, there seemed to be consensus that there should be a minimum of two years, at least that, as a minimum.
MR. SCANLON: But the Department would get comment on that –-
DR. COHN: I think we can leave that as an issue for public comment.
DR. LUMPKIN: Okay, and that’s the reason why we have the question which will remain in the dot point of what timeframe should be adequate for implementation. So is everybody clear on what was in the parentheses under that dot point on timeframes moves to the end of the fourth paragraph on page two, which is the one that discusses timeframes, and that we add the additional sentence in the recommendation paragraph that would say that the committee further recommends after the adoption of the final rule that implementation period would be a minimum of two years. Did I say it twice the same way? Okay.
DR. COHN: We’ll wordsmith it and bring it back.
DR. LUMPKIN: I think we got it. Are there further discussions on the dot points?
MR. HOUSTON: I propose that this letter be adopted.
DR. LUMPKIN: There’s a motion that we adopt this letter, with the edits.
MR. BLAIR: And I would second it.
DR. LUMPKIN: It’s been moved and seconded. Richard, if you have, I see –-
DR. HARDING: I was fully ready to vote for this letter unchanged, I’m a little, could we go through it one more time and just say strike these words and add these words just so we make sure, this is an important letter and we’ve said a lot of things and not everybody has written them down.
DR. LUMPKIN: Okay, we’re going to start from the beginning, we’re not going to read the whole letter –-
DR. HARDING: Right, just say strike these words or add these words.
DR. LUMPKIN: Okay, so if someone has a copy of the annotated one –-
DR. COHN: I think what we’re actually doing to do is we’re going to put the letter up on the, and then we can take a look at it to make sure it’s okay.
Ed I think you need to give Julie space.
We’ll get that up in a minute but I think what we’re saying first of all is the first page is clean if I understand.
DR. LUMPKIN: Right, I think the first page, I’m not even going to mention, no, we’re not going to do that. First the issue of attached and enclosed but we don’t even want to go there.
By my notes I think that brings us to the second paragraph on the second page.
Okay, so we’re down to the paragraph at the same time