Transcript of the June 16, 2004 NCVHS Full Committee Meeting

DR. LUMPKIN: Good morning. We might as well start the meeting. My name is John Lumpkin. I'm Senior Vice President of Robert Wood Johnson Foundation, and chair of the committee.

We are going to start off with some introductions. We have a fair bit of work today. Obviously, this is a fascinating environment, even since the last time I believe that we have met. We will have a presentation tomorrow from David Brailer, who is the new NHIT -- I guess we better like what David is doing, because it was our recommendation. So, I don't think we can actually criticize that.

And far be it from us -- every time we have a meeting, last time we kind of were noting the fact that the secretary was now stumping on our issues, which surprised us, because it took us so long to try to get some attention within the department. But now we have the president stumping on our issues. In fact, I wouldn't be surprised if as his motorcade goes by, he might stop in, seeing that he knows that we are meeting. But maybe he's busy.

Why don't we being with introductions? Even though Marjorie and Jim have been switched, we'll start with Jim.

MR. SCANLON: I'm Jim Scanlon. I'm the Head of the Science and Data Policy Office in HHS, and I'm the executive staff director for the full committee.

DR. COHN: I'm Simon Cohn. I'm the National Director for Health Information Policy for Kaiser Permanente, a practicing physician, and a member of the committee.

MR. BLAIR: I'm Jeff Blair with the Medical Records Institute, and I'm a member of the committee.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.

DR. LUMPKIN: Actually, Marjorie nudged me, as I forgot, as you introduce yourself, if you have any conflicts, please announce them at this time.

MS. GREENBERG: With anything on the agenda.

DR. LUMPKIN: Yes, I mean if you have conflicts with national policy, we really don't want to hear about it.

DR. COHN: John, no conflict.

DR. LUMPKIN: Okay.

DR. WARREN: I'm Judy Warren from the University of Kansas School of Nursing, and a member of the committee. And I'm not aware of any conflicts with this meeting.

DR. CARR: I'm Justine Carr, physician at Health Care Quality at Beth Israel Deaconess Medical Center, and no conflicts.

MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, and member of the committee, and no conflicts.

DR. LENGERICH: Gene Lengerich, Penn State University, member of the committee, and no conflicts that I'm aware of.

DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, member of the committee. And I have the same conflicts Eugene has.

MS. FRIEDMAN: Maria Friedman, Centers for Medicare and Medicaid Services, and lead staff to the Subcommittee on Standards and Security.

MR. HOUSTON: John Houston with the University of Pittsburgh Medical Center. I'm a member of the committee, and I have no conflicts.

MS. BEREK: Judy Berek, Centers for Medicare and Medicaid Services. I'm the liaison to the committee.

MS. HANDRICH: Peggy Handrich, Wisconsin Department of Health and Family Services. I'm a member of the committee, and I have no conflicts.

MR. LOCALIO: I'm Russell Localio, University of Pennsylvania School of Medicine, and a member of the committee, and I have no conflicts.

DR. MAYS: Vickie Mays, University of California, Los Angeles, member of the committee. And I don't think I have any conflicts.

MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member of the committee, and no conflicts.

DR. HARDING: Richard Harding, University of South Carolina School of Medicine, and have no conflicts.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.

[Additional introductions were made.]

MS. GREENBERG: I just wanted to call your attention to a few documents that we have included on the table, in particular a draft list of popular acronyms in health data policy. Justine, Dr. Carr, suggested after her first meeting that this would be helpful, and I agreed with her. We had done things like this in the past, but never really for the National Committee.

So, this is our first attempt at it. Debbie Jackson and I have worked on it, and we would welcome first of all if you see anything missing that you would like to add, this is a living document. That's why we called it a draft. And if we got any of them wrong, let us know. And let us know if you think it's helpful.

DR. LUMPKIN: So, let me see if I understand it. We're going to be keeping track, and there is going to be an award at the end of the meeting with the person that uses the most number of these acronyms correctly in this meeting. Of course my favorite one isn't on there.

MS. GREENBERG: RWJ?

DR. LUMPKIN: No, PMPM.

MS. GREENBERG: Oh, well, just submit them to your friendly staff, and we'll add them.

DR. LUMPKIN: And I almost never get to use that in a sentence, so that was probably only the second time I've used that term. There are a few in this room who know what that is.

Any issues, questions, additions, changes to the agenda? Okay, we are going to move ahead.

[Administrative remarks.]

MS. GREENBERG: [Administrative remarks.]

DR. LUMPKIN: We're going to start off with the update from the department. Jim.

Agenda Item: Update from Department - James Scanlon, ASPE

MR. SCANLON: Thank you, John, and good morning everyone.

Since we met in March -- that's when it was I guess, we had a full committee meeting in March -- we have had a number of significant developments in the NHII and the data policy area occurring. And many of them actually, as John indicated earlier, are in response or consistent with at least, NCVHS recommendations.

So, let me start with the secretary's May 6, Health Information Technology Summit. The secretary convened a conference here in Washington on May 6 involving over 100 leaders in health information technology. And he was looking at ways to accelerate the use of electronic health records and the NHII generally. And several of the NCVHS members were there.

He had a number of announcements, and let me just recap what they were, because I think you are familiar with most of them, and some of them were actually NCVHS recommendations, so they have come full circle. First of all, he announced that HHS and other agencies in the federal health care enterprise were adopting and endorsing 15 additional CHI standards.

There were agreed to by our CHI initiative. And of course they are designed to allow for, and to promote the electronic interchange of health care information. Again, these focus on the federal health care enterprise, but the hope is that by the federal endorsement of these standards, and use in our own systems, that this would serve as a leadership, an example, and a guide for industry directions as well.

He also announced that starting that day, May 6, the SNOMED-CT could be downloaded for free on the NLM Website. So, as you remember, the conditions of that agreement, virtually any health care organization in the US could download and use SNOMED free in the United States. And you are quite familiar with SNOMED itself.

And he also announced that day that the HL-7 had completed a favorable vote. You will remember on a functional model on standards, fairly high level standards for electronic health records. And then we'll be following up HHS this year with another project at HL-7 that will be looking at actual data interchange standards to support the electronic health record. So, there were actually a number of things announced at the conference.

In addition, he announced the appointment of the first national health information technology coordinator, Dr. David Brailer, here at HHS. You will remember that the president signed an executive order creating that position about a week earlier, April 27, and David was actually there at the meeting, and the secretary introduced him as well. And he has been here since then.

Now, Dr. Brailer will be meeting with the full committee tomorrow, so I don't want to steal much of his thunder. But in terms of the challenge ahead, let me read what the executive order asks him to do. "The National Coordinator shall --"

DR. LUMPKIN: Jim, that's on Tab 6.

MR. SCANLON: And you have the executive order, Tab 6. But, "The coordinator shall, to the extent permitted by law, develop, maintain, and direct implementation of a strategic plan to guide the nationwide implementation of interoperable information technology in both the public and private health care sectors that will reduce errors, improve quality, and produce greater value for health care expenditures. The coordinator shall report to the secretary regarding progress on the development and implementation of the strategic plan within 90 days after he begins operation."

So, that was more than 30 days ago, so the clock is ticking already. And I know David and his office are already moving pretty quickly on moving that.

Now, I think as David will tell you tomorrow, he will be presenting some of this framework at our NHII 2004 Conference in July; July 20-23. And I believe virtually all of you have signed up for that conference as well. And there are some sessions designed specifically for interaction with the NCVHS as well.

Any questions on that? I'm going to turn to the National Academy of Sciences study on race/ethnicity data next. Again, we will have David here tomorrow to brief the committee, and you can ask him questions about responsibilities, strategy, timeline, and so on.

Let me turn then to the -- I briefed the committee previously on the progress of a study funded by HHS and mandated by Congress to look at the adequacy of race and ethnicity data in health and human services generally, not just the federal or the public side, but in the health care sector generally. And this was funded by probably half a dozen of our agencies here in HHS.

Ed Perrin, you will remember, was the chairman. John Lumpkin was a member of the committee. The panel released the workshop report last August that looked at some issues and opportunities in the private sector health care organizations, and the full report was released in April. And we will have a briefing later this morning from representatives of the Academy on their findings and their recommendations there as well.

Let me say a little bit about budgets, and kind of where we are in planning. We are just about completing fiscal year 2004, and we are looking forward now to the president's budget, which is awaiting congressional action on the Hill with the 2005 budget. You will remember that the president's 2005 budget on the Hill actually included a number of initiatives relating to the NHII and data policy generally.

And it looks like some of them continue 2004 activities, but just to remind you, we first of all have an ASPE/AHRQ joint initiative on data standards that is continued from 2004 in the 2005 budget. This provides, if enacted by Congress, $10 million for investments in data standards.

You will remember last year we were able to fund some activities relating to the medication standards, RxNorm, DailyMed, and so on, medical device standards, and some mapping priorities as well, which again, we sought the NCVHS's advice on what would be mapped, how would they relate to each other, and what were the priorities for mapping. So, we hope to continue some of that work as well.

In addition in the AHRQ budget, we have $50 million proposed for 2005 that is. We continue the $50 million initiative for planning, demonstration, and evaluation grants, looking at improving patient safety through health information technology in hospitals and ambulatory practice settings. That would be continued. The request for applications have already been issued this later. And later in the year we will be announcing grant awards.

In addition, something new in the 2005 budget at the departmental level, there is an additional $50 million requested that would be slated for demonstrations of community and regional, local health information interchange and data exchange networks. So, the focus here would be on interoperable data exchange at the regional or local level as well.

There is also some very good news on the population statistics side in the president's 2005 budget. There is a $25 million increase requested for the National Center for Health Statistics. This was more or less a professional judgment amount of the resources needed to maintain and transform the core data systems at NCHS, vital statistics, health interview survey, provider surveys, and research as well.

This was the Data Council's highest priority recommendation in the 2005 budget. And the secretary and the president and OMB agreed, and they forwarded the request to Congress, and we are now hoping that that will actually find its way into the actual appropriation.

For the 2006 budgets, we are really in the planning stage, but we are beginning to look at what priorities and investments may be being thought about, and the Data Council will be meeting on Friday, our data strategy group, to kind of do some preliminary thinking and frameworks for what we might look for or ask and recommend in the 2006 budget.

So, let me stop there.

DR. LUMPKIN: Any questions?

DR. FITZMAURICE: I would just make one statement, and that is that I think the good news that Jim has given us about a lot of resources being in the 2005 budget for data standards, for data and surveys, there has been a lot of groundwork that has been laid not only by Jim and his staff, but also by the National Committee. And a lot of that is due to the importance put upon the data by this committee.

DR. LUMPKIN: Any other questions?

Maria.

Agenda Item: Health Insurance Portability and Accountability Act of 1996 - Maria Friedman, DBA, CMS

MS. FRIEDMAN: Good morning, everyone.

I'll start with the update on HIPAA. We are pleased to report that during the May and as of June 4, the percentage of HIPAA compliant claims coming into Medicare is actually in the mid-eighties. As of June 4, we are at 86.4 percent. So, the numbers keep trending upward, and we're very pleased by that.

The number of complaints we have received, total of 140. Of those, 120 had to do with transactions and code sets. A bunch of the others weren't ours. They were privacy and those kinds of things, and we of course sent them to the Office of Civil Rights. We're pleased to help out any way we can.

Almost all of the complaints we have gotten are on the claim. There are a few code set issues. The bulk of those are small providers against health plans and clearinghouses.

On the regulatory front we have NPRMs on claims attachments and the national plan ID. They are in the works, and are expected to be published by the end of the year. We also have a regulation on transactions and code sets policy modifications, which includes streamlining the standards on the change process. That's under development, and we're not quite sure when it's going to come out, but I thought that the committee would like to know that that's in the process as well.

On the consolidated health informatics front, as Jim said, and as you know, CHI had recommended a group of 20 standards to be used in the federal IT architecture, which were adopted by the secretary on May 6. CHI is part of actually the e-gov initiative. And we understand that OMB has announced the intent to graduate these initiatives from the e-gov structure by the end of this fiscal year, the end of September, and these will then become integrated with regard business functions and processes of various agencies across the government.

CHI next steps, there are brainstorming sessions with partners, during which a consensus emerged that three activities are very important: facilitating implementation of adopted standards. Agencies will build these standards into individual IT architecture to deploy new systems and major systems upgrades.

The second is enhancing usability of adopted standards by working with the SDOs to fill gaps and promote harmonization. And finally, the new standards work to support critical business needs. And of course, CHI is working very closely with Dr. Brailer's office to help contribute to the president's agenda for promoting electronic health records.

DR. LUMPKIN: Any questions? Thank you.

DR. COHN: Maria, thank you for as usual, a wonderful presentation. Tell me more about the graduation of the e-gov initiative. This obviously is an area where there is obviously first of all, lots of opportunity. But I think most of us feel that these are probably in early high school, as opposed to quite ready to get their diplomas yet. So, we are wondering what this exactly means. Is there a clarity around all of this?

MS. FRIEDMAN: Unfortunately, the person who can really fill you in on that, Cynthia Werk, is not here today. But I can get information on that and bring it back.

MS. GREENBERG: Just from my own participation on the Council, I think as Maria said, these e-gov initiatives were kind of a one time activity. But the CHI is continuing as a partnership activity among the federal agencies, HHS, VA, and DoD principally, but others such as SSA, et cetera, have also participated.

And it is going to be more kind of integrated into like the federal health architecture work, and sort of ongoing and emerging departmental efforts and governmental efforts. And we've got a whole agenda for phase 2, but it will no longer be as an OMB e-gov initiative, but as an interdepartmental activity.

So, that doesn't seem to be clear to you.

DR. COHN: And I apologize. I guess I'm reflecting on what I'm hearing from you, and the fact that I guess my concern is that without a focus of activity, at times things get lost. And I was actually thinking about the recent IOM report on patient safety that we had a briefing on at our last meeting. It really talked about the need for a structure to enable successful moving into this sort of a standards oriented future.

And so, I'm just reflecting on what I'm hearing, versus that set of recommendations. And I'm not certain that there is a problem, but obviously, I'm just concerned. That's something I will take back to the Committee on Standards and Security. And I'm sure there will be no letter generated today, but it's just obviously a concern about whether or not there will be -- about the durability and resiliency of the process that is being described.

MS. FRIEDMAN: I think also once Dr. Brailer's office gets up and running, there will be some opportunities to further understand how all this integration will take place.

MR. SCANLON: I might mention that Dr. Brailer is not just the HHS -- he's here in HHS, but I think part of his responsibility is to coordinate federal-wide, including DoD and VA. I don't think the change in the original 23 e-gov initiatives at OMB was meant to signify anything of less interest. I think it was purely a bureaucratic decision on their part. They changed the IOs. It's not so much a graduation as a what's next sort of thing.

DR. LUMPKIN: Any other questions? Thank you.

Susan.

Agenda Item: Privacy Rule Compliance Update - Susan McAndrew, OCR

MS. MC ANDREW: On the privacy front, and it may the complaints that Maria has been sending over, as of the end of May, we had received 6,557 privacy complaints. We have closed over 50 percent of those, and are pleased that our closure rate continues to creep up, even though we are not so pleased that our case rate also continues to creep up.

We had been working under an assumption that we were getting cases at about 100 a week, and looking back over the recent month's data, that intake is now more in the range of 120-130 a week.

So, I suppose there is good news in that, and that is that privacy continues to be in the forefront of everyone's agenda. And that the consumers are becoming aware of their rights, and are exercising their rights, and are very protective of concerns that they have that their privacy rights may be breached by covered entities.

We have not to date, had to issue any sanctions. So, we still have not brought our first case under the civil money penalties. We continue to refer cases to the Department of Justice, and they are continuing to investigate and pursue those cases that they think have merit.

So, that is the complaint side. I would say one other thing about our complaint activities, and that is earlier, I guess in late April to May, we were visited by the General Accounting Office, who, at the request of the Senate Health Committee, is doing a quick report on privacy implementation one year out. And part of that is to look at complaints, and to see what complaints may tell them about where people are concerned with how the privacy rule is operating.

They were also going to be surveying, and I don't know if they have talked to you all or not, but they were going to be surveying a variety of stakeholders to get their impressions about how the privacy rule is operating. But in terms of complaint analysis, one of the things that we did for GAO is to generate a database of the first year's worth of complaints.

And we have had conversations with you all before in the past about interest in doing some additional manipulation of the complaint data on a variety of data points. And so, I'm thinking that this may be an opportunity to, if you would like to let us know any particular concerns that you have, or particular interests, we may in fact have an opportunity here to do some more analysis with the first year's data.

In addition to that, on the guidance side we have been continuing to meet with various stakeholders, plans, folks in the research community. We have been -- particularly in the research area, your recommendations were very helpful in that.

And I think that there are a number of fronts where we will be engaging not only the research components within the department, but also in the private sector about concerns with continued roughs between the privacy rule and the Common Rule, and to make sure that we are aligning the two rules to facilitate research as much as possible, as well as looking into making sure the authorizations and the informed consent processes line up as true as possible.

In addition, we have published -- we at the department -- SAMHSA has finished clearance, and has put up on their Website, a document that crosswalks the privacy rule requirements against their existing part 2 of their own confidentiality and privacy requirements for substance abuse. And that is available on their Website, and I think we are in the process, or have linked to that, so that you can access that comparison document.

I would also say that we have initiated our own privacy listserv, which we will be using to disseminate guidance as it is produced. And I think we are three weeks out, and we have something like 12,000 people signed up on the listserv, so lots of interest is out there, and we are continuing to work hard on guidance in a variety of areas.

We have I think two consumer documents that are coming close to finishing clearance. This attempts to translate the privacy rule, and particularly individual rights into a single page -- doubled sided I will say, but a single page. We have done our best to try to produce at least two pieces of general consumer-friendly information and helpful hints on the privacy rule and privacy rule rights. And we're hoping that they will be out soon. They are in their final phase of clearance.

And I will stop there. I know there was one question.

DR. LUMPKIN: Right, just a quick question before I turn it over to Jeff. Those two documents, do you know what languages they will be translated into other than English?

MS. MC ANDREW: I think we will be trying to translate all materials into seven languages. And I can't tell you off the top of my head what they are. But we are going through in the material that is up there now, and as material comes out, we will be sending them for translation into at least seven languages.

DR. LUMPKIN: Great. We'll start off with Jeff.

MR. BLAIR: Sue, thank you. Obviously, I want to commend all of the things that you are doing. The reason that I have a question here is because I have a concern that there are some privacy advocacy groups that are very fearful of the entire HIPAA initiative. And their perception of the privacy regulations is very, very different than the perception we have in this room.

And I think that there is a tendency to wind up saying, well, they are just misinformed, and they just don't understand. But these privacy advocacy groups get reported in the New York Times, and other major media. And I feel as if we really need to make an effort to reach out to these privacy advocacy groups. And it's not very hard to check with Websites to see the things that they are saying, and the way that they are characterizing HIPAA and the privacy regulations.

So, we should be able to pull together an open forum where we respect their concerns and their fears, and we at least make an attempt to clarify on the record, what they HIPAA privacy regulations really do and really say. And I think that we ignore this at our peril. And I strongly encourage there to be an initiative to try to reach out respectfully to educate the privacy advocacy groups.

DR. LUMPKIN: John.

MR. HOUSTON: A couple of things. With regards to the consumer guidance that you discussed, I know in the past one of my questions has always been give me statistics about the different complaints that are being filed. With regard to guidance, are these guidance documents going to take into consideration common complaints from consumers that may be misperceptions of the rule?

Because again, in my organization, I often see people file complaints, and the reality is there is not a violation. It's not a privacy issue, it's just a misunderstanding of what the rule allows.

And I think that any type of consumer guidance, I think it would be helpful to go back through the complaints, look at them, try to understand where there are misconceptions as to what the rule does and doesn't do, so that these guidance documents also try to maybe address the misconceptions, as much as lead the consumers as to what their rights are under the privacy rule.

MS. MC ANDREW: I will say that we made an effort from the beginning in designing the consumer documents about individual rights, to be careful not to I guess oversell or make absolute statements that would distort the right in the consumer's mind. So, we were careful to try to make clear in these documents, the true nature, including some of the limitations about the rights, to avoid the consumer becoming enraged at the doctor, thinking that they had the right to this, and they don't really.

So, we were careful going into these documents, to make sure that they were properly balanced and communicated the true scope of the right. In addition, we have been using not only the complaints that we received which indicate consumer concerns about something that is not technically a violation of the rule to inform the guidance that we give out, as well as things that we hear in the press, and misconceptions that we may get from the adversaries that Jeff had mentioned --

MR. BLAIR: Sue, I really don't want to refer to them as adversaries. I would really rather refer to them as privacy advocacy groups. And while they may be saying some things that we know are not accurate, I think it is our responsibility to reach out to them, to let them know that we are hearing them.

MS. MC ANDREW: I think we have tried to, to the extent that an issue is raised from any of these forums, we have tried to address these in a number of consumer-oriented FAQs, largely about -- to date they have largely been in the area of the ability of friends and family to have communications with the patient and the patient's physician, and how those informal communications can go on.

So, we have tried to address some of the larger misconceptions, the most common misconceptions through FAQs. We are also hopeful that the listserv may also be a forum where some of these myths or misconceptions can be dispelled.

MR. HOUSTON: To put in my request again, I think statistics is something that I am very interested in, and I really want to see them. I think it would be helpful to guide this committee. So, again, even gross numbers, number of complaints broken down by what area of the privacy world they seem to be -- the different complaints are focused on. Just raw numbers would even be helpful at this point in time I think; helpful to me, I know.

DR. LUMPKIN: But I think what I heard Sue say is if you could send her your wish list of what you would like to see, they are now in the process of tabulation, so that would be useful.

MR. HOUSTON: In the past I have indicated areas I'd like to see, but I'll be more than happy to talk to her or write it down.

DR. LUMPKIN: Great.

Richard?

DR. HARDING: Thank you again for all the work that you are doing. I have a quick question. You mentioned that there had, at this time, been no sanctions from OCR. And in the next sentence you said that you had referred to the Department of Justice, a number of cases. On what standard do you refer? That is, there are interpretations, and there are gross whatevers. Can you give us an example of the type of case you have referred to the Department of Justice at this point?

MS. MC ANDREW: Typically, the refers to the Department of Justice are where is an knowing, an intentional disclosure of --

DR. HARDING: Selling of information or something along those lines?

MS. MC ANDREW: It can be selling. It can be a disclosure with malicious intent. It can be a disclosure for personal benefit, for gain. But it basically needs to be a knowing disclosure, or the intentional obtaining of protected health information in a manner that is in violation of the rule.

DR. HARDING: Has this happened 2 times or 10 times or 100 times that you have referred?

MS. MC ANDREW: To date we have referred in the neighborhood of 80 cases.

DR. HARDING: Thank you.

DR. LUMPKIN: Russ.

MR. LOCALIO: I'm Russ Localio at the University of Pennsylvania.

I'm interested in the type of complaints that you get in that my feeling is that the complaints that you entertain are those for individual patients concerning potential violations of their individual privacy rights. Is that correct?

MS. MC ANDREW: Actually, anyone can file a complaint. It doesn't have to be a patient. But they are largely from individuals.

MR. LOCALIO: The reason I ask is that I get lots of complaints, many complaints, HIPAA this, HIPAA that, more now than I used to get. Some people know that I'm on this committee, and they flame me. But they are people who are researchers. And I want to give you some examples of the type of complaint I hear. And then I would like to ask what is the number that people dial if they get that type of complaint?

For example, a researcher with a valid authorization form in hand goes to a hospital and says, this patient has given us permission to access the medical record. And the hospital says, but the signature is more than 60 days old, or more than 30 days old, and it varies by institution.

Or they say, well, yes, we see that this is a valid authorization, but the person who does that is on maternity leave, and won't be back for three months. That's just a flavor of some of the things that I hear. I hear that the authorization forms are so complex that only a lawyer could understand them, and the reason is that a lawyer wrote them, the authorization forms.

What is the mechanism by which you entertain these complaints? And are these part of the tabulations that you are currently weighing or considering? Does that make sense?

MS. MC ANDREW: In part. Your first two examples, were the researcher to file that complaint with our office, we would treat that as a complaint, so it would go into the count of the 6,000 whatever. But neither of those situations are complaints over which we would take jurisdiction, because neither of them represent a violation of the privacy rule, because it is not a violation of the rule not to honor even a valid authorization.

With regard to the complexity of the authorization, that is less of a complaint about a potential violation of the rule than just a complaint about the rule. Although since each entity gets to design their own authorization form, it's kind of a complaint against one's self, or not a complaint against the rule per se.

So, we actually have had lots of discussion with both the plans and providers about potential benefits from having a national model authorization form. I don't know if any comments to that effect have come to the committee, or what the committee might think, or would be interested in weighing in on that issue. But we have had those discussions with various stakeholders.

I don't know whether it would help or hurt the complexity issue, because we wind up having to design an authorization form that would have to serve a variety of functions, which may make it more complex than what is out there today. But it's probably worth considering.

MR. LOCALIO: So, in other words, you do entertain those complaints, and you do document them, and take then down? And that is one way that people who are aggrieved with the privacy rules as they function, can at least make you aware?

MS. MC ANDREW: Oh, sure.

MR. LOCALIO: Thank you.

DR. LUMPKIN: We'll go Michael, and then I have a question. Yes, Michael?

DR. FITZMAURICE: I wanted to follow-up on Russell's question with a scenario. Suppose a researcher came to a hospital, and had in hand an individual authorization, and had a request from the individual to obtain the data for the individual's purposes of turning it over to the researcher, and then had a third document empowering the researcher to receive the data on behalf of the individual. Would that work? And then would the hospital have to turn the information over to the researcher in that case?

MS. MC ANDREW: I'm not quite sure what you are asking me. I will only say that the distinction is only that most of the rule is permissive with respect to disclosure. But to the extent the individual is exercising a right to request access and a copy of their own records, then that is a required disclosure, and the entity must honor an individual's request for access.

MR. REYNOLDS: Susan, I would like to echo John Houston's comments. I think even base statistics, because there are kind of some silent partners in the privacy rule that some of us worry about, and I know we are trying to do some outreach -- employers.

Are the complaints against employers beginning to rise? We all obviously think hospitals and doctors and everything else. But employers is a group that they don't seem to be as awake as they need to be. So, are complaints rising against them? And those are the kind of base statistics that I think would help, as we all try to help people understand the privacy rule, and make sure that they don't hurt themselves. Case law is not going to be the way to find out if we did well on it.

MS. MC ANDREW: I don't think complaints against employers is on the rise. We continue to see complaints filed against group health plans, which may be the surrogate for the employer category. And also some of those really -- the group health plans tend to be split between those where the employer is really involved, and those were the complaint is really with the insurer that is carrying the policy.

But we are looking at the area. We know we continue to get questions about the role of employers and group health plans. New attention is being focused on that with the new health savings accounts, and the other kinds of supplemental health benefit policies that are out there. So, we do have on our agenda, the need to get some technical assistance out to the employer group health plan community.

DR. LUMPKIN: I'm actually going to -- and we'll need to move on, because we are running a little bit behind schedule -- just to toss into the pot a question, which you don't have to answer now. But it relates to some concerns I'm still picking up from emergency care and EMS providers in relationship to the privacy rule. And I don't know to what extent that is a problem with -- I thought we had taken care of that. There was some fairly specific ones.

So just a question on whether or not that is still bubbling up, and something we may want to take a look into, perhaps a hearing or something to determine if there are still some overlying concerns, because I think the department's directives were helpful in that area.

The second is really in response to Jeff's concerns. And I think the question there, there are two reasons why advocacy groups will have positions and interpretations that are different than the department. One is that they are not familiar with the department's guidances and positions. And the second is they just disagree. And I think we need to determine the difference.

My guess right now is given as far as we have been down the road, it's probably that they just disagree with the interpretations. And they are certainly free to have that, and that is part of the reason why they are in existence, is to be checks and balances to our official structures.

But I would urge us as we look at that, to also consider that second option, because in many of these advocacy groups, there are smart people, and they do homework. And sometimes for people in government, they do more homework than we would like them to do. But not all of it is because they are not informed.

MR. BLAIR: One thought on that?

DR. LUMPKIN: Yes?

MR. BLAIR: John, I think you are absolutely correct. The thing about some of the groups that may have disagreements is that the way they express their disagreements is they go directly to the media. And they do it in a manner where it is extremely difficult for the Office of Civil Rights to get those allegations clarified.

So, I thought that it would be beneficial for the public at large if the Office of Civil Rights created an open forum, invited these groups to be able to express these thoughts, but in a forum which really would give the Office of Civil Rights the opportunity in front of the media to get complete, good, accurate information out there.

Because in some ways it isn't a matter of whether -- how do I want to phrase this? Sometimes what gets covered in the media is not necessarily the whole story. And I really felt as if by default, some distortions are being replicated, and the readers don't know the difference, and the readers are getting afraid.

And so, I felt as if it would be a good idea for the Office of Civil Rights to be proactive in this area, and do more than frequently asked questions or publishing things, or having things on the Internet, or responding when a reporter calls. But to actually have an open forum which might give a better opportunity for all of the story to be gotten out to the press.

DR. LUMPKIN: I think we are going to need to move on, but I'm just going to interject that unfortunately I think if OCR were to have such a conference, it would be covered on page 99 of an 88 page newspaper. Whereas, the advocates' press releases, because they appear to be controversy, get more coverage.

And the challenge -- we can't control what the media does. And that really is the real challenge. And given the fact that we have a constitution with a first amendment right on that, I won't say we don't want to, but we can't.

So, I think it is a good issue, it's an important issue, and we certainly would urge that OCR not miss an opportunity to try to clarify the issue, but to recognize the limitation in which they operate.

Simon?

DR. COHN: I was actually going to first of all observe that this is a good time for Jeff to rejoin the Privacy Subcommittee, because it seems to me many of these issues are things that are probably appropriate for our Privacy Subcommittee.

I do, however, also want to just observe that I think part of the conundrum we all face is this issue of covered versus non-covered entities. And as I have looked into this recently, I am actually much more comfortable with the whole issue of covered entities with individual identifiable health information.

But obviously out in the world of the Internet, there are many non-covered entities that are dealing, or accessing, using, asking for individual identifiable health information. And certainly, if I were a privacy advocate, that would be an area that I would be particularly concerned about.

It's probably also something that the subcommittee needs to begin to get in and talk about. And probably something that we need to be asking OCR to work with us around, just because I think it is sort of an open area there.

DR. LUMPKIN: Well, I'm going to thank Sue and Maria, and not to toss this open, but I would suggest that one of the areas that the Privacy Subcommittee may want to start looking at is the banking industry. And wait a second, we had an item in our next item on our agenda is related to that.

Richard.

Agenda Item: Privacy Letter - Dr. Harding

DR. HARDING: Well, thank you, Mr. Chairman. I'm representing Mark Rothstein today, who couldn't be here. And we have been, as most of you know, following the privacy rule for the last 14 months since it was introduced. And we have had hearing in February of this year around three topics: banking, law enforcement, and schools.

The subcommittee, by the way, is composed of Mark, Simon, John, Harry, and myself. And we have had extraordinary support from Kathleen Fyffe, as well as John Fanning and others, and we appreciate it.

We have in Tab 5, the second and through about the tenth pages, three letters that are proposed to come from this committee to the secretary around those three items, banking, law enforcement, and schools. They are to be discussed today, and then voted on tomorrow, is my understanding. And I would like your guidance, Mr. Chair, as to how you would like to proceed.

Would you like me to read those and take amendments and so forth today? Or would you like -- how would you like to proceed?

DR. LUMPKIN: I think the letters have been in our handout. I think everyone has read them. So, why don't we just walk through them one at a time, and see if there are any comments or amendments, starting off with the banking letter.

DR. HARDING: So, it isn't necessary to read the whole letter?

DR. LUMPKIN: That's correct. Just read the recommendations, I think.

DR. HARDING: Okay.

First letter is about banking. And the recommendations are rather brief. There are three of them. I'll read the final paragraph, and then the three recommendations.

"NCVHS notes that the banking industry is evolving and diversifying its services for processing of person health information. For example, financial institutions have begun to acquire health care clearinghouses, and they provide value-added services that potentially involve personal health information. Financial institutions face new privacy challenges and responsibilities in today's environment and with that in mind, the NCVHS recommends the following:

- HHS should clarify the nature of Section 1179..."

If you go back, that is the Social Security Act.

"...exception for financial institutions when engaged in processing health care transactions. Specifically, clarification is needed from HHS about whether the exception applies to consumer-initiated transaction (e.g., credit card or check payments), covered entity-initiated payment transactions, or both."

Is there any discussion recommendation? We are saying that consumer-initiated and covered entity-initiated payments or both.

DR. LUMPKIN: I think the only comment I would have is Section 1179 is not included on our popular acronyms.

DR. HARDING: We will take care of that immediately.

DR. LUMPKIN: I just wanted to point out that Counselor Houston didn't say it loud enough, but he pointed out that that's not an acronym, it's a number. And he is technically correct, as usual.

MS. GREENBERG: Although it's quite hilarious, I see that HIPAA is not in here either.

DR. LUMPKIN: Next recommendation.

DR. HARDING: Bullet two, "Until HHS clarified the Section 1179 exception, HHS should recommend to health care providers and payers that they use business associate agreements with financial institutions." This would be a temporary fix recommendation.

And number three, "Regardless of the technical status of financial institutions under the law and the regulation, HHS should consider whether encryption should be required for PHI moving through the ACH," which is automated clearinghouse, "to ensure that it is available only to final recipients." We're recommending increased use of encryption.

Those were the three recommendations.

DR. LUMPKIN: Michael?

DR. FITZMAURICE: On the last one, Richard, I wonder if that would preclude those clearinghouses from doing coordination of benefits? That is, bursting open the encryption so they can see what other insurance companies might have to share the information. If they are acting as a clearinghouse, then that's one of the functions that a clearinghouse can do. It's a just a thought that somebody needs to consider. It may be the department needs to consider it.

DR. LUMPKIN: Wouldn't that be an issue about where or not the encryption, and how it's set up, depending upon the role that they would play?

DR. FITZMAURICE: Or just a recognition that it may preclude some functions. I think the way it's stated is probably good enough.

MR. REYNOLDS: Because I think the thing that this -- the ACH that is mentioned here is the general banking clearing function. Once it gets into an individual banking institution, if they are in fact a clearinghouse, then they are in fact under a covered entity status, and can do what they need to do with the transaction based on that situation. This is the general flow throughout the whole banking system as it's going from one institution to another.

DR. FITZMAURICE: These are the non-HIPAA transactions?

MR. REYNOLDS: No, they are HIPAA, and we are saying they should be encrypted as they flow through the general process. Once they got to an institution, if it's a bank that is a clearinghouse, they have the ability to take it out of the encryption, because they would be covered in it.

The whole reason this becomes such a big issue is with the 835, which is a remittance. It used to just be the amount of money that was being paid. It's now the entire claim also, because the whole 837, which is pretty much the whole gamut, is attached to it. That's why this whole thing is such an issue for everything that is going on. It dramatically changed the amount of data that is in fact, and back to the earlier discussions on privacy and other things, it bring a whole lot of new data into play.

DR. LUMPKIN: Are there questions or comments? I think the letter is fair straightforward. I think all of us have seen this. If there are no modifications or recommendations, is there a desire by the subcommittee to work on this further?

DR. HARDING: I think the subcommittee would be pleased to finalize.

DR. LUMPKIN: Then moved by Richard, and seconded by John that we would adopt this letter.

DR. STEINWACHS: Is this the expedited John's rules of order here?

DR. LUMPKIN: I just think it's so straightforward, why bring it back if we are ready to move on it today?

All those in favor signify by saying aye. Opposed say nay. Abstentions?

[Whereupon, the letter is unanimously approved as presented.]

Okay, second letter.

DR. HARDING: The next letter is in your back-up material under Section 5. It's the law enforcement letter. to Sec. Thompson. There were no clear recommendations on this one. As I will read the final paragraph, that would be the closest thing we would have.

"NCVHS believes it did not hear testimony from a sufficiently broad range of witnesses about the effect of the Privacy Rule on law enforcement, and thus must limit its recommendations to drug diversion activities. Based upon the oral and written testimony presented at the hearing, NCVHS recommends HHS work with the DEA to educate providers that communicating information about drug diversion or complying with state reporting requirements are permissible under the HIPAA Privacy Rule."

And this refers back to a part of the letter where there was concern about pharmacists and so forth, who had some early recognition that there may be some diversion of controlled substances going on, being concerned about reporting that, that they may be in conflict with the HIPAA privacy rules. We have asked for clarification on that issue.

DR. LUMPKIN: So, we don't believe that HIPAA should be a diversion from these important drug enforcement activities?

DR. HARDING: That's correct.

DR. LUMPKIN: Michael.

DR. HARDING: That's the intent.

DR. FITZMAURICE: I'm just wondering if drug diversion is defined anywhere in the letter. Explain what drug diversion is.

DR. HARDING: It's on the first page, fourth paragraph, or at least what diversion control is.

DR. LUMPKIN: I'm sorry, which paragraph?

DR. HARDING: Fourth paragraph on the first page, where we try to describe what the Drug Diversion Control Program is.

DR. LUMPKIN: Ah, yes, the Office of Diversion Control is responsible.

DR. FITZMAURICE: It does really say from whom to whom. Where is it being diverted to.

DR. LUMPKIN: I think that's a term of art that is fairly widely used throughout the health care industry.

DR. FITZMAURICE: It means diverted from people for whom the prescription is written? It's diverted from the manufacturer to the pharmacy?

DR. LUMPKIN: It's a nice way of saying people taking drugs and using them that shouldn't be given them, because it's prescription drugs and so forth.

DR. FITZMAURICE: I just think it could be clearer as to the problem that we are facing. I agree with you that people shouldn't be taking drugs who shouldn't be taking drugs. It's kind of circular. If it's not a problem, then we don't need to explain it, but it wasn't clear to me just which drug diversions, or maybe all drug diversions are being referred to here.

DR. LUMPKIN: Generally, they are referring to controlled substances, and that is a fairly restricted set of drug items.

MR. HOUSTON: I think this stems out of the fact that there were both physicians and pharmacists who were concerned that when they recognized that somebody was either doctor shopping or was coming in with a pattern of acquiring prescriptions volumes above what they should be, prescribed medications, that they felt they could not communicate to law enforcement or the DEA.

They had seen the same patient with five prescription for a medication that would have killed an elephant if it had taken it in those volumes, something like that. And that they didn't feel that they had the authority to go and say something.

Who is raising the concern I think is the pharmacists and the physicians. If we wanted to clarify that, we could probably add something to this, something in here to indicate it seems like that's where the issue has come from.

DR. LUMPKIN: Does the committee feel that we need to clarify the term "drug diversion" for the letter?

DR. CARR: I do, because this is new, what I'm hearing now. I think that is very different. I think I was thinking more like what John was saying, that in a clinical setting if a drug isn't accounted for at the end of the day, you look to who touched it, and why it wasn't accounted for. So, this sounds very different. This is patients who are taking a lot of medication.

DR. LUMPKIN: I don't believe that's the common term for drug diversion. Drug diversion would be clinicians who are -- you look at the record, and all the sudden they have been writing 300 prescriptions for controlled substances in a month. That would be a drug diversion. That's what the triplicate forms were designed originally to delve with. That would be my understanding. I don't think it's detection of patients who are doctor shopping.

MS. BEREK: It's also patients who pick up multiple prescriptions, and then go out and resell the drug. Those are the people the drug diversion program is looking for, both the doctors and the patients.

DR. WARREN: From what I'm hearing there is enough confusion on the committee that I think we need to specifically define it in the letter.

DR. LUMPKIN: Okay.

DR. WARREN: And there is no definition in the letter.

MR. HOUSTON: Why don't we go back to the testimony and see if we can find the reference specifically to this, because that's really the background as to why this is in here. And I think maybe we can try to get into the testimony real quick and find that.

DR. HARDING: So, the committee would like us to come back with an updated paragraph four, with a clear definition?

DR. LUMPKIN: That would describe the acts that would be described under drug diversion.

DR. STEINWACHS: The only other twist is that since you're addressing HIPAA, this has to have protected health information. So, drug diversion can happen anywhere along the supply chain, I would think, from the manufacturer all the way through. So, you might also make sure it's clear.

DR. LUMPKIN: Yes, and I think we need to define that, because again, the area what we are talking about is that HIPAA component. So, the definition would be where in that potential for diversion are we concerned about?

Any other changes to the document? Mike?

DR. FITZMAURICE: One more thing in the same sentence, I would suspect that we might want to put in there communicating information about drug diversion to law enforcement, as opposed to communicating it to reporters or the man on the street.

MR. FANNING: I think when the man testified, they don't quite consider themselves law enforcement in the same way that let's say FBI does. And I suspect that this more general formulation is safer.

DR. FITZMAURICE: Is it permitted under a different exception than the law enforcement exception in the privacy rule?

DR. LUMPKIN: I think the appropriate authorities or some similar type term may solve that issue.

MR. HOUSTON: But I don't think it's a problem, because the recommendation is for HHS to work with DEA to come up with education materials or educate providers. So, as part of that education, it would be what is appropriate disclosure. I think that we're making a recommendation to do education, which would then further describe what is appropriate.

DR. STEINDEL: John just raised a question in my mind. If the DEA doesn't consider themselves law enforcement, are they entitled to receive this under the privacy regulations as an exception?

MR. HOUSTON: It's a mandatory reporting potentially.

MR. FANNING: I think they may also see it as an element of public health, and possibly of health oversight. But of course, that's the very thing that the committee wants to write to the secretary about, that the department should work with the DEA and sort this out. And I think more detail here is probably not helpful.

DR. LUMPKIN: Let me see if I interpret what your last comment was. The more detailed we are here, the more restrictive the department and DEA may be in trying to discuss what education needs to occur? Is that a fair restatement.

MR. FANNING: Yes, that, and also I think the time and energy in this committee to work up the specific factual elements that you might put in here are probably not worth the committee's time.

DR. LUMPKIN: Okay.

MR. HOUSTON: Regarding the last point, could somebody print out a copy of the testimony? I'll be more than happy to sort of cull through it quickly to see if I can find out.

MR. FANNING: I'll get that.

DR. LUMPKIN: Okay. Any other questions or comments on this?

DR. HARDING: The hope then would be that with the testimony, we would have some changes in paragraph four for tomorrow?

DR. LUMPKIN: Correct. Okay, number three.

DR. HARDING: The final is the school letter. And there was very interesting testimony, as you all have read. We get down to the four recommendations that we made on the final page.

"Based on the oral and written testimony presented at the hearing, NCVHS recommends the following:

1. HHS should continue to work with the US Department of Education to clarify how the Privacy Rule and FERPA interact with respect to confidentiality of school health records, and where possible, to harmonize these regulations and issue guidance."

This of course was discussed in the letter. We are going to the bullets here. It's a very complicated situation, very complicated, and clarification is being asked for.

DR. LUMPKIN: Any questions or comments on the first recommendation? Okay.

DR. HARDING: Number two, "HHS should make special efforts to focus its outreach and educational activities on schools and physicians to clear up any confusion regarding the permissible disclosures of health information the context of dealing with the health needs of children in the school setting."

And this of course refers back to some of the issues of children getting re-immunized because of the difficulty of getting records from the primary care doctor to the school setting.

DR. LUMPKIN: Okay, any question on that? Go on.

DR. HARDING: Number three, "HHS should regard disclosure of immunization information to schools as a public health disclosure, thereby permitting providers to disclose this information to school officials without an authorization."

MS. HANDRICH: This letter asks HHS to do a lot of clarifying. And I am wondering whether or not given the new school year beginning in August, and it's my understanding that in many states immunization records are requested for the new children coming in, that this particular recommendation could be highlighted for an earlier clarification, possibly to reach schools prior to the beginning of the new school year.

DR. LUMPKIN: If I could just respond to that. Actually, most states, at least my experience in Illinois, the agreements have already been reached between the Department of Education and public health in regards to immunization policies prior to the ending of the school year, because it's so hard to get the information out to the families during the summer.

So, we have actually missed that window for the coming school year. So, if the department were to develop clarifications, I think that would be difficult to do between now and school beginning.

DR. HARDING: Could we say something in there that would say in a timely manner, or something? That needs to be clarified as soon as possible.

MS. BRICKFORD: I would encourage you to change the language, and not say children, but use students, so that you can encompass the college level and associate degree and other educational institutions. Children is like K-12, and there are many issues at the collegiate and academic higher education level that need to be attended to for confidentiality of health information.

MR. HOUSTON: Is that just for the recommendation, or throughout the letter?

MS. BRICKFORD: I'm just reacting to the recommendation. And if indeed your letter is focusing on children, it needs to be more encompassing to be students.

DR. LUMPKIN: The second recommendation I think has children in it.

MR. HOUSTON: Children is used in the letter too, in the body of the letter, I believe.

DR. HARDING: So, that would be no problem. In the fourth bullet too there is a children.

DR. LUMPKIN: Right. I think that's a good recommendation.

DR. HARDING: Because a good bit of it was student health in colleges was being a critical issue. That's a good recommendation, thank you. We accept that.

MR. HOUSTON: Throughout the letter though, we are going to change all of it?

DR. HARDING: I would think where appropriate. We would have to go back and look at each thing, but yes, in principle we could change that.

DR. LUMPKIN: The question is does FERPA apply to college students?

MR. HOUSTON: I believe it does.

DR. HARDING: Yes, we had testimony that it does.

DR. LUMPKIN: Okay, then that would be an appropriate change.

DR. HARDING: Because they were trying to choose which way to go in college student health.

Number four, "HHS should clarify the disclosure of health information to school health personnel in the context of dealing with the health needs of students in the school setting is a disclosure for treatment, and thus possible without an authorization."

This of course addresses the issue that schools are dealing with children at this time that would have been in intensive care two decades ago. And it's an extraordinarily different situation than when FERPA first came into existence and that kind of thing. We didn't want HIPAA to stand in the way, in any way, of good care to those individuals.

DR. LUMPKIN: Okay, I kind of see what the recommendations are, to add some language into the third recommendation urging a facilitated review, because even if it's too late for this school year, the next school year rolls around real quick.

MS. HANDRICH: And the recommendation is specific to assuring providers, not parents. So, it would be possible to just have a letter that schools could share with providers locally, and do some good.

DR. LUMPKIN: I think my only comment on that is that given even though this would be done at the federal level, immunization policies and relationships to schools are really a state by state. And so, any ruling at the federal level would then have to be interpreted in the context of state laws, and subsequently sent out.

MR. HOUSTON: But I think part of the issue though was that pre-HIPAA, this was fairly well settled. And then HIPAA unsettled it. So, it does sort of draw everything back to being a HIPAA issue though.

DR. HARDING: The immunizations are now asking parents to come sign authorizations, take it by hand carry to the nurse, and hand it to them.

MR. HOUSTON: So, it's a HIPAA phenomenon.

DR. HARDING: It's misinterpretation.

DR. LUMPKIN: My only twist on that is I think we need to get some recognizition to the role that states have in this, in that if we are going to talk about making an interpretation, and we talk about urgency, we should also urge them to work with states in rolling out this new guidance.

DR. HARDING: Then we accept the changes, where we will replace children with students where appropriate throughout the letter. And we will also change the third bullet to increase the urgency of this, and facilitate it happening. And also to work with states regarding this issue of disclosure.

DR. LUMPKIN: Okay, great.

DR. HARDING: And then we'll come back tomorrow with all those changes.

DR. LUMPKIN: Great. Any other additional comments on this letter?

We are a little bit ahead of schedule, so I think we are going to move to a 15 minute break.

[Brief recess.]

DR. LUMPKIN: Through an oversight in the agenda, we didn't include the last item in Tab 5.

Simon.

Agenda Item: Letter - Dr. Cohn

DR. COHN: This is a relatively brief, and hopefully straightforward letter. This is the result of some work by the Subcommittee on Standards and Security. It's actually sort of a difficult issue, which I don't think we have fully resolved, but I think hopefully have come up with some recommendations that will allow the industry to function well, while we dig deeper into the area of what I would describe as supply codes, which is I don't think anybody's favorite topic, and there has probably been a reason that we haven't been talking about this more.

Anyway, John, would you like me to just read the letter? Or have people had a chance to review it?

DR. LUMPKIN: It's in our notebook. I think just read the recommendation.

DR. COHN: Sure. The recommendation is that the department -- I'll read the recommendation. It doesn't make much sense out of context. How about if I read the paragraph before, and the recommendation paragraph?

"Currently, the NDC is the HIPAA standard for reporting drugs and biologics by retail pharmacies, while HCPCS codes were adopted as the HIPAA standards for supplies, equipment and other items without regard to setting. Testimony indicated that the UPC and HRI codes [which are not in our acronyms I don't think] are used by the industry to identify supplied on retail pharmacy claims. These codes are used within the NCPDP standard, but are external code sets that are separately maintained and updated outside of the NCPDP standard setting process. Their continued use is necessary to provide the industry with a level of detail needed to handle claims processing, ordering, supply management, or the recall of products. Testifiers noted that the HCPCS codes do not provide the specificity needed for the day-to-day operations for retail pharmacies.

NCVHS recommends that the department allow continued use of UPC and HRI codes within the NCPDP Telecommunications Standard 5.1 and investigate rulemaking if necessary." And that is effectively, the recommendation.

DR. LUMPKIN: Any questions or concerns about the letter?

DR. FITZMAURICE: Recommending rulemaking if necessary, does that refer to possibly making them HIPAA code sets in themselves? Or having the department look at the need for making them HIPAA code sets?

DR. COHN: I think the subcommittee stopped short of trying to deal with those specific recommendations at this point, and this is part of the reason why this was such a difficult letter to write. The subcommittee plans in the after e-prescribing era -- sometime later on this year or early next, to hold hearings on supply codes in general. And at that point we may be able to make some further recommendations on that, because there actually are a number of supply codes, some of which are overlapping and redundant, and we need to get our hands around that a little better.

DR. FITZMAURICE: This sounds like a good way to address the issue about getting the additional information sometime in the future.

DR. COHN: Exactly. So, we are interested in the area, but not willing to go forward with where you are going for the moment.

DR. STEINWACHS: Just a very small thing. The NCPDP abbreviation I did find in our glossary here, but you didn't spell it out in the text anyplace.

DR. COHN: So, for the first paragraph we will spell it out, and then put it in parenthesis after that.

DR. STEINWACHS: Just for my education, who are they?

DR. COHN: They are actually one of the designated standards maintenance organizations. They are the standards group that deals with all the electronic pharmacy transactions.

MR. BLAIR: They stand for the National Council on Prescription Drug Programs. We did identify in our recommendations there, Simon, that it is the NCPDP Telecommunications standards, which go between pharmacies and payers the second time we referred to it. The first time we referred to it, we didn't have the word "telecommunications," and maybe that will be helpful, because especially when we go forward with the e-prescribing standards, it's going to be the NCPDP scripts standard. And some folks may be not be aware of the fact that we are talking about different messages.

DR. LUMPKIN: Are you referring to a letter?

MR. BLAIR: In this letter?

DR. LUMPKIN: Because I think in the first paragraph it does refer to NCPDP Telecommunications Standard.

DR. COHN: I apologize. John asked me to do the recommendations. The recommendation is only one sentence long. It makes no sense out of context. I elected to read a paragraph.

DR. LUMPKIN: And that was just because I didn't want to give Simon an unfair lead in the use of acronyms if he read the entire letter.

MR. BLAIR: I do understand these very sensitive issues.

MS. FRIEDMAN: The recommendation does say NCPDP Telecommunications Standard. I thought we conformed it throughout the whole letter, but I'll double check.

MR. BLAIR: That's good.

DR. COHN: So, I think we have heard one friendly amendment, which was spell out NCPDP in the first paragraph. Are there other recommendations for changes, modifications?

DR. LUMPKIN: Okay, there has been a motion by Houston. Is there a second? By Blair that we vote on the letter that is in our packet, with the amendment that first use of the acronym NCPDP will have it spelled out. All those in favor say aye. Opposed say nay. Any abstentions?

[Whereupon, the letter was unanimously approved as amended.]

Thank you.

Okay, Vickie.

Agenda Item: Populations Report - Dr. Mays

DR. MAYS: As you know, today we'll actually have a presentation, I think it's later this afternoon, and we're going to be talking about the report that has come from the National Research Council on issues of the collection of data on race and ethnicity. This is an item that the subcommittee has been working on for quite some time, and what we have tried to do at this point is to come forth with a report.

As opposed to having the full report available, what it is that we were able to do in the time since the last meeting is actually to come up with a summary and the set of overarching recommendations. For those of you who have been on the committee a while, you will remember we came forth with like 60-something recommendations that are way too many. And what we have done is we have determined what are the overarching recommendations that have come from the series of hearings that we had that started back as far as February 2002. We had a series of hearings.

The one that we are focusing on today really are the hearings that focus on population level surveys, as opposed to specific populations. But the broader issues of using population surveys is where we want to start with many of our recommendations today.

The reason we thought it was important to move forth from this time is that again, the National Research Council will be releasing its book I think in July. What is in your packet now under Tab 3 is actually the summary that has currently been out and available.

So, part of what would be important for populations at this point in time is to be able to be a participant in the discussion that is going to take place from the material that has been released by the National Academy.

So, what we have brought forth to you is a summary with our overarching recommendations; another document that you have which is just for your preview, and it's an early version of it, and it's called, "Race and Ethnicity Data Issues in the Measurement and Elimination of Health Disparities." It's an outline. That outline is for the report that we will write, that we will bring forth in September.

So, where I would like to start today is with the document that is entitled - and this is the new name of what the report will say -- "Recommendations on the Nation's Data For Measuring and Eliminating Health Disparities." So, I think that's where we should start.

John, let me ask your counsel on this. Should I read this? Or should I start with the recommendations, and then go backwards? What would you suggest? I'll just start with the document then.

We're starting with the document, "Recommendations on the Nation's Data For Measuring and Eliminating Health Disparities, A Report by the National Committee on Vital and Health Statistics, Subcommittee on Populations."

The abstract for this: "Federal efforts to eliminate health disparities and improve the health of all Americans depend on the ability to target those at highest risk and with the greatest need. This in turn requires information on the diverse array of population groups that comprise the United States. Drawing on hearing testimony, previous recommendations, and other sources, this report for the National Committee on Vital and Health Statistics examines the limitations of health data on racial and ethnic groups as currently collected and used. Some challenges stem from the Office of Management Budget's 1997 Guidance on race/ethnicity classification, and these are discussed. On the basis of this analysis, the report recommends a set of actions to remedy problems and fill information gaps. The most critical of these involves a combination of guidance, coordination, monitoring, funding, and research that must be carried out at the highest level of government."

Should I stop there, John?

DR. LUMPKIN: Any questions on the abstract? Okay.

DR. MAYS: Thank you.

Summary. The section is entitled, "Measuring and eliminating health disparities. Compelling evidence exists that differences in health status, access to care, and the provision of physical and mental health services are significantly related to race and ethnicity. Despite advances in medicine and increased emphasis on disease prevention and health promotion in the United States, the country's racial and ethnic minority populations have higher rates of illness and disease than Whites. For example, life expectancy for Whites in the United States in 2000 was 77 years, while for Blacks it was six years less, at 71 years."

Next paragraph?

DR. LUMPKIN: Yes.

DR. MAYS: "The national goal of eliminating health disparities among racial and ethnic groups has come increasingly to the fore in recent years, along with growing recognition that the nation's health must be improved population group by population group, with the greatest attention to those at greatest risk. This approach and goal are at the heart of Healthy People 2010, reinforced by the recent National Health Disparities Report by the Agency for Health Care Research and Quality (AHRQ), and addressed in multiple reports from the Institute of Medicine (IOM). In addition, as the first of five steps to effectively reduce a community's cancer burden, the National Cancer Institute and the Centers for Disease Control and Prevention recommend reviewing data to identify populations at greatest, and the extent of health disparities between populations."

One of the friendly amendments that I got for that section is that we should probably put the sites in for those various reports, and I think that that's a good suggestion.

Moving onto the next one, "To achieve these goals, the Department of Health and Human Services (HHS) must be able to target interventions and monitor progress for those at highest risk and in greatest need. The targeting and monitoring, in turn, depend on having estimates of the health status and knowledge of the health needs of the many population groups and subgroups that comprise the US. For each racial and ethnic group and subgroup, data are needed not only on health factors -- including health status, health care, health care expenditures, access to care and experiences in the health care system -- but also on contextual factors such as socioeconomic position and the conditions in which people live. The sources of these data include national population-based surveys (the major focus of this report) as well as state data, targeted surveys, and administrative data."

DR. LUMPKIN: Just a question on this, the term "socioeconomic position" versus socioeconomic status.

DR. MAYS: Do you want me to explain those?

DR. LUMPKIN: Yes.

DR. MAYS: Socioeconomic status, typically we have measured it by using things like education, income, et cetera. The thinking now, and actually the research data is showing when we move to socioeconomic position, that we are actually looking at things like a broader array of issues. So, we are talking about rather than just current income, you are thinking about wealth, because what you want to know is more about the life circumstances, as opposed to the current status that a person occupies.

So, in socioeconomic position what you learn is whether or not that there were at an early age, for example, I might make lots of money now, but the question would be whether or not conditions of my early life may actually be important in terms of talking about my health status, and my health outcomes. So, we are trying, I think in many places, instead of talking about one's current status, is to talk about their societal position over the life span.

DR. LUMPKIN: Okay.

DR. FITZMAURICE: So, socioeconomic position refers to the socioeconomic history of a person, or the socioeconomic background of a person?

DR. MAYS: It would be more of a history. Usually, you would ask additional questions. So, besides asking a question of what your current income is, you might ask questions for example of the kind of ownership of things when you were growing up. You might ask more questions about parental status, so that what it would do is allow you to have a sense of over time, whether you have had access to resources, not had access to resources.

DR. COHN: Vickie, I think what you are describing makes a lot of sense, and obviously we're looking at the summary, not at the actual document. I'm presuming that this differentiation that we are describing will be somehow referenced or explained in the actual document?

DR. MAYS: We can. I don't think we did a lot of detail on it.

DR. COHN: I didn't see anything in your outline.

DR. MAYS: In the actual report, I think that that's a good point, and we should probably do that.

Let me just make one other comment, and say for example in the eliminating health disparities measurement and data needs, which is what the National Research Council is coming for, this really maps onto that quite well. They have talked about it.

There is also in the unequal treatment document that the Institute of Medicine talked about, they have made references also to socioeconomic position there. It is really I think where we are going, and the recognition of it is kind of slowly coming through in some of these reports.

Some of the measurement issues are still on the table as to exactly what is the best way to do this, but I would say that we want to be in the forefront of having people think about this, and worry about the measurement of it, as opposed to recommending what people are kind of moving away from, which is socioeconomic status.

DR. LUMPKIN: Thank you, that was well put.

DR. MAYS: "The problem is that the very groups at greatest risk for ill health and poor health care are those about whom health statistics and contextual data are most deficient. National population-based surveys are essential sources of estimates on the health of the United States population, and they are an adequate source for general Black-White comparisons and (to a lesser degree) comparisons among Blacks, Latinos, and Whites. However, such surveys, at least as currently designed, are not an effective source of information about the health of American Indians, Alaska Natives, and Asian and Other Pacific Islanders, or of other geographically distinct groups. It is significant that Healthy People 2010, which has an overarching goal of eliminating health disparities, lacks baseline data to quantify specific improvements for some populations in many areas."

MS. HANDRICH: Given the discussion that we just had about the meaningfulness of information that isn't traditional health data, is it correct to say that there is adequate source of information for the Black-White comparisons, and Blacks, Latinos, and Whites are -- the language suggests that the data available are adequate given the very thing you have just talked about, that we have talked about so much in our state, about the need for more information regarding socioeconomic history and other factors that contribute to populations either being health and resilient or not?

I worry that this statement is as teenagers would say, way positive.

DR. MAYS: I think that's a good point. And probably what we should do is rethink using the word "adequate." I think what we were trying to say is in the past there has been enough data available to do some analysis, but adequate is probably not a good term. So, that I agree with. So, we'll work on that language.

MR. BLAIR: I think that it's important to get this information. As you can tell, I'm also really sensitive to the fact that there are some groups that are especially sensitive to privacy issues, and especially as we expand this from status to position.

And I'm not exactly sure whether it should be in this letter, or whether it should be in subsequent planning to gather this information, is to anticipate the fact that there may be some groups that may feel uncomfortable from the privacy issue, providing some of that information. And I don't know where that is going to fall, but clearly the information is important to gather.

So, there may have to be some extra thoughts about how do you gather that information in a manner that eases the sensitivity and concern about people that may consider some of these things as being private information.

DR. MAYS: I just want to comment that I think Jeff's point is a very important point, and it is one that I think many of the agencies that came to testify are sensitive to, and it's something that is addressed just a bit in the report, when we do the full report.

But it is probably an area that we could stand to learn a bit more about in terms of hearings, et cetera. But it is an area that has come forth to us about for example, one of the issues in the measurement of socioeconomic status or position is asking people about their income, and asking a lot more questions about not just how much you make, but things that you own and possessions, et cetera.

People get very concerned about that. So, this is not an area that is without the need for greater investigation. And I think the sensitivity that you raise is important.

MR. BLAIR: Because if we think of it in advance, as you have, then we can better prepare to construct a survey instrument which is more likely to get cooperation thinking about it in advance.

DR. MAYS: This is one of those things where the call is for methodological research in order to be able to accomplish this. But I think this good for us in the report, to highlight this also in terms of issues, not just of people's concerns, but also linking it to issues of privacy and confidentiality for them. So, thank you.

The next section is called, "The Changing Landscape. Gaps and deficiencies such as these are not easily remedied, and those trying to collect and use data on American racial and ethnic groups face a host of challenges. For example, the US is an increasingly multiracial society; racial and ethnic identities can change over time; the number of subgroups is daunting; the confidentiality of personal information can be compromised when the group size is too small, thus limiting data use; and some institutions cite concerns about legality or acceptability to clients as a reason for not collecting data on clients' race and ethnicity. Race itself, moreover, is not well understood, often being mistaken for a biological rather than social construct."

Next paragraph, "In 1977, the Office of Management and Budget (OMB) required a common language in Federal collection and use of data on race and ethnicity, with Statistical Policy Directive #15. In October 1997 (taking effect in January 2003), OMB issued a new method for accommodating changing population makeup and identities and providing categories for data on additional population subgroups. Specifically, the new guidance provides five categories for data on race: American Indian or Alaska Native; Asian; Black/African American; Native Hawaiian or Other Pacific Islander; and White. It also provides two categories for data on ethnicity: "Hispanic or Latino" and "Not Hispanic or Latino." In addition, for the first time, significantly, the revision offers respondents the option of selecting more than one racial designation. While the New OMB classification opens the way to greater detail in race and ethnic data, it also has created complex challenges in data collection, tabulation and analysis for those charged with monitoring and improving population health. These are discussed below."

Next section, "NCVHS Contributions. The National Committee on Vital and Health Statistics (NCVHS), established in 1949, advises the Secretary of Health and Human Services and Congress on the health information and data issues underlying Federal policy. NCVHS has completed many important initiatives to improve population health data, including a number of activities on behalf of racial and ethnic minorities. The NCVHS Subcommittee on Populations focuses on health data concerning the US population generally, as well as data about specific vulnerable groups within the population that are disadvantaged by virtue of their special health needs, economic status, race and ethnicity, disability, age, or area of residence. The present report summaries recent work by the Subcommittee."

Next paragraph, "While the new OMB classification and the change and questions it has engendered are one important focus of concern, the Subcommittee finds it useful to look at classification-related issues in the context o the broader topic of the information needed to monitor and eliminate population-level health disparities. Drawing on past NCVHS recommendations, other documents, and testimony at a February 2002 hearing convened by the Subcommittee, the report recommends a range of actions by the Federal government to create the conditions for the collection and use of reliable and complete data on racial and ethnic minorities. The ultimate goal is ensuring the Department can play it's key role in helping to eliminate health disparities within the population."

This is called, "Specific Data Issues. The sources noted above highlight a number of data issues that must be resolved. As seen in the recommendations below, in many cases the resolution must begin with research, Federal guidance, and coordination. Some issues pertain to data collection, and others to tabulation, analysis, and interpretation. Sample design is one of the first challenges, partly because of the difficulty of collecting and reporting numbers from small racial and ethnic groups sufficient for analysis but without violating confidentiality protections. Other data collection issues include the need for adequate subgroup data as well as questions about primary race, given the options offered by the revised classification system. There is also a need for surveys in languages other than English and Spanish."

Peggy?

MS. HANDRICH: I just wondered whether this section -- and I thought of this before we had this discussion about the socioeconomic profile or --

DR. MAYS: Position.

MS. HANDRICH: Position, thank you. Is whether this discussion should indicate that there needs to be development of identification of appropriate data to take into account the entire circumstances of the person. The very kind of thing you were referring to before.

In other words, nowhere in this summary do I see a statement that there needs to be development of what data ought to be collected, if we believe that we need to go beyond traditional data in collecting information about health. That would come here, and later in the summary.

I'm just throwing that out as a question. If those of you that have worked more on this report think that's not necessary, that's fine too.

DR. MAYS: Let me see if I understand. Your comment really is one of maybe highlight better the fact that we are still in a stage of needing to do some work to identify the range of questions that should be asked in order to help us best understand the elimination of health disparities in this group.

MS. HANDRICH: Right.

DR. MAYS: And that while we kind of talk about it a little bit, we need to make the statement stronger.

MS. HANDRICH: Right, because the report would suggest we know the right questions to ask. We know the right information to collect, and I don't believe that's the case.

DR. MAYS: I think we think we know some and not all. I'm fine with that, because we talk about that in the report. I think that a statement that maybe emphasizes it a little more in here is fine. And I think the detail is left to the report.

DR. FITZMAURICE: On line 119-120, it starts out, "Simple design is one of the first challenges, because of the difficulty of collecting and reporting the numbers." Oh, I see you've got it already. To me, sample design, the confidentiality is not a problem of sample design, but it's a problem of reporting. You've got it in there, my mistake.

DR. MAYS: "The greatest impact of the OMB guidance is on data usage. In particular, allowing persons to report more than race presents a host of challenges. These and other changes imposed a new burden on states at a time of reduced or flat budgets, forcing them to retool their data systems and bridge old and new statistics. Data collectors and users alike are calling for Federal guidance on multiple questions, including how to present multi-race data, what Census denominators to sue to calculate rates, and how and when to collect data on subgroups. To permit trend analysis, greater guidance is needed in methodologies to 'bridge' or compare data collection under the new standards with data collected under the old ones. Small analytic sizes are another challenge."

Next paragraph, "An additional category of data issues concerns the type of information beside race and ethnicity that are needed to meaningfully measure and monitor health disparities. The most important topics cited on which additional information is needed are socioeconomic position, geographic location, age, primary language, and health care expenditures."

I think, Peggy, your point might actually be well taken there.

The next section is called, "Cross-Cutting Policy and Capacity Issues. Much of the testimony received by the Subcommittee about data on race and ethnicity suggested that these data collection and use challenges are not insoluble; rather, they require a centralized approach to solving them. This calls for a higher federal investment in research, guidance and coordination, with appropriate levels of funding. Important infrastructure capacity issues were also identified, including the need for training and diversification of the survey and research workforces as well as the need to provide researchers and policy makers with timely data on racial and ethnic minorities."

The next section is the, "Overarching Recommendations. Based on its findings, the Subcommittee recommends the following actions to improve and augment the current data available for measuring, tracking and ultimately eliminating health disparities for racial and ethnic minority populations."

"1. DHHS should assume a more aggressive leadership role with other Departments, the Census Bureau, and private and academic organizations to undertake methodological research associated with race/ethnicity and socioeconomic position measurements in surveys, research, and census data, in order to improve the health and health care data collected on racial and ethnic minority populations and subpopulations."

Let me just make a comment, because here is we what have done in our recommendations is to map them onto the National Research Council report, which you have in your booklet. So, if you want to see the specific one, you can turn to I think it's Tab 3. You can actually see what it is. I won't read of this. But again, we thought that this was kind of a wise thing to do.

So, it says, "This recommendation is consistent with the National Research Council Panel on DHHS Collection of Race and Ethnicity Data, Recommendation 4-10 and 6-2."

MR. BLAIR: With the fact that people are now required to report -- or not required to report, but now have the option to report multiple ethnicities or races, my thought on that was that it's both an advantage and a disadvantage in order for us to gather this kind of data.

It means, I would think, that we have to have a much larger sample size. We'll need greater funding to be able to get at the information, because it's going to be divided into smaller and smaller segments. Once we get the appropriate funding to get the large sample size, then the multiple ethnicities provide degrees of shading for us, which also could yield interesting information.

Is what I've said correct? Is that what was in your thinking? Or when you were saying there are difficulties that we have to deal with, are there other difficulties as well?

DR. MAYS: Some of the difficulties that exist is that you are right, in terms of the sample size. Currently what would happen is that a person might for example, give the multiple race, and then you start to do the tabulation, it's so small, that what you are confronted with is how do I use the information?

Some data sets actually ask a person, for example, what do you consider as your primary race? Some data sets do not, and actually in terms of the OMB guidance, that's not something that --

MR. BLAIR: So, it's not being done consistently?

DR. MAYS: The guidance is such that you don't usually ask the question of primary race, because what you take at face value is that if a person has given you more than one race, that they perceive that that's important to them. And then for you as the data collectors sometimes, to go back and then use it in a way in which you then collapse it down.

There are some issues about it, but what we are learning is that if we want to use the data to some extent, having the ability to ask a person that question about their primary race is important. So, some people have requested and received a waiver or variance in order to be able to do that.

These are a lot of the questions that are still on the table, because this is just coming out really Census 2000, even though you could do it before then, Census 2000 and some of the work that has been done by NHIS. So, this is a lot of the work that we need to do.

Also, we have to think about the issue of fluidity. There is data that will tell you that some people might in 2000, give you one set of indicators about their multiple races, and then in 2003, might give you a different set, and that may be a developmental phase, or it might be the context of the particular survey that they are participating in, and what they think you are using it for, and how important they think having a particular race might be. So, there are a lot of questions that are still kind of needing to be answered.

DR. STEINDEL: Vickie, I have a question about the phrase, "a more aggressive leadership role," and what that means.

DR. MAYS: Well, to some extent, within HHS there is the capacity to look at some of these issues. The extent to which there has been the time, staff, and resources to do it I think may be a bigger issue. So, I think when we are saying take a more aggressive role, I think what we are asking is that it assume a higher priority, it have the resources, the staffing, and it use structures that are actually in place to be able to do some of this.

DR. STEINDEL: I think if that's the case, I would change the phrasing a little bit to encompass that. Being from Brooklyn, and you negotiate with a baseball bat.

MR. SCANLON: Actually, you may want to say, Vickie, that HHS should just devote more resources. And some of these are complicated, because the HHS I don't think could just step out on SES and other things when I think OMB would be somewhat concerned. They have already expressed some concern about the Academy recommendations.

So, there has to be some collaborative effort. Ours is to help the human services side of this. So, you could say develop more resources and work with other departments.

DR. MAYS: Okay.

MR. LOCALIO: You mentioned that OMB has already expressed some reservations about the report that is not yet out?

MR. SCANLON: It's out. The report of the Academy is out in pre-publication.

MR. LOCALIO: I have read the pre-publication. But my question is how does one get the OMB reservations so that the subcommittee can deal with them?

MR. SCANLON: I think it's purely a matter that OMB is in charge of the race/ethnicity standard. So, any role that we play -- HHS can't revise the standard. It has to be done in that framework of an OMB standard. So, I think if you use words like collaborate with, or work with OMB and other agencies in doing this, I think that's the only thing. But HHS can't just alone go out and modify or propose changes to the race/ethnicity standard. It's a government-wide statistical standard.

MR. LOCALIO: But we don't have written comments from OMB critiquing the publication?

MR. SCANLON: No, and I don't think you will get any.

MR. LOCALIO: That's okay.

MR. SCANLON: It's a matter of the role. HHS is not the lead on economic measures, for example. That's generally Census and other things, income and things like that. So, I think it's more a matter of understanding roles and not looking like we are trying to move HHS ahead of the rest of the framework.

DR. MAYS: Let me just ask in that first one, just so that I'm clear, we'll deal with aggressive role, so we don't do the baseball bats. And in terms of when we say with other departments, should we also include OMB? Just up front put the name there so that we're clear, and then we'll add a comment also about resources. Jim, would that be a better way to do it?

MR. SCANLON: That would probably be the way it's done.

DR. MAYS: The second recommendation, "DHHS should implement a multiple strategy approach to data development on racial and ethnic minority populations and subpopulations in addition to dedicating appropriate financial and staffing resources. Approaches include:

a. improvements in vital statistics

b. oversampling in national surveys, where feasible

c. conducting follow-up and dual-frame type sampling approaches for special surveys, and

d. sponsoring targeted studies for data development on subpopulations when oversampling is not feasible or cost effective."

And again, we map onto Recommendation 4-2 and 4-3 from the NRC report.

MR. SCANLON: A friendly amendment? Again, this is kind of a circular sort of an approach. HHS has already stated almost five years ago that this was our strategy, and implements it as resources become available. There has been progress in virtually every one of these areas. And then the Academy said the same, and now we are saying the same thing.

So, I think we should acknowledge that this is the strategy we have articulated. Maybe we should say accelerate or continue to implement. But it's actually got a fair amount of continuity, and it is a strategy we have already stated we would follow. So, maybe something like that, accelerate.

DR. MAYS: I think maybe accelerate, because part of what we have done is we have drawn upon recommendations we have made earlier. And with some of these, I don't think agencies are against it, but their ability to be able to do it with speed is usually a resource issue.

Again, we didn't get heavily on resources here, but should we again maybe talk about accelerate and fund kind of within that context? Because this is like mom and apple pie in the sense that they are not against it, but it's hard for some of it to take place, because other things tend to have a higher priority, like doing a targeted survey. It's been on the books for some time, for example to talk about doing another community-like NHANES. But the resources then to do the community HANES is really what becomes the problem.

MR. SCANLON: Right. And actually, on every one of these points there have been plans and budget requests to do these. But they don't necessarily materialize, so without additional resources I don't think we're going to get much further along. But I think accelerate its strategy would be fine.

MS. GREENBERG: Could I just ask for clarification on this improvement in vital statistics? Is it specifically talking about improvements in the racial and ethnic information collected on vital statistics?

DR. MAYS: Yes. We have for example, training needs. One of the things that happens in terms of death certificates is their rate of misclassification for particular groups, and it's often the smaller groups like American Indians. Some of that would benefit from -- and this is what's talked about in the report -- for example, training the individuals who actually develop the death certificates. So, there are a lot of little things in there that go into it.

DR. LUMPKIN: That raises the question of how do you use the OMB guidelines on death certificates, because it's a self-classification.

DR. MAYS: Yes, self-report.

DR. ROBBINS: On the vital statistics, and I may be stepping out of my element here, but what I have learned listening the NCHS is that they are collected at the state level. And that NCHS does have an effort underway to try to standardize, but whatever will be done is going to have to be -- it's a state-by-state collection. And so, we just need to recognize that.

DR. LUMPKIN: But there are a couple of pieces to that. One is that usually there is a collaborative approach between the states and NCHS. And the second is NCHS does purchase the data from the states as long as its in a standardized format, although they are not quite funded to purchase a whole year's worth of data. That's a separate issue.

But there is a collaborative way in which the standards in which how the data is collected, and the fields that are collected are fairly uniform across the states. It's not a mandate, it's a negotiated process.

DR. MAYS: And I don't want to take a lot of time, because I'm almost beginning to use my researcher hat here, but there are also other issues in terms of the specific collection of the data on race and ethnicity in birth certificates. And then what is available in data sets, and that gets a little complicated, but whether or not you have the race and ethnicity of both parents, what's available in the data sets to be able to be used. And then the report will go into more detail on that. So, there are is a variety of actual methodological issues that surround vital statistics.

DR. LUMPKIN: Should we move on?

DR. MAYS: Yes, three. "DHHS is urged to develop consistent strategies and mechanisms for the dissemination of data on racial and ethnic minorities, including data on socioeconomic position, that result from Department data collection efforts, when targeted to specific racial and ethnic minority populations." And this is mapped onto Recommendation 4-9 and 4-10.

Can I just ask, Jim, just so that I make sure I understand, when we recommendation the collection of socioeconomic position data, and say DHHS should do that, is that a problem?

MR. SCANLON: No, not collecting the data, but developing standards for such, general standards would be problematic. Not collecting the data, the measures themselves.

DR. MAYS: Next section is called, "Specific Strategies. The following areas represent strategies aimed at increasing the quality and quantity of data on racial and ethnic populations and subgroups and should be regarded as top priorities by the Secretary of Health and Human Services:

1. Improve coordination of racial and ethnic group data collection and use through partnership development among entities responsible for data collection and issuance of consistent data requirements."

And it's mapped on Recommendation 4-6 and 5-2 of the National Research Council.

Should I stop there?

DR. LUMPKIN: Anything on that?

DR. MAYS: Two, "In consultation with the Office of Management and Budget, provide guidance on the following critical technical and methodological areas:

a. Methodology for bridging old and new data

b. Treatment of primary and multiple race"

And that is mapped onto 4-9.

Three, "Strengthen the capacities of the health statistics enterprise through improvements in access to Departmental data on racial and ethnic minority subpopulations and in the dissemination and research findings on racial and ethnic minority groups."

We also went through the report of the National Research Council, and we could map this onto 5-2, so it will be consistent.

Four, "Provide guidance on critical technical and methodological issues, including:

a. Criteria for racial and ethnic subgroup data collection

b. Use of Census denominators for rate calculation

c. Oversampling in national surveys and alternatives to oversampling

d. Follow-up and dual-frame-type sampling approaches for special targeted surveys

e. Improvements in the collection of racial and ethnic data and vital statistics

f. Determining the cultural validity of data collection tools."

And I think F would be kind of what Jeff's comments about some of the sensitivities. So, I think that we may kind of look at that a little bit to include Jeff's comments.

MS. HANDRICH: Vickie, I have a question. Would the term "socioeconomic position" include a person's religion or spiritual orientation?

DR. MAYS: No.

DR. LUMPKIN: But that would be another demographic characteristic that would be collected separately.

MS. HANDRICH: Right. Are you confident that the way this is worded is broad enough to encompass factors that people might identify as being important that are either health data or socioeconomic position? Is that broad enough to capture that entire not just religion, but the entire arena of surrounding important information? It's just a question. I don't know how people perceive that.

DR. LUMPKIN: There are other measures of connectiveness. When you do an asset of what an individual's support structure, those would not fall into socioeconomic position, but socioeconomic position taken along with these other factors will give you a better idea of identifying risks.

MS. HANDRICH: Really, my question is whether or not the way this is worded, would clearly include those areas of investigation? I don't know with the way it is worded.

DR. MAYS: Here is what I would say -- the feedback is good -- we allude to the importance of things like this in the report. But because most of this is specifically health data, we didn't put it in the recommendation.

But we talk about contextual data. We talk about for example, geocoding. And that is where I think this becomes important. So, it really is the health data needs. I don't know if you can mandate in the collect of the health data that these things are there, unless you can see them as being very specific to whatever the particular outcome is for the particular survey, say like the National Survey of Family Growth, where you are going to ask more family contextual kinds of questions.

But in terms of what is important about health outcomes and access to care is the ability to be able to link this data to other data sets. And the ability to be able to geocode the data. And that's what we do call for. So, I think we are trying to be careful about trying to make a health survey have everything and go beyond what the normal I think range of information is, but instead to call for linkages and geocoding, which is in the report.

MS. BRICKFORD: Carol Brickford, American Nurses Association.

I have two questions. The first one is in reference to the term geographically, which is used on page number three, and describing racial/ethnic groups being geographically distinct. Is geographically correct? It would seem to me that that would be the delimiter for determining these groups, when in reality they are not geography, they are entities.

I'm reacting to the word "geographically" as being the determinor for these groups. And I don't know that's the case, because the American Indians are not in one geographic location. If geographically has a connotation from the population health perspective, it could be misinterpreted.

DR. MAYS: Geographically distinct can be correct. It might not be in all cases, but it can be correct, because what happens is that if for example, and I'm going to take the American Indian as an example, it's that American Indians as a group almost don't make sense, because the distinctions that exist, which quite often may be geographic, are like night and day.

So, what we want to make sure in the recommendation is that you not think that if you assess the population of American Indians, or even certain Pacific Islanders, that if for example you said Hawaiians, and you took the Hawaiians on the mainland, and then you took the Hawaiians elsewhere, you might find that the geography becomes very important in terms of the need to survey both groups, as opposed to feeling that if you have just a few, that they are representative. So, there are times at which geographically is appropriate, I think.

MS. BRICKFORD: That description doesn't come across in the sentence.

DR. MAYS: Again, this is kind of the summary, but maybe we need to -- let us work on that. I think an example may be better.

DR. LUMPKIN: But I think when you look at the application of the concept of ethnicity, which is an enhancement of where we used to be use black, white, and others, that the unifying concept of ethnicity is a common culture, which generally derives from a common geographical origin of that culture, even though the population which we are looking at once they come to this country, or even before the leave their country of origin, may no longer have those same distinct geographic roots. But the culture does have some distinctive geographic origin.

MS. BRICKFORD: And the second issue is in relation to the title of this report, because as I first began reading it in the abstract, I'm looking for those with disabilities, and they are not reflected. And you are only focusing on race and ethnicity. So, if you identify that it's measuring and eliminating health disparities in relation to racial and ethnicity characteristics or something like that, that might be better understanding, because I'm looking for disabilities.

DR. MAYS: Point well taken. We'll address that. Thank you.

DR. WARREN: My question is also kind of one that is definitional. One page 3, line 74, you made the comment of race is often not well understood, and being mistaken for biologic rather than social construct. Which then to me means if it's not that, what is it? So, somewhere I think we need to have a definition of race and ethnicity. It could be in a footnote, something like that. Either define it or get rid of that line.

DR. MAYS: I may choose the latter. It may be better also to refer.

DR. LUMPKIN: I think that the way that sentence is written may also lead to the confusion. Stating it more positively, race itself is not well understood, as it is a sociological construct, and is frequently mistaken for being a biological one, or something to that effect.

DR. WARREN: I still would get rid of the frequently mistaken for biologic, then I think you are okay.

DR. LUMPKIN: I think in any description on this, there are those who believe that there is a biological basis for race. That is a commonly held understanding in this country. And certainly, the experience from the Human Genome Project shows that the genetic differentiation within a race is much greater than that between races. And that is something I think is important to state somewhere in the document.

DR. WARREN: Then maybe what needs to be added is something about what we mean by ethnicity. That may be helpful. It's just this thing if you make that statement, and then a reader is going to say, well, I only thought it was biologic. So, where does ethnicity come in?

MR. BLAIR: Can I echo that? The cultures among Native Americans could be extremely different to Navajo to Akama(?) to Cherokee to Arapaho to whatever. And I'm not sure that the geography necessarily picks that up. Is that a different ethnicity? Do we pick it up with ethnicity?

DR. MAYS: Yes.

DR. LUMPKIN: I have a couple of comments I would like to make about the documents. Somewhere, and this is just a sensitivity in this short recommendations and summary, and I could have missed it, what is not clear, and helps build the argument in reference to Jeff's earlier question is that for the purposes that we are talking about here, we are really talking about aggregated data.

And we need the specificity at the individual level in order to aggregate and then to disaggregate by race/ethnicity and group. And I think somewhere it needs to be stated that when this data is used or reviewed, it is not viewed at the individual record level.

DR. MAYS: It's population-based.

DR. LUMPKIN: Right. Second is that I think that somewhere in here we also need to have some references to our Report on Health Statistics for the 21st Century.

DR. MAYS: Okay, thank you, good point.

DR. LUMPKIN: The third point is -- and I'm not sure where this sort of fits, and maybe I'm wrong on the title, but the AHRQ report that we refer to on page 2, the recent National Health Disparities Report, is that health disparities or health care disparities?

DR. FITZMAURICE: Health care.

DR. LUMPKIN: And I think we just have to be careful, because there is a difference between health disparities and health care disparities.

DR. MAYS: Exactly. And we tried throughout to make sure. Susan Canard is very good on trying to make sure of that, because she had been on the quality one, of making sure we made that distinction.

We just want to acknowledge the yeoman's work that you did in terms of helping us get this report in shape. So, I just want to acknowledge your role in that.

MR. SCANLON: Two things, Vickie. All of our recommendations I hope are dealing with both health and health care, right? We're not just dealing with health status.

DR. MAYS: No, it should be both. And if we haven't been clear, we were actually trying. So, we'll go through again and make sure that we do that.

MR. SCANLON: And secondly, the only thing I don't see here is any recommendations for the private sector.

DR. MAYS: Well, we talk about joining in partnership.

MR. SCANLON: That's where you get the data.

MS. GREENBERG: Private and academic organizations.

DR. MAYS: Yes, there are a couple of areas earlier. I think in one, when we talk about partnership -- if you've got some names you want us to call, but on the very first one we talk about private and academic organizations to undertake --

MS. GREENBERG: Well, that's the research.

DR. MAYS: I don't know where else. We will discuss this and figure out if there is some place else to highlight.

MR. SCANLON: The Academy report actually -- there are not very many, but it includes a couple of recommendations. And that was really one of the focuses of that report, to see how to improve the collection and availability of race/ethnicity data in the non-public world, because that's where everyone relies for most of the health care administrative data anyway.

DR. CARR: Vickie, I wanted to go back to the line where it is mentioned that race is often mistaken for a biological construct. I'm not sure it's in here, but have you mentioned that race is self-identified in here? I think that that's an important concept to keep in, that especially if you are talking about multiple races, that if one were treating it as a biological concept, they might say that the people were certain races. It's really very much up them to report what they are.

DR. MAYS: Okay, so, we'll find a couple of places where we can talk about health reported race.

DR. CARR: I apologize if my question is naive, but it seems to me as I envision this, we are looking at getting a greater level of detail on the non-white population. But as we do that, are we getting that level of detail on the white population?

I'm learning, as I'm listening to this, but if you're a Native American living in Window Rock, Arizona or North Dakota or Plymouth, Massachusetts, you are different. But if you're a white person living in New York or living in Texas, you're different too. Are we applying the same granularity across the entire population, so that when we go to roll it up, we will have comparisons?

DR. LUMPKIN: I was going to actually respond to that in two ways. One is generally, when you do data collection, and you pick a sample, you are going to get a large enough sample of the white population. But the corollary to that, that there are certain subgroup populations, predominantly immigrant populations -- those who are Russian, other Europe extractions -- who form a subculture within the white culture that probably bear having some assessment of their health status, particularly since many cities in areas of the country have a large population of immigrants.

DR. MAYS: The ways in which the questions are asked, it does allow -- it's not that we have a set of questions in which we branch off. But the focus has been in terms of insuring that we will collect data in these smaller groups. And it's like John's point, having grown up in Chicago, there are numerous ethnic enclaves there. And your capacity to be able to comment on that is not in any restricted.

But what we are trying to do here is to say that when we do a national sample, usually what happens is that the numbers are so small, that we are then not able to say anything specific about a particular group. So, it would apply somewhat in terms of again, a national sample in terms of some of the white populations.

Usually, the kind of thing you are talking about, the states will really push for it to happen. Illinois is -- I don't want to just seem like we are biased here, John -- but Illinois is a good example, as is Massachusetts and some other places, where I think they have paid a lot of attention to the culture, race, and ethnicity of a lot of the subpopulations.

DR. LUMPKIN: Seeing as how I live in New Jersey now, it's fine to refer to Illinois.

MR. HUNGATE: A follow-up on that just completed, not quite completed to my satisfaction discussion. It seems to me that part of this is the shift from socioeconomic status, to socioeconomic position also. That's a broader question than the race and ethnicity. And this is kind of the same thing, what is the granularity, and how is that expressed here as going beyond just race and ethnicity. Because that distinction is, it seems to me, a significant one in the way you have described it.

DR. LUMPKIN: Well, and I think that that's the importance of the recommendations about socioeconomic position, because within the majority white population the stratification of socioeconomic position becomes very important. And being able to have granular cuts based upon that means that you need to collect this data in ways that we haven't done before.

MR. HOUSTON: Does that also mean that maybe the title, as per her comment, needs to also indicate socioeconomic?

DR. MAYS: I'm fine with that.

DR. LUMPKIN: I'm fine with that too.

DR. MAYS: I'd love to move it well, so we'll accept it.

DR. LUMPKIN: Well, it would add in addition to race, ethnic, and socioeconomic position, disparities.

MR. REYNOLDS: This has been very helpful to me, not being formally trained in any of this discuss, either as a doctor or as a population expert, but sitting here trying to think as a common person. So, you wouldn't necessarily say I am, but as the common man sitting here at the moment.

And as we think of some of the things that are coming out of the quality committee and may spill over into the standards committee, and just taking a simple example like on lines 81, 82, and 83, where you have five categories, and if you are Hispanic, what do you actually pick as race, just to be very simple.

And start talking about trying to take this entire discussion today, with very knowledgeable people talking about very knowledgeable things, and try to turn it into operational recommendations for the real world, where there are discussions about putting it on every claim, or putting it on this or putting it on that.

I think maybe this recommendations may not go far enough to say the current way that we think about ourselves is broken. The current way that we capture the data is broken. You almost have to have face-to-face interaction with the person to be able to answer this set of questions that I hear going around the table, when you really start zeroing down in on it.

And so, that's just a comment. I would not vote negative or positive about what the committee has done, because you spent a lot of time on it. But I just think as we make recommendations, and then we decide that we are going to actually use them and turn them in to where the real person sitting across the real desk in the real hospital or the real doctor's office or the real other thing has to deal with it, maybe we need to say things a little stronger in some of these recommendations. And maybe this afternoon's discussion may help me, but right now I'm a little left in the open about that.

MS. HANDRICH: My comment has to do with the abstract. Perhaps the abstract should be more specific, that what this is doing is making recommendations to DHHS. And a statement is made in the summary, the ultimate goal is insuring that the department can play its key role in helping to eliminate health disparities within the population.

I think that's a great statement, and perhaps ought to be really hit hard. Recommendations to the department, to assist it in achieving its mission of helping to -- because that's really what this is supposed to be able, is improving outcomes.

MS. GREENBERG: Following-up on what Harry said, this report, although it talks about health and health care data, is primarily focused on population-based data, as opposed to administrative data. Am I correct? These recommendations seem to be, although I do think when you mentioned the Quality Work Group, this does increase the need for this cross-cutting approach in the committee, which we have tried to foster, but with somewhat limited success, because of all the demands.

But certainly, the interaction between the Standards Subcommittee and the Population Subcommittee, because there are certain things you can do in surveys and in population-based data that you really can't do, or that are much harder to do in administrative data.

And that's where vital statistics is kind of bridge there, because vital statistics is used for so many population-based purposes, but is administrative data first and foremost. It's the funeral directors who actually collect the demographics, hardly survey statisticians.

So, I'm just reacting to what you are saying. I think these recommendations relate less -- they don't seem to relate that much to specifically like what should be on the claim. But are there some recommendations on that in the full report?

DR. MAYS: In this particular report, and again, I think it says that, is that we have tried to start at the level of talking about population-based data, which we will discuss this afternoon in our breakout group, plans in terms of other ways to address some of those.

I do think the point though that is being made about this being a little bit more blunt, a little bit more hard hitting, and setting the context for those things I think is important. I think we started there as being more hard hitting. I'm more than willing to go back there.

But in terms of specifics about administrative data, we did have a recommendation that went forth in the quality report. We have in terms of the strategies. Some of these issues are also buried in our strategy section. So, we do have some comments in our strategy section of well, how then would I do this? But we are trying to stay at the level of population health at this point, which is survey data we're talking about, more than administrative data.

DR. LUMPKIN: Let me just sort of toss one other thing in. There was a survey that was released, done jointly by the Robert Wood Johnson Foundation, and America's health insurance plans, that was released at the beginning of this month where half of the surveyed plans are now in the process of collecting race and ethnicity data as part of their quality improvement initiatives in a broader-based sense.

So, the line between this kind of data and administrative data is beginning to blur as health plans are operationalizing the recognition that disparities exist. They need to address them.

MR. HUNGATE: My problem was a semantic one of the distinction between population data and administrative data, because I don't understand the distinction. I understand the distinction between survey data and administrative data as being different.

MS. GREENBERG: Well, maybe that was the distinction I was trying to make.

MR. HUNGATE: But I think our language is important, because I think administrative data does define some populations. But there may be a benefit here to drawing that into this report, and dealing with the issues that were left unresolved in a sense, in the candidate recommendations from the Quality Work Group. And I think it might be helpful to try to at least deal with that in the context of this report, rather than someplace else.

DR. COHN: You know, it's interesting, because I was going to speak exactly against that. I think it's really a question of whether we are passing this summary today, or we are going to spend the next year working on this summary, and working on the report.

I saw this summary. I think it's actually well thought out, and I think it's actually very good. But I also would speak against the body of the text deviating from what's in the summary. And if you want to do future work, which I think is expected, based on what the Quality Work Group came out as recommendations, that is yet another report.

And I guess my only concern is as I'm listening to this conversation is that we may pass a summary, and have the body of the report either go beyond what is in the summary, or somehow add additional things that the committee doesn't agree with, or hasn't agreed to.

I guess what is the position of the Populations Subcommittee on all of this? Is this what this report is, and we can pass this, and you will work on another report? Or is this going to continue to expand beyond this summary?

DR. MAYS: You have an outline also that you have been given. It has a different name, because as you can tell, we have been playing around with titles and abstracts and stuff like that. But it says race and ethnicity data, issues in the measurement. It has a 5-21-04 up that the top.

That tells you the context of the report that we intend to write. Some of the guidance though in writing that report is what we wanted to also hear today. So, the summary that we have brought forth really is going to expand on the points in the outline that you are given, which would be the full report.

Simon, unless I missed something, the things that have been talked about are actually more enhancements. I didn't see that there have been recommendations where they are very different. Like for example, even the one that was brought up now, I think the issue is, and I appreciate this notion of thinking about our language, and I'm probably being a little too sloppy, so let me start by taking that to heart.

And that is when we are talking about population health, there are lots of places that we get information on that tell us about the population's health, as opposed to being from a statistical point of view, where you are talking about drawing a sample, that is a random sample, or some very specific sampling frame that gives you information about a population's health.

So, administrative data, I thought John's example was a very good one. Administrative data can provide you with the opportunity to learn about the population's health. And I think the ways in which we are really getting at that are specific to this committee, that's important for us to remember is that the health plans have stepped up to the plate, and are starting to do that.

We should go back to the presentation at the last meeting that we had, where WellPoint, Carl Volpe presented on behalf of WellPoint. Another good example of how we are moving in the directive of administrative data providing us with more insight into a population's health. So, I don't think we are deviating.

DR. COHN: I guess I said -- and I'll close my mouth after this -- but it's obviously a little awkward to vote on a summary before you have seen the report. So, I just want to make sure that this all sort of connects up at the end day. We don't just go through whole chapters or major sections, and oh, yes, we're now supposed to be passing, that somehow are different than what we are discussing in the summary today.

DR. LUMPKIN: What I would think the process would be is that if we agree upon this, this gives guidance to the committee. And then we will get the full report back, and then at that point we can decide, has it actually changed since we voted on the summary.

But as you know, we have a tendency as a committee sometimes to see a report. We focus in on the text of it, and then we fix the text. And then the next time we come back at it, then we have problems with the recommendations. So, it's an attempt to try to do this a little bit differently in the process.

MS. GREENBERG: Well, the idea I think -- it's my understanding that the subcommittee would like this approved for transmittal to the department.

DR. MAYS: Yes. And see, that was the issue that we raised, was whether or not if it's a summary, if it's problematic because it's being called a summary, we'll call it something else. We do intend, because we have given you the outline, to go back to this. But to some extent, the issue really becomes if that is a stumbling block, then let us call it something else.

But I don't think there is major deviation. As they say, the devil is in the detail. I think like today you get a sense of the explaining of it. But maybe I'm missing where we are going here.

DR. LUMPKIN: I think given that we can sort of let the committee work on exactly the language of how to describe this. Because what we are really asking people to do is vote on this. And the report will be a separate communication that will in some ways support this, and it's sort of informational.

DR. MAYS: And enhancing.

DR. LUMPKIN: And enhancing, but this will be what will be the official recommendations.

DR. CARR: Again, I apologize if I'm not well schooled in all of this. But one question that comes up is are we changing data definitions from as the health group or whatever are collecting race and ethnicity data, are they using the same definitions that you are putting forth, or are there two definitions, one for populations and other?

DR. MAYS: No, we are not changing the definitions at all.

DR. CARR: Because I thought that's what I heard Harry saying, that the nuance of this in terms of how you identify your race or all of that is -- even just going back to biologic versus what you see as your race. I don't know if everybody does it that way. As we are collecting data on administrative databases, I don't know that everybody collects it the same way. They probably don't.

I'm just wondering if this is now setting forth, this is the new definition. Did we all know this, whether for quality data or administrative data or population data?

DR. MAYS: The recommendations about the actual collection are based on the OMB guidance. So, for data that is collected by the federal government, and to some extent data that is given to the federal government -- somebody else can collect it, but when the federal government accepts it, this is kind of the context in which they want it.

And that's what we are saying is that there is something new, and it is a lot of challenges that have arisen as a function of that. The guidance was issued in 1997, but where it was driven home is when the Census 2000 was collected. And now you have a huge amount of data that is fitting into these two questions, which is one on ethnicity and another on race.

And even that in and of itself, what we presented is what we call kind of the minimum that is necessary. You go to some states, and it's like there may be as many as 128 categories that end up by the time you do maximum of all the subgroups, et cetera.

So, what we are proposing is not new. What we are bringing to light is the fact that this guidance exists. Census stepped out, and they did it. And that what we really need from the department is more discussion about it, so that everybody is kind of on the same page, and understands a lot of the complexities of the decisions that are being made when you use the guidance that has been issued.

MR. BLAIR: Let me see if I can ask this question quickly, because I think I'm going to be instructed that I should be in the Population Subcommittee, instead of getting into these details.

Vickie, how do we deal with the fact that now we are in a world where we have to have race self-defined, and it could be multiple races that we identify ourselves with, and yet if we are going to try to understand discrimination, and discrimination probably isn't overt as much as it is subtle, and the individual that is discriminating may not even be aware of the fact that they are discriminating.

But they are going to discriminate based on perception. And the perception may not be the same as the individual who has self-defined what races they are. Is there a way to re-establish those connections or mappings or something?

DR. MAYS: Some recommendations have -- this is a little bit where we are in terms of this report, and I'll even share with you some things from the hearing, and then in terms of other places, and that is the race that a person self-identifies as, in order for us to understand some of the discrimination in health care, people have said that it's important to also ask the providers or the institution or context what they perceive the individual to be that they are working with.

MR. BLAIR: We will capture both then.

DR. MAYS: Well, now we are getting beyond this.

MR. BLAIR: I'm sorry, is this too detailed?

DR. MAYS: No, it's not too detailed. But what I'm saying is that the recommendation really deals with capturing the person, and at the level of providers, institutions, contexts, and others. There are recommendations that are made in many reports about doing that. That's not what is in the forefront here, though we did hear discussions about that in the hearing.

And I have a feeling, John, that I think we're going to talk about removing this word "summary" from this, because I think that there are some of these discussions that we want to make sure that we capture, because they did come up, and it is important.

We think that in terms of access to health care, sort of the health care outcomes, that it does involve exactly what you are talking about. And that it's just not enough to know what race the person is, but that the person treating them perceives them to be, because some of the judgments that are made about level of intensity, type of treatment, et cetera, might be a function of that perception.

MR. BLAIR: Well, then let me jump to the impression that I have on this, and it may be similar to Harry's. I think in order for us to get some real value, not only will the sample size need to be very large, but that we probably ought to do this in a way where it is going on over time, because it may be expensive.

And if it's going to be expensive, then if we could either reuse the data, track it over time, and that will not only provide additional value chronologically over time, but it may be hard for us to go back a second time, I guess is what I'm saying. So, if this becomes an ongoing activity, that is one piece.

The other piece is that I think we really have to look for exactly what we want to measure, because I think that the real value of what we are doing is we want to get at the subtle discriminations that we are not generally aware of are happening. And this is the only way to do it.

I'm just a little bit concerned that we are trying to deal with the reality of the limitations of Office of Management and Budget as they put forward. But if we do adhere too much to those constraints, the value of the survey will be very limited, and it will be very difficult to go back and really get it done right for many, many years.

DR. LUMPKIN: And I think that that's fairly close to a good summary statement, because the challenge that we have in this arena is that not all the data is used in exactly the same way. So, if we are looking at health care disparities, then the data is going to be very granular, because the people who are engaged in quality improvement need to understand what is going on within their systems. And that will be dependent based upon health plan or type of service.

But if we are trying to look at other aspects of disparities, then you are going to aggregate the data or collect the data in different fashions. Part of that is by having a huge sample size. The other part is by oversampling the groups that you want to have represented. And it depends again, on what the purpose is. Sometimes just the five categories are fine.

If you are looking at issues related to the uninsured, the five categories aren't adequate. If you look at the Asian population, the insurance rate for Asians is the same as the white population, but the ones for Japanese are much lower, and the ones for Koreans, the rate of uninsurance is much, much higher.

So, again, it depends on what issues you want to do. And what we are trying to do is provide some guidance to the department, talking about the different aspects, recognizing that we are not going to be able to recommend the perfect system, but some directions for them to go as they move forward in trying to address the issue of disparities in health and health care.

DR. MAYS: I agree, but Jeff is welcome to populations.

DR. LUMPKIN: Okay, so the team will work on that, bring it back. And at this point we are going to adjourn for lunch. The National Research Council Committee on Health Statistics will be presenting the results of their wonderful report, insightful report, overwhelmingly insight report.

Anyway, we'll be back at 1:15 pm.

[Whereupon, the meeting was recessed for lunch at 12:30 pm, to reconvene at 1:15 pm.]

A F T E R N O O N S E S S I O N (1:25 pm)

DR. LUMPKIN: We are very fortunate this afternoon, as follow-up to our discussion, to have one of the earlier presentations of a completed, but not yet published report from the Committee on National Statistics. And it's soon to be published, as opposed to one committee I was on where the report came out a year after the committee released its results. But that gave us an opportunity to re-release it. The Committee on National Statistics of the National Research Council.

This was commissioned by the Department of Health and Human Services. We have Shelly, who is the leader of the group, study director, they claim not to be the leaders. And Denise Love and Carl Volpe, who were members of the committee. It was perhaps one of the more stellar committees that CNSTAT has had together. I guess I should have raised that as a conflict earlier.

So, Carl or you first, or is Shelly?

DR. VOLPE: Shelly is starting. I'm driving.

Agenda Item: CNSTAT Report - DHHS Collection of Race and Ethnicity Data - Shelly Ver Ploeg, PhD, NAS

DR. VER PLOEG: Well, on behalf of the panel and the Committee on National Statistics, I would like to thank the committee for inviting here to give a brief presentation. As John said, we do have a pre-publication copy of the report. It was released in late April, and the National Academy Press currently has it. I just got the first page proof, so progress is being made. We should have it by the end of June, and we'll be happy to make copies available to anyone who wants it on the full committee.

I'm Shelly Ver Ploeg. I was the study director for the panel, and what we're going to cover is just going to go into some of the basics of why the panel was charged to do what it did, and what it did, and talk about some of the conclusions and recommendations. And hopefully, we'll leave some time for questions from any members of the audience and the committee.

The report is called, "Eliminating Health Disparities: Measurement and Data Needs." This report was a congressionally mandated from the Minority Health and Disparities Research and Education Act of 2000. It came through ASPE. Jim Scanlon was the contact there, and several agencies within DHHS -- I'm not going to try and name them, because I always forget them, but Jim can help me if I need to -- also sponsored this study.

The study began in late 2000, and the panel, which I'll talk about in a little bit, met several times. We had a workshop at the end of 2002 that looked specifically at state and private sector data collection issues. A workshop summary was issued from that. I just came from another meeting, otherwise I would have brought a copy of that also, but we can make copies available to you too.

And during the course of the panel's work we had several other folks come in and brief us. Actually, Vickie Mays came to brief us on behalf of the Population Subcommittee of this group. Bill Braithwait briefed us on HIPAA activities, and we had a couple of other presentations. And let me get started then with the slides.

The panel was charged with reviewing the collection of data on race and ethnicity in DHHS health and health care data systems, and more broadly in state and private sector health and health care data systems. The panel took the charge seriously. In fact, two of our panel members here were selected because they represent and know those data systems very well. John also knows the systems well.

In doing so, the panel was asked to identify the key data needs to evaluate the effects of socioeconomic status disparities also. The panel also added language and acculturation to that list, even though it wasn't specifically mandated in its charge.

It was to identify and assess critical gaps in health and health care data systems used to evaluate disparities, and to consider ways in which data gaps can be filled, and the panel had some recommendations for that.

The next slide shows the esteemed panel. Ed Perrin, who is a former director of the National Center for Health Statistics chaired the panel, and the rest of the panel members represented some academics, both economics, sociology, psychology, some folks from states. Alvin Onaka was also on the panel. He's at the Hawaii Department of Health, Denise, and John in his former role, and Carl actually was our main representative from the private sector on this topic. And you will see some other familiar names up there too, I'm sure.

Actually, I'm going to turn it over to Denise now, who is going to talk about some of the things that the panel considered.

Agenda Item: CNSTAT Report - DHHS Collection of Race and Ethnicity Data - Denise Love, NAHDO

MS. LOVE: Thank you.

It's a pleasure to be here. I'm Denise Love.

I wanted to first underscore that the panel made a distinction between health and health care. And that disparities in health, and disparities in health care, even though they are related, they are different concepts, and they should be measured differently. And so, the panel acknowledged that pretty early on.

Examples of disparities in health would be a condition, absence of good health, or patients having ill health. Disparities in health care, the actual treatment of an illness and injury. And that could be related to access to health care, or lack of information. So, that distinction was made.

We also did not get into I think the nuances of defining disparities, and get hung up on that. That would have taken us another year or so. So, we moved on and decided to focus instead on the data needed to measure the concepts of disparities.

The panel also recognized that disparities in health and health care are multidimensional, and as Shelly said, more than just and ethnicity variables are important to measure. And so, the panel focused on the collection of explanatory variables such as race, ethnicity, socioeconomic position or status -- we also debated SES versus SEP -- acculturation and language, rather than on specific outcomes variables.

The panel also recognizes and recognized that data systems and data structures, and the purposes for data systems, and why they exist vary tremendously, and thus, does the quality of the data, and the quality of race/ethnicity data if collected in those data systems. And so, I guess keeping in mind that when we get to the recommendations, that the targets for data collection in each of these systems can be tailored for what is possible or feasible in that system.

So, before we get to the recommendations, some of the questions considered by the panel as we prepared the report, was what the current DHHS data requirements and policies for the collection of race and ethnicity data are. And are these policies adequate and effectively implemented in the DHHS systems, and extended through the state systems, and also the private sector systems, which you will hear about later.

Other questions: what information relevant to disparities can be collected by the federal government, by state governments, and the private sector? And what are the barriers and possibilities for improving data sources and reasonable strategies?

So, the report is organized, and the rest of our presentation will follow this: the overall considerations and conclusions, DHHS data collection systems, some background, and a pretty extensive chapter on those; a chapter on state data collection systems; and then finally, a chapter on private sector data collection systems.

I'll turn it over to you, Carl.

Agenda Item: CNSTAT Report - DHHS Collection of Race and Ethnicity Data - Dr. Carl Volpe, WellPoint

DR. VOLPE: Thanks.

We have about five general conclusions that the committee drew from this. The first three are represented in this slide, and I would imagine are not a surprise to any of you that we need to obtain race and ethnicity data in all health care and health data systems.

There was a fair amount of discussion around socioeconomic position, around education, occupation, wealth, current income, and the relationship between that and measuring health and health status. So, we decided as a committee to make sure that that was included in our recommendations, and you will see that.

Also, issues of acculturation. Primarily we talked about language use, but we did expand our discussion beyond language use, and you will see some of that reflected actual in the final report.

The next two bullets I want to spend a little more time on, because they reflect the diversity of the panel. While we had a fair number of individuals on the panel who were statisticians, and were very comfortable with aggregate data, we had individuals such as myself and Denise and John in his position, where it was more than just aggregate data, but individual data turned out to be very important to us.

So, we expected that the committee would make recommendations about adding data, and collecting data by private sector, by state government. And the question is how much burden could we put on those entities? So, one of our conclusions was, and we used the word "return" and that is that we say that health and health care data collection systems should return information that is useful. But what we are actually saying is that if an entity is collecting the data, we hope that they will be able to use it as well.

And finally, we thought as a committee, and we looked at the data, that linkages weren't there. Lots of data are being collected. We have a hard time linking data, especially Census data in particular. And so, our overall conclusion is we've got to figure out, and we need to make some recommendations around linkages. So, those are our general conclusions.

DR. VER PLOEG: The next part of the presentation talks about our recommendations for federal data systems. And I should say that we made the distinction between federal, state, and private sector data systems even though there is quite a bit of overlap in that.

For example, vital and health statistics are collected by funeral home directors. They are in the health care system. They are aggregated up to states, and the states then bring them up to NCHS. So, our distinction is not perfect, but it was just a way of organizing the report. So, please keep that in mind.

And I have a number of slides here on DHHS data collection systems. I'll talk about some of them briefly. I'm not sure of it will interest this group, but please feel free to ask questions if I'm moving too quickly.

Our first one was as Denise said, the panel considered what are the current policies DHHS has for collection of race and ethnicity data. And the panel understood that the DHHS has this inclusion policy, which I don't have the full name of it up on a slide. But basically, it says that DHHS should in its programs and support where feasible, collect race and ethnicity data. And the panel agreed with that, and re-emphasized it in a recommendation of the report.

This is an important thing for DHHS to be studying. As part of its data collection systems, race and ethnicity should be collected where possible. So, one of the recommendations is just to re-emphasize what was on record at DHHS. The panel also added to that measures of socioeconomic position where feasible, and measures of acculturation and language.

In 1999, the DHHS Data Council, which had a Working Group on Race and Ethnicity Data Collection, released a very important report on the collection of race and ethnicity data. And in this report they outlined a number of recommendations -- many, many recommendations -- about ways and detail that they could feasibly implement some better race and ethnicity data collection apparatus.

The panel reviewed the report, and found four themes to be very important from that report. One was developing feasible approaches for including racial and ethnic groups in national surveys. Most of the national surveys can adequately sample enough African Americans. Hispanics as a broad group is also possible. But when you get to the smaller subgroups, you really have a hard time with the national surveys.

And one of the recommendations of that report was to have a periodic, rotating basis -- maybe how it was determined would be a little, it was not fleshed out -- but somehow have an apparatus where you could periodically oversample some of these more detailed subgroups. And the panel will pick up on that, and emphasize that recommendation as well.

Another important report that the panel picked up on the 1999 report was to improve the collection and analysis of socioeconomic status, and language and acculturation data; to insure the collection of race and ethnicity data in record-based systems, so administrative records; and then to develop mechanisms for linking records across data systems. So, the panel emphasized that those were important points from the DHHS Data Council working group.

And looking over this whole DHHS report, the panel decided that it would be very important to get an implementation plan in order where DHHS could measure how it is doing in implementing the recommendations of that report, and begin right away to implement some of those recommendations.

As I mentioned, one of the recommendations of that Data Council report was to develop a long range plan for national surveys to periodically conduct surveys of racial and ethnic subgroups. The panel found this to be actually a very important recommendation, and singled it out as something that DHHS should follow-up with as soon as possible.

The panel also looked at the data collection systems for the Medicare program, also the Medicaid program, but I think Denise will talk about that a little bit more. Myself and Mary Grace Kovar(?), who was working as a consultant, met with several folks from the Social Security Administration, which provides the basic data on people who are potentially eligible for Medicare, and with the Centers for Medicaid and Medicare Services folks to talk about their data collection practices. And there are actually a number of reports out there on the race and ethnicity data collection through the Medicare system.

As it currently stands, race and ethnicity data in the Medicare enrollment database is somewhat spotty. SSA used to collect these data, and CMS got the data from SSA. But in the old days it was black, white, and other. They have added Hispanic, but as of the late eighties I believe, even though it's collected on birth records, that information is not then reported to the Social Security Administration, because it is not essential for the program. So, for people born after the late eighties, there is no data on race and ethnicity available on those files.

CMS has actually done quite a bit to try to get more data. They did a postcard survey of current enrollees of people with Hispanic surnames to collect data on whether they were indeed Hispanic or not, and had some success, but some problems with that. CMS is reliant on the Social Security Administration for the other data. And the only time that you would get an update is if somebody changed their name and filled out a new form, or was a new enrollee later, or lost their card and reapplied.

So, the panel decided this is a very important source of data. Medicare is a time where people use the health care system. So, it would be a good source of data for understanding disparities, which it's already being used for. And that the race and ethnicity data should be better.

So, it made a recommendation that CMS should develop a program to collect racial and ethnic data, and socioeconomic status data if possible at the time of enrollment for a current enrollee, and for current enrollees in the Medicare program. The panel wasn't specific about how to do that. It did suggest some things like a brief survey, but did not get into specifics.

The panel also thought that it would be important to have socioeconomic position data. And one thing that is possible is that the Social Security Administration does have a summary file of wage data. It's not the specific wage data, but it's a summary file that has been used for research purposes, and CMS could seek that from SSA to get at least some basic data on socioeconomic position. And as I understand, there are some efforts between SSA and CMS to actually do that now. So, those are the two main recommendations on the Medicare program data.

Another important change in the landscape of how race and ethnicity data were collected was the 1997 OMB Guidelines for Collecting Race and Ethnicity Data. They have been implemented. The 2000 Census implemented them. But one thing that the panel found at the workshop was that there is still a lot of confusion about what those categories are, what's the minimum categories, and then how they can be aggregated up if you collect smaller subcategories.

So, the panel recommended that the department should provide more guidance on implementing these OMB standards for the collection of race and ethnicity data. Again, this is sort of a public awareness, especially with the data providers, and those who are actually collecting the data at both state and local levels about what those minimum categories are, what the minimum means, and then how you go beyond that if state and localities need to go beyond that.

And then one final recommendation at the federal level is that the panel emphasized the importance of race and ethnicity and socioeconomic position. And encouraged the DHHS to report in its various health and health care tabulations, differences in race and ethnicity, and classified by different levels of socioeconomic position.

At this point, Denise is going to talk a little bit more about some of the state-based recommendations.

MS. LOVE: Again, the panel recognized that to get better data on race and ethnicity, it's going to require a multi-sector and multi-level approach. And we recognize that states are the source of many of the federal program data and statistics. So, the states cannot or should not be left out of the conversation, nor were they. And the chapter describes the various state data systems, their characteristics, and what they do or do not collect.

Some state data systems are doing better than others. Vital records might be one where they are capturing in all states, race and ethnicity data versus discharge data systems, which it's a mixed bag. Some states are doing it very well, and many are not. And again, the structure of those data systems are different, and the funding is different. And so, that could explain some of the reasons for the variation.

But again, when states do collect race/ethnicity, the data quality do vary across states. And many states again, have missing or are not collecting race/ethnicity systematically. And again, use -- when collected, sometimes they aren't as effectively used.

So, that leads to the recommendations that the panel made that states should require at a minimum, the collection of data on race, ethnicity, socioeconomic position, and where feasible, acculturation and language use. And recognizing that in surveys, it's possible to have a broader scope of data collection, where in administrative data it may not.

But we know that states do and can collect it with the administrative data systems. So, to help those states that do not collect it, or collect it very well along, the panel recommended that DHHS should provide guidance and technical assistance to states for the collection and use of the data, race/ethnicity, SEP, acculturation, and language use.

One example might be the MCH Title V program where there are incentives for states to collect race/ethnicity with some of the MCH measures, and incentives are aligned also with the state agenda. And technical assistance is available, and states have responded well to that.

We know that some states have confusion about what the OMB standards are, so states that might have been collecting race/ethnicity for some time, may not have adopted the OMB standards, and there may be confusion about how to go about that, or even indeed what they are. This chapter also addresses some of the barriers, including costs and education.

DR. VOLPE: I would like to talk about the private sector, which was probably one of the more perplexing areas for the committee to look at. We actually commissioned some surveys, as well as heard testimony at our workshop. And I think we could sort of divide it into three categories.

Hospitals, we sensed that there was a fair amount of data on race and ethnicity collected. We were unclear about how standardized those information were, but information is being collected. Whether it's being passed on to other data sources is unclear.

Physicians and physician groups, we could gather no information on what physician and physician groups collect. Remember, the typical physician group has three practicing physicians. They are small. They don't have sophisticated data systems by any means. So, we didn't find very much at all on physicians.

And with respect to health plans, there was a range. I guess the initial study that was done found about 50 percent of the health plans were collecting some form of data during the period of panel's work. Aetna had announced their intent to start collecting race and ethnicity data. We saw a negative response to that initially, but now the response has been fairly positive.

Just as a comment, when one looks at Aetna, which really needs to be commended for their work, they are collecting information right now on less than I think 1 percent of their entire membership. So, they are doing it. They are working really hard at it, but I think like many health plans, they are struggling to collect the data.

The AAHP study that was released recently supported some testimony they provided to the panel about the differences in the data elements among the health plans, and how the health plans are using it. So, the committee came up with what might be one of their more controversial recommendations, which appears behind me, which is a recommendation that DHHS should require the private sector to collect this information.

That was supported in testimony at the workshop. It was commented on to the committee privately, the primary issue there being that health plans have been afraid, quite honestly, to start collecting the data, because of issues of discrimination and racism, which are real.

We spent a fair amount of time talking about that as a panel, and recognized the importance of safeguards associated with this if these kinds of data are going to be collected in the private sector. So, the committee did this make this recommendation to DHHS. I think the panel I should say, would not be uncomfortable if Congress heard this recommendation as well.

We commented about HIPAA as being a possible mechanism for doing some of this. We talked about JACHCO on the hospital side. But clearly, the panel felt pretty strongly that health plans in the private sector should be required to collect it.

The panel also recognized, I should say we recognized that we needed some leadership in this area. The health plans are fumbling their way, trying to understand their way in this area. And we thought the DHHS could provide leadership in developing standards for the collection of the data. And so, there is a full recommendation in that area as well. And that recommendation is not only for race and ethnicity, it includes socioeconomic position, as well as acculturation and language use.

This last recommendation -- I think it's the last one in this series -- really came out of the concern that it may take a while for health plans to start collecting this information, either for congressional action, DHHS action. And so the question is, was there another mechanism that could not get us there completely, but help get us there?

And we came up with a recommendation about geocoding, and linking information from health plans to Census data. The committee thought that there was a strong possibility we could do this while still protecting privacy rights, so there is a recommendation in that area as well.

Finally, I think the panel felt that more could be done to collect data in this area. But we felt very strongly that even minimal data collection would be very, very helpful. I think the additional contribution of this panel was the recommendation that this is above and beyond aggregate statistics. That there are other entities in the marketplace that could use the data, that could make use of data to help address issues of health and health status disparities.

Other comments from anyone else?

DR. VER PLOEG: I have one more comment I think. All of this costs money, collecting more data. And the panel was actually in the legislation, was asked to look at cost considerations, which is not something Academy panels do very often. We usually punt on that, because we don't really have the expertise, and we don't have time to get into it, and we don't want to do it. But I do recognize that it's a major issue.

Since the report has been released, my colleague and I, Connie Citro(?), who is now the director of the Committee on National Statistics, have been briefing various agencies. We briefed the HHS earlier. We also went up to the Hill with our congressional liaison, and briefed Senate staff.

Sen. Kennedy's staff organized it. I'm trying to remember who was there -- Bingamin's(?) member, Daschle's staff member, and one more that I'm forgetting was also there. And then we also briefed Frist's office, and then a gentleman from the -- I can't remember which committee he was from.

And we raised the issue of cost, and we said DHHS needs money to implement these. Of course they nodded their heads and were very polite to us. But I think they were very interested in the report, and that's on both sides of the Hill. Frist's office has been actually quite interested in this area, and had some interesting questions about data quality, about surveys. And there was some talk about whether socioeconomic position was more important rather than race.

And we actually talked a little bit about how people are maybe not for health insurance plans, but in other arenas, people are much more ready to give data on their race and ethnicity than they are about their income. That's a much harder thing to ask people about. So, that was an educational experience for some of the people on the Hill.

It was an interesting briefing, and they are aware of the reports, we'll be sending them copies when they are finally finished.

I don't know if there is anything John wants to add.

DR. LUMPKIN: Well done. It was an honor to have served with such a distinguished committee.

Questions? Steve?

DR. STEINDEL: This isn't really a question, this is a comment, and it may lead to discussion further. We heard a fascinating discussion this morning. We had a fascinating discussion this morning led by Vickie on our reports, and the concerns in the Population Subcommittee in this area, where they have done a tremendous amount of work for a number of years.

And we have heard the summary of this very important, and as John said, very good report in this area. And I'm looking at the audience, or lack of it. This is an area that is very, very important, and should be raising concern.

I can assure you that if the Standards and Security Subcommittee scheduled a hearing on how we were going to put race and ethnicity coding into HIPAA, that room would be packed. And I think we need to figure out ways to reverse that, or at least get the room packed at this point, so the people who we are going to be asking, as one of your recommendations possibly, understand the significance of this, and may be more attuned.

DR. LUMPKIN: Gene.

DR. LENGERICH: My question had to do with the second last slide, which has to do with geocoding. And I noticed there that you said the DHHS should establish a service that would do that. And I guess I would just like to explore a little bit the idea of DHHS establishing that service.

Private companies will do that. And so, I'm wondering if there was some sort of conscious decision about that happening, and about that kind of recommendation coming forward. And then the leading part after that is who analyzes those data that result from that kind of activity?

So, if you could tell me a little bit behind the thinking of that recommendation.

DR. VER PLOEG: Sure. Agencies within DHHS like NCHS have these data research centers, and they have already built up their firewalls for confidentiality, that what health insurance plans could do, they would have the data on their individuals, would be to send the addresses of the individuals to this centralized unit.

That centralized unit would find geocoded race and ethnicity data or income data that wouldn't be accessible to the outside public, and then match it with the addresses, de-identify it, and send it back to the health insurance plans or whoever, so they could do some analysis that way.

DR. VOLPE: Do you have a follow-up on that?

DR. LENGERICH: I guess there are trade offs in who has the ability to maintain the confidentiality of it. And I'm sure there are groups, individuals that would rather see it go to a private group, rather than to the federal government to do that.

DR. VOLPE: I don't think as a committee we really discussed that in any depth about whether it should be a private entity doing it, or whether DHHS would do it.

DR. VER PLOEG: The geocoded data would be Census-based data that I would assume private companies don't have at that level, although they might be the ones that are actually demasking it.

DR. VOLPE: There are some private companies out there right now that you can go to for geocoding. The sense was that the richness of the data were insufficient.

DR. LENGERICH: Well, I guess I'm fully supportive of this recommendation, and I think it is consistent with some of the testimony that we heard as a subcommittee, as well as kind of our thoughts too that this is a role for NCHS or Census or somebody to play, to facilitate the analysis of data at finer granularity than large geographic areas. And I think that is a strength here.

DR. LUMPKIN: Simon.

DR. COHN: I guess I should just comment that I think stealthful usage(?) should handle some of the issues around this with the geocoding occurring in that.

On another issue, I was actually curious about Recommendation 4-7, which I was sort of fascinated by, which is CMS developing a program to collect the data at the time of enrollment, and for current enrollees. I was first of all curious, at CMS is this an idea that they even embraced? And if so, what have their thoughts been about operation of it? How do you see operationalizing this?

DR. VER PLOEG: I haven't spoken to anyone from CMS since the report was released, but the initial conversation, they were strongly for it, and then raised their hands that we don't have funding for it. And they have done some surveys, like I said. They had mixed response rate, I believe, on that. So, I'm not sure if that's what they would want to do.

I don't know if there is anyone from CMS here in the room.

MR. BLAIR: There are 30 or 40 million beneficiaries.

DR. VER PLOEG: Right, so it would be a very expensive thing to do. But they do send out a postcard when you enroll, right? So, it could feasibly be done on that, although again, cost is a problem.

DR. COHN: Can I ask just one additional question, and then I'll stop. This is in some ways related, which is this linkage issue. And I actually want to congratulate the committee in terms of really putting that out as a key issue. I'm constantly impressed with the fact that the federal enterprise, at least to my view, seems to be awash in data. But they are as bad as the private sector is in terms of multiple different silos of data that doesn't seem to be joined.

I guess I was wondering from your perspective, just whether the linkages themselves would in and of itself solve some large percentage of this issue? And would that be the case? And if so, how much of this issue would be solved by just creating better linkages between all these systems?

DR. VOLPE: My comment is I don't see it as solving. I see it as mechanisms to link data sources that heretofore have not been linked, to ask additional questions. For example, with health plans, if we had a mechanism to link some of our administrative data, our claims data, we could begin to ask questions to support our health improvement programs for example, our disease management programs.

I don't see that as solving a problem. I see that as a mechanism to bring more richness to the data set for wanting to address issues of health and health service disparities.

MS. LOVE: From the state perspective there is quite of a bit of linkage going on to fill those data gaps. Some states are linking across data sets, where they might not have race/ethnicity with hospital discharge data, they may link with other data sets, and vital records being one for birth outcome studies to fill that gap.

With health plan data that could be done, if you collected it at enrollment, and had that data, you could look at health utilization without collecting it at every encounter, but that doesn't solve the problems for hospital discharge data systems outside of a health plan. So, the answer to that is yes, linkage will help some of the problem, but it won't help systematically across the system.

DR. LUMPKIN: Although one of the more important linkages is with the Social Security Administration, because as we discussed earlier, we kind of discussed the transition from socioeconomic status to socioeconomic position. That the historical data that is available -- because I just got recently a mailing from the SSA about my retirement benefits. And they listed my total income for my work experience, and it was kind of depressing.

DR. HARDING: Just comfort me a little bit here. I'm one of the directors of a university special clinic that is all the different specialties in a university, and there are about eight or ten clinics. The front line would collect this data, right?

MS. LOVE: And they often are. In many cases, the front line is collecting it.

DR. HARDING: Yes. And then the collection is supposed to lead to benefits for the front lines somehow. That's part of the selling point?

MS. LOVE: That's one of the barriers.

DR. HARDING: The front line will get feedback is what you said I think, about the data that is collected?

DR. VOLPE: I think that is a possible mechanism, yes.

DR. HARDING: So, what I'm trying to think of is how I'm going to tell my people this. There are probably I would say 15 questions that would have to come up to look at race/ethnic, SEP, acculturation, probably 15 or 20 questions.

DR. VOLPE: I couldn't sell 15 in my company.

MS. LOVE: No, we need a distinction between survey and administrative data collection. And at the minimum, I think the panel felt strongly that race/ethnicity at the front line, is being captured, but not very systematically or uniformly. But to collect all of those data elements at every encounter, it would be nice, wouldn't it? But it probably is not realistic.

DR. LUMPKIN: But I think in addition to race and ethnicity, primary language is an important one. There are class standards, culturally, linguistically appropriate services, requirements on institutions. You can't measure compliance without collecting primary language. So, I think those areas are associated with various performance measurements that an institution ought to be following anyway.

DR. HARDING: I'm not trying to be negative, but in primary care and in physician's offices right now they are right up to here with this kind of stuff. And to put this, and tack it on as a requirement, again, it's unfunded, and it's going to cost $10 a time to do it at least, maybe $20 a time, boy, you better have a good reason why you are doing it.

And it's got to have something that is going to be helpful to the individual clinic that is giving you this information, and not theoretically that this is going to help the big cause. Because right now, people don't have any reserve to give the big causes. It has to be cause and effect right now for people to feel like they want to do another doggone thing in the front line clinic.

DR. VOLPE: I would like to speak to that, because I think the question that you are asking is precisely the right one from what might be possibly known as the private sector. You are asking what is the incremental value associated with the incremental cost associated with this. And I think as a panel we talked a little bit about that at the health plan level.

At the health plan level it's relatively easy to do if you do an enrollment. You do it once. It's much more complicated at the hospital level, or in the individual physician office level. I don't think we spent a lot of time talking about the incremental costs and incremental value associated with that, but the point is well taken.

DR. HARDING: Here we are in public health. I understand what we are doing completely, and I approve of it. But on the front line, it's my clinic and my expenses, and I'm going under, and I've got to do another thing? That's where it's going to be rough. You have to be clear what this is going to be helpful for, and how it will help my treatment of patients and so forth. That kind of thing has to really be explained well.

MS. LOVE: I think one of the recommendations was with HHS providing that technical assistance back, the messages, the reasons why, and the education packet.

DR. LUMPKIN: Now, they have a saying that you can't go back, but I'm going to go back. Harry?

MR. REYNOLDS: Carl, to play off your comment, when you were talking about a health plan could get it at enrollment. Well, CMS is a health plan. Medicaid agencies are a health plan. The private sector is health plans. What is missing from that so that you don't have to do what Richard was just talking about?

DR. VOLPE: I'm sorry, I don't understand all the uninsured.

MR. REYNOLDS: Well, the uninsured aren't included, I understand.

DR. VOLPE: Oh, if health plans got it, you might not have to get that?

MR. REYNOLDS: I can't see a distinction between a health plan, CMS, and Medicaid. They are all health plans.

DR. VOLPE: The differences between health plans, CMS, and Medicaid, I wouldn't see distinctions either.

MR. REYNOLDS: But I wanted to make sure that was clear. So, that's a significant portion. That is the insured population. Obviously, we've got the whole other issue of the uninsured, and that needs to be dealt with in a different way.

But back to Richard's comment, if you use those three for the millions and millions of people that are covered, they don't have to do that if somebody has insurance. You don't have to do it in that doctor's office every time. You only have to pick up the ones basically falling through the cracks right now, are the ones we need to make sure we try to do something. I'm just trying to understand what the segment of the population is we are dealing with.

MS. LOVE: Can I put in a footnote that the next version of 834 enrollment standard will have the OMB 15 standard in there. The scope would need to be expanded by DHHS.

MR. REYNOLDS: That was the second part, so thank you very much.

MR. SCANLON: All of these issues came up before, and in fact they gave rise to this study in the first place. And let me just a little department perspective. And actually, this OMB standard goes back to the seventies, and we've been grappling with these issues. And I think it's classic of burden versus cost and utility.

The origin of this study was actually in the Senate. One of the committees decided they should -- since HHS would not mandate that everybody collect and report race/ethnicity data, that maybe they should pass a statute. And there was a debate about that. And they decided well, maybe we better find out a little bit more about this before we mandate that this occur.

And that gave rise to the study. And it looked at the adequacy of race and ethnicity data, the whole panoply of data hopefully. And now we have come full circle. And the panel has made some good distinctions, and in a way reaffirmed some of the HHS approaches, and some of the other approaches.

You want more obviously, and everybody wants more and it requires more resources. But we still come back to the same dilemma as well. The panel is recommending that HHS or presumably Congress -- I don't think it would happen honestly, without a statute. It would just be impossible to do, particular over entities over which HHS has no relationship. It's not one of our programs.

But you have recommended that among other things, that a mandate for collecting race and ethnicity data, as well as a number of voluntary survey and research kinds of things, standards based and measurement improvement sorts of things as well. And I just don't know what kind of receptive ear there would be anywhere for mandates like that. But I've been wrong before. I was wrong about HIPAA.

The other way to work through this is rather than have a statute that you will and you must, it's to work through the industry processes like the HIPAA process and the SDOs. That's where much of the administrative data, the enrollment data, and the encounter data is being formulated and planned for anyway. And to make a case for it in those settings, the public health case and the business case, and do it that way. Then people have embraced it as their own, as part of their own standard. But a centralized mandate, honestly, I don't see much of a receptive ear for it.

MS. LOVE: Maybe I'm just a naive optimist, but I think HIPAA is an opportunity, the next version of HIPAA, because the OMB standard is in there. The NUBC, the National Uniform Billing Committee has demonstrated its willingness to look beyond what is needed to pay a claim. So, I think the industry is coming along with this, albeit slowly. And I've got to be optimistic that through HIPAA, the next version, whenever that is.

DR. VOLPE: I want to be clear this is a personal view. One of the dilemmas that one has in talking about this is the individuals within health plans, if I can speak about health plans, who participate in these discussions, are not CEOs for the most part. It's not on the CEO radar screen, for the most part.

And like in every organization, I was in Washington and I experienced it too, you have the folks at the top who are the broad thinkers. And then as you go down in the organizations you find folks who are entrenched and unwilling to make some movement.

I think a person view is that when elevates to the level of Congress, it gets on individuals' radar screens, and we can move policy. It's much harder as you go down in the organization. I don't think we said that explicitly in our discussions, but I think that is part of the equation in an issue as complicated and as controversial as this is. It's easier just to say no and move on.

DR. LUMPKIN: Marjorie.

MS. GREENBERG: I think my comments are part of the same theme that you have hearing, but I wanted to ask you a question about that nonetheless. I mean first of all, I congratulate the panel, and I'm glad to see this kind of thoughtful process and these recommendations coming out, which as you well know, have been coming out now for at least the 23 years that I have been working with the National Committee.

And not only coming out of the National Committee, but also coming out of committees of the National Academy, et cetera, out of parts of the department such as the inclusion policy.

One can't help to some degree feeling like Yogi Berra, deja vu all over again. And Denise and I have been babbling on the administrative side for many years together. And the question that I have is was there a sense of the panel as to what the major barrier is to making this happen? As I said, there have been good rationales developed. There have been recommendations made illustrious groups now over a period of 20 plus years. Is it really financial?

Is it financial resources? Because every what if you come up with, you can always think of kind of somewhere if you maybe put intelligent money it, like education or training, or data feedback or all that, you could overcome it. But did you feel it was money, or was it something else?

Because without a sense of that, I'm going to hear the same presentation -- and then attacking what that main barrier is -- I'm going to hear this, well, I may not be here in 10 years, but I'll read about it in 10 years. I hope to be on this earth in 10 years.

DR. VER PLOEG: I don't have as much perspective. I'm new to this area. I think that the IOM report that came out about unequal treatment, actually probably was a big step in awareness. I don't know how much that could move things along, but at least that was a step in awareness, and this is following up on it, the work that DHHS had already done. Maybe that's slow progress.

MS. LOVE: At the state level is it becoming a -- and I'm old, and I've been around, and I've heard all these conversations before, and I've been on this race/ethnicity conversation for a decade. I have a sense that at the state level it is becoming a policy issue that is not going to go away in the short-term. Now, in a few years, maybe so, but right now, every state that I talk to is concerned about getting disparities data.

We had one state use the national NCHS health interview survey and a few other things, just running national statistics, because they didn't have adequate state statistics. And people were clamoring for more, and they want to do more reports and collect better data.

So, it be because it's a policy issue, it will push things along a little bit. That's my sense. The disparities report, we couldn't really get good data at the state level on some of those measures.

DR. VOLPE: Can I speak to the private side? Because I think there really is a significant change on the private side. If you look at the evolution of the health insurers over the last 15 years, and you see how they differentiated themselves in the marketplace, and forgive me for talking like a market person, but it helps.

Plans were differentiating among themselves by product design, benefit structures. We had Kaiser out there that continued to argue on quality, but for the most part was one of the few ones out there. And that is not an insult, that's an acknowledge of Kaiser's voice.

But if you look at what health plans are doing right now, they are much less interested in differentiating themselves on product design, and issues of quality are emerging. Health plans are trying to distinguish among themselves in that area.

We have the studies that were just referred to around unequal treatment. And then issues of patient safety and quality. And all of the sudden you are seeing a convergence, for the first time in the last 15 or 20 years that I have seen watching this, where the time is right. And we know that policy changes only when the time is right. And I think we are getting there now. I don't think we are there yet, but I think we are getting there.

MS. LOVE: Can I add one more thing? In the report, public health is collected. State and federal agencies have collected race/ethnicity data in varying forms for some time, but have under used it as well. And there are a lot of reasons for it, and we don't have time to get into why. I think we need to use the data we have better, and raise that awareness, even if it's not perfect.

DR. LUMPKIN: Vickie.

DR. MAYS: Carl actually made some of my comments quite articulately. But I just want to talk about for example what we saw in California. If you remember, we had a ballot initiative in which it was about not collecting data by race and ethnicity.

And the business case that was made that overturned the initiative was that people were very clear that if they thought that was in any way going to interfere with either the science or the delivery of services or treatment in terms of their health care, they were against it. And that was the case that actually allowed this initiative to be overturned.

So, if you ask what's different, I think what is different is that the dialogue now is not in the realm of politics. The dialogue has a lot more to do with the science that keeps discovering the ways in which one's race and ethnicity might be related to health care. And so, I do think now is the time to push. I don't think it's going to happen right away.

To get to the point that Steve made, when we had the population hearing, we were actually in this room, and we did have the room packed. And the reason we had the room packed is because people wanted to know how to ask the question, how to get better data. They wanted to hear what other people where doing.

But I think what we have to do now, and this is something the subcommittee is going to talk about is there are interested parties. I can tell you there are some people in Congress who are wanting -- if we get this thing passed, they want it, because they want to continue the dialogue.

So, I think it's just a matter of the timing is perfect. I don't think we are going to get everything right away. I think resources will be a big problem. But I do think people are going to embrace at least the dialogue, and make some movements towards some policy changes.

DR. STEINWACHS: Just a small question. You have been dealing with the big issues. In the way in which you conceptualized capturing race, ethnicity, and socioeconomic position, would it be viewed by the person that this is optional, voluntary to complete it, or is it like the insurance forms, the things you get where you sort of say, well, if I don't sign it, I don't have insurance. Did you talk some about the idea of voluntary versus you have give this, or you aren't going to get it?

DR. VOLPE: I think just on the private side we felt pretty strongly that it would be a requirement.

MS. LOVE: I think we have made clear that the patient would have to be educated and told up front, this does not affect -- if you don't provide it.

DR. STEINWACHS: Is there any experience about what kind of response you think you'd get?

DR. VOLPE: Interesting enough, exactly. If you look at what Aetna is did, and you contrast it with what we do. We have a voluntary question at the time of application. It's at the time of application. So, the question is if I check this, is it going to affect my ability to get coverage?

What Aetna does is Aetna comes back after the person is accepted. So, they know already they are enrolled in the health plan, and they are now asked the question. And they have had much, much better success in gathering the data than we have. And Aetna is a really good example of the differentiation there on the private side.

MS. LOVE: We have 27 states that collect race/ethnicity data with their hospital discharge data. That means providers are asking the folks at the time of admission. About half those states or more have mandates. But again, the patient cannot be turned away if they don't provide the data.

DR. STEINWACHS: I have always been suspicious about some of the systems where if the patient doesn't answer, the clerk fills it in.

MS. LOVE: It is happening, and it's self-coded. And that's why we wanted to get everyone to ask. Some uniformity would be nice.

MR. HOUSTON: I just have a quick question with regards to how this might interplay with NHII. And using it as a mechanism maybe to reduce some of the burdens associated with duplicate requests for data. And again, if it's part of that larger infrastructure, it just sort of becomes a data point that is collected once, and maybe updated periodically just simply through the normal course. Is that something that we should consider as part of NHII? Because I don't recollect it really being part of the architecture or otherwise.

DR. LUMPKIN: Yes, actually, I think if you talk to patients, one of the things they find most onerous in dealing with the health care system is every time they see a new doctor, return to the doctor, go to a new hospital, return to the hospital, see at the clinic, they answer all the same questions over again.

And conceptually, the way we envision the personal health record to work and the personal health dimension is that when you enroll in a new provider, you control your health record, and you send them the information that you think is pertinent or you agree upon as pertinent, and this would be one of those items.

So, if you choose to make your race and ethnicity available, which would be part of filling out this record, then that would be part of the enrollment process. Which would then reduce the burden of collection, which is a major obstacle. So, it costs the provider nothing to collect it. It costs the patient nothing to provide it. It's just an electronic transaction. And I think that's where ultimately we want to go. Once we get to that point, then Richard's issue really goes away.

MR. HOUSTON: I don't recollect it being discussed, at least with how I'm involved in NHII. I don't remember there really being any discussion as to collecting this type of data. You probably know better than I whether there really has been any discussion about collecting this type of data, or how it would be handled.

DR. LUMPKIN: I don't think we went into that detail, but there is a specific one where we talk about the personal health dimension. We talk about demographics, and that would be included in there.

DR. STEINDEL: John, it was discussed in depth in preparation to the report, and condensed down into like a sentence or two.

MR. BLAIR: Someone referred to it, and I couldn't tell who it was, about pay for performance in quality. Who was that? I was still resonating and thinking about Richard's comment in terms of motivating providers not just to collect the data, but to institutionalize behavior a little bit.

I'm not sure all these pieces are in place. So, could you get your bows and arrows out, because I'll do a pie in the sky type of suggest here, so I'm ready for the slings and the arrows. But my thought is that if we are going to really get some real value out of this, the real value is something that is changing some subtle behavior, behavior on the part of a lot of clinicians and care givers and providers that they may not even be aware of the ways that they might have variations in the way they provide health care to different groups.

So, in order to pick up that information, not only do we need large amounts of data and data over time, but I think maybe instead of thinking a survey is one of the pieces that we may have to do at the start as a reference point. But what I was thinking of is we build it into the system.

And I thought the place to build it into the system is that if the model for our reimbursement system does alter to where we are reimbursing for quality and safety and cost effectiveness, and I would think that eliminating disparities would fit in quality of care as a consistent, general measure.

And so, my thought is that if we had some meaningful measures that the National Quality Forum, that whatever -- I'm not on committees that are looking at pay for performance, but those groups that are looking at pay for performance, if they could fold in the issues of uniformity of care, so that it's blind to race and ethnic groups, that might be a way to carry this forward on an ongoing basis.

And there is another reason why I think that that may be a very good thing. Twenty to 30 years from now the disparities may shift quite a bit. We may have different ethnic groups coming in. We may have different areas. And the other pieces that they may pick up on may not be race and ethnicity so much, it may be disparities in terms of education or accents or in terms of you were adding socioeconomic position. Socioeconomic position may be a point of discrimination.

So, my thought was if we could start to fold it in to pay for performance, and fit it in on the quality access, then it becomes institutionalized. And the other piece on that I think gets back to Richard's comment. As a benefit to a care giver, I would think that many care givers might go on the defensive if they figure, well, you're going to check up on me to see if I'm discriminating, and I'm going to be vulnerable.

On the other hand, if it's institutionalized, and it is built in where it becomes a positive, that it is non-discriminatory, then it could be built in as a reward. And so I thought that you could maybe put a lot of pluses together if you begin to think of it that way.

DR. LUMPKIN: Well, Jeff, I think that's a good ending note, because that's where a lot of folks have gotten to on the issue of relationship of quality to race and ethnicity. Actually, when you look at probably the biggest barrier and the biggest cause of disparities and quality of outcome is socioeconomic position when you look at it in environment.

That in fact -- and here is the most striking one, and I can just give an example. There was some work that was done in Michigan looking at quality measures related to a pediatric follow-up of kids after emergency department or hospital visits. And the rates for follow-up of African American kids was half that of the white kids. But the rate for white kids was only 40 percent.

So, the quality is certainly a key determinant. Race and ethnicity adds to the quality burden. And if we find solutions to quality, I think we'll be able to make some major strides, particularly if we focus in on those areas where there is the greatest disparities.

And there are a number of folks, including AHRQ as well as my organization of the Robert Wood Johnson Foundation who are looking at demonstration projects in the coming years to really implement tool kits that allow providers to reduce disparities through improving quality. So, I think you have hit the nail on the head.

I would like to thank the panel. It's great. Not only did we have a wonderful presentation, but it's good to see you again after the couple of years of work that we had together. I think it's something that the committee is appreciative of. And if someone is willing to make Steve's motion -- I guess not at this time. But thank you for coming.

We are now going to split up into the work groups.

[Whereupon, the meeting was recessed at 2:30 pm, to reconvene the following day, Thursday, June 17, 2004, at 10:00 am.]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

June 16, 2004

Proceedings By: CASET Associates, Ltd. 10201 Lee Highway, Suite 160 Fairfax, VA 22030 (703) 352-0091

TABLE OF CONTENTS

P R O C E E D I N G S (9:05 am)

A F T E R N O O N S E S S I O N (1:25 pm)

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, VA 22030
(703) 352-0091