[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 705
200 Independence Avenue, SW
Washington, DC
Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, VA 22030
(703) 352-0091
Call to Order - Dr. Lumpkin
Update from the Department - Mr. Scanlon
Data Standards - Ms. Trudel
Privacy Rule Compliance and Issues - Ms. Kaminsky
The Basics of Consensus Standards - Dr. Altman
Status Report from Quality Workgroup - Mr. Hungate
Subcommittee on Standards and Security - Dr. Cohn
Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda - Dr. John Lumpkin
DR. LUMPKIN: I'm now calling to order the meeting of the National Committee on Vital and Health Statistics. Welcome everyone. My name is John Lumpkin.
We're going to start off with introductions, as we go around the room.
[Introductions were made.]
Thank you.
Well, welcome. As all of you know, this is a very exciting time. A lot of our work is moving forward. We have had the implementation of the privacy regulations I think, since our last meeting. And there is still health care being given. Life goes on. And I think that as we look forward to the implementation of transaction standards, it will be another big hurdle. We will have some discussion about that today.
So, between that and some important activities, and then next week there is the summit on the National Health Information Infrastructure, and I think many of us will be there for that discussion. It's kind of rewarding to see the agenda of this committee really getting a lot of focus and attention, as all of our hard work is bearing fruit.
Those of use joined the committee, Simon and a few of us who started off, remember back in 1996 when HIPAA was -- we didn't even know how to spell it, much less say it. There are a lot of people who prefer those good old days, but I think that we have seen a dramatic change in implementation of those visions, and the world of health informatics is moving forward because of that.
So, I think we should all be very proud of the work of this committee, and all of you as members. And especially the staff, who have played and stuck with us throughout the last seven years since the law passed and we began to work on it.
This part of the agenda we start off with seeing if anyone has any conflicts with items that are on the agenda. Okay, we have no declared conflicts with matters on the agenda. So, we will move to update from the department.
Agenda Item: Update from the Department - James Scanlon, ASPE
MR. SCANLON: Thank you, John.
Good morning everyone. It's a pleasure to be here this morning. Let me continue the theme that John started the meeting with. There actually is a lot of progress -- after many years laboring in the wineyard, there is actually a lot of progress now on clinical data standards, privacy, and the NHII issues generally.
You will hear reports this morning on where we are with the HIPAA administrative data standards, privacy regulation, and the CHI initiative. So, I'm going to talk about some other activities that are coming. There are about four activities I wanted to report this morning, and then I'm going to update the committee on where the department is with response to several of the latest recommendations from the committee.
Let me start with the meeting of health last week. Many of you, I think were at that meeting. HHS has joined with the Veterans Administration and other agencies in the federal government to support an initiative at HL7, and also follows the Institute of Medicine, to accelerate the development of a functional model in standards for the electronic health record.
You will remember that HL7 had a special interest on the electronic health record. That's been meeting for quite a while now. And at the request of the federal government, and with support from the federal government, HHS and VA particularly, they were asked to accelerate that work. So, at a meeting convened by the special interest group at AHRQ headquarters last week in Rockville, basically the move was started to help to define what the EHR functional model of standards would be.
And the goal would be to have a draft standard -- this is in HL7 terminology -- to have a draft standard for trial use through the HL7 balloting process. It sounded as soon as this fall.
Jeff Blair, you were at the meeting as well. Jeff, I think you stayed for the whole meeting. But it looks like it is a very accelerated kind of a process. I guess a descriptive kind of a draft will be prepared first. Jeff can probably tell us a bit more.
MR. BLAIR: One of the things is that you can either have normative standards or informative standards. And informative standards of course don't require the level of consensus within the ANSI standards framework. The more you get towards normative standards, the higher level of consensus that is needed.
So, this was sort of a compromise to meet the needs of the customers -- CMS, VA, and AHRQ and HMS(?), that all kind of were sponsoring this effort, the more immediate, direct, primary customers. Of course the health care delivery system as a whole is a customer for this as well.
So, the compromise was that if you wind up having a normative standards for draft use, that would be appropriate for these primary customers in the January timeframe, and you would require a 60 percent approval rate in order to be able to do that. Otherwise, you have to get a higher percentage, and that could take longer.
MR. SCANLON: Many of you are familiar with the HL7 process. But again, this was work that the EHR special interest group at HL7 had underway for a while. And at the request of the federal government, and with some support, that work is now going to be accelerated, so, hopefully we'll actually have a functional model in standards.
There will be a role of the IOM as well. I think the IOM is planning to develop one of the -- the patient safety committee, I think, which Simon participates in at the IOM, I think is going to try to provide a letter report in terms of some basic principles and framework this fall. August actually I think was the projected date. So, it's nice to see that all coming together as well.
Let me go on to a second item. We, in our HHS convener role, are planning a national meeting here in Washington on developing an action agenda for the national health information infrastructure. It is scheduled for June 30 through July 2 here in Washington. All of the National Committee members have been invited, and I think most of you have already registered.
The focus here will be to identify consensus on action steps. This is not identifying a federal agenda. This is identifying a national agenda. I think we would all be disappointed if the only recommendations that came out would be that the federal government should do this or that. This is meant to be a national action item agenda.
There are plenary sessions with keynote speakers, and several of the committee members are involved in keynote speaking roles. And then there are breakout sessions to consider what actions might be needed in eight areas, and let me just read those: research in population health; homeland security; consumer health; financial incentives; safety and quality; standards and vocabulary; architecture; and privacy and confidentiality.
If you have visited the conference Web site, which I will give you in a minute, this is laid out completely, and there is an opportunity to register. So, really next Monday we'll be starting on this, and hopefully we'll have some good recommendations that reflect a consensus of the industry on where we might head next.
Sec. Thompson is scheduled to participate in the meeting. And John Lumpkin is giving the keynote address on June 30. Several other members of the committee are playing key roles, either as keynotes or as facilitators.
Questions there? Let me go on. I wanted to give you the Web site. I'll put this up later too, but it's www://nhii-03.s-3.net. And I hope all of the committee members have already visited the Web site.
Further, the secretary, as you all know, has stated on several occasions that applications of health information technology have the potential to make revolutionary changes to the health system. And our HHS strategic plan, which the committee provided comments on, includes several NHII-related objectives and goals.
The secretary is urging all of our HHS agencies to identify and deploy relevant information technology applications across all of our programs, and to work to promote interoperable health information technology across the public and the private sectors. And recently, the secretary has established within HHS, an internal group, a council on the application of health information technology. This is in the formative stages, and you'll hear more about it later. But this is an internal council.
The goal is coordinate HHS activities in health information technology. All the agencies in HHS are being asked to participate and designate a member, and ASPE and AHRQ are chairing. The inaugural meeting is being scheduled within the next few weeks. And Dr. Lumpkin will be participating in his capacity as the chair of the NCVHS. So, I hope this will be bring these ideas and these activities together as well.
Let me say a quick few words about the fiscal year, the president's 2004 budget, because that too, I think reflects a growing recognition of the contributions that information technology and the NHII can play. The president's 2004 budget for HHS, which is now on the Hill obviously, includes several initiatives to promote and accelerate data standards and technology, and NHII activities.
At the overall departmental level in our Office of the Secretary, my own office, there is an NHII initiative of about $3 million which is kind of an overall strategy, planning, and coordination activity. It would include convening and some other cross-cutting and gap filling special projects. So, hopefully, that will make its way through the process.
In addition, in a joint effort with AHRQ and ASPE, there is a $12 million initiative to support clinical data standards, working with the industry. And in the AHRQ budget there is a $50 million initiative for improving patient safety through hospital information technology that would be a demonstration and a grant program. So, actually many of the ideas of the full committee here, and the NHII ideas generally are being reflected in the budget process, as well as strategic plans.
Let me turn now to the status of a couple of most recent NCVHS recommendations. And I think you have before you, the responses that I'll be referring to. Back on March 27, the committee sent a letter to the secretary with suggestions for improving the adequacy of race and ethnicity data. This originated in the Population Subcommittee.
This was discussed at our Data Council meeting, and the secretary answered the letter. I think you have a copy of the letter before you. But he referred some of the ideas and recommendations to our Data Council and our Data Council Working Group on Race and Ethnicity Data. They are in the process of developing their work plan for the year. So, I think we are hoping to factor those recommendations into the work plan, and to have some response, probably within I think we said 90 to 120 days.
Secondly, in February the committee sent a letter to the secretary expressing some concern about what looked like some budget resource issues relating to the National Health Interview Survey. The committee expressed support for NCHS and the general purpose surveys. This, too, was discussed at our Data Council meeting.
The secretary has answered the letter in an interim form, and directed NCHS to work with the Data Council on resource issues, and then whatever trade-offs may be necessary in terms of overall data strategy for both the 2004 and the 2005 budget.
And finally, going back to November, the committee submitted its report on, "A Vision for Health Statistics for the 21st Century." Dr. Lumpkin presented the report to the full Data Council. It was discussed there. Council members are being asked to look at how it can be addressed, and we'll have a report back to the full committee as we move on.
And then one final item in terms of support for the subcommittees, staff support. The Office for Civil Rights has asked that we rotate Stephanie Kaminsky off as the lead staff, and has asked us to appoint Kathleen Fyffe as the lead staff the lead staff. So, we will be doing that over this meeting as a transition, and then we'll move forward.
Actually, we are very grateful to OCR. They provided Stephanie's excellent support and excellent services during a very difficult and busy time, as you could imagine, just preceding the implementation. I pleaded with the director of the office to let Stephanie stay on, at least for a little while longer. And he acceded, but now I think he has asked if we could make the formal rotation. So, we really appreciate all the work that Stephanie did.
DR. LUMPKIN: We understand the concerns and interests of OCR, but does the person they are replacing her with have any experience with this committee or privacy?
MR. SCANLON: I've never heard of that person. And we noticed that there is no problem in implementing the privacy regulations since the compliance.
That's all I have.
DR. LUMPKIN: Great. Any questions?
DR. MAYS: I'm glad to see the letters in response. Can you may interpret for me a little bit more of what -- I think I understand the one in terms of what they are going to do in terms of race and ethnicity. But the one that we were concerned about in NHIS, what is it the Data Council is going to do?
MR. SCANLON: Well, NCHS is being directed to present -- so far, this has not been discussed at any level of detail. I don't think NCHS has come forward with what exactly the problem is, or what kinds of trade-offs are being considered, and what the scope in each of the trade-offs is. And I think the letter, as well as the 2004 budget contained an agreement that this would be worked through on a more collectively department-wide framework, not just an NCHS decision, and then tell everyone later what it is. And we'll have to see.
The 2004 budget, let me just remind everyone, in any given month, just as back at your own institutions, there are usually three budget years being talked about, the current year, which 2003, what is the president's budget, which is usually in Congress awaiting approval, the 2004, and we have already begun working on the 2005 budget.
So, the issues raised here arose in the 2004 budget, which we don't have yet, obviously. But I think the idea here is to get a more collective analysis, and balanced collective view of what exactly the issue is, and the trade-offs are. And I think until the budget situation is a little clearer, not knowing what the level of the 2004 budget is for example, it's a little harder to know exactly what the trade-offs might be.
I note also that the center NCHS has now established, their Board of Scientific Counselors, which presumably would be asked to look over and make recommendations on methodological and science issues as well. I think we all view this more as a policy issue.
DR. LUMPKIN: Other questions? Thanks.
Let's move on to Karen.
Agenda Item: Data Standards, Including Clinical Data Standards Adoption - Karen Trudel, CMS
MS. TRUDEL: Okay, thank you. This is Karen Trudel, and I'm going to be doing an update on the administrative simplification transaction code set identifiers portion of HIPAA.
I'll talk a little bit about regulations that are pending, a little bit about some of the outreach efforts that we have undertaken recently, and then talk a little bit in more detail about the issue of readiness for the transactions and code sets deadline that is coming in October.
With respect to the regulations, we are still awaiting the final clearance of the provider identifier final rule, and the plan identifier proposed rule. We had, as I believe I reported last time, with respect to the attachment standard, received a request from both Health Level 7 and X12, the two standards developing organizations who were involved in that standard, asking if we could hold up a little bit on that proposed rule.
They felt that they had a better product to propose, and that they needed a few months to wrap it up, package it, and get it to us. And it is our understanding that Health Level 7 will be sending us a report sometime this week or next that will explain what the new standard looks like, how it works, why it is better, et cetera. And that the balloting for that standard is going on right now. That's what is happening with attachments.
We are continuing to work with some of the substantive issues that have to do with enforcement, not just for transactions and code sets, but also for privacy and for security. There are a number of very thorny issues there. What is a violation? How do you count the violation? Who has standing to bring a complaint? What are aggravating and mitigating circumstances? Any number of issues like that, that we're working through with a cross-department team. And I believe we expect that proposed rule to be published sometime this fall in proposed form.
In addition, Dr. Cohn mentioned to me earlier that there was some rumor going around is there going to be another transaction and code set modification rule coming up? We do have one scheduled, just to keep a place in the regulations agenda for those purposes. I'm expecting right now that it would be a fairly minor rule, with corrections, slight modifications, and that it would not come out until sometime early next year.
With respect to outreach, we have just undertaken a really different for us, initiative. Our Atlanta regional office developed a HIPAA Web cast, and they have just added a security module to it. It is free of charge. It's very informative. And they have received quite a few hits on it already. We're getting really rave reviews. So, we are trying to use the resources and the funds that we have to get to the most people.
There is a great deal of attention being given to the readiness for the transactions and the code sets come October 16. And people are trying to gauge how that compliance is going to go. Will it be smooth, will it be rocky, based on the number of people who are current in testing?
We've have heard word of a great deal of concern from the Work Group for Electronic Data Interchange and others. We did write to the secretary and suggested that by all estimates they could come up with, we had a potentially furious situation in front of us come October. That many providers may not be ready. They may not be able to test in time. And we did make several suggestions to the secretary for things to mitigate that circumstance, including permitting health plans to continue to accept both compliant and non-compliant transactions for a period of time.
There is also some misinformation out there in terms of whether the department has actually made a decision. And the answer to that is no, we have not yet. I think that makes the deliberations in the next day or so on recommendations back to the secretary on this issue very, very timely. We are aware that there are potential problems there. We are looking at as much information as we can come up with, and trying to make a good decision as to what course of action, if any, needs to be taken.
That's my update. Any questions?
DR. ZUBELDIA: Karen, Jim was mentioning budgets. Do you have a budget for all these identifiers, and all these things that are coming up?
MS. TRUDEL: I believe so. I'm trying to remember. As Jim said, we are always in three different budget years at one time. And because of the timing of the regulation, we are not talking about starting work until I think fiscal year 2004. And I know there is money in the budget for two or three different years. So, it's not a matter of having to hold the regulation from publication because we do not have funds, if that is your question.
DR. LUMPKIN: Other questions? Okay, Stephanie.
Agenda Item: Privacy Rule Compliance and Issues - Including Enforcement - Stephanie Kaminsky, OCR
MS. KAMINSKY: As a number of people have already noted, it has been a pivotal time in the Office for Civil Rights over the last several months. I was actually thinking about the fact that it really was only three or four months ago since we last met, but it seems as though the Office for Civil Rights has done twice that amount of work in this last period of time, getting ready for the compliance date of April 14.
As you all know, nobody really knew what to expect. There was a tremendous amount of anticipation, and a lot of last minute work to put out additional guidance before the compliance date. And as a number of people have already noted, the compliance date has come and gone, and the transition has been quite smooth. I think that the Office for Civil Rights, as well as the entire department are quite pleased with the transition into this compliance stage of the privacy rule, at least.
We have started obviously, to receive complaints, and again, nobody really knew what the volume was going to be, what it was going to look like. The regional offices are fielding these complaints, and certainly they are all investigators and have experience dealing with complaints on the traditional civil rights side. But given the newness of the privacy rule, it was unclear kind of what the whole thing was going to look like.
To date, we have received 637 complaints. We have closed 124 of those cases. We have 513 open cases. And we have accepted for investigation, 260 of those.
The kinds of things that make us close cases, or the reasons we have closed some cases are because complaints have been about actions that occurred prior to April 14, so that there was no jurisdiction there.
Or complaints don't state an actual violation. Complaints are about an activity not prohibited by the privacy rule, or against an entity not subject to the rule. So, if we don't have jurisdiction, we can't investigate or accept the case.
The kind of complaints that we are accepting and seeing are things like individuals allege they were denied access to their records. Individuals allege inadequate safeguards, or inadequate minimum necessary procedures in various types of offices, usually provider offices that you are visiting in the reception area or the treatment areas of the facilities.
Individual allege they did not receive notice, or it was not posted. We have had a lot of notice complaints. And actually, we have seen insiders in organizations alleging that their offices were not in compliance. So, I don't know if I would call that full fledged whistle-blowing, but certainly something along those lines.
And so it's been kind of interesting to watch all of this regulatory build up play itself out with the kind of complaints that we are getting. I think that we are still working through some of our issues with Justice in terms of a referral system for things that are potentially criminal. And I'm not sure whether there have been any actual referrals to Justice to date. I'm sorry, I just don't have that information.
In addition to working on this whole complaint segment of our office, we have continued to do an enormous amount of outreach, as I said, leading up to the compliance deadline. In particular, we put in place just before the compliance date, a system to enhance our already existing toll free assistance hotline, where we have now operators on these lines who are able to respond directly to many frequently asked questions.
And if the operators can't answer the caller's question, the caller is directed to a telephone where he or she can leave a specific message.
We have been very fortunate that the department and other operating divisions of the department have generously detailed some of their staff to our organization over the last several months, and they will be on board for the next several months. And the details have done a tremendous job assisting with these telephone calls.
My understanding is that since April 1, OCR has received 5,000 calls, and has responded to 4,900 of them, or 98 percent of them. And this is not including those calls that are handled by the call center that I was just talking about. It's just been an enormous call volume of people who are asking questions about how to be in compliance, and we have done the best we can to marshal the resources to address that need.
In addition, we have recently published, and helped other operating divisions in the department publish a number of publications that we think will be useful. We issued a consolidated summary of the HIPAA privacy rule. We have enhanced our frequently asked questions. We have a search engine now.
It has been converted since we last met, and I think it's the most frequently hit Web site, the frequently asked questions part of our Web site is the most frequently hit Web site at HHS. That's what I'm told anyway. It handled like 750,000 hits in the last several months, an incredible number.
And we also assisted NIH and some of the other parts of HHS that work on research, to issue a research booklet, "Protecting Personal Health Information and Research: Understanding the HIPAA Privacy Rule." And we continue to work on some additional supplemental materials that will complement that guide on a number of different research topics. We are working closely with NIH and some of the other agencies on that.
We also assisted CDC with a publication that I think is well received by the public health community, "HIPAA Privacy Rule and Public Health," which tries to address and clarify some of the areas that have been difficult for that community to understand with respect to the privacy rule.
And we are still working on those targeted technical assistance materials that you heard about before. They have taken a little bit longer than originally expected to generate, but we are putting together pieces for providers, practitioners in particular, smaller providers, institutional providers, health plans, group health plans, employers. It's a whole series of materials that are in the works, and hopefully will be coming out in the not too distant future.
In addition to these various activities that have kept us hoping, Karen mentioned the work on the enforcement rule. In March, I believe -- no, sorry, April 17, the department published an interim procedural rule, which is sort of the first installment of the enforcement rule for all of administrative simplification.
When it is issued in its entirety, the enforcement rule will set forth procedural and substantive requirements for the imposition of CMP, civil money penalties, for violations of the HIPAA provisions. This installment that just came out, outlines the procedures that will be followed when the secretary seeks to impose CMPs on persons and required to comply with various HIPAA provisions.
And these procedures include things like investigational subpoenas, written notice of proposed CMPs, procedures for hearings when covered entities wish to challenge the proposed CMPs, et cetera. And just by the way, I'm sure many of you are already aware this rule is based on, and is substantially similar to the procedures followed by the OIG when imposing CMPs for violations of other laws such as fraud and abuse, et cetera.
This was issued as an interim final rule, and it had an effective date of May 19, a comment period that just ended, and I don't know how many comments we received, but it just ended June 16. But the interim procedural rule will expire on September 16 of next year, 2004.
In the meantime, we are working on a substantive -- we will take the comments that we have received on the procedural rule. We will rework the procedural pieces, and at the same time, we are working on a substantive rule. And as Karen mentioned, we are working on issues such as determining violations, considering aggravating factors, calculating CMPs, burden of proof during hearings, and availability of further administrative review following an administrative law judge decision.
So, all of that is in the works, and in the end it will be one integrated rule that will be issued, and certainly that needs to be done before September 2004, because this interim procedural rule will be expired by that time.
So, we are just going full force on all fronts. And it is a very exciting time, and things are going very smoothly.
DR. LUMPKIN: If I could ask a question first, and then we'll go to Jeff. You mentioned that there were 240-some odd complaints that had been approved for investigation.
MS. KAMINSKY: Accepted, 260 is the current figure I believe.
DR. LUMPKIN: So, that's the complaints that have been reviewed that have been determined if they are in fact true, would be a violation. And so they are worthy of investigating to determine the validity of the complaint?
MS. KAMINSKY: Yes, and we have jurisdiction, et cetera.
DR. LUMPKIN: And you have jurisdiction and so forth?
MS. KAMINSKY: Yes.
DR. LUMPKIN: Okay.
Jeff?
MS. KAMINSKY: I have one other thing I wanted to say, which is important along that line. I'm not sure where I had it written, so I'll just have to wing it, which is the following. What has been clearly emerging over the last several months, and I think it was in place when we last spoke, but it's even clearer now is that our orientation toward enforcement is really a voluntary compliance orientation.
Although we have issued this interim final rule, and we are working on the substantive rule, and all of this would be in an instance where we get to the point that CMPs seem like they may need to be applied to a covered entity, et cetera, we are expecting and working toward a situation where a lot of the complaints that we receive might be able to be handled with technical assistance, with helping covered entities to understand what exactly they need to be doing, and giving them the appropriate information so that they can voluntarily comply.
It really is the philosophy of the director and this administration to work hard in that direction. So, even if the cases that we have accepted so far, we certainly are going through an investigative process, but all along the way, the emphasis is to try to help covered entities voluntarily comply.
MR. BLAIR: Stephanie, the NCVHS and Office of Civil Rights has been very focused on preparing the regulations within the framework given to us by Congress. And therefore, we focused on privacy protections among the covered entities and any business associates that might be related to it.
But if we go back to the original thinking of why we needed privacy protections, if I recall correctly, the greatest concern that the public had was that their health care information might be inappropriately accessed by their employers. And that that might jeopardize either their ability to be hired, or their ability to retain their employment. Of course, HIPAA attempted to address this as well as it could within the framework that Congress gave us.
So, now that you have started to have folks issuing complaints, are the complaints primarily inappropriate access to health care information by the covered entities? To what extent are they still showing concern about employers having inappropriate access to health care information? Is it too early for you to tell?
MS. KAMINSKY: Yes, and also I'm not sure I have surveyed the universe of complaints adequately to answer that accurately. I have been involved with reviewing some complaints, but I haven't been in that bird's eye view where you can sort of see the entire universe.
My sense is that that has not been a big area of complaint so far. As I said, a lot of the stuff has been issues around providers who aren't complying with the letter of the privacy rule with respect to giving out notices, or issues around whether incidental disclosures are truly incidental, or if they are more than that.
And it seems like there is a lot of focus about what is going on in provider offices, and some areas with respect to health plans who may not again safeguard information properly. Issues like explanation of benefits being sent here and there, where numerous individuals are listed on a sort of aggregated roster of some sort, and haven't been properly redacted if that information is circulated around.
Or things like Internet prescription companies that give access to more than just the individual who is trying to get a prescription. A whole family could log on to the same account, something like that. So, that would be sort of where it's just too many people are getting information that maybe they shouldn't be getting. But I have not seen a lot personally in the employer arena.
MR. ROTHSTEIN: First, Stephanie, on behalf of the Subcommittee on Privacy and Confidentiality, let me thank you for all of your hard work. You have gone way over in your work for us, and we appreciate not only your hard work, but OCR's allowing us to call on you at a time when they were short staffed.
I have two quick points to mention. One is to answer your question, Jeff, HIPAA actually does really very little, if anything to address that problem that you referred to. That is, individuals being concerned that their employers have access to their health records. And the reason for that is it is lawful for an employer to require that an individual sign an authorization as a condition of employment, after the individual has received a conditional offer.
So, as a result, the disclosure of an individual's entire medical record to an employer is lawful under HIPAA. It's illegal in California and Minnesota, that have specific statutes that address this issue, but in the other 48 states, it's lawful. And so, therefore, HIPAA really doesn't help things. HIPAA will prevent the wrongful disclosure without an authorization, but as long as there was a valid authorization signed, there would not be a problem.
The question I had, Stephanie, is one of the recommendations or suggestions made by the subcommittee to the secretary was that some procedures need to be put in place to study the effect of HIPAA. And that is not on just covered entities, but also what if any, has it had on clinical care, on research, on public health, on all the areas that are affected by the privacy rule?
So, the question is, I know you have been very busy, but have any plans been formulated or any sort of methodology or any thinking given to this? Because I don't think any of us here can answer the question that many of us probably get, what has been the effect of HIPAA? Has it really interfered with our ability to render care? Is it just a bunch of paperwork? Are we really protecting the privacy of health information? So, is that on your agenda?
MS. KAMINSKY: I'm not aware of any efforts or initiatives right now to try to do some kind of a study of the effect of the privacy rule. I have heard murmurs at times about what potential modifications to the rule might be worthy of considering in the future future, but not necessarily from the sort of systematic perspective that you are implying might be useful to undertake.
MR. ROTHSTEIN: And in fact it may well be the kind of thing that OCR -- it's not really OCR's expertise. It may be CMS, it may be AHRQ. It may be some other group within the department that would be better suited to doing that. But I just think that we shouldn't lose sight of that, because that is really the big picture.
We are often concerned with the minutia and the nitty-gritty, but we need to step back and say, okay, we have done this. Is it working? Are there unintended negative consequences, et cetera?
DR. LUMPKIN: Well, I would suggest that that sort of question is not one that lends itself to a hearing type process such as we could do it as this committee, because what we hear at the committee meetings are anecdotes. And the plural of anecdote is not data.
So, if we are going to look at data on this, maybe if I could suggest your committee bring back to the full committee tomorrow -- because it doesn't have to be long -- a short letter perhaps suggesting to the secretary that this would be something that given the resources of the department, ought to lend itself to some sort of appropriate scientific study.
And between the NIH and AHRQ and other agencies, there ought to be resources and expertise to be able to design and grant out such a study. Obviously, it's not going to happen overnight, but it certainly might be worthy of doing.
So, if you can pull it off between now and tomorrow, but I think a very short letter just suggesting this might be appropriate.
Jim?
MR. SCANLON: I might mention that this issue has come up in the context of our research planning and our data planning in public health activities within HHS. And we are in very early formative stages at looking at how we might look at the impact in those areas. We weren't looking at medical care per se. We were thinking of how we might approach such a study.
It's actually a very difficult study to do, as you would imagine, just because you are asking -- first of all, it's fairly early in the process to do an evaluation. And secondly, we are asking about things that are obviously punishable. So, it's kind of a complicated study to do. But we have a group in very early stages trying to conceptualize what such a study might look like, at least in terms of the availability of data for research for public health and for data generally.
MR. LOCALIO: Stephanie, I agree with you that these times are very exciting, but I don't agree that things are going very smoothly. I don't want to engage in anecdotes, but I would offer two suggestions.
One is that you provide additional technical assistance not for small entities, not for rural health practitioners, but for attorneys, because there is a difference between the regulations as written, and the regulations as interpreted. And in any study that is undertaken as to the impact of the regulations, that study should reflect the regulations as interpreted.
The second item that I want to mention has not come up, and that is what is the impact of the regulation on the ability of patients to understand the information that they are being given? There is a large body of literature that indicates that patients have never understood the content of consent forms. And consent forms are far easier than the content of the authorization forms that are appearing for institutions to comply with regulations.
So, I think there are some downstream implications that were not obvious, not to me, and probably were not obvious to others when in the end of 2000, the initial regulations were put in The Federal Register. But they need to be address, because it's now in effect.
MS. KAMINSKY: That's a wonderful point. The regulations take a stab at it by speaking about things like notice being in plain English. And I don't have my regulation with me, which is always a mistake, but I have to quickly look up what we say about authorizations, whether we say the same kind of plain English requirement. I don't think we do.
But it is an ongoing concern of ours to make the Office for Civil Rights serve the consumer. And I neglected to mention all of the technical assistance materials that are out there. That HRSA has actually recently published a plain English guide for a how to do notices in plain English.
There is also a thesaurus -- I don't know if it's an appendix or if it's a part of it -- that takes complicated privacy words and translates them into more reader friendly or sometimes lower literacy level type of options. So, that is another piece of technical assistance that we have participated in. And it reflects the greater awareness of the department that this is certainly an issue that we need to kind of pay attention to.
I don't think we have received any complaints about sort of not being able to understand the authorization or the notice. But I appreciate your raising the issue, and we'll stay tuned.
MR. LOCALIO: Again, I think the guidance that I have seen is good. I think the issue is to make sure that the guidance gets seen by the people in the field, who are dictating the contents of the privacy notices of the authorization forms. And this is generally not patients. It's not physicians. It is hospital and health care attorneys. And this is not a group of people who are used to communicating with patients.
I just looked at the back of my parking ticket from the Wilmington Parking Authority, and I would defy anybody at the table to really understand what it says. And that's an example of something that should be understood by people who park their cars. And an analogy is similar to people who are getting care.
Thank you.
DR. LUMPKIN: And they used to say that physicians didn't know how to talk to patients.
So, before I say any other comments that will get the lawyers in the room upset, I'll turn to John.
MR. HOUSTON: As an attorney, I sort of have a laundry list of things just to bring up. To the prior point though, I think there is always an issue between trying to be brief, trying to be concise, trying to make something readable, and make it substantive. It's sort of the terrorism alert status, where we got to a color coded system, that now everybody is made about, because it's too simple.
Trying to put substance into a privacy notice is very difficult, while trying to make it readable. And it is not a trivial task, because many times people get mad because they don't feel like they are substantive. And that's something that I know we had great trouble trying to balance.
A couple of points though. First of all, I know it's too early to gather statistics, but I think gathering statistics both on any inquiries, as well as complaints, where they are coming from, what the nature of them are, trying to figure out a framework for gathering statistics I think would be beneficial at this point.
So, as we characterize those complaints over the next three or four or six months, we can start to get an understanding of exactly where those problem areas are. I think that would be of great use. Maybe it's already being done, but it would be real helpful to understand almost by section, where complaints are occurring, where a lot of the questions are occurring, just for this committee to understand maybe where some of the more problematic areas are with regards to the privacy issue.
Because I think the desire was to potentially hold some type of testimony in the fall. It would be helpful to use that as a barometer of where maybe some of the attention needs to be. It's just a thought.
Another point, you said the guidance -- you are adding to your FAQ or guidance and the like. Is there a list serve or some other mechanism whereby as new guidance comes out, rather than having to go to the site, obviously, it's getting a lot of hits, 750,000, that you could simply push those out, saying there is a new guidance, or a new FAQ that could e-mailed or made available?
Again, rather than waiting for somebody to come to the site to read, it allow people who are heavily involved in this to get those updates regularly just simply through an e-mail mechanism? I think that would be very effective to make sure we don't miss something.
MS. KAMINSKY: I think it's a terrific idea. I know that CMS has a list serve of some sort that it notifies folks about HIPAA news at times, although I'm not really sure.
MS. TRUDEL: We do have a list serve that we use to inform people about new outreach events. And we can explain to you how to go about doing that.
MS. KAMINSKY: I think that's terrific. It will definitely alleviate some of the burden on people just always having to check the "What's New" part of our Web site.
MR. HOUSTON: It also, I think, gives more information. Again, the more that is fed to individuals, I think the better off we are going to be in total.
DR. LUMPKIN: If I could just add to that, it would be useful to then put information about that on all the various linked Web sites -- our Web site, the CMS and other Web sites, so people can find their way to sign up for the list serve.
MR. HOUSTON: Another point too is through the course of reviewing these complaints, though obviously the complaints are very personal, and people don't necessarily need to get any of the details about them, I'm just wondering whether you have a strategy for taking a complaint, and the outcome of a complaint, and maybe using that as a basis for providing additional guidance, especially where a provider has simply missed the mark on something which has resulted in a complaint?
The OCR has provided assistance in understanding what the issue was and how to correct it. Again, I think that would be a good source of understanding maybe where the industry needs to additional information. Or maybe where we have just simply missed the mark. So, again, I don't know if there is a way to make a process to look at the how the complaints are actually investigated, as to how they can maybe translate into information for the industry on how to better comply.
MS. KAMINSKY: Another great idea.
MR. HOUSTON: And then the last thing was just a question I had. Regarding complaints that have been fielded to date, you talked about provider -- what is the breakdown of -- do you know what the rough breakdown is of hospital type of complaints versus physician office complaints? Or is it too early to tell?
MS. KAMINSKY: There is a report that can be run on the states, who each alleged covered entity is on the other side of the complaint. I did not run that report before coming here. And I'm not sure just by the names of these entities, I would be able to tell so well, although I suppose it could give some indication.
I might be able to see whether or not I could provide that kind of additional information to the Privacy Subcommittee tomorrow. I don't think any formal analysis of types of covered entity has been done to date.
MR. HOUSTON: Again, that sort of goes back to my first comments as a framework for doing statistics. And I think statistics are often very telling. And I just love to be able to dig into the data and just understand statistically the nature of these complaints.
DR. MAYS: Actually, my comments have been touched upon. I just wanted to make sure that when Mark's committee thinks about the letter, that they put specifics in. I was really going to push on the area of research, because if I have heard comments, it really has been the impact on the researcher in terms of this. So, anything you can do to kind of push toward that particular area would be great.
And then the other is interesting. I teach a course in research ethics. And a physician that I co-teach this course with, as we were talking about revamping it for next year, asked that we put HIPAA on, and actually look at things like for example, whether or not people can understand what they are being asked to sign, and things like that.
So, I do think that there are some issues on the horizon that your committee could really help everybody with in terms of requesting this from the secretary, to study these issues.
DR. HARDING: I would just like to repeat Mark's comments about the quality of the help from OCR from Stephanie, and then Vickie, and Kathleen as a replacement. It doesn't get better than that. And we are very appreciative of OCR's help with the subcommittee.
It has kind of been to me anecdotally, an eerie silence during the last two months. I am on a board of a university specialty clinic which has literally thousands of patient services a day in primary care specialty, subspecialty, and so forth at the University of South Carolina, and 600 in-patients, and trauma services, and emergency rooms, and so forth.
For the first two months of the HIPAA regulations, 10 people have asked for access to their medical record, 10 people. Almost without exception, nobody has read the authorization form. They have signed it without reading it, just saying where do I sign, and sign. The acknowledgement, pardon me.
So, I don't think that we have seen yet, any of the drifting down effect that is going to occur eventually. I think people have kind of accepting of it. Maybe because of the war in Iraq or I don't know what, people aren't that interested, or maybe they aren't that interested in the great majority. But it's been very quiet, very easily coming on board.
And it will be interesting to see what happens as things progress, and the consequences of those things start becoming apparent to certain groups of patients. But right now, it's very quiet, very interesting.
DR. STEINDEL: Just a very quick comment. The Atlanta newspaper two weeks ago had a very long article on HIPAA on the front page of the Sunday paper. So, I think people are going to start noticing.
DR. ZUBELDIA: I must be one of those weird ones, because I have been reading some of the notices of privacy practices, and I would like to if OCR can give some guidance on plain non-English notices. Because I have seen some of the notices in Spanish that are totally, absolutely unreadable. They have been translated with some sort of computerized translation, and it's not just unreadable, it's flat out wrong.
So, if you give some guidance, I think it would be helpful to the Spanish speaking community, and other foreign language communities.
MS. KAMINSKY: Well, as OCR also promulgates the policies on limited English proficiency, this is of particular interest to OCR. And it is an area that I know work is being done on in terms of how to approach the juxtaposition of these two policy areas. So, I appreciate your pointing out, and we will continue to work on it.
DR. LUMPKIN: And if I can offer some assistance, in my new job we fund a fairly large demonstration project called Hablamos Unitos(?), which is focused in on trying to bridge the language gap in health care. And if OCR is interested, we can put you in touch with our national program office, and they may be able to provide some assistance in helping with those translations, and making sure that the communication occurs in limited English proficiency areas.
Okay, thank you very much. Once again, I think that the committee as has been stated, has been very appreciative of your services. Obviously, the department has been, because you're the only one I know who has had their picture up on the eighth floor. And probably the reason why they are rotating you off is because they knew we wouldn't let you live that down. We really have appreciated your help.
And we move onto the CHI. Cynthia.
Agenda Item: Consolidate Health Informatics (CHI), Cynthia Wark, CMS
MS. WARK: Good morning. I'm Cynthia Wark, and I'm the technical lead for the consolidated health informatics initiative, and I'm here today on behalf of Jared Adair, who is the project manager for the CHI initiative.
I'll be providing a status update on this initiative. And as you all know, there has been a great deal of work going on in the government over the last approximately 18 months. And we certainly had a number of outstanding accomplishments. And we are continuing and accelerating those as we move forward. And I would like to share some of the newest information with you.
Noteworthy is the relationship that has been forged between the CHI initiative and the Subcommittee for Standards and Security, and the work that has been done with the subcommittee to take advantage of the extensive information that has been provided by that subcommittee over the past few years in regards to standards.
And along that vein, there was an afternoon roundtable discussion on May 20, with the subcommittee, to provide information about CHI to the committee and to all of the attendees who were present at that meeting. And in addition to providing information about the initiative, we reviewed the portfolio. We asked for input to that portfolio.
We proposed a communication strategy, and had a dialogue about how that communication strategy would be implemented. And for the first time, we shared some preliminary thoughts from some of the teams that are currently deployed.
As you all know, we have had an extensive list of federal partners participating in the CHI initiative, with DOD, VA, and HHS as the main partners, and an ever expanding list of other federal agencies that have been getting involved. That list is continually expanding, and we are publishing a new list on the egov.gov Web site this week.
Our goal is to enable data interoperability across the federal health enterprise, and to serve as a leader in standards adoption. We have had extensive questions from organizations and individuals outside the federal health enterprise as to what the impact of this initiative will be beyond the federal health enterprise.
On May 20, we presented information about the scope of our effort, and what the results and outcomes of CHI means for the federal health enterprise by way of adopting the standards, and incorporating those into federal IT architectures. Certainly, that can serve as a model for those outside of the federal health enterprise, and we heard lots of welcoming remarks as to the work that we have been doing in the CHI initiative.
We have started to develop working relationships with the standards development organizations to address gaps, as we all recognize that no standards are perfect. And there was a re-affirmation that use of standards will drive much needed improvements.
We are very pleased at the relationship that has now been established with the NCVHS subcommittee to build on the previous work that has been done, and to achieve compatibility.
We have reviewed the 24 messaging and vocabulary domains with again, a review of the first 5 standards that were adopted in March. We reviewed the 6 vocabulary teams that are working now. And we also have a number of teams that are beginning to form.
We asked questions about the portfolio. Was it on target? Did it have the right domains? And are we approaching it in the correct order? And we received quite a few comments and feedback about the domain that has been helpful.
I would like to update the committee now on the progress that has been made over the past month. On May 20, as I noted, we indicated the teams that are now deployed: the medications teams; the intervention and procedures team; immunizations; demographics; clinical encounters; and lab results contents.
Many of those teams are now coming in to the council with the results of their work and their deliberations. And that information is now being shared throughout the federal agencies so that they may take a look at that, and provide any additional feedback they have to the CHI Council.
In addition, we are launching a new team round of teams including: diagnosis and problem list; anatomy and physiology; devices and supplies. And over the upcoming month to two months, we expect to launch teams on: nursing; disability; text-based reports; history and physical; and multimedia. We're not only making a lot of progress with the teams that are now deployed, but we're also launching a whole new round of teams.
On May 20, our teams that are now deployed shared some of their preliminary thoughts, including the participants on those teams, including the candidate terminologies that were identified, including the scope of that particular domain that was identified by the team, and some preliminary thoughts and issues that the teams have been dealing with.
One of the outcomes of the May 20 meeting was that the subcommittee would find it helpful to have a standardized format to get information from the CHI Council to the subcommittee. And we are working on that format now, and hope to share that soon with the subcommittee, so that we can get the input of the committee and the council, and agree on a format for providing that information.
We heard quite a bit of feedback that was very helpful, and we look forward to a continued, collaborative relationship with the subcommittee.
That concludes my remarks.
DR. LUMPKIN: Well, I think I would just like to take this opportunity, because we sort of started off this meeting with looking backwards and looking forwards, and we're sort of right in the middle of the transition.
One of the recommendations that we have made as a committee consistently has been the importance of federal leadership in the area of informatics and standards and standards development and all the work we are doing. I just wanted to thank you and CHI for really providing that kind of leadership, not only within the department, but across other federal agencies. I think it's really an important development, and we are really pleased as punch to be partners in that process.
MS. WARK: I will take that back to the council, thank you.
DR. STEINDEL: Cynthia, did you mention population health reporting in the next round?
MS. WARK: I did not mention population health, because that team, let me clarify, has been formed. And it has been placed on hold, and will be re-initiated following some of the work to be done by some of the newly deployed teams. We have prioritized anatomy, physiology, diagnosis, problem list, and the devices ahead of population health, because it was thought that those areas needed to come forward to the council with some recommendations that would be helpful to the Population Health Work Group.
Thanks for the clarification, Steve.
MR. BLAIR: Actually, John, your comments were the ones I was going to give. We really appreciate the focus and the leadership that CHI is giving.
DR. LUMPKIN: I didn't mean to end the conversation.
DR. COHN: I was just agreeing with Jeff and others. I think you said it very well. Obviously, we look forward to continued working with you at CHI. Obviously, our next hearings are in August, and based on this conversation I think we need to stick you back on the agenda during those hearing periods.
DR. LUMPKIN: And I think it's important probably to say at this point that we should also give our appreciation to the secretary, because it's very clear that the secretary is taking on this issue. I know that there is the constant question that is coming out of the secretary's office of how come this isn't done last week? And we all appreciate how difficult that work is, and it's nice to know that senior management at the agency is very supportive here at HHS.
MS. WARK: Thank you.
Just to add on one more comment. There has been some skepticism about how we can accomplish this amount of work in such a short period of time. And one of the main reasons that we are able to do it is that we are building on the work that has been previously done by the subcommittee, the extensive work over the past few years.
And we are constantly reinforcing the message that we're not developing anything, we are adopting standards. And we are using the extensive knowledge and work, and the hearing that continue to go on help us gather information and formulate recommendations. So, we thank you for that.
DR. LUMPKIN: It's good to see this work bearing some fruit.
At this time, unless there are other questions, we are scheduled for a -- Marjorie, please.
MS. GREENBERG: [Administrative remarks.]
DR. LUMPKIN: Okay, we will take a 15 minute break, which by means by watch means that we will get back at 10:45 am. We will be slightly ahead of schedule.
[Brief recess.]
DR. LUMPKIN: Okay, we have Dr. Altman, who is here from FDA, to talk about the basics of consensus standards.
Welcome.
Agenda Item: The Basics of Consensus Standards - Melvyn R. Altman, PhD, FDA
DR. ALTMAN: Thank you. Good morning.
I'm not sure how the request for this presentation came down. It came through a lot of people, so I'm not sure what you asked for. And after I've been listening in this morning, I'm not sure you all need it all that much, because it sounds like you know a lot about standards and how they are developed. But I'm here anyway, so I'll give the talk. And maybe I can answer a few questions. I'll give you some background on how the process works.
I'm in FDA in the Center for Devices and Radiological Health. I'm the associate director for standards policy in our Office of Science and Technology.
Consensus standards, we'll talk about a few aspects of it, and how things work, definitions, types of standards, and what kinds of scope standards have.
These are sort of textbook definitions for standards, very general, and include very many kinds of standards, almost anything you could think about.
There are a lot of terms we use in standards development, I'm sure you've all heard -- SDO, standards development organization. ANSI, the American National Standards Institute, which is an umbrella organization. It's important to notice that ANSI is not a standards developer. ANSI accredits standards developers in the United States, and does other work related to international standards development, which I will get to in a little while.
Some examples of SDOs that FDA is involved with is ASTM, the American Society for Testing and Material; ISO, the International Organization for Standardization; ASME, American Society for Mechanical Engineering, and lots of others. ISO is the International Organization for Standardization, and the counterpart on the electrotechnical side is the IEC. And the work is sort of divided between what's electrical and what isn't, although there is some overlap, and there is some joint work.
NIST, as most of you know, the National Institute for Standards and Technology, which has a role to promote standards use, particularly consensus standards use within the federal government in place of regulatory standards, and in place of standards used for procurement.
TAG, technical advisory group, which usually is used in reference to ISO and IEC. And what it really is in the United States, basically the mirror committees in the United States that follow the work of various ISO and IEC committees.
What is consensus? These are the aspects that need to be in the process that you would call a consensus process. It needs to be open to all interested parties. Everyone has to be given the chance to participate in some way. That doesn't necessarily mean everyone has to be able to sit on every committee, but they have to be able to participate in some way.
The committees and the process should be balanced. Nobody should dominate. There should be due process. There should be a well laid out procedure for how the standards are developed by any standards development organization. And in the United States those procedures, if it's an ANSI accredited group, will have to be submitted to ANSI and approved by ANSI. I actually sit on the group at ANSI that does that work.
And there has to be an appeal mechanism, so that when people are aggrieved in some sense by the final product of the standards development organization, or by the process that led to that final standard, there is a way to have their voice heard.
How are consensus standards used by federal agencies? You certainly heard some of that this morning. But there is a codification of that in the National Technology Transfer and Advancement Act, which basically says that federal agencies will use consensus standards wherever they can. There is always of course an out if they can't be used for specific instances, but the NTTAA really puts the burden on the agencies to say why they are not using consensus standards, if they are not.
The OMB Circular 8119 really came before the National Technology Transfer and Advancement Act, and was just advice to the agencies basically. And the National Technology Transfer and Advancement Act really put teeth of some sort into the OMB circular. It is currently being revised. It is basically always currently being revised. I think 1997 is the latest version though.
NIST is charged to implement the NTTAA, and to gather data from federal agencies every year on what progress they have made in using consensus standards. FDA and other federal agencies are a member of the ICSP, which is the Interagency Committee on Standards Policy. Each federal agency or department has what is called a standards executive that sits on the ICSP, and formulates policy for the federal government on use of consensus standards.
When I say consensus standards too, I'm also usually talking about the other part which is conformity assessment. That is, how do we know that standards are being met, the process for that. I'm not going to get into that, but that's sort of the mirror side of consensus standards development.
What types are standards are there? Well, there are obviously regulatory standards, and FDA has a lot of those. And in the part of FDA that I work for, we have not many, 9 or 10 or 12 maybe at the most actual regulatory standards. The reason we have so few is because it is not easy, and it's not cheap to develop them. It is very difficult and costly, both in time and money.
So, when we were developing regulatory standards originally in the radiological health area, we found it took so much time, we just couldn't do it in all the areas that we actually had responsibility for. So, we only did it in some of the areas.
But it is much easier, as I'm sure you found out, to let the standards developing organizations develop, on a voluntary basis, consensus standards, and then use them where you can use them as regulations, if need be, or use them in some other way. And I'll tell you at the end how FDA actually uses consensus standards.
There are standards that aren't necessarily consensus standards that are developed in the United States and elsewhere, and they may be developed by a single entity or by a consortia. You have heard an example this morning of another kind of non-consensus standard or non-full consensus standard, that was the draft standard for trial use. There is actually a system set up in ANSI for how do you do that, and what does it mean, and what are the steps you need to go through.
You want to have a process like that available for cases where you want to try out a standard that isn't critical for health and safety, that people won't die from if there is a mistake in it. And you also want to have a process where you can develop standards quickly when there is an emergency, and you can't go through the full consensus process, and you need to get something out there quickly.
So, you want to have draft standards for trial use, and also basically draft standards for emergency use. And then you will get around later to do the full consensus process. And those systems exist to be able to do that.
So, consensus means the collective opinion of all interested parties. And it obviously is understood by you, and should be understood by everyone that while majority rules, you don't necessarily have to have unanimity.
Standards -- this says scope, but really what we are talking about is the two big divisions between standards called horizontal and vertical, or generic and specific. Example of a horizontal standard are a standard for sterilization, which would cover a lot of medical devices, or biocompatibility, which would cover a lot of medical devices and a lot of classes of medical devices.
Vertical standards, which are much more specific, would be for specific devices. In my case, heart valves, or in a non-medical area film speed or suture strength. These are just examples. There are obviously hundreds, if not thousands of others.
What are the sort of levels of standardization? Well, the first level you might think of is terminology. What are the terms you are going to use? What are the definitions you are going to use? And that's sort of the groundwork for standard setting.
And next might be thought of what are called parametric standards, where you define what are the important variables, and how to test those variables, but don't actually give requirements for what those levels must be. And what we like to think of as the highest level performance standards, which actually establish acceptable levels of performance for in our case safety or effectiveness, or both.
Let's talk a little bit about the structure of the standard systems, both in the United States, and the rest of the world. In the United States, most standards development, as I said, is done under the ANSI umbrella. And we say there are 4 million voters, and I'm sure quite how we get to that number, but the point is it's a large number.
There are 40,000 members of ANSI, but people can vote on standards in ANSI even if they aren't members of ANSI. So, when standards from an ANSI accredited SDO are announced, and they are announced publicly, anyone can vote on those -- not vote, but anyone can comment. We really don't have 4 million voters, but anyone can comment and participate. And so, you get a lot of potential advice from the public.
The actual committees that do the work, and the working groups under the committees usually are fairly small. Twenty is really kind of typical, 200 would be kind of a large committee, but they exist.
Internationally, the three main organizations are as we mentioned before, ISO and IEC, and ITU, which is the telecommunications part of international standardization. And here we have participation by countries. ANSI is the US voting representative in the United States for all three. It delegates the responsibilities to the US technical advisory groups, which are responsible for forming a US position on any particular international standard.
And also, the technical advisory group, the TAG, accredits delegations to actually attend technical committee and subcommittee meetings of these international organizations.
Why are consensus standards credible? Because of the reasons we said that went into being a consensus standard. The process is open. Anyone basically who has an interest, can participate. In terms of ANSI accredited SDOs, there is the balance of representation, due process. Regular review of standards is required, so that standards don't get too old. And typically that happens at least in five years, but sometimes more quickly if the technology is changing more quickly, and of course consensus is required.
And again, for the international standards organizations, the consensus is by nation. So, sometimes people think of the international process as not really a consensus process, because everyone doesn't get a chance to participate. Every nation gets a chance to participate, but not every individual in every nation.
Now, in the United States the process is such that everyone really does get a chance to participate through the technical advisory groups. That doesn't happen in every country. So, it's hard to say whether you are really getting an international consensus, but it's the best we have now, and these organizations really do develop very useful standards, so we do participate, and try to work to get every country to participate in a way that lets all the people in the country have a say.
FDA participates, and the interest I have is in the medical device area and radiological health area. And we participate widely. We have about 250 people within our organization of 1,000 that participate in standards developments. They are in the standards development organizations, all the committees. And we do it again, not just on the technical, but on the policy levels too, because that's the way we can influence the direction of the standards developing organizations.
And finally, I'll just mention what we do in terms of using consensus standards. Before 1997, we didn't have actual statutory authority to use consensus standards in our regulatory program. In 1997, the Food and Drug Administration Modernization Act, FDAMA, came into being, which officially let us recognize standards, and allowed us to even replace regulatory requirements by standards.
We had used parts of consensus standards in the past in our regulatory standards, but not explicitly. We just used certain requirements in consensus standards. But now we had the permission to actually use complete consensus standards in our regulatory programs.
What we do is for devices that need to be cleared before marketing, we have a process. And part of that process is certain requirements need to be met for certain technical areas. With recognizing standards, what we do is we allow manufacturers to use recognized standards to satisfy technical requirements.
And the way they do that is they declare conformity to one or more of the recognized standards in place of sending data into FDA. So, all they need to do it declare conformity to a recognized standard, and we have to accept those declarations of conformity.
We have lists of recognized standards. We have about 600 so far. We publish new ones once or twice a year, but at least once a year. We just did it a couple of months ago. We'll do it again in a few months. And we're always expanding the use of the recognized standards.
The actual fact is that manufacturers haven't taken up the use as much as we would have like them to. People get into a way of doing business, and they don't like to change, so that they are a little fearful of doing things in a different way. But it is coming around I think, and we are working on getting the word out to them that it will really be an advantage not only to them, but to us, and it will save everyone time and money. So, that's the way we do it, and you know the way you do it.
And I just wanted to mention that I don't think he is here today, but Mike Fitzmaurice is a person that works with you sometimes from the AHRQ, Agency for Healthcare Research and Quality, heads up the effort on health care informatics standards. I think he actually heads the Health Care Informatics Standards Board, which is a board -- I don't know if he heads it, but he's on it certainly.
MS. GREENBERG: AHRQ supports the board. Mike has been pretty active though.
DR. ATLMAN: Right. And there is actually an ISO committee on health care informatics. I think it's TC-215. And I think Mike does some work with them as well. I don't know who actually does the work for the United States for ISO TC-215. I'm not sure.
DR. LUMPKIN: There is a new TAG.
DR. ATLMAN: I really don't know. I was working with Mike when this all began four or five or six years ago. But once it got established and everything was moving along smoothly, I kind of dropped off. I think we have some representation on the standards board, but that's not me.
So, that's about all I wanted to say. If you have any questions?
DR. COHN: First of all, Mel, thank you very much for coming and talking about this one. And I have a sense that we may at some point, get you in front of the Subcommittee on Standards.
DR. ATLMAN: Yes, I saw that, and that would be fine.
DR. COHN: Only because I think that there are probably many more questions that we can ask in a relatively limited period of time.
DR. ATLMAN: I left my card when I signed in, so you can get all the information you need there.
DR. COHN: Well, thank you.
I think as I listened to you, I am obviously struck with what I think is a very good basic presentation, as well as sort of reflecting in my own mind that of course there are standards, and there are standards. One of the wonderful things in this world is that there seem to be so many of them.
Now, in our world as we know, and this is the world of medical informatics and health care information and all that, there obviously seem to be a variety of very high quality, commonly used standards, and others that seem to be somewhat ignored. They are all developed through the process that you were describing.
I guess the question is, can the government view on all of this stuff -- it seems like your approach is, as I understand, mostly to sort of pick and choose, at least in the world of the FDA, what you consider to be high quality standards, which is how you insure quality?
DR. ATLMAN: Well, we have a process for looking at standards. When we started this, we knew the standards we were already working with. We looked at those, and decided whether they were suitable for recognition. And we also left open a public process that allowed people to recommend standards to us for recognition, and we got quite a few. And we put them through a process of expert groups in specific areas, and make a judgment on whether we want to recognize them, and if we do, we do.
DR. COHN: Okay, so, you do pretty much what CHI is doing now, where just the fact that it's an ANSI approved standard is not sufficient?
DR. ATLMAN: That's right, absolutely.
DR. COHN: Let me just ask a further question here on this one, which I think maybe relates to the Circular 19TS, which I think I have read, but obviously haven't read any revisions of. How do international standards fit into all of this stuff? Can you just talk about that for a second?
DR. ATLMAN: Well, first of all, the NTTAA encourages the use of international standards for basically trade reasons. They are not just looking at FDA, they are looking at the whole federal government, and they are looking at procurement, as well as regulation. And they really encourage the use of international standards.
Now, it's true that the international standards organizations are not accredited by anybody. They get their credibility just from having been there for 75 years, or close to 100 years in the case of IEC, and we see what the outcome is. They aren't accredited.
Let me back up a little bit though. In the United States, we use standards that are developed by SDOs that are accredited by ANSI. But we also leave it open to use standards that are developed by organizations that aren't accredited by ANSI. When we do that, we need to look at that, and we have done it. We need to look at that organization's procedures to see if we think they embody all of the elements of consensus, even though they are not ANSI accredited. And if they, we will use their standards. And we have done that in a few cases.
In terms of the international standards though, we just have made a judgment that ISO, IEC standards are acceptable in general. We still make a judgment on each individual standard, but as an organization, they are acceptable. We don't look at their process in detail. We accept it.
DR. STEINDEL: A couple of questions, comments, reactions concerning international standards and the ANSI process. I sit on ANSI HISB(?), as well as Mike and several other people in this room. And about a year ago we had a presentation from one of the officers from ANSI concerning involvement with the international process.
And one picture that came out of that presentation was that as you pointed out, the nations have a vote. And as a nation, the United States has a vote. And the European Union has many votes, and generally votes as a block. They have different processes going on. As you noted, they don't reach consensus. Sometimes this is individual opinions, and there is a lot of politics being played out at the ISO level. I think we don't need to go into that in great detail, but I think we are aware of it.
The question that I have is what should we in health care be doing with respect to ISO on the international level when it is so difficult for us to achieve something within that organization, especially when we are having problems achieving it within the United States at times?
And right now, the TAG, the US TC-215 TAG has undergone a change in secretariat. It has moved from ASTM to HIMS, and will be starting back up in HIMS in a few weeks. There was a transition period. Consequently, at the last international meeting, there was not good representation from the United States.
They are hoping that with this change, there will be better organizations within the TAG, but right now the TAG is basically being represented by Ed Hammond and Chris Chute(?), who I think many of us know.
We, at CDC, have a very big question as to whether or not we should make the commitment to get involved internationally. And I brought this up at the last ANSI meeting, and the comment was made there of ISO versus WHO on the international scene. And I think many of us are also aware that national laws in many other countries automatically accept ISO standards.
So, my question is what should we be doing from this group internationally, given that picture?
DR. ATLMAN: Well, let me say a couple of things. We started off with talking about block voting. That certainly can happen. We don't actually see it happen in the parts of ISO and IEC that we participate in. Maybe that is unique, and maybe there are sectors where it does happen. We just don't see it too much, and we have been sensitive to it.
Now, while it's true that there are whatever number, 17 European Union nations, and there is us, and all of them get a vote, and we get one, what I find personally is that when I go to a meeting, and IEC or an ISO meeting related to medical devices, and I'm sitting at the table, while all the nations around the table, the representatives of those nations have one vote, and the US has one vote, when I speak as a representative of FDA, I really get more than one vote's worth of listening.
And I think the same would happen in your area if you got the federal partners to work in the international area. If you don't, then I think it is viewed by other countries and by the organization ISO as well, it's not very important to US government. So, we won't listen to the US anymore than Liechtenstein.
So, I think that's the important thing to do, is to get the government agencies and departments who are interested in this area, involved in the international standardization, and to be at the table. They carry a lot of weight. You would be very surprised. Maybe you wouldn't be surprised, but it's the case.
So, there is a lot of leverage there that you wouldn't think you would get, because we have just one vote. It hasn't been a problem for us. We have gotten what we wanted into the standards that we were interested in.
DR. LUMPKIN: Great. I would like to thank you very much for coming, and encourage the connection with the subcommittee.
MR. BLAIR: One brief comment. Mel, could you pass on to all of your counterparts at the FDA, an expression of appreciation that I certainly have, and I suspect many other people on NCVHS has. In August 2000, when we submitted our report on PMRI standards, we encouraged greater participation of FDA in the private sector standards development organizations, especially with respect to the focus on standards for patient care information for drugs.
And that has certainly happened. FDA has become an active contributor and leader in that area. And I wanted to not miss this opportunity to express my appreciation for the response of the FDA.
DR. ATLMAN: I appreciate that. I will bring that word back. Thank you.
DR. LUMPKIN: Great. Thank you again.
We are going to move on to the status report from the Quality Workgroup. Bob.
Agenda Item: Status Report from Quality Workgroup - Robert Hungate, Chair
MR. HUNGATE: Thank you, John.
I would ask you all to turn to Tab 4, where you have a briefing paper from the Workgroup on Quality. It is interesting. I hadn't realized that my placement on the agenda was going to be right behind the FDA. But I spent several years here in Washington as apart of AAMI and the medical industry, looking at standards related to the products and devices that we sold.
And a take away from that is that the standards that apply to the tools are only part of the challenge of quality. That manufacturers, in trying to get standards, are always trying to make the standard acceptable to what they have got, even if they are not the best, when those who are the best are trying to move the envelope a little bit.
So, standards, in some ways, impede the progress. But they also mean that some progress is possible. So, there is tension in standards. And how the tools are then used by the professional is what ends up with the real result.
I don't know how many times I have seen an EKG repeated from one place to the next, because the EKG machine in the first place met all the standards. The professionals who took the second EKG didn't believe that the first one was necessarily right. And so, standards and the hardware are only part of it. The rest of it goes beyond that.
Now, I also want to preface my remarks by observing that I am a card carrying Medicare beneficiary. And I like to talk about health, and health for beneficiaries. That's been an agenda of mine for years. My wife says, you are unqualified to do that, because I'm healthy most of the time, and never bump into the problems that an awful lot of patients, beneficiaries experience.
And so, I want you to realize that I have made a sacrifice. I have submitted to double hernia surgery about 10 days ago, and now have personal experience with the health care system, and feel qualified to speak a little more definitively.
I would like to try to do three things in short time that we've got to talk about this. I have come onto to this committee, as has Don, with no institutional memory of the prior work of the committee. So, we are heavily dependent on John Lumpkin, who has been a member of that, to keep us calibrated in making recommendations from past work which we did not participate in.
The other part of that is that much of the testimony taken around the workgroup's efforts was before the full committee. And so in fact, there must be expectations on the part of the full committee of what this report should do. So, I would like to get a good sense of that from the committee.
The second piece of it is in the briefing paper itself, there are some recommendations which are at this point, tentative. I think that on page 3, there is the preview of the recommendations to improve health care quality information. I'll come back to that in a minute, but there are four major sessions for administrative data, survey data, support of the adoption of electronic medical records, facilitating the linkage of records through other activities.
That's the way we have structured the recommendations. The point of this discussion is to preview where we think we are going with the report, so that we can have a more complete discussion at the next meeting in September, where we would expect to be bringing a full report before you, having previewed the recommendations for your concurrence.
So, with that kind of introduction, let me ask for comment and suggestion. Am I on the right track, and is that an appropriate agenda for this period of time? Are there inputs that you would like from this process that I haven't described?
DR. LUMPKIN: It looks like you are on the right track. Forge forward.
MR. HUNGATE: Hearing none, we'll go forward.
DR. LUMPKIN: But sometimes you may not want to ask that question.
MR. HUNGATE: I realize that I come at this very much from the beneficiary side, with no experience of working with this committee. And I'm going to need a lot of guidance and a lot of help, so, I believe in asking.
We have expressed the linkages to the other activities of the organizations, the other committees, the other reports, heavily depending on the NHII as the direction in which things are moving. We have expressed a conceptual framework of what the topics will cover. And then as we started to talk about the recommendations, I think we should probably just quickly read through those recommendations, and see if they seem to fit.
Simon?
DR. COHN: The first one sort of caught my eye, and I don't even necessarily want to talk about it yet, but in the process that you have started on, I guess one question I would have is the timeliness of the testimony upon which you are basing these recommendations. Only because I remember it seems like forever we have had sort of sessions on quality before the committee. In fact, it's been sort of a stable activity for the committee.
Are you basing these on the basis of the testimony that you have heard? Do you feel that it's all timely enough to make recommendations at this point?
MR. HUNGATE: We have engaged Kathy Coltin as a consultant to help in the generation of the report, to try to collect some of that institutional memory.
My personal observation, I read all of the testimony to try to bring myself up-to-date. And what I saw in that testimony was very much what I would have heard 15 years ago. And so I don't feel like much has changed in terms of the quality aspect of the discussion.
Now, there is a lot of stuff that has changed, but when you get down to what comes to the patient, I'm not convinced that we've made a lot of quality progress.
DR. ZUBELDIA: I would like to make a comment on that, and I second Simon in that it seems like some of these recommendations are dated. I was looking at this administrative section. And except for the last bullet, which I'm trying to research, I think everything else has been incorporated in the current HIPAA.
DR. COHN: I don't think test result --
DR. ZUBELDIA: Except for race and ethnicity. And race and ethnicity has not been put in there, because it doesn't change from claim to claim, so there is no reason to send it every time you see the patient. But everything else is already in the 837.
MR. HUNGATE: This is exactly the whole discussion I would hope to understand.
DR. LUMPKIN: So, I think that maybe what we need to do is sort of do this in an orderly process. And I think you had a recommendation for doing that. Let's walk through that. Let's hold the question that we will come back to, which is are we still timely enough?
We have to be aware that some of the things that we do in this committee, sometimes just by having a discussion, things move. And sometimes we don't require a recommendation, because we have actually solved the problem by having the open discussion. So, we need to evaluate that at the end of the discussion, how much of this stuff still needs to be done. I think that's an appropriate question to come back to.
MR. HUNGATE: I think it would benefit me most to just go through the recommendations section by section, in whatever detail is necessary to understand them. There is no current pride of ownership attached to them from those of us that are there. So, I think we can deal with them substantively in just the way that you started to do.
So, let's take the first one on administrative data.
DR. MAYS: I just want to make a comment a little earlier in terms of links, in terms of where I see you are going, because it seems like in terms of the links, what is going to happen later is that the recommendation then has some groundwork. And one of the things the quality group did was it has -- I'm trying to remember now -- either two, maybe three, but at least two that I can remember, hearings very specific about issues of quality in terms of race and ethnicity, in terms of those particular subpopulations.
So, I just want to make sure that maybe some of that gets linked in, in terms of the importance of work that is being done in terms of subpopulations, because I think it presents an interesting set of issues that probably will get detailed a little bit more in the recommendations.
MR. HUNGATE: Let's come back to the point that Kepa made at the beginning.
DR. LUMPKIN: Maybe, why don't we march down. Instead trying to do all of A, let's start dealing with the big bullets.
DR. STEINDEL: I believe that at the last NUCC/NUBC joint meeting there was a discussion on adding -- and I was looking at the list and trying to check my notes if this was a complete representation of what was asked at that meeting. But if it's not, it's very close to being a complete list.
If I can summarize what was said at that meeting, the NUCC and the NUBC at this point in time, do not have spaces for this type of information. The 837 does. It's in the 837 itself. It may or may not appear in the implementation guide. And if it does appear in the implementation guide, it appears as optional segments.
And I think what is really being asked for here is that this data, where appropriate, be given as mandatory, and not just having a place for it.
DR. ZUBELDIA: There is nothing option in the 837. This is situational, which is a term that means if the situation is present, it becomes mandatory. So, you can't make some of these things mandatory for everybody. It has to be situational. And perhaps what the SDO needs to do is look at the definition of the situations, and perhaps clarify those situations. But it is there.
MS. GREENBERG: I think it would be useful to go through some of these. And as Steve said -- Steve sits on the NUCC. I am on the NUBC. And I do think feedback from that group was that the focus should be on the electronic version or the 837, rather than on the paper forms, because certainly that's the movement that everyone is trying to go towards, as well as the fact that the electronic environment doesn't have the restrictions, the real estate restrictions as much as the paper form.
But it is my understanding that race/ethnicity is in the 837 standard, but it is not in this version of the HIPAA guide. It is in a health care report guide, which the Public Health Data Standards Consortium has developed, which is compatible with the HIPAA guide, but not compliant.
Test results and vital signs, I was not aware of them being in the 837. I think they could be captured in the claim attachment standard, although as we heard earlier, that hasn't even come out as an NPRM.
DR. ZUBELDIA: There is a test result segment in the 837, and it is required on service lines which bill a report concentration, hemoglobin, hematocrit, APO, starting dosage, creatinine, and oxygen. Now, that is where the situational could be adjusted to meet whatever situation you need, but it's there today.
MS. GREENBERG: Okay, so there are some specific tests. And that probably needs to be investigated.
This indicator field does exist in the 837.
DR. LUMPKIN: We're staying with the first dot.
MS. GREENBERG: Oh, you want to do the first dot. So, what you are saying is that some test results, and obviously they should be situational. And that was I think, the feedback that the committees also gave to the requesters who represented basically employers and purchasers, was that test result or vital signs or whatever should be situational too, rather than for everybody. I think they have come around to that, to some degree.
But anyway, are those fields that you mentioned, are they actually in the HIPAA implementation guide?
DR. ZUBELDIA: Yes, they are.
DR. COHN: I think the bad news is that the devil is in the detail on all of this. And it gets into does the field exist, is it in the HIPAA guide If it is situational, what situations now, what situations in the next two implementation guides?
I hate to go down to layers of complexity, but this is an area where it might make sense to get somebody in, or maybe some representatives from NUBC and NUCC, X12 to sort of address where are they on all of this in a way that we could all understand. Because I think you are hearing pieces of it, but I wouldn't tell you that there is -- if you probably put it all together, there is absolute truth here somewhat.
I think at the end of the day, I think the observation is that most of things are used little, if at all, in any of the transactions we are talking about. So, I think there is probably a reality here. But exactly what needs to be done is I think another question.
DR. LUMPKIN: I think that as we discuss these issues, part of it is I think we need to put them within the context. Clearly, there is significant evidence that race and ethnicity influence the quality of care, and that there are significant disparities that can be measured both within the context of health status, but also within the context of institutional patterns, as well as community patterns of care.
There has also been some recent evidence published that indicates that if you enhance quality, you actually reduce disparities, at least with renal care, if you enhance quality. So, if you improve the level of quality of everyone, then the difference due to disparities narrows. It doesn't go away completely, but it narrows.
So, the validity of saying that there is an importance to quality of capturing that data, I think is the first step. After that, then I think the follow-up portion to that recommendation -- so, it's almost like it's a finding. Then the recommendations are that we need to carry forth the steps that would allow that to be carried as part of clinical data.
And here this gets to the timeliness. We probably want to go away from talking about the specific steps, and saying that the ultimate outcome is. This will be captured as part of the process. And then recommendations say this may include such things as changing the situational status within the 827, assuring that there are appropriate guidelines on how it is filled out within the UB-92, and other similar forms.
MR. HUNGATE: I'm comfortable with that.
I want to raise another question here for my own edification and assistance. I have long been an advocate of risk adjustment outcome measures. And it seems to me that if you are going to use risk adjustment, you have got to do it from the administrative data. But I don't know what the breaks are between administrative data and clinical data, and the discussion of these issues.
One of the sub-discussions of this section was how much clinical data do we want to force into the administrative record? A lot of this is purchaser-driven, where the desire is to assess the quality of what was done. It's an historical looking at the past. My own bias is to try to build a system that is self-improving -- raising the level of all renal care, retaining the ability to see where race and ethnicity is a distinction.
Does that question make sense?
DR. LUMPKIN: Well, to my mind it does and it doesn't, because there is another question that has to be answered first. Is quality measurement clinical, or is it administrative?
MR. HUNGATE: I believe it is clinical, but it can be facilitated by the way administrative data meshes with it.
DR. LUMPKIN: Let me rephrase that, because I heard someone say both, and I'll let Simon throw his hat into this argument. I would perhaps argue that while quality improvement, components of quality in electronic medical record is clearly clinical, that when we look at quality as being used as a tool as GE is doing for instance, enhancing payments for providers who adhere to guidelines in treating people with diabetes.
So, now those measures -- are the getting the hemoglobin A1C, are they getting regular eye exams, are the getting regular foot exams, because administrative data, because they determine reimbursement. And so, that blurs the boundaries. And I think that's an issue that probably ought to be discussed in the document.
DR. COHN: I think you were saying exactly what I would. Obviously, HEDIS, for example, which rests on administrative data, is a lot of what, John, you are just describing. I was also going to chime in here with another hat on. Obviously, you are bringing your Medicare card does remind us that Medicare and CMS are actually in the midst right now of an implementation of the largest demonstration of risk adjustment for Medicare Plus Choice members in the country.
And they are basically using administrative data at this point, not that they can track outcomes, but they are finding diagnoses and ICD-9 are very valuable as a risk adjustment tool. So, that's something that may be once again, very timely to look at that, because they are literally in the midst of that implementation.
MR. HUNGATE: I would like very much to grapple with that in this report. We have not had enough discussion of that subject matter in that subcommittee to be able to do so yet. But it seems to me that here is the right place for it. And some kind of philosophical statement of where that works, and how they mesh should be part of the recommendation.
I have to express a personal feeling that there are severe limits to what HEDIS can accomplish. And that we would be well advised to try to bound what it can and cannot, and find what needs to fall.
DR. COHN: And just to set the record straight, we all know that NCQA and others are really constrained by the fact that they tried to use it.
MR. HUNGATE: It's not a criticism of the participation. It's a recognition of -- I serve on a group insurance commission in Massachusetts. And we try to do a lot of good things for our beneficiaries. We fail more than we succeed in terms of getting something that really works, that works at the patient level.
DR. HUFF: I think there are practical implications to this idea that part of the clinical data is becoming administrative. And I think it comes back to the idea of claims attachments. And though we haven't gotten the new revised proposal before us, the idea that this clinical data would come in an HL7 format, and be included. So, I think it's a question of what's included in a particular transaction.
The practical issue that I want to focus people's attention is that we have an evolving and a maturing infrastructure for sending clinical data around. And I don't think we want to ignore that, and have a new set of people who are worried about the 837 transaction, and whose training and understanding is primarily administrative now, start trying to become clinicians in including that data.
But in fact that data be included using known ways and evolving from the infrastructure and knowledge that has been created over a number of years in the clinical standards development organizations.
DR. LUMPKIN: Kepa, followed by Vickie, and then we are going to move to the next stop point.
DR. ZUBELDIA: I agree with what Stan said. But the fact that the 837 is there, and will be essentially required under HIPAA doesn't mean that everything should be hitched to that wagon. Specifically, race and ethnicity is not appropriate to be sent as part of the claim or encounter. It's not something that changes from encounter to encounter.
It would probably be appropriate to send as part of the enrollment, and it is already part of the enrollment transaction, but it's not something that should be hitched to the claim. And some of the clinical information that is on the claim, X12 has the plans to take it out of the claim, and put it in the attachment.
DR. MAYS: I'm actually going to go to the point on race and ethnicity, so I don't know if Marjorie is on that point.
MS. GREENBERG: That's my point.
DR. MAYS: I thought you were, and I'm on a different one. Are you on his point?
DR. LUMPKIN: Go ahead, Marjorie, jump right ahead.
MS. GREENBERG: This is of course, an old and long debate which this committee has heard, and has been part of the historical testimony that will go into this report. But the reason that race/ethnicity is included in the institutional reporting guide for the 837 is because the vast majority of states require it as part of their hospital discharge data sets, which are used for a number of public health and health services research purposes.
And they have no access to the enrollment data. They have no capacity to match the beneficiary or the patients with the data in the enrollment file. Not to mention that the enrollment data are generally controlled by employers who are not covered entities, and thus don't have to abide by the 834.
So, although intellectually I agree with you that it would be better to collect this once and then link it. And one of the other points I think that gets farther down in these dots points is the fact that there are no patient identifiers as well, so that you can't link it, even if you have the other file.
Practically, certainly the state systems, and anyone else who wants to collect this is unable to do so by using an enrollment file. Now, that is why we created the guide, because certainly a lot of people felt that they did not want this in the claims, and yet they wanted the information, or needed the information.
I think the group who has come forward with some of these recommendations, they are pushing to have all of this on the claim, because they want to get it on everybody. But that's the reality of why having it just in an enrollment file doesn't work.
DR. MAYS: Marjorie just demonstrated why I'm going to say what I'm going to say. And that is, whether or not it would be worthwhile to think about whether to pull out the race and ethnicity piece, and to write a letter of recommendation separate, because it is complex. It's not quite as simple as test results, et cetera.
And I think we might do well to do it soon in the sense of it then being in the discussions that are place in other places about quality of care, and race and ethnicity. As opposed to I assume we would probably do this in September, and then we might be able to get it out in October.
If I understand correctly, that might be the time that the IOM panel that you are on -- it said sometime in the fall is when you are anticipating your report. So, the question would be whether or not it is possible to get something out that also helps to influence their report, so that this becomes something that they take up, that we are able to write something where there is enough understanding of the complexity of this.
Because I think, Marjorie, it couldn't have been better to have you understand the difficulty. And as it stands now, I think what happens is that it is so situational, that to some extent, it is like you can't get it to be able to use it to assess quality of care.
DR. LUMPKIN: So, if I hear your suggestion, what you are proposing would be to cut this out, and then try to prepare something in a shorter timeframe than the report just on the issue --
DR. MAYS: I'm thinking it can be a letter, and it would just be a little bit more explanatory. And you could send to them. We already have the Data Council looking at race and ethnicity. We are going to have a report that comes out. It would be wonderful if this gets picks up in terms of being able to be in that report.
There are some things that you really get a lot more mileage in terms of the timing. I'm worried about that in terms of our own material. But I think that there is a complexity here that would benefit from just putting it in a letter.
MS. GREENBERG: Well, if I could just interject. I think this in a sense too, harks back to Simon's original question about the timeliness. The work group received testimony on this topic a few years ago. I do agree that tout ca change, tout c'est la meme chose.
But the Subcommittee on Populations has had very timely testimony, recently as a few weeks ago probably, on some of these topics. So, some kind of joint effort on this particular subject I think would be very appropriate. It would certainly be more timely information, and it would highlight this topic.
DR. LUMPKIN: So, am I hearing the suggestion that perhaps as a joint effort between the two committees, that we prepare a letter? That the letter would go out when? Because I don't see it being possible to develop such a letter better now and tomorrow. So, that would be September, before September.
DR. MAYS: Is it possible to have it done by the Executive Committee?
DR. LUMPKIN: We could, but the problem is that this is an issue that requires enough discussion, that if we are going to try to do it before then, then I would think that we would need to have a conference call of the full committee. And that's just a very difficult venue in which to do that.
DR. MAYS: Can I make a suggestion? I don't know if it's workable. You will know it more. Sometimes committees have discussions by putting things up on a Web site, and responding. And then you kind of see after that whether you need to have a conference call. But again, I don't know how this group will work. It really depends.
DR. COHN: I guess it's hard for me to imagine a letter on this topic that would not be controversial. I guess it's impossible to imagine that based on our history -- and I'm looking at one member, former HHS staff who was here who still remembers the history very well on all of this.
I just think that it would probably require full discussion by the committee. I think that what comes out in the recommendation -- it's possible that it wouldn't be, but it's hard to imagine.
MS. GREENBERG: Let me interject something else too as the executive secretary. I didn't see Bill behind there, but actually Bill is the one who brought our proposal to X12 for us, so thank you, Bill.
Also, it is I think, important that we need to have any discussion that would lead to a recommendation of the full committee in an open environment, as we do all of our work as a federal advisory committee.
So, we have some times when timing absolutely required it had a conference call, that then was open to the public, et cetera. But I would say that would not work too well probably on this topic. So, I think if the two groups could really get together and put something together, and get it vetted and everything for the September meeting, I think that would still be timely.
DR. LUMPKIN: First of all, I think if I can just go into the timelines, I think it's getting kind of late to have input into the IOM committee. As you know, the IOM process, if it's going to come out in October, the final report is actually in the process of being written and then goes into internal review, and then external review. So, that process is already ongoing.
But I think that given this issue, there are a couple of windows for us to have input. One may be before the committee, but also it may be very important to look at the committee's report from the IOM, and then use that as a leverage for a more refined recommendation from our committee to the implementing bodies.
MS. KANAAN: Just a clarification question, since I'm helping to write the report. I can understand all of the reasons that you would like to push forward the process for the letter. I'm not sure I understand why that then leads to pulling the topic out of this report that you are discussing now. Why would you pull it out? And is that indeed what you are suggesting?
DR. LUMPKIN: I'm just looking at the timelines. I think we are probably on time, because we are looking for the report to come to the committee in September, to continue to leave it in the report, ask the Population Subcommittee to participate in that particular section, to pay close attention to it. And then subsequently, have a follow-up letter after the reports that are coming out in the fall, to further refine our recommendations. That would be the process I would suggest.
Jeff?
MR. BLAIR: The only additional thing that I would add is that Vickie made suggestion about corresponding by e-mail, having a draft, having a conference call. I think that those would still be of value to build consensus on what's in that letter better now and September. So that by the time we get to September, any controversial items would be minimized.
DR. COHN: I'm fine with e-mail. Obviously, as you get into this, this is an area where the Standards and Security Subcommittee obviously has interest too, because how it plays out will likely be one of the transaction standards. We were actually going to nominate Kepa Zubeldia to assist you in this process.
MR. SCANLON: I guess I'm looking at how the different subcommittees relate to each other here. The issue of race and ethnicity data is really a broader issue, and I think you have to approach it in a broader way. This is a reflection of one of the areas, the measurement of quality.
But again, I think trying to carve it out only in terms of quality is a mistake, because there is a broader -- you have to approach race and ethnicity measurement, data standards, and so on in a broader way. Having said that, I don't see why a placeholder at least for the need to develop, the need to improve data on race and ethnicity in a standardized way in the context of health care quality without having the specifics quite ready, wouldn't be a bad thing to include in the quality report, with details to follow.
Again, I hope we can do this in a sophisticated way. I don't think we have really made a whole lot of progress, because we are still not dealing with it in a very sophisticated way in terms of how these systems operate.
DR. MAYS: I guess my thinking was due to the fact -- this is one of the few times where we actually have data to drive a recommendation, just a very clear example of data to drive a recommendation. Again, I have to see the report, but the reason I was advocating to kind of pull it out was that you actually can take this data, make a case, and then make a recommendation.
And I don't know if that is going to fit for everything else in here. So, I kind of thought maybe a separate letter, which would highlight that, would work.
DR. LUMPKIN: I just don't think we have the mechanism, the timeframe, looking at the summer coming on. So, we are going to try to work on that.
One of the reasons why we had the hearing in the full committee was actually just for the discussion that we just had. Which is that if we brought this forward from the subcommittee de novo, without the committee having heard the testimony, we would have greater difficulty in trying to resolve these issues and coming to agreement on these proposals.
So, I'm going to ask as you are working through this particular section, to make sure that both the Populations and the Standards and Security Subcommittees see the working draft, with Kepa as the lead for the Standards and Securities Subcommittee. So, as we work our way toward September, that everyone has had an opportunity to see the draft, and we can be in a position to take some action in September.
MR. HUNGATE: The feel the need to have all the recommendations kind of previewed and looked at by each of the members of this committee. And take a look at them, and give us some feedback directly to the work group. I will be happy to collect it, because I just think we need that substance, because I don't think we have gotten to the same kind of discussion in the subcommittee itself.
DR. LUMPKIN: And I think your comment is helping me try to deal with managing the clock.
MS. KANAAN: Sorry to chime in again, but the writing of this report is a collaborative effort. There are many people contributing. I'm kind of the team leader. If anyone would like to actually offer language, it would be very, very welcome.
DR. ZUBELDIA: My recommendation would be on this point, if you want to leave it in the quality report, I would put race and ethnicity as its own bullet, rather than something under the 837 claim, and that will link with Vickie's letter.
MS. GREENBERG: I just wanted to make an observation that is probably obviously, but I do think needs to be grappled with by the full committee, which is why the group decided to bring it here, and this discussion really needs to continue, if not now, later. And probably we can have some discussion in the Executive Subcommittee tomorrow where all the chairs exist.
But you will see that this group is coming back to a number of issues that have been chewed over by this committee, not just since 1996, but I can tell you since 1986, or possibly 1949. And if they were easy to have resolved, they would have been resolved before. But the committee is on record in making some recommendations in some of these areas.
But there are things like race/ethnicity, single procedure classifications, patient identifiers, these are thorny issues. We have not made that much progress on them. And yet, I think that what they are bringing forward is testimony that has been received over a period of several years, and from many people saying that the lack the solutions to these problems are inhibiting quality assessment.
So, I just wanted to kind of put that on table. That doesn't mean that they are any easier to solve, but many of these are not new. There have been recommendations in the past. They haven't been resolved. They continue to have an impact on the ability to assess quality.
DR. LUMPKIN: And actually, what I would like to suggest as a methodology, Bob has been very gracious in accepting this assignment. Don has been working with him, but I think if we can perhaps twist Kepa's arm. What we need is somebody who is fairly comfortable with the standards issues to participate on this committee and the writing of the report between now and September.
And I think that will help the committee address many of the issues that are listed under A, and some of the issues under C, to make sure that there is an overlap, A being the administration data issues, C being the adoption of electronic medical records.
MS. GREENBERG: And D.
DR. LUMPKIN: And D, the linkage. I don't want to necessarily twist Kepa's arm, because Jeff and Simon could also be twisted. And rather than doing that in the full committee, perhaps in the subcommittee we could get an assignment of someone who would be willing to work with the quality committee to help develop this report.
DR. COHN: I think we will be discussing this a little bit during our subcommittee breakout this afternoon. I think we are all quite comfortable having Kepa represent us.
Having said that, I guess at the beginning of our conversation we sort of put on the table, was this ready for prime time. And as I look through the recommendations -- and Marjorie, thank you for reminding me that we are back to unique identifiers for patients again. I hadn't even gotten there. I was still on the first sub-bullet.
I guess I'm wondering really whether this is an opus that is really ready for prime time, or whether there needs to be some sort of a quick scan by the work group to sort of identify -- because there has been progress made, new approaches on a whole variety of these fronts. And I guess I'm a little uncomfortable with the idea that we are going to be able to produce a report that is going to be in any way either timely, or even agreeable to a majority of the full committee by September.
So, I just want to put that on the table. It's really the issue for the subcommittee chair to determine, but these are obviously very weighty issues.
MR. HUNGATE: The reason for bringing it before you now was discomfort on the part of the subcommittee of being able to get a report that would be useful, and meet the approval of the full committee. We said, let's get started, and then let's see where we go.
DR. LUMPKIN: And I am not as fixated on this September date. I think that there needs to be a draft. It is obvious to me that the only way we are going to get this report out is by bringing additional drafts to the full committee, because trying to resolve these, and then having a final draft from the subcommittee and bringing it here, it will get chewed up, spit out, and then we will end up doing that same process anyway, because I just know how we work.
Given that, if we can maybe task the subcommittee to come up with a draft with some specific involvement by the Subcommittee on Standards, identifying the areas where there are thorny issues, I'm more than willing to make another run at the personal identifiers, now that I don't live in Chicago anymore.
I think that there are a number of issues. I think that we need to kind of move the process forward. We just are trying to get to an iteration where we can produce a document. I think we have important things to say, and to add to the debate. And it's something that has to be done by the full committee with the leadership of the work group.
MS. GREENBERG: I just wanted to say too that there are some issues that can be identified as problems out of testimony, and not have solutions identified. You don't need a recommendation for every finding. But other than to say the department or standards groups or people have to work on this, because it has been demonstrated to be a problem, but without actually agreeing on a solution.
MR. HUNGATE: The other piece of guidance that I need in this process is what is appropriate for this work group, and what isn't because it belongs in the standards and security work. Where are the boundaries?
DR. LUMPKIN: I think that the work group needs to cover what they need to cover to make their case. And the interface with other work groups is by bringing those individuals involved to help make sure that that piece is consistent with what they are doing.
I would be concerned if you start carving it out, because then you have almost no recommendations, and that's not what we want to do. I think that there are key quality issues that overlap over committees. And so, I would charge forward, and then we can coordinate to cover those areas where you move in areas that other subcommittees are working on.
DR. ZUBELDIA: Let me offer a suggestion. The Subcommittee on Quality can determine what is needed, and what are the data elements that you need, and the components that you need. And we can help you with standards and security, and letting you know whether is going to be present in the HIPAA transactions, or what would be the most appropriate transaction to put that in, and things like that. But you determine what you need. We can help you with the how to do it.
MR. BLAIR: As I'm listening to this discussion, one of the things I'm beginning to think of is that we really want to come up with recommendations that are compelling and implementable where we could make some differences. And so, if that is what we want to achieve, and this is a complex area where we really need to not only make our point in a compelling way, but make sure that we are on sound footing, where the ambiguities, and the refinements, and the detail won't trip us up in supporting that.
Maybe we should break it into, if I heard Marjorie correctly, making sure we have properly identified the issues, and then go into a second period in the report where now that we clarified exactly what the issues really are, that we then have precise, meaningful, implementable recommendations.
Now, if this is the case, then maybe this should be in two stages where we take advantage of the September meeting to make sure we come to consensus on what the issues are, and then by December we come together with our recommendations. This also would mean that we probably would have conference calls and e-mails between now and September, and between September and October as we wind up building consensus for each of these things.
Now, that I have made this observation or suggestion, I don't know -- so, this is a question to Vickie -- Vickie, you had a sense of urgency on this. What is behind the sense of urgency? Because I will completely table my suggestions if there is something happening in September where we lose an opportunity if we don't have the recommendations by September.
DR. MAYS: The urgency really was based on the fact of knowing that the Institute of Medicine -- I didn't know it was October, all I know it was sometime in the fall, but there is a re