[This Transcript is Unedited]
Hubert Humphrey Building
Room 505A
200 Independence Avenue, S.W.
Washington , D.C. 20201
Committee Members :
HHS Executive Staff Director :
Executive Secretary :
Liaison Representatives :
Agenda Item: Call to Order, Welcome and Introductions and Review of Agenda
DR. LUMPKIN: Good morning. Welcome. Just to get started, we will start off with introductions.
My name is John Lumpkin and I am the chair of the committee and senior vice president of Robert Wood Johnson Foundation.
Why don't we go around the room and make introductions. Then we will review the agenda. We have a couple of housekeeping items and also as we go around the committee and do introductions, if you have any conflicts with the subject matter of the meeting that you need to declare, please do so at that time.
So, let's start off with Marjorie.
MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, CDC and executive secretary to the committee.
DR. LUMPKIN: Jim wants to clarify. That is financial conflicts, not emotional ones.
MR. HOUSTON: I am John Houston with the University of Pittsburgh Medical Center and I don't have any conflicts, either emotional or professional.
DR. CARR: I am Dr. Justine Carr from Beth Israel Deaconess Medical Center in Boston, Department of Health Care Quality.
DR. HUFF: Stan Huff with Intermountain Health Care, the University of Utah in Salt Lake.
I need to recuse myself from HL7, LOINC, and ICD-10 PCS.
DR. LENGERICH: Gene Lengerich, a member of the committee and from Penn State University.
DR. LUMPKIN: Stan, could you explain that?
DR. HUFF: This is a direction from the ethics committee. So, when I do the non-disclosure thing, they -- because I hold a position as a co-chair on HL7, they think I have a personal bias. I am also a co-chair in LOINC and so I have a personal bias. There is no financial interest there. And about two years ago, I was a one-time consultant to 3M, who produces ICD-10 PCS. I think that one -- actually there is no business relationship any longer. So, when I reviewed again, that one will probably go away.
That is the explanation, sir.
DR. LUMPKIN: I think the important addition I would make to that, it is not the issue that you might -- that you have personal bias, but it is the appearance of bias. Because we love and trust you.
DR. HUFF: Thank you for that vote of confidence.
MR. LOCALIO: I am Russell Localio, University of Pennsylvania School of Medicine. I am a member of the committee.
DR. WARREN: I am Judy Warren, University of Kansas. After talking with Stan, I don't know what I have because I am also a co-chair at HL7 with no financial bias and I am a consultant at the SNOMED Editorial Board with no reimbursement or anything like that either.
MS. GREENBERG: Just for some clarification, one's interests are defined broadly. So, it is not just a question of financial. So, if you have a leadership position in an organization, then generally there is a waiver that allows you to participate in all the general matters, but not matters that are specific to that issue.
MS. BEREK: Judy Berek. I am the liaison for the Centers for Medicare and Medicaid Services.
MS. TORIARES: Nancy Toriares(?) from the U.S. Census Bureau, reminding everyone that you have just seen your last decennial census long form. It is really gone.
DR. LUMPKIN: What if we long for the form?
MS. TORIARES: Well, they long for $12 million to do it. Reminding everyone that this replacement, the American Community Survey, starts in July of this year.
DR. ROBBINS: Aldona Robbins. I am the liaison from the Board of Scientific Counselors, National Center for Health Statistics, CDC.
MR. REYNOLDS: I am Harry Reynolds, Blue Cross and Blue Shield of North Carolina.
DR. STEINWACHS: I am Don Steinwachs at Johns Hopkins, Bloomberg School of Public Health, member of the committee.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member of the committee.
DR. MAYS: Vickie Mays, University of California, Los Angeles, member of the committee.
DR. COHN: Simon Cohn, national director for health information policy for Kaiser Permanente and a member of the committee.
MR. SCANLON: I am Jim Scanlon with the Office of the Secretary, HHS and I am the executive staff director for the committee.
MR. SONDIK: Ed Sondik, director of the National Center for Health Statistics. I am entirely conflicted.
MR. FANNING: I am John Fanning from the Department of Health and Human Services.
DR. FRIEDMAN: I am Dan Friedman, an independent consultant in population and public health information services from Massachusetts. To quote the chairman of the committee, now I have a teenage daughter at home, so I have many conflicts everyday.
MS. LORRAINE: Kathryn Lorraine(?) Office of Policy, FDA.
MS. KOPPELMAN: Hi. I am Lacey Koppelman, Office on Women's Health at the Department of Health and Human Services. I am actually representing Suzanne Haynes, who is senior science advisor in the Office on Women's Health and she is a member of the subcommittee.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC.
MR. HITCHCOCK: Dale Hitchcock, Office of the Assistant Secretary for Planning and Evaluation, co-lead staff of the Subcommittee on Populations.
DR. KYLE: Frank Kyle(?), American Dental Association.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC.
MR. RUMMEL: Nick Rummel(?), HIPAA Compliance Alert.
MS. KAPLER: I am Evelyn Kapler(?) with the Office of Public Health and Science at HHS.
MS. EVELYN: Brenda Evelyn, Office of Special Health Issues, Food and Drug Administration.
MS. FRIEDMAN: Maria Friedman, CMS and staff to the Subcommittee on Standards and Security.
MS. GRANTON: Good morning. Miriam Granton with the Office of Disease Prevention and Health Promotion and I staff the Subcommittee on Population.
MS. RYAN: Hi. I am Colleen Ryan. I am with the Indian Health Service and I also am render staff for the Subcommittee on Population.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MS. WATTENBURG: Sara Wattenburg, Substance Abuse and Mental Health --
DR. LUMPKIN: That is what you get for testing the equipment this morning. If you hadn't tested it, it would have worked fine.
We have Peggy, if you would introduce yourself and state any conflicts of an interest, financial nature. We have stopped with the emotional conflicts.
MS. HANDRICH: I am Peggy Handrich, a member of the committee from Wisconsin.
DR. LUMPKIN: Great. Welcome.
Do we have anyone on the phone yet?
PARTICIPANT: Not yet.
DR. LUMPKIN: Richard Harding and Mark Rothstein will be participating in part of the meeting on the phone. Mark is recuperating. So, we wish him all the best and hope he gets back on his feet very quickly.
Let me start off with a couple of logistics issues.
MR. BLAIR: How about if they could turn the air conditioner on. That is a good logistics issue.
DR. LUMPKIN: This is March. This is a federal building in March in Washington. If we can do something about the temperature in here -- it is a little bit too warm.
We were discussing a couple of logistics issues. The first is if you intend to leave before the end of the meeting tomorrow, please let me know during one of the breaks, just so I can manage a quorum. I don't think we have a problem, but I just would like to know.
Second is that there is a caravan leaving tomorrow morning at 8:15, for those of you who want to go out to the wilds of Virginia to get your --
MS. GREENBERG: No, no, no, Maryland. Hyattsville, Maryland.
DR. LUMPKIN: The wilds of someplace out here east, outside of D.C., Maryland, I guess, for I.D. badges.
MS. GREENBERG: Opportunity to see the beautiful new NCHS building.
DR. LUMPKIN: And an opportunity to see the new NCHS building that is so accessible that -- who is going to go along so that the cab driver can find it? Gracie will go along with you.
MS. GREENBERG: This is to get your badges. It does make life easier once you have the badge.
DR. LUMPKIN: Okay. So, anyone besides Justine going? Okay. So, hook up with Jackie, she will give you the details also during the break.
MS. GREENBERG: Then if you are -- I guess before the lunch break, maybe we will take a head count for the dinner.
DR. LUMPKIN: Okay. We have two people on the phone. If you could introduce yourselves.
DR. HARDING: Richard Harding is on the phone.
MS. HORLICK: Gail Horlick.
DR. LUMPKIN: Gail. Welcome.
MS. HORLICK: I have tried -- I was the first caller before and they finally told me to hang up and try again.
DR. HARDING: That is what happened to me, too.
MS. HORLICK: I won't be able to stay for the whole meeting, but I will call in when I can.
DR. LUMPKIN: Great. Thank you.
Let's go through the agenda. The first item that we have on the agenda -- are there any additions or changes to the agenda? Mike Fitzmaurice, who is our liaison from AHRQ has just arrived. So, I am going to embarrass you by noting that fact and having you introduce yourself.
Any other changes to the agenda? Okay. Seeing none, let's proceed.
The first item on the agenda, we were just passed out a copy of the claims attachment letter. So, I am going to turn that over to Simon.
Agenda Item: Claims Attachment Letter
DR. COHN: Good morning, all.
This is a letter that is being brought forward as a result of hearings of the Subcommittee on Standards and Security. The hearings occurred on December 10th and yesterday, March 3rd. I think as you all know, claims attachment is one of the standards under HIPAA. This has been something that has been percolating around for awhile.
We thought we were going to see one a couple -- NPRM a couple of years ago and then sort of nothing happened with it. In the meantime, the actual standard was taken back to the standards organizations and was basically retooled. So, the subcommittee wanted to take a look, find out what was happening, as well as what needed to be done with all of that. This is really the focus of this letter.
As you know, this is typically an occasion to suggest modifications, changes, additions or others to letters with the idea that the action would occur tomorrow on the subcommittee. If there are major modifications, we will obviously deal with it during the subcommittee break.
So, John, with your permission, we will go over it paragraph by paragraph on this one. It is a relatively short letter.
DR. LUMPKIN: Please.
DR. COHN: Okay. This says, "Dear Secretary Thompson: As part of its responsibility under the Health Insurance Portability and Accountability Act of 1996, the National Committee on Vital and Health Statistics is responsible for studying, selecting and recommending standards for electronic health claims attachments.
"To fulfill these responsibilities, NCVHS's Subcommittee on Standards and Security recently held hearings on standards for electronic health claims attachments on December 10th, 2003 and March 3rd, 2004.
"The subcommittee heard testimony from providers, health plans, vendors, associations and standards development organizations about the need for both basic and advanced functionality in a claims attachment standard. For example, such a standard should be flexible so that providers with minimal infrastructure can electronically transfer claims attachment information to health plans and clearinghouses. At the same time, the standards should possess the flexibility to permit users with more sophisticated infrastructures to fully leverage their investment in information technology.
"Health Level 7 and the Accredited Standards Committee X12 have been working to develop a HIPAA claims attachment standard that can meet these requirements."
DR. LUMPKIN: Any questions or comments on that paragraph?
DR. COHN: I know, it isn't very exciting so far, is it?
DR. LUMPKIN: Okay. Simon, you are on a roll.
DR. COHN: Yes, I know. I am actually a little concerned that nobody is making comments so far, but we will encourage that as we go along.
The next paragraph, "The subcommittee heard the need for demonstration projects and pilot studies to document the benefits, costs, work flow requirements, implementation challenges, privacy concerns and best practices associated with the claims attachment standard. NCVHS urges the department to support..." -- and probably we want to say "support and encourage" -- "...several different claims attachment demonstration projects and pilots that would include a broad representation of affected stakeholders.
"A pilot proposed by Empire Blue Cross and Blue Shield is an example of the kind of projects that should be developed and funded. NCVHS recommends that these demonstration projects and pilots occur expeditiously so that the results and findings will feed into the development of the claims attachment rule."
DR. LUMPKIN: Any questions or comments on that paragraph?
Don.
DR. STEINWACHS: Simon, just one -- the one sentence that said the pilot proposed, for the naive person, who doesn't know what is going on, is there a little descripter of what that pilot is about? It just sort of hangs here that there is one organization who proposed the pilot should be encouraged, but it doesn't -- or am I
just --
DR. COHN: Well, no. You bring up a good question. I mean, we obviously, have testimony from them in a proposal, which we believe has been already proposed to CMS, which actually used to be a parenthetical here, but we thought it was a little strange --
DR. LUMPKIN: Is it safe to assume that what the pilot is is the pilot is a pilot testing a model of a claims attachment?
DR. COHN: Yes, it includes -- I mean, this is basically a Medicare carrier and Medicaid also, I believe.
PARTICIPANT: Medicare.
DR. COHN: Just Medicare. Maybe testing it with various institutional and physician providers and how it would all work. Do you feel that there is a need for a little more explanation of what the whole thing is?
DR. STEINWACHS: I would put a little more explanation or I would drop it, either way. But, you know, if it is important, I would give a little more explanation, just what you said, I think would be helpful to someone who has no idea particularly why you are citing this.
DR. LUMPKIN: Does that sentence really add value to the --
DR. STEINWACHS: We could drop it, too. I mean, that would --
DR. LUMPKIN: Because we say in the sentence before that urges the department to support several different claim attachment demonstration projects and pilots. It just kind of sits out there.
DR. STEINWACHS: It may be easier to drop it.
DR. COHN: It might be easier to drop it. I think we will have to -- maybe that is a subcommittee discussion to see if we -- I mean, the only reason to have that in there would be if we want to make sure particularly that that one gets some notice so that it gets funded and if there are any issues related to it not getting funded. But I think we can talk about that in the subcommittee --
DR. LUMPKIN: Were there other pilots presented?
DR. COHN: No. Some people are talking about pilots, but none were at the stage where they could come forward and say, yes, we have a pilot put together. It needs either encouragement or --
DR. LUMPKIN: You could --
MS. GREENBERG: How about if we say we heard about a pilot proposed by Empire Blue Cross to do x and this is the type that should be encouraged and funded -- or developed and funded.
DR. COHN: I would say the subcommittee can take back this comment and --
DR. LUMPKIN: If it is okay with you, I think maybe we could ask the subcommittee to work on that.
DR. COHN: That is what subcommittees are for, to work on these sorts of things.
Any other comments on that paragraph? I mean, the people we are sort of trying to talk about now, it is like a model that somewhat resembles the Medicare Modernization Act and e-prescribing with the idea that a new standard gets piloted before it gets nationally mandated and the results of that pilot get put into the improvements in that standard before it is announced as a final rule. So, that is the model here.
DR. STEINWACHS: That would be great.
DR. LUMPKIN: And I think just one other addition. If you do include that, you might want to add a modifier that does describe them as the Medicare and Medicaid carrier or intermediary because it sort of -- from a casual reader, why are we picking on Blue Cross/Blue Shield. It is because they have already got some designation and relationship with CMS as a designated intermediary. That is an important distinction.
MS. BEREK: I would use contractor because they are both a carrier and an intermediary.
DR. LUMPKIN: Okay. Whatever the appropriate term is.
MS. BEREK: They will have a new name in a few years.
DR. COHN: So, what do we call it, contracted?
MS. BEREK: If you call it a contractor, it covers both carrier and intermediary.
DR. LUMPKIN: See, and I still want to call them HCFA. I just can't keep up with these names.
DR. COHN: We will ask you to make sure that we are correct on this one, but the more we get into this, the more likely there is going to be -- you are not going to see that sentence when it comes back.
Next paragraph, "NCVHS understands that a notice of proposed rulemaking concerning electronic claims attachment currently is under development. We urge the department to issue this NPRM as soon as possible. This will motivate the industry to participate in pilot projects and invest in the needed infrastructure. We also encourage the department to provide for public comment on the results of the demonstrations and pilots before a final rule is promulgated."
Then, "NCVHS wishes to thank you for the opportunity to offer these recommendations." Are people comfortable with that final part?
DR. LUMPKIN: Now if I can sort of understand this, our prior recommendation was to hold off on doing the claims attachment rule until the field was clearer somewhat. Now we are saying we think the field is cleared up enough to issue the rule and use that as a basis for evaluating the demonstration projects and then coming out with the final rule.
DR. COHN: I don't actually believe we actually had a letter on claims attachments previously.
DR. LUMPKIN: Okay.
DR. COHN: I think that we had held hearings a number of years ago. You know, it is usually our practice to wait until an NPRM is published and then make comments about the NPRM.
DR. LUMPKIN: No, we did have a letter on -- way back when, we did have a letter on claims attachment. We did make a recommendation, which didn't proceed and I think at some point -- and whether we did it by letter or recommendation, we did say, yes, it is a good idea to hold off.
But that really probably doesn't have any impact on this. The important point is is this process that we are recommending, which is to use the NPRM to sort of set the basis for the demonstration projects and evaluation as they moved to a final rule is the approach that we are recommending.
DR. COHN: Is that said clear enough here for those to understand?
MR. BLAIR: One of the things that we struggled with for a little while was to get a balance. We recognized that software developers and folks that would be doing pilots might not invest until they saw a serious intent by HHS, ala in the form of an NPRM before they would really move forward on this.
So, we felt it was important for us to encourage that that NPRM be set forth as soon as possible. At the same time, we were also hearing concern that people wanted the opportunity to make public comment in the rulemaking process after the pilots -- after the results of the pilots were available and before the final rule was issued. So, it was the balance between those two things that we have reflected in the last paragraph.
DR. LUMPKIN: I would wonder if perhaps that -- what you just said might be incorporated a little bit more in that last paragraph because really the sentence says this will motivate the industry to participate in pilot projects and I think it would be stronger if we said that what we heard in hearings is that the industry is waiting for an NPRM in order to move forward and that there was concern that there be adequate ability to comment on the pilots. I think that would make it a little bit stronger paragraph.
MR. SONDIK: I have a question on the -- it says support and encourage or encourage and support, I think, might even be better. Where would the funds come from for this demonstration or pilot? I mean, do you know of a pot that is earmarked?
DR. LUMPKIN: I think they were going after your budget.
MR. SONDIK: Why do you think I told you I was conflicted?
DR. COHN: Money is always an issue in all of this. I think it is why we use the word "support and encourage." "Support" obviously has many meanings, financial support, leadership, et cetera, et cetera.
MR. SONDIK: Support and encourage, I like that, but the way it was written, when it said developed and funded, then it made it seem as if there was a pot simply waiting or that it was very clear how this would be funded.
DR. COHN: Maria, can you comment on that from the CMS perspective?
MS. FRIEDMAN: We just recently got our budget. So, the jury is out on this. CMS recently just got its budget and I know the folks on the Medicare side of the house are looking at this. I don't think they have made a decision on funding this particular one. But I think the broader issue that we heard in testimony, that because funding is problematic everywhere, this might be an opportunity to do a public/private partnership or in some cases we heard that the industry might be willing to kick in.
MR. SONDIK: My recommendation would be to less specific and if, in fact, the offending sentence is going to be dropped or the --
DR. COHN: It may be okay.
MR. SONDIK: And I think the words encourage or encourage and support, I think would be sufficient.
DR. COHN: It sounds like those nails on the coffin of that sentence are --
MR. SONDIK: You raised it.
DR. COHN: That is well said.
Okay. Other comments? The subcommittee will obviously take this back. We will do some modifications to the letter and bring it back tomorrow.
DR. LUMPKIN: I want to make sure that I understand the looks I am seeing and the body language that I am trying to interpret. I don't see any major obstacles to the intent of this letter just to refinement of the wording. Is that a fair statement? Okay.
DR. COHN: Thank you.
DR. LUMPKIN: Thank you.
We will move on -- has Mark joined us?
MR. ROTHSTEIN: Yes, I am on.
DR. LUMPKIN: Welcome. We are sorry you couldn't join us.
DR. COHN: Are you okay?
MR. ROTHSTEIN: I am barely hanging in there but I am going to stay on the call for as long as I can. I would appreciate if someone from the subcommittee -- I know that Richard is not present --
DR. HARDING: I am on the phone, too.
MR. ROTHSTEIN: Yes. Either John Houston or --
DR. LUMPKIN: John is right next to me.
MR. ROTHSTEIN: -- Simon could take the lead in discussing the letter. That would be very helpful to me.
DR. LUMPKIN: Great. Now, we have that under our Tab 4, I think. Thank you.
MR. HOUSTON: "Dear Secretary Thompson: As a part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996, HIPAA, the National Committee on Vital and Health Statistics, NCVHS, monitors the implementation of the Administrative Simplification Provisions of HIPAA, including the standards for privacy of individually identifiable health information, the privacy rule.
"The Subcommittee on Privacy and Confidentiality of the NCVHS held hearings in Silver Springs, Maryland on November 19th and 20th, 2003. The hearings, the first of several to be held over the next year, were intended to gather information about the effect of the privacy rule on public health, research and health care providers, health plans and consumers. In general, witnesses at the November 2003 hearings reported less anxiety and confusions about complying with the privacy role than did witnesses at NCVHS hearings in 2002.
"Several witnesses said that materials posted on the web site of the office of civil rights, OCR, were helpful, but they also stressed the need for OCR to expand its outreach and public education activities so that the privacy rule can be implemented effectively. It was noted that not all covered entities and consumers have access to the Internet."
DR. LUMPKIN: Okay. Any questions or concerns about the introductory paragraph?
MR. HOUSTON: I had one in particular. In the last paragraph that I read regarding NCVHS hearings in 2002, I am wondering whether it might, rather than saying 2002, simply say prior to the compliance deadline for the privacy rule, because it sort of positions before versus after the deadline in a more straightforward fashion than 2002.
DR. LUMPKIN: Mike.
MR. FANNING: Excuse me. Wants the text to strike in 2002 and insert prior to the compliance --
MR. HOUSTON: Prior to the compliance deadline for the privacy rule.
MR. FANNING: Thank you.
DR. FITZMAURICE: On the second paragraph that starts out, "The Subcommittee on Privacy and Confidentiality," the second sentence says, "The hearings, the first of several to be held over the next year," it is hard to have something and say it is going to be part of the next year. I would say, "The first of several to be held over" and insert "a 12 month period," striking the next year.
DR. LUMPKIN: How about just first of several to be held.
We will proceed on to the public health -- let me just get an idea. For those who have read this, are there enough concerns paragraph by paragraph or do we want to read the whole thing and then just take -- let's do the section by section.
MR. HOUSTON: "Paid public health. The privacy rule explicitly permits disclosure of protected health information, PHI, for public health purposes without need for an authorization. Accordingly, the main public health issues involve covered entities that misunderstand the privacy rule and limit their disclosure and their coordination of the public health provisions of the privacy rule with other provisions.
"In general, the witnesses stated that misunderstanding of the privacy rule by many covered entities was adversely affecting the reporting of notifiable conditions to public health officials. At least one witness suggested, however, that some covered entities were merely using the privacy rule as an excuse to avoid the burden of public health reporting.
"Of course, it would be difficult to assess the motivation of a covered entity for being reluctant to make reports to public health officials. One of the witnesses representing the Council of States and Territorial Epidemiologists, CSTE, testified about a CSTE survey of state and territorial public health epidemiologists and Centers for Disease Control and Prevention bioterrorism grantees on syndromic surveillance systems.
"Thirty-five percent of the respondents said that the privacy rule had caused major obstruction or delay in disease reporting and 25 percent said that their disease reporters, health care providers, had a significant problem with the privacy rules requirement that covered entities account for disclosures.
"Immunization is another concern. Often, school nurses need immunization information to assess compliance with state laws requiring immunization as a condition of enrollment in school. State laws vary on whether a school is considered a public health authority and whether immunization records may be shared without the authorization of a parent or guardian.
"In many states providers cannot disclose immunization information to schools without receiving a HIPAA compliant authorization. If authorizations cannot be obtained for any reason, some children receive duplicate immunizations. If OCR indicated that states could designate school nurses as public health officials, the information on immunization could be released without need for an authorization, thereby benefiting the children.
"With regard to accounting for disclosures, the reporting of suspected cases of abuse and neglect has been a particular concern for social service agencies. In many states, agencies receive reports of suspected cases of child abuse or neglect are prohibited from disclosing the report or the name of the individual or entity filing it. The state prohibitions on disclosure, however, apply only to the recipient of the report and do not extend to health care providers, such as hospitals that file them.
"Under HIPAA, an abusing parent acting as the personal representative of the minor child may obtain an accounting for disclosures and learn of the report. This has the effect of discouraging the filing of reports of suspected abuse and neglect. An exception to the accounting for disclosures requirement for reports of suspected abuse and neglect would eliminate this problem."
DR. LUMPKIN: Okay. Let's split this up into three sections for discussion. The first one is just the factual discussion of the fact that the major obstacle of public health is in the privacy rule's misinterpretation, whether intentional or unintentional by potential reporters. Any comments on that first section, first couple of paragraphs?
Don.
DR. STEINWACHS: In the last line of the first paragraph, I didn't quite understand what coordination -- I understood limiting disclosures, but --
DR. LUMPKIN: Accordingly, the main public health issues involve covered entities and misunderstand the privacy rule and limit their disclosures and the coordination of public health provisions of the privacy rules with other provisions.
MS. GREENBERG: I think there needs to be a comma or something after disclosures because I was having trouble with that.
MR. FANNING: I had to read it a few times. That is the correct thing. The verb in front of coordination is involved, not limit. Possibly, the sentence could be polished up a bit just to make that clearer. I don't think there is any point in drafting it out loud here, but the intention is clear and we will make it easily readable.
DR. FITZMAURICE: With regard to that same sentence, what are the two different public health provisions that need to be coordinated of the privacy rule or with other provisions of the privacy rule. It reads to me like people looking at one part of the privacy rule and we are looking at another part of the privacy rule, being with public health and they are not coordinated. I don't know what that means.
MR. HOUSTON: I think the intent was to coordinate with other provisions of the privacy rule, such as accounting of disclosures and things of that sort. I believe that was the intent.
DR. FITZMAURICE: With you saying that, that makes it clear. Thank you.
But I have another question.
DR. LUMPKIN: Okay. Go ahead.
DR. FITZMAURICE: The next paragraph, the last sentence, "Of course, it would be difficult to assess the motivation of a covered entity...," I would put a period right there. At the bottom of the next paragraph, the one that starts "In general," the sentence is "Of course, it would be difficult to assess the motivation of a covered entity for being reluctant to make reports to public health officials." Because we might want to take that sentence out. It would be impugning --
DR. LUMPKIN: It is sort of redundant to have the -- okay. That is an editorial kind of thing. The thought is is that -- well, the first sentence above it says at least one witness suggested, however, that some covered entities were merely using the privacy rules as an excuse to avoid the burden of public health reporting. Then it would read, of course, it would -- actually it is difficult to assess the motivation of covered entities period.
MR. HOUSTON: Do we take out the whole sentence or just the --
DR. LUMPKIN: Well, the problem is is that the disclaimer on the first one, one witness alleged that. We think it is important to report it, but we are not going to impugn covered entities. It was because, you know, there was a lawyer in the meeting.
DR. COHN: I guess I am a little confused. I can't exactly see what you are doing here. You are leaving some of that last sentence?
DR. LUMPKIN: We are making a suggestion to the subcommittee on how to redraft that.
DR. COHN: I guess another way of handling it would be getting rid of the entire last sentence and changing "were" and then the sentence above "or might be using."
DR. LUMPKIN: Yes, softening that statement.
DR. COHN: I take a little bit of umbrage at this one, but it is --
MS. GREENBERG: Change this to some covered entities might be using the privacy rule and then leave out the last sentence.
DR. HARDING: It is pretty hard to hear what you all are saying.
DR. LUMPKIN: No, because actually you are bringing it back tomorrow. So, rather than trying to -- we are not going to try to wordsmith it, but I think as long as you understand what the issue was --
MR. FANNING: What is the choice now? What is the direction of the committee? Is it to strike the last sentence or is it to strike all after "entity"?
DR. LUMPKIN: It is to clean it up. We kind of agree with softening the statement that is made.
MR. HOUSTON: Here is what I think is -- the second to the last sentence simply says at least one witness suggested, however, that some covered entities might be merely using the privacy rule as an excuse to avoid the burden of public health reporting period. And then strike the following sentence.
MS. HORLICK: I like that.
DR. LUMPKIN: Anything else on the reporting issue?
Let's go on to immunizations. Michael. We are kind of walking through the public section. Immunization.
DR. FITZMAURICE: Right above there, the one that says 35 percent of respondents said that the privacy rule --
DR. LUMPKIN: Oh, sorry. Still on public health. Go ahead.
DR. FITZMAURICE: -- caused major obstruction and delay in disease reporting and 25 percent said that their disease reporters, health care providers had a significant problem with the privacy rules requirement. Significant problem, we don't exactly say what the problem is. I would offer a suggestion that the problem with the burden of the privacy rules requirement. Now, maybe it is more than burden, but my sense was that they had a problem with the burden of the requirement. Too much trouble. Therefore, you just don't want to do it.
MS. GREENBERG: Is the burden created by the privacy rules requirement?
MS. HORLICK: Yes, I like that.
DR. LUMPKIN: Is that true, though?
MR. HOUSTON: There is a discussion later in the letter, which describes accounting of disclosures. Okay.
DR. LUMPKIN: I just wanted to be careful because we are kind of editing the summary of testimony and I just wanted to make sure that we were being --
MR. FANNING: I think we would have to go back to the testimony. Now, this is sufficiently general that it doesn't go into detail about what the exact grievance is. Do you want to leave it that way or do we want extract from the testimony that pins down the issue.
DR. FITZMAURICE: I think it is well-explained later on, but the question here was we raised a problem and we don't see what the problem is, by putting "burden" in there --
MR. HOUSTON: Can I --
DR. FITZMAURICE: -- communicate what the problem is.
MR. HOUSTON: Maybe if we defer just until the end of the letter and then go back to this because there is a paragraph that describes in a little bit more detail what the burden of the accounting disclosures is or we move it up, either one of the two.
DR. LUMPKIN: But since it describes it as a burden, I think Michael's point is that we say -- had a significant problem. I think what he is trying to say is that the problem is burden, but we don't say that. So, we kind of leave it hanging. So, we could just add in and say that 25 percent of the disease reporters have a problem with the burden of reporting, which I think is the intent. Then we can leave the two paragraphs separate.
MR. HOUSTON: I am sorry. I thought we had already decided we were going to put that burden language in.
DR. LUMPKIN: Never mind. We are all on the same page. It is page 2.
Anything else on the public health reporting part?
Okay. We are going to move on to immunization section, that paragraph.
Gene.
DR. LENGERICH: A couple of things in the second last sentence where it says, "If authorizations cannot be obtained for any reason, some children receive duplicate immunizations." Is there any estimate of what that some is? And I suppose some already do even without this process and then is it more than just duplicate? Are these inefficient, harmful, unnecessary?
DR. LUMPKIN: I think that unnecessary is certainly the case but I think that probably that can be softened -- may receive.
MR. FANNING: The summary of the meeting says, "Some children receive duplicate immunizations --
MS. HORLICK: This is Gail. I think that it is accurate to say that some children do. I don't have any sense of the numbers on that. I mean, there are clearly children that receive duplicate immunizations because they don't have access to the records, but I don't know if you want to soften it anyway because I don't know how often that is happening, but it definitely is happening.
DR. LUMPKIN: Well, kids definitely receive multiple immunizations, but the issue is as this sentence implies that because they don't get the authorizations --
MS. HORLICK: The provider can't disclose the records. So, they give them the shot again so they can go to school.
DR. LUMPKIN: Or the parent may not have the record. I mean, there is any number --
MS. HORLICK: Right. That is true.
DR. LUMPKIN: So I think that by softening it, we don't imply that there is a one-to-one correlation cause and effect, but it certainly contributes to the problem that results in kids getting multiple duplication.
MS. HORLICK: Well, that is fine. I see that.
MR. FANNING: I am not sure how you would soften it. It is a fairly straightforward sentence. Describe the factual event; namely, testimony to that effect.
DR. LUMPKIN: But if authorizations cannot be obtained for any reason, some children may receive duplicate immunizations. We are not actually summarizing testimony in this line. We are actually summarizing the conclusions on the Hill.
MR. HOUSTON: We say testifiers indicated or --
MS. GREENBERG: No. They indicated they do receive them.
DR. LUMPKIN: Okay. So, you could say the testifiers stated that they believed that -- or whatever, stated, and that takes it off.
I have actually a little bit of concern about the construct and I was trying to work through this as I listened to this issue. HIPAA provides -- actually I am thinking when it voids the preemption, floor preemption to state law. As such, state law governs whether or not the restrictions on movement of personal health information from a clinical setting to a school nurse. So, HIPAA says -- if HIPAA were to say that is okay and state law says "no," it is not, it doesn't really matter because state law will then govern.
So, if we are concerned that state law is prohibiting in some states movement of immunization information to school nurses. Making a change at the federal level will have no impact.
MR. ROTHSTEIN: John, this is Mark. I think the problem is that states don't realize what is going on necessarily and if the Secretary could indicate that the states might want to take a look at their state law and see if it does permit this disclosure, that then the state, if they chose to, could eliminate this problem.
DR. FITZMAURICE: The state could also say that within the privacy rule if disclosure of information is required by law, by state law, the privacy rule does not override that. So, you can disclose it. If the state were to say we require by law that you immunize the students and so along with that, we require by law that you look to see if they have had other immunizations. So, that disclosure is required by the immunization law already. But if you don't state it specifically, it would have to take an OCR interpretation of that communicated to the states, maybe a Q&A.
MS. HORLICK: I think some states are interpreting it that way but other states are not.
DR. LUMPKIN: Well, you know, the difficulty I had is I spent three separate years in Illinois with the legislature trying to change the law, allowing immunization information to go from the public health system to the schools. They clearly did not want that to happen. I mean, it wasn't any ambiguity. They didn't misunderstand. They just didn't want immunization information without the parents consent going to the schools.
So, in a sense, you know, I totally agree with this principle and I agree with the concept, but are we trying to make immunization -- are we trying to make state policy or are we trying to clarify federal policy? So, that is my concern around that paragraph as much as I think it would be neat if that could fix the problem.
DR. FITZMAURICE: I think you raise a good point. If it is a matter of confusion, then I think what is here and my suggestion could clarify it, but if it is not confusion, they simply don't want that information moving. They want to protect the privacy of the individual. A judge might rule that that was more restrictive and, therefore, more protective of the individual's personal health information, even if it didn't protect the person's health.
DR. LUMPKIN: So, actually what we are looking for is clarification at the federal level that HIPAA privacy does not -- should not stand in the way of immunization information being provided to schools.
MS. GREENBERG: It may currently, unless the school nurse is considered a public health authority.
MS. HORLICK: Yes. The interpretation in a lot of the states is that because -- if it is not provided for treatment purposes, then they can't disclose to the school without an authorization.
DR. LUMPKIN: Okay. I think that -- I am going to remove my objection and let it go forward this way in that it may have a potential of doing some good and for those states where they are just bone-headed about it, since I don't live there anymore, it is not going to do any harm.
DR. COHN: Actually, I am sort of buying in, I think, to some of your comments, which is No. 1 that there needs to be probably some reflection that the suggestion here is necessary but not sufficient, which is I think what you were trying to say. I think that that is something that somebody needs to realize. This won't solve it in and of itself. I guess I am going back actually to the earlier piece, which is -- I mean, I think that the whole disclosure piece is a barrier. I am trying in my own mind to think of the fact case where, you know, patients don't get immunizations without some parental involvement, at least to my knowledge.
Now, the issue around immunizations is that people can't attend school unless they have appropriate immunizations. So, this creates a tremendous bottleneck, but if you were a parent and having to deal with the patient anyway and going and getting things -- I guess I am trying to think of what the barrier remains on that one. If you are already having to be involved and it is your choice about whether to sign an authorization for disclosure versus getting the kid a duplicate immunization, I am sort of -- still, I guess, I am thinking back on the testimony and trying to figure that one out.
One of the Johns, do you have a comment on that one? Am I missing the point here?
DR. LUMPKIN: I think your point is is that if the parent has a choice between getting a second immunization and signing an authorization, most parents would sign an authorization.
[Multiple discussions.]
MR. HOUSTON: -- is that it was very difficult in certain cases to have parents be responsive in any way, shape or form, whether it be to sign an authorization or getting a duplicate --
MR. ROTHSTEIN: Can't hear, John.
MS. HORLICK: Yes, we can't hear.
MR. HOUSTON: -- and that there were other cases where if the records weren't available -- I recollect at least in this last testimony we heard not too long ago, that, you know, that the school nurse was indicating that parents were driving hours in certain other cases either to get an authorization signed, especially where they are out in a rural area, where a physician office may not be close by. So, I think there were some concerns over all that just operationally you could solve by simply making these
people --
DR. COHN: I actually agree with what you just said. It is just that that doesn't say that here. What I was sort of thinking was is that the real issue here is is that it is, you know, a tremendous bottleneck. It is a tremendous hassle. Once again, my understanding -- and once again, I only have to speak for the state that I live in, but unless you have your immunizations, you weren't allowed in the school. So, it becomes sort of a major barrier there and that that is really sort of the issue.
It isn't that -- I mean, I guess people could choose to get duplicate immunizations, but, once again, as I said, you know, if you are a parent and you are being told that you can't go to school if you don't get the immunization or sign a disclosure --
MS. GREENBERG: The problem is I think it had to be a HIPAA --
MS. HORLICK: -- that they couldn't even do things by fax, but that was the clarification issue, but I think the major issue, my understanding is that for a lot of these parents in New Mexico particularly we heard these concerns. These were just parents that couldn't take off from work, couldn't go to the doctor, wasn't sure who had their records and maybe the information was in the doctor's office. The parent was willing to sign whatever they could, but because of all these logistical problems, the child was either getting duplicate immunizations or not being able to start school.
MR. HOUSTON: I recollect, again, this later testimony, though, that there were still problems in getting parents to even go and resign authorizations. So, there is a variety of issues that --
DR. COHN: I withdraw that. We will deal with it in the subcommittee level.
MR. HUNGATE: It is a procedural question on my part. It has been a long time since my kids got immunized. So, I am not current, but isn't there a consent form that the parent signs at the time of immunization? Isn't there some formalization of the authorization for immunization? And couldn't the disclosure be included as part of that so that it was done, the decision made at the time of immunization?
DR. LUMPKIN: Well, it could be if the parents so chose to do that, but giving authorization to release the data is not a co-condition for getting the vaccine. So, parents may choose not to sign it. Providers may choose not to have that form filled out.
This is tied in with -- in fact, a number of states have immunization registries, if not the vast majority of them because the CDC has been actively funding these. Another complexity to this, which leads me to say that I think this is fine, let's just go with it, is the fact that states that operate immunization registries could choose to provide that information to schools because they are actually mixed entities. As such, the entity that collects the immunization registry data is generally not a covered entity portion. So, the information is no longer in the HIPAA domain.
MS. HORLICK: John, that is probably true for most every case, but there are probably six or eight states where the entire state health department -- New Mexico, I believe, is one of them -- is a covered entity.
DR. LUMPKIN: And that is the reason why I think we should go ahead with it. Is there anybody here from New Mexico, who can stand up for their state? Jeff. Okay. Jeff was silent.
So, I think we are kind of -- okay. We see that there are limitations, but we think this may be the best way to deal with it.
Anything else on immunizations?
Okay. The last issue is on abuse and neglect. Any comments on that? My only concern on this one -- and I just don't know how to do it -- maybe we should do it in a summary -- this one is a bright light issue to me and I suspect would be to the Secretary. We just need to make sure that this issue doesn't get lost in this letter because this is one that probably will drive quicker action than anything else we raise.
MR. HOUSTON: There is a bullet point in the summary, third bullet point down in the summary. I think these were sort of taken in order of --
DR. HARDING: Please speak into the mike.
MR. HOUSTON: I am sorry. The third bullet in the summary really does describe this and I think the bullets were sort of added sort of in the order in which they were placed within the letter. But, I mean, we could expand or potentially move that up. In fact, if you wanted to try to emphasize this in the summary --
DR. LUMPKIN: Well, I suspect that our conversation here with our federal partners, some of whom might be charged with answering the letter once we send it will, I think, serve to highlight that point. So, I think we can leave it the way it is. But I think it is important for us to note that this is an issue -- the issue of children being abused and our protection as a nation is a very important issue, one that is considered very highly. So, this point here is not the same, I think, level as all the other points that we raised, as serious as they are.
Okay. Anything else on that?
MS. HORLICK: John, I just want to say that I need to sign off now, but I will call in for the subcommittee meeting tomorrow.
DR. LUMPKIN: Thank you, Gail.
Okay. Let's go on to research.
MR. HOUSTON: "Witnesses at the hearing provided frank testimony describing the potential detrimental impact of the privacy rules research provisions on research activities. The witnesses at the hearing overwhelmingly supported the privacy rules intent of aligning its requirements with those of the federal common rule for the protection of research subjects, 45 CFR Part 46 (common rule); thereby, promoting consistency and ease of compliance. In some key instances, however, the privacy rule diverges from the common rule in ways that cause either gaps in privacy protection or unnecessary obstacles to research.
"Additionally, due to the considerable confusion, compliance with the privacy rule provisions on research would be helped by clarification of expanded educational activity. An example of the inconsistencies between the privacy rules research provision and the common rule relates to preparatory to research activities. The privacy rule permits PHI to be reviewed by a researcher for the purposes that are preparatory to research without institutional review board, IRB, or privacy board approval and without a patient's authorization.
"Preparatory to research includes such activities, hypothesis, definition, protocol preparation and research recruitment. In fact, according to the department's August 2003 document, institutional review boards and the HIPAA privacy rule, the privacy rule permits a researcher, who is a workforce member of the covered entity, to contact potential research subjects for the purposes of seeking an authorization as part of the covered entity's health care operations.
"Even if such contact could be construed as coming within health care operations, the interpretation permits recruitment of potential research subjects (as an element of research) absent either a waiver from the IRB or patient authorization and thereby violates a fundamental principle of research ethics in the common rule.
"The privacy rule permits an authorization for the use and disclosure of PHI in research to be combined with an informed consent document, although many researchers prefer to use separate documents. According to the same August 2003 publication, the privacy rule does not require IRBs to review and/or approve authorizations either as stand-alone documents or when combined with informed consent documents.
"The permissive nature of this interpretation has created confusion about whether IRBs have the authority or responsibility to review these HIPAA authorizations. Because IRBs are charged with reviewing all written materials provided to research subjects, as well as considering whether privacy and confidentiality protections are adequate. A revised interpretation recognizing the authority of IRBs to consider HIPAA authorizations would promote clarity and help coordinate the privacy rule with the common rule.
"An area in which the diversions of the privacy rule and the common rule results in burdens on researchers involves general research authorizations, under the common rule, subjected to such limitations as an IRB deems appropriate, a research subject may provide informed consent for future unspecified research, including research using biological specimens.
"Under the current interpretation of HIPAA, however, an authorization may not be for future unspecified research and a separate authorization must be obtained for each trial or study. Unless the HIPAA interpretation is changed, it will be exceedingly difficult to compile research repositories, including the collection of biological specimens linked to medical records, which are essential to many forms of research.
"A January 2004 document, "Research Repositories, Databases and the HIPAA Privacy Rule," indicates that a waiver of authorization could be obtained from an IRB, but this additional step further complicates the process. Several other areas related to research also need to be addressed. Genetic researchers are concerned that any DNA sample, even if not linked with an individual, might not be considered anonymous because analyzing the sample could reveal the unique DNA identifiers of the individual.
"Clarification that unlinked DNA samples are not identifiable would resolve the issue. Clarification also is needed on the applicability of HIPAA to indirect participants (individuals who are not research subjects, but whose PHI may be disclosed by research subjects) in multi-institutional studies. The witnesses also identified some areas in need of additional outreach and educational initiatives to counteract the reluctance or refusal of some smaller institutions to participate in research because of misunderstanding HIPAA and the standards for the de-identification of individually identifiable information.
DR. LUMPKIN: Okay. Any comments, questions on the research?
MR. HOUSTON: I do. A couple things that I have on the second paragraph about halfway down, rather than "in fact," I was thinking maybe the word "specifically" might be a better choice of words. The second paragraph under "Research," about halfway down, there is a word "in fact" or words "in fact, according," the very top of page 3.
DR. LUMPKIN: Okay. That is an editorial change.
MR. HOUSTON: Then I did have some changes at the end or this paragraph --
MR. FANNING: Excuse me. Is there a choice to drop the term "in fact"?
DR. LUMPKIN: That is, in fact, the case, if I could be specific about that.
MR. HOUSTON: In its place say "specifically," I would think.
DR. FITZMAURICE: In the copy that I have before me, it has already been done.
MR. HOUSTON: Then you probably printed out the version I sent out to the committee that Mark said that we should not hold on -- this makes things a little easier then. I wasn't sure whether this was going to be distributed because I think Mark had indicated that he would prefer me to just bring the comments up when we discussed it today.
If we are looking at that document, I think from my perspective, the last couple of sentences of that same paragraph, I think, could use some further clarification.
DR. LUMPKIN: They don't change the content, just the wording.
MR. HOUSTON: I believe, though, again -- maybe I should read it and --
DR. LUMPKIN: Please.
MR. HOUSTON: These are the last two sentences of that same paragraph. "Even if such contact could be construed as coming within health care operations, interpretation permits..." -- this is where I added "...the direct recruitment of potential research subjects and element of research by researchers who do not have a preexisting clinical relationship with the patient." Then I had put a period and then started with "Absent either a waiver from the IRB or patient authorization, such practices would violate fundamental principles or research ethics in the common rule."
DR. LUMPKIN: I like your version.
MR. FANNING: Would you please mark it on your text and give it to me so I can incorporate it into this.
DR. COHN: Do you have a copy of this?
DR. FITZMAURICE: One is a minor one that -- at the top, where is says "Preparatory research include..." that probably should be "includes," just with an s at the end of it.
More substantial, the last one -- the one you just read, the even if sentence, it says, "Such contact by the researcher to a potential recruitee could be construed as coming within health care operations, which..." -- the interpretation is -- "...it permits the direct recruitment of potential research subjects, an element of research by researchers, who did not have a preexisting clinical relationship with the patient." I think that is probably false because a researcher can't do that unless the researcher is working directly with the physician, for the physician or if the researcher has a business associate contact for the purpose of contacting the recruitees to see if they would be willing to participate.
It is the same as if the physician is doing it either because of the labor relationship or because of the business associate contract. That is a direct clinical relationship the physician has with a patient and has extended that, have the researcher do something as a health care operation for him.
I disagree with describing it as researchers do not have a preexisting clinical relationship. If the clerk calls me up and says have you had your immunizations and I give that information, is the doctor's clerk now having a preexisting clinical relationship with me? I think it is all covered by being under the rule of the physician.
MR. LOCALIO: This is Russ Localio. I have a problem I think with the way you have revised the text; whereas, I didn't have as much problem with the way it was. Let's assume that a physician has an ongoing clinical relationship, clinical physician/patient relationship with a patient. The physician, the treating physician then wants to recruit the patient for a research study. The way I understand it, the physician would have to have IRB approval to do that contact. It doesn't matter whether the physician is the treating physician or not the treating physician. That needs to be clear because I think your point is here that the way the privacy rules might be interpreted is that they waive the requirement for IRB approval of research.
MR. HOUSTON: No, what it does do is waives the requirement of IRB approval for research recruitment activities, which are preparatory to research.
MR. LOCALIO: Fine. I think we are in agreement on that. I think the way you revised it, it tries to make a distinction between recruitment by the treating physician and recruitment by a researcher, who is not a treating physician and I don't think that is a distinction that should be made. Certainly, I don't think it is a distinction that is made by the common rule.
Research is research very clearly defined by the common rule and requires IRB approval, even if it is the treating physician. So, in other words, the surgeon who wants to do a follow-up of his patients and not simply call up his patients and say, you know, come back, I want to do a research study on these people. That treating surgeon would have to get IRB approval.
MR. HOUSTON: I believe that is correct.
DR. FITZMAURICE: I disagree with the interpretation. I think in order to obtain the patient's authorization, somebody has to contact the patient and who better than the treating physician.
MR. LOCALIO: That is a separate issue. I think here you are just talking about the IRB would have to approve anyone contacting a patient to recruit the patient for a research study. The IRB would have to approve contacting a patient, except --
DR. FITZMAURICE: You mean because of the common rule.
MR. LOCALIO: That is correct.
DR. FITZMAURICE: I don't disagree with that. I am just talking about the privacy rule.
MR. LOCALIO: Now the privacy rule, let's assume that that piece is clarified. The privacy rule would not prevent -- if the IRB approved it, would not prevent a researcher, who was not taking care of the patient from contacting their patient to recruit the patient for research.
DR. FITZMAURICE: One exception. If the patient does not have a business associate contract with the physician or is not the treating physician him or herself, then that researcher is prohibited by the privacy rule.
MR. ROTHSTEIN: -- in front of me the interpretation from the document, clinical research and the HIPAA privacy rule and it -- let me read the entire Q&A, if I may.
Question: If under the preparatory to research provisions, a researcher identifies subjects that meet the study's eligibility criteria, how can the researcher contact the potential participant to obtain authorization after identifying these individuals?
Answer: Under the preparatory to research provision, covered entities may use and disclose to researchers PHI to aid in study recruitment. They may allow a researcher to identify but not contact potential study participants. A researcher may do so without authorization from the individual under the following circumstances. There are two given.
First, if the researcher is a workforce member of a covered entity, the researcher may contact the potential study participant as a part of the covered entity's health care operations for the purposes of seeking authorization. Alternatively, the covered entity may contract with a researcher as a business associate to assist in contacting individuals on behalf of the covered entity to obtain their authorizations.
Second, if the covered entity obtains documentation that an IRB has partially waived the authorization requirement to disclose PHI to a researcher for recruitment purposes, the covered entity could disclose to the researcher the PHI necessary for the researcher to contact the individual.
So, basically what the interpretation through this Q&A does is say that you can solicit -- that is, a researcher can solicit authorizations from individuals before a protocol has been approved by the IRB and because recruitment is considered to be part of research, what this would allow is an element of research to go forward before the IRB has even seen the protocol. That would violate the common rule. That is the point we are trying to make here.
MR. LOCALIO: Well, I agree with the point you are trying to make, Mark. This is Russ Localio again. I agree with the point you are trying to make. It is just that my understanding is the way the proposed language to amend this was inconsistent with the point you are trying to make.
The point you are trying to make is IRB approval is Step 1 and then all the rest of the stuff is Step 2. The point that I thought I heard was that there was a distinction between recruitment done by the treating physician and recruitment done by a researcher, who is not the treating physician. If Step 1 has been completed, the treating physician would have to complete Step 1 and get IRB approval to recruit a patient for a research study that he or she was doing.
MR. ROTHSTEIN: Yes, Russ, I agree with you. The original draft did not even mention a treating physician. That was an amendment that John Houston is offering.
MR. LOCALIO: And, again, I think the original -- I agree with the original language. I have trouble with the amendment because of what I think is a distinction between treating physician and researcher, who is not a treating physician. Both have to have IRB approval.
DR. LUMPKIN: I think that if the subcommittee could get the message that -- I think that we are probably comfortable with the language that is right here and it would be easier not to change it at this point because I think the rest of us are pretty much lost on this one.
Mark, I agree with you.
MR. ROTHSTEIN: Okay. So, we can go back to the original paragraph 2 under B, research.
DR. LUMPKIN: I think that might be the best.
MR. HOUSTON: There is one point, though, that I think, though, is important then, based upon what Russ had stated, I think, is that there is still the issue of IRB approval that it isn't even discussed here, even in the original paragraph.
DR. LUMPKIN: It is and I think that what is missing from this thing, from this document, which I think may make it a lot easier, is under "Research," we should just say we think the common rules should govern and that the first -- that researchers need to comply with the common rule and then look to see whether or not there are any additional requirements that are placed on by HIPAA that doesn't deal with the issue about the separate authorizations. I think that one is an upcoming paragraph. But I think we should probably make that statement somewhere early as sort of a governing concept.
Then this just becomes explanatory rather than a statement of our beliefs.
MR. HOUSTON: When you say the common rule should govern, do you mean that the privacy rule provisions should be eliminated or should -- the common rule should come first and then the privacy rule should then be applied?
DR. LUMPKIN: You should first apply -- you should first comply with the common rule. After you have assured compliance of that, you should then determine whether or not you are also in compliance with HIPAA.
MR. BLAIR: New Mexico agrees with that.
DR. FITZMAURICE: Wouldn't you say you have to comply with both of them and where they disagree, you have to still comply with both of them at the -- if a common rule is more restrictive, then you go with the one that is more restrictive. It is not a matter of which one comes first. You have to obey both of them and where they do conflict, then you need to get a judgment.
DR. LUMPKIN: Yes, and our judgment is the common rule should govern. If there is a conflict between -- well, no, the more restrictive should govern.
DR. MAYS: We do not want them to actually bring up the issue that there is a conflict between the two and that they should go back and try and ferret out where there are conflicts because I don't know that you always want the most restrictive, but you have to really think about the most restrictive may end up creating problems in terms of research or vice-versa may create problems in terms of, you know, burden relative to kind of the clinical operations that go on. I don't know if you always want to say that.
I think it is better to send people off to try and determine when there is conflict that the common rule is the preferred but that they should really go through and try and see where there is conflict between the common rule and HIPAA.
DR. FITZMAURICE: Vickie makes a good point.
MR. ROTHSTEIN: That is why in the opening paragraph to the section on research, we note both that where there is a distinction between the privacy rule and the common rule, one of two things could happen. It could mean that it is a burden on research or it could mean that there is a gap in privacy protection and we have examples of both from the testimony.
DR. LUMPKIN: Okay.
MR. LOCALIO: Following up on that, yes, I think there were examples of both from the testimony because I was at one of the sessions. So, therefore, I would recommend deleting the word "potential" in the first paragraph in "Research." I heard testimony describing detrimental impact.
The degree of the detrimental impact is certainly subject to empirical clarification, but there was definite testimony about the detrimental impact.
DR. LUMPKIN: Okay. Witnesses at the hearing provided frank testimony describing the detrimental impact.
DR. VIGILANTE: Just to help operationalize this for me, the line that says "Authorization may not be for future unspecified research and a separate authorization must be obtained for each trial or study." Does this mean that, for instance, if you --
DR. LUMPKIN: Are you like in the fourth paragraph?
DR. VIGILANTE: I am in the fourth paragraph -- no, third paragraph of page 3.
DR. LUMPKIN: We haven't gotten there yet.
DR. VIGILANTE: Oh, okay. We are going to try to march through so we can sort of finish up on the first paragraph. Anything we drop potential, we will come back to that.
MS. GREENBERG: We added potential. Why are we dropping it. I know where you are, but why are you dropping it?
DR. LUMPKIN: Because Russell commented that they heard actual testimony of real harm that occurred because of the gaps in privacy. So, it is no longer a potential. The sentence says, "The witnesses at the hearing provided frank testimony describing the detrimental impact of the privacy rule on research and provisions on research activities.
MS. GREENBERG: That is different than on privacy. I think there were people who felt that this privacy rule's research provisions could have a detrimental impact on research activities. Do you feel that you heard that they already had had a detrimental impact?
MR. LOCALIO: Yes. Certainly, that is at least the way I interpreted it. I will just give you an example. You have 20 IRBs you have to go through and 10 of them say "no," because this is the way we interpret the privacy rule and 10 of them say "yes," because this is the way we interpret the privacy rule.
That is a detrimental impact on research because you have a biased sample. By the way that is a severe problem in research.
MR. FANNING: Is that the direction of the committee?
DR. LUMPKIN: Yes. We are now back to the second paragraph --
MR. FANNING: Could we just ask -- Mr. Chairman, you said that you wanted a general statement about the relationship between the two rules?
DR. LUMPKIN: I have been shown the lack of wisdom of my statement by my colleagues.
MR. FANNING: Before we leave the first paragraph, we have here joining the staff of the Privacy Subcommittee, Laura Cutcat(?) of NIH, who will suggest some factual issues in the first paragraph.
MS. CUTCAT: Good morning. I also work with OCR in the development of all the HIPAA research and educational materials that have been cited in this letter. I would like to suggest that the federal common rule for protection of research subjects be revised to reflect the accurate title of that subpart, which is Federal Policy for the Protection of Human Subjects.
These policies are codified for HHS at 45 CFR Part 46, not for everyone who has signed on to the common rule. So, we may also want to suggest adding codified for HHS before 45 CFR Part 46, just to be clear on what we mean there.
DR. LUMPKIN: Mindful of the time, I am going to try to suggest a procedural approach to getting through this document. For people who are on the Privacy Subcommittee, which will be meeting tomorrow, if you have editorial changes, please hold those until tomorrow. Let's try to get to the substance of the document as we move forward.
In the second paragraph we kind of had some changes that John suggested, but we are not going to go with those. We are going to sort of stay with the language as it is.
DR. FITZMAURICE: Except for specifically rather than in fact.
DR. LUMPKIN: The second one deals with the separate informed consent, I think, if I am summarizing that correctly, issue. Do we have any comments?
DR. STEINWACHS: You are on the third paragraph?
DR. LUMPKIN: Now on the third paragraph.
DR. STEINWACHS: I found the first sentence in the third paragraph a little bit confusing as stage setting for that paragraph. I was just going to suggest that the committee might want to just eliminate that sentence and just lead into it.
DR. LUMPKIN: I think it is a little bit confusing what the first sentence does is to say, okay, this paragraph is going to be about burdens, burdens on research.
DR. STEINWACHS: I believe you.
DR. LUMPKIN: It may not say that clearly enough. So, if you have some suggestions -- word changes --
DR. STEINWACHS: I was hanging up on the use of separate documents versus one document and it just seemed to me that it was --
DR. LUMPKIN: I don't think the second sentence talks about the burdens on researchers.
DR. STEINWACHS: Are we on the same third paragraph?
DR. LUMPKIN: I am on the fourth paragraph. I really apologize. I am with Kevin. We are on the fourth paragraph.
MS. GREENBERG: Whether IRBs have the authority
to --
DR. LUMPKIN: So, you are suggesting that we just eliminate that first sentence?
DR. STEINWACHS: It seemed a little clearer to me that way, but that is -- you know, as an outsider reading it.
DR. LUMPKIN: Okay. Any problems with doing that?
MR. ROTHSTEIN: Well, this is Mark. I think we need to set up the issue and that was the purpose of the sentence. Maybe we can make it clearer, but --
DR. LUMPKIN: Okay. Why don't we leave that for the subcommittee saying that we want to make that a little bit clearer. Okay.
MR. HOUSTON: Work on rewording the first sentence of this paragraph to make it clearer or a better lead in to the rest of the paragraph.
DR. LUMPKIN: Okay. Anything else on the third paragraph?
DR. FITZMAURICE: There was an issue that came up and resulted in a letter from the Secretary from OCR back to some group. The issue was that for FDA clinical trials, IRBs were reviewing both the informed consent and the authorization and it was taking up a lot of time and burdensome for research. The result of the letter that went out said essentially, yes, you are charged with reviewing informed consent, but you do not -- there is nothing that obliges you to review the authorization form. That was to reduce the burden on IRBs and to reduce the burden on researchers. I think that they already -- IRBs can already consider whatever they want to consider before they give the imprimatur because they already can. I am not sure I see what is required by this.
They have the authority to do anything they want. They are not required to by the privacy rule, to look at authorizations. But if they think they need to in order to protect the information, then they can.
MR. ROTHSTEIN: Well, the issue was that there is from the testimony great uncertainty among IRBs about what jurisdiction is and we thought that including this tier, that the relief we are seeking is only a clarification that IRBs have this authority and I think this is something that the Secretary's advisory committee will be taking up as well.
So, this will be sort of the HIPAA side of the same issue to try to clarify for IRBs what their jurisdiction is.
DR. FITZMAURICE: So, are you asking, Mark, that the department interpret the privacy rule as requiring the IRBs to look at the authorizations or allowing them to look at the authorizations?
DR. MAYS: Partly what I was going to say is that based on what you just said, it might be helpful to actually have a statement in there that then the IRBs would know that they are not required to do it. I think what it seems like the committee is trying to do is to let IRBs know that based on the typical and customary act of wanting to see everything that they can and that HIPAA doesn't prevent it, but I think it would be helpful in terms of the IRB burden for them to know that they should not feel obliged to do it because of HIPAA.
MR. HOUSTON: I don't think that was the point, though. I think the point was that this paragraph was intended to provide the state with the fact that the IRB should have the authority if they so choose to be able to. I mean, the difference between being obliged, having the right and having the authority, authority says that if somebody -- a researcher is working within an institution and the IRB of record decided that it has the authority to oversee and review all of these materials, then that researcher would be required to go through the IRB and have all those materials reviewed, rather than the thought that the IRB may not have the mandate to be able to review those materials and, therefore, the researcher could decide him or herself whether to have the IRB review those materials.
DR. LUMPKIN: Let me just suggest that if you look at the recommendation that generates from this paragraph, this paragraph really states the problem. The recommendation on page 4 says, "HHS should clarify that IRBs have the responsibility to approve stand-alone authorizations for research.
When you read the paragraph, it states the problem. The solution is not saying that they have to. It says whether or not the issue that is raised in the paragraph -- it is that they are unclear about their authority.
DR. FITZMAURICE: I don't see anything that gives them that responsibility. They have the right --
DR. MAYS: Right. I was just going to say now it is totally different. Here is the recommendation that has the responsibility. They have the right, but HIPAA doesn't make them have more responsibility.
PARTICIPANT: Maybe we should change "responsibility" to --
DR. MAYS: Yes, I think that would be good, yes.
MR. FANNING: This is -- to the recommendation?
DR. FITZMAURICE: It looks like it is encouraging IRBs to look at all the authorizations. That is burdensome.
MR. HOUSTON: I think Mark needs to weigh in on this one. Mark, could you -- Mark, was I correct in what I thought we were trying to do, which was to grant the IRBs the authority to be able to have the oversight of all materials? Correct?
MR. ROTHSTEIN: We can't as a subcommittee or even a full committee tell IRBs what to do. The Secretary might. In trying to act on recommendations from the Secretary's advisory committee, as well as our committee, say that they ought to do that or are required to do that.
At this point, I think the authority language is fine and maybe when the Secretary's advisory committee letter gets to the Secretary, the Secretary may want to strengthen that and change it from authority to, in effect, require.
DR. LUMPKIN: Okay. Before we -- I have to ask one question because as I have been hearing the discussion, the role of the IRB is to assure that any individual, who is a subject of research, is adequately protected and their privacy is protected and that is the purpose of the consent that they give that is reviewed by the IRB.
If that consent is adequate for IRB purposes, why are we concerned about the HIPAA privacy authorization, because the researcher has to comply with the consent that is given in both. As long as they have -- if the one that is by the IRB is more restrictive, then it doesn't really matter what is in the HIPAA one.
If one is looser, because the IRB is comfortable with it, then the HIPAA one is going to apply because it is not a research issue. It is a HIPAA privacy.
MR. ROTHSTEIN: The problem as described that I am hearing, John, is that many institutions do not use a single form, although they may, for an authorization and informed consent document. So, where there are two documents, the IRB clearly could pass on the authorization, the stand-alone authorization. Some IRBs feel that they don't have the authority to rule on the authorization because it comes under HIPAA and, therefore, they only approve one and the researcher is left in limbo because the authorization that is a separate document has not been approved by anybody and without an approved authorization, we are told that they are having trouble getting access to PHI.
MR. FANNING: Mr. Chairman, I think what the recommendation here is, the Secretary should make clear that just because the HIPAA rule does not require IRB or privacy board review of an authorization form doesn't mean that the IRBs can't address that issue. Is that not the point, Mark?
MR. ROTHSTEIN: Correct, yes.
DR. FITZMAURICE: And I would answer that, but they don't have to.
PARTICIPANT: Right. That is why authority is a good word.
DR. LUMPKIN: But my question is --
DR. FITZMAURICE: They have criteria that they have to look at, applied to the research. If to meet that criteria they want to look at the authorization, they darn well can look at it. But the authorization is a legal document and if it meets the legal requirements of the HIPAA regulations, then it is OCR's purview that either does or doesn't.
DR. LUMPKIN: But let me understand because I am trying to figure out why we are in this morass and it is taking up a lot of time. I understand the conflict, but is it a HIPAA conflict or is it an IRB conflict? Because our charge is not to advise the Secretary in relationship to IRBs, except as to the extent that there is a conflict.
Now, are we uncomfortable from a HIPAA viewpoint that IRBs are uncertain about their authority to review HIPAA authorization?
MR. HOUSTON: And I would say "yes," because IRBs are specifically mentioned in the privacy rule as having certain oversight rights or at least can be involved in the oversight of the privacy rule with regards to research.
DR. FITZMAURICE: They can look at anything they want to to make sure that the privacy of that information is being safeguarded.
MS. GREENBERG: Would it be correct to say HHS should clarify that nothing in the privacy rule precludes IRBs from approving stand-alone authorizations for research?
DR. FITZMAURICE: And I would add to that "or requires." It doesn't require them.
MS. GREENBERG: Nothing in the privacy rule either precludes or requires to approve stand-alone authorizations.
DR. FITZMAURICE: Mark, how do you feel about that?
MR. ROTHSTEIN: That is fine with me.
DR. LUMPKIN: Paragraph 4.
MR. HOUSTON: There is only one -- this is a clarifying comment. The sentence that starts, "Unless the HIPAA interpretations change, it will be exceedingly difficult to compile research repositories..." I think there should be a comma after repositories.
DR. LUMPKIN: We are going to leave commas for the committee, subcommittee. I don't think there is any objection to that.
DR. FITZMAURICE: On the sentence that says, "Under the current interpretation of HIPAA, however, an authorization may not be for future unspecified research and a separate authorization," I would add after that or IRB or privacy board approval, must be obtained through a trial or study.
DR. LUMPKIN: Read that again.
DR. FITZMAURICE: "Under the current interpretation of HIPAA, however, and authorization may not be for future unspecified research and a separate authorization must be obtained for each trial or study." I would insert and a separate authorization or IRB/privacy board approval must be obtained for each trial or study. Because you don't need authorization if you have IRB or privacy board approval to get access to the information.
MR. ROTHSTEIN: Well, that is what the last sentence goes to clarify.
DR. FITZMAURICE: But you can clarify it right there in that middle sentence so that people don't get misled.
PARTICIPANT: That was one of my concerns.
DR. LUMPKIN: Okay. We are going to add that in.
DR. VIGILANTE: Just for clarification, is the -- the next sentence that says, "Unless HIPAA interpretation is changed, it will be exceedingly difficult to compile research repositories, including the collection of biological specimens linked to medical records, which are essential to many forms of research." Does this include, for example, linking de-identified genomic data to de-identified tissue to de-identified clinical variables, such as, you know, the nutrition of this particular subject, the co-morbidity, survival, but linking all their elements, but having them all de-identified, is that viewed as problematic?
MR. ROTHSTEIN: If they are all de-identified, that would not be a problem. However, we also received testimony that we get into the next paragraph, that some genetics researchers think that even sort of anonymous DNA samples are not, quote, de-identified because it is the ultimate identifier and could be sequenced to identify only an individual. We are trying to, you know, clarify that in the next paragraph, but I think your concern is one that has been expressed to us by researchers and in the testimony.
DR. VIGILANTE: But the position of -- the current position, is there clarity around that or not? In other words, if you de-identified the tissue, if you have tissue samples linked to DNA, linked to clinical outcomes and they are all linked to each other but they are all sufficiently de-identified. Is that seen as problematic?
MR. ROTHSTEIN: I think the interpretation of the rule would say, no, that is not a problem. Researchers, I think, are mistaken and that is why we call in the next paragraph for clarification that de-identified genetic material is not, quote, identifiable.
DR. LUMPKIN: Okay. I am going to do a little bit of a reality check here because we still have a fair bit of the document to go through. What I am going to suggest is that because the Privacy Subcommittee is meeting tomorrow morning, there are no other conflicting subcommittee meetings and I wonder if we would feel comfortable with having this discussion continue tomorrow morning at 8:30 and then having those parties who are interested or have additional comments to make about the document, bring those to the subcommittee meeting tomorrow morning for -- bringing the document back to us in the afternoon.
MR. BLAIR: So, we are not precluded from attending, but we are not required to.
DR. LUMPKIN: That would be correct.
DR. STEINDEL: John, the only problem that I see with that is that we have arranged for some of the new members to go to Hyattsville for badge photographs at that time, assuming that there would be no conflicts.
DR. LUMPKIN: Then I would ask those who have additional comments and concerns, perhaps to share those with John, if they are going to be going out and getting the -- because we do have a full agenda for the two days and I don't think we can continue to delve into this. Obviously, there are some issues that -- and I don't want to make a slight because I think that some of the work, including the commas, are important clarifications and we don't want to because of the press of time to minimize that input.
I think having fuller time at the subcommittee will do that.
MR. HOUSTON: The only thing I would ask if they come to me, that probably we should have John Fanning around also.
MS. GREENBERG: If you have a cell phone on your route out to Hyattsville, you could call in to the meeting.
DR. LUMPKIN: No, this is like the good old days with the Privacy Subcommittee. Only the older members remember those days, back before we had a proposed rule.
Okay. We are scheduled -- we are going to take a ten minute break and then we are going to come back with our special panel presentation.
[Brief recess.]
DR. LUMPKIN: Let's reconvene. There are a couple of lessons for those of you who are new or relatively new to the committee. First is, as Kathy Coltin can tell you that and Lisa Iezzoni, who were members of the committee, is that if you are involved in a major project even though you cycle off the committee, you may not be able to get away as quickly as you think.
As two of our next panelists will tell you that even though you are gone, you are never really gone. We have a panel that is going to begin to address the issue of the health statistics for the 21st Century, which all of you have in front of you. It is a major report of our committee, which Dan Friedman took the lead on and sort of hammered through, despite all sorts of major obstacles.
We appreciate that. So, we have a panel. I am going to ask the panel members to introduce themselves. I don't think I know the order. Dan is going to go first and Carl is going to go last. So, by process of elimination, Barbara Starfield is going to go in the middle. Just a brief introduction again, although we had introductions in the beginning.
Agenda Item: Health Statistics for the 21st Century
DR. FRIEDMAN: I am Dan Friedman --
DR. LUMPKIN: And as you know before, I always interrupted you and said can you speak into the microphone for the people on the web.
DR. FRIEDMAN: I thought that I was.
I am Dan Friedman. I am a consultant in population health information based in Massachusetts and a former member of the committee.
DR. STARFIELD: I am Barbara Starfield. I am on the faculty of the Johns Hopkins School of Public Health and a former member of the committee.
DR. VOLPE: I am Carl Volpe with WellPoint and I have never been a member of the committee. I am going to be talking about the private sector view.
DR. FRIEDMAN: John, how long would you like me to -- about how long would you like me to speak for?
DR. LUMPKIN: We are scheduled to go until 12:30. So, I think the betwixt the three of you, if we could look at maybe 15 minutes apiece.
DR. FRIEDMAN: Before I get started, let me mention that -- let me emphasize that any of the obstacles or barriers that John alluded to in developing this report in no way resulted from either other members of the committee or staff to the committee because, first of all, I and the other people who worked on the report really appreciated the collegiality and the support from both the committee members and the staff, which was really just super, as well as from NCHS, which was a partner in developing the report and the Data Council, which is also a partner.
I am going to speak about three things. First of all, at Marjorie Greenberg's request, I am going to provide a brief summary of the 2002 NCVHS report on shaping a health statistics vision for the 21st Century. Marjorie asked me to do that. I will try to keep it very brief. Marjorie asked me to do that because there has been the addition of several new members since Barbara and I cycled off and since the committee was released.
Second, I am going to present a very brief overview, very brief, of state health data systems within the context of the report.
Third, I am going to build on the report and to describe three very simple tactics for addressing some of the issues around state health data systems. Even though the discussion is going to focus on state health data systems, let me add that some of these issues really could apply just as easily to national and federal systems. You have the report in front of you. One of the things that the report did, which was very brief and very simple, but we thought was very important, was for the first time actually define health statistics in the public health literature.
The report defines health statistics as numerical data that characterized the health of a population and the influences and actions that affect the health of a population. What is important here, the take-away point, as it were, is that our definition of health statistics focuses on population health.
We also defined the health statistics enterprise as the infrastructure and activities necessary to produce health statistics. In this country, that includes public and private organizations and individuals at all geopolitical levels that perform the processes of health statistics. Again in this country in particular, it is a very decentralized enterprise and it includes organizations that collect, analyze and disseminate data on the health of populations and the factors that influence health.
The mission of the enterprise, as it is defined in the report, is to efficiently provide timely, accurate and relevant information that can be used to improve the nation's health. Again, a focus on population health as the core part of health statistics.
One important part of the vision that we laid out in the report is the need for an overarching conceptual framework for health statistics, an overarching population health conceptual framework. In the report, we emphasized that that conceptual framework is important because it helps to focus the enterprise on needed data and it helps to guide the enterprise in identifying new and emergent issues. It focuses on health, the population and the community, rather than on solely much more proximate influences on the population health.
It emphasizes the distribution and level of health rather than just average health, delineates major influences on health and helps to define a research agenda for improving the population's health. In the report,we lay out a conceptual framework schematic. Barbara and I happen to like this schematic. At the same time, I think what is -- I don't want to speak for Barbara anymore -- I happen to like this schematic. Having said that, there are other schematics that perform exactly the same functions and the functions are basically laying out in an easily accessible fashion what are hypothesized influences on the health of the population. Here, we include a variety of community attributes, contextual influences, including the natural environment, the cultural environment and the political context.
The report includes a more detailed version of this. The report also includes ten guiding principles for the health statistics enterprise. I am going to run through these extremely rapidly with almost no commentary.
First, enterprise-wide planning and coordination. Second, broad collaboration among data users, producers and suppliers at all geopolitical levels.
Third, rigorous policies and procedures for projecting privacy, confidentiality and security. Fourth, flexibility to identify and address emergent health issues.
Fifth, use of data standards. Sixth, sufficient detail at different levels of aggregation. Seventh, integrated streamlined data collection for multiple purposes.
Eighth, timely production of valid and reliable health statistics. Ninth, appropriate access to and ease of use of health statistics.
Finally, continuous evaluation of the data.
Now, let me spend just a few minutes on state data systems. What I am presenting very quickly are an overview of archetypical state data collection systems. This is not an average picture of all state data systems. It is not a modal picture but it is based upon my own personal knowledge. It is based upon information that I collected from several states and I am going to -- very, very quickly -- I am not going to read everyone of these, but I am going to quickly run through it.
What is important to notice here, it starts with claims and billing, client case management, AIDS treatment, WIC within claims billing, from AIDS treatment to WIC within client management to each of these bullet points in most states are separate and discrete data systems, not in all states, but in most states. Each bullet point is a separate industry, discrete data system.
Now we can move on to your reports and then to encounter data. Again, each of those sub-bullet points are separate and discrete data systems. Environmental health data, asthma to water quality. Facilities surveys and reports, each of those bullet points for data systems. Licensure, health facilities and services. Licensure, health professionals, everything from acupuncturists -- I left off here, tatoo artists, but in those states where they are licensed, they are also usually a separate data system for tatoo artists, veterinarians, podiatrists, et cetera.
Occupational health, population-based surveys. Again, each of these -- the behavior risk factor surveillance system, community health surveys, HIV family of seroprevalence surveys, PRAMS, pregnancy risk assessment monitoring systems, youth risk behavior surveys, discrete data systems. Professional association memberships, registries, reportable diseases and conditions.
Now, what we have in what I am positing as the archetypical state are roughly 152 discrete state health data systems. One state I recently visited had 127. Another state that has a fine meta-data site up on the web, states which shall remain nameless, but the former state health officer chairs this committee, had 159 data sets listed.
Now, there are -- these roughly 150 data sets do have some archetypical issues around them, some archetypical questions that we can raise that cut across the states and then cut across the data sets. The first question we can raise is is there a unifying conceptual framework. A second question we can raise is is there interoperability among the data sets and a third question we can raise, is there communication among the data sets, among the data providers, data collectors and data analysts.
What I am going to suggest here is that one thing that the committee can do is try to identify relatively simple techniques for overcoming some of these issues, relatively simple techniques. What I am going to suggest is three techniques as examples.
The first tactic, first technique is conceptual and it consists of learning what data we have and learning what data we don't have. In fact, when you have got 150 discrete data sets, you really don't, my feeling is, have a particularly good sense of really what you have and what it adds up to.
In the interest of time, I am going to skip over here and say that one way of learning what we have is to focus on models of population health and to essentially use a schematic model of population health as a schematic, as a template for evaluating data holdings, literally for plugging in variables from data set to data set into the model and saying what information do we have about the influences on population health, what information don't we have, essentially using population health models as an organizing scheme for learning what we have and trying to be more reflective about what we have.
This is an approach that we really haven't done in this country. The Canadian Institutes for Health Research in conjunction with the Canadian Institute for Health Information in Canada is in the early stages of conducting a project somewhat related to this to basically develop what will probably be a meta-data site for researchers.
A second tactic is methodological and, again, this is what I would suggest is a very simple tactic. The 152 data sets for the most part do not have common identifiers. They don't have common variable definitions. This is despite HIPAA. They do not often have common content on their identifiers. Certainly they don't have common codes and common transaction standards.
Now, what I am suggesting is not the end -- I am going to emphasize this particularly for Jim here -- what I am suggesting is not a national health identifier. I am not even supposed to mention those words here. What I am suggesting is that archetypical state data sets can start using just a simple set of common identifiers, commonly defined with common content, common codes and common transaction standards and just using common identifiers. That relatively simple step would go a very long way toward facilitating linkage and facilitating intersectoral research.
The third tactic is a procedural one and it is somewhat more speculative. The 152 archetypical data sets has different data set holders, not necessarily 152, but certainly more than one or two different set holders. Different data set release protocols, different data set mandates, different data set governing legislation and different data set programmers, analysts and researchers.
Now even though these 152 data sets are held in all likelihood in most states by the state health department, at the same time, the health statistics enterprise, as I said, consists of a great many different organizations. Now, we can think of the governance continuum for producing data, health data for policy purposes, as basically being on a continuum, ranging from governmental organizations, like NCHS, the State Health Data Centers, AHRQ, Australian Institute for Health and Welfare and somewhere loosely speaking in the middle, quasi-governmental organizations, like the United Kingdom Public Health Observatories, Canadians for Health Information and non-governmental organizations, like the Manitoba Center for health Policy.
Now, clearly there is no single correct organizational model for turning data into information for policy and the choice of organization, the models, obviously, needs to be determined by the local and the national climate. Having said that, certainly at the state level one thing I think that we need to really start thinking about are different kinds of organizational frameworks and one of the things that I would suggest we start thinking of are virtual organizational networks as a new point on the organizational governance continuum
Ongoing, highly structured collaboration among participants, organizations and individuals within a clear legal or contractual framework, virtual organizational networks that would build on the strength and capability of each participant organization that would distribute some of the functions and responsibilities of the health statistics enterprise to where they are most appropriate that would maximize collaboration and intersectoral approaches.
Now, one of the requirements for a virtual organizational network is to have a real nerve center, a strong organization or body in the middle, an entity in the middle that would help to organize the enterprise for assessing population health information needs, establish priorities, convening participants, coordinating and planning of participants and facilitating data sharing and linkage.
In the interest of time, I am going to close here and questions at the end, John?
DR. STARFIELD: While we are getting up the slides, I just sort of want to get a sense of the table. I know some of you, but I am not sure I know how you are going to answer the question that I ask. I am going to ask you to try to identify your thinking, whether you regard yourself as basically clinically trained, if you sort of think about individuals, whether you are population trained, that is, you basically don't think of individuals. You think of populations or whether you think there is no useful distinction between clinical thinking and population thinking because after all populations are simply aggregates of individuals.
I was trained clinically. Okay. I originally was trained to think about individuals. I have shifted over the years, but anyway, what about yourselves. How many of you just tend to think clinically, tend to think of individuals? How many of you tend to think -- how many of you think of yourselves as population thinkers? And how many of you think there is no useful distinction between the two?
All right. Let's talk about population health and its implications for health statistics and we will see where you fit.
Challenges of 21st Century health systems -- by the way, how many of you have this presentation in front of you? That is good. I have a few corrections to make. I would hope, please, that you make those corrections when I point them out to you.
Challenges of 21st Century health systems: One, the poor and worsening position of the United States population health indicators, 15 of the most industrialized countries. For about seven or eight of the major health indicators, the United States is last in rank on all of them. That includes infant mortality, probability of death at under age 65, at under age 5, probability of death at ages 15 to 60; a healthy life at age 60, years of healthy life lost, percent of total life expectancy lost and several others. The United States is last of the industrialized countries.
I might point out a couple of things, that the position of the elderly in the United States has fallen in rank. We were among the top two ten years ago and we are no longer among the top two. We are worse off than that.
The third thing I might point out that was surprising to me until I thought about it and that is the percent of the population over 60 has actually fallen in the last ten years in the United States. It is not true in other countries, but in the United States it is true.
Okay. So, the poor and worsening position of the United States on population health indicators, I have some thoughts about why that is the case, but that is not the topic of my talk. So, I will save that for some other time.
The equality of health services and there are several things that might be said about poor quality of health services. One is responsiveness to needs. Now I want to distinguish responsiveness to needs to responsiveness to consumer demands because they aren't the same and I am talking about responsiveness to consumer needs.
I might point out that when evidence started to come through about the dangers of unopposed estrogen and even with the hormone replacement therapy with combined therapy, that those who were taking those medications did not agree with recommendations to stop taking them. They did not believe the evidence. So, there was continuing demand from postmenopausal women for these things and the appropriate course of action was not, of course, to go with demand, but, in fact, go with needs as we knew from the evidence.
Comorbidity, we have always had comorbidity. It is increasing or at least the recognition of it is increasing and that makes us think twice about disease-oriented guidelines. If we are interested in population health and population outcome, we probably want to go well beyond disease-oriented guidelines. Comorbidity.
The third one is coordination of care and that has always been a challenge for us, but it is increasing now, particularly with the increasing use of specialists, largely by virtue of consumer demand, rather than consumer need in my view. People are going elsewhere more often and there is increasing need for coordination.
Overuse. Overuse is something we probably didn't recognize before ten years ago. It is a major problem. Thirty-five percent of the increased costs in the United States health care system are a result of overuse and unnecessary use of services. What I would like you to add in is safety. It is related to overuse. But I would like you to add in there safety.
Now, we didn't really have much population-based data on safety. You could read it in the newspapers, but you couldn't read it in the medical journals before five or six years ago.
Best estimates is that adverse effects and errors account for a third leading cause of death. There is a big difference between the second leading cause of death, which is from cancer, and the third leading cause of death, conventional third leading cause, which is stroke. Estimates of deaths as a result of adverse effects and errors is closer to the rate of cancer deaths than it is to stroke deaths.
Okay. That is the quality of health services. Now there are a couple of challenges in quality of health systems and one is that population outcomes. We need to think about population outcomes, not aggregations of individual outcomes and the need to think about disparities. We didn't do that before five years ago, think about disparities.
I want to particularly distinguish quality of health services from quality of health systems. We focus in this country on quality of health services. Virtually all of our quality assessment systems are on health services and we focus almost not at all on quality of health systems.
I was interested to read an article by Revo(?) in a recent issue of Family Medicine, a supplement, and where he said, "Practicing effectively in today's health system, teaching systems-based care in medical school and in residency-based teaching..." We have actually never done that before. It was in the Journal of Family Medicine. The family physicians seem to much more -- we need to think population than other clinical specialties.
Is population health the sum of individual health than I already told you. What he thought about that, I think the way he thinks. Just think about it. Is the mortality rate, the number of deaths over the population? Shake your head. Is it? The number of deaths divided by the population, is that the mortality rate? Yes, no or maybe. It is. Well, it isn't. I mean, technically it is, but nobody ever uses mortality. That is over population. At least age adjusted.
All right. Now, what about births less than 2,500 grams over the number of births. Is that the low birth weight ratio or rate? Most people would say "yes." And I guess it is, but what does it mean? What does it mean when the low birth weight rate for the African American population is twice that of the -- I mean, would you make policy based on the low birth weight ratio as a number of low birth weights? Not if you are interested in disparities, you wouldn't. It is not meaningful.
What about the number of diabetics or the number of hypertensives in the population, divided by the population, is that the illness rate? No, it is not the illness rate. Okay. It is diabetes over -- but that is not the health of the population.
So, clearly population health is not the sum of individual health. We have known that like -- you know, we have known about mortality rates for a couple hundred years. Right, Ed? I mean, you have to age adjust it. You want information to be useful, right? Yes, you want it to be useful.
We haven't known about low birth weights for that long, but probably at least 75 years we have known that you have to think about low birth weight in the context of different population groups. But we still don't think about health except in terms of diseases. More about that later.
The distinction between a focus on individuals and populations or subpopulations is part of the distinctions among the branches of medicine. Now, I apologize to those who saw these slides the last time I was here, but I will go through them quickly.
Clinical medicine asks what disease might this patient have and how should it be managed. Clinical epidemiology asks what is the relative likelihood that this patient has or is at risk for this disease and what is the evidence to support its management? Now, this is relative risk oriented thinking, right, for both of these. Relative risk oriented. Given a constellation of risk factors, what is the likelihood that something will follow from that? Okay. That is relative risk.
Social medicine, why does this patient have this disease at this particular time and how might this affect management, taking into account the constellation of a variety of factors that influence the occurrence and severity of illness, the genesis of illness.
Community medicine, is this disease important? If so, how important is it, to whom and what is the overall benefit of management to the community. For the first time now, you are beginning to see the notion of attributable risk, community attributable risk, not relative risk, that is making the decision. How important is this in the population?
You know, the risk factor may be very important for a particular disease, but in the whole scheme of things, it is not that important when you talk about the relative frequency of different diseases in the population.
Finally, public health, what characteristics are most salient in improving overall health and the distribution of health in populations and what does evidence suggest should be priorities for intervention. Attributable risk, both in the terms of genesis of illness and in the terms of the effectiveness and impact of interventions.
So, here, you tend to see now why thinking about health of populations disease by disease might not be so important. It is the relative balance and frequency of the diseases and the impact of the diseases in populations that is important.
All right. Now, clinical epidemiologically and social views towards health, this is the diagram that goes along with that. I have a different diagram than Dan presented, but we were really motivated and coming up with a diagram that is in the report by simplicity and so we sacrificed a few things in developing that diagram. It essentially says what this diagram has, but it says it in a little more simple way. Let's start over here on the right.
You have health. We have health over here and notice that I have divided health in two. One of them is average health, which is the kind of thing we usually think about when we think about population health and the other one is distribution of health in the population. Clinically, we think this way. We think about genetic and biological characteristics and we think about sociodemographic characteristics, but from an individual point of view, we are also interested in developmental health disadvantage and those of us, who are pediatricians, really put a lot of focus on this because what happens earlier in life certainly happens in terms of manifestations, certainly reflects in later health.
Then if we are interested in social medicine, we are interested in the impact of these things on health and distribution of health, physiologic state, material resources, social resources, behaviors, panic stress and health services received. Most of social medicine focuses on this. Almost all the literature on social medicine, on social epidemiology focuses on the relationship between social resources and resulting health and distribution of health, in particular, in the last decade.
Now, if we are community oriented, we are thinking at the community level, occupational and environmental exposures, material resources, social resources, behavioral, cultural characteristics, psychosocial characteristics and health system characteristics, not health services, but health system characteristics, which all influence things at the individual level. Now, what this diagram that the diagram in the report doesn't have is it has got the interactions, all of these have interactions. They work both ways. That means that any of these, disadvantage in an of these things makes for greater vulnerability in other things because there are interactions, multiple vulnerabilities. Very important in the context of what we will deal with later is comorbidity.
Then some people will think of political and policy contexts as influencing the community level characteristics. That is an individual level diagram or at most a social medicine and a community medicine diagram.
Now, the community medicine and public health use towards health looks pretty much the same, but it focuses much more heavily on the political and policy context, as influencing these community level contexts. I have left out, mainly because I couldn't fit them in, all the individual level characteristics, as in the last slide. And you have health care again as average health and distribution of health, but you are not only interested in this, you are interested in equity and -- I am sorry -- correction, please.
Let me go back to the last one. This division of health is occurrence of illness and severity of illness. Different things influence occurrence of illness and severity of illness. That is why in describing health, I am thinking that we need to think about occurrence of illness, incidence and prevalence and about severity of illness, disability and death rates.
Now when we get to the population level, we are interested in this average health in terms of occurrence and severity, but we are also interested in distribution of health in populations. Okay. And no longer are we thinking now of individual health disadvantage, but we are thinking of historical health disadvantage.
There was a very interesting article in the British medical journal a couple of years ago that showed that the most important thing that influenced the health of different communities in London was what they looked like a hundred years ago, controlling for a whole lot of other characteristics, what the communities looked like a hundred years ago, more described the health of those communities than any other characteristics and you have got the community characteristics, the policy characteristics and the political context.
So, health system characteristics here, again, is key in terms of influence on distribution of health and on average health. Now, what are the implications for data systems? First of all, is linking individual or aggregated individual data with a contextual or ecological data, what is the difference between aggregated data and ecological data?
The contextual data at a community level really means an aggregation of individual level data. For example, average income of the population is a contextual level variable because it comes from adding up individual incomes and dividing by the population, but pollution level is not an aggregated measure. It is a true ecological characteristic. So, we have got two kinds of things in the community level to take care of things to deal with, things that are aggregated from individuals and things that are characteristic of the community and the new literature on multi-level analyses doesn't really adequately distinguish the two, but they are very important because they have got a lot of policy implications.
It is much more technically feasible to deal with population level in a community than it is to deal with individual incomes and changing individual incomes. So, there from a policy point of view, it is important to make that distinction.
Okay. Linking individual aggregated data with contextual or ecological data, so we have to link the clinical information with the systems information. Implications for information systems at the area level. We need characteristics of areas in which people live and work because we are now beginning to get lots of studies that show the impact of those community level characteristics on individual health and distribution of health.
Social and political or power characteristics of people in an area, the whole concept of what do we call it, social -- social capital, yes, is a very, very fuzzy capital. Some people use it as an aggregation of individual social power.
MR. BLAIR: Just a clarification because I am struggling on one piece and I am not sure that I really understood what you meant when you said was it the community a hundred years ago, individuals a hundred years -- help me understand what that means and --
DR. STARFIELD: Jeff, in that study in London, what they did was they described the health of the community in 1890 and 1990 and then they looked at the characteristics of those communities and they found that what determined the constancy of health was, in fact, the community itself, not the characteristics of the individuals in the community. Okay?
MR. BLAIR: Thank you.
DR. STARFIELD: So, implications for data information systems, the characteristics of areas, the distribution of social and political power in those areas, which is much broader than what Putnam called social capital, which talked about individuals participating on bowling leagues and the characteristics of the health system.
Implications for data and information systems from the point of view of health services, I want to take a few minutes on this. Now, this is health services, not health systems. The first thing I want to mention here is problems, patients' problems.
I think that ultimately if we were really interested in improving health, what we would do is to deal with patients' problems, not deal with diseases, deal with patients' problems. You want people to function better in the community. I am going to give you a definition of health in a minute. What is the purpose of health? Not to do away with diseases. It is doing away with the problems that interfere with people's lives.
So, we have got to be more problem oriented. I know you have discussed at some length in this committee the issue of problem coding and you have discussed the ICPC and I am very pleased, John, that you wrote a letter on behalf of the committee to the Secretary about the ICPC. I think if we are interested in improving health, we need to think about problems, rather than diagnoses. Of course, they are related. But they are not always related. So, we really have to think about doing away with people's problems, things that interfere with their life.
For example, I am going to use the data that Craig Gayon(?) and also that Hank Inga(?) had been working with. Shortness of breath is a risk factor for the diagnosis of the COPD. Any clinician knows that. But for patients, who eventually have COPD, it is an infrequent presentation. Now a clinician thinks of shortness of breath related to COPD, but, in fact, it is a relatively infrequent presentation of COPD; the difference between relative risk and attributable risk.
The second thing is diagnoses. We make a very big thing about diagnoses, not only in this country but pretty much everywhere in the world, which I think is largely a function of increasing specialization, physicians, clinicians, who are interested in specific diseases or organ systems, but we have lots and lots of comorbidity. I mean, you know, among the elderly, the rate of comorbidity is something like 70 percent have three or more conditions at one time.
I mentioned before the irrelevance of most clinical guidelines that deal with comorbidity.
DR. STEINDEL: Barbara, could I get a clarification? When you say "problem," do you mean the patient's perception of the problem or the physician's interpretation of --
DR. STARFIELD: I mean the patient's perception of the problem. We have already shown with studies -- and Don may have mentioned these because he was a co-author on a couple -- that the patient is more likely to get better if the patient and the physician agree on what the patient's problem is.
Management, is it going to be disease or morbidity oriented? Right now, it is disease oriented. And reassessment, is that going to be disease or problem oriented? Are we going to look for changes in manifestations of diseases? Or are we going to look for changes in the way people respond to their diseases and deal with their diseases?
Okay. Now, implications for data information systems, disease morbidity or health oriented, comorbidity and the concept of health. Now, comorbidity, diseases, risk factors and influences are not independent of one another, as I showed you from that previous diagram. Data systems must allow for coordination among different providers and types of providers. These are Dutch data, right? Do you know these from Vandanocka(?). Maryanne has done a terrific job with this topic.
What you have here along the horizontal access is the number of diseases, 0, 1, 2, 3, 4 or more than 4, in a population. What you have on the vertical access is the ratio of the observed -- now expected comes from the frequency of different diseases in a population. Observed is what you observe in terms of number of diseases in the population.
The line, the black line, shows all ages combined and you can see that a much greater proportion of the population in general has four or more -- more than four diseases than you would expect by chance, distribution or diseases in the population. A smaller proportion of the population has fewer numbers of diseases, 1, 2 or 3 diseases, than you would expect if diseases were randomly distributed in the population and a slightly greater proportion, in fact, have none.
What Maryanne has done here is to divide it by age; 0 to 19, 20 to 39, 40 to 59, 60 to 79 and 80 plus. Now, notice here even in the 80 plus group, a greater proportion of people have no diseases than you would expect by random distribution in the population. Over here, only a slightly greater proportion of 80 or older people have more than four diseases than you would expect by random distribution of the population. Disease is much more common in the elderly. So, you expect more and, in fact, you observe only slightly more.
Look at children. Look at the proportion of children that have more than four diseases than you would expect by random distribution in the population. That is pretty striking. We tend to think of kids as healthy, but, surely, there is a proportion, a substantial proportion of children that have more than four diseases than you would expect if diseases were random in the population.
So, comorbidity is a real challenge to a health system that we aren't even thinking about meeting. This is what we call the ACG system and it shows that there is a way to take diseases that people have and fit individuals into one lock based upon the constellation of diseases that they have. We can do it if we want to do it.
What is health? Health is the extent to which an individual or group is able on the one hand to realize aspirations and satisfy needs and on the other hand to cope with interpersonal social, biological and physical environments. It is a resource for everyday living, everyday life, not the object of living. It is a positive concept embracing social and personal resources , as well as physical and psychological capacities. I wish I had made up this definition, but I didn't.
It is not the WHO definition, but it is WHO URO(?) definition. They came up with this in Copenhagen and it was then subsequently buried by the WHO Geneva, but it resurfaced again in Ottawa in 1986 and I think now is certainly pretty well accepted in a lot of circles as a definition of health.
How is population health measured is a question. Infant mortality rates versus neonatal and post neonatal mortality rates. A big difference between neonatal mortality rate and post neonatal mortality rate, not only in terms of when they occur, but in terms of what their causes are. Influences on neonatal mortality are very different than influences on post neonatal mortality, really different. Post neonatal mortality is quite responsive to health services, but neonatal is only responsive to neonatal intensive care services. Big difference in terms of making policy, in terms of what you want to influence.
Yet, it is not common for us to distinguish the two. No international statistics really look at the neonatal separately from post neonatal. Mortality rates versus age adjusted mortality rates, we have talked about that, car specific mortality, life expectancy, years of potential life lost. The GAO gave this one the highest choice, 17 different indicators. They thought this was probably the best one to characterize population health, disease occurrence and severity. We have talked about that. All diseases, target disease is very popular in the United States and worldwide.
Self-reported health and -- there are others, but these are the most common ones. Which of these represent population health?
Alternatives to categorizing population health.
PARTICIPANT: You said you don't know, is that what you said?
DR. STARFIELD: I said I don't know but I am not willing to make the decision.
But I actually have my preference. I have shown you a scheme for characterizing morbidity case mix. That is one possibility if you are interested in diseases. The DALEYs are a good approach, I think, the Disability Adjusted Life Expectancy Years, but as used by WHO, they basically boil down to disability from specific diseases. I think as used, it has a lot of limitations.
The one I want to mention that is the profiles of health, derived from combinations of separate domains and this is something we have worked with in children and I sort of think it is neat. Criteria for defining profile types. We have divided health into four different domains in children. One of them -- let's see if I can remember that
-- we have actually divided them into six domains.
One of them is disease rates. One of them is achievement of social expectations, given stage of development. Another one is comfort or discomfort, which is symptomatology and signs. Another one is perceived health, satisfaction with health and self concept. Another one is vulnerability, what you have that suggests you have compromises to your health. And another one is resilience; that is, what do you have or what circumstances are you in that suggest you are more resilient to insults to health.
We have taken these different domains for children and we have divided populations of children into one of these groups. Excellent health is defined as excellent health on three or four domains with no domains of poor health. We have trichotomized each of these domains, lowest, middle and high and then fit children into these boxes. Good health is at least average health on all domains with excellent health on no more than two domains, et cetera. Worst health is poor health on three or four domains. We found the validity, all kinds of validity, from these characterizations of health and we also find predicted validity in terms of from one year to the next.
So, I think this approach is I think rather promising if you are looking for a way to characterize overall health. Now, dealing with disparities, we don't deal well with disparities in this country. Other countries do a lot better. One of the reasons we don't deal well with disparities is because, you know, the -- what is it called
-- health of the population 2010. Is that the title? Healthy People 2010 -- talks a lot about disparities, but it doesn't give you any idea of what you should do about them because it has no feeling for what it is that is causing the disparities, given that diagram of influence. There is very little in there.
So, whereas other countries like The Netherlands and like U.K. are thinking of disparities in terms of what is the best way to deal with them, that is much more advanced than we are in this country. But one of the things at least we could do is do stratified analyses rather than statistical adjustment. What we almost always do is we put race, ethnicity, income group into a regression and we say controlling for these things, this is what we find in terms of health; whereas, what we really should be doing is look at different levels of health within major important population subgroups.
Now, from the point of view of social and political context, an important future direction is understanding the variety of influences on health. The National Center for Health Statistics is moving us a long way in this direction by making it possible to link individual data with area level data. That is right, isn't it? Yes.
I think that AHRQ is doing that as well. Information systems moving towards characterizing health, towards characterizing contexts in which ill health develops, to characterizing comorbidity, as well as disease, to characterizing disparities, which are systematic differences in one or more aspects of health across population groups to find geographically, sociodemographically or -- there is another one -- bridging clinical medicine and public health to use knowledge about health, risks and resiliencies.
Summary. Population health is not the sum of individual health. Averages don't represent population health and provide information about the context in which systematic differences in health occur and how they can be remedied. Why population health is not the sum of individual health in any useful sense is because comorbidity individual measures of health don't represent health and because of the non-random distribution of health; that is, age, geography, social differences cause systematic differences in population subgroups.
There are a few more slides, but we don't need to do them.
DR. VOLPE: While we are waiting for this to come up, I am Carl Volpe. I am with WellPoint. Dan didn't give a quiz. Barbara gave a quiz during the presentation. My quiz comes after. So, take good notes.
While we are waiting for this to boot up, I do want to give you a context. I am with WellPoint and I am very much going to talk from that perspective. WellPoint is the second largest health insurer in the United States. Arguably, we are the most market oriented health insurance company in the United States. We believe in markets very strongly and you are going to see that influence in my presentation today.
Quite honestly, I struggled when I read the report five, six, eight, ten times, to try to figure out how to link the report to our work. So, I do a bit of a disclaimer here that I am going to be talking a bit about WellPoint. You are going to see WellPoint come up in a very short time. This is not an advertisement for WellPoint, but it is an opportunity to contrast because, I mean, clearly several health plans are represented at this table today.
If you have seen one health plan, you have only seen one health plan. A lot of the work that I have seen in the development of policy on the government side really is a reflection of what we see out of integrated delivery system models, group health plans. We are not that, not at all. About three-quarters of our business are PPO business. We do not own hospitals. We don't have physicians on staff, except for medical management.
So, everything we do is through contract. It is possibly called a virtual health -- a virtual network model. All right. So, let's see if we can get going. This is actually the materials that Dan presented. Okay? The mission to particularly provide time and accurate relevant information and a conceptual framework and the primary purpose of data is to characterize the health of the population and influences and actions that affect the health of the population.
What I did is I said, well, what is WellPoint's mission? How does WellPoint view the world and that is on the next slide. I am going to read a little bit of this because I think it is important to understand. The WellPoint Companies provide health security by offering a choice of quality branded health and related financial services designed to meet the changing expectations of our diverse customers through a lifelong relationship.
Now, you notice the words are highlighted in red. That is the way it is presented in our company material. We highlight those words. What is our conceptual framework compared to what we just saw.
We focus on individual health security not necessarily individual health status. We differ from some of our brethren on that. But that is how we focus our work. We recognize the importance of individual and purchaser choice and changing marketplace expectations. We reinforce the notion of a lifelong relationship. Underpinning all of that are our data systems. And what is the primary purpose of our data? To characterize the transactions between purchasers of care, employers, payers and individuals, payers, that is us, health plans, and providers of care as these transactions relate to services provided to health plan members, a very, very different focus than the kinds of things you have -- yes?
DR. MAYS: Can you just tell me what you mean by quality branded health?
DR. VOLPE: I skipped over that because it was a little bit too -- I mean, how we sell our products. We have many Blue brands. We are Blue Cross of California, Blue Cross of Georgia. It turns out that the Blue name sells product. So, what we do is we make sure that as we are selling our products, we brand it and brand it appropriately. For example, we don't sell anything under WellPoint. We sell nothing under the name of WellPoint. All of our services, but I apologize for doing too much on the business side.
Then what I did is I contrasted the population health information model that we saw earlier with our view of the world; for example, level of analysis as to population. Our level of analysis for the most part are individuals and purchasers. Now, those purchasers can be small companies to a hundred thousand, 200,000, 300,000 lives. Okay. On the population health side, it is enterprise wide planning and coordination, multiple producers. Our information systems are solely designed to facilitate the business functions. That is what they are there for.
Information needs are typically driven by research questions and require empirical data collection. That is not true for the most part. Our data systems are, again, for business operations and may or may not be empirically derived. For the most part they are not. There are a couple of examples I am going to give in a minute where they are, but for the most part they are not.
The expectation of public access and public ease to data information, there is virtually no expectation whatsoever from our view that there is public access to information. Quite honestly, some of it we explicitly keep from the public for competitive reasons. The data on the population health side are census data, federal and state requiring, and CMS claims. The question mark there is I think it is emerging as a stronger area.
Our side, there is a piece missing, eligibility systems and then claims, pharmacy and laboratory results data and CAPHs and HEDIS surveys are really the two types of surveys you tend to see from our side, which are more empirically derived. The data information is critical to -- and I think is probably the most important part, data information is critical to the assessment of existing public policy and to support new policy development. From our side of the world, there is no expectation at all that our data would be used for policy development and, quite honestly, there is a strong bias against the use of our data for policy development.
Let me give you an example. Recently, we were approached by a large research entity, who has a contract with a subset of HHS and they wanted to look at a subset of our data. When we talked to them and we spent a lot of time talking with them, our typical strategy is how does it benefit you, how does it benefit us. Ultimately, the benefit would have been a public policy benefit. We couldn't derive a benefit for ourselves from the data. So, we chose not to do the study, not to do the work.
I know that may sound a little cold, but that is the nature of a company like ours, which I said is very market-oriented and our goal is really toward that end. I failed to mention that we are publicly traded and that will give you a more -- a stronger context for understanding who we are.
There is agreement on the value of data to measure improved population health. We do have that interest. We do try to make our data sets available when we can. The need for data standards clearly we are consistent with the committee on that. We need standardized data. The need for strong but reasonable -- and I should underline "reasonable" -- privacy and confidentiality standards. As a user and in terms of our work, the issue of reasonable information is important to us. Then the need to recognize the influence of certain disease states on population health.
What is going on with health plans right now, especially the large ones, like ourselves? I think also I did want to mention that we are the second largest. We are soon to be the largest one in the United States. If the merger goes through this summer, we will have some 28 million members, again, under this virtual network model for the most part.
A lot of us believe that health plans don't have a long term future solely as claims preparer and payment negotiators. That is really not where it is going to be into the future. We are getting a lot of pressure from large purchasers in particular. They are extremely concerned about their employees' health within the context of improving productivity, reducing absenteeism and reducing their financial burden, but they are talking about it and they are talking about public health and they are talking about population health.
As you can see, we are devoting significant resources now -- I think every plan in the United States is doing this -- to characterize health status of our members so that we can target our work.
What I would like to do now is switch and just talk about four different examples. I was going to skip the first one. Barbara, quite honestly, based on your presentation, I decided to talk a little bit about it. Four examples of how we are broaching and looking at population health at the margins, which is really the -- I want to talk about our health improvement programs and I said I am going to talk about ours, but largely every plan is doing this as well. I want to talk about quality -- physician quality improvement and quality measurement, a project called -- and then early epidemic detection, areas that we have been involved in.
Our traditional disease management, focused on medical interventions to improve the health status of the individual. We are looking at our health improvements, again, to improve health status, but it is really to strengthen healthy behaviors to help the member live their life more fully from the member's perspective.
I don't know how many of you have ever seen this slide, but virtually every health plan is showing it. It is the way we tend to look at how we need to focus our energies in terms of our product design, in terms of virtually everything we do where 8 percent of the membership costs -- about 70 percent of our dollars go to support 8 percent of our members. Twenty-four percent result in about another 23 and 68 percent is virtually nothing.
Now, if we switched this in terms of actual number of claims that are submitted, the distribution changes slightly. Okay? A typical health plan like ours, we get about a hundred million medical claims a year for 15 million members and that does not include drug claims. But you can see from our perspective, our focus is really on that 8 percent.
Our approach has been -- and, again, others have done this as well as early engagement with our members, understand the entire portfolio, the disease burden. I will talk a little about that more in a minute.
We want to work with our treating physicians. It is not done independent of them and we are looking for a cost quality paradigm and that is sort of laid out at the bottom where our goal, of course, is to get very aggressive with our sickest members to help them achieve some incremental change in health status and then lessen their need for health services.
How are we doing that? It is really through a combination of disease management, wellness and prevention programs. We have a strong intermediary role with our members and others do the same thing to provide information. But we are playing with this notion of these ABCs of medical management, which really is advocate, provide education and personal support to our members. We have individuals who do this. Work with the members to change their behaviors and we serve as a concierge actually to navigate the health care system. We have teams of people who do this.
Let me give you an example. We have a woman in her early eighties with heart disease. She is in our disease management program and so we were talking to her and one of the questions we asked her is what do you want to do. What she said is I am in my eighties. I have always loved to travel. I want to continue to travel. I don't want this disease to stop my ability to travel.
So, we said, well, we talked to her and we said what do you think you need to do. She said, well, will you have an exercise physiologist talk with her and we talked with her doctor. The notion was, yes, let's see if we can get her into an exercise program. This is Southern California. So it couldn't be any exercise program. We had to get her into a Pilates program, but we did.
But that was her decision. She made the choice. We had a ten year old boy with asthma, who really, really wanted to baseball. So, we worked up a strategy so that we could get him on a team so that he could baseball. Those are the kinds of things that we -- we are trying to make it meaningful for the member as opposed to just treating the disease.
Physician score cards, I am not going to talk a lot about this, except if you have seen the literature and you talk to folks -- I have spent a lot of time talking in this area -- when you talk to folks about health plans doing quality measurement, you are typically talking with a health plan that has an integrated delivery system model, group model. So, a lot of the work is being done in that area. Well, the reality is for a vast majority of the people in the country, they are not in HMOs. They are in PPOs. We are playing, as well as others, are looking at how you do quality measurement from the perspective of a PPO.
Clearly, quality measurement standards are very, very helpful for us, but one of the things we are struggling right now is the notion of an attribution model. We don't have enough data on it for an individual physician. So, what we are doing is when a person sees -- under a PPO model, may see four or five different doctors. If it is appropriate, every doctor gets credit for every other doctor in terms of developing the metric, if it is appropriate. There are clearly some crossovers that we don't allow to happen.
We think that while it may not be the greatest statistically, we think it starts to build up our base and gives us a database on which we can start giving doctors information. We also think that ultimately if -- we have sufficient data, when an individual physician starts sending patients to a specialist and they can start looking at each other's scores and especially if there are incentives and financial incentives associated with this, which is where we are going, that ultimately we will be able to have physicians start talking with physicians about the quality of their care, which we believe is probably the most important strategy.
These are some of the measures that we have under consideration. I don't think any of you who are physicians or clinical researchers would be surprised at anything that you see here.
Quickly, about antibiotic strength, I am preaching to the choir when I talk to you about growth of antibiotic resistance and the inappropriate use of antibiotics in the United States. There is an organization called the Council for Affordable Quality Health Care, which has most of the large health plans in the United States working or part of it. We came together in several parts of the United States and we pooled our data. That is interesting because of the antitrust issues. We had a third party come in and we sent our data to a third party so that could develop practice patterns for physicians that cross brands and cross companies. Then what we did is we took that information and we provided it back to the individual physician. These are your practice patterns. We didn't see it and the individual plan did not see it. The entity that we hired gave the information out.
Obviously, we had algorithms to determine whether their practice patterns were appropriate or not. We communicated with them. We did this with the CDC. You can see a whole host of other activities that we did to move into this area.
The last one I just want to mention is bioterrorism and SARS. We are actually in a very unique position to help in the early detection of epidemics, partially because of one of the things we do that drive hospitals and docs crazy. That is the prior authorization process or the prior notification process. It turns out that within our plan and, again, we are the second largest in the United State s, every individual who shows up at an ER, at an emergency room, we need to be notified as soon as they show up or within hours.
We can literally -- and we have pharmacy claims that we can run against, which are available to us and many of the large companies have nurse advice lines and when a member calls in, we record and we note with that member exactly what the diagnosis was or potential diagnosis, what at least the symptoms are. Well, we actually have the ability -- and have done this -- where we can aggregate all that data and on a daily basis, we can run data sets to look at legalization patterns and we can actually measure changes in utilization and because we have zip codes for the most part, we can actually get subsets as opposed to full state changes.
We just did a pilot project with CDC on this. They were pretty excited about it. We were pretty happy with it. But, again, it is another example, well, although we are playing at the margins, you know, our mission is not public policy, we can contribute to the effort.
Areas for future collaboration, I don't have to go through these. You know them. We desperately need standards on quality outcome measures. We are particularly concerned about standards on electronic medical records. That would be enormously helpful to us and to you. We are not there at all, not even close, and it is holding us up. I think it is holding the nation up in terms of accountability.
Race, ethnicity, socioeconomic position, it is clearly something you folks have considered. We have considered as well. So, my final conclusions, the vision outlined in the study probably has little utility for us as health plans, quite honestly does. Okay? Our data can help articulate population health, but it is a secondary function and it will remain a secondary function. Now, among us, how strong we play will differ. I mean, there are some plans at this table, who play very, very strongly on the public health side, very strongly in trying to address issues of health.
Others, like my own plan play very little, but for all of us, I think it is a secondary function. The marketplace is beginning to value population health information. There is no question about that, but the application is going to be less rigorous and less empirical than this committee and academic researchers might like. I say that because I was in a meeting last week and one of my co-workers was expounding on population health and how he was building models for population health to sell products. I asked him to define "population health." His answer was, oh, well, you know what it is. You know what it is. He was not able to do it.
I think you are going to see the words "population health" move into the private sector. Large employers are now talking about it, but they are not talking about it the way you do and they are not talking about it with the empirical rigor that you do. So, if I can give one warning, don't let the perfect be the enemy of the good. I think you are going to get something out of it, but you are not going to get it probably at the level of good empirical research.
Now, one might choose that bad research is worse than no research. I am not sure I believe that, but that is up to you. I think that we are going to move ahead, all health plans, around quality measurement and health improvement and I think that for the most part health plan involvement and population health is going to continue to be driven by the marketplace.
Thank you.
DR. LUMPKIN: Thank you.
DR. STARFIELD: You know what the definition of "public health" is is a successive redefinition of the impossible.
DR. LUMPKIN: Okay. Any questions?
Michael.
DR. FITZMAURICE: A question of Carl and then others may want to join in.
You said that health plans think of population health differently than we do. We think of population health, we carve it up and we look to see what are the parts of the population that have different incidences of diseases. I imagine you do a lot of the same thing with your health plan population, that a lot of the methods would be the same. You are just looking at a population that has health insurance and we look at those, who don't have health insurance.
DR. VOLPE: I think that is a piece of it, for sure. But we historically have not taken a broad-based view of the health of the population, even defined as the employer base. For example, an employer will come to us and say what are the six most significant diseases that are costing us a lot of money. That is not a -- I would not argue that that is not a population health approach. That is the kind of information we would provide to them.
DR. FITZMAURICE: But something like, let's say, you are looking to say one of the things that pops up is tooth decay in your younger sponsored beneficiaries and you say all right, we can give them some fluoride toothpaste, give them a price break or we can go to the public health people and say could you step up the fluoride in the water to the optimal amount, whatever that is. You can use population health as a tool to improve your cost benefit relationship.
DR. VOLPE: I think that is right. I think to a much lesser extent we have done that. I think that we are not there in terms of doing that yet. We could do that. That is a mission of mining our data to help feed public policy and --
DR. FITZMAURICE: And would benefit both.
DR. VOLPE: Would benefit both. That is right.
DR. MAYS: I want to ask a couple of questions. I want to start with Carl and then I am going to ask Barbara and Dan.
I want to get back a little bit to this question because I guess I was kind of surprised because it was -- in trying to determine, for example, a business case in terms of your profit line or the best health outcomes, why wouldn't you really want to focus on population health? Do you see that as a route to which you could improve, for example, outcome?
DR. VOLPE: I think that is a great question, but let me tell you how we think of it. We think of it as how do we design products that will be purchased in the marketplace and be perceived as affordable and valuable. That is the way we talk about it. Okay?
[Multiple discussions.]
Let me give you a -- some of our colleagues, for example, are very, very concerned about having good services for people with AIDS, very concerned about that, very concerned about it being publicized because of adverse selection. People with AIDS will want to buy their product. So, in some cases, having structures that provide good outcomes actually disadvantage the marketplace. As I said, I shaved the horns down for this conversation but really it is the way it is looked at.
DR. MAYS: Barbara and Dan, one of the things that this presentation is designed to do is to really ensure that the committee thinks about population health. One of the things for the two of you -- and particularly Barbara started out talking about the committee she chaired -- what should like privacy and confidentiality or standards and security take away from your presentation?
DR. STARFIELD: Do you mean that do the standards for privacy interfere with the population approach? Is that what --
DR. MAYS: How might they think differently or how might they work differently if they were really to embrace the model of population health that is advocated in the 21st Century report?
DR. STARFIELD: I think they would think about how we could identify individuals without identifying individuals.
DR. FRIEDMAN: I would certainly agree with what Barbara has said and I guess I would go on to say that I think that in public health and certainly at the state level, we don't do as good a job as we should and as we can of making our case for why the use of the data are important to the nation as a whole. As an example, in Australia and in Canada, surveys -- population surveys ask respondents whether those data can be linked to administrative and census data sets and there is surprisingly high, by our standards, high positive response.
I think one of the reasons for that is -- I think part of the reason for that differential is that in those countries there has been a better -- there has essentially been better marketing of the importance of population health information, as well as better marketing of the confidentiality protections that are wrapped around those data.
MR. HUNGATE: I want to try to talk to both Barbara and Carl and Dan around a problem that I face in my job in -- I chair the group insurance commission. WellPoint is one of our vendors. We have no measures of health status across our population. We have 250,000 members. If I treat it as a population, I don't have comparable data about my population and other populations. So, I can't judge disparities.
We have demanded that all the plans that supply us pool their data and begin to do the physician profiling, but I would ask you, how do you deal with the variation in risk in patient population by physician in your profiling?
DR. VOLPE: We are just beginning to look at that right now because we are concerned with it ourselves. I think this is a fairly nascent area for a lot of us and we are struggling quite honestly. It is the right question to ask. I don't have an answer right now, but I know we are looking.
DR. STARFIELD: There are ways to do it. I mean, there are case mix systems that do that.
MR. HUNGATE: That characterize the health of a population?
DR. STARFIELD: Right.
MR. HUNGATE: But in order to do those, we would have to have our vendors use common instruments to do that, right?
DR. VOLPE: That is right.
MR. HUNGATE: It would have to be a specified -- and we would have to then have methods that are in common with what DPH had or the state wide population so that we could have common data.
DR. VOLPE: That is right.
MR. HUNGATE: What are the Blues doing to facilitate that generation of common data in the way that there is a public/private kind of partnership around that? What is the action plan to solve the deficit?
DR. VOLPE: Well, let me ask whether there is a perceived need among all health plans right now to have that because that will --
MR. HUNGATE: There is a perceived need to get one customer --
DR. VOLPE: Clearly, clearly, and not just Massachusetts. We have had similar requests in California and Texas and we have seen consortia develop in other states, where they have come together. Now, they have funded that as well because this -- from our perspective -- and most health plans were willing to do it for you, but if it is above and beyond what we do, the question is will you pay for it.
MR. HUNGATE: Usual response.
DR. VOLPE: That is a fairly typical response. That is exactly right because our missions are different. I mean, ours is not a public health mission. As a purchaser, you can tell us what you want, clearly.
DR. LUMPKIN: we are just about out of time. I have a few people to ask questions. So, let me sort of pose one of my own and then get to the last two I had on my list. One of the things that we are seeing as we look at the data is the number of clinicians who are using electronic health records are now starting to increase. The numbers we have seen nationally are around 10 percent, give or take 5 percent. As that number increases, would the answers that you give or Barbara gives or Dan about the functionality of the system change as the cost of data acquisition for more robust clinical data decreases?
DR. VOLPE: It is not the number who are using it. It is how similar the systems are and the standards. We are on the verge of a Tower of Babel here. That is why it -- that point was on my slides. I think if we can get some standards there -- and I am not sure health plans are the right entities to do that. I mean, we have complained bitterly about HIPAA, but there has been some real value to HIPAA.
So, I think that -- I worry about the Tower of Babel because I am experiencing that right now.
DR. STARFIELD: The answer is unquestionably yes, but the value of it will be concepts in which the analyses, the concept under which the analyses occur and how we use the information, what questions we ask of it.
MS. HANDRICH: I kind of have a reflection on what you all have said and then a statement that I took away from this presentation in terms of our approaches. I think about the things you said, Carl, about the difference between the way companies view population health and the more general kind of academic view of public health. There is a company in Wisconsin that characterizes something they did as a population health approach and that was that they paid every employee $50 to contribute towards a complete physical exam and allowed for the employee to report the findings of the exam to the company and concluded from the findings that the majority of conditions presented were lifestyle related.
Then they made some decisions about how they wanted to proceed with wellness and so forth in the future, very different kind of approach in terms of population health. In general, we have a lot of very visionary and positive companies in the states, but they are not at all interested in reporting data or supporting the plans that helped them, reporting data to the state for population health purposes, not at all interested in doing that.
I think the challenge of what all three of you have presented is -- you know, one challenge is how do we find a convergence of interest so that for public policy purposes and for private sector purposes, we can begin to address some point where collection and agreement about data could really move forward.
DR. STARFIELD: You have described it as an academic approach, but it is a WHO approach.
DR. VOLPE: Just as one interesting point, a perfect example of that, we provide coverage. He owns the data. We don't because of the nature of the relationship. So, it gets even more complicated. For example, if we get asked to make some data available, typically, we have to take out what we call our cell-funded business. We can't provide those data because we don't own it. The companies themselves own it. So, it is much, much more complicated than any of us would like, I think.
MR. LOCALIO: Dr. Starfield, I would like to ask you to clarify something you mentioned. I thought you said that you estimated that adverse events from medical care were the third leading cause of death in this country. But I have here the 20 leading causes of death, United States 2001, from an organization called National Center for Health Statistics and that does not appear.
I also have something called the 2001 United States Unintentional Injuries, Causes of Death from an organization with the initials EDC and I see nothing about adverse events from medical care there. I would like to ask you do you think that is a deficiency in the way we report this type of information?
DR. STARFIELD: Yes, I think it is a deficiency in the way we report the information. Anybody, any one of us who have had experience with a parent dying knows that in a substantial proportion of those cases the sign out diagnosis is not what caused the death. I know it is supposed to be the underlying cause of death, but it isn't even that.
MR. LOCALIO: Thank you. You can come and visit us anytime.
DR. LUMPKIN: Boy, that was a softball question.
We actually are out of time. I know this has been a very good discussion. This is really part of the process that -- you know, one of the things that we want to do as a committee is that when we issue reports we just don't want to sort of drop them off, you know, on a stump and run, but that this is a very important component of our work is to monitor the implementation of the reports.
As you know we have from time to time monitored a number of issues. The NHII Committee is actively engaged in revisiting our 2001 report. So, I think these all represent efforts on behalf of the committee looking at this particular report.
Ed, as a partner in the development of this report, I just want to give you an opportunity if you want to make a comment.
MR. SONDIK: I think it is exactly the right thing to do in terms of the follow-up. I think this particular panel has been one of the most stimulating that I have heard. Now, that may be because I am so close to it in a sense, but I think what was offered here were new frameworks, new thoughts on the absolute fundamentals, like what is health and what is happening in the business sector, how they are using information. I think we ought to keep this as a kind of a benchmark, if you will, in terms of panels and come back to this type of thing.
I think the whole purpose of having this vision is so that it gives us a target. We know what we are building toward and I have said this before here, that I think prior to having the report, we really didn't have an articulated vision. We were basically doing the usual thing of you go year to year. You try to deal with the demands from all of your colleagues and so forth and meet those on an annual or on a couple of year basis.
This gives us a longer term vision, but the vision based on what we heard here today, gets a little blurred, I think, from having heard this. The vision I don't think is quite so clear as it was prior to -- for me personally actually, prior to this panel. I won't keep us here, but I think the fundamental question that Dan poses in the diagram that shows the influences and, secondly -- and I think one purpose of health statistics is to help us understand those influences, yet we don't in our data collection do it in an optimum way to do that. I think that is a very important point.
I think, secondly, the point of view as to what health is, it couldn't come at a more timely point for me because, in fact, CDC, as many of you know, has been going through a futures exercise and Dr. Gerberding is very, very serious about this and I am actually at this point involved with several other people, thinking about goals and the question is how do we formulate those goals. This was kind of like, you know, filling an inside straight, although I am not sure I know what that card is that was dealt.
But it is very, very interesting and then to hear you, Carl, also talk in effect about health, what is health -- and I was particularly struck by the two slides on the perspectives in transition and the medical costs and how -- I would like to talk to you more afterwards about how that actually plays out, but I think if this is, in fact, what is happening in health -- and I am not sure that I see it at all and I am quite sure that I don't see in most cases the effects of this, to a minor degree in tobacco, but not much else -- then I think this is something the committee needs to keep abreast of.
I come back again just to how all of this that we deal with here is being used. I think that is the critical thing. So, I thank you all for being here and I thank whoever put the panel together. I think this has been excellent.
MS. GREENBERG: Debbie Jackson actually put it together.
[Applause.]
DR. LUMPKIN: With this, we are going to have a break for lunch. We will get back at -- not at 1:15, but because we are breaking a little bit late, about 1:20.
MS. GREENBERG: Before you break -- well, actually, we are all coming back here?
DR. LUMPKIN: Yes, we are all coming back here.
MS. GREENBERG: Be thinking at lunch as you are eating up there whether you want to join us for dinner, where the food is going to be considerably more desirable.
[Whereupon, at 12:42 p.m., the meeting was recessed, to reconvene at 1:40 p.m., the same afternoon, Thursday, March 4, 2004.]
A F T E R N O O N S E S S I O N [1:40 p.m.]
DR. LUMPKIN: Okay. We are going to get started. We are behind schedule, but we are ahead of schedule. I shudder to say that because there is a corollary of Murphy's Law that says work expands to fill the time allotted.
There is going to be -- the agenda shows that tomorrow morning the Privacy and Confidentiality Committee was going to be in Room 305. That is going to be changed to this room because we have invitees. After a fair bit of research in order to assure that there is going to be adequate time for discussion, it will convene at 6:30 for Jeff and the rest of us may get there later.
MR. BLAIR: I will read all of the controversial paragraphs for you.
DR. LUMPKIN: Marjorie needs to know how many people are going to go to the dinner. Please indicate by a show of hands.
We have the phone line hooked back in. Is there anyone on the phone? Okay. We will continue to monitor as the day goes through.
The next item on our agenda is the Quality Report, which we have seen before in a different format. It is the new revised, revamped and better Quality Report.
MR. HUNGATE: I believe in the Senate vernacular or the House, I have heard someplace about the third reading of the bill and the third reading of the bill is intended to be the final reading of the bill.
DR. LUMPKIN: But unfortunately in the same vernacular, it is possible to move an item from third reading to second reading. So, please, we won't adhere to that vernacular but we will -- I appreciate the sentiment.
MR. HUNGATE: But in order to make sure that we came out with a report that was accurate and correct, we went back and consulted Confucius and we found that he said, "If language is not correct, then what is said is not what is meant and what ought to be done remains undone."
MS. GREENBERG: Have we ever asked him to serve on the committee?
MR. HUNGATE: I want to start by thanking Kathy Coltin for all the work that she has put into this and commending Susan Canaan, the writer, for her help, Gail Janes, Julia Holmes, Peggy -- Justine spent her time on the phone as we worked on these things yesterday. So, thank you all for bringing this to where it is, which I think is a very elucidating, if you will, status report, milestone of where we are. It is a nudge to important priorities. It contains a lot of crosscutting issues.
Now, if I could -- I am not going to use any power points, but if I could just get you to look at the page of contents for just a minute and talk a minute about the structure of the report.
There is an executive summary, which is followed by a matrix and the matrix follows the order as shown in the third section, "Specific Findings and Recommendations." That section is organized into four groups with the major headings of Assessing Health Care and Health Outcomes, Reducing Disparities in Health and Health Care, Building the Data and Information Infrastructure to Support Quality and Balancing Patients Interests in Quality and Confidentiality.
Now, that organization largely evolved from trying to make sense of how we meshed this report into the other activities of the committee, the various subcommittees and workgroups that exist, so that each of these has a natural affiliation with other organizations of subgroups of the activities. The first, Assessing Health Care and Health Outcomes, largely is in partnership with Standards and Security, it seems to me. You know, that is where we are and we talked about some of the content there, had some unresolved issues, which we should talk a little bit about here.
What I want to do in this discussion is first let you know about a couple of things we found yesterday afternoon in the workgroup discussion. One was that we realized after reading again, that we had really focused in the report in hospitals and physicians and quality measurement and had omitted the whole section of long term care, chronic disability. It wasn't intentional, but it happened.
So, we will acknowledge that in the introduction, acknowledge it in the recommendation on functional status, because especially important in those areas. Then finally in the next steps, we will put in a comment relating to dealing with that.
Another content that got dropped somehow in our working through it was in the early versions, we talked a little bit about Leap Frog and Fact as coherent activities on this agenda that are also occurring. That somehow didn't get through to this copy. So, we will add that in in the section in support of the recommendations.
So, back to the structure, the specific findings and recommendations headings are then used within the matrix, which is the summary recommendation of the recommendations, which is on page 5. Now, what I want to do in the context of this discussion is there is no way we can give the specific words the attention that we do in individual letters. It won't work. But that said, I am still assuming that each of you is sufficiently dedicated to the activities around quality that you have read the report.
If you find things that don't seem to say quite what they should say, please give that input directly to Susan and we will incorporate that this afternoon. The things it is very important for you to point out are any factual errors that occur or any wrong decisions, just bad decisions. Because if we said things that we shouldn't say, we shouldn't say them. So, those are where I would like to make sure that we have solicited all the feedback that we observed.
That said, I would just like to leave the floor open for discussion. I have not had good luck in trying to go down through recommendation by recommendation. So, I am reluctant to do that.
DR. STEINWACHS: Bob is trying to tell you that we on the Quality Committee do learn and adapt our behaviors appropriately or at least we adapt them.
MR. HUNGATE: The recommendations read quite differently than they did before. They don't make hard recommendations. They more point -- they more highlight the agenda issue that needs to be addressed. Vickie and I have already talked a little bit about some joint work around the section, Reducing Disparities in Health and Health Care, which is really a very common agenda between the Quality Workgroup and the Population Subcommittee.
So, we will be talking about that. There were -- Simon and I have had brief conversations here and I think we should have a little of that conversation now about what the next steps are specifically around assessing the health care and health outcomes. As we talked in the committee meeting, workgroup meeting, yesterday afternoon, we felt that we probably were going to need a two day period of discussion with representatives of plans, providers, payers, the spectrum of people involved in the content that we have talked about.
Now, in the section here in support of the recommendations, there are many organizations that are listed in that section of the report that are doing things, especially related to assessing health care and health outcomes. So, some of those other organizations it would seem to me to be appropriate content for that same discussion. So, that is one next step that the committee felt it wanted to put into this discussion as well.
I would now like to pretty much throw it open for discussion and let you folks pick up wherever you wish in the content, given the guidelines that are outlined.
DR. LUMPKIN: Okay. We are going to throw it open for questions.
Simon.
DR. COHN: Well, first of all, I want to compliment the workgroup because I think this is a much improved document over previous versions. There are actually a number of questions and issues I have as I walk through them. Specifically -- and I am not wordsmithing at this point -- it is really a question of do we really support that recommendation? Is that really what we mean? Or what is the rationale for things?
I actually just wanted to raise -- I think this is an issue that Bob and I have been talking about -- I mean, before we get into the substances, more the process piece and I think you have heard me before on this one and I don't know that there has been anything in this process that has changed my initial comments about it. So, let me just reflect on it because it really is a key decision that this committee needs to make about what to do with this report.
Now, one option, and I know that Bob and the workgroup and others on the committee would dearly love to get this thing passed so that it is no longer a next
version -- as I say that, I really am very sensitive to that. I actually, I think, made an enemy of life from Lisa Iezzoni from my insistence that a previous report actually be correct before we passed it.
But having said that, I just do have to observe that -- I mean, I think that the tone and the level of the document is actually much better than it was, but I am still left with sort of going, gee, these are issues that were sort of pulled out over four or five years. It would be very useful to me just to get some reassurance from the industry and from others out there that these are still all pressing issues and that they haven't been either supplanted by other things -- in other words, having groups come forward and saying, yes, this is the right agenda, even before we talk about how to do them. That has been something that has been sort of conspicuously absent from this process.
We have had panels at the full committee of sort of what I would describe as narrow experts, but I mean people with -- probably that is the wrong term -- probably experts who have great depth in their areas, but I can't remember seeing people that might actually either have to implement this or might be the people that we would expect to derive value from all of this ever having a chance to reflect on them about these recommendations and see if the corpus in total is the right corpus in total in 2004.
So, you know, as I said, I mean, you know, my preference -- and it is just because I am a cautious person -- would be to say, gee, accept this as draft. Hold those hearings. Get some either agreement, disagreement or whatever and then with that knowledge, go to the final. Now, as I say that, I am just bringing this up for conversation because I know I am making lots of enemies even bringing that up. But I just think it is something that we need to discuss. And I do want to stay Vickie's friend at the end of this meeting.
So, anyway, let me just put that on the table and as I said, I just think it needs to be discussed.
MR. HUNGATE: I agree with him. I think it should be discussed.
DR. LUMPKIN: Okay. Let's focus our discussion on process. There is a -- I don't remember the count -- there are a number of recommendations.
PARTICIPANT: 23.
DR. LUMPKIN: 23. And the issue that Simon raises is do we as a committee want to vet these recommendations in some process before we adopt those recommendations. That is the issue before us for discussion.
DR. MAYS: I guess I want to make a suggestion that might help us to think about how to do that because -- no, no, no, I think what Simon says is legitimate. When I looked at the recommendations, certain groups of them cluster in ways in which I think that the other subcommittees might be able to say whether or not -- because we have all been in the field in recent times. So, I think some of the subcommittees could actually say -- give some opinion on whether or not they think that these are still the cutting edge issues for right now.
I think that might be helpful. I thought that would be useful to hear, you know, like in terms of the privacy stuff, in terms of the race/ethnicity stuff, in terms of some of the others. So, we might out of the 23, Simon, at least be able to comment on some subset. Then we could see how much is left that we don't know. I think that would help in terms of allaying, you know, the concerns that exist.
MR. BLAIR: Here is an idea to see if maybe we could figure out how do we wind up getting the feedback that Simon has properly pointed out without being in a situation where we go into, you know, a significant redo or significant delay. So, my thought was while there may be some of the items that may be dated and need to be updated or revised -- the last four years, there is probably not major change in that, but if we focus on the value and utility of the document and if we had something like a reactor panel or two reactor panels or something like that of people that have expertise in -- I think you divided it into four domains in the matrix. Is that right?
MR. HUNGATE: That is correct.
MR. BLAIR: So, maybe if you had expertise in each of those domains, four reactor panels, for -- and the criteria might be more on whether the recommendations are actionable, whether they are understood and actionable so that we sort of build on what we have and make it more effective. Now that I have said that, I don't know if I have veered too far away, Simon, from your thought about what you might be looking for with having it vetted.
DR. COHN: Maybe I will respond here. You know, you bring up an intriguing idea, which is -- I don't know whether it is getting that reactor panel, but maybe it is sending it out and asking people to comment or respond. I don't know at this point that I need a couple of experts in the field necessarily to tell me it is more -- you know, I mean, I am thinking about the American Hospital Association, NCQA, I mean, other people that, I mean, that might need to review this and tell us whether we got it right or not.
I don't know that it has been through that sort of a secondary review. Certainly, the IOM does that routinely on documents before they finalize them. I guess my view is rather than -- I am trying to think whether the actionable is the key piece here. I think, the question to me is, one, is it understandable and maybe, two, is it important anymore because I even wonder about that in some of these recommendations. You are right, maybe actionable is the third piece, though I do know we were going to try to engage people and to figure out how to make some of these happen, assuming we can identify that they are commonly understood and important.
I guess your idea of somehow doing it in a way that doesn't take lots of subcommittee time, I mean, is actually a very intriguing idea.
MR. REYNOLDS: Being new and not understanding the process completely, as I red this, it appears if you look at the last two columns, Column 3 tends to focus on what I would think would fall predominantly in the Standards Committee; whereas, Column 4 tends to fall into more information that would be in electronic health records, the CHIs, the EHRs and those things.
It seems to me that any hearings or anything that went on would almost be the jurisdiction of both committees to hear it because it really is very disparate groups and provider organizations that tend to do this. Your billing office tends to do a lot of the stuff when you look at the 837 and so on. Whereas, in the medical records world, when you are looking at the other things, the actual parameters are selected here.
I understand the recommendations but I need to understand better what our process would be because it seems like it is almost two committee recommendations firmly entrenched but, yet, I don't see a process as to how both play.
DR. LUMPKIN: Let me sort of toss something into this mix. Let me share my concern. First of all, I am not really thrilled about the idea of holding more hearings. I think we have held four years worth of hearings. The subcommittee has sort of come up with their best approximation. What we really say in here isn't necessarily saying this is exactly what should happen. I think I might be inclined, more inclined -- and this can be done in a number of ways. We could adopt it provisionally, send it out for comment, collate the comment and then present it for a final vote in three months or the meeting after that. Or alternatively just send it out for comment.
But I think that conducting more hearings is not going to necessarily be the most productive. The Quality Subcommittee has other items that ought to be on its agenda and they ought to be getting to work to it and I think we need to move beyond this document in some sort of way that we can assuage the concerns, but at the same time set some sort of agenda for work.
MS. GREENBERG: I agree with you and I am -- I mean, I think there are a few options as you said, but one as to what to do with the report at this meeting, one is to just defer it until you get the comments or have hearings or whatever. Having followed all of this for a good four years would not be in support of that, but, you know, that is for the members to decide. Another would be to accept it as a committee report.
A third might be for the full committee to accept it as a report of the Quality Workgroup and recognizing that -- and commend the Quality Workgroup for having done an excellent job as I think they have and then recommend future -- how to take the process forward, which could be hearings. It could be sending it out for comments. It could be both of those. I think even in that context it could be sent to the department as having been accepted by the committee as the report of the Quality Workgroup with these future plans. That would be an alternative if a majority of members aren't prepared to endorse the report as it is.
I think we should find out whether members are ready to endorse the report as it is, but you don't really want like a 9/8 split or whatever. I mean, you want a consensus type of approach. So, I think to defer the report for this future work, I personally don't see any benefit to it, particularly if it is couched in -- if the acceptance of the report is couched in terms of, you know, this is what we have heard. This is what we have processed and now we are going to try to get more -- get reactions to it, rather than, you know, we absolutely think everyone of these things has to be done and done within 12 months. I do think that there would be value to the field for this summation of the work that has been done by this workgroup and by this committee in the quality area over the last four years for it to get out.
I think it is well put together. I am sure there are some things in here that everyone -- there is somebody who does agree with something in here, but, frankly, this is very consistent with things that are being talked about in a lot of different circles, quality circles, standard circles, electronic health records circles. I don't see anything here that is really completely out of touch with those.
So, I think if we want to say how can we kind of get more visibility to this area and move this quality agenda along, I think we need to move this report along. I think if the goal was to try to kind of -- I don't want to say dumb down, but get the report down to the fact that there is nothing in it that everyone out in the health care industry doesn't completely agree with, then there won't be a report.
I think what this represents is an important body of work. So, you know, again, I mean, I think an alternative would be to accept it as the report of the Quality Workgroup with the following plan if it can't be accepted at this point by the entire committee.
DR. LUMPKIN: Let's go with Jim, Jeff and then Vickie.
MR. SCANLON: A couple of more procedural options if possible. Again, the situation I think Simon was alluding the processes of the IOM. It is often the case where a workgroup has done, a committee has done what it believes to be a cumulative assessment of the state of the art, but really needs to get a sense of priorities on what do others think. I think there are ways to do that. I think, again in addition to accepting the report as a subcommittee report by the full committee could be provisional acceptance by the full committee or acceptance as a working paper, which further -- you know, in other words it is fixing the findings as of that date. It is asking for guidance and comment on the priorities and on the direction and it is to be refined as a result of a review and comment process.
But I, too, agree. I think we need to ratchet in the progress that has been made and really start getting some feedback now. There are very specific recommendations. there are others that are more directions. I don't think it would be helped by hearings, as much as it would be by a broader circularization and asking for comment and guidance and priorities on -- are we sensing -- is this where we are now? This is a cumulative set of recommendations. Does this reflect the priorities and the needs now?
MR. BLAIR: Unfortunately, I have been away from my office now since Saturday morning. So, I did not -- and I apologize -- I did not have a chance to actually read the report before this. So, this question you might be able to answer directly or maybe it is going to prove unnecessary.
But my thought is that maybe one of our next steps is to look at each of the recommendations, identify who or what -- whether the NCVHS would be taking action on those if they are directional or whether it would be directed to -- some of these would be directed to health and human services. In short, I think we ought to focus on how do we take these recommendations and move them to a point where some action or follow-up is taken up on the recommendations and just don't say it is a nice document, but action is taken. Maybe that would be something that NCVHS could take on as its task is to do that. Either that or maybe because I didn't have a chance to read it, maybe it is clear already in the document. So, you tell me whether --
DR. MAYS: I guess I want to kind of piggyback on some of the things that Marjorie said. In the report, there are some areas that it is almost like what they have suggested is work that overlaps with some of the other subcommittees. In particular, I will just talk about mine. I would hate that what we would have to do is kind of wait because I think we were kind of slightly planning that that is an area that we would want to move forth on.
I can speak from having been in hearings that at least that area is still well alive and is something that, you know, probably we might be able to make a contribution on in terms of, you know, moving forth on it. So, it is kind of like for me, Quality has some other things on their plate that I would actually love to see them be able to do. That is one point.
The second is when I looked through it, I wondered about whether or not there weren't also some things that could be pulled out and put into letters. There is the report in and of itself, but if you really want to make a change -- I mean, we have talked about this before, that sometimes things can get lost in reports, but there were some items that I thought -- and, again, that would be for Quality to determine -- whether or not they can pull them out and send them to, you know, either the professional organizations -- I don't know that they all go to the Secretary, but there are other places, I think, that they go. So, you know, that was something, you know, I wanted to also put on the table for consideration.
DR. LUMPKIN: Let me perhaps -- and this could be not a helpful idea, but I am going to toss it out anyway. As I was kind of skimming through the report again because it was a little bit too long to sit here and read it through to check on it, but if we were to develop a concept of a candidate recommendation, that we have a series of 23 candidate recommendations with pretty much the same text that we have here, with maybe one short paragraph in the beginning and stating that these recommendations really set the agenda for the committee in relationships for quality.
Some of these recommendations we believe can be processed fairly quickly and would end up in letters as a final recommendation. Some of these may require some work by one or more subcommittees to really bring to fruition how it can be implemented, if it could be implemented. But it short of sets an agenda for which there are 23 items in this agenda in which we as a committee think that we need to address.
Let's take one of the most controversial, which is, well, one of those that are more controversial, and it has to do with those that affect the 837 for which there is an S deal. We have had a lot of debate about the fact that these recommendations, whether it is to change the character of the race and ethnicity field, to change the identifier of whether or not a procedure existed prior to admission. All these are fairly complex.
By calling this a candidate recommendation, we have put a stake in the sand that this is an issue that needs to be addressed. The 837 may be the place to put it but there could be other alternatives, but it says at some point in our agenda as a committee that we want to address this issue of bringing out this data in a way that is meaningful to allow it to be functional. There are things that may impact our discussion as part of CMS's initiative on pay for performance. All the sudden some of these criteria may seem important to include in a transaction standard because they will be based upon reimbursement.
So, I think there are factors that come into play, but it would allow us to move the report, set the agenda without coming out and saying that every single one of these are things that should be implemented today because we believe that people are ready.
Simon.
DR. COHN: I am trying to think of what a document that lists candidate recommendations looks like. I guess I was -- I am not sure I am against what you are describing. I have been sort of resonating with what Jim Scanlon was describing, which was sort of -- you know, accept a recommendation provisionally, get it off the plate of the Quality Workgroup because I feel that they have probably seen this so many times that they don't want to ever see this one again. That is an overstatement. But certainly bring it to the full committee with the idea being that we would over the next several months get feedback from a variety of others in written form.
I agree with you. I don't think we need hearings on this topic right now. With that information, basically decide in June, does it stop being provisional or what? I guess I was sort of thinking that that made almost more sense than trying to describe all these recommendations as candidate recommendations because I don't know what to do with that exactly. I would much rather have it be provisional, have us accept it, have it be able to be put on the web and then further discussion going from there.
DR. CARR: I like John's idea because I think that as a I read this, there is either too much or too little. We have to either go in greater depth or very superficially. I don't know that either one of those in a report of this kind will give folks the information that they -- that adds value. I think that exactly what you said, like the ethnicity is a big issue. Where it goes is also a big issue. Trying to have a paragraph addressing that doesn't do it. But I think to give credit to the work that has been done so far, it is quite reasonable to say here are candidate recommendations and fast track the ones that are able to move forward and really go in depth on the ones that have a lot of stakeholders, there are a lot of good ideas.
MR. HUNGATE: My comment is related. It is a procedural one and I think that one of the problems that we have with this report is that it is extremely broad. You know, it covers the waterfront. That makes it really hard to get each of the pieces in full agreement with the rest of the structure. So, if we think of this as a report back to the committee of candidates for other subcommittees to assess the priority of with us working in conjunction to whatever way is appropriate, then the actuation comes from a more knowledgeable set.
One of the problems we had in getting the recommendations was that we weren't always sure that we had the best knowledge in the full committee to put here. But we didn't have a mechanism for improving it. So, the sense -- go ahead. I think I have said what I --
DR. LUMPKIN: Jeff, then Marjorie.
MR. BLAIR: A question. It is my understanding that the Institute of Medicine is going to be asked, if they haven't already been asked to come up with performance indicators for quality, safety and efficiency. Are there a lot of these recommendations that would be helpful to them as they begin that effort?
MS. GREENBERG: Well, these aren't measures. These are enablers so that you can develop measures.
MR. BLAIR: I do understand.
DR. LUMPKIN: My guess would be, having sat on Institute of Medicine committees that if we have a report out there, they would look at it as part of the data gathering initiative and it would give them some guidance. So, I think that is sort of the answer, although it is probably not as specific as to drive what they will do.
MS. GREENBERG: Does Don want to say something? I will go after Don if he wants to say something.
DR. STEINWACHS: Simon is in between.
Let me just say one thing because I thought -- there were two pieces here I liked very much and I was hoping maybe they would fit together. One was the idea that the committee might accept this as a report of the Quality Working Group and so, therefore, it is a product and the idea that you were putting forth, John, about this being a possible or tentative recommendations or, you know, it seems to me for the entire committee they are, if you accept this as the product of the working group and to then try and move that along.
I would like to find that kind of middle ground. I know Bob and others would about achieving some closure and then we can direct our attention much more specifically to certain areas because it has been, I think, difficult. Those of us who came along after a lot of the hearings had already been held to wrap our arms around this and try and be responsive. So, if we could find that middle ground, I would really be a very strong advocate.
MS. GREENBERG: I agree and I think it would be -- well, I defer to Bob on this, but my sense is it would be better with, you know, a little wordsmithing here or there or whatever, but to accept this report as it basically currently is as a report of the workgroup and then for the full committee in its distribution of it or transmittal of it or whatever, to characterize these as seen as candidate recommendations that need to be addressed, then to have to change this report and call them candidate recommendations within the report or dilute the report as it is because I think the report -- it is not that these are the only things that people -- that the Quality Workgroup heard or that were heard in these meetings. These are the ones that have been agreed to and that have been prioritized to be included in here in various ways. Sometimes the language is stronger than others. Other times, it says we need to find a mechanism, which, you know, really opens it up as to what that mechanism might be.
But I would myself be sorry to see, for example, pulling things out and putting them in letters or diluting this by calling these all candidates because I think the report was great effort and I personally think it does a good job, pulls this altogether in an organized way around some very important themes. That has been agreed to by the Quality Workgroup. But I think the workgroup would realize that that may not at this point have the same level of comfort in the rest of the committee, but -- so, I mean, that is my sense having watched the process because so much good information came out of those hearings over the years . I think it has been synthesized very well and I think as a product of the Quality Workgroup, I would hope that it not be diluted too much.
DR. COHN: I was actually going to support what Don was saying and I actually thought you said it very, very well. I am not sure exactly what to say now that Marjorie has commented.
MS. GREENBERG: I was agreeing with Don.
DR. COHN: I don't think you were actually. I think you were saying that we put the term "candidate" or whatever wishy-washy -- I mean, whatever words that we might use in the transmittal letter and my observation is generally transmittal letters get lost very quickly and you are left with reports.
MS. GREENBERG: I was thinking if you send it out to people for their comments you would make clear -- if that was the next step, you would make clear that the full committee sees these as candidate recommendations.
DR. COHN: Well, that is what I am saying is I actually thought -- I liked John's suggestion that we need
-- I mean, it may not need to be more than a paragraph some in here and it would be something that could be handled by wordsmithing or whatever after any sort of a vote, that some way to indicate that, you know, that this appears to be the right direction. We think that these are the right things. We call them candidate standards or candidate whatever recommendations --
MR. HUNGATE: These are not standards. These are not recommendations.
DR. COHN: I am in the wrong subcommittee. Sorry.
MR. HUNGATE: We have identified data gaps and need. We haven't said how they need to be addressed.
MS. GREENBERG: There were some suggestions.
MR. HUNGATE: We made some suggestions, but, you know, it is -- and we have clearly deferred to the content of other groups as being the critical part of that and every time we get into it, we get into the multiple priorities of the multiple groups and we are unable to -- that is the problem I have got.
DR. STEINWACHS: When you look at our grid, we do have in the center of that something we call a recommendation. So, I think that it does --
MR. HUNGATE: That is true.
DR. STEINWACHS: It is an assessment from the hearings, what we saw as needs, that we felt needed to be responded to. So, I think going down the pathway Simon was going, if we could put into the introduction of this that makes it clear this is a set of findings from the working group that have been accepted, hopefully by the committee and we see this as a blueprint for next steps by the committee and then the working groups or something like that or, you know, sort of takes it out of maybe actionable outside of the committee.
I think that was the issue. This is sort of a report that says we hope the committee acts on these things and takes them up, not that this is something that is going to the Secretary as itself for action.
MS. BEREK: You are sitting there reading the report trying to figure out what to do. I think one of the issues here is that we are now talking about hearings that almost no one in this room was around when they were held and I think it will -- if we just keep going over it and over it and over it, we will not improve it because almost everybody here wasn't there and isn't sort of bringing anything to it.
I think we owe it to the group to say we will accept this and give them the opportunity to go forward either with some stuff from that report or other things they would like to work on.
So, I think the kind of compromise of putting sort of an opening, it could be a letter that is found in the report if you want to make sure it doesn't get lost that says -- you know, we just need to find some step that says we know this is not a hundred percent finished, but if we try to finish this, it is going to take the rest of our lives and that is just sort of a feeling I have got. I have attended a few of the Quality meetings and it is very hard to sit and try to figure out what to do with recommendations when you weren't there. That is going to get worse and worse and worse. It is not going to get better.
DR. LUMPKIN: Let me suggest this because while I was sitting here not paying attention to my duties as chair, but kind of thumbing through the document to try to find some examples, I think that we can by putting a crafted paragraph at the beginning and the end and with some modification do in the document itself what we are concerned that the letter may not do.
But rather than trying to convince the whole group, let us take this to the Quality Workgroup and with the charge to come back with one of two deliverables tomorrow, one being a cover letter if we don't think that we can do some simple modifications of the document.
The reason why I say that is if you look at this, look at Recommendation 16 or Recommendation 4, Recommendation 4 says, "Operating physician requires an existing data element for operating physician to be reported for the principal inpatient procedure." I know why that is there. I think it is important to have it there, but there is no way you can read that as being anything other than a recommendation.
Recommendation 16 says, "Adopt ICD-10-CM for coding the classification of diagnosis and health conditions in administrative transactions." I don't care how you may disagree with that, we have already taken a position on it and we ain't backtracking because we had enough of those meetings. So, having said that, I think that in that context we have actually used some of these as candidate recommendations and some of these have been vetted and have resulted in letters and recommendations to the department.
So, if it is agreeable, maybe we can try to hash this out in the workgroup and come back with one of two deliverables, either the letter plus this current report of a slightly modified report, which I think we can do fairly easily with just a few sentences and a few extra words that you can do a find and replace to do.
DR. MAYS: That sounds reasonable. There is only one other piece that I am concerned about and it is kind of what we have dealt with throughout, which is Quality has always been the group that had their hearings -- not their hearings, but had their materials report to the full committee. So, what would be really useful is if you all come back also with a process of what you want to happen after this over because if things come in -- I mean, it is like and the workgroup is already off on something else, it is like is this going to be something that the full committee does? Is this something that the workgroup does? I think if you all would just think about whatever you propose, giving us a process of how we are going to deal with it, whether we are going to deal with it as a full committee and make decisions about things or whether or not this is going to be again the workgroup and then the workgroup comes back to the full committee -- because this is not the end of it from what you are saying You are going to put it out there in the world and then what is going to happen is, you know, you are saying to some extent did we get this right, are there other things?
So, somebody is going to give you some feedback and I just want to be clear when that happens, do we have a process by which we will deal with it and is it going to go to the workgroup or are we going to be back to the only way we deal with this because then it gets to be do we have time on the agenda? It gets to be it has to come to the full committee.
DR. LUMPKIN: And that actually could be done on the grid.
MR. HUNGATE: I think from the grid we can designate the content, subset of this organization that deals with the feedback. I would even -- you might want different kind of feedback from different kind of groups from different parts of the grid. It is not clear to me -- it is clear to me how this could help inform our work here. It is not clear to me how we prioritize the pieces inside it in an effective way.
DR. LUMPKIN: But if I could suggest that what that additional column in the grid would do is suggest the responsible pieces of the NCVHS for accomplishing those tasks, which is vetting those recommendations and then as we do all of our other work, the subcommittees will have to determine the priorities of that.
I mean, to be truthful, if there is anything that is dealing with standards between now and when we complete e-prescribing, it is just not going to make it on the agenda because we all recognize that we have been charged by Congress to do something and do something quickly, but there are other items that may appropriately fit within the venue of either the Quality Committee at the next meeting, may look at all these items and say, okay, let's prioritize them. Now we have got the report under our belt, let's look at what we believe as a Quality Workgroup we want to address.
So, I think there are ways to do that and what we can do in the grid is just sort of determine what is the portion of the NCVHS that needs to prioritize that particular candidate recommendation.
MR. HUNGATE: The intent of the first column and category was to provide that.
DR. LUMPKIN: And so, like I said, the work will be very easy to do.
MR. HUNGATE: Well, the thing that may not be quite as easy is that we have got multiple groups named.
DR. LUMPKIN: No, I don't think that is a problem.
MR. HUNGATE: You don't?
DR. LUMPKIN: No. It just means that the prioritization is going to have to take across groups and that is the reason why we had the hearings for those of you who were there then,which aren't very many was because it was so cross cutting.
DR. COHN: It sounds to me like we are maybe getting close to being done with the process things. I was actually hoping we could actually talk about some substance for the recommendations.
DR. LUMPKIN: Time-wise we have -- we don't have a document from populations. We actually have until 3 o'clock.
DR. MAYS: I do want to make -- what the report should be about because everybody here is really new.
DR. LUMPKIN: Okay. So, we will save ten minutes at the end. So, we have another 20 minutes by my watch to go through and identify issues.
Simon.
DR. COHN: One of the values of being a long way from here is that I get to read all of this stuff on the airplane. So, it allows me to -- and Vickie agrees.
DR. STEINWACHS: Simon, I would be willing to buy you some drinks on the airline.
DR. COHN: I just had a -- once again, I think this document is much improved but there are a couple of things that I looked at that I wanted to actually refer back to the workgroup or at least have you consider and this is probably some areas for revision. If it is okay, I will just run through -- I mean, there are not that many of them. I mean, one is on page 31, the functional status coding and also referenced in the executive committee overview.
I think the recommendation is fine. The recommendation has to do with functional status coding. It is to review the available options for coding patients, functional status in administrative transactions, EHRs and other clinical data sets and recommend standard approaches by 2005.
The body of the text only references a 2001 NCVHS recommendation on functional status. I think we would all be reminded that literally a month and a half ago we accepted a CHI report that had a number of action steps related to identifying functional standards for functional status coding and I think we need to reference that, incorporate it and that really needs to be part of the next step. Trying to just keep the various recommendations, things that have approved and why in a line. That obviously includes evaluating SNOMED and other things in addition to ICF here. That was just Recommendation No. 1.
MS. GREENBERG: CHI was mentioned in the matrix, but it didn't get picked up.
DR. COHN: Let me ask a question and this is just because of my own confusion regarding Recommendation 12, which is race/ethnicity data for patient -- this is on page 35 and it says, "Investigate how best to capture race and ethnicity on a standard provider transaction and we recommend adoption of a consensus-based approach. This is once again a question and I don't have the answer to this one. I had initially been reading this as a recommendation that we needed to get comprehensive race and ethnicity data and that this was somehow a proposed recommendation about maybe how to do it or whatever and that that was really the issue here.
I have heard others commenting that really somehow the issue is the perception of the provider, how he perceives the race and ethnicity and I guess I need to understand this one better to understand whether I support it or not because I had thought and had previously before commented that this is an issue that we don't have good race and ethnicity data. If, indeed, this is a way to identify what a provider perceives as a patient's race in this and ethnicity versus the patient's race and ethnicity and identify some sort of something going on. I guess -- can you clarify this one?
DR. LUMPKIN: Let me suggest before you put Vickie on the spot, there is a report from the Institute of Medicine commissioned by the department. That report has undergone -- and a workshop report and that final report has gone through external review and is now -- the reviewer comments are being addressed. So, that is fairly close to completion.
AHRQ is very actively engaged, has had some initial meetings with health plans in addressing the issue of collection of race and ethnicity data. There is a fair bit going on so that really in the context of identifying this as a place that our committee can work within the time frames of saying this is, in fact, a candidate, the clarity will be applied to the water of this decision-making. So, I think it needs to be vague to give us room to come up with a recommendation that will be more specific and consistent with currently developing trends.
DR. COHN: Okay. I think you have responded to my bit of confusion, which is yes.
Now, comment about -- it is the supporting part for Recommendation 20, which is interoperability of clinical data systems on page 39. I am not certain that I know the right wording here, but I don't think lack of standards for open systems architecture is right there. I am not sure if I know what the right word is. But I would urge you to maybe talk to Harry or Jeff and see if -- it seems like the wrong concept for all of this.
Now, the final question I have and it is actually the page for and I apologize -- I am trying to think of how best to ask this one. Recommendation 17, which is standard clinical codes for procedures, I guess the recommendation, which I support, which is create a mechanism for efficient mapping, querying and aggregating procedure information across care systems is, I think, something that we all support. I am not sure it is the same as the title, which is Standard Clinical Codes for Procedures. I guess I would just ask the committee to -- the workgroup to review the couple of paragraphs that relate to that recommendation because it is sort of quite -- maybe you need a different title for that recommendation.
That is what I saw as I was looking through.
MR. HUNGATE: The recommendation as stated and the content preceding it don't seem to talk --
DR. COHN: No, it doesn't seem to connect quite. I think that was -- I thought I had more, but no. I will stop there.
MS. CANAAN: Is the issue just the title of Recommendation 17, the language of the title or is the preceding text?
DR. COHN: It is a combination. It is both. I will just have you all look at it because I found there was sort of a disconnect as I was reading through it.
MR. HUNGATE: There were two substantive changes back up in the matrix that Marjorie had suggested that we should -- that did not get incorporated that I think need some discussion.
On page 6, in the content of the Recommendation No. 7, relating to functional status codes, a suggestion was made that it should relate to existing data systems as opposed to evolving data systems.
MS. GREENBERG: This is No. 7, Recommendation No. 7 on functional status codes and you see this third column is whether it is existing or evolving data systems. In other places when you are talking about doing things on the 837, it is existing data systems. This included consider revising the data sets, NUBC, NUCC, X12, et cetera, for a new standard transaction. So, it seemed that it wasn't just for evolving data systems, that it is for existing data systems and probably evolving data systems as well. The reference was to the 837 in NUBC. These are existing data sets. So, it seemed misleading to say evolving here only.
MR. HUNGATE: That seemed correct to me, that the observation --
MS. GREENBERG: Then it should say existing and evolving.
MR. HUNGATE: Existing and evolving seems most correct. Okay.
She also suggested that in the next following recommendation -- well, No. 9 actually, in the far right hand column, that CHII should be replaced by HHS Data Council.
MS. GREENBERG: I didn't think CHI was doing anything with survey sampling approaches. So, I felt the Data Council was the appropriate group.
DR. LUMPKIN: Any other changes?
Ed.
MR. SONDIK: I just have a question on 12. Recommendation 12. Recommend an adoption of a consensus based approach as opposed to an arbitrary and capricious.
DR. LUMPKIN: Recommendation 12, which reads, "Investigate how best to capture race and ethnicity on a standard provider transaction and recommend adoption of a consensus-based approach. Given that we are going to call this a candidate recommendation, I think we can -- investigate how best to capture race and ethnicity on a standard provider transaction.
MS. GREENBERG: Just end it there.
DR. COHN: Can I ask another question, John?
DR. LUMPKIN: Sure.
DR. COHN: Actually, I think this is sort of a differentiation between the -- what was on the executive summary sheet versus in the body of the recommendations. Recommendation 12 on page 35, that is about investigate how best to capture -- okay, I am sorry -- these are options to be considered. I guess I was looking at the options to be considered on -- relating to Option 12 and you had mentioned -- I think you had mentioned previously new patients and I think I had asked, well, gee, how do you identify a new patient and you came back with, well, it is a CPT&EM code for a new patient service. So, I was sort of coming back to you, well, are you only going to have physicians code this? Is this not also something you would want to get institutional providers to code this or -- I am looking on the top of page 8 under your potential options to be considered. I was just referencing your proposed potential options to be considered. If, indeed, the area you are targeting is really just like -- not providers, but physicians, then this is a solution but you appear in your recommendation to not be at all -- you are sort of saying, gee, we don't need to come up with a solution for hospitals.
MR. HUNGATE: So, that is narrower than it needs to be.
DR. COHN: It showed up here. It wasn't in the body of the text. So, I had sort of missed it initially.
MR. HUNGATE: Thank you.
DR. LUMPKIN: Any other -- Gene.
DR. LENGERICH: In Recommendation No. 7, it says by the year 2005. Is there a particular reason for that? It appears that is the only one with a date.
DR. LUMPKIN: I think we can lose that by 2005. It is in the grid and also on page 31.
MR. HUNGATE: Which recommendation number was it?
DR. LUMPKIN: 7, page 31.
MR. HUNGATE: So, strike --
DR. LUMPKIN: Just "by 2005."
MS. GREENBERG: I think the reason was -- is that the others, you already know -- an approach is already suggested in this one and this was sort of consistent with the CHI. There isn't an agreed upon approach recommended yet.
DR. LUMPKIN: But if we now have these as candidate recommendations, if no committee prioritizes this recommendation, having it by 2005 becomes meaningless. So, if it gets prioritized then --
MR. REYNOLDS: One other consideration that could be in all these ones that deal with the race and ethnicity is why not consider recommending capturing it at the data point? For example, if you are talking about a payer when they enroll someone, Medicaid enrolls people, Medicare enrolls people. That doesn't change.
DR. LUMPKIN: Actually in Medicare you can, in fact, I think it is captured in Medicare. The difficulty is in capturing it at the point of enrollment is that when a provider sees a patient, they don't necessarily have enrollment data. So, that is the conundrum that is associated with how to do it. The plan may have it. The provider may not and it depends by service.
MR. REYNOLDS: I am not sure why that matters because once a transaction goes somewhere, whoever it goes to --
DR. LUMPKIN: Well, because if you are going to -- let me give you an example. If you are going to make a difference in trying to reduce racial and ethnic disparities, if you have a provider, an electronic health record, that data may be pertinent at the time of service delivery. It may be pertinent at the group level, but not necessarily once it gets to the plant.
I am not precluding one or the other, but I think that there are a number of things that makes this such a complex issue.
MR. HUNGATE: So, we are committed to go away and do our work and come back tomorrow.
DR. LUMPKIN: That looks like the plan.
MR. HUNGATE: John, do you think we can do it in an hour and a half?
DR. LUMPKIN: To my mind, in the interim, rather than going and eavesdropping on Simon, I will just try to jot some thoughts down and walk through the documents on what changes I think need to be made.
MR. HUNGATE: The committee was quite of the content here. I think it is a nice recap. The prioritization is not perfect. You know nothing meets everybody's expectations, but it is a pretty good working list of some things that are important. I think that is the contribution.
[Applause.]
MS. CANAAN: Kathy Coltin is not here to receive your plaudits, but she is the one who is responsible for the very large majority of the writing and the intellectual work on this report.
DR. LUMPKIN: Thank you. We are now ready to adjourn, but I did promise because Vickie needs to give us a little ten minute set up. See, she thought I forgot her.
DR. MAYS: No, I didn't. I have already moved the mike.
What I wanted to do because we have lots of people here, who were not here when Populations began. I mean, I am kind of learning listening to this discussion before when Populations actually began its hearings. I think it might be useful since we don't have the report at this point in time to at least give some background so that you have a sense of how it started. We are going to wrap ours up so that we don't have to worry about -- there is not anybody sitting at the table that were at the hearings.
We began in February 2002 to hold a set of hearings. The purpose of the hearings were really to determine whether or not the OMB guidance on the collection of data on race and ethnicity was actually working sufficiently. We wondered the extent to which, for example, there might be variances that were given to agencies. We wondered, for example, whether or not some of the groups who were very -- some of the racial and ethnic minority groups, who were very concerned about how the collection would be done. You know, we wanted to hear from them.
So, we began in that February with a set of hearings in which we invited in -- and that is what the report will be on the next time -- is our federal agencies, who were conducting national population-based surveys. The reason for that was, number one is to find out how they were asking the questions; number two to find out in terms of the small numbers that they might have, how they were allocating the categories for race and ethnicity and how they were reporting them.
Then, third, we also were interested at that time in finding out, since we are interested in health disparities, what questions besides race and ethnicity were being asked to determine whether or not there were health disparities in particular populations. So, that is the background in which we began the hearings.
We moved from that hearing on population-based surveys to hear from the states and then the states we also wanted to hear about vital statistics and then we moved on to do specific racial and ethnic minority subpopulations. The report that will come to you is a report that will just talk about the collection of data on race and ethnicity and the measurement of disparities in population-based surveys. I just wanted to give you just a little bit of background as to what you can expect. We learned our lesson because we came here before with 66 recommendations. So, we now know better than 66. Actually what has happened is over the time is that some of those have been pulled out and sent in other letters. So, I think we have a -- at least my own and the committee's learning curve here, I think that we have a much better sense of, you know, trying to come in with recommendations that actually can make a difference as opposed to just a pie in the sky. We will have some pie in the sky, but, you know, we won't have 60 pies in the sky.
DR. LUMPKIN: Jim.
MR. SCANLON: Before we break up into the working sessions, you will notice that we have added a number of new staff to the various subcommittees and that is the result of a departmental solicitation of all of our agencies for staff to serve on the subcommittee staff.
So, please welcome the new staff when you get into the breakout sessions. These are all very capable folks. We have always had good staff for the full committee. Earlier today, we had a representative from the Census Bureau. She is acting as liaison today. We invited her to the full committee, but whatever suits the committee's purposes, whether we want someone on the -- we clearly want someone to be at the Populations deliberations as well. The census folks said let's see what the best person might be.
We are actually happy to have the new staff. Please welcome them in your breakout sessions.
DR. LUMPKIN: Okay. Standards and Security, I think, is here and Populations will be in 305 and followed by Quality.
[Whereupon, at 2:52 p.m., the meeting was concluded.]