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[This Trranscript is Unedited]

National Committee on Vital and Health Statistics

Full Committee Meeting

September 23, 2003

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201

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

TABLE OF CONTENTS


P R O C E E D I N G S [9:10 a.m.]

Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda - Dr. Lumpkin

DR. LUMPKIN: Good morning, welcome to the meeting of the National Committee on Vital and Health Statistics, we’re going to start off with introductions, we’ll go around the room and then the informational portion of the agenda. I would like to remind everyone that we are going live on the internet as we do for all of our presentations for people who can’t make it to the meeting and because of that we do ask that you speak into the microphone when you have a comment and for those who may speak from outside of the committee we would ask that you would identify yourselves again when you come to the microphone. My name is John Lumpkin and I’m senior vice president of the Robert Wood Johnson Foundation, and we’ll start off with Marjorie.

MS. GREENBERG: I’m Marjorie Greenberg from the National Center for Health Statistics, and executive secretary to the committee.

MR. ROTHSTEIN: I’m Mark Rothstein from the University of Louisville, a member of the committee.

MS. HANDRICH: I’m Peggy Handrich from Wisconsin Medicaid and Wisconsin Health Data.

MR. HOUSTON: I’m John Houston, I’m with the University of Pittsburgh Medical Center, I’m a member of the committee.

MR. LENGERICH: Gene Lengerich, Penn State University, member of the committee.

MS. SANCHEZ: I’m Linda Sanchez, I’m a staffer in the Office for Civil Rights in the Department of Health and Human Services.

MS. FRIEDMAN: Marie Friedman, CMS.

DR. STEINDEL: Steve Steindel, CDC, liaison to the committee.

MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.

MS. BEREK: Judy Berek, CMS, liaison to the committee.

DR. ZUBELDIA: Kepa Zubeldia, Claredi Corporation, member of the committee.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, member of the committee, staff to the Subcommittee on Standards and Security.

DR. SHORTLIFFE: Ted Shortliffe from Columbia University, Anatology(?) Physicians and Surgeons, member of the Committee.

MR. HUNGATE: Bob Hungate, principal of Physician Patient Partnerships for Health and member of the committee.

DR. MAYS: Vickie Mays, University of California, Los Angeles, member of the committee.

DR. COHN: Simon Cohn, Kaiser Permanente, member of the committee.

MR. SCANLON: Jim Scanlon, HHS, Office of the Assistance Secretary for Planning and Evaluation, executive staff director for the committee.

MR. BRUNELLI(?): Sam Brunelli, Team Builders International, Alternative Link.

MS. GIANNINI: Malina Giannini, Alternative Link.

MS. JONES: Katherine Jones, NCHS, staff to the executive committee.

MS. FISHER: Beth Fisher, National Center for Health Statistics.

MS. FYFFE: Kathleen Fyffe, ASPE, lead staff to the NCVHS Subcommittee on Privacy.

MR. SMITH: Merit Smith of the Robert E. Nolan Company.

MR. HAFFANA(?): Bill Haffana, Blue Cross/Blue Shield.

MS. FRASIER: Judy Frasier, American Optometric Association.

MS. TORAKOWSKI(?): Irene Torakowski, American College of Surgeons.

MR. MUSKO: John Musko with the Health Insurance Association of America.

MR. DESMARAIS: Henry Desmarais with the Health Insurance Association of America.

MR. KASTLE(?): Gene Kastle, American Psychiatric Association.

MR. REGERA(?): Daryl Regera, American Psychiatric Association.

MS. CANAAN: Susan Canaan, writer for the committee.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics, staff to the committee.

MR. SPANGLER(?): Tom Spangler, American Dental Association.

MR. BURKE: John Burke, Office of the Secretary, staff to the Subcommittee for Standards and Security and NHII Workgroup.

MS. BEBEE: Suzie Bebee, Office of the Assistant Secretary for Planning and Evaluation, staff to the Subcommittee on Standards and Security.

MS. AULD: Vivian Auld, National Library of Medicine, staff to the Subcommittee on Standards and Security.

MS. MARSTELLER(?): Jill Marsteller, National Center for Health Statistics and an Academy Health Fellow.

MS. JOHN: Jody John, Quadrimed(?).

MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.

DR. EDINGER: Stan Edinger, AHRQ.

PARTICIPANT: Tom (?), director of the Center for Medicare Management.

MR. RODY(?): Dan Rody, American Health Information Management Association.

MS. QUAS(?): Linda Quas, American Health Information Management Association.

MS. LEON-CHISEN: Nelly Leon-Chisen, American Hospital Association.

MS. PROPHET-BOWMAN: Sue Prophet-Bowman, American Health Information Management Association.

MR. GUSTAFSON: Tom Gustafson, Center for Medicare Management.

MR. STAEHLIN: Marty Staehlin, Price Waterhouse Coopers.

MR. BEBEE: Michael Bebee, American Medical Association.

MS. LUWELL(?): Mary Luwell, MedPac(?).

DR. LUMPKIN: Okay, the next item on our agenda are conflicts of interests and recusals, anyway, I can’t get that word out. We got a lot of lawyers in this room, how come none of you guys are helping me? Any conflicts of interests, recusals? Simon?

DR. COHN: Well in the event that we are discussing CPT everyone needs to know that I am on the CPT editorial panel and obviously would be recusing myself from discussion of CPT.

DR. HARDING: I am a past officer of the American Psychiatric Association, which has involvement with DSM and other things and would be recusing myself on a vote on that issue.

DR. LUMPKIN: Okay, actually we have two people on the phone, which we didn’t realize, I just heard Richard.

DR. HARDING: Yes, Richard Harding, member of the Committee, chair of the Department of Neuropsychiatry, University of South Carolina.

MS. GREENBERG: And new grandfather.

DR. LUMPKIN: And new grandfather, congratulations. Anyone else on the phone? And we have --

MS. GREENBERG: Did we have someone else on the phone?

MR. BLAIR: I have a disclosure to make.

DR. LUMPKIN: Yes, Jeff.

MR. BLAIR: I want to get in and not miss this opportunity, my son Brett and my daughter-in-law Vitka(?) are parents of my first grandchild.

DR. LUMPKIN: Congratulations. And Stan if you’ll introduce yourself?

DR. HUFF: Stan Huff with Intermountain Health Care and University of Utah in Salt Lake City.

DR. LUMPKIN: Member of the committee. Jennifer?

MS. MADDENS: Jennifer Madans, National Center for Health Statistics.

DR. LUMPKIN: Great, welcome. Okay, Jim, update from the Department.

Agenda Item: Update from the Department - Mr. Scanlon

MR. SCANLON: Thank you very much, John, welcome everyone. I’m going to try to make up some time on the agenda this morning but I wanted to report back to the committee since we met in late June I guess that progress continues on a number of developments relating to the NHII and health information technology and standards. And I think it’s a reflection of these kinds of issues becoming more systematically included in HHS planning and program operation, and even the Secretary himself on several occasions has emphasized the importance of the NHII and the importance of interoperable health information technology and standards both in our operations here in HHS as well as the health system generally.

Let me report on a couple things. The Secretary after our meeting on June 24th actually announced this at our NHII Conference in early July, as you know he’s emphasized repeatedly on the importance of applications of IT and their potential to make really major changes to the health system. And as you’ll recall in the draft strategic plan that you all had a chance to review and comment on for HHS, which we’re in the stages of finalizing by the way, we include several objectives related to the National Health Information Infrastructure and its importance in supporting the missions of the agencies in HHS and the health system generally. He is urging all of our agencies to try to look at opportunities to employ relevant information technology across all of our programs and to work to promote interoperable health information technology across the public sector and the private sector as well.

To assist in this goal he asks that we establish in HHS a Council on the Application of Health Information Technology, CAHIT. This is an internal group, it’s co-chaired by my office, ASPE, and the administrator of AHRQ. The goal is to coordinate HHS activities and investments in health information technology, so this is within and across HHS, but also to ensure a coordinated approach and more or less one voice in the HHS collaborative work with the industry and the public health and the research community as well. The Council has met about three times already, it’s on a pretty much regular basis, every other week or so or every third week, and Dr. Lumpkin participates in the meetings in his role as chair of the NCVHS. So that’s a very positive development.

Secondly, you may have already seen this in Science Policy newsletter, and it relates to some new proposed guidance from the Office of Management and Budget relating to peer review requirements for significant regulatory information that is disseminated by federal agencies. In the past I’ve briefed the committee on the Shelby I and Shelby II Federal Information Quality Guidelines, and the attempt there was really to make some of the research data more available to the constituents in the industries that use them, and to ensure that federal agencies have systematic procedures and policies in place to assure a quality review before they disseminate any substantive information, scientific or technical, epidemiological or so on.

And about three weeks ago OMB has added to that set of guidelines in a proposed bulletin on peer review and information quality and the intent here as stated on the bulletin, I’ll give you the website later because you can actually look at the bulletin and you can comment, provide comments to OMB, but the goal is to ensure that agencies conduct peer reviews of the most important scientific technical information, and technical information, relevant to regulatory policies that they disseminate to the public, and that the peer reviews are reliable, independent, and transparent. So the focus in general is on scientific regulatory information that an agency disseminates in support of regulatory actions. Now OMB definitions actually provide a bit of ambiguity about what the scope would actually be but the basic intent is to ensure that all agencies when they’re using scientific and substantive information and studies largely, that support a direction being proposed in a major regulation, that they have provide, that they have conducted or provided for a peer review. The peer review can be an internal kind of a peer review from other substantive experts within the agency but outside the program, or it can extend to the full external peer review much as you see in the scientific journal articles and the review articles as well.

The bullet defines regulatory information as any scientific or technical study that is relevant to regulatory policy and information may be relevant to regulatory policy if it might be used, this is the OMB definition again, by local, state, regional, federal, and international regulatory bodies. So it actually when you look at it more closely, it could extend by this definition of relevance to a larger scope then just purely regulatory actions, but I think we’re looking at it in terms of regulatory actions.

OMB is accepting public comments on the proposal through, well, they’ve just extended, it was October, it’s now December 15th, and the final bulletin would be taking effect early part of next fiscal year when it’s finalized. And they would, the bulletin would apply to all information that any federal agency disseminates that’s within the scope, well, originally it was planned for next January but it will probably be a bit later. So we in HHS are looking at this collectively, OMB has asked us to provide some comments and we’re in the process of pulling them together now. In the case of what OMB calls especially significant regulatory information OMB then, the bullet would then require an external peer review.

Let me go on just quickly to our conference follow-up activities. You’ll remember that in early July we convened a national meeting to try to develop a consensus agenda on action steps needed for the NHII, we had a very successful attendance and very successful participation. The secretary gave a keynote address, Dr. Lumpkin gave a keynote address as well. There were eight areas, breakout areas that you’ll recall, I won’t repeat them here, but there were more or less eight tracks ranging from research to public health, privacy and confidentiality, data architecture and so on, and we received a number of recommendations in all of those areas. We’re in the process now of pulling the recommendations together, there’s a plan to pull them together for publication and we also are beginning to plan some follow-up activities with some of the tracks and some of the groups of participants. I think one of the first groups is providers and another group is payers, and I think we’re planning to have specific follow-up meetings with those groups and we’ll do it for the others as well in the months ahead.

We’re also pulling together an inventory on our website, we now have an NHII website as you know as a follow-up to the meeting, and we’re pulling together an inventory of all of the HHS activities relating to the NHII and again, that’s on our HHS website.

Just quickly let me bring you up on where we are with the budget and remember in any given year we’re dealing with three budget years. For the current year, which is really winding down, the current fiscal year, fiscal year ’03 will wind down at the end of this month, September 30th, the new fiscal year, fiscal year ’04, begins on October 1st. We and a very few of the, hardly any of the federal agencies have an appropriations yet for ’04 but it looks like the direction is heading in the manner we hoped relating to a number of investments that were included in the President’s budget for ’04 relating to NHII and data policy, and let me just remind you of what they are again, hopefully in the weeks ahead. Things look fairly optimistic actually that these will actually turn up in the budget, in the actual appropriation. And again these sort of reflect an increasing role for HHS in leadership, convening, and standards, and research and demonstrations for health information technology and some expansion in the public health area as well. At the overall departmental office in ASPE, my office, the budget continues to include a NHII initiative, about $3 million dollars, this would be for overall strategy planning and coordination, convening, and for some special projects that are more or less gap filling that wouldn’t be done otherwise. Some of the work has already begun this year and it would be extended in ’04 as well.

Another investment that’s proposed in the budget is a $10 million dollar investment, this is a departmental investment, it’s a partnership between ASPE and AHRQ, it’s in the AHRQ budget, it’s about $10 million dollars for standards, to accelerate the development and use of interoperable standards, so we’re looking forward to that as well. And in addition there is a $50 million dollar initiative in the AHRQ budget that would be available for research, particularly demonstrations, to improve patient safety through health information technology. I guess the focus would be largely on hospitals but it could extend to other health care organizations. And the Secretary there may give preference to small overall hospitals, but again, this was initiated about a year ago in the department’s planning and it hopefully will be coming to fruition. I think in the optimism and hope of having the money available fairly early we’ve already started to think about what the requests for applications would look like so we can get a fairly good start on that when Congress finishes action and again in the direction we hope.

Again, we’re working on the fiscal year 2005 budget, we’ve just begun work, we’re submitting our preliminary budget request to OMB. Our hope there as well is to continue some of these investments into the next fiscal year and to actually try to on the population statistics side to try to address some issues, a stable source of funding for some of the programs as well. Now again this is very preliminary, the budget has a long way to go for ’05, we don’t even have the ’04 budget yet, but this is at least the thinking and the direction of where we’d like to go.

And finally let me report on the National Academy of Sciences study on the adequacy of race and ethnicity date in HHS and other Health and Human Services systems. This began more than a year ago, Congress passed a law that directed HHS to fund the study at the National Academy of Sciences. The panel was established, it has met I understand three times, Dr. Lumpkin is on that expert panel and Ed Perren(?), Dr. Ed Perren I think many of you know, is the chairman. We asked them to include as part of their deliberations a workshop on particularly involving health plans and providers and to get a private sector focus on what the current policies and practices were in terms of collecting race and ethnicity data in regular and routine medical and administrative data. It was clear that there was a lot of misunderstandings prior to that and we were hoping to get some clarity about what the practices are and so on.

Well, the workshop was actually held, many of you were actually participants in the workshop, and I talked to the Academy folks yesterday and they expect to, the workshop report is expected to be released in a week or so, a week to ten days, so we’ll get that to the committee right away, and I think it will dovetail with some of the Population Subcommittee’s deliberations on improving race and ethnicity data in these very same systems, so I think they’re both heading in the same direction. The full report from what I understand is now in Academy review and I think they were hoping to have it around December, but again this is somewhat unpredictable, but later this year we probably would have the full, we look forward to the full report. I will keep you informed on that as well.

Two quick things from the Data Council, these are kind of follow-up to the vision for health statistics report that the committee completed. The gateway, our electronic web based gateway to Health and Human Services statistics that we talked about at a previous meeting, we’re now expanding and upgrading to include a number of additional sites, we now have about 2500 websites that provide reliable statistics in Health and Human Services. Again there’s some connection with HHS to be included and we have just, we’re just about to start a study to look at geo-coding issues, geo-coding data and standards, this is the HHS part of a larger government wide initiative to improve and standardize the geo-coding and geo-spatial information that we include in a lot of our data. In the health area I think the geo-spatial aspects are somewhat different then EPA and some of the other agencies have where they’re largely dealing with fixed assets that literally in a latitude and a longitude tells you where it is and that’s where it stays, dams and bridges and buildings and so on.

In the health area we have some of those but it’s a little more fluid, it’s more population based and government based and organization based but there are still some good practices and policies that we want to look at. As a start we’ll be looking at our meta-directory of the major HHS data systems, we’ll be looking at what geo-coding information is available now, what’s collected and what’s available, obviously there are confidentiality issues in what you can make available for small areas, and we’ll be looking at what kind of standards and best practices might best serve us all. Again, this is part of a broader government wide effort to kind of standardize and improve the geo-coding, geo-spatial data as well.

Let me stop there.

DR. LUMPKIN: Alright, any questions?

DR. MAYS: Jim, could you talk a little bit more about the geo-coding? When you said that you’re going to do a study, who’s the we that’s doing it?

MR. SCANLON: This is under the Data Council, we’re in the process of awarding a contract through one of our ask order contractors, and they’ll be working with, I can’t say who it is yet because we’re still negotiating, but it will be a contractor supported study, they’ll be working with a working group under the Data Council to kind of give them direction and to keep the project moving forward. But we’ll start with the meta-directory, which is pretty much our holdings, the HHS holdings and data collection systems and we’ll report back to the Populations Subcommittee, I think it’s particularly relevant there as well.

DR. LUMPKIN: Okay, thank you. We’ll go on with a report of HIPAA implementation, starting off with standards. Maria, welcome.

Agenda Item: HIPAA - Data Standards, Including Clinical Data Standards Adoption - Ms. Friedman

MS. FRIEDMAN: Thank you. A couple of significant activities have happened since the last time I reported to the full committee. In the end of July CMS issued guidance enforcement for the transactions and codeset provisions of HIPAA and in the, and a copy of this is in your book by the way, in the guidance we clarified that covered entities that made a good faith effort to comply with HIPAA transactions and codeset standards may implement contingencies to maintain operations and cash flow. And then as a follow-up to that not long ago we announced that Medicare has a contingency plan and a lot of people have asked us both about the guidance and contingency planning and the Medicare contingency plan, under that we would continue to accept and send transactions in legacy format in addition to the HIPAA compliance transactions obviously while trading partners work through issues on implementing the HIPAA standards. The contingency plan will apply to all Medicare’s fee for service contractors and in the next day or so we may be announcing whether we are going to invoke the contingency or not. It’s still up in the air, if that happens while we’re convened I will certainly let everybody know.

Aside from that we are working on contingency planning with our trading partners and continuing our outreach activities.

DR. LUMPKIN: Did you say something was happening next month?

MS. FRIEDMAN: No.

DR. LUMPKIN: Okay, any questions?

DR. HARDING: This is Richard Harding. I wasn’t on right at the start, they let us in when people were introducing themselves. Karen’s not there, it’s Maria instead?

MS. FRIEDMAN: Yes, Karen is up on the Hill at a hearing and I’m sure she’d much rather be here.

DR. HARDING: I imagine it’s tough to make those decisions. I had a question for Karen actually but maybe Maria could help, could I ask that now Jim?

DR. LUMPKIN: Sure.

DR. HARDING: Okay. I was kind of wondering about the issue of codes and what the status of one. Most of you know that about ten percent of electronic code transactions under HIPAA are in the area of mental disorders and I was wondering if Maria or Karen or whoever is there could update the committee now or later on how the department plans to kind of deal with the issue of mental disorder diagnosis codes under HIPAA and the electronic transaction regs. I guess more specifically will mental health professionals be allowed to continue to use the DSM evidence based criteria or has been suggested be required to kind of go back to ICD-9-CM descriptors to define mental disorders? If this isn’t the right time, I didn’t see that in the next number of things, but just wondered if you could comment on that issue.

MS. FRIEDMAN: I can’t comment right now, I know that it’s an issue that’s been under discussion with the committee and I believe we’re waiting for a report back from our Office of General Counsel on a couple of points, and certain when we have that information and are ready to make a report back we certainly will do that.

DR. HARDING: I guess the issue is October, and the Council has had that for some time now?

MS. FRIEDMAN: I think they have, I think they have been a long time is my understanding, so I think we’re due back for a report fairly soon.

DR. HARDING: It’s perplexing to many in the mental health professionals because the thought of going back to ICD-9, which of course was done in 1977, is a little bit mind boggling in today’s current health climate and the hope would be that the descriptors in DMS would continue to be allowed to be utilized. But you’re waiting on the Council to come back, is there going to be any FAQ’s or anything like that on that issue?

MS. FRIEDMAN: I believe that there will be FAQ’s on that issue and as I said I think we’ll be reporting on that fairly soon, just not today.

MS. GREENBERG: I was just going to say first of all Richard, that was a great segue into the next discussion on how old ICD-9-CM, so thank you. But I think, we recognize your frustration, it’s my understanding that there have been very recent meetings between the department and the American Psychiatric Association and that this is, so there has been very recent communication although as Maria said the actual official response has not yet come out, but I think there is an understanding that we’ll allow the profession to use the standard codes, which were mandated under HIPAA, which is the ICD-9-CM, but still not be required to stop using the diagnostic criteria that are currently applied. So I think there’s going to be a mutually agreeable solution, unfortunately we don’t have it all tied up with a bow by this meeting, but I know there have been a very recent meeting and I think a resolution is very close.

DR. HARDING: Okay, I appreciate that Margie.

DR. LUMPKIN: Thank you, any other questions? Kepa, is there any reason why you’re sitting in Clem’s seat? Okay, thank you.

DR. HARDING: I was going to ask the same question.

DR. ZUBELDIA: I have a question for Maria. There is another law that doesn’t effect October 16 and that’s the ASCA law by which all the Medicare providers will be required to file their claims electronically as of October 16. Has CMS looked at a contingency plan in case some providers cannot file their claims electronically as of October 16?

MS. FRIEDMAN: To be very honest we have issued a Medicare billing regulation and there is information on our website on that, I unfortunately am not up with all of the in’s and out’s that maybe our friends from another part of the house can handle that.

DR. LUMPKIN: We have a huddle on the 40 yard line.

DR. COHN: Maria, you’re saying you weren’t, I see the copy of the reg, you’re wondering whether there’s going to be a contingency plan in this one?

MS. FRIEDMAN: No, I think, my impression is and I don’t want to say anything correctly but my impression is that if we invoke the Medicare contingency plan, that’s the big question here, we don’t, as of right now we are not sure whether we’re going to invoke that contingency.

DR. ZUBELDIA: But that’s for HIPAA.

MS. FRIEDMAN: For HIPAA.

DR. ZUBELDIA: I’m asking about ASCA.

MS. BEREK: I just asked Tom Gustafson and he said we have the ability to waive for providers who can’t bill electronically, so that there isn’t a contingency plan but there is an ability to waive.

DR. LUMPKIN: I guess the follow-up question, assuming that you can waive, therefore your intermediaries would have to, because if there’s more then a few trying to do through Baltimore might be a little bit complicated. The issue of the contingency plan might be an important issue, how would someone, some guy who hasn’t been paying attention, be able to submit bills.

MR. BLAIR: Can I ask for clarification on this because this is on the internet, it does go out to the public, and if the word that we used in this particular case is inaccurate that could have some real consequences and Judy, can you verify that the word is waived? Because it was my understanding that the position of HHS was that it would be flexible in the enforcement but waiving is very different from being flexible in enforcement.

DR. LUMPKIN: Jeff, let me clarify, there are two different issues. One issue has to do with implementation of the transaction standards under HIPAA and the deadline that’s coming. The second is under ASCA, which mandates that anyone who, that CMS only pay electronic bills. Those are two different requirements and so there is flexible enforcement for the HIPAA and the question is the mechanism by which flexibility would be granted under ASCA would be the waiver.

MS. BEREK: Right, right, and what Tom Grissam(?) just asked me to tell you, which is that in fact at 9:00 a.m. Tom Skully announced for HIPAA that we are in fact implementing our contingency plan, so since it is quarter to ten I am allowed, this is live, I am allowed to say it. At 9:00 this morning Mr. Skully announced to the press that we would in fact be implementing our contingency plan under HIPAA.

DR. LUMPKIN: You guys are such great troopers.

MS. BEREK: Maria is the person who gets the Academy Award.

MS. FRIEDMAN: I want to thank all the little people.

DR. LUMPKIN: Cause I’ve been there and I know how difficult it is, we appreciate it. Kepa?

DR. ZUBELDIA: So now that we know that, as a follow-up for those providers that need to comply with ASCA and file their claims electronically and they cannot do it in the HIPAA formats, would they be allowed to implement de novo the old legacy standard formats as a contingency under ASCA?

MS. BEREK: This is more detailed then any of us in the room know, we will get you an answer.

DR. LUMPKIN: Thank you.

DR. FITZMAURICE: Is there a copy of the contingency plan available?

MR. SCANLON: Well, there’s probably a press release, we’ll get it at the break.

MS. FRIEDMAN: We had issued a statement outlining it earlier but it’s very brief and I mean it had the details you might be looking for but I would assume that we’ll follow our usual protocol and make something available on the website.

DR. LUMPKIN: And Marjorie reminded me that that only applies to people who aren’t in this area who don’t have power, they can’t get access to the website anyway unless they have a wireless device with batteries. Simon, did you have, that’s kind of an East Coast thing, you guys out West can’t appreciate hurricanes. Earthquakes maybe.

DR. COHN: Actually I was remarking last night I hadn’t seen rain since about May, much less hurricane weather but thank you.

DR. LUMPKIN: Okay, any other questions? Maria, thank you. Then we have from OCR, Linda Sanchez.

Agenda Item: HIPAA - Privacy Rule Compliance Update - Ms. Sanchez

MS. SANCHEZ: Good morning. I just have a few things to say about enforcements, we’ve been enforcing now for five months, since the April 14th compliance date with the Privacy Rule. As of yesterday we had 1,937 complains submitted to us. We received 95 in the last full week we had data, which is the week ending September 13th. Last week as we all know we all got to go home early and batten down the hatches. As you all know also the OCR regional offices investigate complaints and they’ve been in the lead and actually handling everything that’s been coming in. Overall we’ve resolved and closed roughly one third of the complaints we’ve received so far for a variety of reasons. Some complaints submitted to us as a Privacy Rule violation did not actually raise a privacy issue, sometimes the action complained about didn’t actually violate the rule, or we’ve been able to resolve matters through voluntary compliance and technical assistance. We’ve actually been very gratified by the response we’ve had from covered entities when we contacted them, when we’ve received a complaint about a particular action they’ve all, in general they’ve been very responsive to our calls and letters and have taken appropriate action very swiftly.

I know the committee is interested in what kinds of issues that have been coming up in the complaints. Inappropriate uses of disclosures have come up, we did a rough count two weeks ago, these have come up in about 350 of those complaints. Possible problems with safeguards have come up in about 280 complaints. These include inappropriate waiting room encounters where things have been overheard or too much information has been left out where people could see, or other types of facility problems. Inability to exercise an individuals access right has come up in about 170 complaints. Notice, failure to provide notice or inadequate notice has been identified in about 50. Minimum necessary, often related to whether an incidental use of disclosure was actually committed or not has come up in about 50. We’ve also been seeing a number of cases involving inappropriate authorizations.

I’m going to talk a little bit about outreach, our headquarters and regional staff have made about 100 presentations this year to several thousand attendees at various conferences. We’ve also participated in many telephone audio conferences. Our Privacy Rule hotline, which is a joint OCR and CMS endeavor, continues to operate, calls about the Privacy Rule are generally taken by trained operators and issues that come up that they can’t handle are then referred to a Privacy Rule specialist in our office. Since April 1st we’ve fielded about 14,000 calls. The first week we had over 1300 calls, as of the week ending September 13 we had only 480 that week, so clearly volume has diminished and we believe this is because covered entities and consumers are becoming more aware of the rule, are less surprised and are more able to find answers to their questions on our website. We’ve also found that many of the questions that we’ve been getting can actually be resolved by referring people to information in our website.

Speaking of the website, since January our frequently asked questions have been accessed 1.2 million times, I think one of the most popular sites if not the most popular page on the HHS website altogether, so we’re very pleased about that personally. We’ve recently added several new questions regarding how to account for public health access to records, accounting for dates of access and creating notices that might apply in multiple states. And additional FAQ’s in a variety of topics are in development or in clearance right now.

As you know the website contains many other guidance documents, we’ve recently linked to two new NIH guides for researchers and the CDC guide on public health related matters, and additional targeted technical assistance materials for various parts of the industry are also under development through a contractor.

So I’m happy to take your questions.

DR. LUMPKIN: Any questions?

MR. HOUSTON: John Houston. Has there been any attempt to try to break down by type of covered entity as well as type of provider where the complaints are coming in or are they based around hospitals or physician practices or insurers? Have you done any statistics in that regard?

MS. SANCHEZ: No, we have not. Early on in the first couple of weeks we started looking at that, we can look at that again if you’d like.

MR. HOUSTON: I think that would be interesting to understand exactly who’s having the problems with complying or where the complaints received are coming from. And also I would like just to make a comment regarding FAQ’s, I think they’re very good, I know I reference them often and I only hope that you continue to add to them aggressively because I think that seems to be a good source of information. So I think one of the common misconceptions that is still out there, and I’m not sure how you’d remedy this, is that there’s a lot of people at least, I’m from Pennsylvania, who say well HIPAA says I can do this, unfortunately they naively simply discarded Pennsylvania law which in many regards is more stringent. And I guess there’s no way in a FAQ to put that necessarily in there that you still need to consult your state laws, but that has been a source of problems I know in what I deal with typically and just people seem to forget about the state laws.

DR. LUMPKIN: Let me see if I understand the report, nobody’s been thrown in jail?

MS. SANCHEZ: No.

DR. LUMPKIN: The system didn’t fall apart?

MS. SANCHEZ: Not that I’m aware of.

DR. LUMPKIN: Good, good, so I think that the volume actually of complaints is surprisingly low given as much attention was placed on that, and I know it’s still a challenge for your and OCR but we appreciate your hard work in there.

DR. FITZMAURICE: I want to follow-up on one of John’s questions. It’s been remarkable, complaints with it and resolution of conflicts in your report, has OCR seen fit to fine the first $100 dollars of fines to anybody who violated the Privacy Rule?

MS. SANCHEZ: We have not reached that point with anyone, no.

DR. FITZMAURICE: Remarkable.

MR. HOUSTON: Wasn’t there a number of cases that were referred from the Department of Justice?

MS. SANCHEZ: We have referred some cases to Department of Justice, yes.

DR. LUMPKIN: Well, thank you very much. We’ll move on to the next item on our agenda, you’re free to go. We’re now going to start a process of something that has culminated a fair bit of activity by this committee looking at the issue of the transition, whether there should be a transition and how from the ICD-9 to the ICD-10-CM and ICD-10-PCS. I’m going to start with an overview, we’re going to have a presentation of the impact study which was sent out with the meeting materials, which I found to be a very interesting study, and then we’ll have a reactor panel and some discussions which will take us pretty much through lunch.

Agenda Item: Overview of ICD-10-CM and ICD-10-PCS - Dr. Cohn

DR. COHN: Can I make an introductory comment?

DR. LUMPKIN: Please do, Simon.

DR. HARDING: Could everybody do their best to speak right into the microphone? I’d appreciate it.

DR. COHN: Can you hear me?

DR. HARDING: Yes, now.

DR. COHN: This is Simon Cohn. I think as you all know I’m chair of the Subcommittee on Standards and Security. I just wanted to give everybody sort of a brief, maybe much higher level overview then where Jennifer is going to talk about just because I wanted to reflect for a minute on the process and I think as you all know the Subcommittee and indeed the full committee has been involved with these issues for a number of years. We first discussed them in the late ‘90’s during the recommendations on the administrative and financial transactions, and I think at that point if any of you review the final rules for that which of course are now coming into play finally on October 16th, next month, it was felt to be too early to move to ICD-10. More recently the Subcommittee started reviewing these issues and holding hearings back in 2002, and after a number of days of testimony we realized that we really didn’t feel we had enough information upon which to reach a conclusion, which was part of the reason that we asked NCHS to help sponsor a Rand study on the cost on the cost of the impact, so I obviously want to thank both Marjorie Greenberg and Donna Pickett for helping to shepherd that effort through. We’ll obviously be hearing from that study later on today as well as reactors.

What I want the committee to realize is that in some ways we’re really, the focus of this work is really not to come to the perfect cost/impact study, though we will be hearing about the cost/impact, we will be hearing from reactors to it and hopefully we’ll be getting additional information from the industry, both now and in October when the Subcommittee holds hearings on this topic, to come back in November with hopefully the next steps for the full committee. Really the committee needs to remember that the purpose of these discussions is to try to come to a consensus and general agreement about what we ought to be recommending regarding both ICD-10-CM, for diagnoses, as well as uses for ICD-10-PCS. So I want everybody to sort of think about all these things as we listen to both the overview and the reactor panels, and the information on the cost/impact, the cost impact I think Martin Libicki will be first to comment on, is an advance draft at this point and can be further improved. But really we all need to be sort of familiarizing ourselves with what it is we’re talking about in costs and possible benefits and hopefully as I said as we move through this process we can come to a greater consensus about what we ought to be recommending.

Anyway that was just my initial comments. Jennifer did you want to go?

Agenda Item: Overview of ICD-10-CM and ICD-10-PCS - Ms. Madans

MS. MADANS: Thank you. For those of you who don’t me I’m Jennifer Madans, I’m the associate director for science at NCHS, and I’m representing Ed Sondik, the director of NCHS, and first let me convey to you his apologies for not being here today. He certainly was planning on it up until about 1:00 yesterday afternoon when a meeting that was carefully scheduled to be not when this committee was meeting was moved to exactly when it was meeting and unfortunately he had to be at that other meeting. It’s actually in this building so you might see him wandering around, but he did very much want to be here and I think is very much interested in the issue of ICD-CM and classification in general, both personally and I think also from the point of view of the Center. So perhaps the most important message I can convey to you today is that NCHS is extremely interested in classifications in general and in ICD and related classification in particular. It is a major part of what we do and how we view our responsibility to the statistical, health statistical field.

The mission of NCHS is to provide statistical information that guides actions and policies that will improve the health of the American people and in fulfilling that mission NCHS and other partners in the department, as well as throughout the statistical system, is kind of dedicated to improving and maintaining a very high level of data quality and there’s, I don’t know if it’s been spoken in this meeting but an OMB initiative on data quality and we’re very much involved in that, and we see classification systems is a particularly important part of that data quality initiative and really at the very basis of it. And this is I think particularly true in the area of health, and specifically in health care, where there are lots of changes going on. The field seems to be completely in flux and really do need a high quality classification system to keep track of it. The international classifications of disease, which is really a family of classifications, is a key component of NCHS’s statistical work.

I know that you’re aware that the ICD is developed and maintained collaboratively between the World Health Organization and the international collaborating centers. NCHS houses one of those collaborating centers and is responsible for implementing the family of international classifications in the United States, that North American collaborating center includes the U.S. and Canada. I think that it’s important that these are international systems. By joining with folks around the world we not only get the benefit of their knowledge and expertise in this area but we have the ability not only to look at the status of the situation in the U.S. but also across countries, that’s very valuable from a research perspective. I think also I have learned somewhat the hard way sometimes that you don’t really understand what’s not right in what you’re doing until you do do some international comparison, it seems to highlight the very basic flaws in the system very, very quickly. I think we gain a lot by having an international classification rather then just a U.S. based classification, and our collaboration with WHO in this area I think is extremely important.

The other thing that is easy to forget but very important to remember is that classification systems are not static. You don’t develop them and then leave them, they have to reflect the environment that they are devised to reflect. And as that environment changes they too have to change, as knowledge advances they have to reflect that knowledge and knowledge is advancing a lot faster then it used to it seems, or maybe I’m just getting a lot older, but it appears that we are updating and revising much quicker then we used to. And that’s a good thing, but it does make the classification business more of an ongoing kind of business then it had been in the past.

As you know we in the U.S. adopted ICD-10 for mortality coding in 1999 and the U.S. was, and NCHS I’m happy to say, was a leader in this implementation both in the U.S. of course and also worldwide. In the U.S. we have in the past developed a clinical modification of the ICD for use in morbidity coding, and this tack that we have taken is recognized in our agreements with WHO through that collaborating center. Since 1979 we have used ICD-9-CM for morbidity coding, and that classification was adapted from the ICD-9 through an extensive modification. What is important is that the two classifications, the ICD-9, the ICD-9-CM, can be collapsed and compared across the two, that you can look at morbidity and mortality statistics in some kind of coordinated way, and that classification has been of course adopted and is still in use.

The ICD-10 revision was a pretty major one, and also was sorely needed and does reflect the changes in the field and in the knowledge base, and those very same issues that required a change in ICD itself also required a change in the clinical modification and any coding system you’re going to use for morbidity. And I would venture to say that probably more so, it’s even more true in the case of morbidity coding then it is in mortality coding, that the changes in the field really require the revision of that coding system.

I think we’ve been pretty successful in trying to update 9-CM over time to reflect changes in the environment, but I know I have been convinced by my colleagues in NCHS and other places that 9-CM is rapidly losing its capacity to incorporate the additional specificity for newly identified disease entities and other advances in medicine. That it’s just becoming much, much harder to modify the existing system. It would be very hard to have that system grown even if we can do it in a short run. So if we’d come to an agreement that 9-CM is not going to be the answer for the future where do we look, I know there was some discussion of just using ICD-10 for morbidity coding and that also didn’t seem to be appropriate. That wouldn’t provide the necessarily information that we’d be needing to adequately describe the morbidity situation.

So let me just briefly summarize that we strongly believe that the creation, review, and revision of health care policy relies on the availability of accurate and timely health care data, that these data are generated by providers and payers and by statistical surveys and other research efforts, but that the key underlying all of these information systems is the classification system that’s used to interpret these encounters and to provide information on morbidity status of the population. The 9th revision of ICD CM has served I think role very well since 1975, 1979, sorry, but it is really time to move forward and to implement some kind of revised classification. I think it is imperative that we do this in order to improve the kind of health care research we do, to improve patient safety and other quality of care issues.

The U.S. has been a leader, an international leader in this field, I think we still can maintain that position, but probably more important we run great risk if we continue to collect data using an outdated classification system at a time when there’s a greater need for information about the health care system, and I think particularly in the area of quality of care and also in trying to reduce disparities in care. These are areas I know the department is very committed to and without having adequate data it’s very hard to move forward in these areas.

We are very happy to work with the committee as usual and with our other partners in developing a classification system and adopting a system that will meet the needs of all users. My particular interest, given my position, is how to maintain the quality of our statistical systems and how to use that information for policy development and it is really a pleasure to be able to be here with you today to represent Dr. Sondik and to be involved in these discussions. Thank you.

Agenda Item: Overview of ICD-10-CM and ICD-10-PCS - Mr. Gustafson

MR. GUSTAFSON: Thank you, Jen. I’m Tom Gustafson, I am the deputy director of the Center for Medicare Management within the Centers for Medicare and Medicaid Management, the agency formally known as HCVA(?), and my component runs the fee for service side of the Medicare program, which is still very much alive and kicking, we have over 85 percent of the Medicare caseload still in a fee for service environment, and that may change depending among other things on bills under consideration on Capitol Hill, but it is not likely to go away during any of our professional lifetimes.

We process about a billion claims a year, not all in the inpatient sector, which is what we’re talking about today, but we process a lot of claims, they’re done electronically, coding is profoundly important to us because it defines the products and services that we pay for, so we take a very keen interest in this entire area. I come to you as a health finance expert, not as a coding expert particularly, so I offer an apology if I get some of the terms and concepts just slightly askew here, it’s not because I intend to do that but I’m still being tutored as many of us are. And part of my role as I understood it this morning was to make sure that members of the committee were acquainted with exactly what we’re talking about here, and viewed from a payment standpoint and the business standpoint that goes along with that.

So why are we having this discussion in the first place? And the reason for that can be traced back to the existing coding system, the ICD-9-CM, volume 3, which is where the procedure codes lie, and that’s the stuff that the Medicare program uses for paying inpatient hospital services and in several other payment systems that have evolved more recently that use the same coding system. This codeset was first implemented in 1979, that’s 24 years ago by an easy count, for use with inpatient hospital procedures. It involves a four character hierarchical numeric code, so you have four digits and you can only use numbers. It has been criticized for providing inadequate descriptions of many of the procedures contained within it, it is exceedingly difficult to update and expand within its longevity, and it is complicated. It is reflecting a reality that is now out of date, technological change has moved very dramatically in the health care sector in the past few years as I think all of us are aware, and unfortunately we have a data system here, a coding system, that is worse just where it should be best in terms of reflecting the updating of the technology.

The precise specification of procedures is very important for us, it permits us to make accurate payment in prospective payment systems such as the inpatient prospective payment system, and these kinds of codes in the system that’s upon them is used widely, not only in Medicare but with other public and private payers here and abroad. It allows evaluation of the efficacy of procedures, because if you know what’s being done you can check out whether it’s working or not. It allows us to measure outcomes and to some extent measure quality. And it can be very helpful to us in limiting and preventing fraud and abuse, and one particular aspect I’d like to mention there is one of the great concerns of the medical profession at least at present is what I would describe as false positives, and to say as the federal government has become much more interested in seeking patterns, looking for patterns of fraud and abuse and going energetically after the bad apples, there’s a great deal of concern that folks would be labeled as one of the bad apples when they are not. Having a more precise coding system should help alleviate that concern.

It allows a better understanding of technological diffusion, where are new procedures being used, how are they being used, what kinds of cases are they being used for, and it allows us as a payer to identify new technologies emerging on the scene, to ensure that they are paid adequately. One of our major concerns is to facilitate access for our beneficiaries to quality care involving among other things lately arriving technologies, and if we’re not paying enough money for those hospitals may not offer them, and I can come back to that. So in general we think that a system that is simpler and more logical would be a step forward and obviously one that is more modern and up to date.

In considering how the world might proceed in this general area there are sort of two general approaches that could have been considered and I believe these were debated at some length early in the ‘90’s. One would have been to augment the existing ICD-9-CM system by expanding the number of characters or by making them alphanumeric. Now that would have involved systems changes throughout the health care system, but with comparatively little advantage in terms of the improvement in precision. Some, but not overwhelming. On the other hand we could move toward a new and refreshed coding system which would also involve systems changes, and there’s no hiding that, but would also provide a more precise linking of technology and procedure and allow improvement in the underlying procedure codes. And that is the development that has led to today’s discussion, the ICD-10-PCS is the procedure chunk of ICD-10, which was developed as a replacement to ICD-9. This was initiated by this committee, the activity here was initiated, discussed and initiated in this committee back in the early 90’s and was funded in its development by the agency then known as HCVA, now CMS, and most of the legwork on this was performed by 3M, contractor with significant history in this area. The codeset is now sufficiently developed and tested where it merits serious consideration as a replacement for ICD-9-CM as volume 3, as the standard codeset for inpatient use.

The National Committee in November of 1993 specified the characteristics that they wanted to see in a procedure codeset, and let me just tick those off for you very quickly. One is that it should be comprehensive, all procedures should be classified within the codeset. Second, that the codes should be non-overlapping so that substantially different procedures should be able to have unique codes. Third, it should have expandability so that new procedures and technologies can be incorporated as unique codes when the need arises. Fourth, that it should have a hierarchical structure so that the individual codes can be aggregated into larger categories for various kinds of analysis. Fifth, it needs to be multi-axial so that each code character has a consistent meaning, each of those seven digits does the same thing in different places. Sixth, standardized terminology so that all terms are precisely defined, which is not a characteristic of the existing system. And finally that diagnostic information is not included in the procedure descriptions so that you have a separation of what’s going on in the diagnostic code and in the procedural code, and these factors guided the development of the ICD-10-PCS. As I reflect on them they seem to me exactly the sorts of things that a committee like this would imagine might be useful functional characteristics of a code set. And I believe that the ICD-10-PCS does a pretty good job in meeting those kinds of needs.

The structure of this dataset, this codeset, it’s based on a seven character alphanumeric code, so you’re dealing, going from four characters to seven and going from straight numeric to alphanumeric. This obviously provides you a very substantially increased number of possible combinations. The codes are divided into 16 sections such as medical/surgical, obstetrics, imaging, and so forth, I won’t go into them all, but it allies out to the major activities that need to be covered. And each of the seven characters function in a specified and consistent way, and I’m sorry I don’t have a visual aid to show you here, but the hurricane interfered with my ability to produce one in a timely fashion. But if you look in the medical and surgical section, for instance, I would just review these very quickly, you’re first digit tells you what section you’re in, in this case I guess would be medical and surgical. Second, body system. Third digit, what is the root operation, what are we talking about doing here, are we sizing something for instance, would be an example. Fourth would be a body part, so you’re in the abdomen or you’re on a leg or something. Fifth would be the approach, are you doing this laparoscopically, is it open, things of that sort. Sixth would be whether a device is used and if so what kind of device, there’s room for a variety of digits in there obviously. And the seventh field is qualifier field so we can provide some additional information in that seventh field. The approach is slightly different in some of the other sections, imaging for instance, but the same general hierarchical structure, axial structure, persists. And as a result of this, even though it may sound daunting to imagine gee, there are lots and lots more codes, the picture we have is that it’s actually simpler to use and simpler to understand. This codeset has been run in a head to head trial against ICD-9, and it wasn’t an extensive trial but a limited and I think revealing trial, indicated that after a comparatively minimal amount of time of training that experienced coders could code material in ICD-10 more quickly and with more accuracy then in ICD-9.

So in general the approach allows greater precision, greater simplicity, and greater expandability. The current status as I’ve sort of already gone ahead of myself and summarized here, the codeset is developed, we have the tools necessary to make it work, there is a complete crosswalk between ICD-9 and ICD-10 so one can march from one to the other immediately. There are definitions manuals, user manuals, training material of various sorts are already available and have been disseminated on our web page so that members of the community could examine them, and I said earlier that we have tested this. So that is just a short characterization of what’s at stake here with this issue, I understand that we’re going to here the Rand presentation and they’ll be some opportunity for further reaction after that.

DR. LUMPKIN: Any questions on the two presenters before we move on to the Rand? Kepa?

DR. ZUBELDIA: Yes, I have a question of one of the last statements you made that there is a complete crosswalk between ICD-9 and ICD-10. Is there a crosswalk for each ICD-9 procedure code to one ICD-10 procedure code?

MS. GUSTAFSON: I don’t know if it was a one to one crosswalk, but Pat Brooks could perhaps help me here?

MS. BROOKS: It starts with a ten code, you look at the ICD-10-PCS code list on our web page and it gives you a nine code that it goes back to and many of those are one to one, sometimes they are not.

DR. ZUBELDIA: So from ICD-10 to ICD-9 --

MS. BROOKS: Yes.

DR. ZUBELDIA: And it’s many to one.

MS. BROOKS: Yes, there can be many 10’s that have come from 9, because ICD-9 procedure codes have a lot of things involved, they’re procedures of every artery in the body in some codes, so obviously there would be a lot of 10 codes list, go back to one 9 code.

DR. LUMPKIN: Okay, any other questions? Simon.

DR. COHN: I think this is just one for you, Tom, I actually don’t have a specific question to ask you about, I just wanted to make sure that you were going to be around as we hear from reactors because there are a number of questions I have but some of it relates to information we’re going to be receiving later on. So you’ll be with us for the remainder of the morning and the afternoon?

MR. GUSTAFSON: I’ll be here, I think you’ll discovered me listed among the reactors. I’m hoping, I was intended to be instructive at this point and more of an advocate later.

DR. LUMPKIN: Well we look forward to your advocacy role. Peggy?

MS. HANDRICH: Hi Tom. I’m wondering whether in your overview of the coding you represent the CMS view from the perspective of Medicaid, has there been discussion on the Medicaid side about this issue?

MS. GUSTAFSON: Yes I’m told. We are the Centers for Medicare and Medicaid Services, but I don’t know, I believe that there have been some discussions with representatives of the Medicaid community and we could perhaps give you some more detail on that.

DR. LUMPKIN: Thank you, we’ll move on to the presentation of Dr. Libicki.

Agenda Item: Presentation on ICD-10 Impact Study - Dr. Libicki

DR. LIBICKI: Good morning Mr. Chairman and members of the committee. My name is Martin Libicki, I am a senior policy researcher at the Rand Corporation, a non-profit research organization providing analysis and solutions for public and private sectors. My presentation today will cover the work of the Science and Technology Policy Institute of Rand did on the cost and the benefits of switching from ICD-9-CM to ICD-10-CM and ICD-10-PCS. This work it should be noted has not been completely through the Rand quality assurance process although a draft of the report is available for public comments. The views expressed are mine alone and do not represent Rand or the sponsors of our research.

Rand was asked three questions. First, what are the costs and the benefits of switching from ICD-9-CM’s diagnostic codes to ICD-10-CM? Second, what are the costs and the benefits of switching from ICD-9-CM’s procedure codes to ICD-10-PCS? Third, if it is advisable to switch to both ICD-10-CM and ICD-10-PCS should they be done sequentially or simultaneously? In answering these questions we draw on three sources. Prior testimony before the Subcommittee on Standards and Security of the NCVHS, literature review, and interviews mostly by phone of experts and stakeholders throughout the health care sector. In the middle of April until the beginning of August we conducted 80 interviews in which we talked to about 90 people.

Our presentation today will focus first on costs and then on benefits. We will not repeat the introductory and methodological material from last May, nor go into detail about the codes themselves, except to note briefly that their most salient feature from our perspective remains the greater specificity that they offer, a mostly two fold increase in codes for ICD-10-CM and a 50 fold increase for ICD-10-PCS. Although neither ICD-10-CM nor ICD-10-PCS were designed as a strict one to many expansions of their predecessors, ICD-10-PCS by virtue of the 50 fold increase in codes is a de facto one to many expansion while ICD-10-CM is only a one to many expansion for about two thirds of its codes. We intend to present both costs and benefits as ranges in order to reflect the uncertainties of any such estimation. In so doing we will start with costs.

We estimate the costs of the transition to be $425 million to $1.15 billion for the first year, and $5 to $40 million dollars a year thereafter. These numbers assume that the switch to ICD-10-CM and ICD-10-PCS occur simultaneously. If considered separately one can add up to another $20 to $170 million dollars to that number.

The costs basically can be divided largely into two costs, those for training and those for systems changes. The costs of training people to use ICD-10-CM and 10-PCS can in turn be subdivided into the costs of training hospital coders, non-hospital coders, code users and others. The amount of training required for coders has been studied and results from other countries serve as benchmarks. We start off with the roughly 50,000 hospital coders, which can be understood more or less as tantamount to the number of full time coders even though the overlap is not 100 percent. The time to get such coders to proficiency in the new codes, mostly ICD-10-PCS, has been estimated at several days to a week by AHIMA among others. If such training costs $2500 dollars per person, split between expenses and lost work time, then the training bill is roughly $125 million dollars, reflecting uncertainties that gives us a range of about $100 to $150 million dollars. One caveat, however, merits note. Gail Graham from the Veterans Administration informally tested ICD-10-PCS on coders and concluded that while good coders essentially had no problems with the switch mediocre ones did because their knowledge of anatomy and physiology was incomplete. If they have to bolster their knowledge of such fundamental subjects this would endeavor training of several months with a cost of perhaps $10,000 dollars each or more. When multiplied by 10,000, if one talks about the least proficient 20 percent of coders, this would add another $100 million dollars to the costs. That noted there is no evidence that such broad training was required in Canada, where an analogous transition was made in coding procedures except their code expanded for procedures by a factor of six rather then 50. In Canada it took two days of intensive training plus additional follow-on sessions of a few hours each to get coders up to speed. There were initial losses in productivity, they were modest and they disappeared largely or totally within six months. Australia’s training experience was similar.

What of those who code only ICD-10-CM? That is those who deal with outpatient records? With 200,000 doctors offices one can think in terms of an equivalent of 200,000 coders. Yet almost all the diagnoses in any one office usually involves a small number of diagnostic codes, some offices preprint the codes either in hard copy or on disk. Many physicians officers do not record diagnoses with the highest degree of specificity in any case. It is not unknown for physicians, presented with a choice of 40 different diabetic codes in ICD-9-CM to use the most general code in billing, thus little or no training will be asked for in many offices. Some inpatient coders will simply train themselves as they go and there are potential efficiencies in training that may be available by using the web as an instructional vehicle. More broadly AHIMA has estimated the retraining time for part time coders at roughly eight hours, yielding a cost figure of $100 million dollars. We will use $50 to $150 million dollars, however, as a range of costs to train coders outside of hospitals.

Incidentally, those present at the August meeting of the subcommittee heard an estimate from the AHIMA AHA study that indicated that coders for ICD-10-CM wanted an average of two and a half days of training. This figure does not invalidate the eight hours that we used, first their testers were largely full time coders and even teachers, not part time coders. Secondly, working training is not the same thing as getting paid for training. As to the training, retraining of physicians, one responder indicated that the requirement for training would depend on how different ICD-10 was from ICD-9. At the high end another estimated that each physician would need four hours of education on the new diagnostic codes, plus two further two hour sessions in the first year for a total of eight hours. If multiplied by the half million physicians in clinical practice this sums to roughly 2,000 man years of training at a cost of several hundred million dollars. Nevertheless, no physician we talked to said that they themselves would have to be retrained. Professional coders for their part are extremely leery of having doctors do their own coding.

Finally as noted, many physician offices, for better or worse, rely on super bills to capture their diagnoses for the record. If ten percent of all physicians take eight hours of training the overall costs would be roughly $50 million dollars as a point estimate, and perhaps $25 to $100 million dollars as a range reflecting these uncertainties. Code users may also need some time to become familiar with the new codes, perhaps half of the quarter million employees of payer organizations work directly with codes. It is unclear how much training they will get. Formal training in ICD-9-CM remains the exception today.

To some extent employers may count on people seeing codes and descriptions on claims forms often enough together to link them. No payer has mentioned any formal program, formal training program, although to be fair few have yet to focus on the issue. If the average employee needs the aforementioned eight hours of training then roughly $50 million dollars worth of training man years would be required. If only half are trained the cost would be $25 million and these two numbers form our range.

There may also be some loss in productivity. CMS formally tested ICD-10-PCS in 1998 by using two clinical data abstraction centers. One of them, Dinecheypro(?) report indicated that no significant time difference in coding was found between ICD-9-CM and ICD-10-PCS. The other one, F-MAST(?), reported that ICD-10-PCS generated more codes then the ICD-9-CM, and that each record on average took 1.7 minutes longer to code, or 50,000 extra coding hours equal to $3 million dollars when multiplied by the 1.8 million discharges a month from hospitals that have procedures associated with them. If one assumes a six month learning curve, at the end of which only a third of the difference persists, in the long run productivity costs are roughly $12 million dollars a year. But these data must be qualified by the observation that 200 records is a very small sample upon which to base conclusions and most hospitals use automatic encoders these days, which were not part of the clinical data abstraction center studies. So we use a range of zero to $15 million dollars a year to reflect lost productivity among coders.

Another possible source of productivity could stem from the fact that these codes, requiring as they do more input from the patient record, will require in some cases that more information be added to the patient record in order to fill out the codes. If focusing on ICD-10-PCS and assuming one, that 80 percent of the patient records either describe routine procedures or are well documented, two, coders will get back to physicians only half the time they need information, and three, physicians and coders need to spend five minutes for each such patient then multiplying by the aforementioned 1.8 million inpatient discharges gives you at least initially 15,000 physician more work hours, and the same number of additional coder work hours, or $3 million dollars worth in the first month. Again, this figure will decline as physicians get used to what they have to note in the record whenever certain types of procedures are done. So we figure a range of $5 to $25 million dollars in lost productivity over the long run.

Systems upgrades account for the other half of the cost of transition. Providers will have to alter their billing and administrative systems to handle new codes, which in ICD-10-CM and PCS are longer and contain alphanumeric characters rather than just numbers. Most providers, however, buy their systems from vendors and most of the provider/vendor relationships have a software maintenance component which pays for periodic upgrades, especially in response to government regulation. Nevertheless, Bob Hardesty(?) from Cerner did testify before the subcommittee that “it would be expected that there would be professional service fees for planning, testing, training, conversion, and implementation. Providers themselves may have to do some of their own planning, engineering, and user services such as report generation, testing, ensuring backwards compatibility with earlier data and systems integration.”

Overall the level of concern we found with such codes was modest, with neither the AHA nor the FAH raising such issues before the subcommittee, both of which were more concerned about covering training costs. Major hospital chains similarly were not terribly concerned about the change, believing that they would need little additional consulting and for them the major costs would be testing and integration. One hospital chain representing .5 percent of the total inpatient market estimated the cost of training and integration at a maximum of a man year. Another said it would be close to a trivial event. The Veterans Administration, which accounts for roughly three percent of the total potential patients does not plan to spend more then a million dollars. But there were outliers, “easily a million dollars worth of work among hospitals,” which may account for a disproportional share of the costs and makes estimates difficult to generate on the basis of small sample sizes. We therefore used a wide range, $50 to $200 million dollars, to represent the cost of updating provider services.

Estimates were also made for the costs of updating software. At the high end two software vendors expressed a need for as much as three years to make the change. The man year estimates were in both cases roughly one man year for every ten employees they currently have on board. A third major vendor cited a rough estimate of 50 to 100 man years for total adaptation to ICD-10. Others such as Quadrimed, Cerner, Solution, Core Solution, Symetry Ingenics(?) talks of a few man years of effort, so rounding this all up we used a figure of $50 to $125 million dollars for this sector.

Fixing payer systems is also a large cost estimate and payers vary widely. Some, generally the larger ones, develop and maintain their own systems. Their costs could be large and seem to fall either into a lower rate, of 40 cents per member, or a higher rate of $1 dollar a member. Others, perhaps buffeted by earlier changes required by Y2K or HIPAA, have come to rely on vendors and face fewer direct costs and perhaps fewer costs overall. Based on the former, that is those who do not use vendors, we estimated the cost of adapting software to accommodate ICD-10 between $100 to $250 million dollars if extrapolated to the entire payer base.

Finally we have no hard data for CMS, which at the time of our research had only begun to estimate the impact of ICD-10-CM and ICD-10-PCS on their costs. Based on the size of CMS, but tempered by the fact that CMS does not do everything that an insurer does, we used a figure of $25 million to $125 million dollars as a placeholder for their costs.

Last is a word about how costs are distributed. As a rough estimate, hospitals are likely to bear 35 percent of the costs, outpatient facilities 25 percent of the costs, and payers, including CMS, about 40 percent of the costs. Within these categories we found that the likely cost to accommodate a code change are roughly proportional to the number of patients the providers see or the number of members that a payer has. We were not able to detect or predict any systematic shift in payments as a result of the change in coding between ICD-9-CM and ICD-10-CM and PCS. Current plans suggest that DRG’s will not be redefined until sometime after ICD-10-CM and PCS goes into effect. The fact that CMS pays for nearly half of all hospital costs mitigates against any large immediate shift in reimbursement rates elsewhere within the medical sector.

Now for the benefits side of the ledger, where we note that the discussion will be more qualitative in nature and that the ranges assigned to benefits will be accordingly much wider. Assumptions play a large role in these calculations.

We identified five categories of benefits where there could be a reasonable basis for enumeration. The total benefits over ten years we estimate to be between $700 million dollars and $7.7 billion dollars, depending on estimates and assumptions. Following discussion of these five categories of benefits will be mentions of four categories where benefits are possible but which could not be enumerated for reasons detailed below. The five categories are one, more accurate payment for new procedures. Two, fewer rejected reimbursement claims. Three, fewer questionable reimbursement claims. Four, better understanding of the value of new procedures. And five, improved disease management.

We start with category one, more accurate payment for new procedures. As one researcher has argued the predictive power and clinical utility of a DRG classification system is limited or empowered by the precision of the available diagnostic and procedure codes. This dictum applies through particular force to ICD-10-PCS. With more codes available it is now possible to differentiate simple and complex inpatient procedures, there they’re two lumped together. Different procedures can be reimbursed differently. This in theory is a net plus if procedures that would have been optimal for patient care were not performed because providers feared they would lose money doing so. In practice, however, this possibility was not raised by any provider we talked to and certainly not by any payer.

In recent years CMS has started a program to reimburse elected new procedures at rates higher then what is indicated by the DRG’s that says procedures are associated with. The limitations on expanding ICD-9-CM volume 3 are a major reason that very few such procedures have been approved. With ICD-10-PCS the additional approval rate for additional payment, with ICD-10-PCS the approval rate for additional payments for new procedures could rise to several dozen a year. Estimating this benefit required making assumptions about the number of new procedures introduced annually, the number that would not get their own code in ICD-10, excuse me, the number that would not get their own code where ICD-9-CM volume 3 in use, the percent of them whose benefits would exceed their costs but whose costs would exceed the reimbursement allowed for their DRG, and the percentage of Medicare/Medicaid patients who would not get procedures as a result. In this scenario therefore we estimated benefits to range somewhere between $100 million and $1.2 billion dollars over ten years.

Category two, fewer rejected reimbursement claims. As a workgroup for electronic data interchange observed ICD-10-CM and ICD-10-PCS incorporate much greater specificity and clinical detail, which may help reduce the number of cases where copies of medical records need to be submitted for clarification for claims adjudication. By one estimate only one in five hospital claims make it through with complete payment and no additional questions asked. Nevertheless, almost everyone who commented on this issue felt rejection rates would rise initially as people unfamiliar with the codes put down the wrong codes, or as payers who also have to learn the new codes err and reject correct codes. We estimate that within a year or two the rejection rate will be below what it had been otherwise, and otherwise you’ll initially see a rise and then a fall. And now within five years a cumulative number of rejections will fall below what they would have otherwise have been. In other words it takes about five years for the up part of the curve and the down part of the curve to balance off, leaving the down part of the curve in year six through ten. Our overall estimate is based on assumptions about the share of health care financing costs arising from having to adjudicate claims, the number of cycles the average claims makes, and the percent of claims that can eliminate one cycle thanks to more detailed discharge records. We estimated a range of $200 million to $2.5 billion in benefits for this category over ten years.

Category three, fewer improper reimbursement claims. As for fraud, the WEDI report goes on to argue, if a new coding scheme were implemented there would be increased opportunity for fraud in the beginning when people are less familiar with the new codes. It might be more difficult to detect potential duplicates, unbundled services, or up coding of procedures during the transition when two versions of codesets would be in effect. In the longer term it is possible that fraud could be reduced since ICD-10-CM and ICD-10-PCS are more specific and there are fewer gray areas in coding. Although the General Accounting Office has used the figure of $13 billion dollars to represent the sum total of all questionable reimbursement claims, the vast majority are either differences of opinion or providers seeking the benefit of the doubt on close calls. Only a minority of them are improper per se, our estimate was based on the assumptions related to what percentage of the $13 billion are clearly improper, of these how many exploited the ambiguities of ICD-9-CM, of those how many would recognize a greater clarify of ICD-10-CM and PCS and abandon that tack and not exploit other weakness. So in other words we took a large number and we subsequently divided it by a number of percentages. We concluded after that by assigning a benefits range of $100 million dollars to $1 billion dollars for this category.

Category four, better understanding of the efficacy of new procedures. In estimating the value of research on procedures several assumptions could be kept in mind. First, only a certain percentage of procedures, that is those that did not get their own ICD-9-CM volume 3 code are likely to win new separate identifications in ICD-10-PCS and their identification assumes correct coding. Second, insofar as a point of research is to effect decision one is looking at the decisions of dual procedure more often, say for a broader selection of patients or less often, that is to say consider alternative procedures in some cases or not do the procedure altogether. Such research will say little about how to do the procedure, except when two different ways of doing the procedure are identified as different procedures in ICD-10-PCS and are therefore found to yield different outcomes. Perhaps needless to add practice is unlikely to follow research results immediately or totally. Third, many of these procedures are so well accepted that no feasible amount of research is likely to effect a decision to undertake those procedures. Fourth, research using ICD-10-PCS hospital discharge data is only one of many sources of information and procedures. Payers, for instance, already have access to physician based claims and coded NCPT, and there are also in many cases controlled studies that rely on information and patient records, or conveyed directly by procedures. Last but perhaps most important in judging the efficacy of new procedures are stories passed around among specialists of failures and success.

Our estimate picks up many of the assumptions of the first benefit, notably the number of new procedures done every year that do not get their own code, but requires a separate estimate on what percentage of such procedures are significantly informed by the analysis of discharge statistics on who underwent them. We then need to estimate how often based on such information procedures are introduced to new populations or contraindicated for populations who would have otherwise gotten these procedures. Calculating through these assumptions generates a range of $100 million to $1.5 billion dollars to represent this benefit.

Category five, improve disease management. Increasingly care management organizations and providers are working with patients, especially those with chronic conditions such as diabetes, asthma, or heart condition, to ensure that they receive the correct quality of care, reminders for treatments, and referrals to classes and other self management techniques. The point here is to postpone or eliminate the onset of the more serious conditions that send people to hospitals. True, many of these services could provide, could be performed by primary care physicians, these physicians in turn would rely on personal knowledge of the patient or detailed notes on the patients rather then simply on discharge codes. Yet many patients lack primary care physicians or have no single such physician who could manage the patient. Since much of the work of disease management, such as finding eligible patients, sending them reminders, and giving them information can be automated organizations can run through patient records en mass and pick out patients who need disease management and deliver such management automatically.

Although disease management programs are proving popular a tempered optimism is called for in evaluating how better codes may attribute to its efficacy. As it is many primary care physicians do not use the specificity already present in ICD-9-CM. It is unclear whether they will react to a more specific set of codes by using distinctions that previously lay unused. Others produce diagnosis that indicate not the underlying cause of the encounter, such as diabetes, but its proximate cause, such as kidney dysfunction. One respondent has suggested that some differentiation in diabetes, such as neuropathy, exceed what are typically recorded even in doctor’s notes. As a result many care management organizations use other indicators to differentiate diabetic patients from one another. Some use HBA 1C tests and diagnostic codes for comorbidities for diabetes. Perhaps half of all payers classify diagnoses by broad episode treatment groups of which the most popular set has 500 to 1,000 and thus are more aggregated then ICD-9, let alone ICD-10. The more sophisticated algorithms use a mixture of diagnosis, procedures, laboratory tests and medications to determine what the patient may be suffering from and thus whether disease management is warranted. The finer details available from ICD-10 cannot hurt the implementation of this algorithm but responses to date do not suggest it will contribute that much more accuracy to ETG determinations either. One provider is moving away from codes altogether and going over to SNOMED for such purposes.

We chose to focus on diabetes partially because it is such a large disease management challenge and partially because of the anticipated five fold expansion in number of codes available as one goes from ICD-9-CM to ICD-10-CM, which are available for this disease. Two category of benefits were estimated, those from getting more of the right people into disease management, and those that come from being able to refine disease management for the type of condition the patient has among those who are already in disease management. Our calculations first required an estimate of the number of diabetes patients in programs that offered disease management, excuse me, first required an estimate of the number of diabetic patients in programs that, in disease management programs and that use ICD-9-CM as a primary source of information on payments. From that basis we made assumptions about the percentage of diabetics who enter the program as a result of more detailed information available from ICD-10-CM who therefore reduced their primary indicators as a result of being in this program, and who therefore added quality months or years to their life. Under the scenario we used the benefits estimate, the points estimate was $500 million dollars.

The second half of the calculation required estimating the number of patients in the program, the percent of those whose program is fine-tuned by ICD-10-CM information, and the percentage of those who thereby reduced their primary indicators and add quality months or years to their life. Under the scenario we used the point benefits estimate was $300 million dollars.

Our last assumption was that two thirds of all the benefits of disease management that come specifically from using ICD-10-CM accrued to diabetic patients. By contrast the code expansion from coronary disease was modest and the same applies to asthma. Our final estimate range therefore was $200 million dollars to $1.5 billion dollars. As noted there are an additional four categories of potential benefits that we could not estimate very well, or in the latter cases even determine whether they were at all significant, but for fairness they should be presented.

Therefore, category of six, better understanding of health care. The tens of millions of annual hospital discharge records should hold enormous potential for assessing the relationship between health care and outcomes. One prominent researcher observed that ICD-10-CM had the potential to say a good deal about the quality of care and its codes so that data could be used in a more meaningful way, enabling better understanding of complications, better design of clinical robust algorithms, and better tracking of the outcome of care. Nevertheless, several factors should be included when thinking about this benefits. Studies that infer conclusions from hospital discharge statistics are limited in their ability to control population samples or data quality. Furthermore, some of the gains from having finer distinctions are vitiated by the smaller population sizes within each category, which in turn erodes statistical significant. Indeed, many researchers agglomerate information to super categories, not only to create statistically significant sample sizes but to avoid the misleading effect of minor coding errors or coders unwilling or unable to make the fine distinctions that ICD-9 already allows.

Last, hospital discharge datasets alone do not say what happened to the patients after the discharge, how long they lived, how they fared, or whether they reentered the hospital even if it’s the same hospital. There are two ways around the problem. One is that AHRQ maintains a database with ID numbers and if one can get permission to access such data, which a few but perhaps too few researchers have, more follow-up information would be available. Two is that payers and data consolidators that work with payers have access not only to names but to inpatient records as well. Mining such data has already generated useful conclusions about procedures such as coronary artery bypass grafts. On that greater specificity has to be understood to be beneficial but exactly what we will learn from greater specificity is extremely hard to forecast with any confidence. For instance, it is altogether possible that ten years later we will look and say this fact we learned because of greater specificity, and that fact may in fact account for more then half of all the benefits from medical research that have been aided by greater specificity. But that’s an extremely difficult statement to make looking forward and therefore extremely difficult to put a number on that kind of conclusion. Such uncertainty typifies all serious research and all serious attempts to measure research.

Category seven, fewer erroneous claims. Now I had talked about fewer claims that were sent back and fewer claims that were questionable. These are simply miscoded claims that have no other implications other then random ones. The cost of reducing random error is difficult to put a number on without knowing the consequence of such errors. If errors that are not caught result in erroneous payments and such uncaught errors are randomly distributed, in other words people are as likely to over bill as under bill, then the effects washout entirely. If errors are non-random, but not large enough to bias a provision of medical care, the payers’ gains will be the providers’ losses, or if it turns out to be the other way around, vice versa. If the errors are caught the result is likely to be a returned claim, the benefits of whose reduction have already been estimated. Therefore we did not put a number on fewer erroneous benefits, but one has to believe that fewer errors is a good thing.

Category eight, enhance the ability to evaluate providers. One could analyze hospital discharge statistics to gage the ability of various providers to undertake specific procedures or respond to diagnoses that were previously lumped in with others. But one is doing is taking existing data and parsing it finer, bringing statistical significance from such additional information is very difficult when no one provider accounts for more then three percent of the U.S. patient population. In other words to evaluate providers you have to basically say using this procedure how well did they do. You can evaluate it against a total corpus of procedures if you had the data but any one provider only provides on average at most three percent of these procedures, so you have a real problem with statistical significance when you evaluate providers that you don’t have when you take a look at the nationwide database in a particular procedure.

There is an alternative, one might choose to aggregate all new procedures performed by a given provider for analysis. That would generate perhaps statistically significant data but its unclear whether this would generate meaningful data. It is also possible that finders diagnostic and procedural codes could be used to better norm the patients that providers treat so that one understands that hospitals and other providers that have on average, that have sicker patients on average, would have that fact recorded when it comes times to evaluate quality of care. Unfortunately ICD-10-CM’s contribution to indicating severity is slight. We therefore conclude that the measurable benefits from greater specificity when it comes time to evaluate providers is likely to be quite modest.

Category nine, more timely intervention for emerging diseases. It is also theoretically possible that more precise categorization of diseases could help the public health community detect emergent diseases, including bioterrorism, faster. If better diagnostic codes could improve the odds of even by a few percentage points of heading off the next SARS like disease the switch could pay for itself many times over through that benefit alone. SARS is said to have cost the Asian economy over $11 billion dollars and SARS had not run its cost at the time that estimate was provided. Similar benefits may come from being able to spot clusters of diseases that might be traced to environmental or occupational conditions. But that noted, ICD-10-CM was not designed for syndromic surveillance and access to hospital discharge records would have to be accelerated to provide for timely intervention in case of a fast moving epidemic.

Finally, if switching to both ICD-10-CM and ICD-10-PCS is warranted, is it better to do both at once or one after the other? Many witnesses to the NCVHS and its subcommittees and those we interviewed shuddered at the cost of trying to implement new codes before they had finished complying with HIPAA requirements. But no one who testified or who interviewed suggested it was better to implement the code switch sequentially. Canada, which also implemented changes in both diagnoses and procedures, did them together. There are several reasons that switching both at once makes sense. It is easier to get people such as coders mentally prepared for a major change once rather then twice. It is also more efficient. Training only has to be done once. It is easier to review a complex billing software system where ICD-9-CM is used and has to be replaced then it is to do it twice, first for volumes 1 and 2 and then for volume 3. Simultaneous change means testing only once. Dealing with transition issues such as getting through the errors of miscoding or misinterpretation again is best done all at once rather then in two periods separated by months or years. People can focus attention and resources on the process of making a smooth changeover and move on. Finally, the long awaited DRG’s, dependent as they are on both diagnosis and procedures, would have to be further postponed if it had to wait for first diagnosis and then procedures to be revamped.

We have endeavored to estimate the cost and characterize the benefits of switching from ICD-9-CM to ICD-10-CM and PCS but in concluding we thought it would be helpful to introduce a broader perspective of the discussion. At almost a trillion and a half dollars a year the U.S. health care industry is enormous, it would not take a very large percentage shift in its efficacy or efficiency to make the kind of economic difference that would easily swamp cost estimates that are made in the hundreds of millions of dollars. Nearly every other industry has found that if it wants to get on a program of a continuous process of improvement it has to start by measuring input and particularly output. Only after such measurements can alternatives be systematically compared. As an industry it’s fair to say that the health care sector has been laggard in this approach, leaving room for improvement. As such the use of codes, or at least the information contained in these codes, is central to the measurement process and hence central to the goal of continuous process improvement. Anything that improves such codes provided that they contribute to good measurement cannot help but have positive long term ramifications. But all this is predicated on the idea that we know what we want to measure to improve outcomes and how we want to measure them.

Many people we have talked to had done quite a bit of thinking on this score. Patient safety advocates laud the present on arrival adjunct to diagnosis as for from hospitals in California and New York. In other words when you discharge somebody from a hospital and you go through the various diagnoses you ask yourself was this diagnosis present when the person entered the hospital or did this condition arise after somebody entered the hospital.

Those who measure patient quality of care are interested in whether providers comply with HEDIS standards, in other words are ace inhibitors or beta blockers given to heart attack patients within the first 30 minutes in an emergency room is one such measure. Others had noted that they would find indicators that differentiate diagnoses by severity to be quite useful. In many cases severity can be directly indicated through laboratory test results, such as HBA 1C for diagnosis or creatinine for kidney conditions.

Overall there are good grounds for believing that there will be benefits, which we estimate to be $700 million to $7.7 billion dollars over ten years, and that these benefits are likely to exceed the initial break in costs of $425 million to $1.15 billion dollars within a few years of when the code is adopted. What ICD-10-CM and PCS permit is a considerable expansion in what we can know about the health of a population and the care it receives. The extent to which this information will be properly and intelligently exploited is hard to gage at this point, but the potential gain is large if the opportunities are taken.

DR. LUMPKIN: Questions? Kepa.

DR. ZUBELDIA: Thank you for the report, I think it’s a very interesting report and you’ve done a lot of work, I want to thank the Rand Corporation for doing this work. I have a question about, perhaps it’s related, but the lack of CMS information and how could that be assessed rather then just estimate the cost is going to be such, there should be also some benefit for CMS, and there should also be benefits for payers. The concern that I have is that it seems that the study is looking at the benefits from the statistical side, the top three benefits are related to claims payment, but it doesn’t seem to look very far into the costs for payers. And let me give you some scenarios, the payers are going to have to redo their coverage plans and renegotiate the coverage plans for the employers as to what is covered and what is not. They’re going to be have to redo the DRG pricing, every single reimbursement schedule is going to have to be redone. And the potential there is that perhaps it can be done as a probably neutral change, but that’s going to be a substantial disruption to the payment system and I don’t see in the study the costs related to these changes in the payment system. Is that something that you’re planning to do as you continue and finish the study?

DR. LIBICKI: Well, let me kind of address your questions in order. In terms of CMS, when we talked to CMS, I think in the May/June time period, they were about to start studying what their costs were going department by department, so I have to believe that numbers from CMS will be available if they’re not already available from CMS directly itself. In terms of the benefits to CMS from this we did not identify any as such, mostly because we were concentrated on what decisions would change as a result of better information. Not to wax terribly philosophical about this but what you end up with when you change information, when you get better information, is you end up changing decision. If you haven’t changed decisions you really haven’t gotten a whole lot of benefit from changing information, so the difficult part was to try to say okay, which decisions actually get changed and that was the basis of our estimates, is to try to identify okay, we do procedures differently, we do procedures, when we don’t do procedures, we are able to expend less manpower in evaluating, in going through claims, etc., which by the way gets to the second question, which is to say the benefits to the payers. If the payers start getting better data from providers presumably they will not have to do as much work in order to adjudicate claims and that will save them costs, I mean it will save the entire system costs but they will be the first people to get the costs.

Now the last question you have raised is a rather, is a trickier question entirely and there are two aspects of the question. One is how much work is it going to take in negotiation/renegotiations and the second is what’s going to be the impact on the payment schedules. The quality of negotiation/renegotiations actually almost entirely falls on ICD-10-CM, not PCS, and the reason is because if you wish to for your own purposes say okay, here’s a condition in ICD-9-CM volume 3, and I don’t want to change the rules, it is not in my benefit, it is in my benefit to make the least possible changes, then you have 10-PCS things you can crosswalk into easily, because there’s just so many 10-PCS codes and you do a one for one substitution. Where you cannot do a one to one substitution very easily is in ICD-10-CM because you don’t have a one to one relationship and then you’re basically looking at where you have the mismatch, because you are going to have some one to ones and not one to ones. Okay, so you have to take that into consideration.

The second thing one has to take into consideration, particularly when it comes to DRG’s, is we’re talking about a process that takes place over a multi-year period under which you’re going to have to have renegotiations anyway. I mean I think it’s unrealistic to say on the first of October the year 2006 everybody goes into renegotiations, there are various cycles, people are going to anticipate them, some people have annual renegotiations, some people do things on two or three year periods, and some of that can be folded in. Now, if it turns out that a payer says you know, now that we have all this greater specificity I don’t want to pay for this or I’m willing to pay for that, that’s a different issue but then I have to assume that the payer benefits directly from that negotiated change and therefore on net has to be a beneficiary on that basis.

When we talked about methodology back in May that was one of the basically the assertions I made in terms of how you do a cost/benefit analysis. In other words, and this is going to sound silly but it really works out this way, if as a result of new information you do something smart, that’s a benefit. But if as a result of a new information you do something which ends up being dumb, that’s not a cost. It sounds strange but that’s the way we deal with the economics of information, that’s kind of how it comes out.

DR. LUMPKIN: Simon.

DR. COHN: I’ll have to think about that last comment, I’m not an economist and I don’t play one on TV either. It’s almost a follow-on with Kepa but first of all I want to thank you, I think this report is getting much better and really appreciate the way you’re beginning to put sort of bounds around the issues where I did notice in your presentation for the first time began to posit at percentages of costs by payer, provider, hospital. I didn’t hear the same thing, and maybe I just wasn’t listening closely enough, around the benefits. Did you parse out the benefits similarly?

DR. LIBICKI: The benefits, can I parse out the benefits, short answer, no I didn’t parse out the benefits. And the second reason I didn’t parse out the benefits is something called flow through. In other words if as a result, if payers can more efficiently process claims does that become a profit to the payer or a lower cost to the, if XYZ payer now saves $10 million dollars because they can process claims more efficiently, does that mean that XYZ company makes $10 million dollars more worth of profit? Or does that mean on the next cycle they can hold down inflation and reduce costs by $10 million dollars? Unless you know those subsequent decisions you don’t know who the ultimate beneficiary is and therefore it’s safer to basically say there was just a total benefit without having to make that overall statement. On costs at least it’s possible to be more specific on the first order of how costs are allocated because you see direct payers on that. Let me give you another example. I am a patient that gets a $10,000 dollars procedure that I wouldn’t have gotten because now we understand the benefits of the procedure. We will make for assumption sake that I get $15,000 dollars worth of benefits from that. On the other hand, so I’m $15,000 dollars better off but then somebody has to pay for the $10,000 dollars, it’s either my employer or whatever, actually in this case I suppose it would be CMS, so CMS is $10,000 dollars worse off. And it goes on and on and on, what economists call the incidence issues are subject to a large number of further assumptions but they don’t enter into the total if you just have to make an overall guess of cost and benefits. In other words without worrying about who pays for it you at least can conclude that somebody pays for it and it turns out to be a cost.

DR. COHN: Can I follow up on that, certainly if you have thoughts about how we can begin to look at that because certainly there are things we’ll have to think about, is that we now know how the costs break down, the question is is do the benefits accrue to the same groups or is there a disparity there, so any thoughts you have on that will be helpful. I read through your document, obviously a number of them as you’ve draft them, and you made a comment just now about this issue about how costs get transferred and what gets reflected in there. One question I have had and I don’t know how this reflects in your transfer payment model, and maybe it’s the same question that Kepa was asking, but on a more global view there’s, given a new codeset coming in or new codesets coming in that somehow out of that implementation, and lets just sort of posit that on one hand global health care inflation for whatever reason might jump at some point, on the other hand it might increase at some point, and that we were somehow knowing that there are 12 different reasons why that might happen but say we were able to posit some relationship to the introduction of the new codesets, how would you, I mean is one considered and the other one not or are these things that are costs in the system in your model?

DR. LIBICKI: If you were to go back statistically and look at sort of the prices of services and you say ah ha, this changed because of ICD-9/10, only under the case where you could point to a change in the DRG and say ah ha, they now cover this and I can trace this through is it possible to actually make a statement like that. But if you don’t have changes in the DRG’s or you have many changes in the DRG’s, some of which cancel each other out, when we talk about a $1.4 trillion dollar industry to find the effect of several hundred million dollars worth of costs is statistically impossible.

DR. COHN: So it would have to be a major differences --

DR. LIBICKI: Yeah, that’s right, because you have so much variation from one year to the next coming from so many different issues. If I may go, I think the Latin term is ex cathedra, on a further point, a lot of cost/benefit analysis starts with the assumption that you already have an optimized system, and then it makes a change to that system and say okay, this system is already optimal and then how are the costs and what are the benefits relative to that optimum. But there are a lot of people, and I don’t want to get into this issue except to mention it, who suspect that the medical reimbursement system is not optimal today and therefore changes to that system may in fact move you farther or closer to this optimality. But to do that I would have to go into are patients getting the right care, are we having too much care, too little care, etc., and we would have ended up with a much larger study.

DR. LUMPKIN: Michael.

DR. FITZMAURICE: I want to follow on what Simon said about the distribution of costs and the distribution of benefits. I find that the same incident assumptions hold for benefits as for costs, for example, if the health plan incurs $1 million dollars in costs from implementing ICD-10 does this reduce that health plans profits by $1 million, or does it result in higher premiums by a million to its payers of the health plan premiums, or somewhere in between, with any kind of incident, instead of zero to 100 percent, it’s somewhere in between. Likewise the same thing with benefits so I think you could have looked at the initial incidence of costs as you did and also the initial incidence of benefits but realize that over the long run markets will play out and we don’t really know how it’s going to play out.

DR. LIBICKI: That’s a good point.

DR. LUMPKIN: Okay, we have time for one more question and then we’re going to take a break. Peggy?

MS. HANDRICH: I’d just like to put on the table that at some point, either in this study or as analysis of this issue moves forward, that the estimate of the impact on CMS must include Medicaid. And I think when you talk about CMS you’re thinking Medicare and states contribute to the cost of Medicaid programs, they run their own fiscal intermediaries and the cost to states to make such a change, I just think needs to be more thoroughly investigated. Likewise I would encourage us at some point to give some consideration to states in general that operate data repositories that have public health data functions and that use health data for the purpose of state health policy development. And I just don’t see that being addressed in any way.

Kind of moving from the philosophical plane that you were just one to a more practical level, I think the bottom line issue from state Medicaid programs perspective will be with more opportunities for refined coding, how can it possibly be anything but inflationary. States have their own coverage policy, they have their own reimbursement policy, they have their own service limitations, but they do in many cases build on Medicare policy and I think that will be from their perspective their biggest worry. And in spite of all that you’ve said I don’t know that you’ve made a compelling case that that kind of inflationary spiral that would be invited by having more codes to bill could somehow be controlled.

DR. LIBICKI: People we’ve talked to expressed opinions on both sides of that one.

MS. BROOKS: I can address your question about the impact, that CMS is doing a study right now, we’re right in the middle of it, and all parts of CMS are being asked to evaluate their costs so that includes the Medicaid part as well as Medicare, so the entire agency is in the middle of this right now. I can’t give you a time when it will be completed but a lot of the work has been done and we hope to have a report out very soon.

DR. LUMPKIN: Let me see if I understand because Medicaid actually is a shared program and the highest level of match, which my former state was the unfortunately recipient of, is 50 percent so actually the bulk of the costs are borne by CMS for Medicaid expenses, and MMMS changes are also reimbursed at an accelerated rate. So I think it’s very appropriate that we need to look at the balance of the costs --

MS. HANDRICH: If I may just react to that, that may be the case but there is state match and in the current circumstances states capacity to heighten state funds available for systems changes or for reimbursement changes is limited and it might even be fair to say it rates from awful to really terrible.

DR. LUMPKIN: I’m not going to ask you which one you’re in. Jennifer.

MS. MADANS: A quick comment. I’m certainly sympathetic to the difficulty of trying to estimate a benefit, for example, for the research component. I think the same is true for the statistical component of this which I don’t think was really dealt with on the benefit side and maybe can’t be dealt with in some kind of quantification but I think these, the records that these codes are imbedded in are a big part of the statistical system that we use to monitor what is going on out there and even if it’s just in verbiage I think that has to be in there even if it’s an unmeasured benefit.

DR. LUMPKIN: Thank you. We’re going to take a 15 minute break and then we’ll resume.

[Brief break.]

DR. LUMPKIN: Let’s get started. Before we get started with the panel Simon Cohn has asked for a point of special privilege to make a motion.

DR. COHN: Yes, well actually, well first of all we actually have Jared Adair present and I just want to take a moment, I think as you all know that she’s been really the shepherd not only of HIPAA over recent years, CMS, but at least from our usually important and maybe more important Consolidated Healthcare Informatics Initiative, she’s going to be retiring at the end of this month, I personally am very sad, it’s been wonderful working with her and I think I speak for certainly the Subcommittee on Standards and Security, I’m sure for the full committee, in terms of her devotion and work to things that we’ve all been trying to make happen for many years. So I want to make sure that everyone has a chance to acknowledge her and thank her and obviously I’m going to be making a motion for us to write a letter to her expressing our gratitude and thanks for her exceptional contribution.

DR. LUMPKIN: It’s been moved that a letter be written and the procedure that I think Simon made in his motion that it would then be reviewed by the Executive Committee and sent as soon as that’s available.

DR. COHN: Hopefully before she retired, which is very quickly.

DR. LUMPKIN: Is there a second?

MR. BLAIR: I will second the motion.

DR. LUMPKIN: Been moved and seconded, is there a discussion on the motion to send a letter and the procedure for the adoption of the language of that letter? All those in favor signify by saying aye.

COMMITTEE: Aye.

DR. LUMPKIN: Those opposed? Great, thank you.

[Applause.]

MS. ADAIR: It is probably inappropriate for me to say, but appropriate has never kind of stopped, I would thank the NCVHS for their support of our initiatives and the tremendous work that they’re doing to help us move these things forward. CHI is, the success of CHI is due in large part to your assistance and thank you, thank each and every one of you personally, also for your support as we moved on those activities. It has been my privilege to work with you and I thank you for your support. Thank you.

DR. LUMPKIN: We’re now going to move on to the panel of reactors and lets see, you’re not sitting in the order in which I have on my list, so if you would please get up. We’ll see if you can introduce yourself and who you represent, we’ll go down the list and then we’ll start off, was there an order that, maybe we’ll just go in the order that it’s printed on my list even though you’re not sitting in that order.

MS. LEON-CHISEN: Nelly Leon-Chisen, American Hospital Association.

MS. PROPHET-BOWMAN: Sue Prophet-Bowman, American Health Information Management Association.

MR. SMITH: Merit Smith from the Robert E. Nolan Company, talking for the Blue Cross Association.

MR. GUSTAFSON: I’m Tom Gustafson talking for the Centers for Medicare and Medicaid Services.

MR. BEBEE: Michael Bebee with the American Medical Association.

MR. STAEHLIN: Marty Staehlin, Price Waterhouse Coopers as a consultant to the American Medical Association.

DR. LUMPKIN: Great, why don’t we start off with Michael, he’s first on my list.

Agenda Item: Reactor Panels to Impact Study and other Studies - Mr. Beebe

MR. BEEBE: That’s the benefit of having the B I suppose. I’m glad to see it spelled correctly, I guess if you appear before the committee enough you get your name spelled correctly.

Thank you for having me back again, I appreciate it. What we’d like to do today, I’d just like to give a brief introduction to Marty Staehlin and he can get through the details of the cost/benefit study that we, rather the cost study that we had commissioned. The study actually, the formal study presents three cost scenarios, cost involved with CPT as the single procedural codeset, ICD-10-PCS as the single procedural codeset, and then also basically a replacement of the status quo scenarios which is replacing ICD-9-CM volume 3 with ICD-10-PCS. This is the study we commissioned. Today we will only be discussing the third scenario, which are costs associated with replacing ICD-9-CM volume 3.

Briefly, a historical perspective on this, the AMA has been involved with ICD-10-PCS for quite a while, it seems a bit of my adult life at this point. The AMA as the developer and maintainer of CPT has been involved in monitoring ICD-10-PCS as part of the technical advisory panel in 1996. We also contracted with Aspen Systems Corporation in 1999 to evaluate the technical attributes of ICD-10-PCS. We presented testimony at the ICD-9 Coordination and Maintenance Committee, and at this committee, the NCVHS Subcommittee on Standards and Security, regarding technical limitations and costs associated with implementation of 10-PCS.

Our testimony was generated from extensive experience as a codeset developer, but also from the work that Aspen did. And the basic kernel of our arguments in past testimony has been that there are serious technical limitations. That there was significant physician and other health care professional services that are not included in 10-PCS. That the terminology does not conform to traditionally named body systems or procedure descriptions that are commonly used by physicians that they’re familiar with. That there are multiple codes that are needed to fully describe commonly performed procedures and this has the potential to be confusing. And that the procedures cannot be fully understood without reference to diagnosis. We also went through implementation issues such as education issues, system issues, reporting and payment issues, and maintenance issues, all of which relate to cost.

As I said, the current Price Waterhouse Coopers study in ICD-10-PCS was intended to build on our previous study, 1989, when I was in college, 1989 study, which looked at the single procedure costs of theoretical new single procedure codesets. It also is building on other previous studies in this area, such as the 2000 WEDI white paper and the 2002 GAO report. We also wanted Price Waterhouse Coopers to consider the current regulatory context, i.e., HIPAA, the existing codesets in this area, ICD-9 and CPT, and also the health care payment systems in which codesets are used in their analysis of the three scenarios.

The Price Waterhouse Coopers study only looks at implementation costs, it doesn’t look at technical limitations, certainly these limitations effect educational and systems costs. Although the costs of a single procedure codeset were studied by PWC the AMA believes that the committee correctly limited the Rand study to examine costs associated just with the replacement of ICD-9 and as such that’s all we will be discussing here today.

Before turning this over to PWC I just want to direct the committee’s attention to a letter that’s been signed by many national medical specialty societies, and this letter supports the idea of replacing ICD-9 with ICD-10-PCS only, following along the rationale that ICD-10-PCS was developed as an inpatient hospital coding system only and is not suitable for physician services.

So with that, I will turn it over to Marty Staehlin.

Agenda Item: Reactor Panels to Impact Study and Other Studies - Mr. Staehlin

MR. STAEHLIN: Thank you, Michael. Somebody earlier said that information is expanding exponentially, unfortunately my ability to retain information is not expanding at the same rate, so this is a cooperative study, it was done by a number of people and I am here representing the study to give an overview of it and to answer questions as might arise. I have seen copies around so I think most of you if you haven’t read it you at least have a copy of the study and so the alternative that I’m going to be addressing today is basically in section four and it starts on page 38 and talks about the alternative to a single procedure coding system with option of ICD-10-PCS for hospital inpatient services only.

The study goes through some of the general benefits, it talks about key stakeholders, third party payers, third party administrators, that list is on page 38 and 39, and our study followed some of the same guidelines that were addressed in the Rand study, it was done by a literature search, it was done by interviews, and it was done by general following of testimony and talking to a number of the stakeholders. We did not include a list of actually the people we talked to, a lot of people are at different levels of developing the costs of some of these impacts and really did not want themselves alluded to more from the fact that a lot of these costs were under development but they had the templates for what it would cost and how it would relate to other similar large projects such as Y2K and HIPAA implementation, they are in the middle of that and have fairly good cost estimates for how much training is involved, how much systems implementation is involved, and how much software cost is involved.

Before I talk a little bit more about what the study did do, I should say some of the costs that were not quantified, and it’s hard to quantify turmoil, but one of the items that was alluded to, there really needed to be a date when everybody did a major coding change at the same time, and if it’s phased in any regard there may be ways to measure what those ripple effects are but you really haven’t measured the turmoil, the redo, the argument about what a code actually meant, so that cost is really not in here. The other thing is there are, we believe there are significant costs for contract renegotiations. I think a lot of people if you looked at your provider contracts you would see that there’s a schedule, so it’s a really big contract and then there’s a schedule page and you just drop in a new schedule page. Well, if you’re doing a major contract negotiation or a change you would have to read the whole contract because sometimes what you need to do is learn how to pay for things that are specifically specified or if a change happened. So the majority of the contract renegotiations is actually looking through the whole contract, not the time it takes to insert the schedule A that has the benefits. So there are also triple contracts, so where you have situations such as ASO or ASC, which I’m calling, it’s called Administrative Service Only contracts, or Administration Service Contracts, where there are really three parties together making a contract, so it is an employer who hires a health payer to basically do the financing of their benefit payments, happens mostly in the large employer area. You really are asking a payer to just pay your claims, now it sounds really simple but you’re asking them to pay the claims and then they need to negotiate with all the providers and set up those provider networks to get that job done. So there’s kind of a three fold contract situation there, that they’re just paying your claims but they’re supposed to be some understanding about what your claims means. So any change like that actually requires more contract negotiation then we actually measured in this study.

So with those as some caveats I’d like to talk a little bit about the advantages and the disadvantages that we saw of this change, those are listed in the report on page 44 and 45. Generally the advantages fall into the area of flexibility and patient profiling, is that the new system will be more flexible and some benefits will accrue to that and there was a lot mentioned in the Rand study about how you may better be able to track patients and what might happen in the disease management area. We did not look at any of the benefits, but those clearly could be some of the advantages.

Some of the disadvantages, however, and this got to some of the interaction with the GAO study, which was issued in August of 2002, saying that there should be no problem going forward, it’s a long study, but generally what it said is there should be no problem going forward with the status quo in the two areas, that CPT would follow physician services and ICD would follow hospital services with some caveat. And what we’re saying in our study and what was confirmed through literature search and through the additional information that we gathered from the interviews, and we did a lot of literature search around IT costs and with the GAO study, excuse me, that the disadvantages had to do with training, continuity of data, and systems cost and systems testing. And the other thing that I might mention that the study really couldn’t quantify but that you should be able to see in the comments that are categorized in the study, is that a lot of people are not anticipating converting data. They know that when a new system occurs there’s going to be a lot of difficulty, the data for converting more then a short dataset for continuity, sort of like IBNR, so that’s incurred but not reported claims, so you could at least figure out what you need to do on claims that are paid after the date something changes but actually were incurred prior, they are not going to do large dataset conversions so having a timeline of consistent data, at least our indication is, that’s going to be largely impaired by that large change which will again create turmoil that was not able to be measured at the present time.

So what we’re measuring is the training, the systems cost, the documentation and the contract negotiation largely. That again integrates and follows from the GAO study, which talked about the practical constraints to a single procedure codeset, and follows a little bit and fits into us just measuring well what would be the change if you just changed from ICD-9 to ICD-10, again, we just did the procedural codeset because that’s what our former study did and that was an update of our study.

And if we look at now a review of the cost impacts, which is in appendix three, exhibit three which as Michael said there are three parts to this but this morning we’re only addressing one of them. I should also say that appendix two was a data link to the former GAO study for those of you reading the report, but since we did it in PDF form you can’t see the link, but Michael told me most of the committee has seen that study or has it available to them.

So appendix three was then trying to do the costs of updating the study that PWC, then CNL had formerly done. And what these pages are in the appendix is it’s the summarization of the cost models that we have created and it’s a quick picture of the prior study for basing and then to get the data updated to a current basis. And so we measured some econometric updates looking at the shape of the health care system in 1989 and now, and attempting to get the data from the prior study update it to current, looking at the way it was developed in the past. We are assuming that these will be sort of ready to go so that they won’t be in development phase when it happens and that’s what it sounds like was earlier alluded to, so that they would be ready to go and hit the ground and start. And that the costs associated consistent with the past study was $178 million dollars, approximately $200 million dollars.

Now when we talked to a number of people they indicated that well, the previous study and the models that we had were not consistent with today’s data environment and so the training costs, the systems development cost, the software development costs, and the contract renegotiations would really create a multiplier effect. And so what we then did is we have what’s called cost impact but then we attempted to develop a full cost impact and that is detailed in section seven of the report and I just want to touch on some of the issues that were talked about here. We tried to frame the size of the insured health care market, the total costs and benefits of this will certainly as people have said effect Medicare and Medicaid, and that is something that also has to be considered.

But we were also looking at it from the perspective of what would it do to the rates that are charged people and so we were trying to get it framed as a percent of the insured health care costs because to the extent it would be measurable it would be an impact on the health care system, which is currently experiencing a lot of difficulty. We also tied in a cost to one of our, I don’t know why they’re called sister organizations, but anyway, E&Y, Ernst and Young, they’re a consulting firm, has done a lot of IT consulting, and what has happened is that the imbedded costs of care are really a little bit out of control as a result of the larger data projects that are being imposed on the health care system, such as Y2K, such as HIPAA, such as transaction codesets, and anything that would happen is that no one can ever catch up and have a status quo, so you can never have calm water so you can see what’s going on, you’ve always got ripples and you’ve always got waves, and it’s really hard to get that status quo to measure. And as I said a lot of the stakeholders will not convert large volumes of datasets, for those of you that do data you probably ought to have two years of data just as thinking about health care, when we do consulting in health care they’re like well, it’s not the same this week as it was last week but in any case you need at least some time horizon and two years seems to be reasonable so that you can access seasonality. Any time you look at less then a two year period you could be plagued by some seasonality patterns and that would actually plague the different stakeholders differently, so Medicare and Medicaid and commercial insurance have very different seasonal patterns.

So without that timeframe and all these data projects it’s creating a lot of turbulence and that’s what we were trying to assess in section seven, again because some of these issues are evolving a lot of the people we talked to did not have a template that they were willing to send me, or send PWC, but through discussions through these interviews we created templates, we attempted to assess the impacts that were categorized for us on these phone calls and create this multiplier effect which as we have said in section seven is basically due to training and education, contract negotiation, and the use of data, not only is the conversion important to happen uniformly on one day just so everybody can be on the same page, but there are a lot of third party payers and users of data and the health care system goes through cycles of taking things inside and then taking things outside, and so you have a lot of vendors that become specialists, that has happened in pharmacy, through PBM’s, pharmacy benefit managers, it has happened in mental health where it used to be included and now it’s spun out, so there are good things that have happened with care being spun off and there are poor things that have happened, and so there are a lot of third party users of data and so people will be using datasets and will be partnering and they all have to be on the same platform.

The other thing that I would mention about these multipliers is if you would read some of our study you might say well wait a minute, you had training and education and now you’ve got training and education again. And some of the training and education that we’re measuring in this multiplier effect is really the process maps that are needed in businesses because they use health care payers but also providers. They use these codes to do a lot of their internal processes, they don’t just adjudicate or pay claims, they use them to figure out strategy, to do planning, somebody talked about information management and reporting, and the report generation, and the reports that are sent to people, will all have to be retooled so employers, especially large employers, these ASO and ASC accounts that I talked about, they are interested in getting detail on what is happening to their people so they get reports that are the top 50 diagnoses, the top 50 physicians, the top 50 hospitals, and what they’re doing and why they’re doing what they’re doing. And so it’s not just that the code changes, it’s what the outcomes and what the codes means on the reports that you send to all these people, and all these process maps will need to be redrawn and so there’s a lot of training and education involved in that.

So with putting that into the template that we had, doing approximate hours, numbers of payers, updating the data consistent with the study as it was done before, we created a full cost impact that attempts to gage the effect of this multiplier effect, and that is on appendix four, exhibit three, which looks just like appendix three, and that is judged to be $1.1 billion dollars. So this cost that we have assessed is somewhere between $178 million dollars and $1.1 billion dollars.

And with that that really concludes the point of my presentation and the rest of the results are really in the study for your reading.

DR. LUMPKIN: Great, thank you. Merit Smith.

Agenda Item: Reactor Panels to Impact Study and Other Studies - Mr. Smith

MR. SMITH: Thank you for having me here, I’m Merit Smith, I head the Health Care Practice of the Robert E. Nolan Company, we’re a specialized management consulting firm that works with health care organizations on service cost and quality issues. The Nolan Company’s clients include health plans, insurers, payer organizations, hospitals, third party administrator, systems vendors and other health care entities. I think you’ll see in our discussion that in contrast perhaps to other witnesses we have kind of an operational focus rather then a policy focus.

We were asked by the Blue Cross/Blue Shield Association to look at the costs, benefits and operational implications of changing from ICD-9-CM to ICD-10-CM and PCS. And we did secondary literature search, secondary research, we did primary research, we looked at experience in other countries, we did a large number of interviews frequently kind of in in depth multiple times with selected people that were likely to be involved in implementing the change. Most people were operations and IT staffs of payer and provider organizations, health plans, insurers, system vendors, third party administrators.

And our process was benefited by a review mechanism that involved professional groups, some quality assurance groups and some interested parties. Our work was funded by the Blue Cross Association but they really haven’t influenced our conclusions or edited our results. What I’d like to do is go through about five or six things that we found.

The first is that there’s a low level of awareness among the people that are going to be involved in making this change, so if you get much beyond the Beltway or much beyond the folks that have been engaged over the many years that this issue has been in play this issue frankly is not on their radar screen, they’re just not aware of it. They are consumed with this thing that’s going to happen in October, and it has their attention and it’s going to have their attention for the next six, 12, 18 months depending on how well October goes. So they’re just not aware of it. Interestingly we talked with professional associations to kind of see where they were and to understand their point of view and what we found was that many of them were not following the issue, did not have anyone formally assigned to it, didn’t have a formally articulated position, and weren’t conducting awareness building activities with their members. So among many of those people that are going to be involved in this there’s just a low level of awareness.

The next thing that we found is that in addition to that low level of awareness among many of the organizations there is a low level of organizational and technical readiness to make substantial change, they’re just not ready to do it. Again, they’re consumed with the codeset change and getting through privacy. Many of the smaller organizations, and we’re talking about billions of dollars and hundreds of millions of dollars, but for many of these smaller organizations they’re just financially strapped and the numbers when they translate down to them they’re a burden that laid on top of the other changes that we’re having to do just really puts them in a very difficult position. They’re worried and they’re leery of this and they are just having trouble kind of digesting all of these massive changes.

They’re also dealing with the fact that many of them have purchased triple compliance system solutions from system vendors. Now the purchasing of that and the receiving of it are different things and right now they’re discovering that and we would expect from that disappointment, that as they approach something like the change to ICD-9 to 10 that they would be hesitant, having once been disappointed, they would verify and test and be very careful with those. But regardless of where their vendors are in their readiness to help of them any of these changes require substantial expenditures in the items that you just heard about, and these organizations frankly aren’t ready to do that.

We also found that as we talk to people and as people just discussed this we kept hearing again and again that they bookmarked the issue between Y2K and HIPAA codesets, they just naturally frame it in that way and they talk about it in that way and they dimension it in that way. And as we begin to understand that that makes a lot of sense because they have to do many of the same things in terms of project planning and the sequence that you go through and training and system remediation and all of those items. So that makes sense to bookmark it in those issues. It also makes sense as you think about it in your organizations that you’re going to have somewhat the same range of expense for those.

This change if good really is going to take tens of thousands of man year, people year, very large multi year event, that same order of magnitude of Y2K and the codeset. Implementing this change is not simply buying crosswalks and updating software from vendors. It involves testing, validating, verifying, becoming refamiliar with the data that you’ve been using. In hospital based organizations we anticipate that the change would cost more then the HIPAA codeset appears to be costing and less then what Y2K did.

We were asked to look at benefits and we went out and did that by looking at the arguments for certain people that seem to be proponents for this kind of change. And what we found was that although the benefits of a change were be asserted they weren’t being demonstrated in any kind of quantifiable way that could be validated and tested. So it seemed to us that those benefits were quite speculative and we had some difficulty working with that and I think other people have found that same issue.

Then as we thought further through that it became hard for us to see for many of the benefits how making the changes would actually lead to the benefit. It wasn’t necessarily clear that you could see if I change this that I’m going to get that benefit. And I’d like to use a graphic at this point if I can get technology. This is a flow of clinical information and this diagram seems to help these discussions a lot and actually this is derived for some work done by a Professor at Alabama Medical School, Dr. McMullen(?). What it says is that there’s a sequence of events that occurs, a clinical service is being delivered and then at that time or shortly thereafter the clinician terms them, describes them in some way, and later that information is extracted and encoded and then used in a variety of clinical and administrative processes and procedures, my favorite being the bill, which in our system flows money between parties. In a lot of cases there’s groupers and some of these groupers may be ASO contracts, they may be DRG’s, all kinds of groupers, they may be benefit structured, you can think of them as a group. But if you understand this flow, the sequence of events, clinical service, terming, coding, and grouping, and start to think about where the benefits actually start to drive, it kind of changes thinking about coding. And there is a fair amount of literature that talks about the importance of terming as the source of benefits.

I’m not a physician, I think you can tell that, I’m not a lawyer and an economist either, just kind of help health plans and hospitals work through operation problems, it seems that if the physician or the clinician delivering the service can’t describe it it’s going to be difficult for coding and grouping to make up for that. So this is a model that we ended up using in a variety of settings.

In many cases we came to a kind of conclusion that those projected benefits, or the anticipated benefits, and you didn’t have the benefit frankly in the kind of modeling that Rand has been able to do, represented leaps of faith and it seemed from other experience and other countries have gone through this that their experience might not really support taking that leap.

Let me go on to another item and that is beyond the mechanics of this change, we think there’s some implementation issues and some secondary or unanticipated consequences that is possible to anticipate. And we think those can occur unless there’s great care taken in implementation. The first of those is disruption to provider reimbursement. Money follows that sequence of events and if that sequence of events is delayed or if the error rate in it increases disbursement is impacted, and many of these organizations are vulnerable to the impact, financial impact of any kind of delay or change in reimbursement. We think there’s some information out of Australia and Canada that that’s a real risk and something that great care should be taken to avoid.

The second impact is the risk of disrupting the clinical data used in the payer organizations and in the provider organizations. These are very complex entities that use dozens of systems, applications, modules, that use this information and for their day to day routine functioning all of that information has to flow and work together and if it does not, if one application doesn’t work, interfaces don’t work, that organizations activity is disrupted and that disruption causes turmoil. So the new data has to simultaneously of the overall flow of information service and funding flow between all of the entities.

The third area that we think there’s a risk in is in disrupting their access to their existing body of clinical knowledge. What we mean by this is that there’s a huge body of existing knowledge, academic studies, academic literature, medical literature, trials, and algorithms in software that’s based from that. And much of that literature uses the code schemes that we’re talking about and if you change that there’s a potential that for any given one of those you may change in effect their access to the medical knowledge that you have. You may actually end up having to kind of rethink what you thought you knew and restate it in the new scheme. I think a good example of that and a cautionary tale is the story of AIDS mortality reporting in Florida where when you change the coding of that we kind of changed what we thought we knew about AIDS related mortality or HIV related mortality.

The fourth topic or risk point is fraud detection. We agree with the assertion that would probably long term cause create the capability to do a better job with it but we think there’s going to be a short term disruption in it, how short term, don’t know, I think it’s reasonable to expect that might be degraded for several years.

The underlying basic thing in these points of concern is that any process in a payer organization, in a provider organization, in a health care organization, that uses historic data, that crosses the implementation event will need to be reviewed and validated before the organization or the users of that data can become comfortable again that they understand what the data is telling them.

Let’s go to cost, everybody’s kind of interested in cost so drop on down to that, and we’ve been able to estimate some costs that may be of special interest. We think the total cost range is from about $5.5 and $13 or $14 million dollars, and we’ve not included in this ancillary providers, there’s about 2, 3, or 400,000 of those. And those are chiropractors and physical therapists and all those, we’ve excluded them from this. But there’s a couple things that we can say about this. System implementation costs we think will range between $4 and $11 billion dollars, most of that concentrated in facilities where they have very complicated and complex systems and where a lot of remediation will be needed. Training costs range between $1 and $1.5 billion. We anticipate that there will be a productivity loss, that seems to be documented in the literature from Australia and from Canada, seems to decline, come back, but does not appear to come back to the level that it was before. That’s a variance with what we’ve heard earlier and I’m sure other people will comment on that.

There’s rework that will occur in the range of around a half a billion dollars, that’s rework from productivity loss that occurs between health plans and payers. We’ve been able to estimate about a half a billion dollars of contract renegotiations, and that’s just between the entities that have contracted with each other, not from payer groups. And we’ve been able to estimate costs for Medicare and Medicaid, and I can detail those for you and conclude on that.

For Medicare and Medicaid our current estimate is that Medicaid will run between $500 million and $1.2 billion for Medicaid. There’s other state programs that we think will run about $150 million and those are things like correction systems and miscellaneous things where this data is used. And we think Medicare will run between $150 and $200 million.

And with that I’ll conclude.

DR. LUMPKIN: Thank you. We’re going to have one more of the panelists and then we’re going to break for lunch and complete the panel after lunch as per the schedule. So the next one is Nelly?

Agenda Item: Reactor Panels to Impact Study and Other Studies - Ms. Leon-Chisen

MS. LEON-CHISEN: Actually we’re doing it jointly. This way you don’t get a chance to get too bored with just one voice.

DR. LUMPKIN: See if I had read my notes I would know that.

MS. LEON-CHISEN: My name is Nelly Leon-Chisen, I’m director of coding and classification at the American Hospital Association. I would like to thank the National Committee on Vital and Health Statistics for allowing us the opportunity to share with you the results of the American Hospital Association, AHA, and American Health Information Management Association, AHIMA, ICD-10-CM Field Testing Report.

We’ve heard many times that accurate and precise reporting of clinical codes is extremely important because clinical codes are key to benchmarking, quality assessment, research, public health reporting and strategic planning as well as accurate reimbursement. The current coding system, ICD-9-CM is more then 20 years old, it has become outdated and obsolete despite annual updates.

The primary purpose of the study was to assess the functionality and utility of applying ICD-10-CM to actual medical records in a variety of health care settings and to assess the level of education and training required by professional credential coders to implement ICD-10-CM. There was no external source of funding for this project, which was conducted using existing resources of both associations with the generous support of Ohio State University health informatic and information system staff. Participants received no remuneration for their participation.

The AHA and AHIMA solicited health information management, HIM, professionals from across the country, a total of 169 volunteers participated in the testing, which some health care organizations having more then one person participating. Participants represented all geographic regions including Alaska and Hawaii. Ongoing communication with the participants and access to resources necessary for participation in the project were provided through a virtual community of practice, or COP, accessible via the AHIMA website. The resource included training materials, coding guidelines, and a link to submit the survey forms. In addition the COP allowed communication between the participants and the project coordinators. Participants could pose questions pertaining to the training materials, coding guidelines, data submission, or other aspects of the project under COP. Staff of the National Center for Health Statistics provided official answers to questions related to the training materials or coding guidelines. All participants are required to listen to a two hour archive audio seminar accessible via the internet. This audio seminar included a slide presentation and was presented by NCHS staff.

The study was conducted using a descriptive survey research model. Researchers with doctoral degrees and professors from several academic institutions reviewed and advised on the research methodology, including the instructions on record sample selection, process for coding records, and the process for submitting data.

The ICD-10-CM alphabetic index is the means by which diagnostic terms are located and the appropriate code or code categories are identified. Unfortunately the only index file format available for use during this project was extremely unwieldy, cumbersome, and difficult to use. For ICD-9-CM there are a variety of hard copy and electronic index tools such as code books with standard column formats and headings, font styles, and indentations with standard tabs. There are also electronic products with search engines for looking at terms in the index.

For ICD-10-CM the only available tool today was hard copy. The formatting for multiple indentation levels was confusing. There were infrequent name headings, lack of font style changes, or other characteristics that would facilitate the ability to locate a term. In addition text that wrapped around to the next line added to the confusion, and for those main terms that have entries on multiple pages the subsequent pages did not identify the main term. The problems with the index file format will be resolved when ICD-10-CM is implemented in a variety of user friendly easily navigable formats in both electronic and paper product. You may refer to the appendix in the written report for examples of pages from the index of a typical ICD-9-CM book and the ICD-10-CM index.

With regards to records selection, participants were encouraged to code 50 medical records if possible and to randomly select through record samples from the discharges or visits of any month or months from 2003. The sample was to represent a variety of diagnoses treated by the facility whose records were being coded and records were to be selected without regard to payer.

With regard to the process for coding records. The data collection period was June 30th through August 5th 2003, only records of discharge patients were eligible for the study. All records had to be complete. ICD-9-CM and ICD-10-CM diagnosis codes were assigned for each medical record. Participants were required to use hard copy manuals for ICD-9-CM coding rather then encoding software in order for the coding process to be comparable for both coding systems. No procedure codes for assigned for this project.

The entire medical record was to be reviewed when assigning both ICD-9-CM and ICD-10-CM codes. Participants were instructed to assign codes as completely and accurately as possible according to the existing medical record documentation. Participants were instructed not to query physicians for clarification of documentation regarding either ICD-9-CM or ICD-10-CM codes in order to limit the variables in the coding process and to maximize the comparability of the data. The standard for current coding practice today is to query the physician when medical record documentation is ambiguous or conflicting.

Data submission. The data elements to be collected were determined by AHIMA and AHA staff in consultation with researchers at several academic institutions. The data was submitted via web-based survey tool developed by Ohio State University, OSU, and housed on the OSU server. Due to resource constraints we were not able to collect data at the code or category level but only at the chapter level. Collection of data at the chapter level allowed us to evaluate how well each of the ICD-10-CM chapters was represented in the record sample. For any identified problems assigning an ICD-10-CM code or whenever a non-specific code was assigned details on the actual code number involved were required to be submitted.

All data were collected via an electronic survey process. A few weeks after the end of the data collection phase of the project participants were asked to complete a supplement survey to obtain information not included in the initial data collection and to clarify responses to some of the original survey questions. Some of the questions included in the survey were inspired by suggestions made by members of the National Committee on Vital and Health Statistics, Subcommittee on Standards and Security at their August, 2003 meeting.

To validate the accuracy of ICD-10-CM coding diagnostic information from every fifth record coded by one half of the participants was recoded by AHIMA and AHA staff without knowledge of the codes assigned by the participant. Discrepancies in code assignment were then reviewed by other AHA and AHIMA staff to verify whether the code assignments represented true differences and to categorize the types of coding error.

The results. OSU health informatics and the statistical staff cleaned the data and tabulated and reported their results to AHA and AHIMA. With regards to the demographic characteristics of participants all of the participants have an HIM or coding credential, 85.8 percent have one of the two general HIM credentials, RHIA or HIT, and 14.9 percent have a specialized coding credential only.

Regarding job titles, 43.4 percent indicated they were a coder or coding professional. The second most commonly reported job title was manager, coordinator, supervisor, team leader, and that represented 17.2 percent. Over half, or 56.8 percent of the participants work in a short term acute care hospital. The next largest employment setting was integrated delivery system at 17.8 percent. Other settings represented in our participant sample included consultant/vendor, 5.9 percent, physician office practice, three percent, nursing home, 2.4 percent, educational institution, three percent, government agency contractor, 2.4 percent, other ambulatory setting, 1.8 percent, rehab facility, 1.8 percent, long term care hospital, 1.2 percent, home health/hospice, .6 percent, behavioral health facility, .6 percent, and other three percent. Bed size for short term acute care hospitals ranged from fewer then 50, 12.5 percent, to greater then 400, 42.7 percent.

Judging by the reported years of coding experience the participants were experienced coding professionals. 88 percent reported more then five years of coding experience, 68.5 percent reported more then 10 years. Only 43.4 percent indicated that their current job title is coder or coding professional. 37 respondents, or 25.5 percent, indicated they spend 35 to 40 hours per week coding medical records with ICD-9-CM and 13.8 percent indicated they spend one to five hours per week coding. Many of the other responses indicated that they never or almost never spend any time actually coding medical records. Therefore, if the other responses are combined with the responses for one to five hours per week 33.3 percent of the participants spend less then six hours per week coding. This information was obtained from the supplemental survey conducted after the August NCVHS meeting and therefore not available to Dr. Libicki in compiling the Rand report.

Thus while the responses regarding coding experience indicated that the participants are generally seasoned coding professionals, 88 percent reported five years or more of coding experience and 62 percent reported more then ten years of experience, many of them are not currently coding records extensively on a regular basis. The most frequently reported areas of coding experience were hospital inpatient and outpatient at about 32 percent each. 12.3 percent reported post acute care coding experience, 10.2 percent reported physician practice experience, and 10.9 percent reported experience in other ambulatory settings. 3.1 percent reported a variety of other types of coding experience. Participants were allowed to indicate more then one type of coding experience.

I will now turn it over to Sue Prophet-Bowman to continue with the report.

Agenda Item: Reactor Panels to Impact Study and Other Studies - Ms. Prophet-Bowman

MS. PROPHET-BOWMAN: I’m going to talk about the results from coding the records in ICD-10-CM versus ICD-9-CM, a total of 6,177 medical records representing a variety of record types were coded as part of this project. On average 37 records were coded per participant. Almost half, or 42.3 percent, represented short term acute care hospital inpatient records. Another third represented short term acute care hospital outpatient records, and almost 10 percent were records from post acute settings, which encompassed home health or hospice, nursing homes, long term care hospitals, and rehab units or facilities. Six percent of the records were from physician practices with a small percentage from clinics, community health centers, free standing ambulatory surgery centers, and free standing diagnostic facilities, the total from that group comprised at about three percent. Records representing both inpatient and outpatient encounters in a behavioral health facility comprised 1.6 percent of the record sample. Only .6 percent of the records were categorized to the other category showing that the vast majority of records fell into one of the specified categories in the study.

Only 12.3 percent of the 23,122 total number of codes that were recorded for this study were in the non-specific category, non-specific for the purpose of the study was defined as those ICD-10-CM codes that had the words unspecified or not otherwise specified in the code title. This shows that in spite of the concerns about medical record documentation not supporting the value of the specificity in ICD-10-CM today’s current medical records oddly enough did show that the vast majority of them used very specific codes. Although both ICD-9-CM and ICD-10-CM have non-specific codes for use when either the medical record documentation isn’t available or the clinician doesn’t have the necessary information to support a more specific code, the non-specific codes in 10-CM actually provide more information then their counterpart in ICD-9-CM because they classify a narrower range of diagnostic distinction.

It’s important to note that all of the diagnoses resulting in a non-specific code assignment could be coded in ICD-10-CM, therefore while improved documentation would result in higher data quality in some of these areas changes in documentation practices would not be absolutely necessary to implement ICD-10-CM.

We collected data by ICD-10-CM chapter, which came to as I mentioned earlier a total of 23,122 codes assigned for this record sample. The total number may have actually been higher because due to the drop down boxes used in these web based surveys some of the participants experienced computer difficulty and so not every one of the codes, not every one of the codes was submitted. However the results still indicated that we had a very high number of codes and that all chapters were represented in the project. The highest number of reported codes in the project were in the chapter of disease of the circulatory system at 3,885, followed by factors influencing health services, 2,441, and then endocrine, nutritional and metabolic diseases at 2,230. It’s important to keep in mind that these reported number of codes do not necessarily represent unique codes as in different codes in ICD-10-CM but rather the number of times that a respondent reported a code in one of these chapters, so if different responders coded hypertension several times then that hypertension code would show up multiple times in the sample.

Comparison of coding times between ICD-9-CM and ICD-10-CM. We did collect this time which included reviewing the record to identify the diagnosis to be coded, the process of locating the diagnosis in the index of both systems, and verifying the codes then in the tabular list of both systems. Time was measured by noting the time when review of the record began and the time when all relevant diagnosis codes had been assigned. Record review time was included in both the ICD-9-CM and ICD-10-CM coding times, so if they spent five minutes searching for the particular diagnoses to be coded that five minutes was included in both the recording of the time it took to code in 9-CM and the time it took to code in 10-CM. Data submission for the purpose of this study was not included in the time.

Participants reported that there was essentially no time difference between ICD-9-CM and ICD-10-CM for 58.6 percent of the record sample. However, on average, across all record types, there was a nearly two fold difference in the overall average with 6.37 minutes for a record in ICD-9-CM and 12.14 minutes for ICD-10-CM coding. While the difference in time varied slightly by record type the average time to code a record in ICD-10-CM was greater then in ICD-9-CM across all types of records. The participants were asked to provide an explanation for any record that took more then five minutes longer in ICD-10-CM to code then in ICD-9-CM. The vast majority of these cases, at about 92 percent, were due to either difficulty in using the problematic index file format that Nelly mentioned earlier and/or just difficulty locating a diagnostic term in the index, which also could have been partially due to the file format.

Taking longer to code with ICD-10-CM would typically be expected given that these participants were basically unfamiliar with the coding system, received minimal training, and lacked user friendly coding tools to participate in this project. The greatest number of records any individual coded as part of this project was 55, and a number of participants coded far fewer then that, no one really had the opportunity in this project to become extremely proficient in ICD-10-CM coding. Also impacting the time comparison was that not all participants code on a regular basis, some of them are unfamiliar with coding ICD-9-CM on a regular basis. 22.7 percent of the participants spend at least 25 hours per week coding medical records, the rest of them spend less then that per week coding records right now in ICD-9-CM. Also the lack of familiarity with ICD-10-CM and the fact that these records were being coded as part of a field testing project may have resulted in the participants taking more time to ensure that they had selected the most appropriate code then they normally would when coding records.

The availability of much improved coding tools, more training and increased familiarity with ICD-10-CM will reduce the amount of time needed to code records in ICD-10-CM, possibly to the point whereby ICD-10-CM actually may require less coding time then ICD-9-CM as evidenced by the fact that such a large percentage of the records really didn’t require any more time even in the study. A number of participants commented that they had expected ICD-10-CM to take much longer then ICD-9-CM because they had to review index entries, instructions and coding guidelines much more carefully since they were unfamiliar with them.

Also, although participants were asked to follow the same process for locating an ICD-9-CM code that they did for ICD-10-CM it was hard for them I’m sure when they had the ICD-9-CM code committed to memory to really go through every step of the process in determining that code when they knew what that code was as compared to not knowing what the ICD-10-CM code was.

As Nelly mentioned earlier we did validate a sample of the submitted information for coding accuracy to see how well the participants were coding in this study. A total of 360 validation forms were submitted, which is 5.8 percent sample of the total number of records submitted. The codes assigned by the coder and validater were compared, discrepancies identified, and reasons for the discrepancies determined. Almost 80 percent of the ICD-10-CM codes assigned by the participants and validater were considered a match.

Detailed information on errors or conflicts in instruction, index entries and tabular notes were collected, as well as instances when an appropriate ICD-10-CM code could not be assigned. Participants were required to complete a form identifying the specific ICD-9-CM codes assigned and the appropriate ICD-10-CM code if they were able to assign one as well as the detailed explanation. These reported problems will be submitted to NCHS for review, correction of errors in the coding system, consideration of changes or additions to index entries to facilitate the coding process and any other modifications that might be helpful. Many of the identified issues will not require any modification at all, they represented a misunderstanding on the part of the proper code assignment from some of the participants and could be addressed in more substantial training programs or added to the coding guidelines.

Due to our relatively large record sample size, the fact that our field testing included a broad range of health care settings, and the fact that a number of the identified problems were recorded multiple times by different participants, it is likely that many if not all of the most common problems coding professionals would face with ICD-10-CM may have already been identified, which means this gives the opportunity to improve these areas prior to implementation of the coding system.

After the study was over we asked participants through an additional survey tool for some general impressions of ICD-10-CM in general and one of the questions we asked was how much training would be needed. As Martin alluded to earlier, a report that we provided at the August subcommittee meeting, the question had to do with number of days of training and there was some discrepancies in the answers provided by participants, so this is one of the questions that we re-asked in a follow-up supplemental survey subsequent to that subcommittee meeting. In this case we asked number of hours and we asked them specifically to indicate how many hours they felt they would need to feel adequately prepared to code in ICD-10-CM. The majority, 60 percent, indicated that they would need 16 hours or less. The majority of the respondents, or 58.6 percent, thought the training should be provided three months prior to ICD-10-CM implementation, 29 percent suggesting six months prior to implementation. It was generally felt that if training were provided too far in advance of implementation the knowledge would not be retained and retraining would be necessary. The majority of respondents, or 76.6 percent, prefer face to face training, with internet based training as their second choice.

The clinical descriptions of the ICD-10-CM codes were thought to be better then ICD-9-CM by about 72 percent of the participants. ICD-9-CM codes were thought to be better, the code descriptions were thought to be better by 11.2 percent of the participants. And 10.1 percent weren’t sure if the clinical descriptions were better in one system then the other. However, participants coded, some participants did not code that many records so it is possible that the ones who coded fewer felt less comfortable, knowledgeably answering that question, particularly the unsure responses may reflect their lack of experience in ICD-10-CM coding.

In spite of the difficult file format, it was very hard to navigate, 64.5 percent of the respondents still thought that the notes, instructions and guidelines in ICD-10-CM were clear and comprehensive whereas 22.4 percent thought they weren’t and 13.2 percent weren’t sure. The unsure responses seemed to reflect a lack of ICD-10-CM experience, particularly by those who coded fewer records. In fact 32 percent of the participants who coded 20 records or less responded that they were unsure whether the notes and instructions were clear and comprehensive while only eight percent of those who coded more then 40 records felt that way. 67 percent of those who coded more then 40 records indicated that instructions were clear and comprehensive whereas only 51.6 percent of those who coded 20 records or less felt that way.

ICD-10-CM was felt to be an improvement over ICD-9-CM by 76.3 percent of the participants. The number of records coded by the participants also had an impact on this response. Of the participants who coded 20 records or less 67.7 percent of them felt that ICD-10-CM was an improvement, whereas 78.8 percent of those who coded more then 40 records felt that it was an improvement. Of those coding 20 records or less about 19 percent were unsure whether ICD-10-CM was an improvement, but only 13 percent of those who coded more then 40 records were sure.

Migration to ICD-10-CM was supported by 83.6 percent of the participants and the most common reason given for not supporting migration to ICD-10-CM was the problematic index file format, which of course will be fixed with much better tools for using the index by the time ICD-10-CM is implemented. ICD-10-CM should be implemented in three years or less according to 78.6 percent of the participants. Responses from the other 21.4 percent made apparent that some felt the need to implement soon, but were unsure about a definitive timeframe, noting the need to improve the electronic, or make available electronic tools for using the coding system, and that implementation should take place as soon as vendors and payers can accommodate the change. Several individuals noted as soon as possible, and others indicated, did not answer yes but feel it is in the best interest of our profession to get on with this as soon as possible.

For our next step a summary of the data provided regarding any identified problems or minor errors that were found in the coding system will be provided to NCHS. We are still conducting further review and analysis of the field testing data, this data will enable us to provide answers to questions raised by government agencies, health care industry representatives, our members, and others as ICD-10-CM and its associated coding guidelines are finalized and plans for implementation get underway.

In conclusion the coding professionals who participated in the ICD-10-CM field testing favored migration to ICD-10-CM and thought the system should be implemented in three years or less. ICD-10-CM was seen to be an improvement over ICD-9-CM and participants in some of the non-hospital settings that participated in the study indicated that they believed ICD-10-CM was much more applicable to their settings then ICD-9-CM and would provide significantly better data for those settings. As judged by this study ICD-10-CM codes can clearly be applied to today’s medical records in a variety of health care settings, without having to change documentation practices, although improved documentation would certainly result in higher coding specificity and therefore higher data quality in some cases.

AHIMA and AHA have testified in the past that coding professionals will primarily need to be educated on changes in system structured disease classification, definitions and guidelines. The hierarchical structure, organization, and many of the conventions are much the same in ICD-10-CM as in ICD-9-CM and therefore would already be familiar to coding professionals. The feedback from our study participants supports this assertion. Participants felt that a maximum of 16 hours of training would be necessary to adequately prepare coding professionals for ICD-10-CM coding and suggested that training should be provided relatively close to the implementation date, such as three to six months prior. The results of this field testing project and independent data analysis by Ohio State University support the ICD-10-CM as an appropriate replacement for the ICD-9-CM diagnosis coding system.

We’d be happy to entertain questions you may have today and will also be available tomorrow and at the meeting of the Subcommittee on Standards and Security next month. And for those of you in the audience who did not get a copy of the report it is available from both the AHIMA and AHA websites. Thank you for your attention.

DR. LUMPKIN: Thank you. At this time we’re going to go into our lunch break. We’re going to adjourn now, we’ll try to get back at 1:35.

[Whereupon at 12:50 p.m. the meeting was recessed, to reconvene at 1:45 p.m., the same afternoon, Tuesday, September 23, 2003.]


A F T E R N O O N S E S S I O N [1:45 p.m.]

DR. LUMPKIN: Okay, a couple of housekeeping things. The first is that I have in front of me a copy of a press release, Medicare announces, I think that’s available at the table. Medicare announces plan to accept HIPAA non-compliant electronic transactions after October 6 compliance deadline.

Second housekeeping issue, I understand that there’s a very nice dinner being set up for members and staff of the committee tonight. I need a head count of people who will be attending and it will be at Satina(?) at 6:30. Okay, head count, about 13.

We’re going to continue with the panel and according to my list next we have Tom, or did you want to bat clean-up?

Agenda Item: Reactor Panel to Impact Study and Other Studies - Mr. Gustafson

MR. GUSTAFSON: I’m sure I’ll wind up batting clean-up anyway. So let me just, I will make a few remarks here and I don’t have as well prepared a formal presentation as some of my colleagues on the panel, but just to summarize a few points.

First of all the Centers for Medicare and Medicaid Services is indeed conducting a detailed study of the costs that we expect to experience and that our partner organizations, both the state Medicaid agencies and our contractors, may expect to see. I’m sorry that isn’t ready today, I think it would be very timely if it had been, insofar as apologies are germane I’d like to offer those to the committee. We’re working on this as quickly as we can but we are very mindful among other things of the effect of HIPAA on everybody and part of the reason we have not gotten the study further along is precisely because of that interference operating within our own organization and deflecting resources.

So we are looking at this stuff and we are going to be examining with great care obviously the systems costs on our systems for retaining a larger data field and all of those kinds of changes. An element that we are going to be examining that I don’t know has been stressed so far is looking at what effect this would have on our needs to revise coverage policies at various levels of the system, coverage in our parlance means what do we pay for, as distinct from how much we pay for it. And coverage policies tend to be written in fairly detailed form, in fact some of them exceedingly detailed form, and insofar as the diagnosis codes, or to a lesser extent the procedure codes change, there may need to be some revision of that material. Similarly what are called local medical review policies, which implement coverage and other decisions at a local carrier level and again tend to get down into the weeds in terms of the detail with which they are specified and we need to examine how long and over what period of time and what kind of resources would be necessary in dealing with those. And similarly we have a set of what are called correct coding edits, we need to revise our editing system to make sure that it corresponds to the new reality if we in fact go there.

I’d like to note in passing here that a fair amount of this activity is ongoing anyway, I mean coverage rules, local medical review policy and so forth are not static things and in fact that’s true of a number of the systems and processes that people have been point to, it’s not like we’re going from a crystallized reality however imperfect to a new and fluid situation. We’re moving from one fluid situation to another and that has some important implications I believe in terms of how one accounts for the costs of change, because to some extent as long as one has enough time you can get there without necessarily occasioning very substantial costs, although there clearly are some.

From our standpoint we will be focusing very substantially on budgetary costs from the standpoint of the federal budget and also of course our partners in the states. As someone pointed out earlier we have an enhanced match on systems issues but there will be other state issues as well. That has to do of course with the focus that executive branch decision makers and Congressional decision makers will focus on a decision here. We will also examine other costs insofar as we can find them, I don’t want to say we’re going to ignore other costs but budgetary costs matter to us a good bit.

And I’d like to distinguish here in sake of putting something in folks minds and making sure we focus on it, the distinction between administrative and benefit cost as we use it in our parlance. The costs that we’re going to be focusing on are administrative. Benefit costs, benefit dollars going out the door is another whole subject from our standpoint and particularly in the federal system they operate under very, very different rules. But we do not see any reason to expect any substantial change in benefit costs as a result of a coding change of this sort. The revisions to the payment system we would expect to be exceedingly minor in the first instance, the revisions to coverage may be slightly more significant, and it may very well, in fact we do expect it to lead to changes in further years but we expect these are changes that not only the system can adjust to but our budgetary expenditures could adjust to. Now we have the ability to budget neutralize for change, I don’t mean to say that all other systems have those abilities, but state governments do have some ability to control how their payment rates are set and in fact they have more discretion in that then on any other area in the Medicaid program. Private payers obviously there would be some question about renegotiations of contracts and that sort of thing but I think it would be a mistake to assume that any of those payers are passive actors in the system and we would anticipate that they would take steps as we expect to take steps to make sure that there are not significant impacts, either plus or minus on the benefit side simply from a payment change.

A number of folks have reproached me in different times in the course of the past few days and said you know, you really need to get out there and make the business case for a change to ICD-10, and I wish I were better prepared for this, I didn’t have a lot of chance to think through exactly everything I might say on the subject and I think that I’d like to reserve the possibility of coming back at the subcommittee meeting in October and perhaps on elaborating on a few things I would say right now. The Rand report goes into a variety of different possible advantages from the standpoint of the system as a whole and to some extent from a payer perspective. I of course find it, as a representative of a public agency find it a little difficult to separate the payer perspective from the beneficiary perspective because I’m supposed to be the payer serving the beneficiary. Some of the points that Rand notes about disease management or outcomes and so forth are certainly subjects of interest to us and we have a long history now, going back at least until the time when Bill Roper was the administrator in the Reagan Administration of promoting outcomes research and using our absolutely overpowering dataset, I mean we have more claims then anybody.

And one of the great advantages of at least the Medicare data, the Medicaid data lags a little in this I guess but we have accessible to us a very large number of cases, a large in, that provides a great deal of statistical advantage. It’s far from perfect and I don’t mean to suggest for a moment it is but you can get a long way with a large in and outcomes research is something that is perfectly possible with that dataset, has been used with that dataset, we want to encourage it. There’s always the question of to the extent to which we want to or people want us to translate results of that kind of research into changes in payment policy, and that’s another link in the parade, another step in the parade, that we may not get to in any very explicit way or in any great hurry. But we believe it’s very pertinent to let folks know, to let clinicians know what is going on, what is being used, what effect it has and insofar as the claims data can help contribute to that we think this is all a good thing.

That having been said I would like to focus on what I think are two major, or to my mind at least in my present job, more significant issues. The first is the need for greater precision in the payment rates for our diagnostic reimbursement groups. We started out with about 400 DRG’s, so all of the ICD-9 codes that are in use were initially lumped together in about 400 payment cells. We’re now up somewhere the other side of 500 I think, Rich could probably, Rich is nodding okay, so I think I’m in the right, Rich Haverol(?) here helps us maintain the system, and they do a comparatively good job, at least they don’t receive a vast amount of criticism. We’re now in our I think 20th year of using this system in the inpatient setting and we’re generalizing some of the same concepts and indeed some of the DRG’s to other payment systems as well. But it’s still true that notwithstanding the clinical coherence of some of the DRG’s that there is a very wide variance in what, in the cost of cases that are contained within their DRG’s. The standard deviation is high and we are under, I won’t want to say relentless but certainly regular pressure to improve the structure of the DRG’s. This is sometimes used in the term, so severity adjusted DRG’s, I would think that a better way of thinking of it is simply more precise payment cells. It would contribute to our ability to pay more sensibly for procedures if we could refine the DRG payment cells, the existing cells, more substantially, make them more refined, allowing us to pay more for more expensive stuff and less for less expensive stuff. This is all while retaining the advantages that the DRG system provides to us from a payer perspective of permitting payment on the basis of an average cost, a large number of providers so that we are not simply legitimizing or endorsing the cost spending behavior of any particular provider but working in the world of averages.

So we regard that as a sort of intermediate term, need that we think would improve the precision of the payment system, I don’t necessarily expect that that would make the Medicare program cheaper or more expensive, but just better and get the resources where they need to be so that when people are doing cardiology, which happens in virtually every hospital in the country, we’re paying them more accurately then we are today.

The second major point I’d note has to do with technology, and particularly the diffusion of new technology. One point in the Rand report, they made a comment I think perhaps derived from a conversation with me, about coding limitations preventing our making special payment for new technology items and I’d like to elaborate on this area just a little bit. I’d like to dispel in fact the notion that at least so far coding limitations have prevented our implementing an appropriate payment policy in this area. We certainly anticipate the possibility that that may happen in the future if there is not some relief in one direction or another. But at present, and let me start in a different place. For years the Medicare program has operated in a movement where payment rates have been adjusted in a relatively glacial fashion, so it takes about three years for claims data to operate, to get into the system, to be reflected in the payment calculations we do and to translate into a payment rate. So if a new something or other, new procedure comes along, it’s a little more expensive then the old procedure, that will have the effect automatically of raising the payment rate for the associated DRG, but it takes a little bit of time to get there. In principle the same operates on the down side, if it becomes a lot cheaper to take somebody’s spleen out presumably hospitals charge less for that, I say presumably, and the relative weight on spleenectomy or whatever the appropriate term is will decline over time. And that kind of mechanism has sort of worked for 15 years without occasioning vast criticism.

In the last five years it has been the subject of very substantial criticism partly because of the very speedy rate of technical change in the medical sector in the last decade or so. I think we’re all familiar with the kinds of things that are going on here coming at us fast and furiously, more in the pipeline. Biotechnology drugs, drug alluding stents, devices that are very expensive, drugs that are very expensive, and we need to be able to provide a way to code for that stuff early on so that we can provide extra payment for that stuff early on. I can go into a substantial history here but I won’t bore you with it, but the principle is there and we are under statutory mandate to do that. So we are supposed to be providing supplemental payment for high cost new technology stuff in the inpatient sector. We’ve only been doing this now for a couple of years and have only actually done this for two or three different products so far. Part of the reason the take up rate on that has been so low is because the parameters we set on what you needed to be able to show us to get the brass ring if you will to be able to get a supplemental payment were very, very stiff. And in fact this year’s final rule, which will take effect in October, we’ve relaxed at least one of those parameters to make it more generous. We were attempting to move into this area slowly and not be overwhelmed by a vast number of different items.

Capitol Hill has taken notice of our behavior here, the bills on the Hill that are now in negotiation between the conferees would substantially increase the number of technologies that would qualify for special payment. So for instance they would decrease the cost threshold for something in the neighborhood of about, at present I think it’s somewhere in the neighborhood of $17 or $20,000 dollars, would substantially decrease that to about $3,000 dollars. It would effectively remove a standard of newness and the number of technologies that will qualify could be quite large.

We’re now in a situation in ICD-9 where we have approximately 100 codes vacant and able to be used for new technology without serious disruption to the system. We are on the way to exhausting those. When they’re gone there will be some unpleasant choices facing us. We either construct some kind of supplemental dataset that could be used in conjunction with ICD-9, which should give us all pause for thought, or we are going to have to do something to degrade the hierarchical character of the current dataset. Congress will not accept in my view the notion that there isn’t enough room in the coding set as a reason not to fulfill their policy objective here. If you’ve ever tried to explain coding to a Congressmen you may get some sense of this, so it isn’t going to work so we have to do something. There will in short be costs in one way or another as we move through the system.

And just to summarize here, the chairman is giving me some signals that I should move along, that what I’m, using the code word here expandability is a very critical problem from the perspective of this payer and one which ICD-10 offers a very, very substantial advantage in pursuing, so let me stop there.

Agenda Item: Reactor Panels to Impact Study and Other Studies - Ms. Leon-Chisen

MS. LEON-CHISEN: My name is Nelly Leon-Chisen and I’m the director of coding and classification for the American Hospital Association, AHA. Many of you may know my role as the director of the Central Office on ICD-9-CM, editor of Coding Clinic and one of the ICD-9-CM cooperating parties. I’m here today representing the AHA.

On behalf of our nearly 5,000 member hospitals, health systems, networks and other providers of care I would like to thank you for the opportunity to provide comments on the Rand study. I would also like to thank the AHA’s member advisory panel on ICD-10 implementation. This was a group made up of hospital health information management professionals, corporate compliance officers, clinical and financial data leaders from state hospital associations, and many others who will be impacted by a move to ICD-10. We sought this panel’s advice and suggestions in preparing our statements today.

We commend Dr. Libicki and Rand on the thorough and balanced study of a subject not easily quantifiable. For America’s hospital migrating to a newer version of clinical codesets capable of accurately reporting better information on diseases and procedures is essential. Such a decision should not be based on financial considerations alone but should take into account the shortcomings of ICD-9-CM and the consequences of limping along on a broken clinical codeset incapable of recognizing advances in medical knowledge and technology. We agree with the study’s conclusion that there will be benefits associated with migration to ICD-10-CM and ICD-10-PCS in the hospital inpatient environment and that these benefits exceed the initial breaking costs within a few years of implementation.

With regards to cost we agree with the reports estimate that the costs of implementing ICD-10-CM and ICD-10-PCS can be classified into training, productivity losses, and system changes. We believe, however, that based on our studies the Rand study overstates the costs of training and productivity losses for hospital coders. It is important to know that hospital coders as a rule already receive training on a regular basis. They do so to sharpen their coding skills, keep up with code changes, meet requirements of corporate compliance programs, as well as for continuing education to maintain their professional credentials. Such training consists of between ten to 30 hours per year on coding alone, in fact many large health systems have staff at the corporate level who provide system wide coding training in order to ensure the accuracy and integrity of the coding process. Following this model it may not necessary to incur a great deal of money to train America’s coders. Train the trainer programs could be effectively utilized to train coding leaders who would then disseminate the information to their colleagues at the hospital.

As the Rand report states most of today’s coders have been expecting clinical versions of ICD-10 to be implemented. To prepare many hospitals have initiated training to bolster the coders’ knowledge of anatomy and physiology. The cost of ICD-10-CM and ICD-10-PCS training would in many ways replace costs already being incurred by hospitals to keep up with ICD-9-CM. Based on the advice from the AHA’s member advisory panel on ICD-10 implementation the cost of training hospital coders as reported in this study could therefore be cut by at least half to three fourths.

With regards to productivity losses it is true that with any coding system change there will be a period of adjustment until coders becomes proficient with the new system’s rules and guidelines. However, we believe that the Rand study’s estimate of productivity losses is an over estimate. Based on the recent AHA and AHIMA field testing of ICD-10-CM in more then half the records coded coders saw no increase in the time it took to code with ICD-10-CM compared to ICD-9-CM. This, despite the fact that the testing was performed after only two hours of non-interactive training using a cumbersome paper based index file format with coders having to review the ICD-10-CM guidelines. More then likely they would not have needed to review the guidelines the ICD-9-CM.

For the majority hospitals using encoders and with additional training and practice the coding productivity under ICD-10-CM has the potential to be greater then under ICD-9-CM. As a data quality analyst at a large teaching hospital recently so aptly quoted “Coders waste a lot of time today trying to find codes for new procedures where the ICD-9 codes does not exist.”

With regards to the cost to change systems we agree with the study’s assessment that most providers buy their systems through vendors and most of the provider/vendor relationships have a software maintenance component that would include regulatory updates to the systems.

We agree with the reports identified classes of benefits and I will not take up the committee’s time by repeating them again. As reported in the Rand study Australia has cited an impressive list of benefits that resulted from migration to more current and specific codesets. We also recognize the difficulty in quantifying improvements in health or cost savings, but intuitively we believe that better information to measure inputs and outputs makes for better decision making. Clinical codes are an essential part of such activities, maintaining a system that provides incomplete or vague information due to outdated codes hurts the entire health care industry.

An additional benefit not specifically identified in the report is the ability to improve community health based on coding consistency between mortality data and morbidity data. Cause of death data is currently reported using ICD-10 as was already mentioned this morning. In many states, such as Illinois and Utah, mortality data is cross analyzed with hospital data for community health to develop intervention strategies. Resources are wasted converting mortality data back to ICD-9-CM to correlate to the hospital data. From a public health perspective it is also more difficult to compare international health data when the United States is using a different coding system then the rest of the world.

The study offers several suggestions to facilitate the transition to ICD-10-CM and ICD-10-CM, I’d like to address these suggestions one by one. With regards to transition dates, the study recommended selecting a certain day by which everyone must make the transition. Fundamentally we agree, however, we disagree that it be day driven, that is submit ICD-9-CM on one day and ICD-10-CM and ICD-10-PCS on the next. Hospitals, other providers, and payers currently base code version changes on the discharge date for inpatients and service date for outpatient services. We support a similar transition date as we currently have for ICD-9-CM, namely October 1st, regardless of the start of a hospital’s fiscal year. For example a patient discharged on September 28th is assigned the codes effective on that date and valid through September 30th, whether the claim is submitted on September 30th or October 28th. By contrast, a patient discharged on October 2nd is using the codeset version effective October 1st of that year. AHA supports a transition to ICD-10-CM for diagnosis coding and ICD-10-PCS for hospital inpatient reporting on a date certain, preferably October 1st based on the discharge date for inpatients and the date of service for outpatients.

The timeline for implementing the new system should be carefully orchestrated to minimize the administrative burden to providers. The importance of this approach cannot be overestimated. We support an implementation date of two years from the publication of a final rule for several reasons. First, it would allow sufficient time for organizations to incorporate these changes into their budgeting planning cycle. Second, it would allow system developers to make appropriate changes and test those changes before going live. As we are seeing today with the HIPAA transaction standards testing is key to ensuring that both payers and providers can submit and accept claims using the new codes. AHA strongly agrees that migration to ICD-10-CM for diagnosis coding should be carried out in tandem with the migration to ICD-10-PCS procedure codes two years after publication of the final rule. The AHA would welcome the opportunity to work NCVHS and the Centers for Medicare and Medicaid Services to develop a detailed implementation timeline.

We also agree with the study’s suggestion that a reliable and readily understandable crosswalk be prepared and promulgated. AHA believes backward and forward electronic crosswalks between ICD-10-CM and ICD-9-CM diagnosis codes, and ICD-10-PCS and ICD-9-CM procedure codes should be made available by NCHS and CMS free of charge or at a reasonable cost. Such crosswalks would be useful not only in easing the transition into the new codes, but also in converting existing databases to compare clinical data pre and post ICD-10-CM and ICD-10-PCS implementation.

Finally, we would like clarification on the Rand suggestion to have a major provider code diagnoses and procedures in both ICD-9-CM and ICD-10-CM and ICD-10-PCS to determine which codes are interpreted similarly and what a crosswalk is in practice as well as in theory. It is not clear what the objective of this effort would be. What is clear is that this would be a massive undertaking for any organization. An evaluation of the purpose of such an undertaking would be helpful.

In conclusion the AHA strongly support simultaneously a move to ICD-10-CM for diagnosis coding and ICD-10-PCS for hospital inpatient procedure coding within two years of the publication of the final rule. Again, thank you for the opportunity to provide our comments on this important transition of codeset upgrades and we’ll be happy to answer any questions you may have.

Agenda Item: Reactor Panels to Impact Study and Other Studies - Ms. Clausen

MS. CLAUSEN: Thank you. My name is Linda Clausen, I’m the chief executive officer of AHIMA. We had the opportunity yesterday to compare notes in our testimony with Nelly’s as she’s just presented them and realized that there was a lot of overlap and we wouldn’t take the committee’s time in reviewing those same points, so we do support all of the recommendations that Nelly has made.

We’d like to add two or three thoughts to that and just to underscore a little different perspective. Often as we are testifying we are speaking on behalf of those who are coding records and certainly understand all the operational intricacies. We’d like to underscore one point and that is that there’s a real cost of doing nothing, that the productivity today in managing these masses of data is deteriorating and that deterioration is just going to compound itself, in some ways we’re paying the price of having delayed too long. Had we made a change on ICD five years ago or eight years ago when we confirmed the need for such our difficulties and our consternation would perhaps be a little less onerous today. So we’re paying the price not only in loss of productivity but I believe in the loss of innovation, that is vendors would be building new tools for automating and computer based coding if they had a decision about what codeset they’re building these tools around.

A lot of the assumptions in the Rand report relate to kind of status quo, business as usual, 50,000 coders continuing to move paper records from one side of their desk to the other but we have an extraordinary opportunity to change that paradigm, I just don’t believe it will be changed until we have a decision on the codeset and then we can begin automating these processes and actually see some productivity gains that were beyond the scope of what could be researched in this cost/benefit.

My second encouragement to the committee is to please join this issue to all of the other wonderful work you’re doing on the National Health Information Infrastructure on clinical vocabularies. I think we’ve dealt with coding as something off over here while we’ve advanced extraordinary agendas just in this past year having a decision on SNOMED, the National Health Information Infrastructure agenda proceeding, even first draft standard on the electronic health record and somehow we haven’t joined the codeset decision to that and I think that’s a mistake. We should be today building mappings from SNOMED to ICD-10 but again that work is on hold waiting a decision on this important issue, so it will delay further our opportunities to really exploit the SNOMED decision move to the electronic health record if we don’t just kind of get this done with.

So I congratulate the subcommittee on suggesting that we get this important report and research done, it was needed to help us move forward confidently. It’s been a remarkable period but I would just on behalf of my members who are in the front lines on this encourage the committee to make a decision and move forward because no matter what we do it’s still two to three years off and we’re going to have to cope with these problems in the interim.

Thank you very much.

Agenda Item: Reactor Panels to Impact Study and Other Studies - Mr. Desmarais

MR. DESMARAIS: My name is Henry Desmarais, the ending on the last name is actually rais, it’s a French name like Des Moines, I’m the senior vice president of policy and information for the Health Insurance Association of America. I’m really happy that we’ve had this opportunity to be part of this panel. We do have a written statement, I don’t intend to read it, but I’d like to touch on a few key points. I would like to begin though by noting that I’m not a professional coder but that my interest and involvement in coding goes back almost 20 years now and began when in a previous life during years of service at HCVA, what was then HCVA, I was the government’s voting representative on the CPT editorial panel, and I’ve been involved in coding issues on and off in a variety of ways since then. Today I am HIAA’s representative to both the National Uniform Billing Committee and the National Uniform Claim Committee and so this issue here certainly has relevance for the work of those panels as well.

I’d like to start by noting that we really appreciate the work that Rand did, we knew that they did it under a very tight timeframe with fairly limited resource. We were very pleased to be part of the information collection effort that they went through, in fact two members of HIAA staff were involved. In fact one of them, Tom Musko, our director of research and statistics is here today, and Tom was very instrumental in reviewing the report and in preparing for this panel presentation.

I should add one more thing. We did get the draft report a week ago today and so we’ve had a fairly limited amount of time to look at it and that was further complicated by some weather events that all of us had to deal with between then and now. But not to fear, we still have plenty to say.

Let me start with a few general comments. We were really disappointed not to see more in the Rand report about the Medicare and Medicaid implications, and I’m happy that at some point that deficiency will be rectified as CMS is able to do its analysis. And I’m not just talking about the cost implications, I’m also talking about CMS’s plans for revising the DRG’s and adjusting them and I think it’s quite likely that once we have more information about CMS’s own reactions, their cost estimates and their plans our members companies may have a little bit more to say.

The next comment I’d like to touch on is the report makes mention of some comparable Canadian and Australian experience. The one thing that I found kind of startling was that those two countries have fairly recently gone through a thought process and they’ve ended up with a much fewer number of procedure codes. And I think that’s something we all should stop and reflect on, to be more specific Australia has 6,000 procedure codes, Canada 17,000, and ICD-10-PCS is 200,000 plus, in fact another 60,000 of radiology procedure codes. So it raised a question in my mind about what we’re about, what the problems are, what we need to do to address any perceived problems with the ICD-9 system. So just a thought that I would leave with you about those kinds of international comparisons.

The other thing I’d point out is I think the Rand study could do a somewhat better job of comparing total costs and total benefits. We see ten year benefit estimates but we tend to focus on only year one, the transitional costs for adopting the new systems and I think we really should do the math completely when we’re all done and finalizing the report.

I would say that overall our reaction, although I don’t have any hard data to give you today, is that the cost estimates there are under stated certainly from the payer perspective, and one of the things I’d particularly like to highlight is while the report talks about systems changes I think it’s a serious mistake for all of you to imagine that for payers, including Medicare, that the only issue here is software adaptation. We’re talking about the kinds of things Tom alluded to, the potential necessity of the change coverage policy, the potential necessity to involve actuaries and others in determining whether benefit payments will be increased or decreased as a result of the migration to a new coding system. We’re probably also talking about legal work, contractual work, we’re talking about a wide variety of costs to payers, not just payers but the people who purchase their product would in effect be covering as part of this exercise. But I think that’s important to keep in mind.

The next point I would make relates to benefits, I think there were some very elegant formulas in the Rand report. What I was looking for though was some real world examples. For example in the area of disease management the point is made correctly that there’s a lot of new codes for diabetes in ICD-10 that is not in ICD-9. However, I didn’t see any specific examples of where those new codes would effect clinical decision making, the decision making of disease management companies. It seems to me that in finalizing this report it would be sure nice to get a couple of respected diabetologists(?) together with some disease management firms and see if we can find some specific examples. I think that observation about examples applies across the board on all the so-called benefit categories that Rand looked at. They tell us that well, they’ll be less claims returned. I didn’t see a single example of where ICD-10 would in fact lead to that and I think the benefit in the report itself would really be improved and I think it would help all of us to do a better job of assessing the reasonableness of the estimates that were found there.

The last point I’d make and it’s the one that I think my members have been stressing to us is to the extent any changes, any significant changes are made in coding, they really stress the need for adequate time for everybody in the system to prepare, to adapt, to do the necessary work. And I know, as more then a decade ago that HCVA, then HCVA, started this whole process with 3M of trying to develop a new ICD-10-PCS and I think there might be this temptation that we’ve been at this so long lets flip a switch and lets do this tomorrow. I think that would be a very serious mistake and I think that’s the main message that my members will want me to leave with you today, if you’re going to recommend a change please allow everybody an adequate amount of time. With that, I don’t have a hard fast number but clearly even the Rand report and my informal consultations with member companies suggest that two or three years may be what we’re talking about here, especially given the experience we’ve just gone through, or actually we’re still going through with the electronic transactions and codesets. And you might remember that earlier on some people thought that could be done much more quickly then I think is actually occurring in reality and I think we should benefit from that.

Let me touch on a very few minor points before I wrap up. The benefit estimate for fewer returned claims that’s in the Rand report indicates that a benefit return beginning in year six of the ten year period, and part of that is the assumption that they’ll be actually increased returns for the first five years of that period. And what we didn’t see there was a very clear delineation of what the costs of that increase return rate were in the earlier years. There may be a benefit arguably down the road, although we still question, we’d like to see some specific examples of how that would come about, but again I think some honesty in cost accounting would be very nice.

The other thing I’d say in terms of the benefit of migrating to ICD-10, the point is made well that will relieve providers from documentation because of the greater specificity of the ICD-10 codes. That always makes our members very nervous because they begin to worry about the increased potential for fraud because again, part of the reasons we’re asking for additional documentation is concerns about fraud and abuse.

And the last point I would make relates to disease management and it goes to things we’ve heard earlier today and that is that we already hear that a number of folks in the system, in particular physicians, are not making full use of the level of specificity available in I-9. I find it hard to imagine why more specificity in I-10 is necessarily going to produce all the benefits that are being discussed and I think that’s one thing that in particular payers really don’t adjust their payment, if we go from one code to many but all many get paid the same amount, I would wonder about data quality over the long term and a lot of related issues.

So to close up I think the two points I would leave you with, I think we encourage you and others to continue the process of identifying and estimating the benefits and costs associated with any change in the coding system. I think reports that AHA and AHIMA, the Blue Cross/Blue Shield Association, the AMA, all of those who presented today I think help us all and we certainly hope to be able to continue to help in that process as well. And the last point is the one I said before, please, enough time so the whole system can adjust. And with that I’ll stop, thank you very much.

DR. LUMPKIN: At this point we’re going to take about 15 minutes for questions and if there are any of the prior panelists who are also present we can take them for both panels.

Henry if I can just sort of pin you down because I’m keeping a little scorecard, and I don’t know what to enter in your little slot for CM and PCS.

MR. DESMARAIS: And the reason is we’ve not taken a formal position on adopting them but I think that the key point is one I’ve left you with and that is that if there’s going to be a significant change that enough time needs to be provided. I think our members are saying they can accommodate, they can adapt, but they need time and obviously the amount of time may depend a little bit on what CMS will or won’t do because certainly the DRG system is something that other payers piggyback on or adapt or use in one way or another. So there are a couple of things that are a little unsettled here, and also the question would be when will this take place and will it be only after we’re pretty comfortable with the electronic transactions and codeset requirements that we already have, or if we’re going to start the clock tomorrow they might have a slightly different answer about how long that would be. And I’m sorry I can’t give you a we’re for or we’re against, but I think the timing is the most thing.

DR. LUMPKIN: I can almost guarantee you that if this occurs it will occur with all deliberate due federal speed. Like HIPAA in 1996. Okay, Kepa.

DR. ZUBELDIA: Since this is a reactor panel I’d like to hear your reaction about an idea that hasn’t been expressed today but has been expressed a number of times to the Subcommittee on Standards and Security. You’ve talked about implementing this on a certain date, on a date certain, and I question the implementation on a date certain by both payers and providers and then see what happens the day after the big bang. I think that’s a very risky proposition that we’re now experiencing with HIPAA on the TCS side. What would be your reaction to an implementation where either the payers have to implement it first or the providers have to implement it first, or there is some sequencing of implementation from payers to providers or vice versa, along a sequence rather then everybody at the same time?

MR. GUSTAFSON: I’ll leap in here where angels fear to tread. I think it would be completely impractical to imagine a system where you would turn switches on different parts of it on different days. In order to manage the DRG system we need to have the diagnosis and the payment codes in line at the same time as there was some discussion earlier. Your question related to providers versus payers, well it’s the payers who are paying the providers, so we need to be in sync in terms of when we’re going about this. We have experience with making changes of this sort and in fact we revised the codes every year on October 1st, it’s a much smaller scale operation to be sure, but picking up on Henry’s point, with a sufficient lead time so that everybody is used to the idea this is coming and as a second point here, one which we’ve been having some trouble with in the HIPAA transaction world, is sufficient testing. So one of the things, one of the lessons I think the entire health care sector learned from the Y2K experience is you can’t just assume that your trading partner is going to do it right, whoever that partner is, you have to test it, you have to do dry runs, you have to do it at various levels repeatedly for a number of months in advance of such a change so that provider, if we’re going to say October 1st of thus and such a year is the year when this is going to happen, providers need to be assured that the payer systems will be ready on that date, and they need to be assured more then just people like me getting up in suits and saying yeah, all’s okay, you need to have concrete on the ground testing of that. And it works the other way as well, that the payers need to be assured that the providers are paying attention, that they’re coming along, and the way to do all of that is run test files through, run actual claims through and see if they blow up the system and all that sort of thing and do it far enough in advance that people have a chance to react and correct the errors before you wind up with a melt down.

MR. DESMARAIS: I’ll just add two things, I think one key concern for payers is how long they need to maintain dual systems because there’s a huge cost and complexity associated with that so that’s why there’s some attraction to doing it at a certain period of time and then they probably would have to run dual systems anyway for the kinds of examples that were being mentioned earlier. There was one other point I wanted to make, I’m sorry I can’t think of it, it will probably come to me in a minute.

MS. LEON-CHISEN: I think that for the reasons that we’ve already heard the payers and the providers have to go together because if a provider changes, there’s nobody to accept that claim, it doesn’t do anybody any good, and on the other hand if the payer is ready and no claims are coming through with the right codes they’ve already gone and made the change. And we’re working with dual systems where they both have to go at the same time.

MR. DESMARAIS: The point I wanted to make was we talk about payers and we talk about providers, we should remember there are clearinghouses in between, for most of my member companies they don’t get any claims from providers directly, they get them all through a clearinghouse. So the clearinghouses are another sort of stakeholder in all this as well as this goes forward. So just an observation.

MS. CLAUSEN: From the data user perspective also it’s more convenient to have a date certain so that we know that all discharge data from October 1st on is new codeset and prior to that is old codeset from an analytic standpoint.

DR. ZUBELDIA: Can I modify my question slightly?

DR. LUMPKIN: Well you didn’t get the answer you wanted.

DR. ZUBELDIA: To have a transition of this sort all jumping with both feet is very difficult and believe me, I understand the role of clearinghouses, I suffered through a clearinghouse for 18 years. I’m sorry, I worked for a clearinghouse for 18 years. What if the providers had a date certain to start using the codes, and the payers would be allowed lets say a year to do mapping, if they need to do mapping, before they are required to convert to the new codes, what if there is a permissiveness in that during the transition where either the providers convert first and the payers can do mapping if they need to do mapping? Or the payers convert first and then the providers convert later? The concern that I have, and this is more to non-providers, non-payers, is that there is not a lot of experience with what’s going to happen with the contracts with these new codes and I can see how the payers would say on October 1st we’re changing to ICD-10, then we’re going to renegotiate the contracts with the employers between October 1st and December 1st or December 31st, have new contracts for new benefits based on the ICD-10, and then on January 1st we find out that the new contracts don’t work and we can’t renegotiate the contracts for another year and we have a collapse. And I think that because of the tremendous, the biggest cost in this transition, I don’t think it’s the administrative costs of changing programs and databases, changing programs and databases and mapping tables are easy to do. The biggest cost is going to be the benefit cost because if you map from an ICD-9 to ten different ICD-10’s, and the ten different ICD-10’s have a different price, guess with me which one will we use most frequently in that mapping. So I think that we need to have some time to readjust the system if necessary before everybody jumps in with both feet. So what’s your reaction to that?

DR. LUMPKIN: Can I maybe sort of ask a question of your question because I think your question confused me. If I understand this right, if what we’re talking about is changing to an ICD-10 system, consistent with our concepts of HIPAA, it means I as a provider provide a code to the payer. Now that payer could choose, because we don’t mandate their internal systems, to collapse those all back into an ICD-9 code and still continue to operate. Is that?

DR. ZUBELDIA: No, they can’t because there is not a one to one mapping, so that payer when they coordinate benefits with the next payer is going to have to still use the ICD-10 code --

DR. LUMPKIN: For the coordination of benefits.

DR. ZUBELDIA: For the coordination of benefits, which is one third of the claims. When that payer reports a payment back to you as a provider they’re going to have to use the ICD-10 code. And since there is not a one to one mapping that cannot happen.

MR. DESMARAIS: I think that you’re putting a lot of things on the table together, I think the payer needs to be prepared to receive this new information because as you heard there are more characters, so even the paper claim forms need to make room for those additional characters and the payer systems need to be able to receive that and even archive it or do whatever. That’s not the same as saying that they’re going to immediately adjust all their payment and coverage policies. Even if I read the Rand report correctly and if they were accurate they said well, CMS might not change its DRG’s classification system right away, whatever that means. So in other words they would be able to take the ICD codes but not necessarily adjust, make difference in their payments.

DR. LUMPKIN: Simon.

DR. COHN: I guess I sort of had two questions and they’re sort of related to both Tom and Henry’s comments. I mean first of all Tom you had mentioned that you’re obviously working internally to develop costs and benefit data in CMS and I guess I was curious, recognizing that October 16th is coming up pretty quickly, you have a sense of when you think that that might be done? And the same sort of question for Henry about when he thinks he’ll have --

MR. GUSTAFSON: I’m hesitant to answer the question. In the course of today two of my colleagues have told me two not fully comporting things about that, so I would like to be able to tell you that we would have it by October 16th but I can’t say that for sure at this point. You know how the government works, I think the chairman pointed that out just a moment ago. I can promise you that we will give you on October 16th a status update with some more detail about exactly what we’re looking at and that sort of thing. Insofar as we have any results to share we’ll share them, I very much want to get to the committee, I am frustrated that we don’t have better information for you at present, I want to get it to the committee as quickly as possible, so we’ll do the best we can but I’m not in a position to be able to give you a more definite estimate on the time of arrival at this point.

DR. COHN: Okay, no, that’s fine, I just wanted to somehow get a sense of when you thought realistically. Now Henry you had commented that you felt that there were certain dependencies or information from CMS would help HIAA plans?

MR. DESMARAIS: Well I think it’s just, since CMS is such a major payer and its decisions on DRG’s, etc., are something that other folks look to, I think the more we know about where CMS is on the ICD-10 issue and what their plans are and what costs they see, I think that may provide something more for our folks to react to then what is in the Rand report today. And I’d have to echo again, Medicaid also we can’t forget, and I think as we know for electronic transactions and codesets, I mean Medicaid programs, many of them are struggling with this in part because of budgetary and staff resource limitations, so I think we do need to be watching for that as well. It’s not just CMS’s decision making with respect to the Medicaid program, it’s the people on the front lines who are actually doing it.

MS. HANDRICH: Could I just have a clarification? What is the sense of the committee as to where we’re going with this now and kind of the timing of all that? Given the press for these answers so quickly.

DR. COHN: I’ll tell you as much as I know, which is sort of plans. The committee is having, the Subcommittee on Standards and Security is having a hearing the last week of October, I believe it’s the 28th through the 30th, and one of those days, which is somewhere in my pile here, is the day that we’ll be talking about ICD-10. Now the question will be of course is whether the subcommittee can come back with a letter on the basis of those hearings for the November full committee meeting. I think there was a hope that that may be possible, I don’t know --

DR. LUMPKIN: Strong desire.

DR. COHN: Strong desire. At this point I’m a little shy about trying to make any promises, but that would be I think optimally what would be great. And we’d obviously love to have you at those hearings, Peggy.

MS. HANDRICH: Maybe I should come. One reaction that I have is simply to suggest that it might be a good idea for CMS to seek the input of states as you’re doing this cost estimate and follow-up specifically on that score. I couldn’t tell if that is, I’m looking at you Tom not knowing if you would be the one to do that or not, not knowing if that is in fact being planned, it would be a shame for CMS to come out with an estimate as to the impact on states that states haven’t felt they’ve had an opportunity to provide some input in.

MR. GUSTAFSON: I agree with you, I don’t know exactly where we are, I know we’re examining the state aspect of this, I don’t know exactly what our plans are in terms of interactions with our state partners on this but let me assure you there will be some.

DR. LUMPKIN: If I could just follow-up on this, this is an issue we’ve had on our plate for some time and that’s the reason why I’m feeling the need that we need to try to come to a decision if possible in November.

DR. COHN: I agree, I’m just listening to reports that may not be surfacing until that week, which are making me a little --

DR. LUMPKIN: Well, there are many things in my life that I’d like to see happen that don’t so it would not be a huge tragedy if this were --

Okay, any other questions? I’d like to thank the reactor panelists, this has been very helpful. Much of the discussion of this has occurred within the subcommittee, it was very important to have this in front of the full committee because if we, keep our fingers cross, do come to a vote in November it’s very important for all of us to understand the very difficult issues that revolve around the decision of whether or not to make a change like this. So thank you very much for coming.

[Applause.]

We now have two letters from the Subcommittee on Populations and just if I can just give a little introductory note on this. One of the things that I’ve spent the last few months since I changed my job is delving into the issue of disparities and with the release of the report from the Institute of Medicine on unequal treatment it’s been fairly clear that there are significant health disparities. Part of the problem, however, is that even when you look at disparities, for instance in asthma, a major measurement of asthma treatment for instance is whether or not children are followed-up after an emergency department visit or a hospitalization. The disparity between African American and the white population is a rate of, is a factor of 100 percent or something like that, it depends on how you calculate it. In other words African Americans are followed-up half of the rate of the white population. But that’s only 40 percent when the target is 100 percent, and so we need to be able to address not only disparities but also overall quality of care and that’s the reason why this issue is coming up, you will see it both in items that are coming forth from the Populations Subcommittee and from the Workgroup on Quality also comes up with very similar recommendations and I think there’s a very organic reason why that is occurring. So with that introduction I’m going to turn it over to Vicky.

Agenda Item: Subcommittee on Populations - Letters to Department - Dr. Mays

DR. MAYS: That’s a very good introduction, thank you. I’ll give a little background before we just jump into the two letters. I think John started us off with part of why you’re seeing this now and part of why we’ve been trying to kind of rush to get this out. There’s also the issue that the report card on health disparities should be coming out I think in, I guess I should say now, maybe beginning of October because I thought it was going to be the end of September but there’s been a lot of discussion about this issue of disparities and I think what’s been really good about the discussion is that the science has been pushing some of this discussion. And so as we present this we can kind of present a lot of this with great certainty in the sense of what the various studies are showing, both from ILM(?) as well as a series of publications that have been in like Lancet(?), and New England Journal of Medicine and JAMA. But we know that there is a need for additional collection of data on race and ethnicity to really be able to talk about the quality of care, so that’s why we’re here today in terms of what these two letters.

Let me give you the background of the letters. As you know from the updates that Population has presented before that we’ve had a series of hearings and in those hearings the two questions usually that we have been focused on is how for example the collection of data on race and ethnicity is working relative to the OMB guidance that has been issued. And then the second is actually to ask questions about what variables beyond just that of race and ethnicity might be important in terms of helping to determine disparities in health status, access to health care, and even health behaviors for racial and ethnic minority groups.

Our letter on targeted surveys is really based on those hearings because the one thing that came out no matter which group that we heard from was that the data that currently exists is not adequate to be able to answer some of these questions. This seems to be particularly compelling for some of the geographically distinct or small group because for them this issue of well, how is the OMB guidance working and they tell you well we don’t have the data, because what will happen for those groups is that in the course of doing a population based survey so few will participate that they don’t have the ability then to do secondary data analysis for their particular subpopulations. So I would say that consistently came up but it also came up, which was interesting for some of the larger groups, you often think about the data that’s collected for African Americans or Latinos as sufficient but what you find is that in the population based surveys even when there’s over sampling we do have some data but if we try and stratify it too much that we then don’t, the numbers are still small enough that we can’t really do some of the more complicated analyses that we’d like to do. So for those groups also I think this issue of having data that would be in sufficient numbers to be able to do more complicated analysis is really important.

The second letter, which is actually looking at the collection of data in terms of race and ethnicity in health plans, really is drawn from extending some of these recommendations about collecting data to health plans and the support from that actually comes from the hearings that have been help by the Workgroup on Quality. And as you actually see in the Quality report that you had in your agenda book is that there are actually a couple of recommendations that focus very specifically on the collection of data in race and ethnicity. I think we thought if we could get those through we would have put them in the letter but I think they’re still just for discussion at this point in time.

I think one of the things we should do because some of you have actually given me comments, and so some of you may not have letters, so I want to make sure, I can see you --

I really appreciated the comments that were received, they’re received with open arms, part of what Populations has been trying to do is to get this stuff out and we’ve been a little under the gun in kind of behind the eight ball here relative to resources, so I’m fine with the comments, people were a little feeling --

DR. LUMPKIN: So anyone who needs the health plan letter, the 6:00 p.m. letter, raise your hand and we can get those to you.

DR. MAYS: John can we then do the health plan letter first because everybody has that one, and then the few people have given me theirs, they’ll recognize their comments.

DR. LUMPKIN: The purpose of this session is that since we do have comments on the letter we’re going to try to get comments for the committee to make changes in the letter and present it to the full committee tomorrow for final passage.

DR. MAYS: Yes.

DR. LUMPKIN: That’s the process.

DR. MAYS: Okay, so we’re dealing with the letter that was in the agenda that’s marked 6:00 p.m.

Dear Secretary Thompson: The National Committee on Vital and Health, should be inserted here, Statistics commends your initiative to eliminate racial and ethnic disparities in health care. Disparities in access and delivery of health care to racial and ethnic minorities are documented by the research community as well as by federal agencies. The need for the collection of adequate and comparable data for racial and ethnic populations is also well documented. Your initiative confirms the need to collect information on the race and ethnicity of individuals in order to manage, monitor, and evaluate programs to prevent disease and promote better health outcomes. So I’m going to stop there, John, is that --

DR. LUMPKIN: Sure, any other comments on that first paragraph? Gene?

MR. LENGERICH: Is there a specific initiative that should be referenced here or is it in general?

DR. LUMPKIN: In general.

MS. GREENBERG: Maybe it should be plural, could be their initiative.

MR. SCANLON: There’s a major objective in the HHS strategic plan, I think some of which encompasses a lot of specifics so I think just calling it initiatives maybe would work.

MR. LENGERICH: I think either a plural or being specific would be helpful.

DR. MAYS: I think it’s probably better to make it plural.

DR. COHN: Maybe make it plural throughout.

DR. MAYS: Sure.

DR. LUMPKIN: Any other comments on that first paragraph? Okay.

DR. MAYS: I just want to make sure. Okay? Thank you. Since we kind of got this quickly here so I haven’t, okay we’re on our second paragraph.

One of the comments of the first sentence is that it seems redundant, so I’m okay about dropping it.

We commend HHS for taking the lead in promoting the collection of racial and ethnic data using the revised OMB standards in the private sector where the Food and Drug Administration, is it where or when, I guess when the Food and Drug Administration issued guidance for industry on the collection of race and ethnicity data in clinical trials for FDA regulated products. We view this as an important first step towards obtaining accurate and timely health related data that can be used to assess progress and achieving goals.

DR. LUMPKIN: Simon.

DR. COHN: I mean my father was an English teacher so I apologize but --

DR. MAYS: No, feel free, it’s going to the secretary.

DR. COHN: I’m not sure that there’s a non- sequitor or what, I guess I’m having trouble, I mean I think it’s very nice to reference this guidance for industry though I’m, is it important that that be referenced?

DR. MAYS: I can tell you what the spirit of it was, which is in the letter we’re talking about public and private health plans and so it was kind of to acknowledge that the Secretary had promoted something in the private sector. But in terms of its tie in to the paragraph above, a little --

DR. LUMPKIN: The tie in could be most recently.

DR. FITZMAURICE: Could I suggest a rewording of it? Something like we commend HHS for taking the lead in promoting the collection of racial and ethnic data. When the Food and Drug Administration issues guidance for industry on the collection of race and ethnicity data in clinical trials for FDA regulated products the revised OMB standards were used, and then we use this as an important first step. But it is a little jumbly in the middle, I gotta admit that.

DR. LUMPKIN: Lets have the subcommittee unjumble it.

DR. MAYS: Okay.

DR. LUMPKIN: But I think the concept is and whether or not we merge the two paragraphs together, we kind of go from that one of the mot recent things was the FDA thing. John, did you have a --

MR. HOUSTON: I was just going to say you could probably just simply say such as using the revised, such as sort of gives an exemplary by example, something that sort of indicates, this is just an example of that.

DR. LUMPKIN: Kind of that lawyerly talk.

MR. HOUSTON: I have to counter to Simon’s father being an English teacher but --

DR. MAYS: Okay, next paragraph.

A major challenge to accurately accessing progress and achieving goals is the general lack of standardized data on race and ethnicity in health care setting. Without these data disparity cannot be assessed. Administrative data from medical service providers is a critical source of information on the race and ethnicity of individuals. However, a uniform data collection infrastructure does not exist. Thus, health plans use a variety of strategies to collect data on race and ethnicity, and then it should be a parens, e.g., administrative data, electronic medical records, enrollee surveys, federal and state enrollment files for Medicare and Medicaid beneficiaries, and data linkages, and then you close the bracket. Most of these efforts, however, have been limited to small subsets of a health plans member, e.g., new enrollees, those with particular health conditions, or a random sample of enrollees. Further, the NCVHS Quality Workgroup has identified significant data gaps through testimony gathered from public and private sector health plans, large employers, and business coalitions, quality oversight organizations, measurement experts, state and federal health data agencies, and other interested stakeholders. In a soon to be released report the workgroup will make recommendations to improve the collection of data on race, ethnicity and primary language data for use in assessing and improving quality in health care. I’ll stop there.

DR. LUMPKIN: Simon.

DR. COHN: I was going to suggest that you delete starting with the word further, I’m not sure --

DR. MAYS: Oh, delete the whole thing about the Quality Workgroup?

DR. COHN: That would be my suggestion, I think you’re, it may be premature to promise a report you haven’t even considered yet.

DR. MAYS: Okay.

MR. HUNGATE: Just to coordinate the efforts --

DR. COHN: The efforts, oh, okay.

DR. MAYS: Well, see we had two recommendations that they had and we just didn’t think we would get them in the letter but maybe once you look at their report this would be like a friendly suggestion. If you look at the report and you really like those two recommendations and we can take and put them in the letter we’ll take them, but they’re really about like HIPAA and we just think it can big discussion.

DR. COHN: The report’s going to be a big discussion.

DR. MAYS: Yeah, so that’s why we decided not to but if promising is going to create a problem and Quality is okay about it then I’m fine.

MR. HUNGATE: The Quality Workgroup worked very hard to get that recommendation moved over to the Populations Subcommittee in their letter but we were unable to do so.

MR. ROTHSTEIN: Another possibility might be just to delete the last sentence and keep the one before that there.

DR. MAYS: Oh, in a soon to be released? Oh yeah, that may be the way to do it. Pretty good people, friendly amendments, I like them, thank you.

DR. FITZMAURICE: Was that delete the soon to be released report?

DR. MAYS: Yeah, that whole sentence, and I think then that, I think we’re more comfortable with that.

Okay, let’s start with the next one. I have a couple of revisions of this one, so I’m not sure exactly where you want to go but I’m going to give you the most radical one first, which is the sentence is too wordy and so it really cuts it back.

The NCVHS recommends that HHS should strongly support public and private sector health plans, and then you put a colon there, and then you say efforts to collect accurate and complete racial and ethnic data in accordance with the revised OMB standard categories as follows.

DR. LUMPKIN: And what’s the alternative?

DR. MAYS: Okay, the alternative would be the NCVHS recommends that HHS strongly encourage and through leadership provide support to public and private sector health plans as defined under HIPAA to collect accurate and complete racial and ethnic data in accordance with the revised OMB standard categories as follows. So those are the two choices. I think the real difference is is whether or not to have as defined under HIPAA. We did have discussions about that when we were working on the letter.

DR. LUMPKIN: I’m not as concerned about the section as defined under HIPAA as much as it changes the tone. To support them in their efforts is different then strongly encouraging them, and after Aetna’s experience I think health plans that may want to make a change are going to be looking for the federal government to do more then to encourage them.

DR. MAYS: So strongly encourage.

DR. LUMPKIN: I mean more then just, support them, they want encouragement.

DR. MAYS: Okay, so I’ll read that one again and then I think we can see --

DR. FITZMAURICE: I don’t understand what HIPAA is in here except to define what a health plan is, and I think people generally know what a health plan is. I would suggest deleting it unless --

DR. ZUBELDIA: I would remove that.

DR. MAYS: Oh, okay.

DR. FITZMAURICE: Unless you mean to recommend that Secretary using the authority of HIPAA mandate the collection of that data, and I don’t think that’s what you mean.

DR. MAYS: No, it wasn’t, it was making sure that they understood the full realm of what we were talking about relative to health plans. So we were using the HIPAA definition of health plan.

Okay, so it should read now the NCVHS recommends that HHS strongly encourage and through leadership provide support to public and private sector health plans to collect accurate and complete racial and ethnic data in accordance with the revised OMB standard categories as follows.

MS. GREENBERG: Do we need and through leadership?

DR. LUMPKIN: As opposed to just strongly encourage and support.

DR. MAYS: Strongly encourage and provide support. Well, I think we thought the leadership, I was going to say, I think if you leave the other in it was really thought that what this is asking for is for the federal government to do something to make it happen as opposed to just say we strongly encourage it but to do things in order to make it happen.

PARTICIPANT: Provide support could be money.

DR. MAYS: Alright, so through leadership is gone, promote racial, ethnic and primary language data collection and reporting and public and private agencies, provide information and expertise, to assist them to accomplish this goal, and to facilitate data sharing among agencies.

DR. COHN: -- or by bullet?

DR. MAYS: What would you like to do John?

DR. LUMPKIN: We can go by bullet.

MR. HOUSTON: Can I ask a question? Are these bullets, maybe I misunderstood but I thought they were specific standard categories that already existed, you were taking them verbatim from some type of OMB circular or something of that sort, is that the case or have you written each bullet sort of paraphrasing the OMB standard?

DR. MAYS: No, these don’t come from a specific place.

DR. COHN: Are these actions? Can I ask an odd question because the recommendation here is that HHS support public and private sector health plans, and this first bullet has to do about public and private agencies and facilitating data sort of among agencies. Are these, how does that relate to health plans?

MS. GREENBERG: Yeah, I was wondering about that, too. I think we’re still talking about health plans.

MS. BEREK: You mean its sharing among health plans or among health plans and Medicaid agencies, CMS, I mean that’s, who do you want them to share it with?

DR. FITZMAURICE: I would think health plans just broad and would cover state Medicaid agencies.

MS. BURWELL: The thought here on facilitating data sharing among agencies, I guess a better word would be the entities involved here in collecting the data, would be state programs in addition to the private sector payer health plan. Entities, that should be, a better word for that would be public and private entities.

DR. FITZMAURICE: Do you mean to restrict it just to health plans or do you also mean providers in there and anybody who might want to collect, when we might want to collect the data, it seems to me this is focused on health plans and to call them entities rather then health plans changes the direction or makes it broader in a bullet when it wasn’t broad at the beginning? I would think that we’d want to say health plans there but I’m not sure.

DR. MAYS: I would say that given the focus is really on health plans that it’s probably better if we say focused in here and make it on health plans because we do have other letters that will be asking about the collection of data on race and ethnicity in other, like in target surveys, Quality Workgroup is coming through with things, so lets, it’s probably better to be more organized than disorganized here.

MS. HANDRICH: Is the sense of it that in the first bullet what is being promoted is the collection and reporting between public and private agencies and health plans?

DR. MAYS: In both public and private health plans.

DR. LUMPKIN: I would like to suggest maybe dropping that last clause and facilitate data sharing among agencies. That either needs to be gone or it needs to be a full bullet that explains it, otherwise it’s a little bit dangerous sitting out there.

DR. FITZMAURICE: You could say that we’re encouraging antitrust behavior.

MS. GREENBERG: You could say facilitate appropriate data sharing.

PARTICIPANT: I think it’s throwing people off --

DR. LUMPKIN: I’m not sure that we even need to have it in there at this point.

DR. MAYS: I was going to say --

MR. ROTHSTEIN: Can we revisit the introduction before the bullets? It seems to me that maybe we need to make that broader to encompass all the bullets because the bullets are sort of wide ranging but the lead in isn’t, so might we want to have something like the NCVHS recommends that HHS strongly encourage and provide support to public and private, for the public and private collection of accurate and complete racial and ethnic data, something like that?

DR. MAYS: The focus is really on health plans.

MR. ROTHSTEIN: Yeah, but the bullets --

DR. MAYS: I’d like to say health plans somewhere, though.

MR. ROTHSTEIN: But I mean, like the second bullet says inform insurers, health plans, providers, agencies --

DR. LUMPKIN: But that’s, the health plans are going to have to collect the data from somebody and the difficulty they’re going to have in collecting the data is that providers are saying they don’t want to --

DR. MAYS: And they don’t --

DR. LUMPKIN: So really provides --

MS. GREENBERG: It’s related to health plans collecting it.

DR. MAYS: I’m sorry? Marjorie, I can’t hear you.

DR. LUMPKIN: We’re beating them up and we’ve stampeded them into silence.

DR. MAYS: The second one, inform insurers, health plans, providers, it’s probably entities, and the general public that data collection and reporting by race, ethnicity and primary language are legal and often required by law. There is public awareness that data collected is needed to achieve HealthePeople 2010 goals and to comply with Title VI non discrimination requirements.

DR. ZUBELDIA: I would include employers in that list.

DR. MAYS: Yes, thank you.

MS. HANDRICH: To me those are two separate points.

DR. MAYS: The employers?

MS. HANDRICH: -- in that bullet.

DR. MAYS: But they’re two different sentences, I’m sorry.

DR. LUMPKIN: Break out the sentences and just have the bullets.

DR. MAYS: Alright, separate bullet. Next one, support research on best practices for collection and reporting of data by race, ethnicity and primary language. Facilitate the collection of racial and ethnic and primary language data in the administration of selected transactions mandated under HIPAA.

PARTICIPANT: I think we should at least spell HIPAA correctly, it’s our responsibility to oversee it.

DR. MAYS: Yes, I have that here.

DR. ZUBELDIA: Vickie, what do you mean by select, the administration of selected transactions, are we talking about payment or enrollment transactions?

MS. GREENBERG: I think it’s really just in selected transactions.

DR. ZUBELDIA: Well, I think it needs to be a little more specific.

DR. MAYS: I was going to say, I think we appropriately didn’t --

DR. ZUBELDIA: I think it needs to be a little more specific.

DR. COHN: There might be a fight on that discussion, that’s the major recommendations in that workgroup report.

DR. ZUBELDIA: So if we’re going to recommend that it be collected on the plane, which is a payment transaction, still we need to have a little more discussion about that. Because it’s not something that changes from plane to plane, although you can learn a new language and so on from one visit to the next. On the other hand, in the enrollment transaction, it’s already there and I’d just take it up. But it’s not according to the OMB guidance, the enrollment transaction has one code for race and ethnicity in the same code. So perhaps what needs to happen here is that instead of such an ambiguous recommendation there needs to be some specific recommendation to make the HIPAA transactions that support race and ethnicity conform to the OMB guidance. And that may get you where you want in a very specific way.

DR. COHN: Kepa, do you think we should say in appropriate HIPAA mandated transactions and that that might solve --

DR. LUMPKIN: I think that’s, see, I’d like to suggest that, that gives us some direction, gives HHS some wiggle room.

DR. ZUBELDIA: Appropriate HIPAA transaction is fine but I think it needs to be the administration of appropriate transactions still is too vague. What is the administration of a transaction?

MS. GREENBERG: We don’t need those words.

DR. MAYS: Okay, lets do this again so that I understand exactly what we’re getting rid of. Facilitate the collection of racial and ethnic and primary language data in the appropriate HIPAA mandated transaction.

DR. ZUBELDIA: I would add the sentence conforming to the OMB guidelines, because the reaction you’re going to get back from X-12 and the DSMO’s is that this is already there and what needs to happen is it needs to conform to the OMB guidelines.

DR. LUMPKIN: So if I could read that, facilitate the collection of racial and ethnic data conforming to the OMB guidelines and primary language, as well as.

DR. ZUBELDIA: The language is already there.

DR. MAYS: Yeah, it’s already there.

MS. HANDRICH: Since this is a question out of ignorance, what is the purpose then of the in accordance with the revised OMB standard categories up above them?

DR. MAYS: Categories are the classification and down here you’re talking about the guidelines.

DR. LUMPKIN: I think it’s a redundancy for clarity.

DR. MAYS: Yeah, the second one sounds a little broader, though. First it’s just to use just the right classification, and the second actually gives you kind of the broader guidelines and broader thinking about how to do this stuff. It’s redundant but I don’t think it’s exactly saying the same thing.

MS. BURWELL: There was a comment I heard here that said that we should, on the last bullet, facilitate the collection of racial ethnic data and primary language in, no, of selected administrative transactions mandated under HIPAA. The emphasis should be on the administrative transactions instead of the administration of selected transactions.

DR. LUMPKIN: That’s correct, so it’s appropriate administrative, I think I would just leave it appropriate transactions. John.

MR. HOUSTON: I know I’m fixated on this but the paragraph that precedes these bullets speaks about NCVHS recommending to HHS that it provide leadership to the health plans to do these things but yet it seems like these are bullets, or at least that one in particular, are bullets that are things that HHS directly needs to do, and maybe I’m reading it wrong. If that is the case then I think that the preceding paragraph needs to be changed. Again, who’s going to take these actions, these bullet actions?

DR. MAYS: HHS.

MR. HOUSTON: Because the paragraph above it says HHS should strongly encourage and through leadership provide support to public and private health, private sector health plans implying that the health plans are the ones then that need to take the bulleted actions. I guess that’s the way I read it.

DR. LUMPKIN: Okay, we could clarify that by putting a period, to revise with the OMB standard. To accomplish this HHS should --

MR. HOUSTON: That I think makes things a lot clearer then.

DR. LUMPKIN: Or something to that effect.

DR. MAYS: Okay.

DR. LUMPKIN: Okay, anything else with the bullets?

DR. MAYS: HHS should specifically, I’m sorry?

DR. LUMPKIN: The last bullet reads, how do you have that read? With all the changes, can you read it?

DR. MAYS: Okay, I’m sorry, I thought you were on the paragraph above. Facilitate the collection of racial, ethnic and primary language data conforming to the OMB guidelines in the administration of appropriate, I’m sorry, in appropriate transactions, in appropriate HIPAA mandated transactions.

DR. LUMPKIN: Okay, just to order, I think you need to put OMB after ethnic, racial and ethnic data because there is no OMB standard for primary language.

DR. MAYS: Oh, okay.

DR. LUMPKIN: So then as well as primary language.

DR. ZUBELDIA: And instead of saying guidelines, use the standard categories like you used to Bob.

DR. MAYS: As well as the OMB.

DR. ZUBELDIA: Standard categories.

DR. LUMPKIN: Standard categories.

DR. MAYS: Okay, that changes it a bit but okay. Okay, to do so would, colon, provide data necessary to identify and correct disparities in health care delivery. Next bullet, conform to eGov health information standards that are part of the National Health Information Infrastructure and the Consolidated Health Informatics Initiatives. Next bullet, increase capacity to study racial and ethnic differences in access to health care, health status and health delivery. And it’s been suggested to make this other one its own bullet.

DR. COHN: Do we need this whole area? I mean usually, don’t our letters typically end with the recommendations? Is there a value added to these particular bullets?

DR. MAYS: I think that when we discussed it we thought it was making sure that it’s clear the realm of what we were talking about.

DR. COHN: I guess I sort of thought it was redundant to have the first couple of paragraphs.

MS. BURWELL: It was initially before the recommendations.

MS. GREENBERG: It was but it seemed like then it took too long to get to the recommendations.

DR. MAYS: Yeah, we wanted to move the recommendations up --

So should we leave this here? I mean before --

DR. LUMPKIN: He gave up.

DR. MAYS: Oh, okay, then the new bullet is facilitate development of culturally appropriate outreach and intervention programs. And then it was said that the last two seemed to be redundant. So would that help you?

DR. STEINWACHS: One question. In the to do so would particularly we’re going to talk to providing tools and increasing capacity to study. How much of this relates to health plans being able to do this or is this just general? Is this like increasing research support or is this the health plans’ capacity to use tools and to do the other things?

DR. MAYS: I think when it was before it was more general, but --

MS. GREENBERG: I like that.

DR. MAYS: You like what?

MS. GREENBERG: I like the idea of emphasizing what this would do for health plans, and particularly the word capacity, to do so would increase the health plan capacity to identify and correct disparities in health care delivery, to conform to eGov standards, and to study racial and ethnic differences.

PARTICIPANT: I think making it health plan specific strengthens it.

DR. MAYS: To do so would increase the health plan capacity, and then we’ll leave it like that.

MS. GREENBERG: And get rid of provide tools, to identify.

DR. MAYS: Oh, to provide data necessary to identify and correct.

MS. HANDRICH: So is the intention then to have it mean that it would conform health plans to eGov health information standards?

DR. MAYS: Conform or increase their capacity.

MS. HANDRICH: The question I was posing is conform who to, if the intent is health plans might it be a good idea to insert health plans in there.

DR. LUMPKIN: I think the intent was to insert health plans in the sentence above that, to do so health plans would.

DR. MAYS: To do so would increase the health plans capacity, and then each of the bullets.

MS. HANDRICH: But their conforming with these initiatives is optional?

MS. GREENBERG: Right now it is.

DR. MAYS: Right, that’s why I said it increases their capacity.

MR. HOUSTON: I guess a little cynicism here. Putting these squarely on the shoulders of the health plans, though, I question whether the health plan really is in a position to identify and correct disparities related to ethnic and racial disparities. I know we want them to collect the data and isn’t it really under the purview of somebody other then the health plans, who are above the health plans, to try then to correct the disparities?

DR. LUMPKIN: See it says in health care delivery and I think that’s the key component. For instance there was a study that was done from 1993 to 2000 in improving the quality of renal dialysis treatment and it dramatically reduced the differences between African Americans and whites in prescribing that. So that’s all within the control of the health plan to do.

MR. HOUSTON: I understand that a lot of these things are in the control of the health plan but I guess part of my assumption is is there’s a large segment of our population that isn’t covered by health plans. Isn’t there disparity in treatment for that population also and isn’t it above the health, maybe the health plan is part of the solution but it isn’t entirely in control of the solution. That’s my only point.

DR. LUMPKIN: And I think that’s what the next letter is going to address. This is focusing on health plans.

MR. HOUSTON: Then I’m not cynical.

DR. LUMPKIN: No, you’re correct.

DR. MAYS: Thank you for the opportunity to comment and make recommendations on this important issue.

MR. SCANLON: Why don’t we just say the opportunity to make recommendations?

DR. MAYS: Okay.

DR. LUMPKIN: Do we have copies of the next letter?

DR. MAYS: Yes.

DR. LUMPKIN: So I would suggest that you read them during the 15 minute break.

[Brief break.]

DR. MAYS: Should I start? There should be a letter, you should have a letter, now this is the one that was sent out by email and at the top it should say draft letter to the Secretary recommending special population surveys, John I hope you’re okay, they took the one that I had out of my hand that was your comments.

MR. HOUSTON: You know who has already commented on it so you just can’t say anything. Am I allowed to leave the room in fact?

DR. LUMPKIN: No, just switch nametags with somebody and then you can --

DR. MAYS: Okay, we’re going to get started.

Dear Secretary Thompson: We are writing in follow-up to our letter of March 27, 2003, concerning the investigation by the National Committee on Vital and Health Statistics, NCVHS, Subcommittee on Populations, to determine the adequacy of federal health data to document and monitor the health of racial and ethnic groups in the United States and its territories. Such data are necessary to monitor the Department’s strategic plan to eliminate health disparities for vulnerable groups. The data can also be used to determine the extent to which Department initiatives are contributing to the health needs of specific vulnerable populations.

DR. LUMPKIN: Questions?

DR. FITZMAURICE: On the monitor the Department’s strategic plan to eliminate, how about to monitor the Department’s strategic plans’ progress in eliminating?

DR. MAYS: Okay.

DR. FITZMAURICE: Because once it’s eliminated it’s over, you want to monitor the progress, it’s not going to be an overnight thing.

DR. MAYS: Progress to eliminate.

DR. FITZMAURICE: Progress to eliminate.

DR. MAYS: Progress to eliminate.

DR. FITZMAURICE: The Department’s progress in eliminating health disparities for vulnerable groups as called upon by the strategic plan at the end.

DR. MAYS: Wasn’t there a, oh, Jim’s not here, wasn’t there a particular reason that we were putting in strategic plan?

MR. LENGERICH: I think that had to do with the strategic plan of HHS, what they’ve come out with as opposed to 2010, right?

DR. MAYS: Yes, it’s HHS’s strategic plan but I thought there was a specific reason we wanted to refer to the strategic plan.

DR. LUMPKIN: As opposed to 2010?

DR. MAYS: Yes.

DR. LUMPKIN: Because I think the strategic plan resonates better in the Secretary’s office.

DR. MAYS: So, there was some reason we wanted to make sure we put it in.

MR. ROTHSTEIN: I have a question. You used the term vulnerable groups, vulnerable populations, vulnerable as I understand it is not a synonym for minority, so it’s your intent to focus on “vulnerable” meaning the homeless and other medically under served groups?

DR. LUMPKIN: Actually that modifier is probably not even necessary. Just eliminate health disparities.

MR. ROTHSTEIN: That would be fine.

DR. MAYS: You lost me John. The data also can be used to determine the extent to which Departmental initiatives are contributing, are you saying to delete that whole thing?

DR. LUMPKIN: No, it’s eliminate health disparities period.

DR. MAYS: Oh, I’m sorry, I was on the second vulnerable one.

MR. ROTHSTEIN: What about the second one?

DR. MAYS: Well, see, that’s the one I was already on. I think I would change it to racial and ethnic groups. Racial and ethnic populations is what I would change it to.

MR. ROTHSTEIN: Well, racial and ethnic minorities. Everybody is a racial and ethnic population.

DR. MAYS: Thank you, that’s true. The single most compelling and recurrent request that the subcommittee heard in its four recent hearings is for the collection and analysis of health data on subgroups of specific racial and ethnic minorities, especially those who reside in small geographic distinct areas. And you can already see the note there of small, there’s another term that’s desired. We can actually just leave it as reside in geographically distinct areas. What it is is that some of these areas are, when you talk about for example American Indians, Alaska Natives, and then some of the areas, in some the population is so small it is actually a small population, so I think it’s a combination, it’s almost a combination of two terms, a very small population, like you may have a population of Samoans and you don’t have data, they may occupy a geographic area but they’re small in numbers.

MR. HOUSTON: Why don’t we simply say then especially small populations who reside in geographically distinct areas?

DR. MAYS: It’s both, it’s both small and geographically distinct.

MR. HOUSTON: That’s what I’m saying.

DR. MAYS: Oh, well then say it again, I thought you it was --

MR. HOUSTON: Including especially small populations who reside in geographically distinct areas. Or no, is that both or --

DR. MAYS: No, that’s one concept.

MR. HOUSTON: Okay, never mind, I see what you’re saying.

DR. MAYS: Especially those from small populations --

DR. COHN: Or in geographically distinct --

DR. MAYS: Or in geographically distinct areas, but then New York thinks its geographically distinct.

DR. COHN: Geographically remote areas.

DR. STEINWACHS: Vickie, is it the issue that population isn’t distributed across the country?

DR. MAYS: Yes, and typically they’re in very specific areas and also sometimes in small numbers.

DR. STEINWACHS: Well then the population is concentrated?

DR. MAYS: Okay, how about that, concentrated.

MR. HOUSTON: Well defined or no?

DR. MAYS: I think we can fix this because we have some language from a previous --

MR. HOUSTON: Is this to say that you could have in downtown LA a very small group, geographically distinct group, that that would also, this would apply to that, too, or you --

DR. MAYS: I’m sorry, I didn’t hear the beginning of what you said.

MR. HOUSTON: I was saying could this apply to a small group that’s in a very distinct area of downtown LA or is this always going to be out in some rural area?

DR. MAYS: In most instances they’re either a small group, and that would be justified why we’d need the data collection, or that for example they are in geographically remote or distinct areas and it’s hard to collect data on them. So downtown LA would be small. Okay, we will fix this one.

MS. HANDRICH: The way you just said it was great.

DR. MAYS: No, I can fix this letter, I can fix this, so we will fix this. These data are urgently needed to adequately monitor the difference in health status and health care quality of the diverse U.S. population.

DR. COHN: Is it this data? These data are? Data is?

DR. MAYS: I’m sorry, did I not read it right? These data are urgently needed to adequately monitor, these data are, it is plural in this letter, that’s all I wanted to know, is in this letter I’ve made it plural. These data are urgently needed to adequately monitor the differences in the health status and health care quality of the diverse U.S. population.

DR. STEINWACHS: Is disparities a better word, disparities in health status?

MS. GREENBERG: I think what you’re saying, though, is if you don’t have data on some of these groups you are not adequately monitoring the health status and health care quality of the diverse U.S. population. I don’t think you need that other word in there. I think if you’re going to adequately monitor this diverse population you need to be able to capture information on some of these groups who are currently not included in data collection.

DR. MAYS: Members of the group who provided testimony, e.g., American Indians and Alaska Natives, Native Hawaiians, Asian and other Pacific Islanders, indicated that the lack of quantitative data not only disadvantaged them in planning and delivery evidence based health care in their communities but also put them at a serious disadvantage in their attempts to compete for state and federal funding, to investigate or enhance the health of racial and ethnic minorities. Speakers made convincing cases for periodic health surveys that could be used by specific racial, ethnic and geographically distinct groups. Anything else in this paragraph?

Based on what the subcommittee learned from these hearings the NCVHS recommends that HHS should:

1) Develop along term data collection analysis and dissemination plan to ensure that the nation’s system for monitoring the health and health care of its diverse racial and ethnic population groups and geographically distinct groups is sufficient in quantity and quality.

2) Devise sampling frames for core national health surveys that would increase sample sizes for racial and ethnic population groups that would support adequate analysis and information dissemination.

3) Conduct targeted special surveys to collect detailed, timely and accurate data on specific small or in geographically isolated populations to better understand target efforts to reduce health disparities. These surveys should use methods similar to the large national surveys so the resulting data can be compared with national data. Use of defined targeted studies to complement and augment the large national studies would in effect provide an integrated national data system that could provide a more comprehensive assessment of the health and health care of the overall population.

4) Develop methods and procedures to allow control access to data from small or geographic locations while assuring expectations of confidentiality of data, enable monitoring the health and health care of geographically distinct populations.

MR. HOUSTON: In one place you used geographically isolated populations, in another you said geographically distinct, I guess consistency is the one thing I noticed there.

MS. HANDRICH: Would you consider having it read that would support appropriate analysis and information dissemination as opposed to adequate, which seems to suggest settling just for adequate?

DR. MAYS: Friendly amendment is well accepted. Okay.

5) Collaborate with states, territories, tribal governments and private foundations and other stakeholders to develop methods, procedures and resources to accurately collect health and health care data on populations who are within their respective jurisdictions, as well as ensure that all jurisdictions are appropriately represented. As a specific example the states require financial and technical assistance to complete the development and adoption of an electronic vital registration and statistics system that would include the implementation of revised U.S. standard certificates of birth and death. This revised system will ensure that the higher quality and more timely data are available for the most basic health events, birth and death.

There are many special considerations for collection of high quality data on racial and ethnic minority groups. In addition to statistical sampling issues these include issues of cultural proficiency, concepts, methods, outreach, selection and training of interviewers, translation issues, and ensuring community involvement in the areas of outreach, dissemination of findings, and analysis and application of the information. Thus it is essential that methodological research be supported to determine the most effective way to meet these goals over time.

We recognize that financial resources are limited but we have found ample evidence that specific populations experience poor health and inadequate health care. Consequently we urge the Department to consider requesting additional funds to support the above recommendation. These recommendations are consistent with those made in a recent General Accounting Office, GAO, report to Congress and in a briefing for Senator Frist, U.S. Senate Majority leader. The NCVHS believes that these recommendations will make a significant contribution to the important HHS goal of eliminating racial and ethnic disparities in health as well as disparities based on other factors. That one I’m not sure about. Thank you for the opportunity to offer these observations and recommendations.

DR. COHN: This is just a question about who did the briefing for Senator Frist, is that a NCVHS briefing or is that a HHS briefing, or briefed Senator Frist?

MS. GREENBERG: GAO briefing?

DR. COHN: Well, it’s a GAO report --

DR. MAYS: It was a GAO report --

DR. COHN: I just wondered what the briefing is, I don’t think we’re briefing --

DR. MAYS: GAO did the briefing.

DR. LUMPKIN: I think we should pull the Senator out.

DR. MAYS: Okay, pull the Senator out.

PARTICIPANT: Since you never use GAO again you might want to take out the acronym GAO in parens.

MR. ROTHSTEIN: I have a suggestion, in number five, the fourth line, as an example states require, I would change that to need.

DR. MAYS: Okay, that’s a good one.

MS. HANDRICH: [Comment off microphone.]

DR. LUMPKIN: Depends on the meaning --

MS. HANDRICH: As a specific example states require.

DR. MAYS: States need.

DR. LUMPKIN: Okay, I think it’s in good enough shape, the committee can do a little crafting and bring it back tomorrow. Great.

DR. MAYS: Thank you very much, I appreciate it.

Agenda Item: NHII Workgroup - Letter to Department - Dr. Lumpkin

DR. LUMPKIN: We have two letters, additional letters to go through. The NHII letters under Tab six.

The National Committee on Vital and Health Statistics commends your dedicated leadership, this is to Secretary Thompson, to enhance the nations health care delivery system through information technology. Your vision aptly emphasized the need for a comprehensive National Health Information Infrastructure to assure quality health care for all Americans. Much progress has been made through initiatives led by your Department, such as the Consolidated Health Informatics Initiative, the licensing agreement to College of American Pathologists for SNOMED, the recently concluded NHII 2003 conference and appointment of a senior advisor on the NHII.

In a recent hearing before the NCVHS NHII Workgroup on January 27th we heard about internet technology from several expert testifiers in the public and private sector, health care sectors. We were told that the present internet, a key technical component of the NHII, will reach capacity within a decade. We also learned about several federal research projects underway that are vital to the development of a coordinated comprehensive NHII. One such interagency program is the Federal Networking and Information Technology Research Development Program, NITRD, a $2 billion dollar federal program. DHHS participation in this program include NIH, AHRQ, other agency participants include Department of Defense, Department of Energy, National Science Foundation. The program is designed to develop and deploy bionetworking technologies on next general internet networks like Internet II. These technologies can enable health care applications, such as medical consultation at a distance, surgical intervention and simulation, facilitation of essential collaboration amongst clinicians, and research as well as migration of care into the home. Anything on those first two paragraphs? Yes?

DR. COHN: Do you want to get rid of recent at the beginning of the second paragraph, since this was in January?

DR. SHORTLIFFE: I had a suggestion here, I think it will, it’s not quite accurate and it isn’t necessary for us to specify Internet II here. It’s really a very separate program from the NGI initiative and I would just have that sentence say that the program is designed to develop and deploy vital networking technologies on the next generation internet, NGI. That’s the name for the federal research program in networking technology.

DR. LUMPKIN: Okay, anything else? Next paragraphs.

These research initiatives, which develop and deploy the leading edge in networking information infrastructures, highlight the complexities in implementing in NHII. Based on the information we heard the health care community needs a larger cadre of researchers and practitioners who understand health, computing, and communications.

DR. SHORTLIFFE: Having made that observation do we want to make any recommendation about it? We don’t, we just sort of plopped that down there and say nothing more. I hadn’t really thought of this when I saw an earlier version of it but there is a potential federal role here in improving the numbers for any such people.

DR. LUMPKIN: Oh, we’re supposed to do Workgroup on Quality, I’m sorry. Marjorie appropriately pointed out that Mary Jo isn’t here, so maybe, so we’ll stop where we are, okay, because I jumped ahead on the schedule because Simon messed everything up by having his letter, and I just wanted to have our letter first but Simon go ahead.

Agenda item: Subcommittee on Standards and Security - Letter to Department - Dr. Cohn

DR. COHN: I think the good news is is that this is a short letter. This is one that should be on the top of your --

DR. LUMPKIN: Should be in front of you.

DR. COHN: Yes, it is a half page letter along with an attachment. Yeah, let me explain this to you though because you’re going to be seeing this a lot over the next several months. These are meant to be sort of cover letters that indicated that we have reviewed the CHI, various recommendations that they are bringing forward and either we concur, we want clarification, or we recommend that it needs to go back to the shop for more work. Now this is as say luckily these are pretty simple recommendations that we’re coming forward with but this is sort of the template letter that you will see and so I’ll read it over. As I said the differences between now and November will be different bullets basically. So let me just read this to you and then we’ll answer any questions, hopefully this will be a template that we can move through pretty quickly as we go forward.

The NCVHS commends you for your commitment to move towards uniform government adoption of clinical data standards that you first announced on March 21, 2003. NCVHS recognizes and appreciates that there is a new momentum to adopt clinical data standards that is driven by you and the Consolidated Healthcare Informatics Initiative. Consequently NCVHS is now working closely with CHI to study, select, and recommend domain specific PMRI terminology standards. We have mutually developed a process that allows NCVHS to discuss in open interactive sessions CHI recommendations first during their proposed stage and then in more depth as part of the CHI Council acceptance. John.

MR. HOUSTON: A couple of points. First of all do we want to say move towards uniform government adoption or strong support for uniform government adoption? Move towards sort of says you’re sort of moving somewhere, what he really I think he came out very strongly in support of was uniform government adoption of clinical data standards. Move towards sort of says it’s an academic exercise that might get through, it might not --

DR. LUMPKIN: Commitment to uniform government adoption.

DR. COHN: Okay fine, friendly amendment. Anything else?

MR. BLAIR: Question. What does the word uniform do for us in that sentence? Why do we need that?

DR. LUMPKIN: It implies consistent.

MS. GREENBERG: It might be better to say government adoption of uniform clinical data standards.

DR. COHN: Okay. Any other recommendations, wordsmithing?

MR. LENGERICH: The part that says, in that same sentence it says that you, is that really necessary, are you trying to emphasize the Secretary actually doing that or is --

DR. COHN: Yeah, I think we want to give him his due on this one.

DR. SHORTLIFFE: The move of the word uniform changed what its modifying and now I’m confused. I thought it was uniform modified adoption, you’re changing it to modify the standard.

MS. GREENBERG: You thought it was to modify what?

DR. SHORTLIFFE: Adoption. Right now it’s uniform government adoption, so it’s suggesting that this is across government, throughout government, that such adoption will occur. By moving it to come before clinical data standards you’re now saying that these are uniform clinical data standards that the government will adopt. The emphasis I thought was correctly on saying this is a multi-agency activity, that’s what CHI is, so I wouldn’t move the uniform, I would keep it where it is.

DR. COHN: Okay, so move it back.

MR. BLAIR: I guess the essence of my question was that if we’re asking for the government to adopt it then I don’t understand why uniform is necessary, and I don’t understand why uniform is necessary if we’re talking about standards which are uniform anyway.

DR. SHORTLIFFE: Not every agency would need to adopt it, you could get, the VA could adopt it, that would be a government adoption of a clinical data standard. We’re saying uniform government adoption, the whole idea of CHI was to try to make sure that all the agencies were on the same page.

MS. GREENBERG: That’s true but if you said like commitment to federal government adoption or something, the problem with uniform adoption is that of course even if the standards are the same they’re not always adopted, I mean adoption isn’t exactly uniform in the sense that, no, I mean you should, once you adopt them they should be the same but you might, it’s not going to be like lock step all at the same moment, it’s as you build new architectures, as you change a system, then you adopt these standards, so I’m a little concerned about this concept of uniform adoption, it sort of sounds like all on October 16th to adopt.

DR. SHORTLIFFE: How about government wide adoption? Take out the word uniform and just say government wide adoption of the data standard, that’s more understandable.

DR. LUMPKIN: Because uniform could apply to the Navy, the Army, Coast Guard, and public health service.

DR. COHN: So it’s now government wide?

DR. LUMPKIN: Okay, are we done with that paragraph?

DR. HUFF: I thought in the last sentence of that paragraph that, I thought in the subcommittee we actually struck first during their proposal stage and then more depth, just strike that whole part so that it just reads we have mutually developed a process that allows NCVHS to discuss in open interactive sessions our recommendations as part of the CHI Council acceptance. Because saying kind of that we did it early and we did it late is just too much detail.

DR. LUMPKIN: Recommendation, strike first during the first stage and in more depth as part of, okay.

MR. LENGERICH: Can I ask a question then also on that first paragraph? What is domain specific? I wasn’t sure and I asked John, he wasn’t sure either, so I guess that’s two of us that need a little bit of clarity on what domain specific is.

MS. GREENBERG: They identified 24 domains and then they adopt standards for each domain.

DR. STEINDEL: I’d like to go back to Jim’s change, could you repeat that?

DR. COHN: Okay, then we’ll go to Stan’s change and make sure everybody’s got it. I think the NCVHS commends you for your commitment to adoption of clinical data standards within the federal health care enterprise that you first announced on March 25, 2003, that’s the way we left it, is that what we want?

DR. STEINDEL: Didn’t the announcement on March 21st also talk about the intent of, the hope that the CHI standards would be adopted via outside of the government as well?

MR. SCANLON: That’s the hope, but I think the adoption is by the federal health care enterprise.

DR. STEINDEL: But we’re talking about the Secretary’s commitment, and his commitment is for widespread adoption of these standards. His mechanism is through the federal sector, so I would like to leave it the way it is and not specifically say in the federal sector.

DR. LUMPKIN: Which way?

DR. STEINDEL: The way it is right now, which is the NCVHS commends you for your commitment toward government wide adoption of clinical data standards that you first announced on March 21, 2003.

MR. BLAIR: That makes sense.

DR. COHN: Now let’s go back to Stan’s comment at the last sentence here, make sure that we have that. Basically we have mutually developed a process that allows NCVHS to discuss in open interactive sessions CHI recommendations as part of the CHI Council acceptance process? Is that what we have?

DR. HUFF: That’s fine.

DR. LUMPKIN: Okay.

DR. FITZMAURICE: Wouldn’t you want to take the comma out after sessions?

DR. COHN: -- the following attached set of CHI domain area recommendations that have been reviewed at both the preliminary and final stages for your consideration. Now do we still want to go preliminary and final stages here since we got rid of that up above?

DR. FITZMAURICE: Been reviewed by NCVHS, take out preliminary and final.

DR. COHN: How about for your consideration maybe? Domain areas for your consideration.

DR. LUMPKIN: Is pleased to present to you our comments on the following attached set of CHI domain area recommendations for your consideration.

DR. COHN: First is the NCVHS concurs with the CHI recommendations for unit domains --

DR. LUMPKIN: Attached.

DR. COHN: Attached.

DR. SHORTLIFFE: That change you made in the lead-in sentence, is that, you have to move for your consideration up after present to you, or present for your consideration our comments on the following attached set of CHI domain area recommendations.

DR. COHN: That’s better, okay. The first bullet is that, second bullet is the NCVHS concurs with the CHI recommendations for lab result content as modified in the attached document. And finally they’ll be a presentation tomorrow morning on demographics domain, which is just placeholder, we will at our discretion either bring that forward or defer it to November depending on what we hear tomorrow morning. And it goes on from there. We’re going to say that the next stage if formal government acceptance, NCVHS feels that as noted above the CHI Council recommendations should move on to that stage. We’re excited about the value of this continuing process and pleased to support it.

MR. HOUSTON: That whole paragraph NCVHS is pleased to present to you, it just seems, I don’t know, I’m not sure, it just doesn’t sound right, I mean we’re making a recommendation correct? So let’s just simply say based upon our involvement we recommend.

DR. STEINDEL: John we’re not making a recommendation, that’s why it’s worded this way. We’re actually providing our advice on the CHI recommendation.

MR. HOUSTON: Then we should simply say our advice is that you, it just seems like, pleased to present to you for your consideration, I don’t know, if we’re providing advice.

DR. STEINDEL: I’m just questioning the word recommendation.

DR. LUMPKIN: And he’s questioning whether or not we’re pleased. I think the point, and I think it’s an appropriate one, is it’s a little bit flowery.

DR. COHN: Let me get rid of for your consideration, maybe the NCVHS is pleased to present to you our comments on the --

MR. BLAIR: Simon, it was the word pleased that he is uncomfortable with. Why don’t we just say we would like to --

MR. HOUSTON: Or advise is is that --

DR. LUMPKIN: The NCVHS presents you our comments on the following attached set of CHI data recommendations for your, presents to you for your consideration.

DR. STEINDEL: I would just say Simon, John, the NCVHS presents to you our comments, just take out the is pleased part.

DR. LUMPKIN: We can just simplify and say the NCVHS has the following comments. I mean the fact that we’re sending them a letter sort of makes it obvious that we’re presenting it to them. We have the following recommendations.

MS. GREENBERG: I think you want to indicate that the NCVHS has reviewed these at both preliminary and --

DR. LUMPKIN: We scratched that --

MS. GREENBERG: Well you want to at least emphasize that you have reviewed them.

DR. LUMPKIN: Right, but that’s in the paragraph in the sentence just above.

DR. MAYS: Are we finished with that one, I want to go to the last paragraph?

DR. LUMPKIN: Okay, anything else, Peggy?

MS. HANDRICH: I’m going to the last paragraph, too --

DR. STEINDEL: John, could you repeat the final wording on that, the second paragraph? The NCVHS --

PARTICIPANT: -- has the following comments on the attached set of CHI domain area recommendations.

DR. LUMPKIN: Thank you. Last paragraph.

DR. MAYS: It is our understanding that the next stage is formal government acceptance. NCVHS supports the CHI Council recommendations being formally accepted. We are excited about the value of this continuing process. I didn’t like stage was the only thing, and we feel, I was trying to make it we’re supporting --

DR. FITZMAURICE: Is the next stage adoption of these standards?

DR. MAYS: Yes.

DR. FITZMAURICE: Instead of accept.

DR. COHN: Steve, do you have that, Peggy, did you have any additional comments? Steve, can you read that sentence over what you have?

DR. STEINDEL: I have two sentences. We understand that the final stage is formal government adoption, NCVHS supports as noted above the CHI Council recommendations. We are excited about the value of this continuing process.

DR. COHN: Is it the final stage or is it the next stage? I think next stage --

MS. GREENBERG: We understand the next stage is formal government adoption, which the NCVHS supports.

DR. LUMPKIN: Yeah, that’s cleaner.

DR. ZUBELDIA: Simon, is there a possibility for us to not concur with the CHI recommendations?

DR. COHN: There is and obviously we’re sort of destroying the template, but we’ll obviously have to come up with different, I mean there are going to be recommendations where we say geez, this really isn’t ready, you need to take it back. It may be tomorrow morning, so when we come back, when we see what demographics --

DR. ZUBELDIA: But in that case it won’t be a letter to the Secretary, it will be going back to CHI. We would not just have a letter to the Secretary, it would just go back to CHI.

DR. COHN: We’ll figure this out as we go through.

DR. LUMPKIN: You’ll see this template tomorrow with the real last dot point, either it will be there or not be there. The hope is is that when other letters come up again that we will not need to discuss anything but the dot points. Unless we get a new member, you get a new idea, hey.

Okay, so we’re going to move forward, thank you Simon. The attachments will be made available for people to look at if you want to look at where the modifications that are recommended are. Please do so before tomorrow, or before tomorrow’s session.

We’re now going to have a structured discussion --

MR. HUNGATE: By definition a structured discussion.

DR. LUMPKIN: Yes, on the evolving Quality report, and who is that sitting next to you?

MR. HUNGATE: You have to introduce yourself.

DR. LUMPKIN: Just for the folks on the internet.

MS. COLTON: Cathy Colton and I’m functioning as a consultant to the Quality Workgroup.

DR. LUMPKIN: Now I would have thought that you had learned your lesson from Lisa, it ain’t over until the report’s done.

MS. COLTON: I have learned.

DR. LUMPKIN: But we appreciate you agreeing to work with us on this as we’re trying to get this report out after all of your significant effort leading our activities as a committee and moving forward the Quality agenda, so thank you.

MR. HUNGATE: I think you for coming also Cathy.

Agenda Item: Workgroup on Quality - Discuss Proposed Recommendations - Mr. Hungate

MR. HUNGATE: We have in the report that is in section three a sum total of 21 recommendations as it ends up because there are four that are added in section three following that. I think it’s important to think about where this report fits in the spectrum of things. I’ve been working on that in my own understanding and I think I’ve got a place that I think it belongs. It’s following the reports on the reports on the National Health Information Infrastructure and the Strategy for Statistics for the 21st Century, those are both very big structural reports of things that are important and are going forward. What you see here is much more a snapshot of current day realities of paper and needing to do some things today that you’d like to do with the national health information system later but you don’t have it, and so you need to take advantage of what systems you have now to improve quality.

The focus here really ends up being quite narrow and it’s hard for me to tell whether the recommendations that show up here are the same kind of recommendations that show up in some of our other discussions. It’s a pretty wide ranging approach to the issues of quality today. Of the 21 recommendations there are 12 that relate to data content of which six of those have to do with risk adjusting. There are four that relate to data standardization of which two have impact on risk adjustment. Two relating to functionality requirements for electronic health records and three relating to data linkage.

Now in the pages that you have in section three there are really two places where the recommendations appear. They appear beginning on page 21 in the form of information followed by recommendation, and then later on page 38, 36, excuse me, they appear in the form of just a recommendation with a rationale behind it.

Now as I look through our list I know it will be impossible to do the kind of wordsmithing we’ve just done on the letters that we’ve gone through, it’s not going to work. We’ve got roughly 35 minutes remaining before 5:00, there are 21 recommendations, we can’t spend a lot of time on these yet the Workgroup itself needs your input on where we are here, because in fact we’re trying to put down recommendations that we think are supportive of either group because most of the testimony has been here. So that’s what we need from you. Now Cathy is here to help as we go through it, I think what we ought to do is read the recommendations fairly quickly or will that take too much time?

DR. LUMPKIN: Well, I think the issue is first of all we’re not going to try to deal with the language as much as the substance of the recommendation and it’s whether or not the content of that is a problem.

MR. HUNGATE: Let me think of it this way, too, this is done without respect to politics if you will, it’s done to say what do we need, what are the information needs, what are the gaps. It doesn’t pretend to identify a process to achieve those, and so that’s where it hangs up I think somewhat in the recommendations. Like we refer to ICD-10, obviously that’s bigger then the content of this report.

DR. LUMPKIN: And that should be resolved by the time this report comes forward so it can be synchronized. Peggy?

MS. HANDRICH: Is the goal of, well, is the question that’s on the floor right now what is going to be our process for the whole committee giving reaction to the report in terms of substance? Is that the question we’re addressing right now?

HR. HUNGATE: Partly and also to identify those things where there are real issues, to identify those which are the most critical that need that kind of feedback, which we can then take back to the workgroup and work more on and in dialogue.

MR. BLAIR: When I read the copy in the briefing book over I was really pleased to see the outlining structure of the letter. Somehow it wasn’t clear to me exactly what our recommendation was, I had no problem with the delineation of all of the different methods and techniques for measuring quality, or improving quality, that were there. But what is the specific recommendation that we’re asking the Secretary, specific action we’re asking the Secretary to make? If I know that then I’ll feel pretty comfortable with giving some discretion on the list that you’ve come up with.

DR. MAYS: Two questions, one is --

MR. BLAIR: Was there an answer?

DR. LUMPKIN: I think that Jeff there are a series of recommendations and after we get through this process I think we need to sort of walk through them very quickly. Actually there was an answer, I kind of thought it and I’m sorry I didn’t say it.

DR. MAYS: Okay, one is a question, one is a comment. The comment is I don’t know if maybe process wise, because some of these things really break into the subcommittees and whether or not the subcommittees could be charged to work in some liaison fashion to give feedback as part of the process. But at least, I mean that’s the best I can think, but in terms of the question I would like if we have the time to do it to understand for recommendation one, which is on race and ethnicity, because we would have used it but as I understand there’s probably objections but I don’t know what those objections are. So in order to be able to help it would help me to know what it is that may be the difficulty with those recommendations.

DR. LUMPKIN: Okay, Simon?

DR. COHN: I just wanted to stop for a second, I guess maybe I didn’t understand what you were just asking.

DR. MAYS: What I’m saying, process about how to do this maybe there are areas in the recommendations that I think are probably under the auspices of particular subcommittees, and one that would be under my subcommittee would be this issue of race and ethnicity data, but I don’t know what the objections are.

DR. LUMPKIN: And it addresses issues related to the 837 as well as the 834 and the EHR content, and so the issue is, and I think that’s the reason why I bring it up here, those kind of issues where it is a cross cutting issue, we should probably try to resolve or identify how we’re going to resolve them here. Those which are purely within the domain of a specific subcommittee I think can be dealt with by interactions between Quality and that subcommittee. Cathy?

MS. COLTON: I would make a suggestion in that sometimes we were clear about what it was that we thought needed to happen, and less clear about how it should happen, so that in some cases we tried to puzzle through how we thought it could happen but oftentimes we didn’t get it quite right. And those are the particular areas where I think the subcommittees that have the expertise to help us to fine tune the how pertaining to a recommendation would be helpful. And let me give you a concrete example, I’ll take the race and ethnicity recommendations. The workgroup was clear that it wanted to recommend that race and ethnicity data be captured on both the enrollment transaction and the claim transaction. How to do that we made a stab at, but we may not have gotten it right, and it may be that if conceptually there’s agreement that this should happen how it should happen could be worked through by another subcommittee.

DR. LUMPKIN: Simon.

DR. COHN: I do understand your issue, I guess I’m, I first saw this document I guess about, it was a week ago and Bob gave me I guess it was a call and sort of said geez, why don’t you look it, obviously I looked at it on the plane yesterday and I was actually sort of surprised by everything in it. Quite frankly having been here with everyone else I think we spend a lot of time understanding the issues and the problems, but I’d never seen the recommendations for the solution, which I think is what you’re beginning to refer to and it really occurred to me that, for example, if I were a hospital and were suddenly being told that I had to do all the things that are being required here in these various recommendations I might like to be asked about it, about my feelings as a hospital entity that I would now have all of these requirements. So I almost sort of looked at this and I sort of said geez, I’m familiar with the issues that we brought up over the years but obviously these are sort of posited as our recommendations as opposed to these are possible recommendations that we need to investigate further, and I sort of find myself feeling more comfortable with that as a frame for this document as opposed to yes, these are the recommendations and holding hearings on these specific recommendations. I don’t know if others have other feelings about it, I know the race and ethnicity issue is obviously been sort of an explosive one about how to actually get it.

MR. HUNGATE: We actually hardly got by it at the last discussion, we tried to work through the recommendations knowing that we were recommending things that the committee had not really discussed, so that’s the reason for this time to try to get that going forward, and we got stuck and there are other sticking places farther through and so that’s part of what I’m trying to grapple with, how do we deal with that.

DR. LUMPKIN: Stan and then Kepa.

DR. HUFF: Simon is a step ahead of me because this is the first time I’ve had a chance to read it. My first impulse is your intentions are good but yeah, I would like to give you the kind of direction you’re talking about, for instance, you know with test results, I’m fully in favor of sending test results, whether putting them inside of administrative transactions is the right thing I’m not sure because looking at it as an implementer in my own institution it would probably be a lot easier for me to just send you the HL7 message directly clean without having to put it inside of an administrative transaction and then send it that. So I mean there seems to me that there should be some more discussion about the possible solutions to meet the same end. But I’m in agreement with the end so that’s not a problem.

MR. HUNGATE: Yeah, I think we do better on ends here then we do on the rest of it.

MS. COLTON: And that was the point I was trying to make before about how to do it as opposed to what we were trying to accomplish.

DR. LUMPKIN: Kepa.

DR. ZUBELDIA: I have several concerns with this, for the recommendations. One is that this level of micro management of the transactions would be unprecedented, where the NCVHS says we want to change the specific language of a sentence in implementation guide. Also the extra transactions do not lend themselves to this sort of implementation, first it has to be in the standard, then in the implementation guide, so the standard for 4050 is two years old, you can’t change that. So this, the how that you’re asking for needs to be different from what is expressed in here.

Also X-12 has had a lot of debate on this very topic, whether the race and ethnicity should be in the claim or not, the same as other things, should they be in the claim or not, and the conclusion of that debate, which debates never conclude, but the conclusion, temporary conclusion of that debate is that the data element in question is not dependent on the encounter, but is a constant for the patient, it doesn’t belong in the claim, and it should be in other transactions, such as enrollment transactions. Now I understand the difficulty of gathering enrollment information, I know that’s very difficult, but perhaps instead of in the claim it should be in some sort of attachment transaction, it should be something that can be sent once, perhaps attached to a claim, I’m not saying that’s impossible, but to require race and ethnicity in every single claim out of the billions of claims that go through in the country would probably result in very poor quality data because people would react to that by hard coding the information. And if you want great information you probably should not require it from every single claim, it should be the kind of information that you get once --

MR. HUNGATE: Let me try a mechanical approach here to a question. We have the recommendation one, it’s clear to me that there’s input both from Populations and from Standards that needs to be factored into that recommendations. Can we just go down through the list here and identify what cross cutting functionality we need to build into what we’re doing so that we can know what we can do effectively in the workgroup and what we need to work across? Is that a satisfactory?

DR. LUMPKIN: What I’m hearing the suggestion, because I think that because of the cross cutting nature of this, this is going to be different for how we’ve done most everything else that we’ve done. And so it’s going to be important to identify which recommendations people want to own, in other words do subcommittees want to have input into the development of that. Now the way that we can handle that, I mean there are a number of ways, we can have, on those issues which need “refinement” we can have the responsible subcommittee refine that recommendation for the Quality Workgroup. For those issues that require debate, such as the first item, we will schedule time in the full committee meeting to try to come to some resolution, because I don’t see any other way to resolve, we’ve bantered back and forth on whether or not it should be included in each of the claims attachment and I think that that’s not a refinement issue, we’re going to have to decide, are we going to cut on one side of the issue or the other and that’s going to take a full committee discussion. Simon.

DR. COHN: I apologize, Vickie, it was probably a bad idea having Vickie and I sit together because we strategize around the side. I’m probably replicating some of what you were saying but it occurred to me that obviously there’s an executive subcommittee meeting coming up and maybe, to me there’s, I mean this is sort of overwhelming trying to even figure out how to approach, but there are some recommendations that are probably reasonable, don’t need much work, others that probably shouldn’t even be here to begin with and just sort of got plopped here as best I can tell, and others that really need further working. And it might be the executive committee can think about, get advice from their subcommittees and try to figure this out and maybe this is really part of the work plan for next year, trying to make progress on what we need to make progress on. And I agree with you about your issue about race and ethnicity codes, that one is not going to get solved tomorrow, we obviously need to figure out what we want to say about it but beyond that as Kepa was commenting there are actually whole institutions that have been put into place because of HIPAA regulation, agreements between HHS and DSMO’s and all of that that come into play with these things. I mean this is not just NCVHS deciding something or if we do that’s sort of where it ends because it doesn’t go anywhere from here. If we’re really serious about talking about getting something implemented we need to be aware of all of that and think about how best to approach that. But as I said that’s just one issue, that’s one out of 17.

MR. HUNGATE: And I can predict that there’s several more down through here that are going to need the equivalent level of activity.

MR. ROTHSTEIN: Well, I want to follow-up on what Simon said and preface it by saying Cathy, we’ll be seeing a lot of you I think because, I just think this is such a cross cutting issue that we need to do a lot of work on what we want this document to be before we get to the specifics, and that’s where I’m troubled. I’m not sure what the scope of this is supposed to be, whether it’s supposed to be health, information, health information measures, quality, or effects quality, or can influence quality, and I don’t know what exactly the parameters are. I mean when we start getting into issues like patient safety, which is sort of infused in parts, that brings in a whole new area to consider in terms of the incentives and disincentives to share information about medical errors and things of that sort. And so I think what we need to do before we get to the specifics is reach some consensus on what the scope of this project is because it could be immense.

MS. COLTON: I think to do that you have to go back to the charge to the Quality Workgroup, which was very specific here, and it was a relatively narrow focus and one that relates to the role of this committee around advising the Secretary on data standards and data policy. And so it really was focused narrowly on not how do we fix all the problems in health care or how should we measure quality in health care. There are many organizations that are out there doing work in those areas, we felt that the unique contribution that this group could make was to say all of them rely on data to do what it is they’re doing. What are the problems with the underlying data infrastructure, where are the gaps and where are the areas where the underpinnings need to be repaired or fleshed out more in order to provide the information necessary to assess quality and to improve quality. And so it really was very narrowly focused on the data.

DR. LUMPKIN: And in order to carry out that because we knew it was such cross cutting issues, most of the hearings for the Quality Workgroup were conducted in full committee. Vickie?

DR. MAYS: I just want to piggyback a little bit on what Simon and Mark have said but also to put out a concern that I have. I think it might be useful to think about taking some time at the executive subcommittee to figure out what part of this might there just be consensus on and what part of it really requires even being separated out. It may be that we have too much in one place, in one document, you may need like a series of reports and maybe everything isn’t a recommendation. I think taking some time to kind of triage that stuff and decide that might be really helpful because then we can also plan that we need two hours at the March meeting or four hours at, I don’t know, I can’t get beyond March, whatever the next date of the meeting, June I guess. But in doing that what I’m concerned about is this notion of delay of getting this out and I mean part of what we have to think about is that there is going to be a quality report card coming out, right, and so if we’re too late in this it’s going to be another instance of nobody kind of wants our report, we’re kind of, it’s been said, it’s been done, there’s kind of a time at which to ride the wave and we may miss it. So I think we kind of have to balance this with what are some of the things we might be able to do and get out and to kind of be a part of what AHRQ is going to do and then what things might we take serious debate with, have some hearings to come up with something, and then make recommendations on those.

DR. LUMPKIN: Don.

DR. STEINWACHS: Let me pick up on where Vickie left it. It seemed to me as a member of the committee and actually, as a member of the committee but Bob and Cathy get all the credit because I’m the guy who sort of sits out there, reads and says this sounds pretty good and I like it. I think that building on what you were saying Vickie, it would help at least me as a member of the committee to be able to set some priorities for where to focus and this report covers a lot, it’s all very important, each piece I can get up and justify but it might be helpful to say well, the focus ought to be on the national report cord on disparities and on quality, or something that helps sort of say well what are we trying to move ahead first. And maybe the place to deal with that is at the executive committee level and you sit down and talk about it because each of these things, if I talk about paying for quality, which CMS plans on doing some experimentation, that’s a different set of items that will pop up probably as being more critically important then if I’m talking about racial and ethnic disparities and quality or I’m talking about the quality report card.

DR. LUMPKIN: Marjorie.

MS. GREENBERG: I agree with what both Vickie and Don just said but, and I’m not quite sure how this would work out, but I think it’s important to have a single report that does identify and summarize the findings from this broad range of hearings or panel discussions that have been held over a period of five years is it, and the panels were excellent and I think that Cathy and Susan Canaan was also working on this and working with Bob and the group have done a really good job of bringing together these findings. And I wouldn’t really want to see them necessarily piecemeal. I think in developing the recommendations you could have recommendations related to the findings at different levels. For example, on the race ethnicity issues, which we’ve only been talking about probably for 100 years in my memory, quite actively for at least ten or 15 years in this committee, it may be that you can’t reach agreement at this point on exactly what should be recommended. But on the other hand we did seem to get agreement about an hour ago, a statement about facilitating the collection of race and ethnicity in the appropriate transactions. So a minimum of something like that which we already agreed to it seems, I think I heard that right in that letter, could certainly get into this. The issue of the vital signs or whatever, it may be again a more general kind of comment, recommendation like Stan was suggesting that would give some flexibility in the implementation, depending upon where an organization is so that if they have these HL7 message that might be it, or they could use a claims attachment, or maybe some place could be made available on the claim, different options.

But the bottom line would be lets get going on trying to figure out how to do this. There may be other recommendations here that exactly as they’re stated, people are comfortable with, or which as John said maybe coming out of other deliberations until they can fit into here. So I think if possible, I don’t know about November, I mean that was the goal to get this report out by November, but obviously the executive subcommittee isn’t meeting until later in November, but it is possible that you could have a report that would get through the committee in March but that would have all of the findings and in some cases very specific recommendations to address those findings and in other cases more general ones that will require further investigation or even further hearing, and that would be one approach. I mean I guess I would want, I would sort of resist piecemealing this, the findings at least in some general recommendations to address each finding into too many different things because I think it would, as a document I think it could be a real contribution from the committee.

DR. LUMPKIN: I think that as I’m listening to this discussion there are a number of ideas that sort of start bouncing around, and maybe in that regards its been productive. One is that there are certain recommendations that do impact current transactions. For instance the one on being able to have a placeholder to indicate whether or not a secondary diagnosis was present prior to admission, that’s one that needs to find a place in the current transactions.

MS. GREENBERG: It’s in the standard but it isn’t in the guide, that is actually already --

DR. LUMPKIN: Right, but I don’t think we need to, again, if we go towards a goal, the guides are going to be revised on some sort of regular basis, it may not be able to change the guide that’s two years old but it may change the guide that’s going to be published in a year or two. And that’s where we can play a role. There may be those kinds of things which are important for quality which don’t necessarily directly relate to the bill, now we have to think about paying for performance, if that becomes, if those experiments by GE and CMS are successful all of a sudden they have some significance in paying bills. Well, I don’t think we can rely upon the claims attachment to necessarily carry that information, but it wouldn’t be impossible for us as a committee to recommend that there be a separate transaction standard that may relate to transmission of quality information, and it could be generated at the same time as the 837 through the same EDI(?) engine that would just parse out data that may be repetitive but as long as it’s the same engine it doesn’t take anybody’s time to generate that, that’s an idea that we may want to kick around.

And then there’s others which may be more batch data, that plans may want to aggregate or whoever the entity is aggregating the report. So as we start working this through we can get some structure and think outside of maybe more traditional ways that we’ve thought about it in trying to bring a recommendation so that we can take in where the points of resistance are in changing the current transactions, to just thinking outside the box and maybe we might need a second or an additional transaction that would address the issue of quality because quality is not going to go away. Kepa.

DR. ZUBELDIA: John, I think that’s a great idea and I think there are some things that we can do, perhaps a little bit outside of the box of what the committee does. Perhaps we can request the DSMO’s to look at these recommendations and see what their response would be, and perhaps we can have a presentation next week, during X-12, next week X-12 is going to meet from Sunday until Thursday in San Diego, a presentation of half an hour or one hour to X-12 as to what are the requirements that we see for quality that X-12 needs to look into, put it into their implementation guides, whichever way they technically see fit. And that could already get the ball rolling within that environment to make things much easier later because if we’re trying to bypass the standards and organizations and then try to bring it from the top it just won’t work. And perhaps just a totally informally presentation, I could make that presentation, you could make that presentation, I could get you a time and just work it out that way.

DR. LUMPKIN: Marjorie.

MS. GREENBERG: I was just going to mention that actually some of these recommendations or variants of them have already been brought to the National Uniform Billing Committee and the National Uniform Claim Committee by, what’s the name of the group, Arnie Millstein(?) is the person who did it but I’m blanking on the name of his group but it’s a coalition of employers who want to move towards pay for performance.

MS. COLTON: The Consumer Purchaser Disclosure Project. It’s a group of purchasers who are saying they want to pay on the basis of quality, they’re mostly large self insured purchasers who are paying large numbers of claims and want to pay for quality and feel that the data they need are not currently captured on the claims that are coming in to their TPA’s.

MS. GREENBERG: But that is consistent I think with what you were saying because I think those are two of the DSMO’s, but I don’t think anyone has taken anything to X-12 at this point.

DR. ZUBELDIA: I’m going to be there all week, I could make a presentation, if you want to come and be part of the presentation.

MR. BLAIR: I don’t know the answer to this but when we start to think of pay for performance and pay for quality and patient safety and reduced costs this document begins to provide I think very valuable information to begin the discussion, the dialogue, and maybe a new paradigm. And I am not sure whether the best course for us is to assume that our vehicles for improving quality are the current vehicles that we have out there under HIPAA, namely claims attachments and the current reimbursement process. I think this may be the beginning of a dialogue that we could have, an exploration we could have, as to what aspects of improved quality could be implemented within our current structure and if we’re to achieve these quality goals to what extent do we have to participate in imbedding quality into a new reimbursement structure.

MR. HUNGATE: There’s kind of two steps in there I think in that many of these fairly minor on the surface changes, which you could do through X-12, would tremendously leverage the large and growing payer concern about what they’re paying for and whether it’s appropriate or not. And so a lot of these recommendations relate to getting the information so that they can make valid judgments about a difference between one place or another, a difference between one case and another. And that is a part of moving forward in quality improvement, is to use that assessing ability more effectively in the system. And maybe that is best met outside the system, outside this pattern, through the X-12 activity. And if Cathy has time it might be that that would be the best thing to do because she has certainly the knowledge.

DR. MAYS: I think it would be useful, even though we’ve had some of these before, is to put the issue back against, see whether people’s readiness to adopt and move forth on some of this have changed to some extent, and it also I think would give you a sense for us as a committee, we’ll get a I think a sense of where they are, which will tell us kind of what approach would help in terms of moving this forth. So I think if Kepa can get it on the agenda that meeting that they should do a presentation.

DR. ZUBELDIA: I can get it on the agenda, I want to make sure somebody from your subcommittee makes a presentation, from the workgroup, yes.

MS. COLTON: I can’t commit today for next week --

DR. COHN: I guess I don’t in any way disagree with it going and being presented at X-12 or to the DSMO’s or NUCC or NUBC. However, I guess as I look through it, and there’s a lot of recommendations here, many of which I agree with and some of which I really have not decided about, I’m willing to say that. I mean these recommendations have to my knowledge not been vetted, certainly not by the full committee, many of them I recognize because of emails I’ve received or presentations have been made to me, none of which were at the NCVHS --

MR. HUNGATE: 17 of the 21 were in the package last time, we just didn’t get through of them.

DR. COHN: That’s right, and then there are some additional added on --

MR. HUNGATE: Then there are four more that have been added.

DR. COHN: Yeah, so I guess I’m just sort of wondering whether, I mean I guess a question I would ask is is it time to go and represent these to X-12 as these are our recommendations, what’s implementable, or how do we, if we were to go at this point what we would say to them about these?

DR. LUMPKIN: Well, I could see that the presentation would be something along the lines of based upon a series of hearings these are the barriers that are perceived, the data and information barriers that are perceived by the quality community in trying to use access health information for quality purpose. In trying to form recommendations the National Committee for Vital and Health Statistics is trying to get a realistic view of how these barriers can be overcome and what role X-12 could play in overcoming those barriers. And I think each one of these recommendations are based upon a barrier that we can present in that way.

MS. GREENBERG: Without a specific recommendation.

DR. LUMPKIN: Right, without the specific recommendation. It’s a logistics issue, I don’t know if, again, we’ll have to look at whether or not we can actually do it but what I hear is as a methodology we want to try to reach out to X-12 if we can next week, we want to have some more discussion about framing this at the executive committee retreat, perhaps sometime on the November agenda to further flesh this out, looking at recommendations that may bunch into tweaks and out of the box kind of thoughts that we can then move forward through the full committee.

MR. HUNGATE: It would help to get people’s reading of the ones that are here in a category of okay as is, revise, needs serious discussion, I think you suggested a pattern of something like that. There’s a pattern of understanding what’s there that the subcommittee, the workgroup, needs to get feedback on in order to help that discussion.

DR. LUMPKIN: So maybe what we can do is --

MS. COLTON: Would it be helpful to go through the exercise that you just outlined for X-12 here? In other words what were we trying to accomplish, what was the barrier we were trying to address with this recommendation to at least arrive at a point where people either agree that it’s a barrier that needs to get addressed or they don’t. Because then we can move to how to address it.

DR. LUMPKIN: There are a couple of ways we can do that, there’s a process called the Sysco(?) and Ebert(?), which is not a real strong vote, it’s just whether or not this is a barrier that needs to be addressed And we could rapidly go through these just to get a feeling where there’s clear agreement and I’m going to try to reframe if that’s okay each one of these as a barrier. So we’re not going to look at the language of the recommendations, and I’m going to assume that based upon our current activities on the two letters that we believe the collection, the inability to collect in a meaningful way race and ethnicity data is a barrier. Anybody disagree with that? Okay.

Second is primary language. Do we agree that that’s a barrier?

The third is laboratory results, that quality, many of the quality measures, HEDIS and others, are tied into using certain specific laboratory results, whether or not they’ve done an actual results and that is something that’s a barrier, collecting that data.

DR. COHN: I guess you’re including vital signs now, too.

DR. LUMPKIN: No, that’s the next one. This is clinical laboratory results.

DR. COHN: And our concern here is that this needs to be solved separately from any sort of a claims attachment issue or anything like that.

DR. LUMPKIN: Yeah, we’re not getting into how it’s resolved but it’s an issue that we believe needs to be resolved. Michael?

DR. FITZMAURICE: How do we think that these administrative transactions are going to get the information to the eyes of the clinician or the eyes of the patient? How are the lab tests values going to get to the doctor through an administrative transactions as opposed to the --

MS. GREENBERG: To excerpt them.

DR. LUMPKIN: No what we’re talking about is once the provider has the data do we perceive or agree that there is a quality value in moving that data from where it’s collected and analyzed into an organization that would be evaluating that quality, whether that organization be a payer, a purchaser, or a certification group or whatever. Okay.

Vital signs, which is utilized for risk adjustment. Do we agree that that’s of value to look at ways to figure out how we can transmit that?

MR. BLAIR: John, as you’re going down through this construct, at least in my mind, it seems as if it would be helpful if we wind up doing it as near term and long term and in my mind I’m translating near term into the current mechanisms we have for reimbursement versus long term where we’re thinking of this without the current constraints of our current reimbursement system, because I think there’s a lot of thought of how do we reform our reimbursement systems so you get focused more on improving quality, improving patient safety, improving costs, and I feel like this really, we really have an opportunity to begin to lay a foundation for that transition.

MS. BEREK: I’m assuming all we’re agreeing to now is that we ultimately want to do what Jeff has asked for on this issue. So that we’re not saying we want to do vital signs tomorrow or vital signs ten years from now, but that we do believe it is a barrier and therefore we need to begin the process of figuring out how to address the problem and that’s all we’re agreeing to.

DR. LUMPKIN: Yes but I’m just a little bit concerned now having gone through the first through sets that we have now taken all the controversy out of there, and I don’t see any of these recommendations being turned down. In which case this is not a worthwhile exercise.

DR. ZUBELDIA: John, for clarification, this data content issue section, recommendations one through seven, we are talking about sending data from the health care provider to a health plan or data capture entity that can improve quality.

DR. LUMPKIN: Correct.

DR. ZUBELDIA: So they would all be related to the HIPAA transactions essentially at this point as we do the collection today. Now once the data collection improves according to Jeff’s foundation then they could be in different transactions and different mechanisms, but as we do it today they all relate to the HIPAA transactions. I want to clarify that.

DR. COHN: That’s sure what it looks like, that’s just the good and the bad.

MR. HUNGATE: That was the intent of the way these are written.

DR. COHN: So these are all near term recommendations, so we’re not talking about anything long term yet, so what are we voting on, are we voting on near term or are we voting on do we think this is important --

DR. LUMPKIN: I don’t think we’re going to vote. What I’m going to ask that Bob if you can, given this discussion, if you can develop a very short questionnaire that would be emailed to each one of the members so that they should just check near term, long term, don’t even do it, that may be a better way to try to get a little bit more structured feedback on looking at these issues.

MR. HUNGATE: We can do that.

DR. COHN: Also, is there something to indicate importance? I mean some of these things I think are relatively important things that probably wouldn’t be that hard --

DR. LUMPKIN: And add two others, one is relative importance, we can do a one through five scale, is that too much, one to three, high, medium, low, we need to try to cut some on here, we need to sort and determine. And then the second issue is doability, and that is high, medium, or low. In other words the flag on the secondary diagnosis, that may have a high doability given where the DSMO’s are. Race and ethnicity because that’s been battered around so much by the 837 committee, maybe a very low doability, but I think we get some assessment on the doability under the current structure. That may give us the, Cathy?

MS. COLTON: I would like us to sort of think outside the box a little bit because I think a lot of the issues that have been batted around in the DSMO’s have been batted around in the context of what is the information needed to adjudicate a claim. And that we need to broaden that to say what if we’re changing the paradigm here for health providers who reimburse, and that in fact we’re going to pay for performance, and what is the information needed on a claim to support a pay for performance strategy. And that may lead to different answers from the very same people about whether a data element is necessary or not necessary.

DR. LUMPKIN: And I think we’re trying to get to the same place, my thought is is that if you have something, an item, like adding race and ethnicity to 837 which gets a very, very low doability score, then that indicates in order to solve that one we need to do outside the box thinking. So it may have a high value rating, high importance rating, very low doability rating, that would be something we would want to prioritize as lets come up with an outside the box solution to that issue.

DR. ZUBELDIA: Cathy, the way the process works in X-12, essentially you have to present your business case for asking for that data element and the better the business case the more changes you have to get it. In general X-12 is always accommodating the needs of the department, the department has a need, just like everybody else, presents the business case and the business case makes sense, you’re going to get a yes and they’re going to try to accommodate the needs. But you have to come with a business case not just a request to do this without a business case behind it.

MS. HANDRICH: I’m just wondering what our operating assumptions here are? Is an operating assumption that the report is intended to summarize what you heard in all your hearings? Or are we opening it up to other ideas? And Cathy I heard you suggesting basically that we’ll open it up and think about it a little bit differently then perhaps the question had been posed in all those hearings.

MS. COLTON: Actually the question was posed very openly in the hearings and we have in here really does reflect a lot of out of the box --

MS. HANDRICH: So is the intent to simply format feedback that has already been received? That’s the first question.

MS. COLTON: Yes, that was the intent, was to summarize what we heard --

DR. LUMPKIN: But I think the function of the recommendations are to, we summarize what we heard, we process it, and then we make recommendations. So we may bring in additional ideas as we are in the process, as part of our processing, so we’re just not --

MS. COLTON: No, it’s not just that but that certainly is a big part of it. The identification of the barriers as we were discussing them came primarily from the testimony. The suggestion of how those barriers could be addressed came through the processing that John was just referring to.

MS. HANDRICH: If in fact we’re going a little bit beyond the testimony in thinking about just the kind of things you two are both talking about, the second working assumption is are we only talking about barriers that can be remedied through information on a claim? And what I am thinking about is a comment that I made to several of you earlier, in the world of quality as it relates to long term care there is an element of consumer preference and consumer satisfaction that normally information about that would not be solicited on a claim or captured on a claim. Are we going to open it up to topical areas that would go beyond something that would normally be on a claim if we considered them to be legitimate factors that we would encompass in a lexicon of quality?

DR. LUMPKIN: The answer is maybe --

MS. COLTON: We have recommendations that have to do with surveys and we have recommendations that have to do with electronic medical records, we’re not confining ourselves to claims and in fact it’s this processing portion of the activity that sort of led us to say this sounds like it might be addressed through something, some change in the survey mechanism, this is something that we think might be better addressed through some change in administrative transactions. Or this is something that needs to become part of the required functionality for electronic health records as those get processed.

DR. LUMPKIN: The difficulty with the process is and has been that the Quality Workgroup is extremely small, mostly hearings have been conducted in the full committee, and because all of you, this is clearly one of the busiest committees, advisory committees in HHS if not in all of government for one that’s not full time and not paid much, I keep on forgetting others do get paid. But anyway --

MS. GREENBERG: I’ve always said I would worry about anybody who was on this committee for the money.

DR. LUMPKIN: That’s right. Of trying to get you to focus in on the recommendations outside of the time when you actually have to vote on the committee to be part of that process, and that’s the reason why I was thinking of the survey as a way to, in a relatively painless way to identify where those obstacles are, whether or not they’re even worth trying to get over, because we could come up with all sorts of solutions to obstacles but if the rest of the committee don’t even think the problems are worth solving then it’s just going to be spinning wheels. Gene.

MR. LENGERICH: If the survey is still an option on the table I wanted to make a suggestion for it related to the previous comments and that is could there be a place on it also for us members to make suggestions as to how to deal with it? For instance the X-12 committee or the executive subcommittee or a subcommittee could take it on, that there could be a place for a note to be made there.

MS. GREENBERG: The more input the better.

MR. LENGERICH: And then I guess the survey’s going back to the Quality Workgroup and that would give them some additional information, some specific contacts in process to begin working it through.

DR. LUMPKIN: Simon.

DR. COHN: I just want to say I like your idea, John. I like his idea of getting it as a survey.

MS. GREENBERG: As a process the workgroup could kind of come up with the survey and then maybe it could be shared with the executive subcommittee just by email so --

DR. STEINWACHS: Marjorie, do we need OMB approval?

MS. GREENBERG: I thought about that but I don’t think if you survey yourselves --

MR. HUNGATE: Use the executive subcommittee as a pilot.

MS. GREENBERG: That’s another way of looking at it, yeah.

DR. LUMPKIN: Actually this is not a survey, this is a communication between the members. Keep those OMB folks at bay.

MS. GREENBERG: Actually there are no burden limitations on federal employees, we can be as burdened as anyone, when you’re functioning as committee members you’re special government employees.

DR. LUMPKIN: Okay, we’ve got a plan, we’re assuming that by everybody agreeing to this plan that you also agree to turn around this communication fairly quickly.

MS. GREENBERG: The goal would be to get feedback to the workgroup by the November meeting?

MR. HUNGATE: It will have to be sooner then that, we want any more input for the November meeting we’ve got to have something to work on --

DR. LUMPKIN: Now when’s the executive committee retreat?

MS. GREENBERG: The executive committee is meeting November 21st. The full committee is meeting November 4th and 5th, or 5th and 6th --

DR. LUMPKIN: I think I would like to have the results back soon enough to help structure the November agenda. Because otherwise we’ll lose a whole meeting in moving this forward.

MR. HUNGATE: I would appreciate that.

MS. GREENBERG: So it probably should go out in a week with two weeks to respond or something like that.

DR. LUMPKIN: How about a week to respond?

MR. HUNGATE: I think I need to add into this communication a request for thought on what is the purpose of the report, I sense a lot of uncertainty on that and maybe that will come out of the survey, maybe it will be clearer from the survey, but I’m not certain.

MS. GREENBERG: Maybe the workgroup could articulate what you see as the purpose and then have reactions to that.

DR. LUMPKIN: Correct. Okay, we have gone over the schedule but I think this has been a very useful discussion to get this moving. Let me just say that there are a couple of changes to the agenda, which will get us back in shape. The first is that the NHII Workgroup wanted to actually revise the letter before we do any more discussion on it in the full committee, so we don’t need to do that. We are going to now break into the two workgroups and remember that if you’re going to dinner you have to be there between 6:30 or 6:45 or if you don’t make it there by 6:45 you could end up with your seat out in the rain. Now for Simon that would be a new experience but most of you might not like that. So we will reconvene, I just have to apologize, I will not be here tomorrow, Simon has agreed to chair in my stead, the Board of my new job, the Board of Directors of the Foundation is meeting tomorrow. They pay my paycheck because I can’t accept federal funds so I will be there in Arkansas tomorrow.

[Whereupon the meeting was recessed at 5:25 p.m. to reconvene the following day, Wednesday, September 24, 2003.]