[This Transcript is Unedited]
Silver Spring Hilton
8727 Colesville Road
Silver Spring, MD 20910
Call to Order - Dr. Cohn
Patient Medical Record Information Standards: Final Recommendations on Core Sets of Terminologies - Dr. Sujansky
ICD-10 Letter - Dr. Cohn
Planning for Upcoming Meetings - Dr. Cohn
Agenda Item: Call to Order - Dr. Cohn
DR. COHN: Would everyone please be seated? We're going to get started. Okay, while we're dealing with computer logistics we'll get started here. Good morning, I want to call this meeting to order, this is the third day of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. I want to thank all of you for hanging in there all three days. The committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy. I'm Simon Cohn, chairman of the subcommittee, national director for health information policy for Kaiser Permanente. I want to welcome fellow subcommittee members, others here in person, and those listening in on the internet. As always I want to remind to everyone to speak clearly and into the microphone so that those on the internet can hear us.
This morning we focus on a couple of issues, one is that we're going to be reviewing and updating as necessary the PMRI terminology recommendations letter, and I think in some way making sure that this is consistent now with our companion report, and that will take the bulk of the morning. Jeff will be leading that session but we'll all be working together to sort of move through the report and we're obviously very thankful to have Walter Sujansky, our consultant who's been working on this, joining us this morning.
We will also at some point during the morning be taking a final look at our ICD-10 letter going to the full committee next week to make sure that it has the appropriate syntax and content. We've obviously worked on that mostly yesterday.
I want to emphasize this is an open session, those in attendance are welcome to make brief remarks if they have information pertinent to the subject that we're discussion. We'll also try to have time at the end of the session in case there needs to be any just sort of public comment on any of the issues that we're dealing with this morning. Obviously those who are on the internet, we do welcome emails and letters on any of the issues coming before the subcommittee or full committee.
I do want to also comment that we are making some slight changes to the agenda in the sense that right now I think we are intending to go till mid-afternoon with lunch and break, I think based on the amount of work I would be projecting that we will probably go some into the lunch hour but hopefully we will rather then break for lunch hour we will adjourn sometime in the 12:00 to 1:00 timeframe would be my expectation, though we will see as we go along.
With that let's have introductions around the table and then around the room. For those on the national committee I would ask if there are any issues coming before us today for which you need to publicly recuse yourself, please do in the process of your introduction. Jeff?
MR. BLAIR: Jeff Blair, Medical Records Institute, vice chair of the Subcommittee on Standards and Security. I'm a member of AMIA, ASTM, HL7, and HIMSS, and there's nothing that I'm aware of where I need to recuse myself.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
DR. HUFF: Stan Huff with Intermountain Health Care and University of Utah in Salt Lake. I would need to recuse myself from voting on LOINC because I'm a co-chair of the LOINC Committee, but also I have to recuse myself on HL7 because I'm a Vocabulary Technical Committee co-chair, and any issues related to 3M, which includes ICD-10-PCS, because I've been a sometime consultant for 3M.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the committee and subcommittee.
MS. GREENBERG: Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
MS. PICKETT: Donna Pickett, National Center for Health Statistic, CDC, staff to the subcommittee.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.
DR. SUJANSKY: Walter Sujansky, independent consultant and advisor to the subcommittee on patient medical record information terminology standards.
MS. HUMPHREYS: Betsy Humphreys, National Library of Medicine, staff to the subcommittee.
MS. GRAHAM: Gail Graham, Department of Veterans Affairs, staff to the subcommittee.
MS. FRIEDMAN: Maria Friedman, CMS, staff to the subcommittee.
MR. LINCOLN: Mike Lincoln, Department of Veterans Affairs.
MS. WALWORTH: Shelly Walworth, Unicorn Medical.
MR. BROWN: Steve Brown, Department of Veterans Affairs.
MS. ECKERT: Karen Eckert from MediSpan.
MR. ROBINSON: George Robinson, FristDataBank.
MR. NELSON: Stuart Nelson, National Library of Medicine.
DR. LEVIN: Randy Levin, Food and Drug Administration.
MS. PROPHET-BOWMAN: Sue Prophet-Bowman, American Health Information Management Association.
MS. HARPER: Danine(?) Harper, the American Hospital Association.
DR. BICKFORD: Carol Bickford, American Nurses Association.
MS. LESH: Kathy Lesh, the Kevar Company.
MS. FRASIER: Chris Frasier, American Academy of Professional Coders.
MR. DECORNEY(?): Frank Decorney, American Dental Association.
MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.
DR. COHN: Anyone else? And obviously this is Simon Cohn again, I need to also publicly recuse myself in any discussions related to CPT since I'm a member of the AMA CPT editorial panel.
Jeff, you are vice chair in charge of the PMRI issues, do you have a couple comments that you would like to make prior to us delving into our report?
MR. BLAIR: You betcha. First of all I want to thank Walter Sujansky for the work that he has done to assist the subcommittee during this last year essentially, 12 months, 15 months, and also the work on the companion report that Walter has pulled together. I also want to thank Steve Steindel, Steve has provided significant assistance to us, especially in coordinating the language on some of the things that we're going to be reviewing today. Let me give the audience just a slight bit of guidance. If you recall back on, I think it was August 28th, I don't remember the exact date, but in last August the subcommittee met and we reviewed the second draft of the PMRI terminology recommendation letter and we pretty much got through those first five pages, so we have agreement on those, there's a couple little minor editorial changes on those, but the rest of the letter as we start to get into the drug terminologies we found that there were issues that we couldn't resolve at that time. So hopefully we're going to be in a situation now where we can come to consensus on those issues. For those of you, we're trying to get the hard copies available to everybody, that should be up momentarily, the staff is making copies of those as we speak, however, it will be projected on the projector that Walter will be displaying.
In order to have us focus on the remaining issues we're going to start in the section where we left off, so the items that we have finished discussions on in August were our recommendations on SNOMED, recommendations on LOINC, and now we're going to be beginning today on discussing our recommendations for the federal drug terminologies. So Steve, did you have any comments before we start?
DR. STEINDEL: I think that's a good summation Jeff except that of course we probably should pick up a little bit from where we finished yesterday and not revisit.
MR. BLAIR: Oh, thank you, and I really should mention that the subcommittee had a little bit of time yesterday afternoon and we took advantage of that time to look through the letter that was sent out electronically last Friday and that is the reason why the hard copies are being reprinted today for everyone to have, so what you're going to see has been edited a little bit since last Friday, so at this point Walter, can I ask you to begin reading at the point of where it indicates the federal drug terminologies.
DR. SUJANSKY: Sure, since we don't have the paper copies yet, can people read this? Can people on the subcommittee read this? Okay, very good, we should have the printed versions soon.
Alright, so we're picking up here with the federal e-drug terminologies. I'll just go ahead and read this whole section then we can discuss it.
In it's July 2000 report “Uniform Data Standards for Patient Medical Record Information” NCVHS recommended “improvement of drug data capture and use through 1) requiring the Food and Drug Administration to make publicly available in an easily accessible format its National Drug Codes, NDC database registry information. 2) Requiring the FDA to develop a drug classification system based on active ingredients so that all drugs that fall into a given category can be identified by the name of that category. 3) Encouraging the FDA to participate in private sector development and ongoing maintenance of a reference terminology for drugs and biologics that promotes the ability to share clinically specific information for patient care purposes.”
The NCVHS notes today that HHS has made great strides in implementing these recommendations through cross agency partnerships that can serve as an example for future efforts. Because the Food and Drug Administration has regulatory responsibility for approving safe and effective drug products in the U.S., and has engaged in efforts to harmonize drug related terminologies nationally and internationally, it serves as the basic source for terminology and information about drug products. Since our July 2000 recommendations the FDA has been working in partnership with the National Library of Medicine and the Department of Veteran Affairs in an open collaboration within the HL7 Standards Development Organization to address the substance of the above recommendations by 1) NLM creation of Rx-Norm, a non-proprietary vocabulary that represents drugs at the level of granularity needed to support clinical practice. 2) VA creation of NDF-RT, a non-proprietary terminology that classifies drugs by mechanism of action and physiologic effect. 3) Linking the above to FDA drug terminologies that represent medication information required for regulation, formulation, linkage to commercial drug information services, and other special instances of clinical practice.
There's a footnote there that we'll address later.
And 4) taking steps to improve the quality and low cost electronic dissemination of all the linked federally supported drug terminologies.
Next paragraph. Versions of Rx-Norm have been available quarterly for several years through the NLM's Unified Medical Language System, UMLS. It is our understanding that full documentation for Rx-Norm will be available before the end of the year. NDF-RT, currently used in the VA and now available directly from them, will be released in the UMLS in April 2004. Rx-Norm also facilitates the clinical use of associated drug product information in electronic form from the FDA.
MR. BLAIR: Now I believe this is where the next paragraph starts with our recommendation, is that correct?
DR. SUJANSKY: There's one more sentence. Then it begins Rx-Norm, NDF-RT, and the linked FDA terminologies have also been proposed as target U.S. government standards by the Consolidated Health Informatics, CHI, Initiative.
MR. BLAIR: Thank you. I think this is maybe a good stopping point here if people have comments or questions on what you've read so far.
MS. GRAHAM: This is Gail Graham, I just have one, NDF-RT we had talked about yesterday that in the first instance we should spell out what the acronym stands for.
DR. SUJANSKY: I'll find that and do that.
DR. STEINDEL: It's National Drug Formulary --
MS. GRAHAM: National Drug File Reference Terminology.
DR. HUFF: Back at the very start I think we decided to kill the e in the federal e-drug terminologies, just call it federal drug terminologies.
MR. BLAIR: Is everyone able to hear what your comment was?
PARTICIPANT: In terms of the Rx-Norm documentation the first release of that documentation will probably be with the January, with the first version of the UMLS in 2004 since we'll want to make sure that it directly reflects that version, it's the previous sentence, April is correct there, that's referring to NDF-RT.
DR. SUJANSKY: For the end of the year, okay, be available by January 2004.
DR. STEINDEL: Jeff, there was some discussion yesterday about bullet four, taking steps to improve the quality and low cost electronic dissemination of all linked federal supported drug terminologies because later on in the document we call for that to be a function of NLM in general for all PMRI terminologies. And there was a question about whether or not it was needed to be redundant at this point, and the group reached the conclusion.
MR. BLAIR: What do you suggest?
PARTICIPANT: I don't care, I think that here you're referring to activities that have gone on, subsequent to your recommendations, and then later on you're explicitly recommending this happening, going forward, but you could take it either, I don't think it matters.
DR. STEINDEL: I would prefer to be a little bit explicit here, just leave it, I just wanted to close the loose end from yesterday.
MR. BLAIR: Is there any other comments or questions about the text in this section?
DR. COHN: Well, I guess the only question really relates to that item four, and I guess the question is is the way I read this is that this problem has now been, I'm not sure, I'm trying to think of some way of differentiating the taking steps here from the calling for more effort in this area and I'm wondering if we want to somehow, early steps or initiating initial steps --
PARTICIPANT: You could say taking initial steps, yeah.
DR. COHN: And that obviously communicates that we're not handled yet on that area.
MR. BLAIR: Has Walter captured that now?
MS. ECKERT: Karen Eckert from MediSpan. I know we wanted to start with this section but I believe the section before this has three bullet points that reference this section, that I'm not sure we ever changed the header on to either reference this federal drug terminologies or if you want to leave that still referencing Rx-Norm, is this background information --
DR. STEINDEL: Actually that's been changed.
MS. ECKERT: You did change it, okay.
DR. MCDONALD: This is Clem, I had a little trouble getting in, could somebody orient me to which we're on? And it's not very loud at that end.
DR. COHN: Clem, can you hear me?
DR. MCDONALD: I can hear you but not very well, now I did, but I could hear you but all of you are very soft or the speaker is someone far.
DR. COHN: Well, on day three we all tend to get a little soft, we'll try to be a little harsher here. We're on page six going into page seven, we're starting off with the federal drug terminologies. And be aware that we're working on a document that we've already done some wordsmithing on so I think you'll just have to sort of, I don't know if there's any, was he emailed --
DR. MCDONALD: Was this the one sent out last night? I have that.
DR. COHN: I think you're going to have this version hopefully via email in about five minutes per Kepa.
DR. MCDONALD: Oh, well maybe I don't have that. I'll catch up.
MR. BLAIR: If there are no other comments on this section then Walter, can you begin to take us through the actual recommendations --
DR. COHN: Actually, let's look at that footnote first.
DR. SUJANSKY: So again, I didn't want to interrupt in the middle of that sentence, but there's a footnote on the third item, linking the above to FDA drug terminologies, this is where the footnote is, and then the footnote refers to the following text --
DR. MCDONALD: I can't hear Walter at all. It's very broken up.
DR. SUJANSKY: I'm sorry, I'm away from the mic, is that better Clem?
DR. MCDONALD: Yes.
DR. SUJANSKY: The footnote refers to the following text describing the FDA's supported terminologies. “FDA supported terminologies include bullet item four, ingredients, not yet published ingredient name and unique ingredient identifier, UNII. Next bullet, product name and code and packaged product name and code, National Drug Code. Next bullet, manufactured dosage form and package type. And last bullet, the developing terminology for the electronic product label. The FDA terminology set is required by the CHI Initiative for federal agency exchange of drug information and when appropriate may be used as PMRI terminology.
Any comments on that?
DR. COHN: This is actually much better then yesterday where we couldn't, we were having a hard time figuring this one out. I think that the not yet published probably is not in parentheses and probably needs to be at the end or something, or we need to somehow reference --
PARTICIPANT: The whole thing is in parentheses?
DR. COHN: Yeah, I would say that probably is after at the end of the parentheses maybe --
DR. MCDONALD: But they're not yet published in this version, is that going to be true when this gets passed all the way up?
DR. COHN: Clem, that's a good question, I think we need to ask Randy when the, I mean if indeed it's going to be published next week I don't think we have to deal with this.
DR. MCDONALD: Well either that or we say expected to be published on and leave a blank there or something.
DR. COHN: Randy is there an expected publication date?
DR. LEVIN: Well, first the ingredient names are published, so that's already published, and then the unique ingredient identifiers is yet to be published. What we have are first 2,000 that we've generated but we have not yet published those. So it's just the unique ingredient identifier for the ingredients, that has not been published.
DR. SUJANSKY: So we'll move that to the end, correct?
MS. HUMPHREYS: Just stylistically it seems like you can't begin that with four, so you might want to say terminology for, or ingredient names, or just say, you've got ingredient name later on, if you just split ingredient names and unique ingredient identifiers, not UNII, not yet published, maybe that would take care of it, you don't need the first ingredients I guess.
DR. COHN: I think that would help clarify understanding on this one.
DR. SUJANSKY: So we'll delete this, move this to the end --
MS. HUMPHREYS: And make it plural ingredient names, or maybe not, everything else is singular I guess.
DR. COHN: So we're dividing it into two bullets I think.
DR. SUJANSKY: We are? Okay.
DR. COHN: Well, I think that helps with understanding since one of them is there and one of them isn't. Randy, are you okay with that? Okay. And Randy, just to clarify, the UNII should be listed as not yet published as opposed to expected publication date X or anything else like that? Just to make sure that we're being accurate.
DR. MCDONALD: Well not yet published sort of begs a bunch of questions.
DR. LEVIN: We can begin, we won't have the complete list but we can begin publication, would that be --
DR. COHN: We could say initial publication date X, would be one way to handle that.
DR. MCDONALD: If you said something, which will be published in part before X, or leave it blank while we process this through the next level.
MS. AULD: Is it not yet published or not yet publicly available?
DR. LEVIN: We have codes that are not publicly available, not yet publicly available, we have not, they could be publicly available yes.
MR. BLAIR: Are you able to give us some wording that could help us make this more accurate?
DR. MCDONALD: Well, Clem's, what he mentioned, a partial, that would be helpful to --
DR. MCDONALD: Yeah, if we said the early listings or partial listing or, an early version will be available by or before something.
DR. COHN: I think what we should say is not publicly available, first public release scheduled for, is that, am I being inaccurate by that sort of a comment?
DR. LEVIN: That would be fine, it's the date that --
DR. MCDONALD: The problem with saying not publicly available is there may be a three month lag in this coming out, and it also suggests, it begs the question well, what's the use of it.
MS. GREENBERG: If you have a date by which you can say first publicly available by X then you don't need to say not currently publicly available, but then it doesn't lose its currency because, provided you meet the deadline.
DR. COHN: I think Randy's having a hard time with the X date is my sense of it. Randy if you can give us an X date that's fine, if you can't we just have to say not publicly available --
DR. MCDONALD: At least say yet.
DR. LEVIN: I don't have the exact dates.
DR. MCDONALD: Could you make a bet before the end of 2004?
DR. LEVIN: 2004.
DR. COHN: Well, that sounds fine.
DR. SUJANSKY: Change it to be publicly available in 2004?
DR. MCDONALD: I would think you'd say early version would be publicly available in 2004 would be a best kind of statement.
DR. ZUBELDIA: How about expected publication in 2004?
DR. STEINDEL: Just as a point of information when we were discussing the CHI standard with respect to this the CHI standard, which was for information at that point in time, said that they anticipate publication of 2,000 UNII codes by the end of 2003, and during that discussion it was pointed out that that probably would not be met and because of that in the letter that we're writing concerning this CHI recommendation we're asking that additional funding be provided to the Food and Drug Administration to expedite the publication of those. So we've addressed it in the CHI letter.
DR. ZUBELDIA: Clem, you should have this document available via email now.
DR. SUJANSKY: So do we have a phrase, there have been several suggested, how about initial version expected to be published in 2004?
DR. HUFF: And then, so for the next sentence, I wonder shouldn't we break those out so that we have product name and code as one line and then packaged product name and codes as another bullet? I mean those are separate things right?
DR. SUJANSKY: It's starting to make for a rather large footnote, well, I guess it's okay.
DR. HUFF: It's becoming understandable now though.
DR. SUJANSKY: Well, I just wonder if it's something that maybe should be put in the body, we can think about it, leave it as is for now.
DR. HUFF: Yeah, you could make an argument that it should just be part of the body.
DR. SUJANSKY: Any more comments? Are we waiting for Clem to review this?
DR. MCDONALD: Waiting for me?
DR. COHN: No, I think we're waiting for all of us to review it. The next to last bullet where we say manufactured dosage form and package type I guess we have now, I presume that's from the FDA CDR Data Standards maybe or am I mistaken there? Where we reference the, isn't that where that's from?
DR. LEVIN: That's where it currently is.
DR. COHN: Okay, so we need to put that in parentheses then like we did the NDC and not have it marked out. Walter, I was really at the manufactured dosage form and package type and I just think we need to, like we did the National Drug Code above, we need to undelete the FDA CDR Data Standards Manual I think.
DR. SUJANSKY: Need to undelete, so keep it like that?
DR. COHN: Yeah, or in parentheses, however you want it.
DR. LEVIN: You might want to just change the package name code to just package type.
DR. SUJANSKY: And we're still including this last piece here? The developing terminology?
DR. COHN: I'm getting confused about what's there and what isn't.
DR. SUJANSKY: Do you all recall if that was removed?
DR. STEINDEL: No, that was not removed, that should remain.
DR. COHN: Well, that's another bullet though.
DR. SUJANSKY: It's another bullet.
DR. COHN: And it isn't the developing terminology, it's electronic product label, parentheses, under development. Randy, have we accurately reflected the FDA supported terminologies at this point?
DR. LEVIN: Yes.
DR. COHN: Okay, certainly if there's any factual errors here just let us know, as you look at this one I don't think we need to take the full committee's time to wordsmith every aspect of this but we just want to make sure that we're accurate.
DR. STEINDEL: Randy, I have a cleaner version if you want look on mine.
DR. COHN: Okay, is everybody satisfied with this footnote?
DR. MCDONALD: Simon, I didn't hear what you just said.
DR. COHN: I asked Randy if he had factual changes, if there were any factual changes that needed to occur to this footnote, that he should let us know but we didn't need to deal with it in fully committee session, so I just wanted to have him look at it, if there any minor technical references or otherwise that needed to be made for accurate that we were obviously open and would be open probably until next week for that. I'm sure you agree with that.
Okay, everybody okay with this and we can move on?
DR. SUJANSKY: Would anyone like to take a look at it without all the change tracking just to see how it looks or are we fine with the way it is?
DR. HUFF: The only other thing I would say is that for putting, I think it's most understandable to have everything that's an independent thing on its own line and so I mean manufactured dosage form is actually a separate thing again from package type, so I'd make two bullets out of that line you're on right now.
DR. SUJANSKY: Are they both from the FDA CDR Data Standards Manual?
DR. HUFF: Probably, well, yeah, that might be a reason to keep them together I guess.
DR. LEVIN: They're both in the same manual.
DR. HUFF: Okay, well that's a good reason to keep them together then.
DR. COHN: I would observe we don't have anything referencing the product name and code, do we need to have something that represents --
DR. LEVIN: Actually the product name and code and the packaged product name and code, they're all incorporated in the National Drug Code so you can put those, I mean if you want to put them on the same line.
DR. HUFF: That's probably a good reason to put them on the same line.
DR. SUJANSKY: So we'll go back to that?
DR. HUFF: Now are you also Randy, I mean the thing that I don't see here is the codes for the finished dosage forms, that's what you were calling what would be, or is there a better name for what codes that correspond to an exact form of a pill from a particular manufacturer?
DR. LEVIN: Right now usually if there's dosage form there is the same as the product.
DR. HUFF: Okay.
DR. LEVIN: Now occasionally there are multiple finished dosage form in one product so that's, but not on this list is something for the finished dosage form specifically. If you have ampicillin 250 mg. tablet that's the product and the finished dosage form at the same time, sometime though there are two, there's dosage forms like in a birth control product --
DR. COHN: So Randy, what you do is you put in parentheses mg. finished dosage form under product, right beyond product name and code, and that would be National Drug Code right?
DR. LEVIN: Usually the product is just one finished dosage form but not always, so it's not, it's the code is fully the product, not always for a finished dosage form.
MS. GRAHAM: In the CHI recommendation that's the one you had us remove the finished dosage form because of this issue.
DR. COHN: Okay, thank you, okay. Let's move on.
DR. ZUBELDIA: Help me understand this again. The NDC shows the package product name --
DR. LEVIN: The NDC has components that identify the labeler, identify the product, specifically for the product.
DR. ZUBELDIA: For that labeler --
DR. LEVIN: For that particular product which is specific to that labeler.
DR. ZUBELDIA: Identifies the particular product for that labeler, so ampicillin would have different codes for different labelers.
DR. LEVIN: Yes.
DR. ZUBELDIA: So you're not talking about a product name and code, you're talking about, it only makes sense when you combine the product code with the labeler and the packaging code as an NDC, not the pieces, to list both of those in the same line I think it's misleading because you're actually talking about the same thing.
DR. LEVIN: We distinguish, if you have a different distributor it's a different product, even though it has the same, might be a very similar ingredients, the same ingredients is a different product, so a definition of the product, so we would say the National Drug Code, if you take the labeler and the product code together that's a unique identifier, that would be an identifier for products.
MS. HUMPHREYS: I think Kepa is asking what is the difference between the product name and code and the package product name and code.
DR. LEVIN: The package then adds the packaging, so if you have the tablets, 100 capsules in a bottle, that's where the NDC distinguishes that, the product and its packaging both --
DR. ZUBELDIA: So, then let's not call it product name and code, it's a labeled product name and code because it doesn't make any sense without the labeler information for that product. And we still don't have --
DR. COHN: Let's stay away from labels since it's the bottom.
DR. LEVIN: That's our definition of a product.
DR. COHN: Randy, maybe I need to follow up about Kepa's question because I'm a little confused now. It seems to me that the NDC is really the packaged product name and code and I guess I'm having trouble at this moment trying to figure out why we're even referencing the product name and code here at all, because my understanding, I mean first of all it's a little ambiguous what that means --
DR. LEVIN: The National Drug Code has imbedded in it a code for the product as well.
DR. COHN: From that manufacturer.
DR. LEVIN: But that's what --
MS. HUMPHREYS: Is it ever used separately from the full NDC then --
DR. LEVIN: Yes, yes.
MS. HUMPHREYS: So that's the reason.
DR. MCDONALD: I didn't understand there was any meaningful code that anyone could make sense out of that was separated from it. Isn't that just the internally designated code by the vendor, which no one knows what it is for sure?
DR. LEVIN: There are issues with how that product code is generated and that's something that is one of the issues, one of the problems with the National Drug Code.
DR. MCDONALD: But I wanted to make sure everybody understands, it's not usable at the product code because no one knows what it means in any systematic way except combined with the whole long code.
DR. ZUBELDIA: And Randy what we're saying is that product 12345, if I don't tell you who the labeler is you have no idea what I'm talking about.
DR. LEVIN: Yeah, but for me the product code is the labeler code plus the first five digits, four or five digits in the second section, the first two sections, which is the product code and the labeler code combined is what I'm calling as a product code. That is only, each, according to our rules on how you are supposed to use or designate a product code, that would make that code unique for that product.
DR. MCDONALD: Is that the whole NDC code though?
DR. LEVIN: No, then you add the last part of the NDC is for the packaging, so what you essentially have is the first part of the NDC, that's the labeler and the product code together, is unique for the product, then you add the last two digits, one or two digits, is describing how it's packaged.
DR. ZUBELDIA: But we're running into a terminology problem because you call, the first part is the labeler code, the second part is the product code --
DR. LEVIN: No.
DR. ZUBELDIA: That's what he keeps saying.
DR. HUFF: No, that's not what he keeps saying, that's what you keep hearing. The product name is the combination of the labeler code and that second part that uniquely identifies the thing.
DR. ZUBELDIA: But he keeps calling that second part a product code.
DR. LEVIN: No.
DR. HUFF: No, I think he's been very careful not to do that.
DR. LEVIN: If you look at the NDC it has three different numbers. The first and second number combined together equals the product code, the first, second, and third combined together equals the packaged product code.
DR. ZUBELDIA: And the name of the second thing is --
DR. LEVIN: There is a labeler code, there's what called a product code and a package code. The labeler code --
DR. ZUBELDIA: That's what I was hearing.
DR. LEVIN: But that's not what I'm saying though. The labeler code, the way it's used now is that the labeler code plus the product code is equal to the drug product code, that's how it's used and that's how it's to distinguish. Remember also the last digit is also called the package code, that is of course never used as a package code, it's all used with all three components. So if you combine the labeler code, the product code, and the package code, that is the NDC.
MS. GREENBERG: And we expect someone to understand this?
DR. COHN: Randy, I'm actually being reminded by you of why we all have so much trouble with this particular area and why we've called for a new drug terminology.
DR. LEVIN: Can I bring up another issue? All these codes and these names come from a regulation that's quite old and this, a lot of the problems that have been brought up about the National Drug Code need to be corrected, that would require changes in that regulation.
DR. COHN: Okay, let me just ask and I actually want to finish this conversation because somehow this feels like an issue of fact and yet the facts are not completely clear. I guess to my way of thinking there is something called a product name and code, which is really the first two sequences of the National Drug Code, and then there's something called a product, a package product name and code, which is the entire all three sequences of the NDC, is that correct?
DR. LEVIN: That's correct.
DR. COHN: Okay, well why don't we then specify that up there rather then arguing about it and having them under two different bullets, and the first one will say it's product name and code, the first two sequences of the National Drug Code, and the second one is package product name and code and say it full National Drug Code. Is that okay? Is that correct?
DR. LEVIN: That is correct.
DR. COHN: And you're okay with that Kepa? Okay, I think we've all learned something just now.
DR. SUJANSKY: Want to say first two sequences, first two segments?
DR. COHN: First two segments?
DR. LEVIN: That's fine.
DR. SUJANSKY: And now a separate for --
DR. COHN: Yes, for packaged, and then we say maybe the full, complete NDC drug code.
MR. BLAIR: I'm especially grateful that you came up with that solution Simon because I was afraid we were going to wind up with a footnote to the footnote.
DR. COHN: Randy, at some point you probably ought to write an article for publication explaining all of this to everyone, but for the moment we will leave it as a footnote.
DR. STEINDEL: Simon, I do wish to point out that in the CHI transmission letter one of the bullets said that we, let me quote exactly, the FDA National Drug Code process be investigated and improvements identified be expeditiously pursued, and I think we can see why that was put in.
DR. COHN: Are we okay with this footnote at this time?
MR. BLAIR: Are we ready to move on to the next paragraphs, which get to do with our recommendations?
DR. SUJANSKY: Okay, let's do that, I'll read again from the letter.
PMRI core drug terminology recommendations. Based on these developments NCVHS recommends that Rx-Norm and the representations of the mechanism of action and physiologic effects of drugs from NDF-RT be part of the core set of PMRI terminologies. These portions of NDF-RT complement rather then compete with the capabilities of drug knowledge bases that have been developed within the private sector.
Further recommendations. The NCVHS recommends that the --
MR. BLAIR: Let me stop on this one just to make sure that there's no comments or questions or concerns about those two sentences, especially if we have representatives from the private sector.
DR. COHN: Well, we have somebody from the VA raising their hand, Gail?
MS. GRAHAM: Well, I just wanted to confirm, Dr. Brown is here and he just confirmed that this is factually correct, Steve, do you have any comment?
PARTICIPANT: -- they're happy with that last sentence, that these things don't compete with --
DR. COHN: Actually I guess the only question I have there would be the word portions, these sections, maybe we should just leave it alone, forget my comment, I withdraw it.
DR. SUJANSKY: Further recommendations. The NCVHS recommends that the federal government increase funding to the NLM to support the Rx-Norm project and accelerate the development of terminology content, it should read to accelerate, why don't we do that, to increase links to the NDC HIPAA standard and to improve the distribution mechanism to accommodate frequent updates. The NCVHS also recommends increased funding for the FDA's efforts to improve the timeliness and efficiency with which it collects and distributes drug product information. The success of these efforts will streamline the maintenance of Rx-Norm and NDF-RT, enhance their value as national standards for coding medications, facilitate patient safety activities, and improve information dissemination to private sector drug terminology suppliers.
DR. COHN: There's something wrong with the first sentence beyond to accelerate, I guess I'm questioning why anything needs to be beyond to support the Rx-Norm project and to accelerate the development of terminology content period. It may be fine, to increase links to the NDC HIPAA standard --
MS. HUMPHREYS: If you want to end it at the end of terminology content that would be fine.
DR. COHN: Is that okay with everyone? I mean that's where it seems to be sort of --
MS. HUMPHREYS: There is the issue of increasing the distribution --
DR. COHN: Well, maybe, why don't we leave that then, maybe when we get rid of the links to the NDC HIPAA standard --
MS. HUMPHREYS: I gather there was a question yesterday about whether it was necessary to include NLM in this recommendation and I don't actually think it is if you prefer to take it out.
DR. STEINDEL: No, there wasn't a question about that, it was just after the --
MS. HUMPHREYS: I would say you might say increase funding to the NLM for the Rx-Norm project, just to have fewer words in there.
DR. SUJANSKY: And we're taking out this phrase here, about the links to --
DR. COHN: I guess I'm sort of wondering whether it's really increasing funding to NLM, it gets to the NLM or something, for the Rx-Norm project, to accelerate the development of terminology content and functionality and to improve the distribution mechanisms to accommodate more frequent updates.
MS. HUMPHREYS: Well, you're talking about drug terminology here.
DR. COHN: Maybe what we need to do is get rid of that links to the NDC HIPAA standard, I think maybe that solves the problem there.
DR. SUJANSKY: Everyone okay with that?
MS. HUMPHREYS: I would have thought that maybe in this last line that we should be referring, I mean I defer to those in the audience who know more but I think it might be better for you to refer to private sector drug information suppliers, it seems like they're supplying more then terminology.
DR. SUJANSKY: Shall I read it again?
DR. COHN: Yeah, I guess the only question I have is now about the last part of that first sentence, which I'm wondering don't we have other places where we're talking about, well we're talking about both mapping, which I think we've gotten rid of but I thought that there were other places where we were making recommendations about distribution mechanisms, and it says to improve the distribution mechanism to accommodate frequent updates. Is there a place later on where we're talking about --
DR. SUJANSKY: We talked about the role of the NLM in distributing or disseminating the core terminologies, we don't talk about frequency in that section.
DR. STEINDEL: I think, Simon, it pays to call this out separately because the distribution of Rx-Norm may occur at a frequency that's different from the rest of UMLS, it may require special mechanism.
DR. COHN: Well, actually I don't disagree with that, I'm just trying to think of whether the issue here though is improving the distribution mechanism or whether there's something else that relates to enable frequent updates. Is there a distribution mechanism issue here that needs to be solved or is it more that there needs to be enough money to do more frequent updates?
MS. HUMPHREYS: It's just that we have to make a lot of system changes to accommodate the updates, so if you don't want to confuse the issue with more frequent updates, if you don't want to confuse the issue by having distribution mechanism in there then --
DR. COHN: Well, maybe it's the Rx-Norm, so that we can accelerate the development of terminology content and support more frequent updates.
DR. ZUBELDIA: Or to enable frequent updates.
DR. COHN: Will enable more frequent updates. Okay, great. Anything else here?
DR. SUJANSKY: I believe that's all for the drug terminology section, unless there are any other comments about that I'll move on to the next section.
DR. ZUBELDIA: Did you catch the physiologic effect thing in the recommendation in the drug terminologies? Where you have the mechanism of action and the physiologic effect --
DR. COHN: Let's go to the next section.
DR. SUJANSKY: Next section, mappings among core set of PMRI standard terminologies. To form a cohesive internally consistent terminology resource, a core set of PMRI terminologies must be integrated. The mapping relationships should be part of the content of the PMRI terminology standards and maintained in concert with changes to the constituent terminologies.
MS. HUMPHREYS: This is Betsy. I would wonder whether it wouldn't be worthwhile to make some reference to the UMLS in this context --
DR. MCDONALD: Which paragraph are we on?
DR. COHN: We've now moved to mapping, Clem, we're on page 10, mapping among core set of PMRI standard terminologies, there's only one paragraph to that recommendation.
MS. HUMPHREYS: The issue that I see here is that it says the mapping relationship should be part of the content of the core, of the PMRI terminology standards --
DR. COHN: Maybe it should be should be available as part or something --
MS. HUMPHREYS: Well, I mean the issue here is do you want every, I mean it makes it sound like you want each of the standards to be distributed with the relationships to each of them, I mean the issue is that they're all, I think that the appropriate approach to this is that they all should be mapped within the UMLS, not that we should be expecting to have all of these independent mappings with coming out with each one of them, I mean --
DR. MCDONALD: I would agree with that.
DR. HUFF; I agree with that, too, so I think maybe we would have wording say something like the core set of PMRI terminologies will be maintained in the UMLS metathesaurus --
DR. ZUBELDIA: In that last sentence where we say the mapping to the UMLS is to the mapping relationships.
MS. HUMPHREYS: You could say the mapping relationships should be part of the UMLS metathesaurus and maintained in concert --
DR. COHN: That's fine, we have a comment, please.
MR. ROBINSON: George Robinson, FirstDataBank. I agree with the UMLS reference because the copyright protection is already handled through the language of the UMLS and you don't have to address it then in the recommendation.
DR. COHN: Thank you, good point.
DR. SUJANSKY: I think if I could just clarify the language there in that second sentence, the intent of the phrase should be part of the content of the PMRI terminology standards is in this case to explicitly specify that the mappings, of all the mappings in the UMLS those mappings related to these core set of terminologies are part of the PMRI terminology standards, there are other mappings in the UMLS that are not part of the PMRI.
MS. HUMPHREYS: Okay, so I think that probably what we need to do is somehow convey that but still mention that the mappings are in the UMLS metathesaurus.
DR. SUJANSKY: I might suggest changing the second sentence that's been deleted to this integration should consist of mapping in the Unified Medical Language System.
DR. MCDONALD: I didn't hear that Walter, could you repeat it?
DR. SUJANSKY: I was suggesting taking the second sentence, which has been entirely deleted in this version and changing it to this integration should consist of mappings in the UMLS, and then leaving the next sentence as is.
DR. HUFF: I'm fine with that.
DR. COHN: Show us what you're thinking.
DR. MCDONALD: Could I, I mean I'm sorry to be far away and I'm not sure I heard everything, but I think, don't we want, we want to have, we want to use transitivity to accomplish lots of the mappings, correct? That is we want to have one mapped, things mapped to one thing and then if other things want to connect or there's an interest in the connection they're by implication connected through transitivity. And the way this reads it sort of still sounds like pair wise.
DR. COHN: Clem, I actually wish I understood what you just said.
DR. MCDONALD: Well, if you map to a common, let's talk about real terms as it is now, let's say we map to CUI(?), if everything is mapped to CUI they're all mapped to each other. The way this reads it sounds still like pair wise mappings, which would be some other kind of structure within the UMLS, going to be an explicit that what we're really saying is integrated via the UMLS mappings to their common codes.
DR. HUFF: The reason we struck this sentence yesterday was because I really didn't want equivalent concepts that were then mapped --
MS. HUMPHREYS: Well, this is strange language to me as well, I'm now getting this, because the fact is that I think I was almost on to your next topic where I was still feeling that we should mention it in the UMLS context and not separately. But the fact is that when we're through coordinating the PMRI standards we will, the recommended PMRI and CHI standards, we will have, the goal is that there is no overlap among them so it's a question of relating them, not mapping them, in the sense that they somehow are addressing the same content but at a different level of granularity, as opposed to when we talk about relating the PMRI standard terminologies to the HIPAA code sets, well then yes, we're absolutely in the mapping game because they are, in many cases they have the same granularity but in other cases they don't, so you have to go from something that's more specific to more general as somebody who slices the world differently to somebody else. So the issue here it seems to me is you want these to be able to be integrated in such a way and also for people to be able to pull them out as an integrated set and where they do have relationships know what those are, which mapping is kind of a strange name for that in my word.
DR. COHN: This is actually very good because we're actually I think going to change the title here, because I think you're right, that this is different, you're talking about mappings and now we're suddenly talking about different kinds of mappings.
MS. HUMPHREYS: Yeah, and I think that it sort of is more the issue of integration of the core set or relationships between them or something, but it isn't --
DR. HUFF: Or even just creation of an integrated core set or something like that because what you're really doing is throwing away the parts you don't want and making, and relating the concepts together that are left.
DR. COHN: Well let me just ask what words we should use here, we've talked about integrated, there's a word I mean that we don't use very often but I've written on before which is called interlocking, I don't know what the right word is here but it sure isn't mapping.
MS. HUMPHREYS: Your first sentence is correct and it doesn't include mapping.
DR. MCDONALD: Simon, could you get closer to the microphone?
DR. COHN: Me? I'll be eating the fuzz here soon. I was actually just describing that mapping is the wrong word here --
DR. MCDONALD: I heard it but it's a struggle.
DR. COHN: Okay, I thought that the term needed to be integration or interlocking or something, and I don't know what the right word is. Now does integration have any implications that have anything to do with the actual owners of the terminologies?
DR. MCDONALD: I think not, I think that actually integration is what we're talking about and you could get into, I don't know how explicit we want to be about how this, the mechanical details. But part of it is the fact that everything will have a CUI, which kind of in effect accomplishes the linkages where they have the same meaning.
DR. COHN: Clem, I think you're right, we don't want to get that exact, I'm actually thinking that maybe if we have the first sentence as it is and maybe get rid of the word mapping, we'll just say the relationships should be part of the content of the PMRI terminology standards, in that sentence that may do it.
MS. HUMPHREYS: If you just said relationships among the core terminologies.
MR. BLAIR: There's two other items --
MR. HUFF: I think we still want to get this, that these things are part of the UMLS --
MS. HUMPHREYS: Yeah, we still want to get the idea that the relationships are part of the UMLS.
DR. COHN: So Walter, how are you on this?
DR. SUJANSKY: Confused.
DR. COHN: We have just taken the word out mapping from the third paragraph there, talking about relationships --
DR. SUJANSKY: We need to introduce the word relationships earlier so I think in another sentence or in the first sentence to say the integration consists of relationships --
DR. HUFF: In the UMLS, you could say that, yeah, you could make a second sentence that said the terminology will be integrated by creating relationships in the UMLS metathesaurus.
DR. STEINDEL: From a style point of view we don't really call for a role as the holder of this terminology until towards the end of the letter, and it might be better to put that in that paragraph. Or we can put it here. I'm just saying from a stylistic point of view where we introduce the National Library of Medicine and the role of the National Library of Medicine is in a later section of the letter, and we're actually assigning a role here to it.
DR. COHN: Probably, I mean we're going back a step here, I think your sentence is good, it's probably rather then will, probably should be integrated.
DR. SUJANSKY: I would suggest that it's important to have that second sentence here because integration of the terminologies to some could imply that somehow they will be merged into a single terminology, and this clarifies that that is not the intent.
DR. MCDONALD: What's the second sentence now?
DR. SUJANSKY: The first two sentences now read to form a cohesive internally consistent terminology resource the core set of PMRI terminologies must be integrated. The terminologies should be integrated by creating relationships within the UMLS.
DR. COHN: And actually I think the last sentence should be changed to where it says the relationships should be maintained in concert with changes to the constituent terminologies --
DR. MCDONALD: I didn't hear that sentence.
DR. COHN: Okay, the relationships should be maintained in concert with changes to the constituent terminologies, as opposed to saying it should be part of the content of the PMRI terminology standards.
DR. MCDONALD: I don't know what that means.
MS. HUMPHREYS: When the core set of terminologies change the relationships if necessary have to updated among them.
DR. COHN: Pretty basic.
DR. MCDONALD: I don't know if that says any more then it said at the beginning, though, maintain and integrate.
MR. BLAIR: We have somebody who has a comment as soon as we come to agreement on these sentences.
DR. COHN: Well, I just haven't seen that change made, so let's make that change.
DR. SUJANSKY: So we're in agreement on that?
DR. COHN: I think so.
DR. SUJANSKY: Make sure everybody's in agreement.
DR. COHN: Now Jeff, your turn.
MR. BLAIR: The FDA has a comment and then I do, is it Randy?
DR. STEINDEL: Well, actually Jeff I've been, the recommendations for PMRI drug terminologies probably should include in the first line based on these developments NCVHS recommends that Rx-Norm, the representation of mechanism of action and physiologic effect of drugs from NDF-RT and associated FDA drug terminologies be part of the core set of PMRI terminologies.
MR. BLAIR: If we start to include that someone I think would begin to think that we're adding to the core FDA pieces, whereas they're being included and integrated in Rx-Norm and in those two axis of NDF-RT, I guess I sort of feel as if we're starting to move this from some clear delineation to something that becomes very confusing if we wind up looking at the source from the source from the source from the source.
DR. HUFF: I disagree, Jeff, I think the parts from the FDA are the essential building blocks that build Rx-Norm and other things, you don't have the complete picture if you start just with clinical drugs and Rx-Norm and NDF-RT, the definition of the parts that are used to build those things are the essential parts so it's not like you can start at that other level and you know what the other parts are because you --
DR. COHN: Actually, I disagree with you Stan, I guess I'm a little concerned here, I think we need to maybe have a sentence here that talks about the other FDA, whatever was the terminology, core terminologies, and is supportive of it, but I guess I'm, that includes NDC, that includes a whole bunch of things which are critical but I'm not sure that I think they're quite in this bucket. Help explain to me why that, as opposed to mapping of NDC to all of this, why the level of information you're describing needs to be there.
DR. HUFF: In describing a clinical drug you need to know the ingredient, the codes for the ingredients, and if I understand this correctly the FDA is going to be the source for the primary code for the ingredients.
MR. BLAIR: What if we say that instead, and say the source of this information of the ingredients is of course the FDA, which we've already kind of said I thought.
DR. COHN: You think a sentence where it says the critical to these terminologies is adequate support and maintenance of the FDA supported terminologies?
DR. STEINDEL: This would be in the recommendation area, Walter.
DR. SUJANSKY: I was going back to where someone just said we had already said that, so I was jogging up to where we may have already said that.
MS. HUMPHREYS: Yes, you do say it and it is further up, it's the, on page seven of this draft that I have, you are saying because the Food and Drug Administration has regulatory responsibility, etc., it serves as the basic source for terminology and information about drug products.
DR. COHN: So now I am confused, what do we want to do ?
DR. HUFF: Well, maybe we can what, how we think this is going to work and then decide how to word it. But I mean my assumption is that the FDA is the primary source for determining whether something is an ingredient and assigning it a code, and that it would then give those to the National Library of Medicine that would create concepts for those in the metathesaurus if they didn't already exist. I mean to me in a sense, I guess what I'm saying is that I don't see how that's different then LOINC making codes and giving them to the UMLS and putting them in there so it seems to me that the FDA is in fact a source for, is providing concepts that are part of the core PMRI terminologies. Tell me if I'm saying that wrong, Betsy --
MS. HUMPHREYS: I think that the issues is as is pointed out here, and particularly with the ingredient identifiers and so forth which will go into the UMLS, I guess the issue is, which I think I'm hearing, is if you say Rx-Norm do you already have what you need from the FDA terminologies, and I think people would argue that maybe you don't have it all because of this whole list of things, which is what the footnote was referring to Steve, that sometimes this other level of details that is not going to be carried in Rx-Norm is clinically relevant, and sometimes it isn't, but when it is I think the footnote was in essence saying when that level of detail is clinically relevant then it's considered part of the PMRI terminologies, so that's what your footnote already says, I guess what they're saying is we'll making that a little bit more explicit up in the first paragraph.
MR. BLAIR: First paragraph, I think that's --
DR. STEINDEL: Because the footnote already does say that when needed these could be used as PMRI terminologies, and what we're asking is that, to consider is whether it should be made more explicit in the recommendation paragraph.
DR. SUJANSKY: Just for my clarification, in the case of an ingredient for example in Rx-Norm their ingredients are already included, active ingredients with a code, and in the FDA, among the FDA terminology content is a unique ingredient identifier --
MS. HUMPHREYS: And this is going to be I think, somebody can leap up and tell me if I'm wrong, the FDA ingredient identifier is going to be across the board, not only active but also inactive ingredients, and of course the issue of when the inactive ingredient may be very clinically relevant if it does come up, and that's not part of Rx-Norm now, so clearly once that gets off the boards and it start going then if we would be getting in terms of the inclusion of inactive ingredients, if we were in the UMLS, we would be getting them from the FDA because we don't have another source of that information.
DR. HUFF: I mean there are other, the same is true of the package types and those kind of things, they're not part of Rx-Norm but they would be a part of the UMLS metathesaurus and would be part of the core PMRI terminology.
MS. HUMPHREYS: You know that in terms of the UMLS we don't actually intend to have UNII concepts in the metathesaurus sense for NDC codes, we're going to carry that information as an attribute of the Rx-Norm form that is that here are the 100,100 products, package products that actually deliver this equivalent Rx-Norm form.
MR. BLAIR: Let me ask a question here that may be, this could resolve, we already have NDC codes recognized as a HIPAA standard, and when Stan or when Steve you were suggesting associated codes from the FDA, the piece that I felt uncomfortable with was that blurry, fuzzy idea of associated codes. If we could specify that it's active and inactive ingredients from the FDA I would feel more comfortable, does that, no?
MS. HUMPHREYS: Following your line of thinking, Jeff, I would think that you would have to, given that the NDC code is already a HIPAA standard, if you didn't want to restate that, then it would seem to me that you would have to deal with the ingredient names and identifiers and also you would have to deal with the manufactured dosage form information, which is also sometimes clinically relevant I believe. Clearly the electronic product label may in the future be very relevant but since that's under development I think that would be a little difficult to declare as a standard at this point.
DR. MCDONALD: What's at issue?
DR. COHN: I think Clem was asking what's at issue and I'm sort of struggling myself, I think what's at issue is, I was going to say is I think what's at issue is whether we radically expand our drug terminologies to basically, I think what we might as well do or consider is basically just attaching as an appendix the CHI recommendations in their entirety as an appendix and reference them I think is sort of what's beginning to feel like, and I don't mean to overstate that but I guess I'd have to ask others at the table what about these recommendations are different from what everything that was accepted by CHI, and that may be fine but I think that is really the discussion right now. We're talking about adding, I think we've talked about maybe not adding NDC codes but maybe, and once again just sort of doubling or tripling what we've been describing as the core drug terminology to include the FDA CDR Data Standards that relate to manufactured dosage form and package, the UNII as well as ingredient names, is that, am I --
DR. MCDONALD: But I thought we already did that, didn't we?
DR. COHN: That was CHII, that was not here.
DR. MCDONALD: Well, I thought we did that in the earlier page that we were discussing.
DR. COHN: That we actually said that that was part of the core terminology?
DR. MCDONALD: Well what were we talking about in this whole document?
MS. HUMPHREYS: Your language as it currently is stated in this footnote does indeed say --
DR. MCDONALD: On page six --
MS. HUMPHREYS: And when appropriate may be used as PMRI terminology. That's the last line of the footnote.
MR. BLAIR: Maybe I missed that. The last line of the footnote says --
MS. HUMPHREYS: The FDA terminology set is required by the CHI Initiative for federal agency exchange of drug information and when appropriate may be used as PMRI terminology.
MR. BLAIR: That's different then saying it's part of the core set of terminology standards.
DR. HUFF: How does it, it seems to me we're struggling with words, nobody's disagreeing about how it's going to be used, and I don't know why we're having trouble saying that it's part of the core if that's how we're going to use it, which I think it is. Actually I think if everybody understands how it's going to happen what we say is less important.
DR. BROWN: I think what we say here is probably important to FDA and although we have a common understanding of what it may be we're going to be using for instance their ingredient names as part of the core, let's say so, help them get their job done, they have enough battles to fight, and it's a way of showing support for them, too, which I think is entirely appropriate.
DR. COHN: Well, Steve, since you're there let me ask you a question, Steve, do you want to go back to the microphone so you can respond? Is the issue here that it needs to be part of the PMRI core terminologies or do we need to say something about the critical importance of the FDA terminologies to support the PMRI core terminologies, and as we said with the CHI recommendations the need for that to be adequately funded.
DR. BROWN: I think it's both honestly.
DR. COHN: This particular area might benefit from us taking a ten minute break and coming back to it, and I'm going to suggest since we're into this about an hour and a half it might be appropriate to take just a brief ten minute break and we can come back together at 10:10.
[Brief break.]
DR. COHN: We're restarting the session here, I hear there's been some suggested wording that we can consider in the drug terminology area. Steve, did you have something you wanted --
DR. STEINDEL: Yeah, the suggested wording for the recommendations that has developed during the break was based on these developments NCVHS recommends that Rx-Norm, the representations of the mechanism of action and physiologic effect of drugs from NDF-RT, and ingredients, manufactured dosage form, and package type from the FDA be part of the core set of PMRI terminologies.
DR. COHN: Okay, are people satisfied with that? Stan are you okay?
DR. HUFF: I want more but I'm satisfied.
DR. MCDONALD: I'm satisfied.
DR. STEINDEL: This is a consensus, everyone can live with it. We do have a minor, Mike Fitzmaurice, our keeper of the current phraseology on stuff, in the footnote for the FDA where we say the FDA terminology is required, CHI doesn't require, it recommends.
MR. BLAIR: And may I add one other piece? And Walter, where you have the heading for this section --
DR. SUJANSKY: For the recommendation section?
MR. BLAIR: Yeah, tell me when you get to it.
DR. SUJANSKY: Okay.
MR. BLAIR: I just want, throughout the letter we refer to the core set of PMRI terminologies, sometimes we add the word standards at the end, core set of PMRI terminology standards, but I think there the word standard is inserted prior to terminologies, let's be consistent and have core set of PMRI terminologies, and if standards is added then it's at the end.
DR. SUJANSKY: Okay, it is not added in this particular place, add it or, are you suggesting that I add it or if it were there it should be --
MR. BLAIR: I'm sorry, I thought that I heard it before, so anyway if you could just follow that convention then we'll be consistent throughout the letter.
DR. ZUBELDIA: Steve, in this new insertion, instead of ingredients are we talking about ingredient names?
DR. STEINDEL: Yes.
DR. SUJANSKY: To be consistent we should probably say ingredient name.
DR. COHN: Are we okay? Okay, now I think we were, let's move forward into the mappings again, and I think we've dealt now with the integration of the core set of PMRI standard terminologies, is that correct? Okay, now we're into mappings to important related terminologies?
MR. BLAIR: Yes, next section.
DR. SUJANSKY: Okay, mappings to important related terminologies.
NCVHS also recommends that the federal government recognize an additional group of terminologies as “important related terminologies”, and that the government promote the creation and maintenance of mappings between these terminologies and the core set of PMRI terminologies specified above. Although these terminologies did not meet the NCVHS criteria for inclusion in the core PMRI terminology standards their use in important administrative and clinical processes will continue and should be compatible with the recommended PMRI standard. The NCVHS asserts that compatibility of the core set of PMRI terminologies with these important related terminologies specifically in the form of mappings will enhance the value and accelerate the adoption of PMRI terminology standards.
The NCVHS recommends that mapping to the important related terminologies be prioritized as follows, priority one, terminologies previously designated as HIPAA medical code sets, and then a bulleted list, reading CPT-4, CDT, level two HCPCS, ICD-9-CM, NDC, as discussed above. Priority two, terminologies in common use as enablers of important health care functions. These terminologies include but are not necessarily limited to, a bulleted list, DSM-4, FirstDataBank NDDF+, ISBT128 Coding System for describing blood products and tissues, Medcin, codes for structured entry of clinical notes, Medra, international code set for use by drug regulatory agencies, MediSpan drug knowledge base, Multum Lexicon drug knowledge base, nursing terminologies not otherwise included in SNOMED CT.
That is the end of that section.
MR. BLAIR: Comments, questions?
DR. COHN: Well, slight wordsmithing, I don't think under NDC where you say as discussed above, I think I might get rid of the as discussed above.
DR. SUJANSKY: Did we remove that part or --
DR. COHN: Yeah.
DR. MCDONALD: I'm sorry, I didn't hear what you were saying to remove.
DR. COHN: This is just a wordsmithing piece, it's just under priority one we have NDC and we ought to just leave it as NDC, there is an additional comment that is not necessary.
Other comments, Michael.
DR. FITZMAURICE: The last bullet, nursing terminologies not otherwise included in SNOMED CT, do we mean all nursing terminologies, some nursing terminologies, or we don't know what they are but as they come up they should be included? It's the only one that's not specific in that list.
MR. BLAIR: I think it's the latter really because, the latter is there are nursing terminologies being developed now which may be appropriate candidates that are not already included in SNOMED.
MS. HUMPHREYS: But your whole thing is predicated around things that are in common use.
MR. BLAIR: Good point.
DR. FITZMAURICE: So maybe qualify it by saying some nursing terminologies.
DR. COHN: Other nursing terminologies in common use.
MS. AULD: I believe there's only one nursing terminology that isn't already in SNOMED CT.
MR. BLAIR: Which one is that?
MS. HUMPHREYS: But there is all this other issue about how much of the terminology is in SNOMED CT and how much isn't, this is quite a complicated issue. There are many and I think I've got it correctly that in many cases, in some cases all the concepts from the nursing terminology are in SNOMED CT but not necessarily the exact names that appear in the nursing terminology, and in other cases both the names and the concepts are there, and in a lot of cases, I think most cases, the codes, all cases perhaps, the codes are not there, so it is sort of a somewhat complicated thing. So I can understand why you wanted to use a nice general phrase like this.
DR. FITZMAURICE: But should it be there or should we qualify it?
DR. COHN: We have a comment from the floor here.
PARTICIPANT: Just a comment, we have three of the proprietary knowledge bases on drugs mentioned by name and the fourth one is not, so I would suggest that if you're going to include them by name that we include Micromedex.
DR. COHN: Good point. Anyway back to the nursing, how are we going to handle this one, do we say nursing terminology, other nursing terminologies in common use, is that the way we want to leave this, is there some better wording here? Carol, thank you, I was wondering when we would have your comments on this.
DR. BICKFORD: Carol Bickford, American Nurses Association, perhaps you would want to expand it to not limit it only to nursing, but look at is as other health care providers, for example, OTPT's, speech and hearing language folks, may identify some common terms that have not yet moved, they may be using common language but it's not included someplace, so I'm suggesting that that might be a better approach. I'm just putting it on the table for discussion.
DR. MCDONALD: Can I comment? I would almost think you'd want to have something specific bullet for nursing terminologies and if there's need for more have another bullet.
DR. COHN: So Clem you're suggesting common, nursing terminologies in common use not otherwise included in SNOMED CT, and then another bullet that says other commonly used health care terminologies not otherwise specified, NOS? NEC?
DR. STEINDEL: Stylistically I oppose that.
DR. COHN: I'm sorry, Clem.
MS. HUMPHREYS: I have to say something that I think I've said earlier on this same point, that I understand your interest in including these other terminologies and I agree --
DR. MCDONALD: Betsy, you're a little hard to hear.
MS. HUMPHREYS: Sorry, I have to say that, I just feel compelled to say that I assume that everyone in the room and on the committee understands that creating robust mappings between any or all of these things and the PMRI standard vocabularies is a non-trivial proposition and that it's, and we're grateful to you for having laid out the full employment act for many centuries in the number that you have suggested need to be mapped. I don't even disagree that they do but this is a substantial investment in activity where you're outlining here.
DR. MCDONALD: But in terms of this mapping isn't this the same issue about integration though? Or couldn't we clarify that there's not all pair wise mappings we're talking about?
MR. BLAIR: Well, here we're mapping to the important related terminologies --
DR. MCDONALD: Well, what we say I think, we're mapping the important related terminologies to the core terminologies in one of these places, which then implies end by end mapping.
MS. HUMPHREYS: Well, in this particular case, Clem, I would think that some of them have to be that way if the purpose for example is to take X vocabulary that is used in describing procedures or is used in describing diseases and make sure that there's a robust map to a HIPAA code set so that we can report the bill, then this is going to have its own set of rules and have to be created for that purpose in mind or it won't work right probably.
DR. MCDONALD: Well, if you had, getting back to really concrete things, if you had CUI's for them, and the CUI's didn't, were the same as another concept it would come out fine.
MS. HUMPHREYS: The issue is when they're not synonymous, which of course for many of these things they won't necessarily be, and then you have to know the purpose for which you were doing the mapping and that is not necessarily a generalized purpose, I mean if the purpose is to make sure that this detail results in the accurate billing code then you have a very particular purpose in mind.
DR. BICKFORD: Carol Bickford, American Nurses Association. As we're moving forward on trying to identify outcomes that's going to be a whole new entity that's going to be added into the structure. Nursing already has that so I'm thinking about what we're really talking about is when we have our evolving health care and we have new terminologies that develop how are they going to be incorporated in the PMRI mapping structure, so it's bigger then just the ones you have listed.
DR. COHN: Sure, and that's why we say but not necessarily limited to.
DR. BICKFORD: Okay.
DR. COHN: I don't think this was meant to be a truly inclusive list, which is the jokes about NOS and NEC, but I think this is probably a good starter list. I guess I would wonder if maybe just some subtle reorganizations since, it sounds to me like we're going to be talking about, we have the complete drug knowledge database universe as best I understand with the addition of Micromedex and so we might want to describe it as commercial drug knowledge bases or including da da da da, as a single bullet rather then having each commercial as a separate one, that's just an organizational issue. And I guess we do need to come to some conclusion how we're describing these nursing terminologies, not otherwise included in SNOMED. How do we want to handle that? I had mentioned in nursing terminologies in common use, is that something we want to accept? Or is there another way we'd want to describe that? I mean I think, it's probably as good a way of making that differentiation as any. Okay, so we want to add that, Steve?
DR. STEINDEL: Simon, I'm sorry, I was in a side conversation, why are we questioning the phrase as it exists right now?
DR. FITZMAURICE: Because all the others are specific and this one isn't.
DR. SUJANSKY: I think the reason is in addition to that is that there may be some nursing terminologies that, those that perhaps are not in common use that we do not want to include on this list of ones that should be mapped.
DR. STEINDEL: I have a problem with defining it as commonly used because what does that mean?
MS. GREENBERG: We've already said that in a previous sentence here so maybe it's redundant but it says --
DR. FITZMAURICE: It's a criteria for the others.
MS. GREENBERG: It says terminologies in common use as enablers of important health care functions. These terminologies conclude but are not necessarily limited to --
DR. STEINDEL: So we've already said commonly used nursing terminologies --
MS. GREENBERG: -- this bullet would specify, what I think through us off was Jeff's suggestion that it could be ones that hadn't been developed yet --
MR. BLAIR: And I was wrong.
DR. STEINDEL: I would just prefer to leave it the way it is.
MS. GREENBERG: I think then we can just leave it the way it is because it already qualified --
DR. SUJANSKY: Just to be clear on Simon's suggestion about the commercial drug knowledge bases, and I agree with this because in fact there are others even beyond Micromedex that we're not listing, Gold Standard, Multi Media, a small company, there may be others yet.
MS. HUMPHREYS: So you would say drug terminologies in commercial drug knowledge databases, e.g., and then list the four that we --
DR. ZUBELDIA: On the previous list the HCPCS level two, they like the level two spelled with Roman numerals.
DR. COHN: Comment from the floor.
MS. ECKERT: Karen Eckert with MediSpan. What you have there is fine but just earlier on, on an earlier page, I believe page nine, we referred to them as the private sector drug information suppliers and I wondered if we should use the same terminology here, other then using commercial database drug --
DR. COHN: Thank you.
MS. HUMPHREYS: Well in this case it would be in your resources, right? So do you want to say drug information databases?
MS. PROPHET-BOWMAN: Sue Prophet-Bowman from AHIMA. Just a clarification on the spelling out of the acronym for HCPCS, I believe the current name is Health Care Common Procedural Coding System, not HCFA(?).
MS. HUMPHREYS: Will somebody check me on this? I believe that Medcin is not an acronym and that it would be capital M, little edcin, am I right? Somebody in the audience, Mike, tells me I'm correct.
DR. COHN: Can we move on to the next section?
DR. ZUBELDIA: Change the level two in HCPCS to Roman numeral II.
DR. COHN: Kepa, we'll take care of that.
DR. SUJANSKY: Alright, next section then. Central coordinating body. The NCVHS recommends that you designate the National Library of Medicine as the central coordinating body for the PMRI terminology standards. As such the NLM would 1) be the official repository and low cost distribution center for the core set of PMRI terminologies. 2) Be the organization responsible for integrating the core set of PMRI terminologies into a cohesive internally consistent pool. 3) Provide a mechanism for extraction of the individual PMRI terminologies from the core set. And 4) be the organization responsible for funding, coordinating, and/or performing mapping between the core set of PMRI terminologies and the important related terminologies.
That's all for that section.
MR. BLAIR: Hear, hear.
MS. HUMPHREYS: Could we add a reference to the UMLS in the second one, be the organization responsible for integrating the core set --
DR. MCDONALD: Betsy, you're getting soft again.
MS. HUMPHREYS: Sorry. I would like to add a reference to the UMLS in this and I thought that the easiest way of doing it would be to just add within the UMLS maybe to the end of the second bullet --
DR. COHN: That's fine.
DR. SUJANSKY: Second item --
DR. COHN: Other comments, we have somebody from the floor.
MR. ROBINSON: George Robinson, FirstDataBank. I'm just noticing low cost distribution center, is there some inner meaning there or, I mean that just opens a can of worms and should it be just and distribution center, leave that for future decision. The whole premise here is that the UMLS or the National Library of Medicine would be the vehicle for distributing the PMRI vocabulary, correct?
DR. STEINDEL: Since George, you and Betsy weren't here yesterday, the reason why low cost was added was just simply because the HIPAA regulations call for a low cost distribution for the HIPAA code sets, and the suggestion was just made that we track that language. That was the only reason it appears, that's just for information, now we can carry on with the discussion.
DR. MCDONALD: Can I just clarify, is the question whether it's low cost should be no cost, or whether it's low cost should be whatever cost?
DR. STEINDEL: I think the issue is whether the low cost that was inserted for that reason yesterday remain or not.
DR. MCDONALD: Well, I mean I was worried about the question that was asked at the microphone.
DR. COHN: Carol?
DR. BICKFORD? Carol Bickford, American Nurses Association, does this language in the second sentence where it's talking about NLM being the official repository and low cost distribution center have implications for the AMA and their CPT-4?
DR. COHN: CPT is not one of the PMRI core terminologies.
DR. BICKFORD: But if you interpret it as repository and low cost distribution center that becomes a question perhaps, I'm just asking for consideration.
DR. COHN: You know I'm actually based on all this conversation, including Clem's, I'm actually thinking maybe we should get rid of and low cost, I'm not sure that there's a tremendous value added there by those comments.
MS. HUMPHREYS: Yeah, I think it's going to raise a bunch of questions to which there are good answers but, like when are you going to start charging for the UMLS and the answer is going to be we're not going to, so I think it might be better to leave it out.
DR. STEINDEL: We want to put in in place of public, public distribution center?
DR. COHN: I think we're saying that already, official repository and distribution center. Should we just get rid of the low cost, everybody okay with that?
DR. MCDONALD: I think it would be safer.
DR. COHN: If it takes us this much conversation about it think of anybody else reading this.
DR. MCDONALD: Well, you might want to say the distribution center referred to in the HIPAA legislation, if you wanted to make that linkage.
MS. HUMPHREYS: Well, the HIPAA legislation is referring to the distribution of the HIPAA code sets.
DR. COHN: So anything else here? Can we move on to the next paragraph? Okay, let's go.
DR. SUJANSKY: Okay, next section. Relationship between PMRI message format standards and PMRI terminology standards. In previous recommendations to you the NCVHS identified a set of PMRI message format standards that included HL7 version 2.2+, HL7 version 3, DIECOM, NCPDP Script, and IEEE-1073. Each of these message format standards includes its own code sets, which are used to represent clinical and non-clinical information needed for standard message exchanges. These code sets, while not part of the PMRI terminology recommendations presented herein remain essential elements of the message format standards and are in no way supplanted by the core set of PMRI terminologies described above. To the extent that there may be overlap in meaning between certain elements of these code sets and elements of the PMRI terminology standards efforts should be made to achieve consistency. These efforts may include 1) use of codes from PMRI terminology standards within PMRI message format standards where appropriate. For example, HL7 messages may require the use of codes from the PMRI terminology standards for certain agreed upon coded element fields. 2) Mapping of codes from the message format standards to codes from the terminology standards where the message standards and the terminology standards both encode the same concepts. For example, mapping may be specified between HL7 and the SNOMED CT codes for gender and units of measure, and mappings may be specified between the ISO 11073 and the SNOMED CT codes for systolic and diastolic blood pressure, etc. Specification of the required constraints and mappings will require additional work and cooperation on the part of the Standards Development Organizations and the terminology developers responsible for the various individual standards that comprise the PMRI standard suite.
DR. COHN: Well, I have one comment and then Marjorie. I guess I'm, well, first of all just generally whether we even need this whole thing but beyond that in two we're taking, the example two where we're talking about ISO 11073, I thought maybe we should not have that as an example since that seems to be completely out of scope and not otherwise discussed.
MS. GREENBERG: It might be the IEEE-1073, is that what you were talking about?
DR. STEINDEL: No, no, no.
DR. COHN: This is something else, I think we should just use the first example and leave it at that. The second one is sort of interesting but it leads you to go well what does that have to do with this --
MS. GREENBERG: It hasn't been --
DR. COHN: -- ever discussed, yeah, ever discussed before in this document. Other comments?
DR. SUJANSKY: The only reason ISO 11073 is there is because that's, no I think that's another name for the IEEE 1073 and I just used the alternative name there instead of IEEE --
DR. COHN: Well, if that's the case then I can understand, if it's indeed the IEEE whatever then that's probably --
DR. SUJANSKY: There's actually two names for that same terminology.
DR. COHN: Well, in that case I withdraw my comment as long as we may make the change. Let's not even use the ISO --
DR. SUJANSKY: We may not need two examples there, though, it gets the point across.
MS. HUMPHREYS: Clem, were you saying something?
DR. MCDONALD: Well, I have two concerns. What we're really saying if we must constrain the use of codes for the PMRI standards, first I can note the CUI couldn't be sent, is that correct or is that incorrect? Which is inconsistent with some other specification we made. And secondly it might mean that a CPT couldn't be sent, or ICD-9 couldn't be sent. I think that's too strong.
MS. HUMPHREYS: It's not very strong, I mean do you have this version in front of you?
DR. MCDONALD: It says 1) in parentheses, constrain the use of codes from PMRI terminology standards --
DR. COHN: Clem, you have the hold version.
DR. MCDONALD: Or on message format standards where appropriate. For example HL7 messages may require the use of codes from PMRI chronology standard research.
MS. HUMPHREYS: You have an old version there.
MR. BLAIR: That sentence was deleted.
DR. HUFF: The sentence wasn't deleted but the constraining, so the sentence now reads use of codes from PMRI standards within the PMRI message format standards where appropriate. The other thing is that I think you could clarify it or at least alleviate it by saying use of concepts from the PMRI terminology standards rather then saying codes.
MS. HUMPHREYS: Yes, that's good.
DR. HUFF: Use of concepts from the PMRI terminology standards.
DR. MCDONALD: I still worry about some tangles where there are required codes and certain HIPAA transactions which are not --
MS. HUMPHREYS: But Clem this whole area is introduced by saying to the degree that there may be overlap in meaning efforts should be made to achieve consistency. And then it says these efforts may include, and it isn't really I think excluding anything that might need to be done with HIPAA code sets.
DR. HUFF: There's a second occurrence of codes in the last sentence that you can change --
DR. MCDONALD: Well then the item two again is if, if CUI's wouldn't count, it's not clear to me whether that part that is a PMRI terminology standard or not.
DR. STEINDEL: I would like to bring us back to where we ended yesterday and sort of where Simon under his breath introduced this section and I think we need to address the question of whether or not this section is needed.
MS. HUMPHREYS: You know I was going to make a comment about that Steve. I think that there's a lot of work that needs to be done to do this, and it's valuable work, and it will require resources, so I think to not include anything about it might, is not supporting the notion that people might be having to put forward that resources have to be expended so that this degree of consistency and mapping between the vocabularies and the message, connections between the vocabulary and the message standards are in fact an effort worthy of resources. So for that reason maybe not at this level of detail if it's causing you problems but I think that acknowledging that this is a job to be done and a useful job to be done and has to be done would be helpful.
DR. STEINDEL: Okay, with that explanation I agree with you Betsy.
DR. COHN: In that case we will go through this painful process. Clem, you keep making comments about CUI's and I guess my own suggestion on this one, I mean we can decide to deal with that but I don't think that we're, I guess I would be concerned if we get into that conversation whether or not --
DR. MCDONALD: I'm not so much worried about saying CUI's, I'm worried about saying something else very specifically and excluding that possibility.
DR. COHN: Well, I don't think we've said anything one way or another and I think that that's an issue probably for another letter, and if you want to include it in this letter we'll probably not make it through this letter today.
DR. MCDONALD: Specifically, mapping of codes from message format standards to codes from terminology standards where it may code the same concept.
MS. HUMPHREYS: We changed it to concepts.
DR. MCDONALD: I mean I don't know the implication for what you send them, if I'm getting gender codes in HL7 I don't want to have to change that.
DR. SUJANSKY: Just as a point of clarification that second point is not suggesting what codes may or may not be used in the standard message formats, it's saying for example if a HL7 gender code is used in a message that it would be useful to have a mapping from that code to PMRI terminology standard code because some institution receiving that message may use the terminology standard codes within their medical record for example.
MS. HUMPHREYS: A though just occurred to me, if you go back up to the sentence that said to the degree that there may be overlap between certain elements, etc., in the PMRI terminology standards, efforts should be made to achieve consistency. And if you then scratched out the next sentence and the two bullets points and then go down to the bottom, so you exclude these efforts may include, go down to the bottom and in that sentence you take out the specification of required constraints and mappings and just say this will require additional work and cooperation, then you convey that this is a job that has to be done so if somebody comes in and says I need resources to do it everybody says, don't say well we've never heard of it. Then that gets you out of some of these individual details.
DR. HUFF: I like that better, too.
DR. MCDONALD: Does that mean one and two go out?
MS. HUMPHREYS: Yes.
DR. MCDONALD: I think that would be less troublesome then, too.
DR. COHN: And shorter. Okay, everybody okay with that? Good. Next section.
DR. SUJANSKY: Next section, which is the last section, additional research. The NCVHS recommends additional research to address outstanding content issues related to the core set of PMRI terminology standards.
Dental content and medical device content. Standard terminology for dentistry and medical devices is an important element of the core set of PMRI terminology standards. However, the NCVHS must resolve a number of outstanding content issues before it can put forth recommendations in these specific areas. The NCVHS is in the process of investigating and resolving these issues and plans to make additional recommendations upon completion of this work.
Clinical LOINC. The NCVHS recommends further research into the need for and value of incorporation the clinical subset of LOINC “clinical LOINC” into the PMRI terminology standards. This research should focus on the degree of overlap between clinical LOINC and SNOMED CT and the general applicability of concepts from clinical LOINC to the PMRI terminology standards.
DR. HUFF: I think I'd like to see a change there. You guys yell at me if I'm, I think the first sentence is good, I think the last sentence is detail that specifies, goes beyond what we need, this process is already in order and I think this is micromanaging the process. If anything I think the idea is, there may be additional clinical content and we may want to get it in, the degree of overlap with SNOMED is not the important issue.
MS. HUMPHREYS: That's not to say that we're not investigating that issue but I agree, the first sentence covers it, right?
DR. HUFF: Yeah, the first sentence covers it and the other thing just stirs controversy.
DR. COHN: So I guess the suggestion is whether to get rid of that second sentence --
DR. MCDONALD: What's the suggestion?
DR. HUFF: That we strike the second sentence, we just say, and I mean even change the first sentence a little bit and just change, no, I think the first sentence is fine, so we just leave the first sentence that says we look at whether we want to incorporate clinical LOINC or not.
DR. COHN: Okay, comments from the subcommittee? Marjorie?
MS. GREENBERG: I'm assuming that Stan is raising a factual issue here.
DR. COHN: I know, I thought it was getting pretty close to the edge there myself.
MS. GREENBERG: I defer to Betsy on that one.
MS. HUMPHREYS: I think that the real issue is the need for and value of incorporating the clinical subset and/or all or parts of it, and the research that's going on is going to look at it in relationship to the other core vocabularies and see what unique value it offers. So I think the first sentence covers the waterfront here.
DR. COHN: I'm certainly satisfied with that. Jeff, comments?
DR. MCDONALD: Just maybe a tangle but there is another part of LOINC for attachments, which may end up as part of the HIPAA thing, so that would not have to be in this, is that right or --
DR. COHN: This is the PMRI core terminology standard --
DR. MCDONALD: And maybe it's irrelevant if it ends up being part of the --
DR. COHN: I think it's maybe another conversation.
MS. HUMPHREYS: I don't think it has to be referenced here.
DR. FITZMAURICE: Somebody said something, do you want to put in that first sentence into the core set of PMRI terminology standards as we have in the paragraph above? Standard terminology for dentistry and medical devices an important element of the core set of PMRI terminology standards.
DR. COHN: I don't know that that's necessary --
DR. FITZMAURICE: Do we not mean core set or do we --
DR. COHN: I think we do but I don't know that there's a tremendous value added of --
DR. FITZMAURICE: I'm only looking for consistency of somebody reading it --
DR. COHN: Let's say core set of, okay, any other changes to this section? I guess we seem to be going from section to section rather then reading this whole section. We need to make a change then to the top one --
DR. SUJANSKY: Right, to take out the devices, why don't I read the device piece first and then who knows, we may decide to omit it or something.
Then third subpart of this section, device terminology. The NCVHS heard testimony from the FDA about the global medical device nomenclature, GMDN, and ECRI about the universal medical device nomenclature system, UMDNS. We learned that the two terminologies are in the process of merging. We support the merger of these two terminologies and will defer any recommendations in this area until that occurs.
DR. COHN: Well, can I ask a question? Is that true?
MS. HUMPHREYS: I think that what we heard was that the two terminologies may be merged, I don't think that we heard that it is happening right this moment, I think, my understanding based on the testimony is that the FDA supports this but they are not the only actor in the field to make it happen so I think that it would be better to say may be merged and then you could say will defer any recommendations in this area --
MR. BLAIR: I'd rather not say defer, I'd rather say that we will consider recommendations after, or follow this activity and consider recommendations as appropriate or something like that.
DR. COHN: So what we're saying is that, so basically the sentence before that, we've learned that the two terminologies in the process of merging, we're sort of saying is --
DR. FITZMAURICE: May be in the process.
MS. HUMPHREYS: May be merged.
DR. COHN: Well, I sure didn't, I mean I was at the same hearings, maybe there was something more since our last hearings, I certainly didn't hear that, I heard that there was some discussion underway --
MS. HUMPHREYS: Maybe you could say that we learned that, maybe that there is interest in merging the two terminologies or something like that? I don't know.
DR. STEINDEL: Are exploring merger.
DR. SUJANSKY: We just want to make sure this isn't new to them.
DR. COHN: You see what I heard, and maybe it was in a different hearing, but what I heard was is that they had tried a couple of years ago and it had failed --
DR. STEINDEL: No, they're redoing it again.
DR. COHN: And it was sort of like they were just barely beginning to talk again and any sort of talk about this seemed to be a couple years off, did I mishear?
MS. HUMPHREYS: Maybe we should say we learned that the merger of these two terminologies is being explored --
MS. AULD: By FDA and ECRI.
DR. COHN: Sure, that sounds fine. Carol?
DR. BICKFORD: Carol Bickford, American Nurses Association. You've included the terms we, is the intent to remove those and put the NCVHS?
DR. COHN: Sounds good, thank you.
DR. SUJANSKY: NCVHS learned that the FDA and ECRI are exploring the possibility of merging these terminologies. Is that true? And not the GMDNS people?
MS. AULD: FDA is going to take it to the GMDNS people.
DR. HUFF: Is ECRI expanded somewhere? Is this the first time we use that?
MS. HUMPHREYS: ECRI that is their official name, it used to stand for something but now ECRI is the official name. There's a classic one in the library community that's like this, too, OCLC, used to mean something else.
DR. SUJANSKY: We're okay with that? Now I'll go up here.
MS. HUMPHREYS: Wait a minute, did you fix the second sentence too Walter? Yes, you did, sorry.
DR. COHN: Actually in the device area do we want to have another sentence that says standard terminology for medical devices is also an important element?
DR. SUJANSKY: I'm sorry, Simon, I missed that.
DR. COHN: We do have a device terminology, it sounds like we need that first sentence that looks like the dental content except relates to medical devices, it says standard terminology for medical devices is also an important element of the core set of PMRI terminology standards.
DR. SUJANSKY: Oh, I see, to repeat that, gotcha.
DR. COHN: Just as the introductory sentence to the device terminology. We may want to describe that as medical device.
MR. BLAIR: I question whether we're losing the value of the word importance when we are using as frequently as here, do we need it in either case?
MS. HUMPHREYS: Is there an overarching paragraph to this that --
MR. BLAIR: Well, we already have important related terminologies and then we're winding up having this be research, but anyway, I think Steve said that he'd rather keep it in.
DR. STEINDEL: No, I said I'm fine with taking it out.
MR. BLAIR: Oh, you said you're fine, alright.
DR. SUJANSKY: Okay, we'll take it out in both places.
DR. HUFF: You didn't say clinical LOINC was important.
MS. HUMPHREYS: That's because it should say we're doing research to see if this is important or not.
MR. BLAIR: What we need is another footnote.
MS. HUMPHREYS: Jeff, I wish you wouldn't do that when my mouth is full of coffee.
DR. SUJANSKY: Okay, I think there's one last subsection, yes. Content from other terminologies. The NCVHS recommends exploring the incorporation of content from terminologies other then those selected for the core set of PMRI terminologies, for example the international classification of functioning disability and health, ICF, which was highlighted in a previous NCVHS recommendation to you, may be valuable source of concepts for encoding functional status although the terminology as a whole lacks certain technical features required for the core set of terminologies. Similarly codes from terminology specific complementary and alternative medicine may also constitute useful additions. Augmenting the content of the core set of PMRI terminologies in this way may accelerate any needed enhancements to the terminology standards.
MS. GREENBERG: Do you want to say concepts from terminologies specific to complementary and alternative medicine rather then codes?
DR. COHN: I'm sorry, Marjorie, help me with that again because I thought it said concepts here, okay, got it. Does the last sentence have value?
MR. BLAIR: What is the last sentence?
DR. COHN: It says augmenting the content of the core set of PMRI terminologies in this way may accelerate any needed enhancements to the terminology.
DR. SUJANSKY: I think the intent there is to draw a distinction between enhancing, just adding to the content of the existing terminologies in the core, sort of de novo versus incorporating content from other existing terminologies specific to these area, if that makes sense.
MS. HUMPHREYS: If that's the intent I would try to get that into the first sentence and get rid of the last one.
MS. GREENBERG: I don't know that you should foreclose the decision of how that might work.
MS. HUMPHREYS: Yeah, exactly.
DR. SUJANSKY: How what might work? I'm sorry.
DR. COHN: How additional content is added.
DR. SUJANSKY: Yeah, this is just saying an area of research, content may be added in this way, I don't think it's, it's not definitely saying it will be or anything like that. I think Betsy's suggestion is good and we can perhaps just add to this first sentence to accelerate any needed enhancements to the terminology.
MS. HUMPHREYS: I think the broader issue is coming up about exactly how this would be done and maybe not specifying how, so that would mean just getting rid of the last sentence and leaving the first one the way it is.
DR. COHN: Yeah, we could support that. Carol, comment?
DR. BICKFORD: Carol Bickford, American Nurses Association. I've seen the term core set interspersed throughout this document and I'm getting confused as to what the core set is. When we take a look at page five it talks about the initial terminologies recommended were SNOMED CT, LOINC, for the lab subset and the federal drug terminologies --
MR. BLAIR: That is the core set.
DR. BICKFORD: Okay. So are we making a bigger core so that we are talking about core set version two, three, and four as we insert more terminologies? I'm just confused as to what core set means by the time we get to the end of this document.
MR. BLAIR: Well, the thought was and you identified the core set and maybe we need to label that more clearly that that's the core set of PMRI terminologies, and then we wanted to recognize that there are other important related terminologies that they needed to map to given that those two pieces, could you reference exactly where the ambiguities remain that we need to fix? What are you looking at right now?
MS. HUMPHREYS: Is it because you have this bit about the research where you imply I think correctly that in the future you might add to the core set? So I think that Carol's point that yes, this core set might get bigger when you make more decisions is in fact what you intend to convey.
DR. BICKFORD: On page five when you state the three you state they're the initial.
MR. BLAIR: Yes.
DR. STEINDEL: From what I recall when we started crafting this letter initially we always had the intent that we would word it such that the core set is expandable.
DR. SUJANSKY: But also though, just to point out, the first sentence is somewhat ambiguous on whether enhancement of content entails adding other terminologies to the core set or adding content from terminologies to existing terminologies in the core set --
DR. COHN: And I think that's fine.
MR. BLAIR: We want to retain that flexibility.
DR. SUJANSKY: I'm saying we probably don't want to state definitively one way or another.
DR. ZUBELDIA: On the ICF that you have there on the screen, I would strike out the last part of that sentence, where it says although the terminology as a whole lacks certain features required for the core set of terminologies, I would just take that out.
DR. SUJANSKY: Yeah, the only reason that's there is to answer the question that someone will say well, if it's useful why didn't you put it in the core set to begin with? But if you feel that's obvious why that is then we can remove it.
DR. ZUBELDIA: You're saying that it may be a valuable source of concepts, and I would stop, valuable source of concepts for encoding functional status, period. We're saying it may be but it's not, we've already addressed the issues in the letter before.
DR. SUJANSKY: I'm fine with that.
MR. BLAIR: Do we just have our closing paragraph?
DR. SUJANSKY: Salutary closing paragraph.
MR. BLAIR: At this point I want to thank Walter, I especially want to thank Steve Steindel for the work that he's been doing during the last couple of months in helping us pull together the last half of this letter. We will have an opportunity to revisit the first half of the letter next week when we have our full committee meeting but basically subcommittee has already reviewed that, Simon, did you --
DR. COHN: Well, I guess we need to talk about that one because we haven't, we need to vote on this letter still. Do the members of the subcommittee feel comfortable with voting at this point? Do we need to read through the first six pages again at this point? What would be the preference of the subcommittee? Recognizing that you all went through this relatively significantly at our last session, what is the desire, I think I myself would be comfortable going forward.
DR. HUFF: I reread the first part in preparation and I'm comfortable with what it says.
DR. COHN: Okay, Kepa?
DR. ZUBELDIA: Yeah.
DR. COHN: Jeff, you're also comfortable?
MR. BLAIR: Yes.
DR. COHN: Okay, would somebody like to make a motion then for approval --
DR. HUFF: I move that we approve this document for advancement to the full committee.
DR. COHN: Marjorie, what's the problem?
MS. GREENBERG: We have a problem with some of these recusals, since two of the four, one, two, three, four, we have four members, five, two of the five members are supposed to recuse themselves regarding LOINC, any votes regarding LOINC, and these recommendations definitely include LOINC although they include other recommendations as well.
DR. COHN: So they should not be making motions --
MS. GREENBERG: I think that just to get a sense of the group is probably adequate otherwise if you're voting, you have a quorum to vote but probably only three can vote. There's some mention of CPT but it's only mapping so I don't think that's a problem.
DR. COHN: Okay, that's good, because otherwise we'd only have two voting. Well I think under the circumstances it sounds like maybe Stan should not make a motion, it sounds like Kepa is making a motion.
DR. ZUBELDIA: I'll make a motion that we vote to move this to full committee next week.
DR. COHN: I think with the ability to make minor word modifications and grammatical changes as we go forward. Jeff, do you have --
MR. BLAIR: I'd like to second the motion.
DR. COHN: Okay, any discussion? All in favor?
SUBCOMMITTEE: Aye.
DR. COHN: Opposed? Abstentions?
MR. BLAIR: Clem, are you there?
DR. COHN: I think Clem needs to be in the abstentions category. Two abstentions. I think you're abstaining.
DR. HUFF: Is that what we're doing?
DR. COHN: Yes, that's what you're doing. You thought you might be recusing yourself but what you are is abstaining. Now with that let's move back to the ICD-10 letter.
DR. COHN: Clem, I think you have what we think is the near final version for the ICD-10 letter?
DR. MCDONALD: I'm sorry, I don't think I have that, I didn't get, that was something printed last night, too?
DR. ZUBELDIA: Clem, I sent you both emails so you have both.
DR. MCDONALD: I didn't get that, I can, I think I can, are you doing that right now? Well, I'll stumble along.
DR. COHN: Where are you that you can't get this?
DR. MCDONALD: I'm at home and I have a fax and I can call my office and have them fax it to me but I'm on the fax line right now, but I can still do that, I don't think you should wait. I understand how it's going to go.
DR. COHN: Well Clem just as long as you understand how it's going to go. And I actually should comment only because I'm seeing a couple people leaving, one of the areas that we've been talking about with the PMRI recommendations which is dental content may very well come forward to us in January as a discussion, I see our dental representatives leaving, just as a comment, just so that they know.
Anyway we're doing the ICD-10 letter at this point and hopefully we'll finish that up and then we'll just sort of talk very briefly about the next couple of months and then adjourn.
Okay, this is the October 30th letter, it says Dear Secretary Thompson, as part of it's responsibilities under HIPAA the NCVHS monitors the continued effectiveness of the health data standards adopted pursuant to the requirements of HIPAA's administrative simplification provisions. That's your typical salutary beginning. During the past several years NCVHS' Subcommittee on Standards and Security has focused considerable attention on the feasibility and desirability of replacing the current diagnosis and inpatient procedure classification system, ICD-9-CM Volumes 1, 2, and 3 with a newer expanded version, ICD-10-CM and ICD-10-PCS. ICD-9-CM Volumes 1 and 2 was adopted as the HIPAA standard for diagnoses in all settings, and ICD-9-CM Volume 3 as the standard for inpatient procedures reported by hospitals, which is a change to your written version there. At issue are the one to one replacement as HIPAA code sets of ICD-9-CM Volumes 1 and 2 with ICD-10-CM for diagnoses in all settings, and ICD-9 Volume 3 with ICD-10-PCS for inpatient procedures reported by hospitals. This would not effect the usage of other code sets under HIPAA, such as CPT and NDC.
I'll stop there for just a second.
DR. HUFF: We added those last sentences specifically to clarify the point that you'd raised before Clem.
DR. COHN: Are you still there Clem?
DR. MCDONALD: I couldn't, I heard my name, is that Stan?
DR. COHN: Stan, you need to get that microphone way closer to you.
DR. HUFF: Okay, the last sentence was added specifically to try and address the question that you raised, that we be perfectly clear that we're not suggesting that a change in the use of CPT codes, so the last sentence says this would not effect the usage of other code sets under HIPAA, such as CPT and NDC.
DR. MCDONALD: Okay, good.
DR. COHN: Next paragraph.
ICD-9-CM was developed in the 1970's. Despite an annual update process ICD-9-CM Volumes 1, 2, and 3 have structure and space limitations that increasingly constrain their ability to accommodate advances in medical knowledge and technology. ICD-10-CM is recognized as a logical successor code set to ICD-9-CM for diagnoses. In fact, ICD-10 has already been used for mortality classification in the United States since 1999 and has been implemented for that purposes throughout much of the rest of the world since the mid-1990's. Many of these countries also have adopted ICD-10 or a clinical modification of it for reporting morbidity. ICD-10-PCS was developed by the Centers for Medicare and Medicaid Services, CMS, as a successor to ICD-9-CM Volume 3.
Are we okay? And Clem, I'm presume you're hearing me.
DR. MCDONALD: Yeah.
DR. COHN: More then some number of days of hearings, and we'll figure out how many days that was, have been held by NCVHS since 1997 and letters and oral and written testimonies have been provided by more then 80 public and private sector groups representing the health care industry, the federal and state governments, the public health and research communities, insurers, and providers. A chronology of the development of ICD-10-CM and ICD-10-PCS and a synopsis of testimonies and letters are attached. Also attached is a complete listing of groups that have provided input.
Okay so far?
The issues surrounding the migration to a replacement diagnoses and inpatient procedure classification system in the United States are complex. For example, there are concerns within the health care community that ICD-9-CM is an antiquated system that cannot meet the current and emerging needs of payers and providers in today's fast paced highly specialized and technologically sophisticated environment. There also are concerns that ICD-9-CM is increasingly unable to address the needs for accurate data for health care billing, quality assurance, public health reporting, and health services research. This has been well documented in the testimony given to the committee over the past several years.
Okay so far?
MS. FRIEDMAN: Do you want to say, instead of testimony, the input given to the committee over the past several years so that incorporates the letters and all that.
DR. COHN: And we might even call it testimony or input. Maybe testimony in letters --
MR. BLAIR: Testimony in letters.
DR. COHN: Okay. At the same time the committee has heard concerns from the health care community about the costs, potential benefits, and implementation issues associated with transitioning to ICD-10-CM and ICD-10-PCS. Given the widespread usage if ICD-9-CM there could be significant implementation costs in terms of hardware and software changes, lost productivity, and training among others.
Everyone okay so far?
DR. COHN: Benefits are harder to quantify but appear to outweigh the costs. They include improvements to the quality of care and patient safety, fewer rejected claims, improved information for disease management, and more accurate reimbursement rates for emerging technologies. These costs and benefits and related issues also have been substantially documented in testimony before the subcommittee as well as in a specially commissioned cost/benefit study by the RAND Corporation.
MR. BLAIR: Did we specially, I thought we said NCVHS --
MS. GREENBERG: An NCVHS commissioned --
DR. COHN: Yes, that's right, an NCVHS commissioned cost/benefit study by the RAND Corporation. A copy of the RAND study is attached.
Okay?
In addition many in the public and private sectors are concerned about the additional administrative and resource burdens posed by this implementation since they would follow on the heels of HIPAA's other mandated requirements. Along with the testimony and cost concerns the subcommittee received considerable input about the timeframes that would be needed to effect a successful transition to ICD-10-CM and ICD-10-PCS.
Everybody okay so far?
While taking into account the diversity of input and lack of industry wide consensus, and we either have a majority of or the NCVHS, probably to be determined next week, concludes that it is in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation in place of ICD-9-CM Volumes 1, 2, and 3. As a result the committee recommends that the Department of Health and Human Services initiate the regulatory process for the concurrent adoption of ICD-10-CM and ICD-10-PCS. By issuing an NPRM the Department would provide a structured environment in which critical implementation issues may be addressed. We further recommend that the NPRM specifically invite comments on the key issues presented in testimony before the committee. And then we have a number of bullets, which include what could be done to minimize the cost of transition to ICD-10-CM and ICD-10-PCS. What could be done to maximize the benefits of implementing basically CM and PCS. What are the potential unintended consequences of such a migration and how could they be mitigated. What timeframes would be adequate for implementation, and then in parentheses we say the NCVHS heard in testimony that the industry would need a minimum of two years for implementation, however such timing could be further clarified and refined through the regulatory process. And then what additional steps would be required to ensure the realistic and smooth migration.
And then finally NCVHS wishes to thank you for the opportunity to submit these recommendations.
Now, comments or discussion from the committee.
MR. BLAIR: I think the only one that really kind of didn't express themselves was Clem because he wasn't here for that revision yesterday. Clem, do you feel comfortable?
DR. COHN: Clem, are you there?
DR. MCDONALD: Yeah, I thought you guys had left, couldn't hear anything for a minute there.
DR. COHN: Jeff was specifically asking you if you had thoughts about this letter that you wanted to share or other comments about it.
DR. MCDONALD: No, I accept the view of the group.
DR. COHN: Well, Clem, I will tell you that one of the things for you to think about next week is obviously there's alternative wording in one of the paragraphs which talks about either the NCVHS or a majority of the NCVHS, and that will obviously be an active area for discussion at the full committee meeting next week in terms of the unanimity of support for these recommendations. Gail?
MS. GRAHAM: I just have one question about the last, very last sentence in the second paragraph. Would it make more sense for it to say such as CPT-4 and HCPCS Level II since those are really the pertinent code sets we're talking about?
DR. COHN: That's actually a very good point.
DR. HUFF: I think that's better.
DR. COHN: And we now know how to spell Level II HCPCS. Yes, Marjorie?
MS. GREENBERG: I hesitate to even bring this up but when you say about it's already been adopted or a clinical modification of 10, just about reporting morbidity, I've been surprised over the years how many people don't know what morbidity is.
DR. COHN: No, I actually can imagine what you mean. What word would you like to use instead of morbidity?
MS. GREENBERG: Well, certainly for reporting in hospitals is a fact but some also use it outside of hospitals, too, but for hospitals and other health care settings you might say, I mean I've just been surprised of people who are really smart, when I say something about, they understand mortality --
MS. FRIEDMAN: They originally said diagnoses yesterday --
MR. BLAIR: I'm really suggesting this seriously although you'll probably laugh when I say it, what if we add a footnote and give a definition of morbidity at the bottom.
DR. COHN: I think the real question is do we put the word diagnoses there.
MS. GREENBERG: We had diagnoses but of course, and actually I think diagnoses does apply more to the non-mortality because you don't really have a diagnosis when you're dead, you have a cause of death. So I think diagnoses is okay.
DR. COHN: Well, we could say diagnoses from all sites of care. I guess the mortality is only for one side of care --
MS. GREENBERG: For diagnoses in health care settings, I mean you could just say that.
MS. GRAHAM: Where are we at?
DR. COHN: We're on the third paragraph, around the word morbidity.
DR. HUFF: Second to the last sentence in the third paragraph.
MS. GRAHAM: What's the recommendation?
DR. COHN: I think where we said diagnoses --
MS. GREENBERG: Diagnoses in health care settings.
MS. GRAHAM: Reporting diagnoses --
DR. COHN: In health care settings.
MS. GRAHAM: It's probably explicitly though diagnoses sign and symptoms and health care settings, I don't know --
MS. GREENBERG: It's not just diagnoses --
DR. COHN: I guess I would question whether, maybe I'm way off on this one, but I think that a sign and a symptom is a diagnosis to the highest level of specificity --
MS. GRAHAM: It's not a disease but it's a diagnosis.
DR. COHN: It's a diagnosis, yeah, thank you.
MS. GREENBERG: I mean this despite the fact that NCHS is responsible for mortality and morbidity classification --
DR. COHN: Yeah, I think that someone else reading this would like to know what it means. Okay, well I guess a question is is does this, obviously we worked over this very significantly yesterday, is there anything else that needs to be changed here? Does this have the right sense, I guess I'm looking at this one and I'm trying to decide as we wordsmith through it whether it still has the right sense of, that there is hardly a united industry behind all of this stuff and I think we've said --
DR. HUFF: I think it's getting close to as good as we can make it and I think it's balanced --
DR. COHN: Okay, we'll I'm just sort of asking. Well, would somebody like to make a motion? Or is there a comment? Oh, I'm sorry, Carol.
DR. BICKFORD: Carol Bickford, American Nurses Association. In the fourth paragraph there's a chronology development, it should be is attached rather then are.
DR. COHN: Thank you.
MS. GREENBERG: I have one other small concern and that is that at the request of the subcommittee RAND did not complete the analysis, the study, because it was, so we asked them not to finalize the report until after we had had these additional testimony in September and in today, this week, so there is a certain amount of additional work that they're going to have to do which actually requires us to do some additional contract work also because the previous contract expired. So I'm just wondering about when we're going to actually have that final report from RAND --
DR. COHN: Well, maybe this really is a conversation, you obviously brought that up last meeting though in a slight different context about whether there should be more work done. What do you expect that would be further done in terms of this? Are you anticipating that the RAND will probably making references to the other cost/benefit studies we've seen? Or is it more that they will just sort of acknowledge that other people have other --
MS. GREENBERG: It's your preference because we have not actually finalized this. One possibility would just be to accept the RAND report as it was reported, as it was presented at the September meeting, and then the other studies, etc. would be part of the record. That way we could then readily if this letter gets approved send it with that report. If you want them to take into account the other studies and respond to them in some way, or the other testimony, then it's going to require some more work and it may actually be a bit of time before we actually get the final report. At this point I might propose the former.
DR. COHN: Accepting it as it was. Steve, comment?
DR. STEINDEL: My only question about accepting it as is versus going on is whether CMS could use the RAND report as part of the cost/benefit analysis that needs to be done for an NPRM, and if they need it expanded for that, and that would be the only reason I would want it expanded.
MS. FRIEDMAN: I think we would certainly use it as part of the impact analysis if we were going to do an NPRM.
DR. STEINDEL: Yeah, but I don't think it needs to go beyond where it is now for that.
MS. FRIEDMAN: I don't think so.
MS. GREENBERG: Because you'd also have the Blue Cross one, it could go on forever actually and Blue Cross would have to respond, so it might be best to just, I mean if any of you as the subcommittee members had any additional things you wanted included in there, I mean we had opened it up for comments, but I don't think we really got any, but beyond that it would be most expeditious if you feel its adequate to just probably have them --
DR. COHN: Well, let's ask the other members, I have a feeling about this one but I'm curious to see what the other members feel.
DR. HUFF: I think if --
DR. MCDONALD: I can't hear all the words, that was about the RAND report, is that what you're talking about? I couldn't hear what was at issue.
DR. COHN: We're trying to talk about whether or not the RAND report should be accepted as it was presented to the full committee at the last meeting or whether further work needs to be done to update it.
DR. MCDONALD: Who's arguing for what?
DR. COHN: We're just asking the committee opinion. Marjorie felt that it probably would be most expeditious to accept the RAND report as was presented for the last meeting but we're asking subcommittee members their opinion at this point.
DR. HUFF: Yeah, if it doesn't have any further value in the NPRM process I think it's served its purpose and we should just finish, leave it where it's at.
DR. COHN: Kepa?
DR. ZUBELDIA: The only additional work that I feel would have some value would be to identify the numbers from CMS and that's something that can be done outside of the RAND report by CMS, so as far as I'm concerned we can just close it as it is.
DR. MCDONALD: Kepa, I didn't hear what you said about CMS.
DR. ZUBELDIA: The RAND report doesn't have the cost analysis for CMS and I think that can be obtained outside of the RAND report directly from CMS, so I don't see any more value in continuing the RAND report.
DR. MCDONALD: So I guess I would then also say we should accept it. Is that what we're saying?
DR. COHN: I think that's what we're asking everybody. I certainly think myself that this was actually, I actually very much appreciated the report, I know it isn't quite what the accountants are usually used to seeing in the way of a cost/benefit report, at least that's as been explained to by some of the staff, but I thought it was a remarkably candid and useful document which I think was very helpful in our conversation. I think it would also be a pity if it didn't accompany this letter because the document really does provide I think a very good glimpse into the issues that the industry has been facing as its tried to grapple with all of this stuff, so I think it would be a very valuable piece to have attached.
MS. GREENBERG: Right, and that's my concern, that we might end up having to really delay this and then have additional review --
MR. BLAIR: Clem probably can't hear you.
MS. GREENBERG: That was my concern, that if in fact you wanted the report to accompany this letter in an expeditious way it probably would be best to accept it as presented.
DR. COHN: Well do we want to vote to accept the report at this point, is that a valuable item?
MR. BLAIR: That's fine, I move that we accept the report as is.
DR. ZUBELDIA: Second.
DR. COHN: Okay, Kepa second. Okay, all in favor of accepting the report? Actually, any conversation about it first of all?
DR. MCDONALD: Aye.
DR. COHN: That's the end of the conversation. Others in favor?
SUBCOMMITTEE: Aye.
DR. COHN: Opposed? Abstentions? Okay. Now regarding the letter.
MR. BLAIR: I make a motion that we forward the letter as is to the full committee next week.
DR. FITZMAURICE: A suggested modification is whether it needs stylistic changes that don't change the intent.
DR. ZUBELDIA: And we'll identify the number of hearings, the number of days of hearings.
DR. COHN: So I think the motion is to accept with grammar modifications, obviously I added a couple of things when I was giving, was reading through this. We obviously I think as Clem commented we need to make sure at every junction that there is no confusion about what it is we're recommending, and I think we've done a pretty good job but there may be a couple of areas where we even need to be more redundant so somebody doesn't quote a paragraph and not the rest of the document and misread our recommendations. With those sorts of things, I think the issue is the general intent of the letter with all of that. So that's been a motion, request for modification which I think has been accepted, is there a second?
DR. HUFF: Second.
DR. COHN: Okay, is there a discussion? I guess as part of the discussion, Marjorie, can I vote on this?
MS. GREENBERG: Yeah.
DR. COHN: Okay, just thought I'd ask.
DR. HUFF: Actually I guess I can't. I'm blocked on more then one front, so I'll abstain again. You need somebody else to second it.
DR. ZUBELDIA: I'll second it.
DR. COHN: Okay, all in favor?
SUBCOMMITTEE: Aye.
DR. COHN: Opposed? Abstentions?
DR. HUFF: I have to recuse myself.
DR. COHN: Clem, how are you voting?
DR. MCDONALD: I'll vote in favor.
DR. COHN: In favor, okay, well motion passed. And as I said, obviously the motion is to bring this forward to the full committee, which we will do, you'll probably all see a subtly different or, we tighten it up with more verbiage and clean it up per Mike and whatever, it will be subtly different but we will try to police it to make sure the tone remains unchanged, and the recommendations remain unchanged.
First of all, thank you all, it's been a major effort over many years, I know Marjorie is pleased with the outcome but I think we've done, we have done what we needed to do to really elicit input from the industry and recognizing that even now there is no consensus. I think we've done everything we can do to sort of get further clarification and clarity about this issue and move the issue forward, so I just want to thank everyone.
Agenda Item: Planning for Upcoming Meetings - Dr. Cohn
DR. COHN: Now, other issues and for the next couple of days I think A, obviously we have a number of letters that have been action items today. My expectation is is that there will be whatever final wordsmithing on them and that we will hopefully by end of day tomorrow be able to send them out to the rest of the full committee so they don't walk into the full committee meeting next week not having had an opportunity to see any of this.
MS. GREENBERG: My only question to Donna is that she has to do some additional work on those appendices or attachments, it seems to me we could send them without the attachments.
DR. COHN: That's probably fair, we'll bring the attachments and recognize that those things, we just need to have honesty and have them be right as opposed to necessarily have them voted on. But certainly the letters, I think all three letters, I kind of feel badly about the CHI letter, that may be, Steve is there some way to nicely send the CHI letter that doesn't have eight attachments on it? Well, I mean we've got three letters, ICD letter, PMRI letter, and then the CHI letter that would likely have eight attachments attached to it, which could be sort of overwhelming --
DR. STEINDEL: No, it has three attachments.
DR. COHN: Oh, three attachments, that isn't so bad.
MS. FRIEDMAN: Just the final reports.
DR. COHN: Okay, so that would be, is there actually a way to send that as one single document?
DR. STEINDEL: Yeah, assuming I can get the one from Cynthia.
DR. COHN: Well I just don't want to overwhelm people, I know what it's like to open up an email and have eight attachments associated with it, I'd like to have them at least be able to see what it is they're getting and hopefully be able to have a chance to review it.
MS. GREENBERG: It might make sense to, well, which would you prefer as a member, three emails?
DR. COHN: No, I'd like to have email with three attachments. So we'll expect that hopefully by the end of the day tomorrow, obviously though we continue I'm sure to have some wordsmithing changes. At our meeting next week obviously the first priorities will be to deal with whatever full committee input there is to our letters and then sort of as a to follow will be the additional CHI final recommendations, which may yet cause more modification to our CHI letter, or a separate one, any additional one going out. Marjorie is looking at me funny, there are apparently some final recommendations --
MS. GREENBERG: You're getting some additional finals next week?
DR. STEINDEL: That was the question I was going to ask, did we convey to Cynthia that there might be more time available at the November meeting and that she should add some finals, that we were deferring?
DR. COHN: I think that it's, I would defer to you and her in terms of how you schedule and what your priority is. I think it remains a to follow item in that they can put as many as they think that they can accomplish on that. Yes?
MS. FRIEDMAN: My understanding from Cynthia is that they need to get through the preliminaries first because the finals can drop back to December but the preliminaries have to be presented first before they can become final so it's a process issue.
DR. STEINDEL: Okay, we'll let Cynthia, just convey to Cynthia that the letters probably will not take as much time and that she should plan accordingly.
MS. GREENBERG: Aren't there additional finals that are coming forward next week?
DR. STEINDEL: There could be.
MS. FRIEDMAN: But they need to get through the preliminaries first.
DR. STEINDEL: As Maria just said there's probably preliminaries that are more important.
DR. COHN: I think we've got to make sure, we need to try to get through the preliminaries --
MS. GREENBERG: Preliminaries that have not yet been reported.
DR. STEINDEL: Right, because we can't move on to the next stage until the preliminaries, while there are some finals that could be reported at the November meeting deferring them to the December meeting doesn't make that much difference.
DR. COHN: And I don't know how much time we've given for the CHI but I think that whole meeting of the breakout is like two hours --
MS. FRIEDMAN: And CHI people are on notice that we're going to try to get through as much as we can, I couldn't give them a specific time slot because we just don't know how long the letters are going to take.
DR. STEINDEL: Well, right now we have an hour and ten minutes blocked off for the letters.
MS. FRIEDMAN: We may not need that much, who knows.
DR. COHN: We'll see, I just don't think we can guarantee anything at this point. Now we obviously have hearings in December and right now I think CHI has a lot of those hearings, so just be aware of that, I think they're asking as I understand a day if not more. We are meeting on the 9th and 10th, I am trying to hold steadfast to not having it be three days but I don't think any of you should be expecting to be leaving on the 1:00 flight on day two. We're going to be trying, this is I think something Jeff and I are going to have to work on, Maria and others and Steve, to try to put something together, at least one session on claims attachments and CDA and how all of that stuff sort of works together as well as other pieces that relate to, it's a sort of document issue. I think we need to do that in December because we may very well see a final rule on claims attachments coming out sometime early 2004 and if we haven't done our work we won't know what comments to make, proposed rule, thank you, proposed rule, we will need to make comments on the proposed rule and we obviously need to hold hearings before the comment period, so I think that really puts us into December, and that's really what I'm hoping we'll doing for there. In January we have meetings at the end of the month, on the 27th and 28th, and we have a half day already blocked off for security and the security final rule. We'll be getting input from the DSMO's, their yearly report at that point --
MS. GREENBERG: Which meeting is this?
DR. COHN: This is January 27th and 28th. Security, DSMO's report, probably beginning to have some discussions about lessons learned from HIPAA if we feel that we're in a position to start doing that at that point. And we're going to be talking some about the dental content relating to the PMRI and any other issues that seem appropriate at that point. Anyway that's as far as I've scoped out, if there's any other issues in January you can all think about it.
DR. STEINDEL: Simon, what are the other dates?
DR. COHN: December?
DR. STEINDEL: Not December, in 2004 that we set so far.
DR. COHN: Okay, we have January 27th and 28th, we have March 30th and 31st, and we have May 25th and 26th as hearing dates.
Okay, are there any other things in relationship to this? Well, I just want to take a moment and thank everyone, I mean this has been three very hard days of work and hearings. If you think about it we've done a tremendous amount of work, we have three major deliverables coming forward and I really want to tell you how much I appreciate you all for hanging in there, and it's not always been easy, so anyway thank you very much and we will continue on until next week. With that the meeting is adjourned. Thank you all.
[Whereupon at 11:52 a.m. the meeting was adjourned.]