[This Transcript is Unedited]
Department of Health and Human Services
National Committee on Vital and Health Statistics
Subcommittee on Standards and Security
March 3, 2005
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201
Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 180
Fairfax, Virginia 22030
(703) 352-0091
P R O C E E D I N G S (3:35 p.m.)
MR. REYNOLDS: Good afternoon. I am Harry Reynolds, Co-chair of the Subcommittee on Standards and Security for the National Committee on Vital and Health Statistics.
I’ll let my Co-chair, Jeff Blair, introduce himself in just a moment.
NCVHS is a federal advisory committee consisting of private citizens that make recommendations to the Secretary of Health and Human Services on health information policy.
On behalf of the subcommittee, and staff, I want to welcome you to today’s breakout session, where we will follow up on the items that came out of the full committee meeting that just ended, especially our letter that goes to the Secretary, as well as review upcoming agenda items that we want on our work plan.
We are being broadcast live over the internet, and I want to welcome our internet listeners as well.
As is our custom, we will begin with introductions of the members of the subcommittee, staff – we don’t have any witnesses today – and guests.
I would invite subcommittee members to disclose any conflicts of interest. Staff and guests need not disclose conflicts.
I will begin by noting that I have no conflicts of interest in this session.
With that, I will ask for introductions around the room, please.
Jeffrey.
MR. BLAIR: Jeff Blair, Vice President, Medical Records Institute; Co-chair of the Subcommittee on Standards and Security; and there is nothing that I am aware of that is a conflict of interest for this session.
MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the subcommittee.
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 the University of Utah in Salt Lake City, a member of the committee and subcommittee, and I don’t know of any conflicts for things that we are discussing today.
MS. BEE-BEE ASPIE: Suzie Beebee Aspie(?), staff to the subcommittee.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.
MS. AMATAYAKUL: Margret Amatayakul. Independent consultant, contractor to the subcommittee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the full committee and staff to the subcommittee.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, Sutter Health. I think I was volunteered to sit in on this session.
MR. BLAIR: Drafted. Drafted.
MS. PICKETT: Donna Pickett, NCHS, CDC and staff to the subcommittee.
DR. WARREN: Judy Warren, University of Kansas, School of Nursing, member of the committee and member of the subcommittee, and I am not aware of any conflicts today.
MS. TRUDEL: Karen Trudel, CMS, liaison to the full committee, staff to the subcommittee.
MR. KYLE: Frank Kyle(?), American Dental Association.
MR. DE CARLO: Michael DeCarlo with the Blue Cross Blue Shield Association.
MS. BOWMAN: Sue Bowman, American Health Information Management Association.
MS. BICKFORD: Carol Bickford, American Nurses Association.
MS. WATTS: Patricia Watts, Department of Veterans Affairs.
MR. BRUCK: Steve Bruck, PEC Solutions.
MS. FORITO: Michelle Forito(?), Drug Enforcement Administration.
MR. REYNOLDS: Okay. Thank you. We are happy to have all of you with us.
Now, the first thing we want to go to today is to the changes that were recommended to the letter that was read in public session with the full session of the committee. So I am going to ask Margret to take us directly to those, and, then, we’ll have our open discussion as to what we would like to see done with those.
MS. AMATAYAKUL: The first change that I noted was just editorial, on page 5, and I am not able to see my numbers here anymore, after I have increased the size of the font, but the sentence read, Testifiers that currently use PKI in health care – and it occurred to me that we had not defined – we had not spelled out public key infrastructure or indicated that there was digital signature associated with public key. So I thought, Testifiers that currently use digital signature through public key infrastructure, PKI, in health care are experimenting with it in environments that are relatively limited in scope, et cetera.
MR. REYNOLDS: Any comments or concerns by the committee?
MR. BLAIR: I feel comfortable with that.
MR. REYNOLDS: Steve.
DR. STEINDEL: Again, this is like with Margret. It’s editorial. I actually noticed that while we were reading it, and there’s a lot of places where we do have the abbreviation for the first time. Sometimes, it exists in the glossary. Sometimes it has been spelled out like in the background section, and I just think we need to be consistent.
MS. AMATAYAKUL: I have been looking through and picking up those as well, but this one I thought was something that was more notable than just –
DR. STEINDEL: No, I agree with you. I was just making a general comment.
MR. REYNOLDS: Okay. Next, Margret.
MS. AMATAYAKUL: The next one is in Recommended Action 1.1, where it was suggested we change the first sentence that read, HHS, DEA and state boards of pharmacy should recognize the current e-prescribing network practices that are in compliance with HIPAA security and authentication requirements as the basis – change to a basis – for securing electronic prescriptions.
MR. BLAIR: Correct.
MR. REYNOLDS: That was John Lumpkin’s comment earlier.
MR. BLAIR: Yes.
MR. REYNOLDS: Everybody okay with that?
MS. AMATAYAKUL: In Observation 6, since sig is not that well understood by the general public, I suggested adding, Latin for patient instructions in the parentheses.
DR. WARREN: You may need to spell that out a little bit more, the way Michael has. Actually put in Latin the whole word. I would do, Signatura, Latin for patient instruction.
MS. AMATAYAKUL: Yes, I will, soon as I –
MR. BLAIR: Latin used for.
DR. WARREN: Yes, Latin used for.
SPEAKER: That is not what it means in Latin. Used to signify.
MR. BLAIR: Yes, used to signify.
SPEAKER: Yes, I like that.
MR. REYNOLDS: Okay. Everybody good with that?
MR. BLAIR: Yes.
MR. REYNOLDS: Okay. Margret.
MR. BLAIR: You’ve got a typo on the next one. (Laughter).
MS. AMATAYAKUL: Pardon me?
MR. BLAIR: Nothing. Just –
MS. AMATAYAKUL: Jeff.
MR. REYNOLDS: Margret, ignore the background noise. Margret, there’s some background noise. Ignore it. Go to your next change, please. (Laughter).
MS. AMATAYAKUL: In Observation 10, in the last paragraph, second to last sentence, The same issue of balancing the privacy, interest and consumer control with the interests of healthcare quality and efficiency is central to the NHIN.
It was suggested to be added healthcare, patient safety, quality and efficiency.
DR. WARREN: Shouldn’t that be like patient safety, healthcare quality and efficiency?
MR. REYNOLDS: Yes.
Read that one more time, if you would, Margret.
MS. AMATAYAKUL: The same issue of balancing the privacy, interest and consumer control with the interests of patient safety, healthcare quality and efficiency is central to the NHIN.
MR. BLAIR: Excellent.
MS. AMATAYAKUL: And then I think the last – second to last change was to provide a citation for the Joint Clinical Decision Support Workgroup, and I did that, but I still have to go look up the URL tonight.
MR. REYNOLDS: Okay.
MS. AMATAYAKUL: Because it wasn’t on the document.
And then –
MR. BLAIR: I think it may be at the Connecting for Health website.
MS. AMATAYAKUL: Yes, I’m sure I can find it. It just wasn’t on my document, and I didn’t have access to the internet right now.
DR. STEINDEL: Margret –
MR. REYNOLDS: You have a question –
DR. STEINDEL: Yes, I have just a comment, an editorial comment. On the diagram, you know, why back up, the – you know – the –
MS. AMATAYAKUL: Here.
DR. STEINDEL: Is it possible to switch that to landscape?
MS. AMATAYAKUL: Sure.
DR. STEINDEL: Yes.
MS. AMATAYAKUL: Yes.
DR. STEINDEL: Because I was trying to read the text during the presentations today and couldn’t.
MS. AMATAYAKUL: This is a clip, as opposed to an actual document.
DR. STEINDEL: Yes.
MS. AMATAYAKUL: That is the other part of the problem. Yes.
DR. STEINDEL: Just rotate the photo.
MR. REYNOLDS: Any others, Margret?
MS. AMATAYAKUL: Yes, and then I took the list of acronyms that we had in the September 2nd letter, and I added it to this, and I went back and just double checked that all of the acronyms that we had in this letter were in there, and, if not, I added them all. So this is now a complete list.
In addition to the acronyms, I did provide a definition for Daily Med, NDC, RxNorm and SCRIPT, and SPL, just because they were really not that clear in the document.
Do you want me to read those?
MR. REYNOLDS: Yes, that would be good, since we changed –
MS. AMATAYAKUL: Okay. Daily Med, collaborative effort of government agencies, pharmaceutical companies and healthcare information suppliers to provide computer-accessible, up-to-date, reliable medication information to be distributed free of charge by the FDA through the NLM.
DR. HUFF: PDQ. (Laughter).
MR. REYNOLDS: Any other comments on that one? .
MS. AMATAYAKUL: NDC, National Drug Code, a universal product identifier for human drugs.
MR. BLAIR: I’m sorry, I missed that.
MS. AMATAYAKUL: NDC, National Drug Code, a universal product identifier for human drugs.
MR. BLAIR: Product –
MS. AMATAYAKUL: Identifier.
MR. BLAIR: Isn’t it product labeling –
MS. AMATAYAKUL: No.
MR. BLAIR: Okay.
MS. AMATAYAKUL: RxNorm, a clinical drug nomenclature produced by NLM in consultation with the FDA, VA and HL7. It provides standard names for clinical drugs and for dose forms as administered.
MR. BLAIR: Sorry. Could I go back to NDC again?
MS. AMATAYAKUL: Sure.
MR. BLAIR: It says, product labeling. I thought it was NDC codes.
MR. REYNOLDS: It says a universal product identifier for human drugs.
MR. BLAIR: Oh, the codes.
DR. FITZMAURICE: Yes.
MR. BLAIR: Okay.
DR. FITZMAURICE: Identifies the box.
MR. BLAIR: No, I wasn’t thinking of that, but I was thinking of the package labeling.
MS. AMATAYAKUL: We have structured product label later on, Jeff.
MR. BLAIR: Okay.
MR. REYNOLDS: Is everybody okay with the ones we have covered so far?
DR. COHN: Well, I guess I am still struggling with NDC, which – I mean, first of all, I don’t know if it is human drugs, but, beyond that, I am – I mean, it’s sort of like the HIPAA standard code set for the identification of whatever.
DR. STEINDEL: I don’t believe Randy is in the room and he could give a definitive answer, but I do believe that NDC is supposed to be used just for human drugs. Now, of course, it probably isn’t, but –
DR. COHN: I guess – is human drugs drugs licensed and approved to be used on humans? Is that what –
DR. FITZMAURICE: On humans by FDA. Yes.
DR. COHN: Okay. I just – Anyway. Whatever is fine.
DR. STEINDEL: You just wanted a clarification.
DR. COHN: Yes.
MS. AMATAYAKUL: So if I said a universal product identifier approved by FDA for human drugs, identifier for drugs approved by FDA for humans.
DR. STEINDEL: No, that doesn’t work –
MS. AMATAYAKUL: No. Okay.
DR. STEINDEL: – because all NDCs are not approved by FDA.
MS. AMATAYAKUL: That’s true.
DR. COHN: Okay. I withdraw my comments. MR. REYNOLDS: Okay. Here we go.
MS. AMATAYAKUL: RxNorm, a clinical drug nomenclature produced by NLM in consultation with the FDA, VA and HL7. It provides standard names for clinical drugs and for dose forms, as administered.
MR. REYNOLDS: Comments? Okay.
MS. AMATAYAKUL: SCRIPT, NCPDP standards for prescription transactions.
MR. BLAIR: It has to be –
SPEAKER: No.
MR. BLAIR: – NCPDP SCRIPT. Doesn’t it have to be both?
SPEAKER: Describing transactions?
DR. STEINDEL: No, it is specifically for, I think – No, I want to get the sense of real time in there.
MR. BLAIR: But can you have SCRIPT without having NCPDP SCRIPT? Because SCRIPT could mean something else.
DR. HUFF: Well, this is all in caps, so that gives you one visual cue at least –
MS. FRIEDMAN: Shouldn’t we say it’s from the prescriber to –
SPEAKER: Yes.
DR. FITZMAURICE: Would it be accurate to say for real-time prescribing?
MS. FRIEDMAN: We are relaying prescription information –
DR. STEINDEL: Yes. Yes, it’s not meant to be used for batch. It’s meant to be used in real time. Now, whether it is used in real time or not depends on how it is implemented, but it is not meant for batch mode. It is meant for real-time mode.
MR. REYNOLDS: So what do you think about what she’s got up there now?
MS. AMATAYAKUL: NCPDP standards for the electronic data interchange of prescribing transactions between prescribers and dispensers.
DR. FITZMAURICE: Is it just – or could it be web based? I don’t know that much about the standard –
DR. STEINDEL: I don’t believe they actually prescribe the mode of transmission.
MR. BLAIR: Is it not proper to say NCPDP message format standard?
DR. FITZMAURICE: Yes. We could take out the electronic data interchange, I presume.
MS. AMATAYAKUL: NCPDP message format standards for prescribing transactions between prescribers and dispensers for real-time prescribing – to enable real-time prescribing?
DR. STEINDEL: To enable, um-hum.
MS. AMATAYAKUL: NCPDP message format standards to enable real-time prescribing transactions between prescribers and dispensers.
MR. REYNOLDS: Everybody okay with that?
MR. BLAIR: Yes.
DR. STEINDEL: Yes, I am very happy with this one, because I thought – all the editing has been too easy up to this point. I feel better now. (Laughter).
MR. REYNOLDS: We feel appropriately thrashed on that one.
DR. STEINDEL: I mean, I was really upset when the only change was a the to an a. (Laughter).
MR. REYNOLDS: Okay. Now, we are going to SPL, going to structured product –
MS. AMATAYAKUL: Last one is structured product label. SPL, structured product label, a document markup standard that specifies the structure and semantics for the regulatory requirements and content of the authorized published information, such as a product label, package insert or other product information that accompanies a prescription drug.
MR. REYNOLDS: Why don’t you read it once more, just –
MS. AMATAYAKUL: A document markup standard that specifies the structure and semantics for the regulatory requirements and content of the authorized published information, parentheses, such as a product label, package insert or other product information that accompanies a prescription drug.
I did steal this from their website.
MR. REYNOLDS: As a lay person, I struggle with what a document markup standard is.
SPEAKER: XML.
MR. BLAIR: XML.
MR. REYNOLDS: Okay.
DR. FITZMAURICE: Document formatting standard?
DR. HUFF: Well, that took care of you, but everybody else reading that – (laughter).
MR. REYNOLDS: So we used one nebulous term to define the other one, right?
DR. FITZMAURICE: Could we put formatting somewhere in parentheses that –
DR. STEINDEL: Yes, I would say what it is first, and then say – you know – like comma or parenthetical remark that it is in a document markup language, because Harry is right. Just saying that, a lay person would not understand it.
DR. FITZMAURICE: Document formatting standard or –
DR. STEINDEL: I would say something like a standard – you know – that defines what is in the label, you know – document format – document markup language.
MS. FRIEDMAN: You could take out document markup language and move it to the bottom and make a separate sentence and say this is expressed in document markup –
DR. FITZMAURICE: Standard language.
MS. FRIEDMAN: – standard language, such as XML.
DR. FITZMAURICE: Yes.
MR. BLAIR: Good.
DR. FITZMAURICE: A standard that is specified. Yes.
MR. REYNOLDS: Everybody good with this?
Read it again, one last time, Margret.
MS. AMATAYAKUL: A standard that specifies the structure and semantics for the regulatory requirements and content of the authorized published information, such as a product label, package insert or other product information that accompanies a prescription drug. This is expressed in a document markup language such as XML.
MR. REYNOLDS: Okay. Next.
MS. AMATAYAKUL: That’s it.
MR. REYNOLDS: That’s it.
Okay. Maria.
MS. FRIEDMAN: I have two sets of comments, one from Randy Levin, who, unfortunately, had to leave. These are minor technical corrections.
At the top of page 9 –
MR. BLAIR: Is this Observation 7?
MS. AMATAYAKUL: Can you tell me what paragraph it starts with?
MS. FRIEDMAN: That very first sentence that says, Drug Listing.
MS. AMATAYAKUL: Oh, okay. Good.
MS. FRIEDMAN: Top of the page, and he would like to strike drug-listing rule and have that to say the electronic label system is, and then strike promulgated and say ready, and then I’ll give you the corrections to the next sentence, and then we can go back and read them both.
NLM indicated that the FDA estimates that full implementation of the structured product label requires promulgation of the drug-listing rule, which will take several years to complete.
MR. BLAIR: Could you read the first –
MR. REYNOLDS: We’ll start at the beginning of the whole sentence up there.
MS. AMATAYAKUL: So NLM expects to start receiving structured product labels from the FDA later this year, as soon as the FDA’s electronic-label system is ready.
MS. FRIEDMAN: Labeling system.
MS. AMATAYAKUL: Labeling system.
NLM indicated that the FDA estimates that full implementation of the structured product label requires promulgation of the drug-listing rule, which will take several years to complete.
That doesn’t sound quite right.
MR. BLAIR: I think there’s two thoughts in that last sentence, and we may have to separate that, because the second thought is how long will it take to complete, and it blurs with the front part.
MS. FRIEDMAN: I know what the problem is. We have an antecedent problem, so if we put a period after rule and then say this and eliminate which. You gotta implement – implementation of the SDL is dependent on the promulgation of the drug-listing rule, and the sequencing, I think, will take several years to complete.
MR. BLAIR: It is always good to have somebody on the subcommittee that knows what an antecedent is.
MS. AMATAYAKUL: I think we would be better off saying this implementation will take several years to complete, rather than the promulgation –
MS. FRIEDMAN: Right. Yes.
MR. REYNOLDS: Read starting at –
MS. AMATAYAKUL: Okay.
MR. REYNOLDS: – NLM, right above there.
MS. AMATAYAKUL: NLM expects to start receiving structured product labels from the FDA later this year, as soon as the FDA’s electronic-labeling system is ready.
NLM indicated that the FDA estimates that full implementation of the structured product label requires promulgation of the drug-listing rule. This implementation will take several years to complete.
MS. FRIEDMAN: I think that does it.
MR. REYNOLDS: Everybody good?
MS. FRIEDMAN: Okay. And then I had just a couple of picky comments back on page 6.
MS. AMATAYAKUL: Which paragraph.
MS. FRIEDMAN: The one that begins e-prescribing networks, down on line 23.
MS. AMATAYAKUL: E-prescribing networks.
MS. FRIEDMAN: Right.
MS. AMATAYAKUL: Okay.
MS. FRIEDMAN: And down in the sentence that says, as a result, if PKI were required for e-prescriptions for controlled substances, the near-term response would be for the industry to continue its current practices, which is patient based.
So we either have to make it practice, which is patient based, or practices which are patient based. Picky.
And then in the next sentence I think we are missing a word, substances. After controlled and non-controlled in the next – right there. It should be substances.
You okay? You want her to read that for you, Jeff?
MR. BLAIR: I’m okay. I just wanted to say, Harry and Margret, thanks.
MR. REYNOLDS: Yes, ma’am.
MS. BICKFORD: Carol Bickford from the ANA.
What was the resolution on the question about the drug-knowledge basis on Recommendation 7.1?
DR. WARREN: Wasn’t that the one where we were going to put something in the glossary and dodge that bullet for right now?
MS. AMATAYAKUL: Do you want me to define drug-knowledge base in the glossary? I have a glossary. Hang on. I can get it and I can come up with –
MR. REYNOLDS: While you’re getting it, let’s ask – does that suffice for the committee or do we want to branch into discussing –
DR. HUFF: The sentence would actually be a little more accurate if you said – instead of the way – you would say with other proprietary coding systems from drug-knowledge-based vendors –
SPEAKER: Right. Get the word vendors in there.
MR. BLAIR: Um-hum.
SPEAKER: Yes.
MR. BLAIR: Why don’t we do it that way, because I would – I really would like to skirt the issue of drug-knowledge bases in more detail in this letter.
DR. WARREN: Would you still not want a definition of what those are?
MR. BLAIR: Yes.
MR. REYNOLDS: Yes, but let’s –
DR. WARREN: Steve’s looking –
MR. REYNOLDS: Hold on for a second. Let’s make sure we fix the letter first. Then, if we want to do – keep a couple of conversations going.
MS. AMATAYAKUL: So we are at, Recommended Action 7.1. The last sentence would be, RxNorm should also be evaluated for use where a proprietary code is used for the orderable drug and the RxNorm code is included in the message to provide interoperability with other proprietary coding systems from drug-knowledge-based vendors.
MR. REYNOLDS: Is that what you –
SPEAKER: Yes.
MR. REYNOLDS: Everybody good?
MR. BLAIR: Pause a sec?
MR. REYNOLDS: Yes.
MR. BLAIR: It is as if – it is from, and it is if it’s the drug-knowledge-based vendors are providing the codes –
MS. FRIEDMAN: Coding systems.
MR. BLAIR: Yes, it’s coding systems. Aren’t they – within is not the right word. I’m just thinking from almost implies that they are providing it to others, and I don’t think –
DR. HUFF: They are.
MR. BLAIR: Is that the way it works?
DR. HUFF: Yes, they make up their own code – clinical drugs, and that is what ends up in the transaction.
MR. BLAIR: Okay. I thought they sort of give like the result of the drug-to-drug interaction. Didn’t know they actually supplied the codes.
DR. HUFF: They supply the codes, and –
MR. BLAIR: Okay.
DR. HUFF: – you can only use their system if you know their codes –
MR. BLAIR: Okay. Never mind.
MR. REYNOLDS: Okay. Now, let’s go back to definition and – We still want a definition in there, correct?
MR. BLAIR: Yes.
DR. WARREN: Well, I think that is what we heard from Justine, and when I thought about some of the responses, I mean, for those of us who interact with these things, you know, it surprised me to hear some of the questions that came from that. So I think maybe a definition would clarify.
MR. REYNOLDS: Okay. She’s got one up here right now. Let’s look at it.
MS. AMATAYAKUL: Drug-knowledge base. Typically, a subscription service provided by a vendor to information about drug data that can support healthcare professionals in making decisions about dosing interactions, allergy alerts, disease contraindications and drug identification.
MR. BLAIR: I think that the key thing we want to get in that definition is what they are used for. In other words, you know, the key thing to support the drug-to-drug interactions is – maybe it’s there, but I didn’t catch it when you read it.
MS. AMATAYAKUL: Typically, a subscription service provided by a vendor to supply – we could say to the prescriber, if you want – information about drug data that can support healthcare professionals – that is probably better, because then it’s broader – in making decisions about dosing interactions, allergy alerts, disease contraindications and drug identification.
DR. WARREN: One of the things, too, is I know that at least two of the vendors that we talked to also provide patient teaching sheets.
MR. REYNOLDS: Patient what?
DR. WARREN: Patient teaching sheets, which was one of the questions that came out – Now, I don’t know that all the vendors do that, but some of them certainly provide a handout that the prescriber can give the patient on how to take the drug.
Now, still, the only access the patient has is through the prescriber. They don’t have access to the knowledge bases.
MR. BLAIR: After you finish that, I have a thought –
MR. REYNOLDS: Judy, you said that it is only to the prescriber’s –
DR. WARREN: Yes.
MR. REYNOLDS: So do we need to say that up –
MS. FRIEDMAN: I would make that a separate sentence. I would edit it right there and say some vendors supply providers with educational materials or –
DR. WARREN: It is more educational materials, rather than just instruction.
MS. FRIEDMAN: Is that true, Carol?
MS. BICKFORD: The question I have is is this the same content that is provided to you through your pharmacy when you pick up your prescription? The patient instructions, is that coming from that same database structure that you are addressing?
DR. FITZMAURICE: My understanding is that what we would have in RxNorm and on the Daily Med would be the information coming from the manufacturers to FDA to the National Library of Medicine, but, in addition to that, there might be late-breaking news, there may be journal articles, there may be off-label uses that the knowledge vendors could add in their drug databases that cannot be added to the structured product label.
MS. FRIEDMAN: Some of the systems used by the big pharmacy chains and stores – you know, the Walmarts and supermarkets and all that – are propriety systems. So it is possible that you could get similar but different patient instructions –
DR. WARREN: Absolutely. I don’t think they are standardized, and you also need to look at most of those materials are written either at the sixth- or eighth-grade level. So there is a lot of variability in who is putting those together, but, I mean, that was the comment that Don wanted us to address is, you know, access.
MR. REYNOLDS: The first question is do we want a definition of a drug-knowledge basis plus all the ways people use it?
I guess I am trying to get a sense of – on the others, we have given a definition. This one, are we telling a story or are we setting up a definition?
Steve.
DR. STEINDEL: Just as an observational comment, we did not define drug-knowledge-base vendors in the previous e-prescribing letter, nor in the PMRI terminology reports.
MR. BLAIR: Really?
DR. FITZMAURICE: So, finally, we’ve got it in?
MR. BLAIR: PMRI? We didn’t have it in there?
DR. STEINDEL: We did not define what it means.
DR. WARREN: Is that –
DR. STEINDEL: I am pointing that out. We are now taking a precedent in defining what it is in this –
DR. FITZMAURICE: I think it is a good idea. Do you think it’s a good idea?
DR. STEINDEL: I am somewhat mixed on it –
DR. WARREN: Why?
DR. STEINDEL: – if you want to know the honest truth – about how far we go. You know, I would like to leave the period after, you know, it is something like – it is something supplied by vendors, not say what it does.
DR. COHN: Can I make a comment here? Because I think that actually I agree with Steve on this one.
The last sentence was an issue brought up that was actually referred over to the NHII Workgroup to talk about this issue of patient interaction with drug-knowledge bases and how they get these instructions. This was not a responsibility for this subcommittee to have to come up with wordsmithing to answer that question.
DR. WARREN: Go with that.
DR. COHN: What?
DR. WARREN: Go with that.
DR. COHN: We’ll go with that. So I think – I think, at some point, NHII may deal with it or we’ll ask questions when we are talking about personal health records, how they deal with patient information about drugs.
DR. WARREN: I guess I missed that. I thought that the request was for both groups to take a look at it, but I am more than comfortable –
DR. COHN: Yes.
DR. WARREN: – to turf that off to NHII.
DR. COHN: Well, we could take a look at it, but I don’t think our solution to taking a look at it is to put an additional sentence talking about what vendors do in the glossary. I don’t think that’s going to solve our problem.
MR. BLAIR: Yes.
MR. REYNOLDS: Okay.
MR. BLAIR: But could we go back to Carol and ask her if we do this does this address the issue, Carol?
Wait. Wait. You have – microphone, please.
MS. BICKFORD: I was just bringing to your attention that there was an outstanding issue in the letter structure itself, and I don’t have any problem with the drug-knowledge base as it is structured right now, either. So – I am not the expert. I am just bringing it to your attention there was a leftover item from the discussion.
MR. REYNOLDS: And were you referencing the part that has been taken out also? You are okay with that?
MS. BICKFORD: Absolutely.
MR. REYNOLDS: Okay.
MS. BICKFORD: I think that you are putting too many parameters on what this drug-knowledge base is for now and for the future.
MR. REYNOLDS: Okay. Why don’t you read it as it is now, Margret, and let’s get approval.
MS. AMATAYAKUL: Okay. As it is now, and, then, I also heard Steve suggest we should take off the end. So there’s two ways of going here.
Typically, a subscription service provided by a vendor to supply information about drug data that can support healthcare professionals in making decisions about dosing interactions, allergy alerts, disease contraindications and drug identification.
MR. REYNOLDS: Any issues?
DR. TANG: Is it implicit that this is for use in a computer or even an EHR?
DR. WARREN: I don’t think that makes a difference. It could be a book.
DR. TANG: I don’t know that it is available as a book.
SPEAKER: PDR.
DR. TANG: But you don’t get drug interactions – well, I suppose you do.
SPEAKER: You do. The product label. That is what a PDR is.
MR. REYNOLDS: Okay. Any changes from the committee?
DR. STEINDEL: I would like to – you know, she’s put this as a closed list, and I would like to put, and others that may arise or something at the end, in case we haven’t been all inclusive.
MS. FRIEDMAN: Such as –
MR. REYNOLDS: That’s at the end of –
DR. STEINDEL: Or start it with, such as. Yes. Just so it is not an all-inclusive list.
MR. BLAIR: For example.
DR. STEINDEL: Um-hum.
MR. REYNOLDS: Okay.
DR. WARREN: Get rid of the about, if you are going to do it that way, so making decisions, such as –
MR. REYNOLDS: Everybody good?
Okay. So that’s it, Margret?
MS. AMATAYAKUL: Yes.
MR. REYNOLDS: Do we need a motion to accept a letter or –
MR. BLAIR: Before we do, Carol pointed out that we had omitted that. Is there anything else we have left out?
Then I make a motion that we approve the letter.
MR. REYNOLDS: Second?
DR. WARREN: Second.
MR. REYNOLDS: Judy seconded it.
All those in favor –
It was unanimous.
SPEAKER: Simon voted.
MR. REYNOLDS: Okay. So the letter will go forward to the full committee again tomorrow, and we are ready to go. So thanks, all of you. Nice job. (Applause).
Okay. Agenda Item 2, Margret.
MS. AMATAYAKUL: I should just comment, we have a list of testifiers that was only to the Subcommittee on Security and Standards, and we are going to add the testifiers to the privacy group as well, soon as I get those.
MR. REYNOLDS: Okay. Let’s go to the next – move the next agenda item, and our next agenda item is we have been very focused on the e-prescribing and have had some HIPAA discussions and other things, but, now, as Simon said, with a change in the committee – and, also, we heard some of the stuff from David Brailer and other people today – it is important to go ahead and establish a list of what we want to do next. What is our sequence of doing it? What do we want to do? What do we have to focus on? And I think, more importantly, initially, list some of the things that we kind of have to do. The one of them that was mentioned today was the yearly administrative simplification report to Congress, so – but we are going to go through a list, but I would like to make sure that we list the things that we are required to do, so that we make sure we have those pegged in the right spots, and then go into the things that we may want to build on further, if that is an acceptable approach.
So other than the yearly – the simplification report to Congress, are there any things that are mandatory that we produce?
DR. COHN: I was actually going to comment. I think that there is a series of things that we are going to be watching for related to this letter that we need to be – as we have said it, we are going to have to do it, and these are obviously follow-ups of some of the standards that are left outstanding and recommendations around that.
MR. REYNOLDS: Well, we are actually watching and reevaluating the standards from our letters, from the letters we have produced to the Secretary.
MR. BLAIR: Continuing to monitor those.
MR. REYNOLDS: Okay.
MR. BLAIR: And then the other piece – well, I guess the other piece – you are going to be getting to the FHA stuff. Is that down on your list?
MR. REYNOLDS: Yes, but I’m not sure it is a requirement. I mean – and we’ll get into that list with the other stuff, I think, but I am not sure that –
So are these the only – so, obviously, the simplification report, we have to do. We need to follow – everything we have said to the Secretary we said we would watch we need to watch.
We have already scheduled, in April, a HIPAA RLI discussion, haven’t we? Is that correct, Maria?
MS. FRIEDMAN: Far as I know. And Michael DeCarlo is sitting there saying that all we have to do is give him the word and he’ll be here.
DR. COHN: Good.
MR. REYNOLDS: There would be one of many, right?
DR. COHN: Yes, and I don’t want to get in the way. MR. REYNOLDS: No, please.
DR. COHN: I think the conversation is the right conversation, but I do want to – once again, being the old Chair I remember all the to-dos in my mind, some of which didn’t make it on paper, but I just do want to remind the new Chairs that we have subcommittee member meetings scheduled for April and July. We do not have any subcommittee meetings scheduled beyond that. So we just need to make sure that – I mean, I don’t think we have new members – none of them seem to be joining this subcommittee. We, at least, are checking about people’s dates for the remainder of the year.
MR. BLAIR: Well, Simon, if the subcommittee meeting is in July, is that after the full committee meeting in June?
DR. COHN: I sure hope so.
MR. BLAIR: So we’ve got only the April piece to bring anything forward to the full committee, and a lot of the stuff in NCPDP probably won’t be ready ‘til June. We hear it in July, which means we can’t wind up moving it forward ‘til September.
MS. FRIEDMAN: I mean, the timing is what it is.
DR. COHN: Yes, and, certainly, the committee has the right to check dates for additional meetings either before the full meeting in June or elsewhere. I think we would have to be pretty certain that there will be things for us to make comments on for the June meeting before we scheduled one, but you could certainly check. The reason we didn’t put a meeting in in the May-June time frame was, quite honestly, that when we were checking with people we couldn’t find a date that would work for everyone, but, certainly, people’s availabilities do change.
DR. STEINDEL: And from what I understand from NCPDP, while they are going to be trying to get everything done by June – May-June time frame, this is an SDO, and –
MR. BLAIR: Okay. We have to accept that.
MS. FRIEDMAN: I think maybe we can pencil in or make a mental note that if situations arise and we need to lay on a hearing, we’ll do it, and we have done that in the past.
We also have some regs that will, hopefully – HIPAA regs that will, hopefully, be coming out this summer. So there is continuing monitoring of the regulatory process with us.
MR. REYNOLDS: Well, category is, obviously, our responsibility is to continue to monitor HIPAA, correct?
DR. FITZMAURICE: Claims attachment will come out – right? – and so we have to make comments on that.
MR. REYNOLDS: Which one?
DR. FITZMAURICE: Claims attachment.
MS. FRIEDMAN: Claims attachment, and the modifications reg also, the updating process. So that is certainly something that the committee will want to spend some time on.
MR. REYNOLDS: Obviously, we continue to monitor transactions and code sets, the security rule, its rollout. Any other key entities – and the ROI, we already have scheduled in April. Are there any other key pieces that we have missed?
MS. FRIEDMAN: I think there will be the opportunity, also, for input and/or review of some of the annual-report material, but, generally, that is more of a review than a generation of information. Usually, that information generation comes from me and some of the other staff.
MR. REYNOLDS: Okay. Some other things that were listed – and I’ll go through a list that Jeff and Simon and I kind of put together. We just listed all the tracking and implementation of HIPAA, improving the HIPAA process, whether or not there’s any changes that a DISMO – changes to the federal process for adopting HIPAA, new 835 transaction recommendation coming from the DISMO.
DR. COHN: And I guess, just to remind you, I think we told the DISMOs when they testified in January that we were going to be – I mean, I think they wanted to bring something forward for a change, and I believe – once again, I – remember what I think we told them was is that we would consider that in April, I believe.
MS. FRIEDMAN: Right. That was one of the reasons for including in – shoehorning them in in January is so that they could back, and we told them the earliest opportunity would be April.
MR. REYNOLDS: Okay. From an April standpoint, Maria, I guess, being a new chair, I have a question. You help set the agenda, right? We set the agenda, you work on getting people here, is that correct?
MS. FRIEDMAN: Right.
MR. REYNOLDS: Okay. So you mentioned – do we or don’t we officially have scheduled for April the ROI on HIPAA?
MS. FRIEDMAN: We have nothing officially scheduled at this point.
MR. REYNOLDS: Okay. Well, let’s go through the rest of this list, then, and we need to come back and definitely decide on April and June for sure, so we can make sure –
MR. BLAIR: On improving the HIPAA process, Simon, that was at the top of the list that you gave us, and is it that you – could you help us a little bit understanding that? Is it that the DISMOs are planning to present to us their suggestions for improvement or where’s the ideas for improvement going to be coming from?
DR. COHN: Okay. I will apologize for having to translate cryptic notes that I make to myself. Notes that I passed on to you are sort of long-term watch items that are not in any particular order, generally.
I think that the process issues – improving the HIPAA process is something that I think has to do with the – I mean, an assumed NPRM that is going to be coming out, as well as looking and working with the industry to identify other opportunities to help improve the overall process.
To my view, one way to begin to look to that is this ROI discussion, which is – I mean, this sort of fundamental issue is how are we going to maximize the value of this thing, and does maximizing the value also mean that we need to do something to improve the process, even beyond what is going to likely be in the proposed rule?
MR. BLAIR: So ROI was focused on maximizing the value, not helping to quantify the benefit that the industry has received from implementing HIPAA?
MR. REYNOLDS: If they discuss the ROI, they should – that should give us some indication of what’s happened, and it also should give us the groundwork for what we could recommend maybe be done differently going forward, because, if they haven’t achieved the ROI, most people are going to say, why, and what were the processes, what was the implementation or what was the situation that created that? So, hopefully, we could get both of those out of there.
MR. BLAIR: Okay.
MR. REYNOLDS: I’m not trying to talk you into it. I’m just making a –
MR. BLAIR: No, no. I am just trying to understand the intent of what those items are, so we could pursue them.
MR. REYNOLDS: Another thing that came up today, I know, was standards organizations and how they interact in general. One thing that – and I think we found positive in e-prescribing was that the industry, along with the standards organizations, came forward and are working very closely together to make sure some things happen. How that works for everything else that is going on, especially as we move into the next phases of standards, is another question that I am not sure exactly how to address right now or whether you have them all come in and discuss it, but that is another subject.
DR. COHN: Yes. I was actually going to – yes, I was actually just going to sort of, I think, second that sort of general view.
I am struggling a little bit, because we’ve got things – I know there’s going to be at least one or two groups coming up to the full committee in June. I actually think it would be valuable for the subcommittee – and, once again, I don’t know the time. I don’t know whether it is in April or if we have a June meeting it is a June meeting or a July meeting or whatever to sit down and talk with the HMOs about how coordination – you know, what coordination is occurring, how is it working, what is really – I’m sorry. It’s been a long day. Yes, standards development organizations, not health-maintenance organizations. I work for a health-maintenance organization.
MR. REYNOLDS: That would be an interesting subject.
DR. COHN: Steve, though, I understand why you are confused and looking at me but what I mean is standards development organizations and groups, like the DSMOs and all of that, to begin to understand sort of is coordination occurring? If so, how is it occurring? Is it working? Is it not?
MS. FRIEDMAN: It may have changed over time. We are two years into HIPAA, and then some, and what was then may not be the same thing as what is now.
DR. COHN: Well, I think there’s that question. I think – I mean, what I guess I would observe is – you know, there’s the DSMOs relating to HIPAA, so how is all that working? That is an MOU phenomenon. We are obviously asking, because of e-prescribing, HL7 and NCPDP to be doing some work together. Is that working? Then what about other venues where coordination is occurring or whatever, how are all those things working?
Steve, I can see –
MR. REYNOLDS: Judy had a question first.
DR. WARREN: Simon said a lot of what I was going to say, except, I guess, specifically, I would really like to know how the coordination between NCPDP and HL7, along with the relationships they had – because I know they brought in some other groups into that collaboration, – how well did that work, and, you know, what can be the lessons learned for future activities like that? Because I know they brought – RxHub submitted their stuff for a draft to be got on the standard. I know SNOWMED came in and played in that, and I think there were a couple of other organizations –
MS. FRIEDMAN: Correct me if I’m wrong, but wasn’t this somewhat of a unique process?
DR. WARREN: Yes.
MS. FRIEDMAN: And, really, a first-time –
DR. WARREN: Right.
MS. FRIEDMAN: – process.
DR. WARREN: And so, specifically, you know, what kind of people did they bring together to handle the issue? How did they work out how they were going to work together as kind of – to close the loop for us on how did this work, since it started here, and would this be a good model to continue with other groups?
DR. FITZMAURICE: So that might be good testimony for our next meeting – right? – to have them come in and report –
DR. WARREN: Yes, kind of like a panel or something. Yes.
DR. STEINDEL: Harry, I would like to pick up, because I was going to kind of pick up a little bit differently, but more or less the same thing as what Judy just said, because it has been my observation that when there’s a business interest for the SDOs to coordinate, they do a wonderful job of coordinating, and, you know, in one case, we have this beautiful example of what has gone on with e-prescribing, you know, where these groups have come together, there’s been something – a target and something that needs to be done.
Another area where this has happened and we don’t talk about it as much is with the claims attachment, you know, where X12 and HL7 came together to develop a unified standard to support what was needed by the industry, and, you know, this is the type of thing I don’t know if it is going to be – should be left at the subcommittee level, if we should think about using that as the vehicle that we have allocated time for at the full committee, because I see some other things coming up in the near future where we are going to be involving business interests from outside groups that need to come together. A lot of it I’m looking at with the FHA.
MR. BLAIR: There is something I am missing in this discussion, so help me out.
Let’s say we wind up focusing our time on this and we wind up learning about issues on getting standard-development organizations to coordinate together, I am missing the next step of how this makes any kind of significant difference either in what we do or what the SDOs do, because the next time around when they are coordinating, the issues involved in what makes good coordination may be completely different. So why is this important to look at?
DR. WARREN: Because I think it is a lesson learned, and Brailer even pointed it out, the technical compatibility, I think he talked about or – but, I mean, we are going to have to start getting some of these people coming together to talk about the same thing, because there is, occasionally, some overlaps between the SDOs and what they are working on.
MR. BLAIR: Okay. So, Judy, you think that the lessons we learned from looking at these prior examples will still be applicable to new cases in the future? That was the piece that I was questioning is I tend to think of these as each one-off situations, each kind of unique.
DR. WARREN: You know, Brailer called it technical harmonization, and I think we are going to need more of these kinds of partnerships in order to achieve them.
DR. COHN: And let me just further comment about it, because I absolutely agree with you. I am sort of struggling, I mean, we have – I mean, up ‘til now, obviously, our approach to standards has been sort of recognizing that there’s – one of the wonderful things about standards is there are so many of them, and it has been really our role to – or we have seen our role as to identify in that crop of growing standards what are the standards that should be the standards that the federal government considers or otherwise.
That has been fine, as long as everybody was sort of widely separated in terms of their standards domains and all of this, but the removal of the NHII and all that, suddenly, everybody is getting sort of very crowded. I mean, we’re already seen this with e-prescribing, where HL7 and NCPDP live in – I mean, if they don’t live in the same space, they live certainly very close and there is a thin wall between those bedrooms, and – at least, you know, for some of the functions – and we are going to be seeing, I think, more and more of that as well as how – you know, if we really do get computerized, you know, how is all this going to sort of work together going forward?
And so, you know, I think it is an occasion to sort of look at what seems to work in terms of this. I mean, they are obviously – you know, the bedrock of all of this is ANSI-accredited standards development organizations, which are, at the end of the day, private organizations, and the question is what has worked for them around coordination is the model that we want to promote, the one that we have – promoted, which is we select a priori and that’s it or do we see some – like a DSMO-type structure going forward? I mean, what would work better moving forward? And I don’t have the answers. I’m just sort of asking the questions.
MS. FRIEDMAN: I think one of the things that we saw on e-prescribing is that there are a bunch of these standards organizations that aren’t talking to each other necessarily. We saw – you know, we saw ASTM and we saw – I mean, certainly, the ones closest to the industry, NCPDP and HL7, we found them pretty early on, but then there was a role of X12 and ASTM, and, you know, and some of the international work that’s going on and how that intersection works or doesn’t work, and I was concerned, towards the end, very frankly, that with these groups cropping up, we weren’t going to hear from everybody. I think we did, in the end, but, you know, it was clear to me, at least in the world of e-prescribing, that – in some cases, there was really great collaboration and technical harmonization, and, in other cases, there wasn’t at all.
MR. REYNOLDS: See if this makes sense: Previously, standards organizations have done their things and people have picked those standards to go do something.
Whereas, now, we are coming up with subjects – whether it is electronic medical record, e-prescribing – where you are talking about a subject of things, and them just continuing to do a piece of something and hoping that it fits may not necessarily extrapolate itself when you move to these full subjects and these full subjects are – if we can’t pull a piece off the shelf or they haven’t thought about it in the context of the full piece, rather than just setting the next data format, then I am not sure we are going to mesh in a way. So, Steve, go ahead.
DR. STEINDEL: Harry, I would like to read – because this is just factual information – the first sentence, and then I’ll paraphrase the rest of an email I got. As people know, I am a member – CDC is a member of ANSI-HIS(?), and I serve in that role, and the first sentence says, as follows, “On Wednesday, February 16th, the ADA, ANSI, HISB, HIMSS, HL7, IEEE, NCPDP and X12, among others, met with Dr. Brailer of the Office of the National Coordinator for Health Information Technology.”
The rest of it I can paraphrase very bluntly and it seems to indicate how are you going to work and play well together in this new environment? So, you know, Dr. Brailer’s office, as he indicated earlier, is very interested in this subject, and he has already started communicating with the SDOs about it.
MS. FRIEDMAN: That is a long list and it says, among others.
DR. STEINDEL: Um-hum. Those are the ones that ANSI has pulled out. They all happen to be members of ANSI-HIS.
MR. REYNOLDS: Stan, you had a comment.
DR. HUFF: Well, I was just going to say that the – when it gets big – for instance, HL7 has an EHR set of folks who are worried about exactly those questions. So they are trying to address it internally. Now, the problem is is whatever applied – you know, whatever from ASTM might apply to that isn’t necessarily at the table, but they see the need and they are looking at the bigger picture.
And I appreciate Steve’s – you know – further information. I mean, this has been – I mean, this has a long history. HISB started out being – it attempted to be a true coordinator of standards activities, and that was the vision that Clem had when Clem was the head of HISB was that that committee would say, you are going to do this part, and you are going to do this part, and here is a gap, and we need somebody to step up and do that, and that was basically voted down as being un-American and undemocratic to have that kind of coordination, and that was essentially the issue that caused, you know, a change in leadership in that, because they didn’t – the standards organizations didn’t want to be governed in that way.
DR. FITZMAURICE: Well, and, also, it was kind of contrary to ANSI’s rules, too.
DR. HUFF: Yes.
DR. FITZMAURICE: You couldn’t enforce it.
DR. HUFF: That’s right. So there are some tricky – I mean, as much as we would like it, in some ways, to be more top down and directed, in some ways, it is sort of antithetical to ANSI open consensus –
DR. FITZMAURICE: This is America.
DR. HUFF: – stuff and everything. So it’s –
MR. REYNOLDS: Okay. So we have it listed as a subject –
DR. STEINDEL: Yes, and, Harry, as a further example is I think the government has gotten much more savvy since we first started with working with SDOs, which, in the medical area, was with the initiation of HIPAA really. Before that, it was kind of a techie – We went occasionally, but with the introduction of HIPAA, it became part of our business, and we spent a lot of years learning how to become more savvy in this area, and I think the way the government interacted with HL7 in developing EHR draft standard for trial use is a good example of probably how the government is going to be working with SDOs in the future.
DR. HUFF: So this is a new subject, a new topic for the list.
DR. COHN: Okay.
DR. HUFF: Okay?
DR. FITZMAURICE: Remember, we are having the – at least NC HISB and maybe U.S. Tech or ISO coming in and testifying either to us or to the full committee. I think maybe it was the full committee. So –
DR. COHN: Yes, I think they were presenting to the full committeein June.
DR. FITZMAURICE: So this is a very timely topic.
MR. BLAIR: So is that going to be April?
DR. COHN: No, that is coming in June, and so I think the question is do we ask the subcommittee to begin to look at this beforehand or after or not at all. I mean, I think it is a worthy topic. I –
DR. FITZMAURICE: Decide what our role is. I think we need some discussion on that.
DR. COHN: But as I said, there’s – I mean, once again, I don’t think necessarily this has to be – in April. It could be done in August. Obviously, I think there should be a little more light shine shown on all of this.
MR. REYNOLDS: And what’s the new subject –
DR. HUFF: So this is one I raised very briefly at the end of a meeting before, and that is the idea that the vision that has been put forward for a lot of the coding of detailed clinical data is, in fact, that, you know, you would collect appropriately what you need to document at bedside with LOINK(?) codes and SNOWMED codes in the detailed coding systems, and that we would then be able to automate the process of determining quality and determine billing classifications and determine morbidity and mortality classifications, based on that detailed clinical documentation, and I would like to get educated about anything anybody is doing along the lines of actually having – you know, having that vision realized, and if nothing is happening, then I would like to talk about how we could encourage a research agenda that would lead to automation of those things, and I think that would revolutionize a lot of our thinking relative to health statistics and population statistics and other things, and so I – and it is obviously more strategic. I mean, a lot of these things are things that I think are more urgent in a short time frame. That sort of subject, I think, long term, could change dramatically the face of what we are doing, and –
MR. REYNOLDS: What would you term the subject again?
DR. HUFF: I guess I would – maybe the – well, I don’t know how to put it in a single –
DR. WARREN: It is one of those things where we talk about the real spinoff from EHRs or the secondary uses, and I think we are now at the point where we can start identifying the secondary uses, but they are not as easy as what we once thought, especially when you are trying to pull off quality indicators off of clinical data. That is a little harder, and I think –
DR. HUFF: I guess maybe if I were going to say a phrase that would be driving quality and – quality billing and statistics from primary clinical documentation, something like that. I don’t know –
MR. BLAIR: Could I go back to an earlier statement that you made? You wound up saying automation, and I am afraid I have now lost the phrase, but that is sort of where I got lost, in terms of what you were suggesting. Are you able to get me back on track? Do you remember what you were saying?
DR. HUFF: Yes, what I said was that you would be able to automate the creation of billing codes and quality indicators and other information in an automated way from the clinical charting.
In other words, if we had standard code sets and standard data representations, I should be able to write a rule that tells you what you are legal to bill for, so that it is not a person sitting in a terminal and you are not doing DRG group – you know, you are not doing DRG grouping with an expert person. You are saying, Look, this is the rule. If this happened, this is what you can bill for, and if this happened, this is the outcome you should report, and, you know, if you do these – you know, some of this is already starting to happen. If the HEDUS(?) measurement is that hemoglobin A1Cs need to be measured, I can determine your HEDUS measurement by counting the LOINK codes that measure hemoglobin A1C and saying how many – So that is a report from my clinical database, not some newly-developed thing that is driven, you know, by chart review or some other manual process.
MR. BLAIR: Okay. Is this the same as decision support rules?
DR. HUFF: This is the same thing that Chris Shoot calls aggregation logics.
MR. BLAIR: All right. But how does this – It sounded to me like you were talking about decision-support rules. This is not that different or –
DR. HUFF: It’s different. Well, decision support is so broad you can throw anything in that tent, but this is different than the usual kind of decision support. This is a rule base that allows me to assert what I can bill for –
MR. BLAIR: So you are saying –
DR. HUFF: – as opposed to the normal kind of rule sets, which is – you know – are protecting you –
MR. BLAIR: Okay.
DR. HUFF: – from drug interactions and from –
MR. BLAIR: So what you are saying is we should be looking into whether standards are being developed for these rule sets that we could recognize. Is that what you are saying we should have on our agenda?
DR. HUFF: Well –
DR. COHN: I think it is an exploration –
DR. HUFF: I think that is one part of it. The other thing is – I mean, is the vision right? Can we, in fact, do that. Is that a vision we should hold? Should we create those kind of rule sets? Is it feasible? Should we do some experiments to see whether it is feasible and –
MR. REYNOLDS: Simon –
DR. COHN: Yes, I was going to say, Stan, I mean, you bring up an interesting set of issues. One is is that I would say that if one decided to go down that area, some of those things may be joint hearings with some of the other subcommittees, only because, if you think about it, downstairs and over are all the secondary users of information, you know, it is Populations and Quality Workgroup, and us talking about – uses of information in the abstract sort of lacks a business case. So it is a thought.
Now, having said that, also, you know, one of the things with my Kaiser hat on – and, you know, we are working with the NLM, trying to figure out how to map CPT and SNOWMED, which is – I mean, which is like way simpler than figuring out how to figure out what is the primary thing versus the secondary thing versus a whatever thing, you know, or how things come – you know, I mean, all that other stuff, and I’ll tell you, even that isn’t very easy. So I would just sort of observe that there’s various levels of complexity about this also.
DR. HUFF: Oh, it is hugely complex but I think it has a potentially huge reward, and I do think it is strategic. This isn’t something we have to do this year, but it seems to me that it is something that I would like to start us talking about.
DR. COHN: Yes, and investigating.
DR. TANG: I wonder if the vision piece could be enumerated out of the NHII Workgroup, since that is sort of part of the dream or the payoff from NHII, and then a standards gap analysis would be done by this committee looking at revision, if – that is one scenario for it to go.
Another area – and I thought that is where you were going to go – is the standards or how to use data in an EHR system to address, let’s say, quality reporting, such as that that the QIOs request.
We are part of the POQ, the doc project, that purportedly was to understand what information could you glean out of an EHR to answer these quality-reporting requirements.
MR. BLAIR: Doc or docket?
DR. TANG: Doc – which – the measures of which are supposed to be vetted and doced so that it goes onto docket. But the question, actually, is, so they are looking at the data coming out on EHR, but they handed us the measures and methods from the claims-based paper system. So my either issue or complaint back is why don’t we take a look at what you could get – So you have real questions you are trying to ask. You had to fudge around to get answers out of the paper claims-based system. Now, why don’t we look at your real questions and figure out can we answer your real questions from data – from an EHR in a coded way? But, right now, I am answering the old question, and so the question on the table is could we look at the normative question that you actually wanted to ask way back when? I don’t know whether that is something that is dealt with with CMS or whether it is something that NCVHS could make a recommendation.
MR. REYNOLDS: Steve, you had a comment.
DR. SEIDEL: Yes, I have a comment, and I am sorry Simon walked out of the room, because I really wanted him to hear it, but I’ll brief him on it later, and this gets back to some comments that were made earlier about the Federal Health Architecture and that it – and David mentioned that he is going to be coming to the NCVHS, and what he doesn’t realize is he is probably going to be coming to the NCVHS a lot sooner than he thinks, because one of the hats I wear is I cochair with a colleague of mine from VA, the Public Health Surveillance Workgroup of FHA, and one of the things we both realize is that, in the Federal Health Architecture, we have to represent exactly what Stan is asking about, and so we are probably going to start coming to some part of NCVHS – and as Simon points out, when we start talking about public-health surveillance, this may be not standards and security or it may be the whole committee or it may be a different part – and since we are still in the formative stages of what we want to come to NCVHS about, and, you know, we are not specifically asking yet, but we are thinking about coming someplace to NCVHS in September, in that time frame, for a first validation report on what we want to do and where we want to go in looking at what – exactly what Stan is bringing together, how we take clinical information, which is the VA side, and turn it into public-health surveillance information, which is – we look at as very broad scope and not just infectious disease. So we have to be able to develop an architecture to span that.
MR. REYNOLDS: Jeff, you had a question, comment here?
MR. BLAIR: Yes, and I don’t want to get out of sequence, because you had a long list there. Did you want to go through the rest of your list? Because I have one that I wanted to add.
MR. REYNOLDS: No, go ahead. I know my list.
MR. BLAIR: Okay.
MR. REYNOLDS: So you’ve got something you’ve got a hold of, put it out there. I know the list –
MR. BLAIR: Paul mentioned something when he just was commenting on a few of the areas we may work at, which was the one that I was thinking of that I thought would have the greatest urgency, which is where do we still have standards where they fall short of interoperability? Because I think we are getting to a stage now where the lack of solid, complete interoperability is becoming or is about to become a major concern, especially with a docket program, and you are trying to connect small, solo practices to other facilities, and I would think that would be the most urgent area, and where I think this might lead us, if we start to explore this, to try to fill in those gaps or make recommendations to fill in these gaps – and, Stan, help me with this, because this is – you know, I think it relates very much to HL7.
I am almost wondering whether this is going to get to some of those areas with HL7, Version 2, where they are still the equivalent of Z codes, and maybe, at this point, the federal government could provide enablers or facilitators or subsidies or something to help HL7 get past that, whether that is to help folks migrate to Version 3 or whether that is to – and I haven’t followed all the details at HL7 to know what the right answer is, and it may be different with other standards. Whether it is NCPDP or whether it is ASC X12, you know, some of them, when we started to pick up these gaps, as we went through the e-prescribing standards, and we wind up saying, you know, Okay. You use it in an e-prescribing environment. Is that same eligibility in benefits message going to – and, particularly, the eligibility ones, I guess, you know, is that going to impact its use in the traditional HIPAA sense? That is another example.
So – but I thought that identifying the limitations and gaps to dramatically improve interoperability as quickly as possible would probably be our highest near-term priority. Yes? No? Thoughts?
MR. REYNOLDS: Any comments? I’ll make one –
DR. HUFF: I think that is, and there are some initiatives underway. I mean, in a sense, the National Library of Medicine’s contract – both parts of the contract, for the vocabulary as well as for the EHR exchange – are trying to address that.
The vocabulary part is really saying, Okay. You know, the intent of that is to say we need to hook up the HL7 messages to KI-approved(?) terminologies and have that be standardized and so that addresses, at least, you know, one big part of the interoperability.
Now, could more be done? I think the answer is yes, you know, because that – certainly, those two initiatives don’t cover everything that needs to be done.
So, you know, we could think about it, but – because it is being addressed, I guess I didn’t put it in as high a priority as you are thinking of.
MR. BLAIR: Well, maybe it is a question of priorities, and maybe it’s – because everybody is working on these issues. It is not like people are not working on them. It is a matter that we still are not where we want to be, and maybe our focus should be to speak to each of the SDOs and the terminology developers, find out where the gaps are and to then wind up prioritizing where should the federal government place its resources to provide help first and second and third, or something like that.
MR. REYNOLDS: Okay. I captured that – In other words, that could be a cosubject with the SDOs and how they work together on these things, and then, also, especially how they are working together on interoperability.
Vivian –
DR. HUFF: How does this interleave with – what is the name of the other interoperability task force? Whatever that other committee – Maybe we ought to get a report from them and see what –
MR. BLAIR: You know, that is a good point. Maybe they are covering some of this.
DR. FITZMAURICE: Simon is on that council.
MR. REYNOLDS: Vivian, you had a comment.
MS. AULD: My comment was that an awful lot of what NLM is doing touches on various of these topics that you are discussing. So it might be very useful for us to schedule a briefing from NLM just to make sure that you are all up to speed on everything that we are working on.
MR. REYNOLDS: You said NLM, right?
MS. AULD: Yes.
MR. REYNOLDS: Okay. One other item I want to bring up. I know in the privacy committee, we are starting to think about things related to electronic medical records and those types of things in some of the hearings we heard the other day. Is it time for this committee – you know, we just finished e-prescribing. Is it time for this committee to start looking at that? And, if so, what is the catalyst? What is the – Steve.
DR. STEINDEL: I definitely think so. We have never even had a presentation on what the HL7, EHR, DSTU looks like and what HL7’s vision of what NEHR is and where standards fit in it and all the myriad of features that HL7 has put in this function set, all of which we have touched on here, but a lot of it we start – you know, would be a good vehicle to flesh out in here. The certification commission, I know, is dealing with a lot of these issues, and it would be nice to have outside validation bodies.
DR. TANG: I was just going to second what you said in the sense of it is lock step, you know, the HL7, which expires actually – what? – maybe a year from now. It gets two years. So it expires in, I think, about a year, and that, supposedly, fed into CCHIT, and, you know, it would be nice to have that sequence laid out for us and ask them these questions.
MR. BLAIR: Yes, that was what I was about to say is I think the thread, Harry, that I would like to capture begins with the EHR DST draft standards for trial use for the functions for the HR, but then, also, the progress of the minimal function sets by domain, small practices, the large practices, the small hospitals, the medium hospitals, the long-term care – all of those – e-prescribing – and, then, that is sort of the second phase of that.
The third phase of that is the status of the conformance definitions, and then the fourth stage would be the CCIT, so that we get the entire flow and see where the gaps and the problems are.
DR. STEINDEL: Harry.
MR. REYNOLDS: Yes, one more comment, then I want to make sure we close –
DR. STEINDEL: I just wanted to comment that from a time-frame point of view, this is all coming together around our June meeting, just before.
MR. REYNOLDS: Okay. One of the – it looks like we’ve got a – I’ve tried to take this list down, and we’ll get it put together and route it through the committee, but one other thing I was thinking about as we do it, one of the things I thought was really good about e-prescribing was that somebody on the committee was the leader, and that was Jeff – really kind of driving what it was, the subject, and whether or not the committee would be willing that on some of these some people bring – their talents on the committee are really aligned for some of these subjects and whether or not members of the committee would be willing to kind of own the agenda of a subject, so that we have somebody that is really looking at it and somebody that is bringing the right things in together, and then all we do is just pretty much schedule out when that particular subject would or wouldn’t come in, and whether or not you would be amenable to that approach, because I thought – you know –
DR. DUFF: I liked it better when Jeff was doing all the work. (Laughter).
DR. STEINDEL: Well, Harry didn’t say who would take ownership.
MR. REYNOLDS: That was the effect. Yes, obviously, if nobody else does it, Jeff and I –
DR. DUFF: So, in the general, yes, I’m very much in favor, but the specifics, no.
No, I think it is a good idea, Harry. All joking aside, I think it is a good idea.
MR. REYNOLDS: Is there any other business we want to cover in the committee? Any other comments from anybody in the –
MR. BLAIR: Was there something else from – in Simon’s list?
MR. REYNOLDS: No, we pretty well got them. We bounced around them, but we pretty well got everything that was from your list, my list and his list.
The only other one that I do want to mention quickly is we still have an exhaustive list on page 11 of our most recent letter of e-prescribing things, some of them that we say, in fact, have not been addressed. So that will also be –
MR. BLAIR: Well, could I offer my thoughts on that?
MR. REYNOLDS: Quickly because we have Carol standing up here, too.
MR. BLAIR: I think we start to hit diminishing returns on the things that we haven’t been able to address on our e-prescribing list, and so I am not sure, even though they are left over, whether some of these other things we have talked about may have a higher priority than the remaining items on the e-prescribing list. So what –
MR. REYNOLDS: I would agree, but I think that is a good resolution. In other words, you – I wanted to make a point that they were out there. You are making the point that not all of them are necessary, and that’s good. That is what we need to do. We need to – If they are not going to get done soon, then we need to just –
DR. STEINDEL: May be things that have a higher priority.
MR. REYNOLDS: Yes. Yes.
Yes, Carol.
MS. BICKFORD: Carol Bickford, American Nurses Association.
We have been talking about existing business practices and documentation methodologies, and I want to find out if this is the group that should be addressing electronic mail and instant messaging. It is beginning to be an important consideration, as you are looking about the personal health record and the communications with clinicians. It serves as a foundation of business practice within your healthcare enterprise, and those components are being lost as part of the clinical record.
So I want to bring that as a question to this group. Is this something you guys own from the standpoint of standards? Because there aren’t standards for instant messaging. There aren’t standards for email. There aren’t standards, necessarily, for retention of those components and how do you save those and how are they integrated into the record, and there’s also the security pieces related as well, and there’ll be privacy issues.
So it becomes sort of a big issue, but is that something you own or is it bigger to the NHII?
MR. BLAIR: Carol, my thinking is that now that there’s a committee for systemic interoperability that I think is trying to identify where those gaps are that maybe they are in a better position right now to wind up looking at it.
I sort of feel like – we seem to be so much more focused on just struggling with basic standards for messages and terminologies and identifiers and how to get healthcare administrative data and clinical data back and forth – we haven’t even gotten to documentation standards, for example, or some of these other pieces, and I am not saying that we shouldn’t. I am just saying that, you know, realistically, as we start to look at these things, maybe the systemic interoperability group can deal with it faster than we could get to it.
MR. REYNOLDS: For purposes of today, Carol, we have captured it, and we’ll talk with Simon and others to see whether or not it fits in that committee.
Vivian, last comment.
MS. AULD: Just a quick comment that, FYI, the official website for the commission just went live yesterday, and I will send Harry and Jeff the URL to distribute to everybody.
MR. REYNOLDS: Okay. Stan.
DR. HUFF: So this might be a minority. The one item from our list of leftover things for e-prescribing that I think would be of great interest to people is the patient identification thing. I mean, there are just – and I carefully didn’t say patient identifier. I said patient identification, so that if we are not going to come up with a patient identifier, we at least ought to try and find a set of rules that allow interoperation of systems around some strategy of patient identification.
MR. BLAIR: And that includes master-person indices, right?
DR. HUFF: Yes.
MR. BLAIR: Okay. And that was the other piece that I had remembered that we had forgotten.
DR. TANG: Can I just make one –
MR. REYNOLDS: – and then we’re done.
DR. TANG: A brief comment on that is that the collaborative that I think John mentioned, Marco’s(?) Connecting for Health Group, really came out with a proposal that should be reviewed by this committee in that regard.
DR. REYNOLDS: Okay. No other business, we stand adjourned.
Thank you.
(Whereupon the subcommittee was adjourned.)