[This Transcript is Unedited]
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
Subcommittee on Standards and Security
Conference Call
Subject: To discuss recommendation letter to the HHS Secretary on initial e-Prescribing standards.
August 27, 2004
12:00 p.m. EST
UNKNOWN MALE #1: Hello?
SIMON COHN (ph), NATIONAL DIRECTOR FOR HEALTH INFORMATION POLICY, KAISER PERMANENTE: Yes. Good morning, everyone. This is Simon Cohn (ph).
MARIA FRIEDMAN (ph), CMS: Good morning, Simon. It’s Maria.
SIMON COHN (ph): Maria, hi. Good morning.
STEVE STEINDEL (ph), CENTERS FOR DISEASE CONTROL AND PREVENTION: Steve. Hi, Simon.
SIMON COHN (ph): Hi.
MARJORIE GREENBERG (ph), NATIONAL CENTER FOR HEALTH STATISTICS CDC: Hi. Marjorie (ph).
HARRY REYNOLDS, BLUE CROSS AND BLUE SHIELD OF NORTH CAROLINA: Harry.
MARIETTA: And Marietta.
MARGRET A.: Margret A..
VIVIAN AULD (ph), NATIONAL LIBRARY OF MEDICINE: This is Vivian.
JORJE FERRER (ph), VA: Hi, Simon. It’s Jorje Ferrer (ph).
SIMON COHN (ph): OK. Hi. Federay (ph), I feel like we’ve been on many conference calls over the last couple of days.
JORJE FERRER (ph): I feel like I work for Kaiser (ph).
SIMON COHN (ph): Well, that’s right. I mean, it took me a while to realize you work for the VA now, so now I remember.
ANN CANFIELD (ph), ARC (ph) BENEFITS COALITION: Canfield.
SIMON COHN (ph): Who?
ANN CANFIELD (ph): Ann Canfield.
SIMON COHN (ph): Oh hi, Ann.
STAN HUFF (ph), NEW MOUNTAIN HEALTHCARE: Stan Huff (ph).
UNKNOWN FEMALE #1: Oh hi, Stan.
UNKNOWN FEMALE #2: Hi, Stan.
MARK BUCKLE (ph), ACADEMY OF MANAGED CARE PHARMACY: Mark Buckle (ph) with the Academy of Managed Care Pharmacy.
SIMON COHN (ph): All right.
BILL ROBIN (ph), EXPRESS (ph) SCRIPTS: Bill Robin (ph) with Express (ph) Scripts.
MARILYN SIGMUND-LUKE (ph), AMERICA’S HEALTH INSURANCE COUNCIL (ph): Marilyn Sigmund (ph), New AA Fi-Team (ph).
LYNN GILBERTSON (ph), NCPDP: Lynn Gilbertson (ph), NCPDP.
JEFF BROWN, RX HUB: Jeff Brown, RxHub.
MARK MILLICAN (ph), MEDISTAN (ph): Mark Millican (ph), Medistan (ph).
KEN WHITAMORE (ph), SURE (ph) SCRIPTS: Ken Whitamore (ph), Sure (ph) Scripts.
SHELLEY WOOLEY (ph), RX HUB (ph): Shelley Wooley (ph), RxHub.
SCOTT ROBERTSON (ph), KAISER PERMANENTE: Scott Robertson (ph), Kaiser Permanente.
SIMON COHN (ph): Yes. We’re going to wait another 60 seconds and then we’ll get formally started here.
Well, I’m not hearing anybody more coming on, so I figure we probably should get started at this point. Now Marjorie (ph), first of all, question, this is being recorded, correct?
MARJORIE GREENBERG (ph): Yes.
SIMON COHN (ph): OK. Good. I’d like to welcome everyone to this conference call. This is an open conference call of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics.
I think as you all know the Committee is the main public advisory committee to the U.S. Department of Health and Human Services on National Health Information policy. I am Simon Cohn (ph), Chairman of the Subcommittee and the National Director for Health Information Policy for Kaiser Permanente.
I just want to welcome all of you, both subcommittee members, HHS staff and others that are participating. Obviously I want to make sure that everyone identifies themselves, especially those who are not actually part of the subcommittee when you’re speaking since this is all being recorded.
Obviously the point of this session, and this may last as long as the next five hours, is to deliberate an open session discussing our draft recommendations and our draft letter that we will be being forwarded to the full committee next week related to e-prescribing. As you all know, this is the first set of recommendations that we will be bringing forth to the full committee.
The second set is slated for March. So there will be further recommendations coming on this, on these issues, and we’ll be holding further hearings in relationship to issues that we’ve not had a chance to get to yet.
Obviously I want to thank Jeff Blair (ph), our Vice Chair, for his work on this as well as Maria Friedman (ph) and Margret A. who has been our consultant in all of this. I also, as always, want to emphasize that this is intended really to be an open session.
We will, of course, as you know, as the Chair, it’s hard for me to know when people want to make comments, either on the subcommittee or any of our guests who are calling in. But I do want to make available as much as possible the opportunity for both subcommittee members and those participating and listening in to make what they feel are important comments.
Therefore we will stop from time to time and just sort of ask are there any other comments, and certainly if those of you who are not on the subcommittee feel that there’s something important that you need to say, we will try to make time as we go from item to item to take your comments into account as we make decisions on the observations and recommendations.
Now, the — what we’re intending to do here is to sort of finish up, first of all, with the observations and recommendations. And by my count we’re now on Observation 12, and so we will, once we get started we will continue on from Observation 12 through the end of the observations and sort of next steps.
My hope is at that point is that we will loop around looking at our most recent version of the document which has been posted to the Web site, starting once again with the observations and recommendations to make sure we’re comfortable with them.
And then finally we will take the opportunity to look at the first part, the first couple of pages which are the introductory wording and make sure that we’re all comfortable with that and we don’t need further substantiative changes to that wording.
As always, we will try to defer to specific wordsmithing to email communications to Margret A. But certainly our main concern is to make sure that we have gotten the right observations and the right recommendations.
Now, with that I would ask first for the subcommittee members to introduce themselves to assure that we have a quorum as well as giving you the opportunity to accuse yourselves if there are any issues coming before us today which you need to publicly announce.
And then we’ll ask for the staff to introduce themselves, and then we want to go around again asking those who are joining us on the call to also introduce yourselves and your affiliation.
So Jeff, are you there now?
JEFF BLAIR (ph), VICE CHAIR OF THE SUBCOMMITTEE, MEDICAL RECORDS INSTITUTE: I am. This is Jeff Blair, Medical Records Institute, the Vice Chair of the Subcommittee, and I’m not aware of anything that I, that is a potential conflict of interest within the discussion of this recommendation letter.
HARRY REYNOLDS: This is Harry Reynolds, Blue Cross and Blue Shield of North Carolina. I’m a member of the committee. No conflicts.
JUDY WARREN (ph): Judy Warren (ph), member of the committee. The only potential conflict I have is with the HL7 piece.
SIMON COHN (ph): OK, Judy. For further communications, you either have to get a little closer to the speakerphone or turn up your mic a little bit.
JUDY WARREN (ph): OK.
SIMON COHN (ph): OK.
JUDY WARREN (ph): Is it better now?
SIMON COHN (ph): Yes. Thanks.
STAN HUFF (ph): This is Stan Huff (ph) with New Mountain Healthcare in the University of Utah in Salt Lake City. I would need to recuse myself from any vote on matters related to HL7.
SIMON COHN (ph): OK. Thank you. Now staff?
MARIA FRIEDMAN (ph): Maria Friedman (ph), CMS, lead staff to the subcommittee.
STEVE STEINDEL (ph): Steve Steindel (ph), Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
KAREN TRUDEL (ph), CMS: Karen Trudel, CMS, staff to the subcommittee.
VIVIAN AULD (ph): Vivian Auld (ph), National Library of Medicine, staff to the subcommittee.
JORJE FERRER (ph): Jorje Ferrer (ph), staff to the subcommittee, VA.
MARJORIE GREENBERG (ph): Marjorie Greenberg (ph), National Center for Health Statistics, CDC, and Executive Secretary to the Committee.
MARGRET A.: Margret A., Independent Consultant, and Simon, could we remind people to mute their phones so we don’t get interference?
SIMON COHN (ph): I think you reminded them. Thank you. OK. Others in attendance for this conference call.
MARILYN SIGMUND-LUKE (ph): Marilyn Sigmund-Luke (ph), America’s Health Insurance Council (ph).
ANN CANFIELD (ph): Ann Canfield (ph), ARC (ph) Benefits Coalition.
LISA MILLER, X12: Lisa Miller, X12.
ALICIA ENDORSEY (ph), AMERICAN ACADEMY OF OPHTHALMOLOGY: Alicia Endorsey (ph), American Academy of Ophthalmology.
KEN WHITAMORE (ph): Ken Whitamore (ph), Sure Scripts.
MARK BUCKLE (ph): Mark Buckle (ph), Academy of Managed Care Pharmacy.
TERRI (ph) BURNS, RX HUB: Terri (ph) Burns, RxHub.
SHELLEY WOOLEY (ph): Shelley Wooley (ph), RxHub.
ATIT JALA (ph), SURE (ph) SCRIPTS: Atit Jala (ph), Sure (ph) Scripts.
BOB TENANT (ph), MEDICAL GROUP MANAGEMENT ASSOCIATION: Bob Tenant (ph), Medical Group Management Association.
BILL ROBIN (ph): Bill Robin, Medical (ph) Express (ph) Scripts.
LYNN GILBERTSON (ph): Lynn Gilbertson (ph), NCPDP.
JEFF BROWN, RX HUB: Jeff Brown, RxHub.
MARK MILLICAN (ph): Mark Millican (ph), Medistan (ph).
JILL HELM (ph), ALL SCRIPT (ph): Jill Helm (ph), All Script (ph).
SCOTT ROBERTSON (ph): Scott Robertson (ph), Kaiser Permanente and HL7.
SIMON COHN (ph): OK. So I think we have — anybody else on the call? OK. Well, I want to thank you all for joining us.
I actually should just make my public recusal statement which is this is Simon Cohn (ph). As you all know, I’m a member of the CPT editorial panel. I’m a little hoarse today but obviously if there are any CPT issues that come before us today I’ll be recusing myself from those conversations.
Though, given the nature of the letter, I don’t think that that’s particularly likely. I just want to take a moment, and I’m going to let Jeff make some introductory comments also if he chooses, but I really want to thank the subcommittee, staff as well as all of our participating experts for, sort of hanging in there with us.
I think we’ve, we’ve really — I can speak for myself, really appreciated the expert advice both in testimony and ongoing discussion that you’ve all been able to provide us as we’ve been going forward with this process both in open sessions and face-to-face hearings and now during our open conference calls.
So I just want to thank you all. I realize that this is not the easiest process in the world, and I do want to sort of publicly announce that we may be going five hours. I’m hoping we’re going to go a little less than that, but I do want to publicly announce that we are going to be giving people breaks during the next five hours rather than just going straight through like we did for our last three and a half hour session.
So we will try to be reasonable with everybody and afford stretch breaks and other things as we move forward with the issues. Jeff, do you have any opening comments?
JEFF BLAIR (ph): The only thing that I want to do is acknowledge the tremendous help that Margret Amacheokan (ph) has done, you know, for us and Maria Friedman (ph) and Steve Steindel (ph). And the other thing is an administrivia (ph) piece and that is that since we have so many people on the phone, if folks could leave their phone on mute until they’re ready to speak then that will minimize the background noises for the rest of us.
Thank you, Simon.
SIMON COHN (ph): OK. And I just want to publicly acknowledge also an email that I received with some wordsmithing comments to an issue that’s coming up. I guess it was sent — actually it was sent to Margret, I guess, with the subcommittee being cc’d from Ross Martin, who has obviously been one of the other experts that’s been participating in all these calls.
I guess he’s finally decided that it’s time for him to take a vacation. Hard for me to believe but true. So we will be, I think, noting his comments — his, I guess primarily his single comment as we move forward but obviously ascribing it to him.
Anyway, any other comments? Does anybody need to make any introductory comments before we move into the observations that we want to start working on?
MIKE FITZMAURICE (ph): Simon, this is Mike Fitzmaurice (ph). I just want to note that I am here. I didn’t get recorded on Wednesday’s phone call.
SIMON COHN (ph): Oh.
MIKE FITZMAURICE (ph): So that will get it into the record.
SIMON COHN (ph): Thank you very much, Mike. OK. So no introductory statements from the subcommittee or staff? Any introductory statements or otherwise from those…
ANN STINTON (ph): Yes. This is Ann Stinton (ph). I didn’t recorded for Wednesday’s call either. So I just want that on the record.
SIMON COHN (ph): OK, thank you.
MARJORIE GREENBERG (ph): I guess just one thing about, that we do have a call scheduled for Monday, and I guess at the end of today’s call it will be decided whether that Monday call is still needed?
SIMON COHN (ph): Yes. I think we will reflect on that. It probably will be necessary only because the purpose of that call will be to look at any editing changes that may occur over the weekend.
MARJORIE GREENBERG (ph): OK, fine.
SIMON COHN (ph): And so it’s hard to me — I mean, my hope is that it won’t be long, but then again, I’m an eternal optimist.
UNKNOWN MALE #2: Simon, I’m sorry. I missed the time of that call.
SIMON COHN (ph): That call is at …
MARJORIE GREENBERG (ph): I think it’s at 10 a.m.
SIMON COHN (ph): Yes. It’s seven a.m. California time. That’s all I remember.
MARJORIE GREENBERG (ph): Yes. Which, I guess we’ll do our best in getting — the information about the call is currently posted along with the information about this call.
UNKNOWN MALE #2: All right. Thanks.
JEFF BLAIR (ph): And the 10 a.m. is Eastern time.
MARJORIE GREENBERG (ph): Ten a.m. Eastern time, but you know I hope we’ll be able to get a letter posted but that will, you know, depend upon when we get it and actually our Web site is maintained by someone in California through our contractor.
So do we have anything more on that? So we’ll just have to do our best and if worse comes to worst, since there aren’t that many people on the call, other than, you know, who aren’t part of the subcommittee or staff, if the people on the call if we haven’t been able to get it posted, get the email addresses. We can send it to them in PDF.
SIMON COHN (ph): Well, we could. Or we could just read over changes that we’re intending.
MARJORIE GREENBERG (ph): Right. So however you want to do it.
SIMON COHN (ph): OK.
MARJORIE GREENBERG (ph): OK?
SIMON COHN (ph): OK.
MARJORIE GREENBERG (ph): There’s a different number and password I believe for that call. So just take note of that. It’s slightly different dial-in number and it’s actually an alpha rather than numeric pass code. But it’s all posted. OK?
SIMON COHN (ph): OK, Margret. Thank you very much. Marjorie (ph), thank you very much. We’ll get this — too many M’s here.
Margret, would you like to lead us into the next observation and we can sort of move forward?
MARGRET A.: OK. That’s Observation 12, Standards Versioning: There are lessons learned from HIPAA regarding both the need for standards and the flexibility…
UNKNOWN MALE #3: Which version — just so I’m absolutely sure, which version of the document are we working from now?
MARGRET A.: This is the one that was sent out last night by Maria.
UNKNOWN MALE #3: OK.
MARGRET A.: There are lessons learned from HIPAA regarding both the need for standards and the flexibility to respond to industry needs and technology changes. The CHI has addressed this through adopting a version of a standard as a baseline from which new versions may be adopted by the industry when ready; although this process is not consistent with the process required for standards adopted under HIPAA.
Recommended Action 12.1: HHS should recognize new versions of e-prescribing standards if they are backward compatible without a separate regulation. HHS should issue a new regulation if a new version of a standard is not backward compatible.
And we also have a comment from Ross Martin. Simon, should I read that?
SIMON COHN (ph): Yes. Why don’t you read that just for the record.
MARGRET A.: OK. I encourage the subcommittee to consider asking HHS to investigate adding language that sets (ph) a method for determining when to sunset an older version of the standard that doesn’t require issuance of a new regulation.
If the sunset rule turns out to be too restrictive then a new regulation could relax that rule for a specific instance. Setting an automatic retirement rule for a version that puts this determination in the control of the industry may be the best option of all.
For example, in order to ensure that the industry as a whole stays current with advances and e-prescribing standards, the SDOs (ph) overseeing the development of the respective standards cited in this regulation shall, in accordance with their voting procedures, determine when the use of an older version of that standard should no longer be considered acceptable for use. Just a suggestion.
SIMON COHN (ph): OK. Other comments from the subcommittee?
JEFF BLAIR (ph) (?): This is Jeff. I think what Ross is suggesting is a good idea but I don’t think it’s necessary to include it in our letter.
SIMON COHN (ph): OK.
MARJORIE GREENBERG (ph): I have a comment also, Marjorie (ph), when you wish to call on me.
SIMON COHN (ph): Go ahead.
MARJORIE GREENBERG (ph): OK. This last parenthetical phrase in the observation, I think it’s a little confusing or misleading, “although this process is not consistent with the process required for standards adopted under HIPAA,” because of course the CHI standards are for clinical standards and it doesn’t need to be consistent.
It might just — if it said “although this process is different from the process required for standards adopted under HIPAA.” It’s just the idea of it not being consistent leads one to think it should be consistent but it isn’t.
So maybe just saying it’s different. That would be my suggestion. I had to read that several times to — I mean, not everybody understands that the CHI is a different process and is not the same type of…
SIMON COHN (ph): OK. Marjorie (ph), I think we understand your comment. I actually sort of agree with you that probably using the word different rather than consistent probably — I mean, it’s kind of considered to be sort of wordsmithing, and sort of a friendly wordsmithing change.
Do others agree with that?
LYNN GILBERTSON (ph): Does that mean that CHI — this is Lynn Gilbertson (ph), can adopt things — adopt different versions under HIPAA?
SIMON COHN (ph): No, no. Not for the HIPAA standards…
LYNN GILBERTSON (ph): Oh, OK.
SIMON COHN (ph): ..but for the other things.
MARJORIE GREENBERG (ph): CHI is for the use of electronic messages or electronic messages and vocabulary for exchange within the federal enterprise. And if, as adopted, the HIPAA standards where the HIPAA standards are required — I mean for HIPAA transactions.
But for the exchange of clinical information, it is outside of the HIPAA regulation process, and it’s only within the federal enterprise.
SIMON COHN (ph): OK.
HARRY: Simon, this is Harry. I have a question to make sure I understand the structure of this. CHI can adopt versions. E-prescribing we’re recommending can adopt versions. HIPAA can’t but we reference HIPAA regulations in here as part of e-prescribing.
So is that saying — let’s just take the 270 for example. When a new version of the 270 comes out, can we adopt it? Can it be adopted by the industry for e-prescribing even though it hasn’t gone through the whole process of the SDOs (ph) requiring others to use it that are not e-prescribing?
MARGRET A.: Simon, this is Margret. I believe, and Maria hopefully is on this phone. I believe Karen said that the HIPAA standards would have to go through regulation to get a new version out.
SIMON COHN (ph): Yes. I guess I’d have to look back at the actual wording of the regulations, but my understanding is that a HIPAA, you know, HIPAA sort of covers aspects of this.
HARRY: Yes, I was thinking that’s what it said but if you got CHI, e-prescribing and HIPAA all mentioned, and I just wanted to make sure that’s exactly what it said, and I believe that’s what it says, but I want to be sure.
UNKNOWN MALE #4: Yes. Karen, if you’re still on the phone you can correct me if I paraphrase you wrong. But I believe yesterday in respect to the HIPAA transactions that have been adopted for e-prescribing, Karen’s words were HIPAA trumps primarily because the administrative procedure that section of HIPAA requires that these transactions be used for the designated items like eligibility, and e-prescribing is a medical eligibility.
It is done electronically. Therefore it must be done according to HIPAA requirements.
SIMON COHN (ph): Yes. You know, let me refrain the recommendation on action 12.1 because I think what we’re observing is, of course, the tension. And the question we’ve all had — we’ve actually had previous hearings on the issue of clean (ph) flexibility and how people move forward with the HIPAA transactions.
And I guess I’m wondering if really the recommended action 12.1 starts out with a sentence that says, “We urge HHS in its rule-making process to explore what the industry, how best to afford flexibility in adopting — basically in moving forward with standards.”
I don’t have the right wording there but this is sort of, you know, a beginning sense. For example, HHS might want to consider, and this is the example, recognizing new versions of e-prescribing standards, if they are backwards compatible without a separate regulation.
I think we might also want to say that we are — while not — I guess obviously this is off the top of my head, but I’m sort of thinking that we need to make some reference to the HIPAA process, and almost along the lines of, “While not within (ph) the focus of this letter, we also encourage HHS to explore further with the industry how to make the HIPAA rule-making process more flexible.”
KAREN TRUDEL (ph): Simon, this is Karen. I think that works beautifully.
SIMON COHN (ph): Yes, because I think we’re — is that OK with everybody?
HARRY: Yes, Simon. This is Harry. I agree.
KEN WHITAMORE (ph) (?): This is Ken. I agree.
STAN HUFF (ph): Yes. This is Stan. I agree.
SIMON COHN (ph): OK. Because that makes everything somehow work together suddenly.
STAN HUFF (ph): Can I ask one clarifying question?
SIMON COHN (ph): Sure, Stan.
STAN HUFF (ph): When it says HHS should recognize, I mean, how are people thinking — what are people thinking that means? I mean, they send out an email? Or they publish it in a national register but not as a regulation? How would HHS recognize new versions if it didn’t, you know, if it wasn’t a regulation? Would they just — how would it be published or known?
SIMON COHN (ph): Well the devil’s (ph) in the detail, isn’t Stan? And that’s why I’m changing this to where HHS…
STAN HUFF (ph): Yes. I think…
SIMON COHN (ph): For example, HHS might consider recognizing.
STAN HUFF (ph): Yes. I think your change may obviate the need for an answer to my question because you answer that question when you did that other process.
SIMON COHN (ph): Yes. But I agree with you. The devil’s (ph) in the detail on this one, and we obviously, you know — this is — one of the issues that we actually have on our ongoing list, which is to my mind, I want to say quite stabilized in the HIPAA process, but making it more flexible moving forward.
And certainly some people have suggested that HIPAA regs ought to be this version and future versions or whatever. But you’re right, it does bring up the issue of making sure the industry knows what version we’re expecting people to be on.
So this is one where I think the industry needs to — I mean, this needs to be part of the formal rule-making process for both HIPAA and e-prescribing, HHS enlisting (ph) how best to move forward.
STAN HUFF (ph) (?): I think that’s an excellent idea, Simon. And one of the other advantages of that is it allows more exploration of Ross Martin’s suggestion because that, you know — I think the reason for not saying more about that now is, as I thought about it is that there are rules already in place with the standards organizations about how long standards can be a standard without being updated.
There are anti-regulations, actually, about how that part works. And so while I like his recommendation, it has to be carefully thought about in terms of process. And so that could all be part of the thinking here about how this could be done.
MARGRET A.: Simon, this is Margret. I have some language could I run by the group and see if I’ve captured everything?
SIMON COHN (ph): Boy, if you’ve got it already, that’s good. I was hoping that you were taking notes and were hopefully improving what I was trying to say so go ahead.
MARGRET A.: I’m trying. I actually made — I actually have a suggestion for something in the observation section as well. Let me read that first.
SIMON COHN (ph): OK.
MARGRET A.: The sentence that describes the CHI, “The CHI has set precedence for this through adopting a version of its clinical information standards as a baseline from which new versions may be adopted by the industry when ready, although this process is different from the process required for standards adopted under HIPAA.”
The recommended action 12.1 might be, “HHS should work with the industry in its rule-making process to determine how best to afford flexibility in keeping e-prescribing standards in pace with the industry, including standards for HIPAA. For example, HHS might consider recognizing new versions of standards if they are backwards compatible without a separate regulation. HHS should issue a new regulation if the new version of this standard is not backwards compatible.”
MARJORIE GREENBERG (ph): Margret, could you speak up a bit?
MARGRET A.: Sure. Yes. Sorry.
SIMON COHN (ph): Yes. I think I should — that last sentence is probably no longer necessary.
UNKNOWN MALE #4: I think I agree with that, too. We don’t want to tie ourselves into having to do a regulation when in fact it may be an agreement that a change is necessary even if not backward compatible without going through the long regulatory process.
SIMON COHN (ph): I’d like, I guess to (ph) ask others on the call. Jeff, what do you think?
JEFF BLAIR (ph): I feel comfortable with Margret’s wording without the last sentence.
SIMON COHN (ph): Stan?
STAN HUFF (ph): Yes.
SIMON COHN (ph): OK. Harry?
HARRY: I really liked the idea of mentioning backward compatible because I…
JEFF BLAIR (ph) (?): It’s still there.
SIMON COHN (ph): I think we’ve taken out the last sentence which said that they would need to issue a new regulation if a standard is not backwards…
HARRY: Got you.
SIMON COHN (ph): …compatible. I was just sort of saying given that we’re talking about this as an example…
HARRY: Got you. I’m sorry.
SIMON COHN (ph): …maybe that’s not necessary anymore.
HARRY: Margret, just like somebody said, speak up. I lost her last comment, so.
SIMON COHN (ph): Oh, OK.
HARRY: Thank you.
JEFF BLAIR (ph) (?): Yes, but the idea of backwards compatibility is also mentioned in a previous sentence.
HARRY: Yes. Got you.
JEFF BLAIR (ph) (?): OK.
SIMON COHN (ph): OK. Judy?
JUDY WARREN (ph): Yes. I agree with what the — the new writing of it. That sounds much better than what’s there.
SIMON COHN (ph): Right. And we’ll obviously always have a chance to further wordsmith but I think — it sounds like an improvement of what we had up until now. So are we OK generally with Observation 12 at this point?
JEFF BLAIR (ph) (?): Yes. And you said Observation 12 and…
SIMON COHN (ph): And Recommendation Action 12.1. I’m sorry.
JEFF BLAIR (ph) (?): Yes.
UNKNOWN MALE #5: Yes.
JEFF BLAIR (ph) (?): Now one of the pieces that — and Simon, I don’t know whether you’re going to be getting to this or whether I missed this or it’s just out of sync, but the piece on Ross Martin’s note to us was considering that we should make some statement about sunsetting.
That was what I was saying. I think that that may be a good idea but I don’t think it’s necessary for us to include in the recommendation. And I…
SIMON COHN (ph): Yes, I don’t think — I think we all heard Ross’s comments and we consider them as comments.
JEFF BLAIR (ph) (?): OK.
SIMON COHN (ph): So I don’t — they are not part — I mean, what you heard in terms of us agreeing with on 12 was what Margret just read.
JEFF BLAIR (ph) (?): OK. Then that…
SIMON COHN (ph): And I think unless somebody wants something more in relationship to sunset issues or otherwise, I think we’re fine with Observation and Recommended Action 12.1.
JEFF BLAIR (ph) (?): Fine.
SIMON COHN (ph): Judy, you’re OK?
JUDY WARREN (ph): I’m fine.
SIMON COHN (ph): Stan?
STAN HUFF (ph): Yes.
SIMON COHN (ph): OK. So shall we move on to 13 then?
UNKNOWN MALE #6: Yes.
MARGRET A.: Observation 13, General Pilot Test Objectives. Can you hear me OK now? Mr. Blair (ph)?
JEFF BLAIR (ph): Yes.
MARGRET A.: OK. Good. NCVHS has observed that there were many impediments to full adoption and implementation of the HIPAA transactions and code sets standards. Issues such as implementation sequencing, use of acknowledgements, and guidance on when transactions should be rejected were not addressed in the standards’ implementation guides.
Recommended Action 13.1: HHS should identify specific goals, objectives, and metrics to guide the design and assessment of the 2006 pilot tests so that the resulting information from the pilots facilitates industry adoption. The metrics should include measures of economic and quality of care factors.
Recommended Action 13.2: HHS should develop and widely promulgate information concerning the economic and quality of care benefits of e-prescribing, provide comprehensive education on implementation strategies, and address other elements that contribute to successful and widespread adoption.
Recommended Action 13.3: HHS should ensure support for appropriate incentives to expedite e-prescribing implementations that reflect the integration of potentially successful products or pathways found through testing.
SIMON COHN (ph): Comments from the subcommittee?
JEFF BLAIR (ph): The only — this is Jeff. On 13.3, the last part of that phrase, I don’t know if the incentives should be limited to what we find in the testing. I mean, that may be one — that may be valid but I would think the incentives might be broader than just what we learned through testing, unless maybe the intent of that recommendation was specific to that because you felt that the other incentives were specified in MMA and that’s beyond the scope of what we’re doing.
MIKE FITZMAURICE (ph): Let me — this is Mike. Let me add a thought here, and that is it might be useful to have the word “interoperability” in here. In other words, “to expedite interoperability e-prescribing implementations,” or “expedite e-prescribing implementations that reflect the interoperability and integration.”
JEFF BLAIR (ph): I like that.
MIKE FITZMAURICE (ph): Because you want the items to work together. We don’t want to pick on any one particular product and say, “That’s the best one.” We want to say, “Work together, guys. Use these standards and work together.”
SIMON COHN (ph): You know, you’re all really bringing up the question of what we mean by 13.3. And I guess I’m struggling with — and on some hands, I’m almost thinking about maybe we should remove it, but it’s probably good having it there.
But I’m trying to think if it needs to be said in a completely different way. And I guess I’m reflecting on the recent MMA notice of proposed rule making, where they actually — I believe in the rule making, it actually explicitly makes a comment about incentives.
JEFF BLAIR (ph): Simon, maybe we could go back to Margret and she could elaborate a little bit on the thinking of how, why she came up with those particular words.
SIMON COHN (ph): Yes. I guess I’m sort of wondering whether there needs — this somehow needs to be linked to the — I guess the question I would have is does this need to be linked to the NPRM (ph) or reference it, and the other piece is whether or not — the piece here is that HHS should ensure support for appropriate incentives to expedite interoperable e-prescribing implementations.
JEFF BLAIR (ph) (?): Yes.
MIKE FITZMAURICE (ph) (?): Yes. That will work, Simon.
UNKNOWN MALE #7: Right.
SIMON COHN (ph): You know, my father’s an English professor. I guess this is coming out, isn’t it? Is that OK with people? And we’ll let Margret see if there’s some — and I guess the other question is do we want to link it in any way to the, either the NPRM (ph) or the legislative language that does talk about the ability of PDPs and Medicare Examine (ph) organizations to provide incentives.
JEFF BLAIR (ph) (?): I don’t — I don’t think we need to get into that. I think this recommendation is consistent with the observation and, you know, if we get into those other areas and incentives, maybe that goes beyond the scope of this observation.
SIMON COHN (ph): OK. Other thoughts on the subcommittee?
UNKNOWN MALE #8: I like the proposal to abbreviate this.
SIMON COHN (ph): OK.
UNKNOWN MALE #9: I do too, Simon.
JUDY WARREN (ph): Me, too.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Yes.
SIMON COHN (ph): OK. Jeff, you’re OK?
JEFF BLAIR (ph) (?): Yes.
SIMON COHN (ph): OK. So why don’t we then move forward?
HARRY: Simon, I have a question on 13.1.
SIMON COHN (ph): Please.
HARRY: This is Harry. We heard a lot of testimony on whether or not the prescribers will actually be able to use this in an office setting. Under the metrics sentence in the last part of 13.1, I would like to consider a reference there that the metrics should include measures of prescriber usability — and I’m not coming up with the — but I think the ability of the prescribers to use this in their office or use this in a way that’s going to be feasible is as important as the economic quality and other things.
And I don’t think we touched on that much throughout this letter. And this may be the point where we can make it.
UNKNOWN FEMALE #4: Is that a work flow improvement?
HARRY: It’s not so much — well, it’s whatever usability is defined by CMS or the prescribers themselves. I’m not going to try to define it here, but I think that’s one of the big things we have.
We’ve got a lot of standards established and we’ve got a lot of process. But we don’t actually say anywhere in here that it’s really got to be usable to make this thing go.
SIMON COHN (ph): So, Harry, help me with the lingo (ph). So you’re saying the metrics should include measures of economic and quality of care factors and usability?
HARRY: Plus be usable in an — be embraced by the prescribers in their environment — and again, I don’t have the right words. Margret or somebody else can come up with the right…
SIMON COHN (ph): Well, I don’t — I guess I’m trying to think of how you deal with the idea of embracing. Embracing is sort of a hard term to measure.
HARRY: Again, I’m not…
SIMON COHN (ph): Well, do you think usability is what you…
HARRY: Yes. Well, I said usability initially because if we don’t know from the pilots whether or not — hooking all this together, however the industry agrees to hook it together, if the docs aren’t going to use it, we don’t have anything yet.
So we’ve got to — that’s got to be taken into consideration because you may have to up the incentives dramatically if, once this is put in place it changes their work flow to a negative versus a positive.
I assume it’s going to be positive, but I think the tests are going to show that, and then it’s going to reflect on it pretty much a lot of the incentives and a lot of the other things that are going to need to go on.
MARIA FRIEDMAN (ph): This is Maria. Maybe we could just add at the end of that previous sentence that, sort of, “the resulting information from the pilots facilitates industry adoption and prescriber usability,” and just keep the metric sentence the same because the economic measures that we, that are talked about very broadly there include physician ROI and some other things as well as some other kinds of factors.
HARRY (?): I could agree — Simon, I could agree with Maria’s recommendation.
SIMON COHN (ph): OK.
JUDY WARREN (ph): Simon, this is Judy. I guess when Harry was talking about usability, I start getting concerned, are we talking about the development of the actual software, which is where I see usability coming in or especially for a prescriber.
Or are we talking about — I guess I need to know more about the type of usability that Harry’s talking about because it sounds more like the way the product works, not the standard or the scope of our looking at this.
HARRY: And Simon, that was my challenge in bringing it up. We heard a lot of — we try to capture in this document all the types of testimony we have. I’m very comfortable with the standards we’re setting, and I agree with Judy in the fact that the standard itself doesn’t really go to where my question is.
SIMON COHN (ph): Well, I think…
HARRY: The standard’s fine. It’s just that at some point I would hope that we — and it could be later on on things that aren’t addressed or whatever, but I want to — this looked like a good time to at least bring it up.
SIMON COHN (ph): Yes, well this observation here is certainly beyond standards since we’re talking about pilot test objectives. Anyway, Stan, were you going to make comment?
STAN HUFF (ph): Well, I was just going to say, you know, I — well, first of all, I agree with Maria’s change. And secondly, I don’t think you can separate the standards entirely from the application.
And what I mean by that is if we don’t have the right standards, then it may be impossible to make a correct application because we don’t support — there aren’t messages to support the work flow that needs to exist.
So I think it’s appropriate to include it here, even though it may not — you know, even though there’s a part of it that relates just to the application. It’s not maybe the appropriate subject to this letter.
But I agree with Maria’s change, bottom line.
SIMON COHN (ph): Yes. And I agree with it, too. Others? Judy?
JUDY WARREN (ph): I agree with Maria’s change. I mean, if we feel that the usability is the observation, I’m fine with that. I just didn’t want anything down in the recommendation.
SIMON COHN (ph): Well, actually I thought the usability was in the recommendation.
MARIA FRIEDMAN (ph): My proposal was to add that right at the end of that first sentence in 13.1.
SIMON COHN (ph): Yes.
MARIA FRIEDMAN (ph): Because the pilot test should inform adoption by the industry and prescriber usability, or prescriber adoption, for that matter.
JUDY WARREN (ph) (?): Say that one more time, Maria.
SIMON COHN (ph): Yes, you’ve completely…
MARIA FRIEDMAN (ph): All right. The sentence would read, “HHS should identify specific goals, objectives and metrics to guide the design and assessment of the 2006 pilot test so that the resulting information from the pilots facilitates industry adoption and prescriber usability.”
JEFF BLAIR (ph): This is Jeff. I think those words are excellent.
JUDY WARREN (ph) (?): Right. OK. And I agree, too. I see how she’s putting that in, and that’s fine.
SIMON COHN (ph): OK.
HARRY: Maria, thank you for putting some structure to my bumbling.
SIMON COHN (ph): OK. So that’s — that’s why we’re all talking. Maria, thank you. And I’ve heard Stan approves. I don’t hear any objections from the subcommittee on this one. Are there any other comments or concerns regarding Observation 13?
LYNN GILBERTSON (ph): This is Lynn Gilbertson (ph).
SIMON COHN (ph): Please.
LYNN GILBERTSON (ph): I would ask that in the observation, the issues statement be removed. I think there were a lot of impediments or a lot of learning lessons to full adoption at HIPAA, but to just call out a few, it number one, doesn’t, that wasn’t really any of the problems seen in the pharmacy industry so we’d either have to qualify that.
And that’s why I thought perhaps it could just be removed.
LISA MILLER: Lynn (ph), this is Lisa as well. I don’t have any issue removing that. I agree. Most of the implementation sequencing resulted around the claim which is not part of e-prescribing. So I do not disagree.
JEFF BLAIR (ph): This is Jeff. I wouldn’t mind us modifying that sentence. There was a purpose for that in this observation, and maybe that sentence didn’t set forth the objective as well as it should have.
Maybe it sounds like it’s more critical than was intended. The intent was that it would say, that we’ve learned some lessons from the experience of HIPAA where having greater attention to these, the tests, would be need to ensure and facilitate adoption, especially in doctors’ offices.
And so we were trying to call upon the fact that we needed to do more than what we did with our HIPAA experience. And maybe we can say that a different way. That would be a…
STAN HUFF (ph) (?): I thought it was well done. I mean the previous sentence notes that this is talking about HIPAA and not about the transactions. So it’s really — and I think it adds to have specific examples there of the kinds of things that were learned from HIPAA.
And I think it says it accurately.
LYNN GILBERTSON (ph) (?): But note the last part of the statement says these were not addressed in the standards’ implementation guides.
STAN HUFF (ph) (?): That’s right.
LYNN GILBERTSON (ph) (?): I would argue that use of acknowledgements in the pharmacy world, you can’t send a real-time request without a response so that’s not…
STAN HUFF (ph) (?): This isn’t talking about the pharmacy.
LYNN GILBERTSON (ph) (?): Well, but — see it doesn’t…
STAN HUFF (ph) (?): So how did you know?
LYNN GILBERTSON (ph) (?): …it doesn’t say. And I don’t know that the standards implementation guide should really talk about the sequencing.
JEFF BLAIR (ph): Oh, this is not necessarily saying that it has to be in the implementation guides. This is things that HHS needs to do to make sure those pilot tests are crafted better, to be able to provide better information.
SIMON COHN (ph): Yes, Jeff, I think Lynn (ph) has a very valuable point here because it’s — I mean, I looked at this sort of briefly myself and that was a little odd. But I think she is making the point that one would not expect implementation sequencing to be in the standards implementation guide.
And I think that we’re — I think what we may need to do is maybe just a little wordsmithing at the end here where we talk about these issues, were not adequately addressed — it’s almost an HHS regulation or whatever.
I mean, that’s really more — or we’re not uniformly addressed is probably the better term.
LYNN GILBERTSON (ph): Or if you want, you know — and I understand the intent. Not that, but just — it needs to be more carefully crafted then because when transactions should be rejected were not addressed in the standards implementation guide.
Well, once again, if we’re just talking medical, perhaps. I do not know. If we’re talking pharmacy, I can point to lots of sections on rejection transactions in the implementation guide. So I know what you’re saying.
It’s just — I think it needs to be reworded then if you really want to hit those hard points.
LISA MILLER (?): And one simple way to do that would be to say in the full adoption and implementation of the HIPAA, X12 transaction and code sets.
One caution, though, if we do that, I do take exception to the fact that acknowledgements in some cases were addressed in the implementation guides, specifically the 270/271. And the term reject really didn’t revolve around the other transactions but specifically to the healthcare claim.
So I think if we’re going to point it just towards X12 and keep — or X12 and keep this sentence in that some of this does need to be wordsmithed because the last line isn’t really a true-set sentence.
In addition, sequencing and prescriptive guidance and base standards for X12 specifically are foundational documents such as X12.5, X12.6, do tell us about the use of acknowledgements and guidance on transactions, not specifically rejected at a business level.
So there is lots of room there for our recommendation, as already stated, that really is needed for the industry, especially on the educational side. So there’s a lot here.
HARRY: Simon, this is Harry. I’d like to agree with Stan, and I’d like to consider some wording change towards the end of the sentence that’s under discussion. If it said, “Issues such as implementation sequencing, use of acknowledgements and guidance on one transaction should, are examples of such implementation issues.”
MARIA FRIEDMAN (ph): This is Maria, and I agree with Harry. We’re getting a little bit down in the weeds…
HARRY (?): Yes.
MARIA FRIEDMAN (ph): …focusing on implementation guides when really this whole section refers to lessons learned from HIPAA, both in terms of the implementation piece as well as basically the HIPAA process in general.
HARRY: Let’s call the implementation issues rather than guides.
STAN HUFF (ph) (?): I agree.
HARRY: And then it absolutely needs to stay, in my opinion because — it gives HHS and CMS a chance to go back and review the issues that came up with HIPAA and make sure that we don’t bump into them again in this implementation.
Whatever the vehicle for actually defining that, that leaves them that capability to do that.
JUDY WARREN (ph): I like Harry’s suggestion, too. This is Judy.
SIMON COHN (ph): OK. So…
MARGRET A.: Simon?
SIMON COHN (ph): Yes, Margret.
MARGRET A.: Can I suggest a wording here and see if you want all of this in or part of it in?
SIMON COHN (ph): Sure.
MARGRET A.: In the full adoption of the ASCF (ph) 12N (ph) transaction, there were issues such as implementation sequencing, use of acknowledgements, and guidance on when transactions should be rejected, as examples of such implementation issues.
UNKNOWN FEMALE #5: Can you read that one more time, please?
MARGRET A.: Hold on a second. I thought I had it and I missed it.
UNKNOWN FEMALE #6: In that story (ph) do we still want to get down that far and identify specific transactions? Or do we want to just take it up a little higher level and just talk about implementation issues with some more global examples?
UNKNOWN FEMALE #7: And that there wasn’t adequate testing, that people didn’t implement the full suite of things, you know, those kind of pieces.
SIMON COHN (ph): Don’t all speak at once.
HARRY: Simon, let me — this is Harry. Let me take one more shot at it.
SIMON COHN (ph): Sure.
HARRY: On that sentence, get rid of “issues such as,” and just start with, “implementation sequencing, use of acknowledgements, and guidance on when transactions should be rejected were examples of such implementation issues.”
JUDY WARREN (ph) (?): Good one.
SIMON COHN (ph): OK.
HARRY (?): Then it doesn’t point at a guide, it doesn’t point at X12. It just — these were, in fact, implementation issues. And then nobody has to defend a guide or nobody has to defend NCPDP or X12 or any — those were issues.
UNKNOWN MALE #10: I like that.
JUDY WARREN (ph): This is Judy. I like it, too.
JEFF BLAIR (ph): This is Jeff. I feel comfortable with that.
SIMON COHN (ph): OK. Stan?
STAN HUFF (ph): Yes. I liked it.
SIMON COHN (ph): OK. I guess the one question I would have for you on this — and I agree with actually that last sentence. I don’t think we need to rediscuss that one. But I’m wondering if there’s another sentence that, as at the end of here is that, “Further the NCVHS applauds both legislation and HHS intent that new standards should be piloted prior to formal adoption and has already gone on record making such recommendations related to claims attachments.”
HARRY: I agree. This is Harry.
MARGRET A.: Simon, could you please repeat the suggestion?
SIMON COHN (ph): Oh, God. I was afraid you were going to ask me to do that. I guess it’s along the lines of, “Further…
MARGRET A.: You said NCVHS and somebody else.
MARIA FRIEDMAN (ph) (?): Applauds HHS and the legislative intent.
SIMON COHN (ph): Yes. I mean, basically the — the legislative language and clear HHS intent to pilot test — God. This is one of those problems. Maybe we’ll be able to pull it out of the…
JEFF BLAIR (ph) (?): Maybe to include pilot testing in order to ensure greater acceptance of the standards.
SIMON COHN (ph): Well, no. We’re talking about new standards.
JEFF BLAIR (ph) (?): Right.
MARIA FRIEDMAN (ph) (?): It was to ensure pilot testing before adoption.
SIMON COHN (ph): Of new standards.
MARIA FRIEDMAN (ph) (?): Of new standards.
SIMON COHN (ph): Than has previously gone on record, on recommending such pilot testing for such new standards as claims attachments standards. I think this one’s going to take a little bit of wordsmithing.
MARGRET A.: That last part, the going on record business?
SIMON COHN (ph): Previously gone on record?
MARGRET A.: Yes.
SIMON COHN (ph): In other words, what I guess I maybe said was previously recommended to HHS that other new standards such as claims attachments be piloted before formal adoption.
Yes. Margret, my apologies about my short-term memory. These things come out of the mouth sounding reasonable.
MARGRET A.: That’s OK. Just as long as you sort of talked it a little bit more.
SIMON COHN (ph): OK. Are people generally in favor of that sort of a transition sentence?
JEFF BLAIR (ph): This is Jeff. It’s fine.
HARRY: This is Harry. It’s fine.
JUDY WARREN (ph): This is Judy. It’s fine.
STAN HUFF (ph) (?): Yes. That’s good.
SIMON COHN (ph): OK. And we’ll see, obviously, how it turns out when we — I’m sure it will go through a considerable wordsmithing over the weekend, but obviously the intent here is to just provide a transition as well as state our support of the idea that the pilots are good ideas for new standards, or previously untested standards. Whatever, however we want to describe that.
OK. Are we done with 13? Anything more? OK. Shall we move on to 14?
MARGRET A.: Observation 14, NCPDP SCRIPT Pilot Test Objectives: The NCPDP SCRIPT Standard is available for use today, with a number of its functions currently being used by the industry.
However, it does not include several capabilities necessary to support all MMA requirements. For example, NCPDP SCRIPT does not include the exchange of drug labeling and drug listing information maintained by the FDA and NLM.
It does not include the ability to transmit a structured and codified SIG. It has limited ability to capture decision rationale for drug choice (for example, when off-formulary drug is chosen, or there is a known allergy).
Recommended Action 14.1: HHS should include as many enhancements as possible to the NCPDP SCRIPT Standard in the 2006 pilot tests.
UNKNOWN MALE #11: Now does this mean that HHS should take the SCRIPT Standard and then add on to it for the pilot test? Or should encourage NCPDP to put into its standards as many of these enhancements as is possible? And then pilot test what results?
UNKNOWN MALE #12: Yes, on the latter, I agree with you. I was thinking that we needed a statement as it encouraged NCPDP to make a new version of the standard that would include those capabilities.
UNKNOWN MALE #11: Yes, I think that’s the direction that we want to be headed in.
JUDY WARREN (ph): This is Judy. That was my big concern when I read this is I was left with, well, if these things sound important we should have standards for them, and so the pilot should include this (ph). But can we get back to NCPDP for them to add those functionalities?
JEFF BLAIR (ph): Would we want to add a separate recommendation, the recommendation goes to NCPDP to do that?
UNKNOWN MALE #12 (?): Yes. I think — in fact, I think that should be the first recommendation and the one that we’ve got here now should be a second recommendation. The first recommendation should be that NCPDP work on needed (ph) enhancements, you know, as — or that HHS should support NCPDP to work on these enhancements as quickly as possible.
JEFF BLAIR (ph) (?): OK. I think that’s the way to say it.
SIMON COHN (ph): Yes. Let me ask a more global question. And this is actually a piece of confusion for me. Maybe other members of the subcommittee can help me with this one. Is it — I’m confused the Observation 14 is separate from Observation 2.
And it seems like we sort of say some of Observation 14 in Observation 2 when we talk about free text in certain fields and choice of codes. And I don’t know — I mean, I think what we’re — I mean, I think what we’re trying to say in both Observation 2 and Observation 14 is sort of the same thing?
I mean that, you know, most of what’s in NCPDP SCRIPT, with probably the one exception of the, what is it, the fill status notification, is a foundational standard. We feel that it’s critical that is the basis for a number of the other — I mean, and what really needs to be tested in the pilots are enhancements for a number of, in a number of areas.
STEVE STEINDEL (ph): Right.
SIMON COHN (ph): Can people help me with this one? Am I missing something?
STEVE STEINDEL (ph): Simon, I have a similar type of concern and a question for Lynn Gilbertson (ph). Is the observation correct? Because it’s my understanding an NCPDP SCRIPT can currently, is currently formed to carry this information. It’s just the information isn’t available for it to carry.
LYNN GILBERTSON (ph): That’s basically what I was going to bring up. I mean I agree.
STEVE STEINDEL (ph): Yes. So the observation is incorrect. And once you look at the observation being somewhat incorrect, we’ve actually made the statements that are included in here and in two, as Simon points out.
LYNN GILBERTSON (ph): And then the one regarding the RxNorm as earlier as well.
STEVE STEINDEL (ph): Right. So I think we’ve covered everything that’s in this observation previously, and the observation itself is technically in error.
HARRY: Simon, this is Harry. One consideration, if we leave that recommendation there is that we — if we covered most of it in two but here we’re saying — are we saying go ahead and do the test with the current versions of NCPDP SCRIPT but after the pilots don’t set the baseline NCPDP until you see what else has already been put in there?
SIMON COHN (ph): OK. Now I am confused. Basically the…
HARRY: Let me…
SIMON COHN (ph): Well, no. Let me just go back to the legislation. Legislation says the foundational standard — well, not foundational standard, but standards that are in use and generally accepted by the industry can be basically — the secretary can identify them as standards for 2006.
And then there’s a whole piloting with eventual adoption of other standards in 2009. Now are you talking about a third category or are you talking about that enhancements may become part of the standard by 2009? Or are you saying something else?
Harry, I’m sorry.
HARRY: At some point, at some point after the pilots, there’s going to be an establishment of baseline NCPDP version.
SIMON COHN (ph): Of a new one.
HARRY: Or the current one. If those adoptions, none of those enhancements get in by ’09, I think we heard in testimony that we could still do e-prescribing. Not quite like we want to.
SIMON COHN (ph): Keep going, Harry. I’m confused but go ahead, please.
HARRY: That’s fine.
SIMON COHN (ph): I just may be missing…
HARRY: No, no. I’ll withdraw it. It’s a — because I don’t think it’s a big enough concern to — if it’s not catching all with everybody to continue to push it, so I’ll…
SIMON COHN (ph): Well, no. I just may not be understanding exactly the point…
HARRY: Oh, no, and I don’t feel, I don’t feel that that’s an issue. I don’t feel that that’s a concern. The hard part, when you think about doing pilots in ’06, NCPDP is going to be working with CMS and everybody else to try to add things to it.
But at some point there’s going to have to be a stake in the ground that this is what we’re going to do going forward. And they’ve only got X amount of time to work together. And then there’s going to be an establishment of, “This is the baseline. Let’s go.”
Because you need vendors, you need everybody else starting to actually develop things.
SIMON COHN (ph): OK.
HARRY: And so this says, “HHS should include as many enhancements as possible in the pilot test.” So it may come out and say, “Here is the baseline for pilot testing.” Then they could come back later and say, “Here is the baseline for actual implementation.”
SIMON COHN (ph): OK. But I think — I guess I hear, from what you’re describing, I guess there’s really three baselines we’re talking about. I mean, it’s very likely or at least possible the secretary might as early as sometime in mid to late 2005 say that anybody who implements e-prescribing in 2006 and forward shall use whatever commonly accepted industry-approved standards are out and name them.
And then what they would say is for those who want to do further testing, that these are enhancements that would be the baseline for the pilot, and that would be yet another baseline, then there would be a third baseline — or actually that’s not really baseline, but that’s a set of pilot tests, and then there’d be a final, what comes out in 2009.
Is that what you’re sort of saying?
HARRY: That’s going to be the flow. I’m not sure how to say it but that’s going to be what’s going to have to happen. And there are a lot of people on the call that probably want to be involved in the ’06 pilot test, and this says, “Make as many changes as you can before the pilot test in ’06.”
And I think even the NCPDP process, it may be a little quicker than X12, probably isn’t going to get a lot of those done. And so we need to make, at least show some kind of a process that’s going to have to happen, even if those enhancements don’t get made.
Are we recommending that if those enhancements don’t get made that we don’t have enough to do a pilot? I don’t think so.
JEFF BLAIR (ph) (?): Yes, I think we want to be silent on that. That’s…
KAREN TRUDEL (ph): Simon, this is Karen. Could I provide a clarification.
SIMON COHN (ph): Sure. Please. Maybe I’m confused. Go ahead.
KAREN TRUDEL (ph): Well, I think we’re all confused. I think the intent of that recommendation to begin with was simply to say we really think that you ought to put as much advanced functionality into the pilots as is available at the time.
For instance, if the structured SIG is ready, let’s put it in. If there’s a formulary representation standard, let’s put it in. I would feel a little bit uncomfortable getting into the process of what’s going to happen after the pilots because I’m not sure that anybody really knows, and I think I would be a little more comfortable if we remain silent on that point.
HARRY: Karen, I’m fine with — this is Harry. I’m fine with it.
SIMON COHN (ph): OK. Well, I think maybe we’re going…
STAN HUFF (ph): Simon?
SIMON COHN (ph): …around in a circle and maybe we’re in agreement…
STAN HUFF (ph): Simon?
SIMON COHN (ph): Yes, Stan. Please.
STAN HUFF (ph): Well, I agree on that part, but there — I think there’s still a part here that is new and different than what we’ve said in two. First of all, I don’t think there’s any part of SCRIPT now that would handle drug labeling information or drug listing information, which are things that are required in the legislation that be done.
And secondly, even though there’s a place for a textual SIG, there is no standard for how that would be encoded, and then, you know, I think we really want that work to be done. And I don’t think it’s specified anywhere else where we recommend that that work be done.
And so I think that’s where I see the difference between 14 and two is that there are at least three things here that SCRIPT does not do, or at least it doesn’t do in the way that would enable the intent of MMA.
And we would like to help with resources and support in having NCPDP address those issues.
UNKNONW MALE #13: Stan, I think Observation 9 addresses the structured SIG, you know.
STAN HUFF (ph): OK.
STEVE STEINDEL (ph): And…
STAN HUFF (ph): So I’m…
STEVE STEINDEL (ph): And the labeling information is actually contained in part, in various parts of this standard in the clinical drug information up above in Observation 8 and also probably will be contained in some of the areas — well, we haven’t even discussed drug utilization review.
And we’re deferring that. And that’s where I think some of that will come in.
SIMON COHN (ph): Yes. Steve, I…
STAN HUFF (ph): You’re right. I’m seeing now on — yes, I forgot about Observation 9.
SIMON COHN (ph): OK. Well, let me make the following comment because I’m actually going to reverse my previous comment because I’ve looked at this hard. I think where it’s possible to put Observation 14 subsume it under two, unfortunately it goes out of context because you don’t understand all of the other pieces.
And so I think Observation 14 probably is OK where it is. However, and I think what we’ve all talked about is whether the term enhancements in Action 14.1 is the right term. And we were talking about…
STEVE STEINDEL (ph): Well, if you’re going to include Observation 14 then you have to completely change the observation.
JUDY WARREN (ph): Simon, let me — this is Judy. One of the things that I remembered when we struggled about the observations is that we knew that part of the NCPDP SCRIPT was already ready for prime time and probably didn’t need to be pilot tested because it was in such good use.
And so that’s why we put it in Observation 2 because we wanted to recognize it up front. But we also knew that there was current work done and there was functionality required in MMA that SCRIPT as of today did not have but they were working on.
And so that’s what we tried to put in Observation 14 was to encourage that work to happen, and that if it was finished, that it be included in the pilots. Does anybody else have that memory?
SIMON COHN (ph): Well, I think we’re saying something else here, and I think what we’re trying to say is that basically the NCPDP SCRIPT is good to go but it becomes the vessel for which other functionality gets piloted.
STEVE STEINDEL (ph) (?): Yes.
SIMON COHN (ph): I mean, I think that’s what we’re trying to say here.
JUDY WARREN (ph): I thought there were also things within the NCPDP standard that were not in widespread use and needed to be piloted but the core of it was still good. Am I wrong on that?
SIMON COHN (ph): Didn’t we just say the same thing? Did I miss it? Am I saying something more?
UNKNOWN FEMALE #8: I think you’re saying something a little bit different, Simon. Same with Judy.
SIMON COHN (ph): OK. Please.
UNKNOWN FEMALE #8: I mean, that’s why we had this in the two places.
UNKNOWN FEMALE #9: Oh, but then to really have all your recommendations you need to pull recommendations about how the FDA and the NLM need to create the RxNorm to get it to NCPDP. And then all the recommendations for the codified SIG because they’re all part of that observation.
JEFF BLAIR (ph): Could I ask a question — Jeff. Margret?
MARGRET A.: Yes?
JEFF BLAIR (ph): What was your understanding as to why this was an independent observation and recommendation?
MARGRET A.: I think basically Judy summarized that in terms of my recollection was that we wanted to make sure we had NCPDP SCRIPT standards up front, that it was one of the foundational standards to be adopted but that there really was no way to test RxNorm and other, the structured SIG, et cetera, unless we tested the NCPDP with those enhancements.
And so I’ve been trying to listen to what’s been said in terms of the observation. And I think where we went wrong in the observations is we said that it doesn’t accommodate it. It can accommodate it but it can’t do it until these pieces are supplied to it.
STEVE STEINDEL (ph) (?): Yes. And Simon, I’d like to point out, we added a sentence in the introductory, the second introductory paragraph to the observations and recommendation action section. It’s on page four of the document.
And you know, the sentence specifically reads, “However, the foundational standards will need to be included in a 2006 pilot test to assess new functionality in other standards.” So we introduced that concept as a broad overarching concept in the very beginning of this section.
And we had a lot of discussion about that on Wednesday.
STAN HUFF (ph) (?): You know, as I think about it, I think — I’m seeing the light a little bit in terms of the action that we really want, I think, is closer to what Karen stated. You know, the goal is to basically say that as many as enhancements are available should be included, you know, at a minimum in the observation here because it’s handled above.
There’s no reason to remention the SIG. That’s being handled. And then the other thing I think actually as I think about it, see, there is already a standard, this structured product labeling standard from HL7 that is actually focused on exchanging drug labeling and drug listing information.
So I’m not — at least if we were going to charge NCPDP alone with doing that, I’m not sure that’s something we’ve discussed or agreed to as a committee.
MARGRET A.: Simon, could I add…
SIMON COHN (ph): Yes, Margret — I can’t figure out where to go with this conversation. But please.
STAN HUFF (ph) (?): Well, I’m thinking we should really basically make the observation that, in the observation that there are — I wouldn’t even necessarily focus on NCPDP. I would just say that the standards that are being proposed need further enhancement to meet the needs of product labeling and other stuff, and then say HHS should include as many enhancements as possible to the standards in the 2006 pilots.
JEFF BLAIR (ph): That makes sense.
SIMON COHN (ph): That’s fine. OK. Margret?
MARGRET A.: Yes. So if we’ve got for the observation, “The NCPDP SCRIPT Standard is available for use today with a number of its functions currently being supplied, currently being used by industry. However, it does not include several capabilities necessary for all MMA requirements, such as the exchange of drug labeling and drug listing information, until supplied by the FDA and NLM a structured and codified SIG until a standard is supplied, and the ability to capture decisions.”
I think that should be left off because actually there is some capabilities today. And then say 14.1, “HHS should support NCPDP SCRIPT in including as many of enhancements identified in other recommendations as possible to this NCPDP SCRIPT Standard.”
STEVE STEINDEL (ph): No, I’m sorry, Margret. I don’t like the idea of picking on NCPDP SCRIPT in this observation. The observation is that we would like HHS to include all enhancements for all standards as possible in the 2006 pilot.
I think it should be a generic recommendation, and I think the observation should generically state that there are weaknesses in the foundational standards that other observations note where improvement is needed.
STAN HUFF (ph) (?): Yes. I agree with Steve.
SIMON COHN (ph): That might be a simple way out of this thing.
STAN HUFF (ph): Yes. I think you just leave out, just say something like where we say, “NCPDP SCRIPT,” just say, you know, “The foundational standards that are being recommended don’t cover all of the requirements of MMA and we expect that there will be continued development and enhancements to the foundational standard.”
And then the recommendation is, “HHS should include as many enhancements as possible to the foundation standards in the 2006 pilot.”
JEFF BLAIR (ph): This is Jeff. I concur. I agree.
JUDY WARREN (ph): This is Judy. I like that one, too.
SIMON COHN (ph): OK. Well great. Others? Harry, are you still there?
HARRY: I’m good.
SIMON COHN (ph): You’re good. OK. So Margret, do you understand?
MARGRET A.: Yes. Got it.
SIMON COHN (ph): OK. I think this actually helps us — I guess we’d also have to look when we’re done with that to see if whether — actually, it’s probably still not, should not be part of Observation 13 but this almost becomes one of the General Pilot Test Objectives as we talk about.
JEFF BLAIR (ph): Yes.
UNKNOWN FEMALE #10: Yes.
JEFF BLAIR (ph): Yes, I — this is Jeff. I would agree with that. I would move this up to general.
SIMON COHN (ph): OK. So maybe there’s some ways to incorporate those — we have a new Observation 13 that handles all of this. And probably there’s another recommended action…
JEFF BLAIR (ph): You lost me. You said a new observation…?
SIMON COHN (ph): No, another recommended action. I’m sorry. I think a new Observation 13 that includes 13 and 14, and I guess I’m wondering if there’s a, we need to sort of say as a recommended action that HHS needs to work with all the affected standards developers to assure that draft standards for trial use are in place for the 2006 pilot that meet all the above objectives.
JEFF BLAIR (ph): I’m a little confused. I thought that we had just been talking about moving this up into the general recommendations.
SIMON COHN (ph): Oh, I’m sorry. I thought it was General Pilot Test Objectives.
JEFF BLAIR (ph): Well, at least my understanding was that we have one statement under general and that this would become the second general statement because this applies to all enhancements for the pilot test. Did I misunderstand? That’s what I thought…
SIMON COHN (ph): OK. Well, Jeff, I guess I’m confused. Are you referring to — you’re not referring to Observation 1, which is general standards?
JEFF BLAIR (ph): No, it…
SIMON COHN (ph): You’re referring to General Pilot Test Objectives? Is that right?
JEFF BLAIR (ph): Stan had just offered language about how the foundation standards may not need all of MMA requirements and therefore this recommendation that we had in 13, which is saying that HHS should make sure that the pilot test include all of the enhancements, that that is a very, very broad recommendation.
It’s kind of across the board, and the way Stan articulated it, it sounded to me like that should be moved up as our second general recommendation at the beginning. Now did I misunderstand, Stan? Is that…?
STAN HUFF (ph): No, that’s — no that’s — but you made a mistake and said 13 when you meant 14 in what you just said, but.
SIMON COHN (ph): OK. Well, actually I guess I was referencing Observation 13, which is entitled, “General Pilot Test Objectives.” And I had thought that this was part of General Pilot Test Objectives.
I think what we’re talking about is whether Observation 14 is important enough to become the new, an observation that follows General Standards Compatibility, or whether I think it becomes part of Observation 13.
STAN HUFF (ph) (?): I mean, as I go back and read 13, it’s — the intent of 13 is just different enough that I don’t think it fits.
SIMON COHN (ph): OK.
STAN HUFF (ph) (?): Though it’s certainly related.
STEVE STEINDEL (ph): I’m not totally certain it fits under the overarching one.
STAN HUFF (ph) (?): I think it fits in with the overarching one better.
SIMON COHN (ph): OK. Let me just ask, is our overarching one General Standards Compatibility? Is that the topic?
MARGRET A.: Yes.
JEFF BLAIR (ph) (?): I thought overarching — we had a…
STEVE STEINDEL (ph) (?): General Standards Compatibility.
SIMON COHN (ph): Is that the overarching one, Jeff, you’re referring to? I guess — you can tell that I’m getting a little confused here.
JEFF BLAIR (ph): No that’s — that’s OK. We had a general section that included Recommendation 1, Observation 1 and Recommendation 1. And I don’t feel strongly about this. I just thought that Stan was suggesting this and that it was a good idea, and that was that Stan’s wording become Observation and Recommendation 2.
STEVE STEINDEL (ph) (?): Well, we have a two. It would be that there would be a third one in there.
JEFF BLAIR (ph): What I meant was that it would be moved up so it would be the second recommendation under at the beginning of all of our recommendation list.
STEVE STEINDEL (ph) (?): OK. That would make three observations, three recommendations under general. The second one is to ensure e-prescribing standards are compatible with those adopted as HIPAA and CHI standards, et cetera.
STAN HUFF (ph) (?): Right. There are two recommendations — yes. So that — yes.
JEFF BLAIR (ph): I’m sorry. I lost track, so that’s fine.
STAN HUFF (ph) (?): Yes. So what we’re saying is this would become Recommendation 1.3.
SIMON COHN (ph): Well, does then the observation title get changed? I mean, the title right now is General Standards Compatibility.
STEVE STEINDEL (ph): That’s why, Simon, I feel it fits better under 13 and we may need to modify 13 a little bit to accommodate it.
UNKNOWN FEMALE #11: See, I think I agree with Steve. I don’t think what we’ve just done with 14 fits under Observation 1.
SIMON COHN (ph): Yes. I think it’s a really important observation. Don’t get me wrong. I just, I’m just having a hard time reading over Observation 1. And here is a new observation with a new action, or it’s a — or folds in with 13.
I guess I don’t, truthfully, I don’t really care a whole lot, just to make sure that, I just need it to fit somewhere. Margret, do you have any — I mean, this is editing stuff, I think, almost more than anything else.
UNKNOWN FEMALE #12: No, no. Simon, I think this is critical. But when I look at the current Observation 14, we’re talking about pilot test objectives. We had singled out NCPDP. And now we’re saying, you know, don’t single out NCPDP but we’re still talking about pilot test objectives.
For me, that then makes it fit under Observation 13, which also talks about pilot test objectives.
STAN HUFF (ph) (?): Yes. If you include it under 13, I think the thing is you’ve got to include some more — you’ve got to include part of the observation part of 14 in 13 as well, not just the recommendation.
UNKNOWN FEMALE #12: Right. You need to include the contents that we just wrote 14 under 13.
SIMON COHN (ph): Yes. Well, certainly I think we’re agreeing that 14 is more important than 13. I guess I would almost defer to Margret in terms of her wordsmithing, whether or not the titles of these things get changed in Observation 14 is, has to do with general pilot test objectives, and then the new Observation 13 has a slightly different title where, for specific pilot test objectives.
MARIA FRIEDMAN (ph): I think — this is Maria. I think if you’re going to fold the two together, you could just call them Pilot Test Objectives.
SIMON COHN (ph): Sure.
MARIA FRIEDMAN (ph): And leave it at that.
MARGRET A. (?): Right.
SIMON COHN (ph): OK. So how do people feel about this one? Stan?
STAN HUFF (ph): I would — I’m happy either way. I tend to agree that now I look at one, I think it’s probably not good to move it into one. So I’d either have it, you know, in a simplified version standalone or combine it with 13.
JEFF BLAIR (ph): I feel comfortable with Stan’s — this is Jeff. And actually, I think I feel more comfortable now that I understand 13 that we do put it under 13.
HARRY: Simon, Harry. I’m fine under 13 also.
SIMON COHN (ph): OK. Judy?
JUDY WARREN (ph): Yes because I recommended it. Yes.
SIMON COHN (ph): Good. OK. In that case, I’ll support your recommendation. OK. So Margret, some wordsmithing work there.
MARGRET A.: Yes, sir.
SIMON COHN (ph): OK. I think it’s going to take a little bit of work to try to put all those together.
MARGRET A.: Yes.
SIMON COHN (ph): And it’s probably second paragraph under the observations, and probably that Recommendation 14.1 is the first of the recommendations in this new section.
OK. Shall we move on to 15?
UNKNOWN MALE #13: Yes.
MARGRET A.: Observation 15, Support for Standards Collaboration: A significant level of collaboration is occurring among standards development organizations and with vendors who have proprietary solutions as there is growing momentum for e-prescribing and other components of the NHII. It is important to support the voluntary nature of standards development organizations while accelerating the process of standards development and I should say coordination. We didn’t want harmonization.
Recommended Action 15.1. HHS should provide financial support to standards development organizations for facilitation of, we should put coordination, efforts that ensure a seamless e-prescribing process across provider domains (for example, physician office, hospital, long term care), dispensers, and payers/PBMs.
15.2; HHS should encourage standards development organizations to adopt a change management process that permits versions to remain.
SIMON COHN (ph): To remain in harmony, right?
MARGRET A.: Or remain coordinated.
SIMON COHN (ph): Well, I guess Steve was the one who didn’t like the harmony last time. Steve, are you happy with harmony or do you feel it…
STEVE STEINDEL (ph): Coordination.
SIMON COHN (ph): …should change? To remain coordinated?
STEVE STEINDEL (ph): Yes.
SIMON COHN (ph): Now see, I don’t know what — what does remain coordinated mean?
MARGRET A.: So that when — Simon, I think actually you brought this up before. It’s hard to keep standards that you’re harmonizing in harmony forever.
STEVE STEINDEL (ph) (?): Simon, how about “maintain coordination?” “Versions to maintain coordination?”
MARGRET A.: Yes.
SCOTT ROBERTSON (ph): This is…
SIMON COHN (ph): OK.
SCOTT ROBERTSON (ph): This is Scott Robertson (ph). Would another option be to say, “to maintain interoperability?” I don’t if that’s any better. Just a thought came through.
SIMON COHN (ph): I sort of like inoperability. That’s a pretty good word.
UNKNOWN MALE #14: I agree with Simon that it hooks (ph) at what the end product is. It has to work together.
STEVE STEINDEL (ph): Yes. That’s a great buzz word today. Let’s use it.
SIMON COHN (ph): OK. So it’s “to maintain interoperability.” In that case, do we want to change — Margret, what did we say in 15.1 at this point? We have harmonization efforts…
MARGRET A.: I changed coordination efforts.
SIMON COHN (ph): OK. Other thoughts, comments?
STAN HUFF (ph): On 5.1, I wonder if we want to generalize that first sentence? I mean, this specifically says that they would give financial support to the standards development organization. If we made it more general and said something like, “financially support standards coordination.”
That would give HHS the option to give money to the standards organizations or it might allow them to give money to their employees or other people who could, you know, supply travel money. I’m a little nervous that we’re being so directive about what they should do.
MIKE FITZMAURICE (ph): That would be broader, Stan. This is Mike. I agree with that, and it increases the flexibility.
STAN HUFF (ph): Yes. I would just, I’d like to give the some leeway to financially support it how they see best to do it.
MIKE FITZMAURICE (ph): So we financially support the activity of coordination, harmonization and inoperability.
STAN HUFF (ph): Right.
MIKE FITZMAURICE (ph): And maybe in conjunction with the standards development organizations somehow.
STAN HUFF (ph): I mean, I’m not opposed to money going there. I just — yes, if we could say both things that would be OK too, but if we could think of a way to say it a little more general so that they could support it financially in more than one way, if that was reasonable.
SIMON COHN (ph): Margret, do you have some thoughts on wordsmithing there?
MARGRET A.: Would it have to say, “HHS should financially support standards coordination for facilitation of efforts among,” no.
SIMON COHN (ph): No.
JEFF BLAIR (ph): Stan was suggesting that we add the word activity, standards coordination activities.
MARGRET A.: OK. “HHS should financially support standards coordination activities among standards development organizations.” Would that help?
STAN HUFF (ph) (?): Yes.
SIMON COHN (ph): OK. Say that again.
UNKNOWN MALE #15: And users of the standard.
SIMON COHN (ph): I don’t think we’re trying to financially support the users of standards but maybe — OK. Margret, help me with it — read this one again because I’m getting confused.
MARGRET A.: Yes. I’m trying to wordsmith it at the same time I talk so.
SIMON COHN (ph): OK.
MARGRET A.: “HHS should financially support standards coordination activities to support standards development organization,” — I don’t like that either.
UNKNOWN MALE #16: I don’t think we need to mention the standard development organizations. We’ve already said, “support standard coordination activities.” I think that’s sufficient.
UNKNOWN MALE #17: I think we need to think about what our objective is here. Is our objective to support the standards coordination or is it support standards coordination through the standard development organizations?
UNKNOWN MALE #16: Let’s leave HHS flexible to determine that.
UNKNOWN MALE #17: That’s fine. I just want to make sure that that’s the committee’s, the committee’s objective.
UKNOWN MALE #18: Well, so who are we going to…
UNKNOWN MALE #17: Because there is a slight different implication of the two wordings. If you want a generic wording, then use the first style. If you want it specific to the SCOs, use the second style. I’m comfortable with either style. I just want to make sure everyone’s clear that there is a difference.
MARGRET A.: So just leave it, “HHS should financially support standards coordination activities to ensure a seamless e-prescribing process,” blah, blah, blah.
UNKNOWN MALE #17: Good.
STAN HUFF (ph): Good.
SIMON COHN (ph): OK. Other comments on this one? OK, this — Judy, are you OK with this?
JUDY WARREN (ph): Yes.
HARRY: I’m fine, too, Simon. That’s great.
SIMON COHN (ph): OK. Jeff?
UNKNOWN MALE #19: I’m good.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): OK. So let’s move on to 16.
MARGRET A.: Observation 16, Policies to Remove Barriers: Testimony identified special sensitivity to ensuring safe harbors, preserving provider/patient choice, and that messages should be free from commercial bias.
Recommended Action 16.1: HHS should ensure that regulations define the parameters of safe harbor, ensure preservation of provider/patient choice, and require that e-prescribing messages be free from commercial bias.
JEFF BLAIR (ph): On this one, I just read recently that the GAO was looking into this, I guess on behalf of the National Coordinator of Health Information Technology. And so maybe — is it that e-prescribing activities to remove the barrier should be working in concert with, I don’t know — maybe Karen or Maria could help, in concert with GAO? In concert with the…
MARIA FRIEDMAN (ph): The GAO — Jeff, this is Maria. GAO already came out with its recommendations, and they were more global saying that some of, especially in the Medicare world, some of the specific, like the stock and the safe harbor, legislation needs to be better coordinated, that there are some pieces that may hinder wider spread adoption of…
JEFF BLAIR (ph): Right.
MARIA FRIEDMAN (ph): …NHI and all, you know, EHR (ph) and all of that in general.
JEFF BLAIR (ph): Well then maybe I have a question to you, Maria, and that is have we worded this particular recommendation in the best way?
MARIA FRIEDMAN (ph): I think so, and I think we’re definitely looking at those issues for regulatory purposes.
SIMON COHN (ph): Yes, you know, I’m actually OK with the action. What I am actually concerned about is the observation. And I don’t mean to wordsmith it because I’m not sure if I have a better word, but there’s two terms that concern me.
One is the term sensitivity and the other is ensuring. And I guess I’m wondering about testimony identified, you know, maybe it’s wide spread industry concerns or — I mean, I don’t know what special sensitivity means, first of all.
So I guess I have to ask others if that’s a term that somehow represents really what we heard. I also don’t know exactly what ensuring safe harbor means because I don’t know — I mean, not being a lawyer maybe I don’t know whether the word ensuring is right, is the right term.
UNKNOWN FEMALE #13: Meaning for this purpose.
SIMON COHN (ph): What?
MARGRET A.: Simon? How about “testimony identified wide spread industry concerns relating to safe harbor preserving,” et cetera.
SIMON COHN (ph): That would be a — I think I’d be happy with that one. What do others think?
MARIA FRIEDMAN (ph): This is Maria. Just another point. The MMA specifically recognized messages should be free from commercial bias. And I don’t have it in front of me but I think either in the statute or at least in the conference report there was concern about preserving provider in patient choice.
UNKNOWN FEMALE #13: Oh, yes.
SIMON COHN (ph): Well, actually it’s the other way around.
MARIA FRIEDMAN (ph): Is it the other way around?
SIMON COHN (ph): Yes, preserving patient/provider choice as part of the legislation. The other one is part of the conference report, the free from commercial bias.
LYNN GILBERTSON (ph): Does it actually say — this is Lynn (ph), the messages should be free from commercial bias? Or is it the e-prescribing environment?
Because when I think of messages, I think of, “OK, I won’t put any commercials in SCRIPT.”
MARIA FRIEDMAN (ph) (?): I think they were talking about having pop-ups and full-fledged advertising and…
LYNN GILBERTSON (ph): Right.
MARIA FRIEDMAN (ph) (?): …that kind of thing so…
LYNN GILBERTSON (ph): So that would be part of the environment rather than the actual message itself.
MARIA FRIEDMAN (ph) (?): Well, there’s a — we have kind of a specific notion in our heads about messages for those people who are working with standards all the time as opposed to the kinds of messages that you get when you turn on your computer and you get all that SPAM. And I think that’s what they were talking about.
JEFF BROWN: This is Jeff Brown, RxHub. The statutory language is that, “standards shall allow for the messaging of information only if it relates to the appropriate prescribing of drugs,” et cetera.
So the commercial bias language as was pointed out earlier is not in the statute, but that’s the basis of the statute for the conference report talking about the issue.
SIMON COHN (ph): Yes.
JUDY WARREN (ph): I think we need to be careful because in testimony, what we were being told is that some of the commercial bias could be very subtle, such as in the listing on the formulary, the order of which drugs are listed, or the order of which they are put into various packages.
UNKNOWN MALE #20: I think that’s a debatable item as to whether that’s considered commercial messaging.
JUDY WARREN (ph): Oh, OK. I thought that was…
UNKNOWN MALE #20: I mean, I understand what you’re saying but, you know, if you need to show four screens of drugs, does it make sense to show the least expensive first? I mean, is that necessarily commercial messaging or is that a practical use of screen space?
MARIA FRIEDMAN (ph): Well, that — this is Maria again. I agree with Judy. I heard that very loud and clear in testimony, too, that there are very subtle ways of promoting, I won’t say commercial messaging but promoting your own commercial needs.
SIMON COHN (ph): OK. Well I actually…
MARIA FRIEDMAN (ph): I would just back off…
SIMON COHN (ph): I agree with the conversation but I don’t think it should be in this observation…
MARIA FRIEDMAN (ph): I was going to say that, Simon.
SIMON COHN (ph): …at this level it’s specific…
MARIA FRIEDMAN (ph): I was just going to back off from normal — I’m sorry I introduced this statutory stuff in the first place. And I can live with it the way it is.
SIMON COHN (ph): Yes. So Margret, can you re-read the observation as we’ve, as you’ve wordsmithed it only because of my sensitivities?
MARGRET A.: Yes. And I did try to clarify this message, and see if this helps. Otherwise I can take it out.
“Testimony identified wide spread industry concerns relating to safe harbor, preserving provider/patient choice, and that messages received through e-prescribing applications should be free from commercial bias.”
SIMON COHN (ph): Is everybody OK with that? Does that…?
JEFF BLAIR (ph): That sounds good.
JUDY WARREN (ph): Yes. I’m happy with it.
STAN HUFF (ph) (?): I like it.
UNKNOWN MALE #21: I’m fine.
SIMON COHN (ph): OK. OK. Well, it sounds like we’ve got agreement on 16 as wordsmithed. Let’s go on to 17 then.
MARGRET A.: Can you hold just one minute. I have to make note here.
SIMON COHN (ph): OK.
MARGRET A.: All right. Seventeen, Conformance Testing and Certification: Testimony identified the need for conformance testing of e-prescribing standards and for certification of e-prescribing systems.
17.1: HHS should support standards development organizations in their development of tools for conformance testing of the e-prescribing standards and their implementation guides.
Recommended Action 17.2: HHS should require that vendors use conformance testing tools developed by the standards development organizations to validate that their e-prescribing messages are interoperable.
17.3: The Office of the National Coordinator for Health Information Technology should investigate how e-prescribing applications might best be certified.
SIMON COHN (ph): OK. Comments, questions about this one.
JEFF BROWN: This is Jeff Brown from RxHub. I’m a little confused what it means to say, “Conformance testing of the standards.” I understand about conformance testing for certification of the e-prescribing systems to the standards, but I don’t know what it means to conformance test to standards themselves.
UNKNOWN MALE #22: My guess is that maybe what would be meant by it is that when the standards are written, or when they’re adopted by HHS that they be written in such a way and therefore the patient guides be written in such a way you can tell when something is in conformance with the standards or not, that — when a system is in conformance with a standard or it is not.
JEFF BLAIR (ph): Maybe — this is Jeff. Maybe the clarification is that it’s a test that validates whether a particular vendor or user is sending a message that conforms with the standard.
SIMON COHN (ph): Yes. Actually I guess my view is that conformance testing is of an implementation typically, isn’t it?
UNKNOWN FEMALE #14: What’s the difference between conformance and certification?
SIMON COHN (ph): Well, very different. One is that you’re actually — one is a system certification. The other is an implementation certification. In other words, certification e-prescribing systems and the certification that a system is capable of sending something in a standard fashion.
To my view, a conformance test is that once you’ve implemented it, at that implementation are they capable of sending, I mean, prescribing message in a standard fashion.
JEFF BROWN: And this is Jeff Brown again. So the idea is that there’s a need for conformance tests for the e-prescribing standards? That they can be used by the industry for the certification testing?
JEFF BLAIR (ph): No. The conformance test is that a vendor or user, when they send a message, does that message conform with the standard?
UNKNOWN FEMALE #14: Well, that’s what we call certification.
JEFF BLAIR (ph): No, the certification is for the, like the e-prescribing application itself, the software application.
UNKNOWN FEMALE #14: Oh.
JEFF BLAIR (ph): Does the application have the functions in it, the software, the — well, I won’t — it’s the software package as opposed to the communications between the systems.
SIMON COHN (ph): Do others have comments about this one? I actually think, I guess one thing we need to decide if we are all under agreement about what we mean by conformance testing versus certification since I’ve heard others actually on the call have different perspectives on what terminology they use.
Certainly the minimum, I think the — I mean, assuming there’s an agreement that you’re doing the implementations, I guess I would say that the observations conformance testing, the e-prescribing implementations. But I guess I would ask others on how they want to wordsmith this.
HARRY: Simon, this is Harry. I agree with Jeff on the terminology of conformance and certification. My concern in 17.1 is that maybe NCPDP does but I have not seen X12 develop a conformance tool.
I have seen people develop, in the industry develop. I’ll use a specific example so it’s not cloudy. Under HIPAA, you have Clarity, Edifax (ph), Foresight (ph) and I’m sure others that built testing tools.
But X12 didn’t build the 271 conformance tool, so I’m not sure that HHS and the standards organization shouldn’t identify conformance tools that then have to be used to certify people’s readiness.
I don’t — and Lynn (ph), you may jump in. I don’t know if NCPDP does that, but I know I never saw anything like that for X12.
LYNN GILBERTSON (ph): No. That is correct. I was going to ask a question about 17.2 because we don’t develop those kind of things. So I’m not sure if conformance — conformance things are statements that are made in an implementation guide, and if so, NCPDP could look at that.
But as far as certification, I guess our industry’s mature enough that there were enough trading partners already testing. So there wasn’t really an industry need to point to one company or something to do that, even though yes, it would have been nice.
SIMON COHN (ph): Yes. Well, Lynn (ph)…
STAN HUFF (ph): Simon?
SIMON COHN (ph): … this — who’s this? Harry?
STAN HUFF (ph): This is Stan.
SIMON COHN (ph): Oh, Stan, go ahead because we may need to modify 17 one and two a little bit here. Go ahead.
STAN HUFF (ph): I think so, too. The thing — and again, so this is, I think this falls into the category of just factual information about HL7, for instance. What HL7, HL7 has a conformance committee, and their responsibility is to set up suites of conformant messages and other things that can be used to test conformance.
But they don’t actually make the tool. They don’t make a software tool that actually does a comparison. And I think, I mean, what you want to do is, you know, with NCPDP and others is really have the standards organization be the people who have the authority to say whether something is conformant or not.
And I think we want to allow anybody to make the tools that would do the testing.
SIMON COHN (ph): OK. Well, Stan, I agree with you. So what we should do with 17.1, at least as a proposal, would be to is to have support standards development organizations and development of conformance tests, right?
JEFF BLAIR (ph) (?): Correct.
SIMON COHN (ph): And then 17.2 should be vendors use conformance testing tools to validate their e-prescribing messages or interoperable and just completely remove by who it’s developed by. Is that…
UNKNOWN MALE #22: Yes.
UNKNOWN MALE #23: Yes.
UNKNOWN MALE #24: Yes.
LISA MILLER: Simon, this is Lisa from X12.
SIMON COHN (ph): Sure.
LISA MILLER: Are we going to then remove the word certification completely from this?
JEFF BLAIR (ph): Certification is really dealing with the software application, not the standard message.
LISA MILLER: Here’s my one concern about the word certification, and this is truly from implementing X12 and watching the extra burden that word put on the X12 implementation of HIPAA where it was a very confusing word to the provider community especially, and they did end up spending exorbitant amount of money to become quote/unquote certified, which actually gave them no value towards their end goal of implementation.
And it really increased the frustration. So I would recommend if we use the word certification, we somehow explain what, in what manner we’re using it so that we don’t create another burden to that particular community and confusion to the industry as a whole.
UNKNOWN MALE #25: Simon, comment on Lisa’s point.
SIMON COHN (ph): Sure.
UNKNOWN MALE #25: The problem was that people got certified by the vendor that they used. They didn’t get certified by X12 and they didn’t get certified by HHS or anything else. So I still think there needs to be some kind of a certification process that says these people can really do business.
Not that some vendor says they can do business but whether its HHS or somebody else says their ready to do business.
MARIA FRIEDMAN (ph): This is Maria, and one of the lessons learned from HIPAA is that people were told that what they were buying was HIPAA compliant, and it wasn’t.
UNKNOWN MALE #25 (?): That is correct.
MARIA FRIEDMAN (ph): And we also heard in testimony that one of the barriers to adoption is the bad taste that was left in the physician community’s mouth from previous exercises where they were sold stuff that didn’t do what they were told it was going to do.
SIMON COHN (ph): Yes, I guess the final point I’d make on 17.3 is that it’s basically a recommendation that — an investigation recommendation. So I guess this is calling on them to take a look at how all this should best happen.
So I guess that would be my final comment. Margret?
MARGRET A.: I was just going to say that first of all, the Office of the National Coordinator is already starting to work on product certification, for electronic health records in provider offices.
And I think the intent of that is to be able to certify for the purpose of providing incentive so that if there’s going to be incentive, you have to have a certified implementation.
JEFF BLAIR (ph): Yes.
MARGRET A.: And I think that’s really the point of the certification piece of this.
SIMON COHN (ph): OK.
MARGRET A.: And maybe that should be explained a little more thoroughly in the observation.
JEFF BLAIR (ph): I don’t think we need, we really need that.
SIMON COHN (ph): Yes, I think 17.3 is fine the way it is, actually.
MARIA FRIEDMAN (ph): This is Maria and I agree with that. Because this is a new area and we’re still figuring out how it’s going to work and who’s going to do it and all that, I would leave 17.3 the way it is.
MARGRET A.: I was actually suggesting that something be put in the observation, not the action.
SIMON COHN (ph): Yes. And I don’t know that that — do others feel that there’s a need for that? I’m actually fine the way it is.
JEFF BLAIR (ph): No. I think it’s fine.
SIMON COHN (ph): OK. Group, shall we have Margret read through 17 as we’ve modified it to make sure we’re all, we’re comfortable with it at this point? Or propose other changes?
MARGRET A.: Conformance Testing and Certification: Testimony identified the need for conformance testing of e-prescribing standards and for certification of e-prescribing system implementations.
Recommended Action 17.1. HHS should support standards development organizations in their development of conformance tests of the e-prescribing standards and their implementation guides.
17.2; HHS should require that vendors use conformance testing tools to validate that their e-prescribing messages are interoperable. The Office of the National Coordinator for Health Information Technology should investigate how e-prescribing applications might best be certified.
JEFF BLAIR (ph): You, I think, added the word implementations after certification of e-prescribing systems.
MARGRET A.: Right.
STAN HUFF (ph) (?): As opposed to conformance testing.
JEFF BLAIR (ph): Yes, I think implementations I don’t think goes with the certification of e-prescribing systems. Or did I hear that wrong?
MARGRET A.: No. I can take that out. I thought it would clarify. Certification of e-prescribing systems.
JUDY WARREN (ph) (?): Right. Because it’s software…
JEFF BLAIR (ph): Correct.
JUDY WARREN (ph) (?): …being certified (ph).
SIMON COHN (ph): Yes. So…
JUDY WARREN (ph) (?): Could you read Recommendation 17.2 again?
MARGRET A.: HHS should require that vendors use conformance testing tools to validate that their e-prescribing messages are interoperable.
JUDY WARREN (ph) (?): Thank you.
LISA MILLER: Simon, this is Lisa.
SIMON COHN (ph): Yes?
LISA MILLER: On 17.2, are we still — and I want to make sure I’m hearing this right. We’re still using the word conformance testing tools but I almost feel that vendors use the conformance tests and remove testing tools because I think that could be inferred as, “I have to go out and find somebody like, you know, Foresight (ph) or somebody that I have to use if I’m building my system,” rather than, “I can go and get the conformance test from the standards development. No, I meet my objective because I’ve used their conformance test.”
SIMON COHN (ph): OK. So you’re basically saying just using conformance test and let everyone decide how their…
LISA MILLER: And get rid of the word…
SIMON COHN (ph): Yes. Right, tools.
LISA MILLER: Yes.
SIMON COHN (ph): Do others agree with that? I think that’s a reasonable modification.
HARRY: I agree, Simon. This is Harry.
STAN HUFF (ph) (?): Yes. That would be fine.
SIMON COHN (ph): OK.
LISA MILLER: Thank you.
SIMON COHN (ph): So I guess the only question I’m left with is in the observations. So are we comfortable with describing conformance testing of e-prescribing standards implementations? Is that the right way to describe that?
MARGRET A.: No, I didn’t say implementations there.
SIMON COHN (ph): Well, you had it at the end of systems, which we agreed was probably not the right place.
MARGRET A.: Shall I re-read it?
SIMON COHN (ph): Why don’t you read the observation then?
MARGRET A.: Testimony identified the need for conformance testing of e-prescribing standards and for certification of e-prescribing systems.
SIMON COHN (ph): OK. And I guess the question I have is are we conformance testing e-prescribing standards?
STAN HUFF (ph) (?): No.
SIMON COHN (ph): And so how do we want to describe that because I don’t know whether we’re talking about conformance testing the e-prescribing systems, or whether we’re talking about conformance testing of e-prescribing standards implementations.
UNKNOWN MALE #26: That would be OK.
SIMON COHN (ph): What do people think?
UNKNOWN MALE #27: I would vote for standards implementations.
UNKNOWN MALE #28: Yes.
LYNN GILBERTSON (ph): So we’re conformance testing the systems and we’re certifying those systems, two different actions?
JEFF BLAIR (ph): No, it’s separate. We’re conformance testing that the message standards comply — that the messages comply with the standards when it’s communicating so that the conformance testing is, with respect to the communications between systems.
The certification relates to the software application, the vendor system, the All Script system, the Dopta First (ph) system.
LYNN GILBERTSON (ph): OK because — see, and I apologize. I understand the concepts but in the pharmacy industry, certification is I send you a request, it goes through all the engines, it gets tested, you send me a response, I check the out, the messages work, the data elements are lined up correctly, we’re certified.
JEFF BLAIR (ph): Yes…
LYNN GILBERTSON (ph): So I’m just trying to see how pharmacy’s going to interpret these statements.
SIMON COHN (ph): Yes, and that’s what I typically call conformance testing.
JUDY WARREN (ph): Same here.
SIMON COHN (ph): And they require certification to be potentially something else that looks more like it has a full suite of functionality needed, all those other things…
JEFF BLAIR (ph): Right.
SIMON COHN (ph): …that are yet to be determined. I mean, am I — I mean, that was Lynn, wasn’t it?
LYNN GILBERTSON (ph): Yes. Sorry.
SIMON COHN (ph): Yes, I mean, it sounds like we’re using — I mean, unfortunately, you know, it’s like sometimes the words we use mean different things…
LYNN GILBERTSON (ph): Yes.
SIMON COHN (ph): …and I’m — that’s why I’m sort of asking the subcommittee also because it’s, we just want to make sure that whatever it is we say, that we really mean and we have the same understanding.
UNKNOWN MALE #29: Simon, the reason I like what you said is we had a lot of — using Lynn’s example, we had a lot of people in HIPAA that would dummy-up the records, but they really couldn’t implement anything.
And your statement allows whatever guidance HHS or CMS has on what certification really is, I would hope they had some kind of box that checked, “And oh by the way, you didn’t dummy this data in just to get this stuff to look like it works.”
SIMON COHN (ph): Yes. But as I say this, I’m obviously concerned about what Lynn (ph) just said because we just don’t want to confuse everybody in the industry.
TERRI (ph) BURNS: Simon?
SIMON COHN (ph): Is there a way in parentheses to clarify more what we’re talking about? Who’s this?
JEFF BLAIR (ph): What we might be able — I’m sorry. This is Jeff. What we might add — how do I want to say this? What Lynn (ph) was talking about was that if a conformance test is done and somebody succeeds in a conformance test that it might be considered that there would be a certification that they conformed.
We haven’t been talking about that. But that is true that that might exist out there in other areas. So maybe we have to add a sentence that says we’re not talking about the certification that somebody has conformed.
SIMON COHN (ph): Yes. Someone else had a comment, too.
TERRI (ph) BURNS: Yes, Simon. This is Terri (ph) (ph) Burns. I just was going to agree completely with what Lynn (ph) said because we also refer to certification as the ability to, that you’re utilizing the standards in a correct way using the appropriate messages back, et cetera.
LISA MILLER: Right. And Simon, this is Lisa. In X12, certification had a different connotation. It meant you went to another vendor, and so I think there is a disconnect, and it is an overloaded term that perhaps needs further clarification here.
And that was where my original question of whether or not we’d use the word certification. And maybe more simplistically, if we list that certification is simply the act of being able to — and I may be putting this way too simplistically, but being able to use the conformance test as developed by the standards bodies in your production system.
And that’s proof of certification. And that would not, then, step on as, what Lynn (ph) was talking about, how they use certification.
JEFF BLAIR (ph): I think the problem is coming from the fact that the Office of the National Coordinator for Health Information Technology already is developing an investigation program to certify whether the applications, whether the systems will have the functions that are needed for electronic health record systems, for example.
And so we were pulling the word certification from that program that is about to emerge that certifies the application functions and trying to keep that separate from the conformance testing of the messages.
SIMON COHN (ph): Yes, Jeff, let me try a different way of describing 17 and see if this helps us at all. It says “Testimony identified the need for the development of conformance tests for e-prescribing standards implementations and the overall certification of e-prescribing systems.”
Now…
STAN HUFF (ph) (?): Yes, I think that’s very good.
JEFF BLAIR (ph): That’s fine.
SIMON COHN (ph): Now, I’m wondering if that helps us at all. So we stay away from whether conformance testing is the same as certification or not. And we can leave a little bit of ambiguity given that we’re asking the Office of the Coordinator to investigate how e-prescribing applications might best be certified.
JEFF BLAIR (ph): But Simon, I think that we need to add a sentence to indicate that we’re not — when we talk about certification, we’re not talking about issuing a certification when somebody successfully passes a conformance test.
UNKNOWN FEMALE #15: And I think a lot of people think of that as, “Where can I go get my Good Housekeeping seal of approval?”
SIMON COHN (ph): Well, and I guess Margret …
UNKNOWN MALE #30: Well, I’m not sure we’re not talking about that, yes. See, I think some of us, at least, were thinking that you do, that that’s exactly the thing that we want to do. That there is somebody who is authorized, has the authorized voice of what is conformant and, in fact, they are the ones who can say whether you’re conformant or not.
SIMON COHN (ph): Yes. You know, this is something that — once again, I’m assuming that we like that first sentence that we described. I guess I’m wondering if we can leave this issue about the extent of certification and what it may mean and whether there’s a two or even three stage certification that may occur. That’s something that the Office of the National Coordinator needs to investigate.
STAN HUFF (ph) (?): I think that’s right.
LYNN GILBERTSON (ph): This is Lynn (ph). I think…
STAN HUFF (ph) (?): I think it…
LYNN GILBERTSON (ph): …that’s what they’re wrestling with right now, among other issues.
SIMON COHN (ph): Well, that’s good. And we’ll just give them yet something else to do. We wouldn’t want them to be bored. But I’m just wondering if leaving this level of ambiguity serves us in this one, because I think what it means is that it will tell people that they — you know, I mean, what we’re saying is that there needs to be, at the very minimum, probably this issue of is it conformant with the standards.
And then the other question is do we need to also be looking at some of the functionality issues, which is something — I mean, both of these things are things that ONCHIT would need to look at. Is that…
LISA MILLER: Simon, this is Lisa again. I think if we can verbalize the difference between conformance, which is really how the X12 implementation looked at conformance as certification, you’re certified that you met the standard.
And now we’re using a different word called conformance. And certification’s at that different level, as you’re describing it. If that can be articulated here, that would be very good.
MARIA FRIEDMAN (ph): This is Maria. Maybe we need to add a sentence that says that there are different uses and interpretations of certification — you know, by different segments of the industry. And for this purpose, we mean that.
STAN HUFF (ph) (?): I was thinking the same thing, that we might want to add, you know, just say for purposes of our actions, we’re taking conformance to mean this and we’re saying that certification means this.
HARRY: Simon, this is Harry. I concur with Stan’s comments, and I also concur clearly with the idea of the Good Housekeeping seal because in the end, it’s the smallest doctors’ offices that are going to have vendors walking in saying they’re ready to go.
Those are the people that can least afford to be misled.
SIMON COHN (ph): OK. So I guess we have a second sentence here where we recognize that there is some ambiguity or some — I don’t refer to it as confusion but…
STAN HUFF (ph) (?): You could just say there are different, you know, different…
SIMON COHN (ph): Perspectives.
STAN HUFF (ph) (?): meanings or perspectives implied to conformance and certification.
SIMON COHN (ph): OK. For these recommended actions, we mean conformance to mean X, Y and Z with sort of implicit passing of the conformance test, and we’re obviously talking about really an overall certification which relates to both functionality as well as ability to send and receive e-prescribing standards, standard messages.
Is that what we’re sort of saying?
STAN HUFF (ph) (?): Right. Yes.
SIMON COHN (ph): And Margret, please don’t ask me to repeat that one. Is that sort of where we’re going?
MARGRET A.: So let me just try to get the essence. Conformance means determining the message adheres to the standards.
JEFF BLAIR (ph): Yes.
MARGRET A.: And then certification means something broader, that the implementation has certain functionality?
SIMON COHN (ph): No.
MARGRET A.: That wasn’t clear. The certification part wasn’t clear how you define…
SIMON COHN (ph): Yes, I guess I look at certification as — I mean, this is why I actually though that we needed to have the office flush this out a little better.
UNKNOWN MALE #31: Well, maybe that’s the other way to do this is not to do that — yes, to just — I mean, I think we could note the ambiguity and then just, and then leave it — because our actions, you know, our actions don’t require us to say what those things mean.
We just — our actions just say that we want, you know, conformance, you know, the standards development organizations to develop conformance testing information and we want the Offices of National Coordinator to investigate how to do it, which would include defining what they mean by certification and conformance.
SIMON COHN (ph): You know, we could put in parentheses after certification e-prescribing systems, which might include both, you know, passing of conformance tests as well as functional requirements.
JEFF BLAIR (ph): Could I suggest this?
SIMON COHN (ph): Yes?
JEFF BLAIR (ph): Because I think in our first sentence we specified that it’s conformance testing of its standard and that it’s certification of the e-prescribing system. I think the problem we’re having is that the industry also uses the word certification in a way that has, in the past, related to conformance as well.
And I think if we just simply note that while we recognize that that’s the case, or maybe we could just simply say we recognize that that’s the case, that the industry also uses the word certification as it may apply to conformance.
SIMON COHN (ph): Yes, I think this is going to need some work. So how do people want to wrap this up? I want to give everybody a break here in just a second since we’re two hours into it.
Jeff, I guess I’m reminded also that the PMI (ph) recommendations I thought talked some about conformance testing.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): And I’m wondering if there’s some verbiage there that might help us.
JEFF BLAIR (ph): And this is kind of consistent with the way we were thinking there. I think that, to be honest with you, I really think that if we just simply recognize the fact that the word conformance in the industry may also be used to relate to somebody successfully passing the conformance test…
SIMON COHN (ph): You mean certification.
JEFF BLAIR (ph): I’m sorry. That the word certification may also be used when somebody successfully passes a conformance test, that that might reconcile the problem.
SIMON COHN (ph): Well, OK. Well, then let me ask. I mean, if we put in parentheses after certification of e-prescribing systems, and put in parentheses saying that potentially both as it relates to passing of conformance tests as well as functional characteristics of the system, end of parentheses, does that solve our problems?
JEFF BLAIR (ph): Well, I said it a little slightly differently, Simon.
SIMON COHN (ph): Well, I’m just talking about referencing the ambiguity in the industry, you’re right.
JEFF BLAIR (ph): Yes. But what I was going to wind up simply suggesting is that we have a statement that says we recognized that the industry also uses the word certification to designate when a vendor successfully passes a conformance test.
SIMON COHN (ph): OK. And so what does that say — so what is the point that you’ve said that now.
JEFF BLAIR (ph): The point is that we…
SIMON COHN (ph): So what do we mean by certification?
JEFF BLAIR (ph): We’ve indicated in that first sentence, “our use,” and this sentence would simply indicate that we recognize that the industry also has an additional use for certification.
SIMON COHN (ph): Yes. Jeff, the problem is in the first sentence it doesn’t state that use that you’re describing.
JEFF BLAIR (ph): No, it doesn’t. But that — the first sentence was the way that we had pulled together our consensus, and now this additional sentence would recognize that the industry has a different use for the word certification.
STEVE STEINDEL (ph) (?): Jeff, I’m concerned about the way you’re throwing around the word, “the industry.” What industry because there are two industries that we’re talking about here, and they have different definitions.
One is the standards development organization industry and they look at conformance — they actually don’t look that much at conformance testing, and they tend to use the word in a multiple of different fashions, and we’re having a lot of trouble with that with the HR (ph) TC (ph) on HL7.
The other is conformance testing and certification with respect to the people who are actually selling devices. And that is very clear. That’s like United Laboratory approval of a device. Conformance testing and certification in that arena is clear, and we need to be clear what we mean here.
Do we mean the standards that are being used? Or do we mean the actual devices that are going out the door?
STAN HUFF (ph) (?): Yes, I — you know, I kind of like the addition you made to the sentence. I was thinking that a way to attack this is just say that, as the very first sentence under the observation, or maybe a last sentence to say, you know, there was confusion in the discussion about the specific meaning of certification and conformance testing.
And then add a sentence down in Recommendation 17.3 that says part of the responsibility of the Office of the Coordinator is to determine the exact meaning and implementation of certification and conformance testing.
JEFF BLAIR (ph): This is Jeff. I’ll go for that.
SIMON COHN (ph): Let me think about this one. I know we’ve been going for two hours and 10 minutes, but you want us to put a second sentence here that states there was confusion about what we mean by this observation?
UNKNOWN FEMALE #16: No.
STAN HUFF (ph) (?): I would just note — you could just note that in the testimony and subsequent discussions, there was confusion or…
UNKNOWN FEMALE #16: Nomenclature differences?
STAN HUFF (ph) (?): Yes. Differences in use of the terms conformance testing and certification.
SIMON COHN (ph): OK. You know, I guess I’m getting increasingly concerned by this conversation because we seem to be creating yet even more confusion by our statements of confusion.
And I think we need to be clear by what we mean by these things and say them. Now I’m actually happy — and I think we can do this by just sort of stating it. Now I’m personally willing to, given that at least some parts of the industry talk about certification as the successful passage of conformance tests…
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): …that I don’t see that there’s any real problem to be expansive enough in our definition of certification to sort of say, “Yes, certification might mean that, but we’re also talking about it meaning potentially, you know, meaning overall, you know, having overall functional specifications and yet other things.”
JEFF BLAIR (ph): Could we hold on to the sentence you just offered us, that we understand that the industry also defines certification as the successful passing of conformance tests. If we just add that sentence, why does that not resolve our problem?
SIMON COHN (ph): Well, because we’re not — OK, Margret, help us with this.
MARGRET A.: OK. How about if I read you — this is the observation and this is the 17.3. Testimony identified the need for the development of conformance tests for implementations and overall certification of e-prescribing systems. It should be recognized that some parts of the industry use the term certification in a limited sense of passing a conformance test.
And then 17.3, the Office of the National Coordinator should investigate conformance testing and certification of e-prescribing applications.
JEFF BLAIR (ph): I think that’s fine. Just after the word conformance test, you need that’s a conformance test of standards implementations.
SIMON COHN (ph): Well, why are we having the National Coordinator investigating conformance testing?
MARGRET A.: We wanted to…
MARIA FRIEDMAN (ph): This is Maria. I liked the original 17.3 because that’s broad enough to encompass all of that.
JEFF BLAIR (ph): I agree.
SIMON COHN (ph): Yes, but I do like your observation.
MARGRET A.: OK.
SIMON COHN (ph): So what do other people think? Do other people want to read her — shall she re-read her observation, see if it gets us out of this quandary.
MARIA FRIEDMAN (ph) (?): Yes.
UNKNOWN FEMALE #17: Please.
MARGRET A.: Testimony identified the need for the development of conformance tests for implementations and overall certification of e-prescribing systems. It should be recognized that some parts of the industry uses the term certification in a limited sense of passing a conformance test.
SIMON COHN (ph): I think that’s actually not bad. What do people think?
HARRY: Simon, this is Harry. I’d like to maybe add another consideration. Testimony identified the need for both conformance testing to standards and certification of e-prescribing functionality, parenthesis (systems and work flow) as the observation.
JEFF BLAIR (ph): I like that.
HARRY: Because I would hope that the Office of the National Coordinator working with HHS — this whole idea of functionality is key. So I agree with everybody there’s conformance to standards. That’s step one.
And then there’s certification that this is really going to work.
SIMON COHN (ph): OK. Margret, did you get that?
MARGRET A.: Yes. Let me read it back. Testimony identified the need for conformance testing to standards and certification of implementation, parenthesis, (i.e. systems and work flow.)
HARRY: No. A little different. Conformance to standards and certification of e-prescribing functionality.
MARGRET A.: E-prescribing functionality.
HARRY: parenthesis, (systems and work flow.)
MARGRET A.: OK.
JEFF BLAIR (ph): Yes.
HARRY (?): Then the clear definition by whoever defines it of those two terms should be very clear to everyone.
LISA MILLER: Simon, this is Lisa again. Could we — I’m kind of lost on where we ended up on 17.1, 17.2 and 17.3. Could we just read through those one more time so that we get kind of the whole picture again?
SIMON COHN (ph): Margret, would you go forward? I think the rest of it looks pretty simple.
MARGRET A.: Simon, let me read it from the observation forward just to be sure I’ve got it all.
SIMON COHN (ph): OK.
MARGRET A.: Testimony identified the need for conformance to standards in certification of e-prescribing functionality, (i.e. systems and work flow), to be recognized that some parts of the industry use the term certification in a limited sense of passing a conformance test.
17.1: HHS should support standards development organizations in their development of conformance tests of the e-prescribing standards and their implementation guides.
17.2: HHS should require that vendors use conformance tests to validate that their e-prescribing messages are interoperable.
17.3: The Office of the National Coordinator for Health Information Technology should investigate how best to certify e-prescribing applications.
SIMON COHN (ph): I thought how e-prescribing applications might best be certified.
MARGRET A.: Might best be certified. How — I’m sorry. I left the how out.
SIMON COHN (ph): OK.
MARGRET A.: How e-prescribing applications might best be certified.
SIMON COHN (ph): Comments.
JEFF BROWN: This is Jeff Brown. Just a question on the 17.1, did they say, did Margret say conformance testing of e-prescribing standards or e-prescribing standards implementations?
MARGRET A.: Standards and their implementation guides.
JEFF BROWN: And their implementations.
MARGRET A.: No. And their implementation guides.
JEFF BROWN: And their implementation guides. Is that testing on or testing for? That was a question I had a long time ago.
SIMON COHN (ph): Margret, read it again, 17.1?
MARGRET A.: HHS should support standards development organizations in their development of conformance tests of the e-prescribing standards and their implementation guides.
SIMON COHN (ph): So we’re talking about the development of tests.
MARGRET A.: Yes.
JEFF BROWN: And my question — this is Jeff again, is tests of or tests for.
UNKNOWN FEMALE #18: And Simon, we’re specifically saying by the standards development organizations?
SIMON COHN (ph): Yes, I think conformance tests probably are the province of the standards organizations, unless others — I guess that’s to my view, the people that should really be doing that.
UNKNOWN FEMALE #18: I agree completely. I just want to make sure that we’re saying that. It’s very clear in 17.2 that when we say that vendors should use conformance tests that we’re referring to the ones in 17.1 that came from the standards development organizations.
I think that will help the industry as a whole not be confused about where conformance requirements come from.
JEFF BLAIR (ph): Yes, I think that was the intent.
SIMON COHN (ph): Yes.
MARGRET A.: In 17.2, Simon, do you want me to put HHS should require that vendors use the standards development organization’s conformance tests to validate?
JEFF BLAIR (ph): I will…
MARGRET A.: We had taken that out before.
JEFF BLAIR (ph): See, I wonder whether it’s necessary. I mean, they’re back to back, and you know, we wind up saying in one who’s developing them so — and then the second one says who’s using them, so.
SIMON COHN (ph): Yes.
JEFF BLAIR (ph): I don’t think it’s necessary to…
UNKNOWN FEMALE #18: No, I was just being clear. I was fine with 17.2.
JEFF BLAIR (ph): Yes. I agree with — I think that’s the intent of what…
SIMON COHN (ph): OK.
JEFF BLAIR (ph): …we have.
SIMON COHN (ph): OK. OK. Other comments from either our subcommittee, staff or others?
OK, are we ready to vote on this one?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Yes, you’re ready to vote or yes, you mean you’re in favor of it?
JEFF BLAIR (ph): Both.
SIMON COHN (ph): Oh, OK. Me, too. OK. So we’re done with 17 now. Obviously we have a chance to look at it in its next version, and obviously I suspect that we further wordsmithed by our editor over the weekend.
Now I’m — it’s now, at least in California, 11:18, so we’re two hours and 15 — it’s two hours and 18 minutes into this. I’m going to suggest we take a 10-minute stretch and other break, and we will reconvene California time at basically 11:30, which is 2:30 Eastern time. OK?
UNKNOWN MALE #32: That’d be great.
SIMON COHN (ph): OK.
UNKNOWN MALE #33: Is it best to hang up and just call back?
SIMON COHN (ph): No. I would just keep on the line.
UNKNOWN MALE #33: OK.
SIMON COHN (ph): OK?
(BREAK)
SIMON COHN (ph): Are people back on the line yet?
MARGRET A.: This is Margret. I’m here.
SIMON COHN (ph): Good.
LYNN GILBERTSON (ph) (?): Lynn’s (ph) still here.
UNKNOWN FEMALE #19: (INAUDIBLE) here.
STEVE STEINDEL (ph): Steve’s here.
SIMON COHN (ph): Let’s see, we have our subcommittee members. Jeff, are you there? You give people 12 minutes, you just never know what’s going to happen. Harry? Judy?
JUDY WARREN (ph): I’m here.
SIMON COHN (ph): Well, good. There’s two of us. Let’s make sure we have a quorum before we start moving forward.
JUDY WARREN (ph): Oh, the other three guys that are late.
SIMON COHN (ph): Stan?
UNKNOWN FEMALE #20: Gee and it’s usually the line at ladies’ room.
SIMON COHN (ph): I guess I should ask, Margret, you’re doing OK?
MARGRET A.: I’m here.
SIMON COHN (ph): OK. Well, I guess possession is, what is it nine points (ph) of the law? The fact that you’re sitting here with us is probably a good sign still.
MARGRET A.: I appreciate the break.
SIMON COHN (ph): OK. Jeff, are you back yet? Stan, are you back yet? Harry? I knew Harry, for the record, is, I think was going to drop off after two and a half hours or so. I think he had some other things that he had to do.
Have any of our subcommittee members reappeared?
JORJE FERRER (ph): Simon, this is Horjay (ph).
SIMON COHN (ph): Hi, Horjay (ph). Welcome back.
JEFF BLAIR (ph): This is Jeff. I’m here.
SIMON COHN (ph): You’re here now. OK. So now we — and so we have I think Judy and I and you. Is Stan back on, available now?
Well I think we have a quorum at this point so hopefully we’ll get Stan back any moment, but why don’t we get started. Margret, I think we’re into Observation 18.
MARGRET A.: OK. Observation 18, Items Not Addressed in Initial Set of Recommendations: There are several other message format, terminology, and identifier standards and important related issues that were identified by the NCVHS, but are not addressed in this initial set of recommendations.
The NCVHS plans to receive testimony on as many of these topics as possible prior to making a final set of recommendations in March 2005. The topics include — and this list, I just wanted to point out, is not really organized in any way. I mean, it’s not most important, least important, alphabetical. It’s just a list by virtue of how we moved them down.
1. Issues relating to privacy and security with respect to e-prescribing.
2. Electronic signature for use in e-prescribing.
3. A directory that would identify prescribers, nursing facilities, and pharmacies that are able to accept e-prescribing transactions.
4. Codification of allergens, drug interactions, and other adverse reactions to drugs.
5. Incorporation of indications for drug therapy into e-prescribing messages.
6. A standard for units of measure.
7. Methods for patient identification for e-prescribing.
8. Use of the National Health Plan ID for e-prescribing.
9. Formulary identifier.
10. Exchange of medication history among all participants in the e-prescribing process.
11. Exchange of medical history within the e-prescribing process.
12. The need for a collaborating body to assist standards development organizations with their coordination efforts, and standard codes for orderable items (such as insulin supplies) covered by Medicare Part D.
SIMON COHN (ph) (?): OK. Comments by people. I mean, is this the right listing?
STEVE STEINDEL (ph): Simon?
SIMON COHN (ph): Yes?
STEVE STEINDEL (ph): A standard for units of measure. There is a CHI standard for units of measure that the NCVHS has endorsed.
SIMON COHN (ph): Well, that’s — not only that, I don’t even think that this is an issue that we need old testimony about.
STEVE STEINDEL (ph): Right.
SIMON COHN (ph): Do others agree?
UNKNOWN MALE #34: Yes.
SIMON COHN (ph): Because my preference is to remove that from the list.
UNKNOWN FEMALE #21: Agree.
JEFF BLAIR (ph): This is Jeff. I agree.
SIMON COHN (ph): Stan, are you back yet?
STAN HUFF (ph): I’m back.
SIMON COHN (ph): OK. So you agree also?
STAN HUFF (ph): Yes. That’s fine with me.
SIMON COHN (ph): We’re looking at Observation 18 and we’re moving down…
STAN HUFF (ph): If we assume — yes, if we assume we’re going with the previous CHI recommendation then I’m good.
SIMON COHN (ph): OK.
UNKNOWN FEMALE #21: What is that, Steve?
STEVE STEINDEL (ph): Excuse me?
UNKNOWN FEMALE #21: What is that called?
STEVE STEINDEL (ph): The CHI recommendation is basically the HL7 units of measure.
UNKNOWN FEMALE #21: OK. And I guess to follow that, is the HL7 units of measure…
STEVE STEINDEL (ph): Are they…
UNKNOWN FEMALE #21: …are they any resemblance to the X12 units of measure?
STEVE STEINDEL (ph): The HL7 units of measure are basically the ISO (ph) table.
UNKNOWN FEMALE #21: OK because there might not — there might need to be harmonizations because SCRIPT references X12 units of measure to try to harmonize.
LISA MILLER: This is Lisa. There is — I’m concerned we may have an issue here as well. I don’t have details but I would voice a concern here.
SIMON COHN (ph): OK. So let’s put it back on the old (ph) set. Is that what we’re hearing?
STEVE STEINDEL (ph): Yes.
UNKNOWN MALE #35: Yes.
SIMON COHN (ph): OK. Sorry, Steve. OK. Let’s see if there’s anything else we wanted to remove or otherwise — I guess, Margret, I guess I would ask — let’s see, I guess we’ve got 18.10, which is exchange in medication history among all participants in the e-prescribing process, which is I think we had referenced earlier with something that — OK. Why don’t we leave that off, basically.
MARGRET A.: We had only addressed the medication history exchange…
SIMON COHN (ph): Right.
MARGRET A.: …between payers and prescribers.
SIMON COHN (ph): And we didn’t note it as a set (ph) for additional recommendations. So that’s fine. Help me with item 18.12. I’m not sure I disagree with it but maybe you can…
MARGRET A.: Yes. When we were talking about the coordination among the centers development organizations we said, “Is there a need for a body, like the NCH ISP (ph) or some other group to be sort of formally convened or appointed or designated.
SIMON COHN (ph): OK. You know, I’d almost describe this in a different way. And maybe I’m stepping back even a further step, but I think it’s really — the question is how best to ensure adequate harmonization between different standards development activities.
LISA MILLER: Simon?
SIMON COHN (ph): Yes?
LISA MILLER: This is Lisa. I might recommend here that we actually name HISB, which is the American National Standards Institute’s Healthcare Informatics Standards Board. It’s ANSI HISB. It’s an open public forum for the voluntary coordination of healthcare informatic standards among all United States standards developing organizations.
HL7, X12, and NCPDP all participate.
SIMON COHN (ph): Well, Lisa, I mean, thank you for that comment. And as a former member of that group, I’m not willing to accept that as a recommendation for a — a recommendation from the full committee without hearings on that.
But having said that, I guess I’m still wondering whether the topic here is not — I guess I would ask the subcommittee and others whether the role of topic is here about the need for a collaborating body or whether the question is really a more fundamental one about exactly how best to ensure harmonization or coordination.
STEVE STEINDEL (ph): Simon, I would go along with the more fundamental.
SIMON COHN (ph): Yes.
STEVE STEINDEL (ph): Because ANST HISB itself, I personally do not think it’s a suitable body because it has, it can air ideas but it has no teeth.
SIMON COHN (ph): Yes. And actually — and Lisa, before I — obviously I cut you off. And I do apologize because others may feel differently than I do. It was just that my view was that HISB may be absolutely the answer to the question but I’m not willing to face (ph) that because we didn’t have any testimony.
I guess I would speak against us making that recommendation without hearing other testimony. But to me, really the question was is are we asking the suitable question here before we come up with the right answer.
And so I think that was really the reflection that I was having. But I guess I’d like to hear from others. Stan?
UNKNOWN MALE #36: I liked the recommendation to make it a more fundamental statement about how we can coordinate.
STAN HUFF (ph) (?): I have the same reservations Steve has about HISB being the solution.
SIMON COHN (ph): Yes. Well, I think we need to hear testimony on there if the Judge wants that (ph).
STAN HUFF (ph) (?): Yes. We can — sure. I mean, it’s…
HARRY: Simon, Harry. I agree also.
SIMON COHN (ph): Yes. Jeff?
JEFF BLAIR (ph): I’m fine. However, I thought that Steve’s earlier comment was that he preferred the word coordination rather than harmonization, so is that, you know, what did we pick on that?
STEVE STEINDEL (ph): I believe Margret actually attempted to correct it while she was reading it.
SIMON COHN (ph): OK.
JEFF BLAIR (ph): OK.
SIMON COHN (ph): So anyway, Margret, can you re-read this new one then as its…
MARGRET A.: Yes. How best to coordinate standards development organizations.
JEFF BLAIR (ph) (?): Related to e-prescribing, right?
MARGRET A.: How best to coordinate the e-prescribing efforts of the standards development organizations?
JEFF BLAIR (ph) (?): Yes.
UNKNOWN FEMALE #22: So we need to say the SDOs, or do you want to leave it more broad?
JEFF BLAIR (ph) (?): I think it has to be broader.
UNKNOWN FEMALE #22: But that begs for Simon’s earlier, wanting to just keeping it very plainly about how best to ensure coordination efforts.
JEFF BLAIR (ph) (?): Yes, but I don’t think she stuck in SDOs. Coordination efforts for e-prescribing, because I think there’s coordination efforts outside of the domain to be prescribing that exists that we’re not going to try to get into.
MARGRET A.: How best to ensure coordination efforts for e-prescribing.
JEFF BLAIR (ph) (?): Yes.
MARGRET A.: Or e-prescribing standards?
JEFF BLAIR (ph) (?): E-prescribing standards, and that would include both SDOs and terminology developers and identifier developers. So it would include all of them.
SIMON COHN (ph): Well, and maybe if we’re talking about this, maybe it’s how best to ensure the success of coordination efforts. Is that what we’re talking about?
JEFF BLAIR (ph) (?): Yes, that’s fine.
SIMON COHN (ph): Margret, I might let you wordsmith this one a little bit as you think appropriate and we’ll review this one.
MARGRET A.: OK.
SIMON COHN (ph): But it’s — I don’t think we’re — I mean, it’s — I mean, I guess I should ask everybody, are we talking about — I guess I brought up just yet another twist on this whole thing. Now are we talking about how best to ensure the coordination efforts are successful?
Or are we talking about how to ensure, how to assure that coordination efforts are ongoing and…
JEFF BLAIR (ph): You know, Simon…
SIMON COHN (ph): Yes.
JEFF BLAIR (ph): Your idea of successful maybe brings up something useful here because I think what we really want to make sure is that they’re effective. This is an area where there’s been many attempts in the past to coordinate that haven’t been effective.
MARGRET A.: How best to ensure the effectiveness of coordination efforts for e-prescribing standards.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): That actually doesn’t sound too bad. Others? Is that OK?
STAN HUFF (ph) (?): Well, I wondered again — and I don’t care strongly about this but whether we even want to be stronger and say, you know, the interoperability of — is that, I mean that’s stronger because it’s sort of a search that we really are trying to strive, that the coordination is about interoperability, not just sort of knowing what each other are doing or something.
JEFF BLAIR (ph): That’s fine.
SIMON COHN (ph): Other thoughts on that one?
HARRY: This is Harry. I’m fine.
SIMON COHN (ph): Yes. I think interoperability is a very — is a goal that we need to be, you know, sort of reaching towards. So Margret, have we changed it yet again?
MARGRET A.: How best to ensure the effectiveness of interoperability among e-prescribing standards.
SIMON COHN (ph): That’s a pretty good…
HARRY (?): I like that.
SIMON COHN (ph): Yes. OK. Other comments?
MARIA FRIEDMAN (ph): This is Maria again. Are we just still limiting it very strictly to standards or are you talking — we’ve talked about it in broader context. I just want to make sure we’re comfortable with how we, how narrowly we circumspread (ph) this.
STEVE STEINDEL (ph): Maria, I thought about that when we were discussing this and we’re actually talking about a coordination effort of standards.
JEFF BLAIR (ph): And standards in my mind includes messages, terminologies and identifiers.
STEVE STEINDEL (ph): Yes. So this, to me, is an area where we do want to be specific.
SIMON COHN (ph): Yes. Yes, I’m pretty much fine with that. And obviously, just to — you know, further comment from, I think, a previous suggestion about this one and whether ANSI HISB will play a role in this one.
I think we certainly hope that when we get to this issue that HISB is one of the testifiers and they give us the results of their wisdom. And who’s to know what the recommendation, how the recommendations might evolve from there.
Any other thoughts on these things? Are we missing any major item? And maybe these things all need to be wordsmithed a bit but I’m — I mean, they don’t, they look like a reasonable set of issues for us to be working on.
JEFF BLAIR (ph): I’m satisfied.
STAN HUFF (ph): I wondered if we wanted to call out or — and this really has to do with our work plan, I guess, in a sense, whether we want to hold specific questions about drug labeling and drug listing information?
I mean, those are two (ph)…
SIMON COHN (ph): Well, Stan, you have to sort of help me with why we would want to do that.
STAN HUFF (ph): Because they’re named in the legislation and we haven’t addressed them.
JEFF BLAIR (ph): Stan, this is Jeff. This is my thought on them. My thinking is that we are aware of the fact that, you know, who’s working on those, and that most of the work effort will not be in place until beyond March of 2005.
STAN HUFF (ph): No, SPL is an HL7 standard. It’s valid. And the — I mean, I think we would benefit from having the FDA come and present that standard.
JEFF BLAIR (ph): Do you think we could come up with additional recommendations by March on SPL?
STAN HUFF (ph): Well, there’s a standard, and if we found that acceptable, yes.
MIKE FITZMAURICE (ph): This is Mike. One of the things that may delay that is FDA doesn’t move quickly on it’s regulations for implementation. There was a subtle mention of that at the last meeting, I guess it was last week, by Randy who didn’t want to state it too strongly.
JEFF BLAIR (ph): I don’t mind adding it to the list. You know, this list is frankly so long that after September 1st and 2nd we will probably have to prioritize and, you know, figure out what we can do because I shouldn’t (ph) (INAUDIBLE).
STAN HUFF (ph) (?): I don’t care strongly so I’m fine if we leave it off.
RANDY: Hi. This is Randy.
MIKE FITZMAURICE (ph) (?): Hey, there you are.
RANDY: Hi. How are you doing?
MIKE FITZMAURICE (ph) (?): The sleeper.
RANDY: I just came in, so just a perfect timing.
MIKE FITZMAURICE (ph) (?): Yes.
RANDY: The other issues we were talking about before was SPL for other FDA regulated products. Are we going to address that at all? You know, we were talking about that at the last time, and not another…
MIKE FITZMAURICE (ph) (?): Exactly.
RANDY: …to bring it into this letter but we were talking about maybe in March addressing that issue.
JUDY WARREN (ph): Is that part of our (ph) team?
MIKE FITZMAURICE (ph) (?): You know, see that was — yes, I think that’s best there.
UNKNOWN MALE #37: With codes (ph) to orderable items such as insulin…
STEVE STEINDEL (ph): That’s 18.13.
MIKE FITZMAURICE (ph) (?): Yes.
SIMON COHN (ph): Is it not properly stated, Randy, from your perspective?
RANDY: Well, our discussion was we, at the last time, the meeting of the letter, just talked about drugs as what’s applicable to the, you know, just drugs. And then there was discussion about where should we go for medical supplies and other FDA regulated items or orderable items that are not included under drugs.
And our members came and talked to me about, “Well, let’s maybe we defer that to the March list.”
SIMON COHN (ph): Well, OK. Randy, what I was asking was we have an item here that is 18.13, which is standard codes for orderable items (such as insulin supplies) covered by Medicare Part D.
So I guess what I was asking is does that cover your concern, your thought, or is there something else here that we’re missing?
RANDY: I guess that covers — if that covers the, what’s covered in the Acts, I guess that’s it. So I don’t know exactly what’s covered but if the things I’m thinking about are other habits, things like dietary supplements. Is that covered?
STAN HUFF (ph): This is really just a list for us. I mean, I think we can — I don’t think this is necessarily — this is a reminder to ourselves so, you know, when we talk about this, I think that would be within the scope of the discussion.
RANDY (?): That’s why I thought that — Stan, you had brought this up before and I thought that’s what you were aiming for.
STAN HUFF (ph): It was and it is, yes.
RANDY: OK.
SIMON COHN (ph): And Randy, remind me, dietary supplements are prescribed?
RANDY: Well, I guess some people write prescriptions for certain things that FDA itself doesn’t consider a drug, but someone is writing it saying that they…
STAN HUFF (ph) (?): Like Ensure for, you know, oncology patients and simply (ph) that stuff.
SIMON COHN (ph): And they’re covered by Part D? That’s covered by Part D?
UNKNOWN FEMALE #23: I don’t think so.
SIMON COHN (ph): OK. I’m just sort of curious because obviously I can buy insulin supplies but, you know, I mean, you know, we could also expand this to vitamins and…
RANDY: Right.
SIMON COHN (ph): …everything else. And we could certainly do that but I don’t know whether that’s really topics under this letter. I guess that would be a question of I think we do probably need to get back into that area again.
STAN HUFF (ph) (?): Well, I think…
SIMON COHN (ph): But it’s probably not part prescribing.
STAN HUFF (ph) (?): …it’s not part.
SIMON COHN (ph): Yes.
STAN HUFF (ph) (?): But again, we’re trying to make this work and you know, for somebody who’s really supporting an ordering system and you need a solution for those things, whether we say it’s part, you know — it’s not part of Part D but it’s part of a solution that you need if you’re going to provide a solution for physician to pharmacy communication.
SIMON COHN (ph): OK.
MARGRET A.: Simon, would it be appropriate to remove “covered by Part D” and just leave it as standard codes for orderable items such as insulin supplies, dietary supplements?
SIMON COHN (ph): I guess I’d ask others what they think.
STAN HUFF (ph) (?): You might just want to leave it as orderable items.
SIMON COHN (ph): Yes. Subcommittee members, what do you think?
JEFF BLAIR (ph): I think it’s fine to remove the “covered by Part D.”
JUDY WARREN (ph) (?): Yes, that’s good.
SIMON COHN (ph): Yes, I guess my only…
HARRY (?): I’m fine either way.
SIMON COHN (ph): Yes, I guess I would be happy to remove the Part D. I’m concerned as we start expanding the e.g.’s on this one. So I guess I would — I would just ask the committee, I don’t feel strongly about this one but I think “such as insulin supplies” is probably a good…
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): …and we can just leave it at that.
JUDY WARREN (ph): I agree with that.
SIMON COHN (ph): OK. And obviously as we get into this area, we can decide exactly what scope we may choose to go after in relationship to this. So I think what we’ve done is “standard codes for orderable items such as insulin supplies” and we’re leaving it at that?
JEFF BLAIR (ph): Yes.
JUDY WARREN (ph): Yes.
SIMON COHN (ph): OK.
STEVE STEINDEL (ph): Randy, you didn’t really specifically answer the question that Stan asked is that we, should we include something on SPL in this list? Because otherwise we will not be looking at it and we can’t make any real recommendations about accelerating the regulation if that’s what comes out of conclusion or any other recommendations concerning it.
RANDY: And you’re talking about the list, the March list?
STEVE STEINDEL (ph): The March list, right.
RANDY: Well, if you’re talking — would you — and I think we’re just talking about your expanding SPL to include those?
STEVE STEINDEL (ph): No. No. I’m just saying there is no item on the March list that talks about drug labeling, and as is pointed out by Stan, this was something that is included in the law and we are not looking at it in March because we’ve heard nothing can be done about it in a short time period. Should we formally look at that?
STAN HUFF (ph): What I was thinking about specifically, Randy, is the — I mean, there is an HL7 standard that, you know, we use a CDA and it, I guess unfortunately or it’s called SPL too, right, for the standard product labeling standard or…?
RANDY: Right. We’re working on a second version that will include more details than what’s in the first version, which is the first version has the content of labeling and drug listing information, like ingredients.
But the second version we’re looking at including more information about drug interactions, indications, classifications, things along those lines.
STAN HUFF (ph): I mean, that’s what I was thinking, see, is if — we might not be able to make a recommendation but I think there’s — at least I would like to be more informed about where they’re actually at because I think there are some things that have been balloted in their standards and might be ready for use, or at least be ready for testing.
RANDY: That’s right.
SIMON COHN (ph): Other opinions from people?
JEFF BLAIR (ph): I don’t mind having it on the list.
SIMON COHN (ph): Sure. Thirteen’s always a bad number to leave things at.
MARGRET A.: May I ask, Simon, should it be identified as drug labeling and listing?
STAN HUFF (ph) (?): I would use the same terms that are used previously and in the legislation.
MARGRET A.: All right.
SIMON COHN (ph): Which are?
STAN HUFF (ph) (?): I think they’re what we used previously in the thing (ph)…
MARGRET A.: I’ll check it.
STAN HUFF (ph) (?): …what we said in…
SIMON COHN (ph): OK. That sounds good.
STAN HUFF (ph) (?): We said, “drug — exchange of drug labeling and drug listing information,” is what we said before in.
SIMON COHN (ph): Well, that sounds pretty good.
MARGRET A.: Good.
SIMON COHN (ph): OK. Anything else before we — do we need to talk about dependencies for second also?
MARGRET A.: Simon, can I ask one more question on this?
SIMON COHN (ph): Sure.
MARGRET A.: Is this OK to just leave it in this order? There is no really particular order.
JEFF BLAIR (ph): I think that’s fine. There’s nothing…
SIMON COHN (ph): Well, I think the only thing that I would say is that the electronic signatures should probably be number one since we know we’re going to be holding testimony on that in October.
STEVE STEINDEL (ph): I mean, also, we know we’re going to hold testimony on privacy in November, so those should probably be the top two.
SIMON COHN (ph): Yes.
STEVE STEINDEL (ph): And they are already.
STAN HUFF (ph) (?): Well, I think the other one that’s, you know, more important than maybe some of the others is the discussion of patient identification procedures. That’s another one we’re committed to, right?
SIMON COHN (ph): Yes, but we don’t have a date on that one yet.
STAN HUFF (ph) (?): OK.
SIMON COHN (ph): So we’ve got — I think we’ve got that in a, what I would vote as sort of the right spot, probably.
STAN HUFF (ph) (?): OK.
LYNN GILBERTSON (ph): Simon, this is Lynn Gilbertson (ph).
SIMON COHN (ph): Yes?
LYNN GILBERTSON (ph): I received an invitation that came on behalf of AMIA and HIMS from On Kit (ph) related to doing some, a white paper for a near-term and long-term steps to promote high value CDS, clinical decision support in e-prescribing.
Do you know of this effort and what I’m after is are there any goals that are supposed to be coming out of On Kit (ph) or that side that NCVHS needs to be aware of or needs to include here in the list? I’m just not quite sure where all this is going.
SIMON COHN (ph): OK. Well, I guess I will give you the limits of my knowledge. I’m sure Stan probably knows more also but my understanding was that this was an area that On Kit (ph) is looking at but is literally looking at. And I think that that’s why white papers, and I think there’s other meetings that are being planned or sponsored to sort of look at issues related to decision support.
It’s obviously, it’s a big issue.
LYNN GILBERTSON (ph): So is this like our long term?
SIMON COHN (ph): But it’s a big — I mean, it’s like there’s lots of facets to this one. Do others have a comment? I don’t think this has any direct relevance to our letter in September, but it may have something to do with March.
But do others have comments? Stan or Steve?
STAN HUFF (ph) (?): I don’t have any, you know, further information. I mean, all I know is — is this a conference on October something?
LYNN GILBERTSON (ph): No. This is actually like September 9th.
STEVE STEINDEL (ph): This is going to be held at Med Info (ph).
SIMON COHN (ph): Right.
STAN HUFF (ph): Oh, that one.
LYNN GILBERTSON (ph): Yes. And I’m just trying to figure where they’re going — and especially since some of the same participants are on the list, and just trying to figure out are they going to be bringing recommendations forward for our March environment, or…?
STAN HUFF (ph): No. I think that’s very unlikely.
LYNN GILBERTSON (ph): Oh, OK.
STAN HUFF (ph): I mean, there’s nothing — well, I can’t say I think that there’s nothing that’s mature enough within HL7 in this area that it could be brought forth as a proposal, you know, for a March letter.
STEVE STEINDEL (ph): I think the best comment we can make on this is On Kit (ph) hasn’t communicated anything about this to NCVHS.
LYNN GILBERTSON (ph): Whoops. OK.
SIMON COHN (ph): No, I mean we’re aware of it, but it’s just, it’s not a — there’s no recommendations on any of this stuff.
JEFF BLAIR (ph): Yes, and I think some of us have been invited to the meeting too…
LYNN GILBERTSON (ph): Yes.
JEFF BLAIR (ph): …but it’s — as far as being on this particular list, I think it was a good thought that, you know, maybe. For the most part, the items that are on this list were the items that were part of the MMA requirements that we didn’t have time to begin, or didn’t have enough time to get testimony to be able to make recommendations on.
LYNN GILBERTSON (ph): OK.
SIMON COHN (ph): OK. So anything else here or are we OK for the moment?
JEFF BLAIR (ph): I’m satisfied.
SIMON COHN (ph): OK. Now I guess my — let’s take a quick look at what we’re going to do with the Appendices and then let’s move back to the beginning of the recommendations to make sure we’re all OK or whether we have additional things or changes to the recommendations.
And then, as I said, from there the next step is to look at the first couple of pages of the letter.
MARIA FRIEDMAN (ph): This is Maria. Regarding the Appendices, I realize that I’m on the hook for one and I didn’t read this closely enough. I didn’t realize I was on the hook for it so I will develop it forthwith.
STEVE STEINDEL (ph): Yes. Simon, we had a comment from Ross Martin on Appendix A. He was asking to include the Health Affairs article from the RAND (ph) study in addition to the…
JEFF BLAIR (ph): This is Jeff. To be — there’s a whole lot of things we could add with respect to e-prescribing, and I would rather — I think that the list that we have now is the things that are especially relevant to e-prescribing standards.
And the RAND (ph) study is very useful and interesting, but the way they looked at standards, they were standardizing functionality as opposed to the standards that we were looking at. So I would not be in favor of including the RAND (ph) study.
STEVE STEINDEL (ph): I was just bringing it up as something that Ross put on the list. I concur with you.
SIMON COHN (ph): Well, Jeff, let me ask just another question. Is right now, the first appendix is the executive summary from the eHealth Initiative report on e-prescribing. Now obviously I think that’s a wonderful report but the rational for including the executive summary as an appendix is?
MARIA FRIEDMAN (ph): This is Maria. Wasn’t that in reference to our discussion early on in the background material about the current environment of e-prescribing and we referred people to the EI report for…
JEFF BLAIR (ph) (?): That’s right.
MARIA FRIEDMAN (ph): …a fuller explanation?
JEFF BLAIR (ph): Yes, I think it was just the background that the committee used because that background did lead to our selection of standards, of the types of standards that we worked with. It seems more appropriate.
But I don’t feel strongly. If you feel like the eHealth Initiative executive summary shouldn’t be in here, that’s fine with me.
SIMON COHN (ph): Well, why don’t we look through the letter and we can make a decision. I mean, I know that we have referenced it, and I think it’s an important document. I just wasn’t sure why, you know, given that everything else in our appendix are things that are basically specifically relating to our work products, I guess I’d have to be convinced as I review the first couple of pages that there’s a need to reference that closely that it needs to be part of the same document.
JEFF BLAIR (ph): You mean the eHealth Initiative?
SIMON COHN (ph): Yes.
JEFF BLAIR (ph): Yes. I’ll go either way. If, you know, if…
SIMON COHN (ph): So let’s just keep that in mind as we look through.
JEFF BLAIR (ph): Yes.
MARIA FRIEDMAN (ph): This is Maria. If we just go ahead and decide to reference it but not include it as an appendix I would add the eHI (ph) Web site as a place for people to go to find a copy.
SIMON COHN (ph): Well, which might be the legitimate way to do this. And I just feel a little funny with — I mean, it just is sort of a funny set of — I mean, otherwise all the Appendices seem to fit together.
But I don’t feel strongly about this. I don’t know if others have opinions on this one way or another.
JEFF BLAIR (ph): Can I piggyback on Maria’s thought because if we reference the eHI (ph) initiative paper, which I think is a very good idea, that gives us the flexibility that we could reference the RAND (ph) one as well because they did testify to us without making this thing bulkier and bigger than it needs to be.
STEVE STEINDEL (ph): I was thinking the same thing, Jeff.
SIMON COHN (ph): OK. So I think we’ll go forward with that unless after we look at the first couple of pages we decide that for some reason we really do need that executive summary, actually physically part of the document. OK?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Great. OK. Other things, or shall we go back to the beginning of the recommendations?
JEFF BLAIR (ph): Did you want to slip through the Appendices, or are you satisfied with those?
SIMON COHN (ph): I’m sorry. I thought that’s what we were just talking about.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Are there other comments about the Appendices?
JEFF BLAIR (ph): No.
SIMON COHN (ph): Do others, Stan, Judy? I don’t think Harry’s on the phone right now. Other comments about the Appendices?
MARIA FRIEDMAN (ph): This is Maria. And when I do the list, obviously I’m going to include people’s name and their organization. Do you want me to include the date they testified or is that just irrelevant?
JEFF BLAIR (ph): I don’t think we need the date.
MARIA FRIEDMAN (ph): OK. Makes it easier for me.
SIMON COHN (ph): I guess I think…
STAN HUFF (ph): I’m happy with the list.
SIMON COHN (ph): OK. Sounds good. Let me just see here. So basically we have work group 10. I just should mention (ph) why — I guess this now gets sort of formatted if potentially we get rid of, we don’t do A. It’s like B, C, D, E, F, G or whatever.
So basically we have group of stakeholders to testify, criteria for selection of standards, I guess that’s all part of work plan version 10. I’m sorry. We’ve got the work plan, list of testifiers and then observations and findings from testifiers, which is the working document.
So those are the three.
MARGRET A.: Simon?
SIMON COHN (ph): Yes.
MARGRET A.: It’s Margret. I would suggest that this little list here be removed when the actual Appendices are provided.
SIMON COHN (ph): So it’s just A, B and C.
MARGRET A.: It’s just, it’s just to make sure that we keep track of what we need to append.
SIMON COHN (ph): OK. That sounds better — I got a little confused as I looked through this also. Sounds good.
JAMES BLAIR (ph): I agree.
SIMON COHN (ph): OK. Other comments on the Appendices before move back to the beginning of the recommendations? Can you all face the recommendations again?
OK, let’s go back then to the beginning of the recommendations to review these and the changes. And I guess I’m suggesting that maybe we start with the — let’s see, where should we start here. Maybe the Standards Evaluation Process? Is that a reasonable place to…
MARGRET A.: Yes. I think that’s a good idea because you’ve got that extra paragraph.
SIMON COHN (ph): Right. Exactly. We’ll make the first part a little less onerous when we get back to that again. So let me start there doing it. After we’re done with page three, back going forward, we’ll go back and look at the very first couple of pages.
JEFF BLAIR (ph): Fine.
SIMON COHN (ph): So Margret, I hope your voice is OK?
MARGRET A.: OK. Standards Evaluation Process. Do you want me to read paragraph by paragraph or section…
SIMON COHN (ph): No, read the section down to Stakeholder Testimony.
MARGRET A.: OK. Got you.
Charged with the task of recommending standards for e-prescribing to promote patient safety and quality health care, the NCVHS scheduled testimony in 2004 to learn: Which standards are needed to support e-prescribing; how MMA requirements are supported or not fully supported by current standards (i.e., standards gaps and limitations); what related issues exist that may affect the implementation or acceptance of e-prescribing.
After this information was gathered, the NCVHS then reviewed the standards gaps and limitations with the standards developers. This dialogue helped the NCVHS determine what actions are necessary to address gaps and limitations in standards for them to be available for the MMA demonstration projects beginning January 2006 near-term and what actions are needed in the longer term. See Appendix, it will be A, for NCVHS work plan.
The MMA provides that pilot testing of standards is not required where there already is adequate industry experience with the standards. At the July 21, 2004, Health Information Technology Summit, HHS announced its intent to accelerate the implementation of e-prescribing by proposing an initial set of well-established standards for implementation by January 2006, when the Medicare Part D benefit begins.
Standards appropriate for inclusion in this initial set are identified in the NCVHS recommendations below as “foundation standards.”
SIMON COHN (ph): OK, comments by everyone?
MIKE FITZMAURICE (ph): I would note that later on in the document we call these foundation standards, foundational standards, so we ought to be consistent at least. Foundation standards is fine.
MARGRET A.: Mike, I think that was a function that was Maria and Karen sent this out with this paragraph added and I didn’t get a chance to then…
MIKE FITZMAURICE (ph): OK.
MARGRET A.: …make the other changes. But I noted that also.
SIMON COHN (ph): OK. I guess I actually like this new paragraph that’s in here. Though others have ways to even further wordsmith it, I’m certainly comfortable with it.
I guess I’m wondering about the paragraph now right about it where we are referring apparently — it says, “This dialogue helped the NCVHS determine what actions are necessary to address gaps and limitations and standards for them to be available for the demonstration project and what actions are needed in the longer term.”
And I guess I’m, there’s a little bit of a disconnect because I think what the dialogue helped the NCVHS determine what actions — I mean, literally determine what standards are mature and usable immediately, what actions are necessarily to address gaps and standards. I mean, is that sort of what we’re saying?
JEFF BLAIR (ph): Well, the only thing is that — OK. Say again what you said. What actions are…
SIMON COHN (ph): No, before — I mean, the actions you already have here, but what standards are available…
JEFF BLAIR (ph): Oh, you mean to add that to it?
MIKE FITZMAURICE (ph) (?): We’re not saying that we’re determining the foundation standards. Standards that can be moved…
JEFF BLAIR (ph): So we need to add that in there.
SIMON COHN (ph): Yes. We’re sort of missing that, the stuff that would be available now for use.
MARGRET A.: Simon, could I suggest some wording?
SIMON COHN (ph): That would be great. You can tell I’m struggling.
MARGRET A.: I think also we don’t need this near-term stuff anymore. This dialogue helped the NCVHS determine what standards have adequate industry acceptance and what actions are necessary to address gaps and limitations and standards for them to be available for the MMA demonstration projects beginning January 2006.
MIKE FITZMAURICE (ph) (?): That was really good.
MARGRET A.: See Appendix A for the work plan.
STEVE STEINDEL (ph) (?): Yes.
JEFF BLAIR (ph) (?): Yes.
STAN HUFF (ph): Yes, I like that.
SIMON COHN (ph): OK. I guess I would ask, though — I mean, that sounds like it’s much improved. Now is everybody comfortable with this new paragraph, and I guess the question I would have for everybody is I read this — I mean, I guess I read it as sounding OK.
I guess the only question I would have for everybody is there are currently things that we’re saying further down that may be, you know, that we’re not saying today are foundation standards but we might say six months from now are foundation standards.
I think that this is open enough that that gives us the option of saying that. And I’m thinking, of course, of some of the things that were following along, depending on how proprietary solutions become part of the standards portfolios.
JEFF BLAIR (ph): That is a key point, Simon.
MARIA FRIEDMAN (ph): But that’s — this is Maria. That’s kind of why we worded it that way…
SIMON COHN (ph): OK.
MARIA FRIEDMAN (ph): …because we wanted to leave open that the initial set of standards, and that since we’re only talking about these foundation standards in this document, I think it leaves it open for that possibility.
SIMON COHN (ph): Yes, you know, I think it does, too. I just wanted to make sure everybody else felt that way and that there wasn’t anybody reading this differently.
JEFF BLAIR (ph): For my benefit, could you just read the last sentence? That was the one that I got hung up on before and then, you know, you and I had a conversation, Simon, and you convinced me that it’s, you know, my concern was not a problem.
Could I just listen to it once more?
MARGRET A.: Standards appropriate for inclusion in this initial set are identified in the NCVHS recommendations below as “foundation standards.”
JEFF BLAIR (ph): Well, it — the only — I’m hoping that that wording will be considered broad enough that if by March we want to identify something else as a foundation standard that it won’t be considered…
MARIA FRIEDMAN (ph): It doesn’t say that these are the only ones. It says “standards appropriate for inclusion are.”
JEFF BLAIR (ph): OK.
SIMON COHN (ph): A very good point.
JEFF BLAIR (ph): I heard that and I was looking for that and I just wanted to make sure that everybody is reacting that way. OK.
SIMON COHN (ph): Yes, I think I’m comfortable with the way it reads right now also. I mean, the secretary will take our recommendations, of course, as the secretary takes them.
JEFF BLAIR (ph) (?): Sure.
SIMON COHN (ph): But we have no control beyond recommendations in trying to be clear. Subcommittee members, are you comfortable with the wording as has been described here for these pieces so far?
JEFF BLAIR (ph): Yes.
STAN HUFF (ph): Yes.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Yes.
SIMON COHN (ph): OK. Let’s go on to Stakeholder Testimony then.
MARGRET A.: NCVHS received seven days of testimony from all stakeholder groups identified in the MMA (i.e., standards setting organizations, practicing physicians, hospitals, pharmacies, practicing pharmacists, pharmacy benefit managers, state boards of pharmacy, state boards of medicine, experts on E-prescribing, other appropriate Federal agencies).
In addition, testimony was heard from e-prescribing networks, demonstration projects, software developers, and consumer advocacy organizations. See Appendix C for list of testifiers.
SIMON COHN (ph): OK. The only thing I might like to see is maybe a final sentence here which says, “In total, the committee held X number of days of hearings related to e-prescribing.” I think that comes out to be about 11 or 12, doesn’t it?
I don’t feel strongly about that but I feel that we did a lot more work than seven days of hearings. Jeff, do you think that’s necessary?
JEFF BLAIR (ph): I think we had, of hearings, one, two, three, four, five, six. And then the other days we have an additional two or three beyond those six where we were working on the document.
So I don’t care whether we put the numbers in there or not. You know, that’s up to you.
JUDY WARREN (ph) (?): Simon, I’d like for us to put the extra days in there because even though we were working on the document, we were still having dialogue with people who had testified to get clarity on what their testimony meant.
And it was the same level of clarity that we were trying to get, you know, when we asked them questions after their testimony.
JEFF BLAIR (ph): Well, what about this, Simon? We could put in the total number of days we dedicated to e-prescribing and indicate that it was, you know, both testimony and deliberations. But the other thing maybe that you’re trying to get at here is to point out the magnitude of the number of folks we heard from.
So maybe after Maria compiles the list of all the folks that testified to us, we could put that number in there as well. Is that what you’re looking for?
SIMON COHN (ph): Oh, that would be nice also. Yes.
JUDY WARREN (ph) (?): I like the notion of doing both of those things, Jeff, both the amount of time that we dedicated to this as well as the magnitude of the number of people we talked with.
SIMON COHN (ph): Yes.
JUDY WARREN (ph) (?): Both of those numbers are important.
SIMON COHN (ph): Yes. You know, I guess I’d like — and once again, this is wordsmithing but maybe rather than us calling out the number of days of testimony but it’s the number of days of hearings that we had on this. And that’s really the pertinent number.
JEFF BLAIR (ph): So hearings can include days when we didn’t have testimony.
SIMON COHN (ph): Well, I would think so. I mean, basically you know, hearings spanning X number of days and heard testimony from. I mean, that’s sort of a distinction there. And then a statement as you described it, “In all we heard from X number of testifiers.”
JEFF BLAIR (ph): Let me just ask for clarification on this, and I’m happy to go with what the subcommittee feels. I always thought that having a hearing was essentially synonymous with conducting testimony, and I didn’t — I was afraid that we’d be misleading if we included the times when we weren’t having testimony.
If the rest of the subcommittee feels like hearings includes both, I’m willing to accept that.
SIMON COHN (ph): You have to defer to our staff about the appropriate use of these terminologies.
STEVE STEINDEL (ph): Simon, I would say something like, “Over N days of deliberation, the NCVHS heard testimony from Y people.”
JEFF BLAIR (ph): Great.
SIMON COHN (ph) (?): Yes. That’s good.
MARIA FRIEDMAN (ph) (?): Did you say Y or was?
STEVE STEINDEL (ph): I was using the letter Y. So I didn’t use X, Y.
SIMON COHN (ph): But we do agree with both.
STEVE STEINDEL (ph): And I would like to put in there, “During the period of time from March to September.”
MARIA FRIEDMAN (ph) (?): Do we count these two rounds of phone calls as an extra day?
STEVE STEINDEL (ph): A week.
MARIA FRIEDMAN (ph) (?): Yes.
STEVE STEINDEL (ph): Jeff’s email to me indicated that he’s happier having a root canal Monday than…
UNKNOWN MALE #38: Jeff, I assume the root canal’s without anesthesia?
JEFF BLAIR (ph): Well, I figured I didn’t need it anymore. I’ve gotten plenty of practice.
SIMON COHN (ph): OK.
MARIA FRIEDMAN (ph) (?): Yes, we consider these calls in lieu of meetings, and I do think a hearing, the term hearing generally you’d be hearing from somebody other than discussing as a committee but…
SIMON COHN (ph): OK.
MARIA FRIEDMAN (ph) (?): …it sounds like it we’ll be just dealing with this.
SIMON COHN (ph): Yes. So, Margret, we’d look for your help but I think deliberations may be the better term.
MARGRET A.: Over X days of deliberations from March to September 2004, the NCVHS heard testimony from X people, Y people.
STAN HUFF (ph) (?): Thousands and thousands.
SIMON COHN (ph): Well, I think basically we’d say basically heard — yes, that sounds fine. This included all stakeholders, groups…
MARIA FRIEDMAN (ph): I think we might want to add — and my list will provide the exact number of people who formally testified, but we had a lot of very valuable input from the industry as it — well, at open microphone sessions. We might want to add that, too.
JUDY WARREN (ph) (?): Right.
SIMON COHN (ph): OK. Sounds good. OK. So this will look a little more impressive by the time we’re done. Now, Margret, you understand what we’re talking about here?
MARGRET A.: Yes. Yes.
SIMON COHN (ph): OK. Good. And Maria, we need your help, and obviously this will be something that will be wordsmithed a little bit when we go forward. OK.
Are we OK with this at this point?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): OK. Let’s continue on.
MARGRET A.: Guiding Principles for Selecting Standards. In making its recommendations, NCVHS utilized the guiding principles and requirements identified in the MMA for selecting e-prescribing standards: Improve patient safety; improve quality of care; improve efficiency, including cost savings; not present an undue administrative burden on prescribers and pharmacists; be compatible with other standards; permit electronic exchange of drug labeling and drug listing information maintained by Food and Drug Administration and National Library of Medicine; include quality assurance measures and systems; permit patient designation of dispensing pharmacy; comply with HIPAA Privacy regulations; support interactive and real-time transactions.
In addition, the NCVHS believes the standards should be vendor neutral and technology independent, preferably developed by ANSI-accredited standards development organizations, and have suitable indications of market acceptance.
STAN HUFF (ph): That sounds good.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Yes, I think it sounds good. Other comments?
JEFF BLAIR (ph): Satisfied.
SIMON COHN (ph): Good to go?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): OK. Judy and Stan OK?
STAN HUFF (ph): Yes.
SIMON COHN (ph): OK. Let’s keep going.
MARGRET A.: Types of Standards and Important Related Issues. There are three types of e-prescribing standards that NCVHS identified and evaluated as being necessary to support e-prescribing. They are: message format standards that provide communication protocols and data content requirements including those to support medication decision making; terminologies to ensure message accuracy; and identifiers for all points within the e-prescribing process.
The NCVHS further observed that deployment of e-prescribing may involve policy or workflow issues that are outside the scope of standards but are important related issues.
SIMON COHN (ph): Looks good. Other comments?
STAN HUFF (ph): For identifiers, I would suggest alternative wording and say, “Identifiers for all relevant entities within the prescribing process.” Points somehow, in my mind, evokes like locations or something only.
SIMON COHN (ph): OK. So relevant entities. Are we OK?
STAN HUFF (ph): Yes. Identifiers for all relevant entities.
SIMON COHN (ph): I think that’s a friendly amendment. Jeff?
JEFF BLAIR (ph): That’s fine.
SIMON COHN (ph): OK. Judy?
JUDY WARREN (ph): Fine.
SIMON COHN (ph): Fine. OK. Otherwise good to go?
STAN HUFF (ph): One other…
SIMON COHN (ph): OK. Please.
STAN HUFF (ph): Wordsmithing a little bit. Terminology to ensure accuracy. I’m thinking, I would have said — and maybe it’s too esoteric, but to say something like to ensure consistent semantics or something like that.
SIMON COHN (ph): Well, I sure don’t want to say that but…
STAN HUFF (ph): OK.
SIMON COHN (ph): But can you come with a new idea (ph)? I want you to explain that in one word.
STAN HUFF (ph): Well, actually — OK, if we want to — accuracy is fine then.
SIMON COHN (ph): I mean, you can go with other words, but semantics is not exactly going to play.
STAN HUFF (ph): OK. To ensure, how about…
STEVE STEINDEL (ph): Stan, what about just consistency?
STAN HUFF (ph): It’s — well, I mean what they really provide is shared meaning.
STEVE STEINDEL (ph): Yes.
STAN HUFF (ph): Interoperable meaning.
JEFF BLAIR (ph): I suggest — we need to use that phrase data comparability.
STAN HUFF (ph): That’s a good word, too.
JUDY WARREN (ph): Yes. I like that one.
SIMON COHN (ph): So to ensure — so basically terminology to ensure data comparability?
STAN HUFF (ph): Yes. That’s very good.
MARIA FRIEDMAN (ph): Do you want to add on to that, and interoperability?
STAN HUFF (ph): Well, that’s even better.
SIMON COHN (ph): Well, that sounds good. Base (ph) terminology to ensure data comparability and interoperability.
STAN HUFF (ph): Yes. That’s what they’re doing.
SIMON COHN (ph): Yes. That sounds better than semantics. Good. OK. Are we — Judy, are you OK with that?
JUDY WARREN (ph): Oh, yes.
SIMON COHN (ph): So we keep everybody on the line here by calling you out by name. Jeff, are you closer to the phone now?
JEFF BLAIR (ph): Yes, I am.
SIMON COHN (ph): OK.
JEFF BLAIR (ph): My goodness, you — I think you wait until special moments, Simon, to ask me if I agree.
SIMON COHN (ph): Well, now that I know what you have in your office, I’m always curious. Stan, are you OK with that now?
STAN HUFF (ph): Yes. I’m good. Thanks.
SIMON COHN (ph): OK. So are OK to go to the next section?
JUDY WARREN (ph): Yes.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): OK. Observations and Recommended Actions.
MARGRET A.: OK. And here I did try to fix the disconnect between foundation and foundational a little bit.
The NCVHS observes that the healthcare delivery system has made considerable progress in developing pragmatic solutions for e-prescribing. These solutions provide an excellent foundation to build upon. The status of each e-prescribing standard evaluated is described in detail in the working document in Appendix C.
Following is a list of observations and associated recommended actions. The observations describe the purpose and extent of industry experience regarding a standard or issue. The recommended actions under each observation first recognize any foundation standards, then the actions to address enhancements, development, and pilot testing necessary to meet the MMA requirements.
While foundation standards do not in themselves need to be pilot tested, enhancements will need testing. The observations and recommended actions are grouped as follows: general overarching items, message format standards, terminologies, identifiers, and important related issues.
SIMON COHN (ph): And Margret, thank you for including one of my comments.
MARGRET A.: Yes.
SIMON COHN (ph): How do people think about that so far?
JEFF BLAIR (ph): I feel since we’ve gone through probably many iterations of that, I feel like that sets up the observations and recommendations in as concise a matter as we can get it.
SIMON COHN (ph): I think it sounds actually very good at this point, and I think…
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): …it’s an orderly statement that, you know, if we’re piloting, obviously these foundation standards or foundational standards are obviously implicitly part of the pilot, but it’s really we’re looking at the enhancements to be the part that’s really going to be assessed…
JEFF BLAIR (ph): Exactly.
SIMON COHN (ph): …and all of that. So I think it says this very well in terms of setting things up. Stan, comments?
STAN HUFF (ph): I like it as amended.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Sure.
SIMON COHN (ph): OK.
HARRY: Simon, it’s Harry. I agree also.
SIMON COHN (ph): Oh, good. You’re back.
HARRY: Yes, sir.
SIMON COHN (ph): OK. So Observation 1.
JEFF BROWN: Excuse me, this is Jeff Brown…
SIMON COHN (ph): Oh, I’m sorry.
JEFF BROWN: …of RxHub. And I was just — when we say, and I’m reading, it says, “to assess new functionality and other standards,” that was, this is interoperability issues and things of that nature so that even if a standard doesn’t get changed, it would still, in it’s foundation, it would still be part of pilots so that they can evaluate how it works in the whole system?
SIMON COHN (ph): Margret, I think you changed that area a little bit, didn’t you?
MARGRET A.: Yes. While foundation standards do not in themselves need to be pilot, need to be pilot-tested, enhancements will need testing.
MARIA FRIEDMAN (ph) (?): I think this is the issue about we’re going to — we’re recommending NCPDP SCRIPT for certain applications, and that’s a foundation standard. And obviously that’s got to be in the pilots for everything to work because that’s the way the world works now.
And as somebody said, we’re looking at the enhancements.
JEFF BROWN: But as I hear the change — this is Jeff again, we’re looking — I would think we would not only look at the enhancement but also the way that the original standard works in conjunction with other new standards that have been included in the pilot for…
JEFF BLAIR (ph): I thought that was implicit in what we said, not — in other words, you feel like what we said fails to include?
JEFF BROWN: Well, what I would be worried about, what I’ve heard — and this is actually when I say this I’m not speaking just RxHub but really all of RxHub but what I’ve heard from other folks is that there’s a concern that HHS might say, “Well, you can use these foundational standards as they are current in the industry without modifications, and that doesn’t need to be pilot tested. And that’s going to be a requirement under Medicare.”
When you put all the standards together with the new additions, it might not work as a group, as a whole, and that’s the concern I would have at (ph) the public (ph) standards address.
SIMON COHN (ph): I’m sorry, and the new standards, you’re talking about the ones that are being piloted?
JEFF BROWN: The ones that are being piloted so that we have NCPDP SCRIPT and that’s taking the SCRIPT from the physician prescriber to the dispenser, but how you use that in conjunction with the new standards for medication history and the other kinds of information that are going to come at the front end, et cetera, that those inter-relationships and the usability of the whole system would be something that would be piloted as well.
MARGRET A.: I have a suggestion, Simon.
SIMON COHN (ph): Please, Margret.
MARGRET A.: While foundation standards do not in themselves need to be pilot tested, they do need to be tested with their enhancements.
JEFF BLAIR (ph) (?): Very good.
SIMON COHN (ph): OK. I think that might address, I think, the concerns we’re hearing.
HARRY: Simon, this is Harry. One question on the word enhancements. Enhancements seems to say that if it gets done, it’s OK, if it doesn’t get done it’s OK, rather than base functionality — there were some things discussed earlier that are part of the MMA law that need to be done in these base standards.
And I don’t know if those are called enhancements or those are basic functionality that needs to be added because enhancements to most people says, “I can go ahead and do it and I can go ahead and make it happen.”
STEVE STEINDEL (ph): Yes, Harry. I had the same problem with the word enhancement and I might…
HARRY: So I worry about that word. Back to the earlier statement — if you said to me, “I’m going to do a project and then I’ll do some enhancements,” I would implement the project. I would be able to go on full speed.
MARGRET A.: Simon?
SIMON COHN (ph): Yes?
MARGRET A.: Would it help to say, “While foundation standards do not in themselves need to be pilot tested, they do need to be tested with the enhancements required by MMA.”
JEFF BLAIR (ph): Oh, that’s good.
HARRY: How about the necessary functionality of MMA.
STEVE STEINDEL (ph): That’s what I was going to import too, Harry. Thank you.
MARIA FRIEDMAN (ph) (?): That’s better because some of this stuff isn’t still going to be ready.
UNKNOWN MALE #39: Core requirements.
SIMON COHN (ph): Did somebody say something?
MARGRET A.: Core requirements?
JEFF BLAIR (ph): Then you get into defining what core is. I think the last suggestion, maybe it was Steve who offered it, I thought it was pretty good.
MARGRET A.: While foundation standards do not in themselves need to be pilot tested, they do need to be tested with the necessary functionality required by MMA.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): With the necessary functionality. With the additional necessary functionality or something?
MARGRET A.: With the…
HARRY: Yes, additional would add to it. Yes, Simon.
UNKNOWN MALE #40: Or maybe additional, additional required.
SIMON COHN (ph): With the expanded functionality. Is that…
STEVE STEINDEL (ph): Required — that’s good. The expanded functionality required by MMA.
HARRY (?): That’s great.
UNKNOWN MALE #40 (?): Yes, I like that.
STAN HUFF (ph) (?): I like it.
SIMON COHN (ph): OK. It sounds like we’ve come up with at least one wordsmithing solution. At least until the next time we review this. OK.
Otherwise everybody OK?
STEVE STEINDEL (ph): Yes. Simon, I have to drop off now. Sorry.
SIMON COHN (ph): OK.
STEVE STEINDEL (ph): OK. Have fun.
SIMON COHN (ph): I’m not sure that’s the right word but we will continue anyway. OK. Everybody’s good at this point? Any other comments?
HARRY (?): Good to go.
SIMON COHN (ph): OK. Let’s go to Observation 1 then.
MARGRET A.: General Standards Compatibility: Many testifiers emphasized to the NCVHS how important it was for e-prescribing standards to be compatible with all HIPAA standards, CHI standards, and the clinical data terminologies recommended by NCVHS in November 2003.
This is to avoid dual standards for Medicare Part D and all others. The testifiers’ observations are consistent with the MMA requirements that e-prescribing standards should be compatible with HIPAA standards and “general health information technology standards.”
Recommended Action 1.1: HHS should ensure that e-prescribing standards are not only appropriate for Medicare Part D, but are also appropriate for all types of prescribers, dispensers, and public and private sector payers.
Recommended Action 1.2: HHS should ensure that e-prescribing standards are compatible with those adopted as HIPAA and CHI standards, and those recommended in November 2003 by NCVHS for clinical data terminologies.
SIMON COHN (ph): Comments?
JEFF BLAIR (ph) (?): Feel comfortable with it.
SIMON COHN (ph): Yes. Sounds good. Harry?
HARRY: Yes, sir. Fine. Stan?
STAN HUFF (ph): Yes. I like it.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Me too.
SIMON COHN (ph): OK. Any other comments about this one? OK. I think we’re good to go. Observation 2.
MARGRET A.: Prescription Messages: The NCPDP SCRIPT Standard provides for the exchange of new prescriptions, changes, renewals, cancellations, and fill status notifications. Each function has varying degrees of industry experience.
The NCPDP SCRIPT Standard allows for both free text in certain fields and choices of codes. It is critical to standardize on a single code set to providing automated decision support for many of the elements required by the patient safety portions of MMA.
The NCPDP SCRIPT new prescription function is most widely used. The renewal function has good industry acceptance, and I don’t know why and was removed but and represents an easy transition and provides the most immediately apparent return on investment.
The NCPDP SCRIPT Standard cancellation and change functions are rarely implemented, although I think we had said before currently under-utilized.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Then it should be gone back to that one.
MARIA FRIEDMAN (ph) (?): OK.
MARGRET A.: OK. The business case for fill status notification from the dispenser to the provider has not yet been made.
Recommended Action 2.1: HHS should recognize as a foundational standard the most current version of NCPDP SCRIPT for new prescriptions, prescription renewals, cancellations, and changes between all prescribers and dispensers. The NCPDP SCRIPT Standard recognized would include its present code sets and various mailbox and acknowledgement functions, as applicable.
Recommended Action 2.2: HHS should assess the value of the NCPDP SCRIPT Standard for the
fill status notification function in the 2006 pilot tests.
SIMON COHN (ph): Well, I think it’s actually getting very good. We’re OK with currently under-utilized in that …
JEFF BLAIR (ph) (?): Yes.
SIMON COHN (ph): …observation. OK. Comments, questions?
MARIA FRIEDMAN (ph): This is Maria. A comment and a clarification. We took out that and because we thought it was a list, so the renewal function has good industry acceptance, represents an easy transition and provides.
MARGRET A.: Oh.
MARIA FRIEDMAN (ph): There were two ands. You didn’t need the first and because of it being a clause and all. The other suggestion I would have is in the middle of that paragraph, the sentence that begins, “It is critical,” I would change providing to provide. So it would read, “It is critical to standardize on a single code set to provide automated decision support.”
MARGRET A.: Yes.
JEFF BLAIR (ph): Good.
JUDY WARREN (ph): Maria, I was having trouble with that one too.
SIMON COHN (ph): OK. Other comments? Any objections to the fundamental recommendations?
STAN HUFF (ph): Well, if you’ve got the one word change there in recommendation 2.1 to just say foundation standard instead of foundational.
MARGRET A.: Oh, yes. Thanks.
SIMON COHN (ph): Yes. That’s a good point. We ought to stay with the same terminology here.
MARGRET A.: I’ll do a word search for that.
SIMON COHN (ph): OK. Other comments?
LYNN GILBERTSON (ph): This is Lynn (ph). In Recommended Action 2.2…
SIMON COHN (ph): Yes?
LYNN GILBERTSON (ph): …I’m struggling with what we’re doing there. Is it assess the industry usage, the value of…
SIMON COHN (ph): Is the word value that you’re having trouble with?
LYNN GILBERTSON (ph): Assess the value of the SCRIPT Standard. I’m not — I understand what we’re trying to get to. I just — let’s see…
SIMON COHN (ph): Shall we say HHS should include…
LYNN GILBERTSON (ph): Its value to the industry?
SIMON COHN (ph): Should we say HHS should include the fill notification function of the NCPDP SCRIPT Standard in the 2006 pilot test?
STAN HUFF (ph): I think there’s a — part of the problem is that we shouldn’t — it’s not we’re evaluating a single transaction and this sounds like we’re evaluating a standard. So another way to — so that’s maybe an independent problem from the other one.
But I mean it should say something like, “should assess the value of the NCPDP SCRIPT notification standard transaction in the 2006 pilot.”
LYNN GILBERTSON (ph): Because it’s really the value to the industry or what the — does it do, you know…
SIMON COHN (ph): What do we want — I think value’s the wrong term.
STAN HUFF (ph): Yes.
SIMON COHN (ph): I mean, if you’re piloting something, you’re not assessing the value.
MARIA FRIEDMAN (ph): We haven’t used that. This is Maria. We haven’t used that, if you’ll pardon the expression, value-laden word in the other recommendations. We’ve simply said that we include, that these things should be included in the pilot.
SIMON COHN (ph): Yes. I’m thinking it just should say, “HHS should include the fill status notification function in 2006 pilot tests.”
MARGRET A.: Simon?
STAN HUFF (ph): Should include — yes, should evaluate or assess.
SIMON COHN (ph): Well, whatever. So Margret, it sounds like you have some thoughts?
MARGRET A.: Oh, I was just going to say the reason we added value was that there was some concern that it wasn’t just a matter of testing this function for transactions. It was understanding whether this transaction was going to be used by the industry, whether we thought there was value to requiring it as a standard, that type — that was the issue when we added value.
MARIA FRIEDMAN (ph) (?): So it’s really two-parter then. It’s one, does it work, and two, how is an implementation or adoption issue?
MARGRET A.: Yes.
LYNN GILBERTSON (ph): Well, and it’s trying to satisfy — and I don’t think we have it in here, the requirements of the MMA for this type of compliance. We don’t have any kind of transaction yet that addresses that level of compliance, but did the patient actually get the prescription, things like that.
UNKNOWN MALE #41: The medication history gets at it but after the fact.
LYNN GILBERTSON (ph): Right.
UNKNOWN MALE #41: Because when you pull down somebody’s medication history, if I’m a doctor and I’ve prescribed something and I pull down their history and they didn’t fill it, it’s going to be apparent.
SIMON COHN (ph): So what do we want to do with this one?
LYNN GILBERTSON (ph): I mean, should we — something about that it, evaluate it meeting the needs of the compliance environment or MMA for — whatever the MMA statement is.
SIMON COHN (ph): I don’t know — I’m not sure what the compliance environment is here. I don’t like (ph) compliance environment.
LYNN GILBERTSON (ph): I don’t care (ph).
SIMON COHN (ph): I hear issues related to both number one is it’s used so little that no one knows whether it, I mean — I mean there is not general industry sense of how well this works, and the other piece being even if it does work, is there a reason to use it?
JEFF BLAIR (ph): Question.
SIMON COHN (ph): And that’s really the piece.
LYNN GILBERTSON (ph): Right. Right.
JEFF BLAIR (ph): Question, and if I could glance through, you know, maybe I’d be able to answer my question, but if we simply wind up indicating that it needs to be included in the pilot test here, the other question is whether or not the standard is appropriate or will be accepted, and that assessment piece, I think we’ve covered in other recommendations for pilot tests in general.
So we may not have to call out the assessment here separately.
SIMON COHN (ph): OK.
JEFF BLAIR (ph): Just indicate that it should be included in the pilot test.
SIMON COHN (ph): Well, I think I’m fine with that. Others?
TERRI (ph) BURNS: Simon?
SIMON COHN (ph): Yes?
TERRI (ph) BURNS: This is Terri (ph) (ph) Burns.
SIMON COHN (ph): Hi.
TERRI (ph) BURNS: I almost hate to bring this up but…
SIMON COHN (ph): Oh, please.
TERRI (ph) BURNS: Something dawned on me when Lynn (ph) described this transaction the way she did. I wonder if — and maybe we should defer this recommendation to March when we look at presenting drug history from the dispensers back to the physicians because I would think that that type of transaction would have fulfilled the same need as a fill status.
SIMON COHN (ph): Actually, we said it — I mean, it’s not quite. It’s different stuff. I mean, one is this issue of bringing down the medication history. The other is 17 (ph) back to physicians saying, “this was prescription was filled today.”
TERRI (ph) BURNS: OK.
SIMON COHN (ph): So I mean, it’s — I mean, the question is whether it’s necessary, which I think you are bringing up, but it’s, but they’re obviously not quite the same thing.
TERRI (ph) BURNS: Well, I’m more concerned about the work flow and how it fits into the work flow. And since neither of those transactions is in today’s work flow — and I’m not sure that prescribers are going to want to hear, “Yes, they picked it up today,” and you know, get it back in a requested medication history. I just don’t know.
SIMON COHN (ph): Well, that’s why we want to put it in a pilot.
JEFF BLAIR (ph): Yes.
MARIA FRIEDMAN (ph) (?): That’s what the pilot will tell you in the end is…
JEFF BLAIR (ph): Right.
MARIA FRIEDMAN (ph) (?): …if it works and under what circumstances.
SIMON COHN (ph): And whether it has any value.
STAN HUFF (ph) (?): And the other thing is, I mean you are right about the work flow, but the other point is that the work flow might not be that the physician looks at that. I mean, I can imagine, for instance, this information comes back, it becomes part of the electronic medical record and there’s a, you know, a program that daily looks at this and then people follow up, not necessarily the prescriber.
HARRY (?): Right.
STAN HUFF (ph) (?): It could be, it could be a case manager who is looking at this information.
SIMON COHN (ph): Yes.
HARRY (?): Right.
JEFF BLAIR (ph): And it then winds up supporting the improvement of patient safety, which is the MMA.
SIMON COHN (ph): OK. So I think what we’re — let me just help with this. I think what we’re doing is just coming up with a cleaner version here where we’re sort of saying HHS should include the fill status notification function of NCPDP SCRIPT in 2006 pilot tests?
STEVE STEINDEL (ph) (?): Yes.
SIMON COHN (ph): Is that what we’re saying?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Harry, agreed?
HARRY: Yes. I couldn’t get my phone unmuted fast enough.
SIMON COHN (ph): That’s OK. Judy?
JUDY WARREN (ph): I agree.
SIMON COHN (ph): OK. So it sounds like we’re good to go then. Other comments before we move on to three? OK. Let’s do three.
MARGRET A.: Coordination of Prescription Message Standards: Health Level Seven is commonly used to communicate medication orders within a hospital and with clinical pharmacies within an enterprise.
Coordination of HL7 with NCPDP SCRIPT would result in functions appearing more seamless across healthcare environments. This should remove a barrier to adoption of electronic medication ordering and prescribing. HL7 and NCPDP have already begun to map their standards that support common functions.
Recommended Action 3.1: HHS should accelerate the coordination activities between HL7 and NCPDP for electronic medication ordering and prescribing. HHS should also support ongoing maintenance of the HL7 and NCPDP SCRIPT coordination.
Recommended Action 3.2: HHS should recognize as outside the scope of MMA standard specifications for exchange of new prescriptions, renewals, cancellations, changes, and fill status notification within the same enterprise.
Recommended Action 3.3: HHS should require that any prescriber that uses an HL7 message within an enterprise convert it to NCPDP SCRIPT if the message is being transmitted to a dispenser outside of the enterprise. HHS also should require any retail pharmacy within an enterprise be able to receive prescription transmittals via NCPDP SCRIPT from outside the enterprise.
SIMON COHN (ph): OK. I have one wordsmithing on Recommended Action 3.2. You have the word for. I think that the word’s really the. It might be for but it feels like, it doesn’t sound like for is the right word there.
MARGRET A.: I think for the exchange is better.
JUDY WARREN (ph): And this is Judy. I had a question. When I relooked at 3.1, what do we mean when we say “accelerate the coordination activities?” I mean, how would HHS accelerate?
JEFF BLAIR (ph): They could do a number of different things, and we’re sort of leaving it up to them. One of the things — the examples, the types of things that they might do were the things they did to try to accelerate the HL7, EHR system functionality model.
In some cases they paid for experts to attend the meeting. In other cases they, I believe — Horjay (ph) is actually on the phone. Maybe he could, you know, indicate this…
SIMON COHN (ph): Well, I guess the question is it accelerate or is it fund and promote?
JUDY WARREN (ph): Right. That was my…
JEFF BLAIR (ph): Well, I think — yes, but I think the thing is — if it’s just fund and promote, then there’s no sense of the urgency. We want to make sure that this moves forward quickly in order to be, you know — so the…
SIMON COHN (ph): We determined (ph)…
JEFF BLAIR (ph): …as a box (ph) for the pilot test.
SIMON COHN (ph): Yes, I think we were just talking about the verb here and I’m not sure what the right verb is either. So I guess if we can get more specific. Because accelerate — I mean, we’re not (ph) all of a sudden sure that coordination activities are successful. That’s almost what we’re talking about here.
But what do other people think? I mean, I don’t know that I have the right word here either.
JEFF BLAIR (ph): Well, if HHS doesn’t intervene then these folks have to go forward on their own resources and time. But if HHS does intervene with support in different ways, they might move it faster.
JUDY WARREN (ph): My concern, Jeff, is that HHS can not make these organizations do anything faster, even if they get the money. And what we really want to do is for HHS to support this, and certainly with money and support they can accelerate it.
But it’s not HHS that’s doing the acceleration. It’s the SDOs that are accelerating their process.
JEFF BLAIR (ph): Is the word that HHS accelerate or HHS help to accelerate or facilitate the acceleration?
JUDY WARREN (ph): The wording right now says, “HHS should accelerate the coordination activities.”
JEFF BLAIR (ph): Oh, OK. Then I see what you mean. Would you feel comfortable if we said, “HHS should facilitate the acceleration?”
JUDY WARREN (ph): That would be better, yes.
VIVIAN AULD (ph): This is Vivian. Or should it say “encourage acceleration?”
SIMON COHN (ph): I hate to use encourage.
JUDY WARREN (ph): I don’t like encourage.
VIVIAN AULD (ph): I should finish my thought. I was also thinking you might want to further in the sentence put in examples, such as funding or whatever, that Jeff was talking about.
JEFF BLAIR (ph): What about if we said, “HHS should support the acceleration?”
JUDY WARREN (ph): There we go. I think I like that one better because I wanted an active, strong word, and encourage to me is kind of a weasel.
SIMON COHN (ph): Yes. OK. So support the acceleration. That sounds good.
JORJE FERRER (ph): Jeff, this is Horjay (ph), I mean, that’s dead on the money. If there isn’t a time line and a certain subtle pressure, the only reason we did anything with HL7 was because there was that subtle pressure and money to do it.
JEFF BLAIR (ph): Yes.
JORJE FERRER (ph): And incentive amortizations (ph) because in HL gave it (ph) to us and that sort of leads to (ph), very bright but, you know, they can ponder things until the cows come home.
SIMON COHN (ph): OK. So we’ve got support the acceleration. Do others have other changes? Did everybody agree with that change, first of all? Stan?
UNKNOWN MALE #42: Yes.
STAN HUFF (ph) (?): Yes.
SIMON COHN (ph): Harry?
HARRY: Harry. I’m fine.
SIMON COHN (ph): OK. Judy?
JUDY WARREN (ph): Yes.
SIMON COHN (ph): You were the one who suggested it so you’re fine. Jeff, OK. Are there any other changes we need to make to these? OK. I’m sure there’ll be some minor wordsmithing as the editor gets it and tries to figure out some of the various terms and all of that.
OK. So we’re moving to Observation 4.
MARGRET A.: Formulary Messages: Formulary and benefit coverage information, including information on the availability of lower cost, therapeutically appropriate alternative drugs, if any, from payers/PBMs to prescribers currently is communicated with proprietary messages.
RxHub, a formulary and pharmacy benefits information exchange network, has communicated its intent to submit its proprietary Formulary and Benefit Information File Transfer protocol to NCPDP to establish industry consensus and ensure the protections for the industry afforded by becoming an ANSI-accredited standard.
Development of an ANSI-accredited standard appears to be possible in an accelerated timeframe. This process will enable convergence to any specific requirements affecting the implementation of Medicare’s new Part D prescription drug program.
Recommended Action 4.1: The Centers for Medicare and Medicaid Services should actively participate in and support the rapid development of an NCPDP standard for formulary and benefit information file transfer using the RxHub protocol as a basis.
4.2: NCVHS will closely monitor the progress of NCPDP standardizing a formulary and benefit information file transfer protocol and provide advice to the secretary in time for adoption and/or readiness for the 2006 pilot tests.
SIMON COHN (ph): Comments from the subcommittee.
JUDY WARREN (ph): I just had one. It’s probably in the category of picky wordsmithing but it would help me to really work this better. When we said that RxHub, the formulary and benefit files transfer protocol, there’s a comma after protocol. That needs to be taken out.
That’s not a clause.
MARGRET A.: This sentence is also extremely long. Would it be OK if we put the definition of RxHub in a footnote?
JEFF BLAIR (ph) (?): Yes.
JUDY WARREN (ph): It would be better, yes.
TERRI (ph) BURNS: And to that, I don’t believe that still is the correct definition of RxHub. This is Terri (ph) (ph) Burns.
MARGRET A.: Could you either — could you please send me something because I didn’t get anything and I took this off the Web, off your Web site.
SHELLEY WOOLEY (ph): Margret, I sent you, I sent an email directly to you so you should have that now. This is Shelley Wooley (ph).
MARGRET A.: OK. I see it here. Thanks.
SIMON COHN (ph): OK. So we can wordsmith that one and we’ll defer to you whether it’s a footnote or just different wording there. I guess the only — is someone taking a shower? Are people there?
UNKNOWN FEMALE #24: You just finished then (ph)?
SIMON COHN (ph): The final sentence in this first paragraph under observations, I guess I just wonder about convergence to. And I’m just, and once again, it’s just noted, there’s probably some better wording than that.
JEFF BROWN: This is Jeff Brown from RxHub. I was looking at that wording, too, and in Recommended Action 4.2 there’s the concept of standardizing a ANSI-accredited formulary benefit information file transfer protocol, which seemed like the concept that we were looking at.
MARGRET A.: I think the intent here is that the Medicare Part D may have some new requirements that…
SIMON COHN (ph): So this, so this…
MARGRET A.: …we’re unaware of.
SIMON COHN (ph): …so this is included, inclusion of…
MARGRET A.: Right.
SIMON COHN (ph): …any specific requirements. OK. That sounds fine.
MARGRET A.: That’s good.
JEFF BROWN (?): Or you could — another way you could say it would be to say, “This process will accommodate any specific requirements affecting”…
SIMON COHN (ph): That sounds good, too. All right. I’m easy as long as it’s…
UNKNOWN FEMALE #25: Provided that CMS is engaged because if they don’t bring anything forward or whoever…
SIMON COHN (ph): Is that what Recommendation 4.1 is?
UNKNOWN FEMALE #25: Right. I’m hoping that’s what they’re playing off of.
SIMON COHN (ph): Yes.
UNKNOWN FEMALE #25: Because the process is not going to do any convergence. It’s people getting involved.
SIMON COHN (ph): Yes.
JEFF BROWN (?): That’s understood. Yes.
SIMON COHN (ph): OK. Now, 4.2 I think is going to need a little bit of — just still doesn’t sound right. I’m not going to try to wordsmith it here but I think it was brought up — I don’t think NCPDP is standard — the wording is somehow wrong. It isn’t NCPDP standardizing a protocol but it’s sort of developing a standard for, which is I think what we’re talking about here.
UNKNOWN FEMALE #25: And maybe that could be two sentences, too.
STAN HUFF (ph) (?): I liked the proposed change that you said.
SIMON COHN (ph): Developing the standard for …
STAN HUFF (ph) (?): Yes. Monitor…
SIMON COHN (ph): OK.
STAN HUFF (ph) (?): …yes, the progress of NCPDP creating a standard for formulary and benefit information file transfer.
SIMON COHN (ph): OK. So are we OK on that, roughly, knowing there is some wordsmithing?
UNKNOWN MALE #42: Yes.
STAN HUFF (ph) (?): Yes. I’m good with it as amended.
SIMON COHN (ph): OK.
TERRI (ph) BURNS: Simon, this is Terri (ph) Burn. Can I just ask one question?
SIMON COHN (ph): Sure.
TERRI (ph) (ph) BURNS: And this might be picky but I’m not sure why we have the, in the observation in the first sentence, after appropriate alternate drugs, why do we have “if any?”
MARGRET A.: That was the language from MMA.
TERRI (ph) BURNS: Oh, OK. OK.
SIMON COHN (ph): Yes. You know how that is sometimes. It’s the legislative language. OK. Other comments on this one? I think it feels like we’re pretty much good to go on this one with some picky wordsmithing.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Yes? Judy? Judy?
JUDY WARREN (ph): Here.
SIMON COHN (ph): Yes?
JUDY WARREN (ph): Working.
SIMON COHN (ph): Are you in agreement?
JUDY WARREN (ph): Does that work better?
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Well, I can hear you.
SIMON COHN (ph): Well, I’m just asking whether you agree with Observation and Recommendations 4. Did you say yes or no? Have we lost Judy now?
MARIA FRIEDMAN (ph): Judy, we’re losing you. You might want to try to redial back in.
JUDY WARREN (ph): OK.
HARRY: Simon, this is Harry. I concur and I have to go in for my appointment that I mentioned to you. Sorry.
SIMON COHN (ph): OK. Sounds good. Anybody have any objections to this before we move on to Observation 5?
STAN HUFF (ph) (?): No, I’m good.
SIMON COHN (ph): OK. Well, we have a quorum and I think a majority voting for it then. OK. Observation 5?
MARGRET A.: Eligibility and Benefits Messages: The eligibility and response are HIPAA transactions, and standards have been adopted for their use in retail pharmacy and other sectors.
The HIPAA standard for eligibility communications between retail pharmacy dispensers and payers/PBMs is the NCPDP Telecommunication Standard, while the HIPAA standard for eligibility and benefits communications between dentists, professionals, and institutions and health plans is the ASC X12N 270/271 Health Care Eligibility Benefit Inquiry and Response Version 004010X092…
SIMON COHN (ph): Sorry.
MARGRET A.: And we put in parentheses 270/271 so we can use it in the future.
There is good industry experience in using this standard for basic batch eligibility functions. Industry experience with its use for real time inquiry for drug benefits information from prescriber to payer/PBM appears to be limited.
ASC X12N has identified workarounds for some of the gaps in 270/271 with respect to drug listings and step therapy. ASC X12N reports that version 4050 addresses some of these workarounds more directly, and that version 5010 is under development and can more tightly address industry needs for e-prescribing.
Because Medicare’s Part D prescription drug program is new, specific requirements are not known at this time and new requirements may emerge.
Recommended Action 5.1: HHS should recognize the ASC X12N 270/271 blah, blah, blah as a foundation standard for conducting eligibility inquiries from prescribers to payers/PBMs, foundation standards.
HHS — 5.2: HHS should support NCPDP’s efforts to create a guidance document to map the pharmacy information on the Pharmacy ID Card information to the appropriate fields on the ASC X12N 270/271 in further support of its use in e-prescribing.
5.3: CMS should work with ASC X12N to determine if there are any requirements under MMA with respect to how situational data elements are used in the 270/271, especially with respect to the quality of information needed for real time drug benefits. Use of these situational data elements can be addressed in trading partner agreements. These, and proper usage of the functional acknowledgments, should be included in the 2006 pilot tests.
5.4: HHS should ensure that the functionality of the ASC X12N 270/271, as adopted under HIPAA, keeps pace with requirements for e-prescribing; and that new versions to the standard be pilot tested.
SIMON COHN (ph): I like the recommendations, but comments from people?
JEFF BLAIR (ph): This is Jeff. We’ve played (ph) this a foundation standard, but we’ve also indicated — the thing is the real use of this in e-prescribing would be interactive, not batch. Is that a correct statement, predominantly (ph)?
STAN HUFF (ph) (?): No, I don’t think it is.
JEFF BLAIR (ph): So I’m wrong.
STAN HUFF (ph) (?): It could be used — I think it would actually be used — it could be used for sure in batch, and then it has possible use depending on testing, probably, in an interactive mode.
JEFF BLAIR (ph): OK. Then it’s fine.
TERRI (ph) BURNS: Can I please — this is Terri (ph) Burns. I think I need to clarify, and I’m not sure that this, good industry experiencing being a batch mode is referring to the ARCA (ph) model? We don’t use it in batch mode. We use it in real time mode.
JEFF BLAIR (ph): Well, that’s even better.
TERRI (ph) BURNS: Well, I want to make sure that that’s clear. We — and especially when it comes to this standard because there is a batch standard for this, and a real time standard. And we are using a real time standard and we do a request and a response in a real time mode.
It’s not always when the physician has his hand held or his application. It’s not in the request from the physician, but it is a request, a real-time request from the physician application.
SIMON COHN (ph): Yes. And Terri (ph), remind me how many transactions of this type have you…
TERRI (ph) BURNS: Since 2002 we’ve done 8,900,844. That was at the end of July.
SIMON COHN (ph): OK. You know, I guess I’m wondering, I know that we’ve struggled with our wording around describing the experience here as well as the issue of workarounds and all of that, and I’m wondering as I look at this, recognizing the least — some people have used this a lot without too much trouble.
I’m actually wondering if this limited needs to be maybe changed to use. And this in the observation area, but basically industry experience with its use for real time inquiry for drug benefits information from prescriber to payer/PBM appears not to be widespread, though those that use the standard have not reported any problems.
Are people still there? Did I lose everybody?
JEFF BLAIR (ph): I think we’re just waiting to see if Margret’s captured the wording.
JUDY WARREN (ph): And Simon, this is Judy. I’m back in.
SIMON COHN (ph): OK. Good.
JEFF BLAIR (ph): Oh, Judy. Did you agree with our last one? I’m assuming you did.
SIMON COHN (ph): I presume you did.
JUDY WARREN (ph): I could hear everybody but obviously you couldn’t hear me. So thank you, Maria. I did hang up and came back in.
SIMON COHN (ph): OK. So Margret, did you come up with — did you hear what I suggested?
MARGRET A.: Yes. From prescriber to payer/PBM appears not to be widespread, although those who have used the standard report no difficulty with it.
SIMON COHN (ph): Is that a — I was wondering if that was sort of maybe a little better rendition of reality than limited.
JEFF BLAIR (ph): That’s fine.
TERRI (ph) BURNS (?): Simon, this is…
STAN HUFF (ph) (?): Yes, in considering Terri (ph)’s and thinking about our own use, I actually think I may have misspoke just a second ago. I think what we’re finding — we tried, we being IHC, we tried to use the batch eligibility and though it works, it doesn’t work with the work flow.
That is, nobody trusts yesterday’s eligibility to work for today. So they want to ask today whether this patient is still eligible today. And as you point — and as she points out, our work flow would be sort of when the patient is registered at the clinic, whether we’ll get the eligibility information at that point.
And then it’s in our system by the time the physician is ready to prescribe. So it may not — yes. Well, so I guess I would echo Terri (ph)’s question and say, you know, who’s using it in batch mode? Or whether that sentence is needed.
TERRI (ph) BURNS: Well, my other question, too, is, you know, what would you consider to be widespread because I know I’ve heard testimony that, you know, 75 percent of the pharmacies are ready to use SCRIPT, but how many prescription transactions have actually been dispensed in production and how many prescribers, et cetera, are doing that?
So I’m only challenging that we’re differentiating here for some reason the adoption of a particular standard and how widely it’s used.
JEFF BLAIR (ph): I guess we’ve got to go back to Margret on this.
TERRI (ph) BURNS: I don’t notice that we have statistics on how many actual prescriptions have been dispensed fully electronically in production. But yet we’re saying SCRIPT is tried and true. Which I believe it is, but I also believe this is.
SIMON COHN (ph): Yes. Well, and I think we — I guess the question is how to describe — I didn’t like the word limited. I thought not widespread was a better way to describe it. You’re obviously asking why we make it, even bring this whole issue up to begin with.
TERRI (ph) BURNS: I would like to say that this does have good industry experience.
JEFF BLAIR (ph): Margret, what was the basis for your choice of words originally on using the word limited?
MARGRET A.: I think only that the industry experience, whether it’s batch or real time, appears to be a limited amount of information. So you get a yes or no response in a few other pieces of information.
But you’re not getting a lot of specific drug information. You’re not getting, you know, steps (ph), steps or the (ph), et cetera, that kind of information.
JEFF BROWN: Margret, this is Jeff Brown from RxHub and obviously Terri (ph) can correct me about the actual use in the industry, but my understanding is that your sentences made sense except that we could take out the word batch from the first sentence and the word real time from the second sentence.
And then the distinction is between whether the eligibility query is being used for basic functionality or if it’s being used for the more expensive drug medicines (ph) information functionality.
MARGRET A.: I think that would work really well.
JAMES BLAIR (ph): Good suggestion.
SIMON COHN (ph): Thank you. As always, we really appreciate those joining us on these calls. So Margret, do you want to read those two sentences at this point?
MARGRET A.: Yes. Let me make sure that I took out — I’m not sure I took out both things. There is good industry experience in using the standard for batch, for basic eligibility functions. Industry experience with its use for drug benefits information from prescribers of payer/PBM appears not to be widespread.
TERRI (ph) BURNS: I don’t think I agree with that because then it’s implying that you’re just doing eligibility versus drug benefit eligibility. If you want to say the experience is using it for a real time inquiry for a specific drug, I would be OK with that.
But then we probably should also note that there have, you know, all the applications that testified said this model works. The PBM says this model works. There also does not appear to be a need in the industry to do a real time drug request.
JEFF BROWN: And Terri (ph), of course I’m not going to argue with you since you’re my client (ph). This is Jeff again. But I think what we may be able to do on the first sentence is to say, “In using this standard for basic eligibility functions related to e-prescribing.”
TERRI (ph) BURNS: OK. Or for the drug benefit.
JEFF BROWN: Or for the general drug benefit in e-prescribing. And then the second sentence is, “For more detail of drug benefit information about specific drugs,” or specific, yes, specific drugs.
TERRI (ph) BURNS: Yes. I’d be OK with that. But then you’re also maybe leading them to believe that there’s a need for that. So…
JEFF BLAIR (ph): I think — we don’t know yet. That’s Recommended Action 5.2 is that they want to look into it. OK.
SIMON COHN (ph): OK. I’m actually wondering — Margret, help me with this one. I’m looking if we can’t get rid of batch in that first sentence there. I’m actually wondering if we can just get rid of the second sentence period.
JEFF BLAIR (ph): Well, I like the way that they just crafted this, Simon. I think they kind of resolved it.
SIMON COHN (ph): Well in that case maybe you can read it to me in a way that I can understand. Margret, where are you on this?
MARGRET A.: I’m — hold on one second, Simon. OK. There is good industry experience in using this standard for the general drug benefit functions. Industry experience with its use for specific drug information from prescriber to payer/PBM appears not to be widespread.
STAN HUFF (ph) (?): I would be in favor of just striking that second sentence. I think I’m persuaded by Terri (ph)’s explanations and other things, as well as my own experience.
JEFF BROWN (?): I think…
STAN HUFF (ph) (?): I think we’re OK if that second sentence didn’t come (ph) with that.
LISA MILLER: Simon, this is Lisa Miller from X12. Since we’re down in 5.2, I think that’s where we were saying to explore things a little bit further. I would agree that taking out that line seems to make sense.
STAN HUFF (ph) (?): And it’s actually 5.3, not 5.2. I misspoke, on this recommended action on this.
LISA MILLER: OK.
JEFF BLAIR (ph): To take out which on that line?
LISA MILLER: The second sentence, “industry experience and for specific drug.”
MARGRET A.: But we’re in the observation.
LISA MILLER: That’s correct. Yes.
MARGRET A.: OK.
STAN HUFF (ph) (?): But we don’t need it in the observation because we have a recommended action that deals with it.
LISA MILLER: Exactly, so I don’t know why we want to observe it if we’re recommending something.
JEFF BLAIR (ph): OK. So you just want that struck from the observation…
LISA MILLER: Yes.
JEFF BLAIR (ph): …but you feel OK with the recommendation.
LISA MILLER: That’s correct.
SIMON COHN (ph): Boy, say that again? You want to get rid of it from the recommendation but…
JEFF BLAIR (ph): No.
LISA MILLER: No, no, no.
JEFF BLAIR (ph): The other way around.
LISA MILLER: Other way around.
SIMON COHN (ph): OK.
LISA MILLER: From the observation.
SIMON COHN (ph): OK.
LISA MILLER: Recommendation — because the recommendation addresses that need or that — there’s no reason to make it an observation. It’s kind of redundant.
SIMON COHN (ph): OK. Good. OK. Well, do we at that point also want to describe this as basic eligibility functions period, as opposed to further specifying it in the observation? Margret, you have it described somehow as a basic eligibility function for something to something, right?
MARGRET A.: There is good industry experience in using this standard for the general drug benefit function. ASC X12N has identified workarounds, blah, blah, blah.
SIMON COHN (ph): Well, I guess that’s probably fine. Others?
LISA MILLER (?): Simon, I have two small, very small wordsmithing issues.
SIMON COHN (ph): Please.
LISA MILLER (?): The first one is that we need to add A1 to 004010X092 because we have an addenda.
MARGRET A.: Oh, right.
LISA MILLER (?): OK. It’s fine. And where we refer to X12, can we refer to X12 the body instead of going down into a subcommittee, so remove the N even though we all know that’s where it will happen? N isn’t its own entity. X12’s the entity.
SIMON COHN (ph): OK.
MARGRET A.: Yes.
LISA MILLER (?): Very little ones.
SIMON COHN (ph): Well, actually, hey, we’re down to the little ones. We’re doing well.
MARIA FRIEDMAN (ph): Following down to the little ones, this is Maria and I have three real quick ones. In 5.2 I’d like to add Part D in front of the pharmacy ID card just to clarify that it’s Part D.
In 5.3 we have “respect to” twice very close together in that one sentence, so I would like to take out the second “with respect to” and just make that concerning. So after you get through the first clause, “the data elements are used in the 270/271, especially concerning the quality of information.”
And finally, in 5.4 we don’t need a semicolon after e-prescribing.
STAN HUFF (ph) (?): And while we’re doing those, in 5.2 where it says, “the pharmacy information, on the pharmacy information card information,” it seems to me that second information doesn’t fit.
MARGRET A.: That’s something we need to (ph)…
SIMON COHN (ph): OK.
MIKE FITZMAURICE (ph): This is Mike. On the Recommended Action 5.3, the sentence that reads, “Use of these situational data elements can be addressed in trading partner agreements,” it’s not clear whether that’s a recommended action that we’ve recommended that trading partner agreements be used, or whether we’re seating something in the background, such as today they’re used in trading partner agreements.
In a robust standard, you might not have all those trading partner agreements.
JEFF BLAIR (ph): Is it to change the word “can” to “are being?”
MIKE FITZMAURICE (ph): That would do it. Are currently being, yes.
MARGRET A.: Simon, I think the issue here is that they’re not being addressed in trading partner but could be.
MIKE FITZMAURICE (ph): Oh.
SIMON COHN (ph): OK.
MIKE FITZMAURICE (ph): But that’s not desirable, is it?
SIMON COHN (ph): Well, what’s — I mean, there are always going to be trading partner agreements, Michael.
MIKE FITZMAURICE (ph): Yes.
MARGRET A.: And if you adopt a 270/271 4010 as a foundation standard, the only way you can do some of this other stuff is through trading partner agreements.
MIKE FITZMAURICE (ph): OK.
SIMON COHN (ph): OK. I think could is probably the…
MARGRET A.: Should?
JEFF BLAIR (ph): He said could.
SIMON COHN (ph): Could, should.
MIKE FITZMAURICE (ph): Yes. Ideally you’d want to have a lot of this stuff embedded in the standard as opposed to the trading partner agreements.
SIMON COHN (ph): Michael, you still always have to have trading partner agreements, I’m sorry.
MIKE FITZMAURICE (ph): That’s quite all right, Simon.
SIMON COHN (ph): But so how do we want to — I mean, could or should, I don’t really care.
JEFF BLAIR (ph): Could.
SIMON COHN (ph): OK. Are we ready to go on from 5.4?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Now, just in the interest in time, down into four hours and 15 minutes of this, you know, I’m going to suggest that — I mean, I know that everybody loves to wordsmith down to menuga (ph) and this is really probably the time.
But rather than giving them verbally to Margret, let’s restrain ourselves on purely punctuation or purely grammatical stuff. You know, we’re too wordsmithing. And let’s send them back to her via email.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): So, OK? Because otherwise, I mean, there’s going to be no way we’re going to get much further at all. And we obviously have a fair number of other recommendations we need to talk about. Is everybody OK with that?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): OK. Good. Margret, are we OK with five? Good to go? Jeff?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Harry? Oh, Harry’s not there anymore. Judy?
JUDY WARREN (ph): Yes.
SIMON COHN (ph): Stan?
STAN HUFF (ph): Yes.
SIMON COHN (ph): OK. I’m good to go. Let’s go on to six.
MARGRET A.: OK. Six. Simon, you had a question and I think I’ve tried to find a way to respond to you here, so I’ll read it as I’m going to suggest it. It’s a minor change.
SIMON COHN (ph): OK.
MARGRET A.: Under HIPAA, claims, eligibility, and benefits information between dispensers and payers/PBMs are communicated using the NCPDP Telecommunication standard. The need for prior authorization for a drug is identified between the payer/PBM and dispenser through this process.
The formulary and benefit file transfer protocol being developed by NCPDP provides information from the payer/PBM to the prescriber about the need to obtain prior authorization of a drug. The NCPDP SCRIPT Standard may be used between the dispenser and prescriber to communicate the prior authorization approval for a drug.
However, the request for a prior authorization for a drug from the prescriber to the payer/PBM is now conducted in a manual mode. This is due in part to the complexity of the decision making involved in ensuring that use of an expensive drug is medically warranted.
The ASC X12N 278, et cetera…
SIMON COHN (ph): Et cetera, yes.
MARGRET A.: is a HIPAA standard that provides for prior authorization inquiry and response in general. It provides very limited support for prior authorization of drugs and is not widely used.
Recommended Action 6.1: HHS should support X12 in their efforts to incorporate functionality for real time prior authorization messages for drugs in the X12N 278 for use between the prescriber and payer/PBM. HHS should then recognize the 278 for use in e-prescribing.
6.2: HHS should support standards development organizations and other industry participants in developing scenarios to ensure the proper flow of prior authorization information throughout the entire communication process including NCPDP Telecommunication and SCRIPT Standards, and the S 278 Standard.
6.3: CMS should evaluate the economic and quality of care impacts of automating prior authorization communications between dispensers and prescribers and between payers and prescribers in its 2006 pilot tests.
SIMON COHN (ph): OK. Comments from everyone. I guess I have a question, starting with 6.1. I’m just wondering why the last sentence in the recommendation where it says, “HHS should then recognize the 278 for use in e-prescribing,” I’m just wondering why it says, “HHS should then pilot the use of the 278 for use in e-prescribing.”
It seems to me it’d the logical recommendation there.
MARGRET A.: You have pilot test below in 6.3. We could take that sentence out.
LISA MILLER: Simon, this is Lisa. Were we trying to say that we should recognize 278 as the foundational standard?
SIMON COHN (ph): Well, no. See, that’s why — I don’t think we’re saying that, are we?
LISA MILLER: Well, I wondered because it was like we were redundant on 6.1 with what we were saying down lower. And I thought earlier we had said that it was foundational standards.
SIMON COHN (ph): I don’t think we ever said that 278 was a foundational standard for this purpose. I think we — and that has to do with the fact that it isn’t in widespread use…
LISA MILLER: OK.
SIMON COHN (ph): …for this — I mean, this is not in widespread use. We have it as (ph) a HIPAA standard. Actually, as I’m looking at it, maybe we can just get rid of that sentence.
LISA MILLER: Yes. And then Simon, one…
SIMON COHN (ph): At 6.1 and leave the piloting in 6.3 as it is. I’m sorry, Lisa, you were going to comment?
LISA MILLER: One other comment. Just as we have 5.4, we had made a comment earlier that we were going to add a 6.4 to help keep in sync with HIPAA. It was one of my notes but I don’t see a 6.4 noted here.
So in 5.4 we state that we’re going to ensure the functionality is adopted, keeps pace with the requirements – that we were going to add a 6.4.
SIMON COHN (ph): Comments from everybody?
JEFF BLAIR (ph): I think Lisa’s right.
SIMON COHN (ph): OK.
JEFF BLAIR (ph): But let’s verify that. Look closely. Margret, is that consistent with…
MARGRET A.: Yes, I think that’s fine.
SIMON COHN (ph): Yes. Super idea.
STAN HUFF (ph): I would agree with that addition.
SIMON COHN (ph): OK. So I guess what I’m going to suggest is on 6.1 that we get rid of the last sentence. Anything else? Do people generally agree on it? Other changes, suggestions?
TERRI (ph) BURNS: Simon, this is Terri (ph) Burns.
SIMON COHN (ph): Yes?
TERRI (ph) BURNS: I just have one thing. On the last sentence in the observation where it says, “due in part to complexity of the decision making involved in ensuring that use of an expensive drug is medically warranted,” I don’t want to speak for the health plans, or maybe I do, I think that there are other reasons that you fire (ph) off a drug.
It could be potentially dangerous, overused, things like that. So I don’t know if there’s a reason we had that…
SIMON COHN (ph): Do you want us to get rid of the word expensive?
TERRI (ph) BURNS: Yes.
SIMON COHN (ph): OK. People, do you agree with getting rid of the word expensive?
JEFF BLAIR (ph): Well, I liked — I thought it was helpful to help folks understand why somebody would do that. Could we set that as just as an example, for example?
MARIA FRIEDMAN (ph): That was my — Jeff, that was my thought as to — this is Maria, is to add after warranted, a comma and just say for example.
MARILYN SIGMUND-LUKE (ph): Simon, it’s Marilyn Sigmund-Luke (ph) with AAIP.
SIMON COHN (ph): Sure.
MARILYN SIGMUND-LUKE (ph): We would suggest that you substitute the use of the word expensive with an alternative drug.
JEFF BLAIR (ph): You want to do…
SIMON COHN (ph): Well, alternative is the wrong word there.
JEFF BLAIR (ph): …expensive or alternative, or…
MARILYN SIGMUND-LUKE (ph): The discussion at the testimony really was using this as a cost control mechanism, and that’s why I like the notion of having expensive in. It kind of gets that across.
JEFF BLAIR (ph): I agree.
MARK BUCKLE (ph): This is Mark Buckle (ph) with the Academy of Managed Care Pharmacy, and there definitely are more reasons than just the cost of a drug to put it on prior authorization. And I would certainly vote for removing the word expensive.
I mean, that is not the primary reason for putting a drug on prior authorization.
SIMON COHN (ph) (?): Should we suggest the word…
JEFF BLAIR (ph): The thing that you just said, though, was that you didn’t say that expensive wasn’t one of the reasons. You’re saying there’s more reasons than expensive…
MARK BUCKLE (ph): Right, but…
JEFF BLAIR (ph): If we kept expensive in there and then wound up indicating alternative or something else, but it did seem to me that that was one of the compelling testimonies of that was one of the reasons.
MARK BUCKLE (ph): Yes, but if you only list expensive, then that’s going to be the thing that’s standing out on people’s mind, that prior authorization is there for an expensive drug and it’s just to prevent, you know, the cost of a drug to prevent payment.
So I mean, you can’t just leave expensive as the…
JEFF BLAIR (ph): Right. I wasn’t suggesting we only have expensive. I was saying, for example, expensive or alternative or maybe we’d even want to add a third.
MARK BUCKLE (ph): Well, you might want to say neurotherapeutic index, drugs that require special handling or administration techniques.
JEFF BLAIR (ph): Fine.
SIMON COHN (ph): Yes, I guess I’m wondering if whether the solution here is to basically ensuring the use of certain drugs, or of a certain drug as medically warranted, is probably the better way to leave it.
I guess I’m struggling with our, you know, a level of this particular adjective, or even going to the e.g. issue.
UNKNOWN FEMALE #26: Well, could we just say that the use of prior authorized drugs are medically warranted?
MARIA FRIEDMAN (ph) (?): Well, that doesn’t really make sense.
MARILYN SIGMUND-LUKE (ph) (?): Well, the point of this sentence is to point out that the reason it hasn’t been done yet is that it’s complex, that the decision-making process is complex, isn’t it?
STAN HUFF (ph) (?): Well, I mean we heard testimony to that effect. I’m not sure that’s really the situation.
MARILYN SIGMUND-LUKE (ph) (?): Well, I was trying to understand what the point of this sentence was. Was it to talk about why drugs are prior-authorized, or, you know, why the manual mode today?
MARGRET A.: Why the manual mode today.
MARILYN SIGMUND-LUKE (ph) (?): And that’s to do the complexity in the criteria, not why the drugs are prior authorized.
SIMON COHN (ph): Yes. What is the sentence then, that this is due in part to the complexity of the decision-making currently involved with prior authorization, period?
JEFF BLAIR (ph): Maria, do you feel comfortable with that?
MARIA FRIEDMAN (ph): I still like the sentence as it originally stands with the for example tacked on to the end of it, but…
SIMON COHN (ph): OK. Well, if you guys can come up with enough examples…
MARIA FRIEDMAN (ph): I don’t think we need the whole list, the whole panoply of reasons why prior auth is used. I just think for some of the people reading this, they’re not going to understand it unless we give an example, and the example that most people understand and has had happen to them, and the most common reason we’ve heard is because of cost, not to mention the panoply of other reasons.
JEFF BLAIR (ph): And I agree with you, Maria.
MARK BUCKLE (ph): And this is Mark Buckle (ph) again. I guess my question is do we really need to explain the reasons, especially (ph) in this particular observation? I mean, we’re just, you know, we’re just saying that it’s a manual process to review them.
I don’t know that we have to explain the reasons that prior authorization are put in place.
SIMON COHN (ph): Well, I’m going to ask the subcommittee at this point for your views on this one because clearly we can go — there’s a number of ways we can go on this one. We can go e.g., one or a couple of different reasons, we can shorten this dramatically.
I guess I would speak just to find out. Stan, where are you on this one?
STAN HUFF (ph): Well, I think, you know, I would be OK with just any of the solutions that have been suggested that — I think, see part of my reason for making it — I guess my real preference would be for making it simple because my real feeling is we heard testimony from the physicians especially.
I’m thinking of Clem (ph) and the gentleman from Massachusetts who said their perception is that this truly is — that it’s an arbitrary road block and that people aren’t putting things into logic, not because their complex but because they want to be arbitrary in how they do it.
And so I mean — so I agree that this statement is correct, that in part it’s due to other stuff. But you know, the implication of the testimony was that, in fact, they might look and say, “Gee, if we’re, you know, we’re over our quota for drugs, you know, we’re going to lose money this month if we approve all these things.”
And if, you know, I think there’s some element of people wanting to not make their logic explicit so that they can, in fact, change it quickly to accommodate the economic realities of the allocation.
So, you know, this — the more we put in here the more, sort of, would obligate us to put in, you know, a bigger discussion about all of the issues related to why prior authorization is hard.
TERRI (ph) BURNS: Well, and this is Terri (ph) again. I mean, if you call out this specific one, don’t you need to go back to formulary, and there are a lot of, you know, political things around formulary and people who don’t believe we should have formularies, et cetera.
And the fact is, there are drugs that are prior authorized and there’s a reason for that. Just like…
JEFF BLAIR (ph): And being expensive is a valid reason.
TERRI (ph) BURNS: Right. I guess I had an issue with just calling out that specific reason because I do, you know, I believe there are like safety reasons that they prior auth drugs as well, which…
JEFF BLAIR (ph): Right. And I would suggest that we say for example, safety reasons, complexity reasons, expense reasons, and we have maybe those three as examples.
TERRI (ph) BURNS: And then maybe add in others…
JEFF BLAIR (ph): Yes, well, it says for example.
TERRI (ph) BURNS: Yes.
JEFF BLAIR (ph): Or if you want to say — yes, others. Yes.
SIMON COHN (ph): OK. Judy?
JUDY WARREN (ph): I guess I like the idea of putting the examples at the end of the sentence because I do think a lot of people think that it’s for money only. And if you have money as a reason, everybody knows that’s true, and then add one or two other reasons, that helps people to broaden their ideas.
SIMON COHN (ph): OK. Jeff, it sounds like you’re in favor of that also.
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): And Harry’s not around. So why don’t we attempt to have somebody work on, sort of an e.g. or for example or whatever. And Margret, I’ll leave that to you to try to wordsmith out. Is that a reasonable expectation?
Margret, are you there?
MARGRET A.: Simon, I’m sorry. I had it on mute.
SIMON COHN (ph): Well that’s all right. I thought we had lost you completely. I thought five hours was a long time.
MARGRET A.: I’m sorry. Yes. I will re-word this and I will include expense, patient safety and is there one other example you want to include?
SIMON COHN (ph): I think expense and patient safety are the two that come to mind. Does anybody else have a third one?
JEFF BLAIR (ph): Expense, safety and others.
MARGRET A.: Good.
MARK BUCKLE (ph): How about the require special handling or administration procedures.
SIMON COHN (ph): That would be fine.
JEFF BLAIR (ph): Fine.
SIMON COHN (ph): Thank you.
MARK BUCKLE (ph): This is Mark Buckle (ph), by the way. Sorry.
SIMON COHN (ph): Yes. It’s just hard if you do an e.g. to put a comma, others. That never quite…
JEFF BLAIR (ph): Right. Right.
SIMON COHN (ph): That is like the wrong thing to put as an e.g.
JEFF BLAIR (ph): Exactly.
SIMON COHN (ph): So, OK. Well, great. OK. Other comments on this one? We’ve made a couple of changes here. I think we’re — I mean, I guess we never really did talk about 6.1, removing that last sentence from the action. Do people have issues with that one?
JEFF BLAIR (ph): I concur.
STAN HUFF (ph): I agree.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Yes.
SIMON COHN (ph): OK. Anything else for 6.1?
JEFF BROWN: Small points — oh, 6.1? No.
SIMON COHN (ph): Yes. I mean, I’m sorry, for six period.
JEFF BROWN: This is Jeff Brown. Small point. We need to address the Addenda in the reference.
MARGRET A.: I got it.
JEFF BROWN: I’m sorry. And then also I think we may want to do the same versioning 5.1 with the telecommunications standard, wherever it appears. It’s not as important but it’s out there.
MARGRET A.: Right.
SIMON COHN (ph): OK. Are we good to go onto seven?
MARGRET A.: Yes.
SIMON COHN (ph): Hey. Good. Please go forward.
MARGRET A.: Medication History Messages from Payer/PBM to Prescriber: The exchange in medication history may occur at multiple points: among prescribers, between patients and prescribers, between payers and prescribers, and between prescribers and dispensers.
MMA indicates that medication history should be provided to prescribers and dispensers but does not explicitly identify the source or sources or actual intended use of the medication history. When e-prescribing applications capture medication history, they generally do so using free text or a National Drug Code.
Medication history from payers/PBMs to prescribers is currently performed in proprietary formats. RxHub uses one based on NCPDP that is being submitting to NCPDP to go through the standards development process to become an ANSI-accredited standard.
The following recommended actions address only exchange of medication history from payers/PBMs to prescribers. The NCVHS plans to address other medication history communications in its March 2005 recommendations.
7.1: CMS should support rapid development of an NCPDP standard for a medication history message for communication from a payer/PBM to a prescriber, using the RxHub protocol as a basis.
7.2: NCVHS will closely monitor the progress of NCPDP standardizing a medication history message standard for communication from a payer/PBM to a prescriber and provide advice to the secretary in time for adoption and/or readiness for the 2006 pilot tests.
SIMON COHN (ph): Comments?
TERRI (ph) BURNS: Hi, this is Terri (ph) Burns.
SIMON COHN (ph): OK.
TERRI (ph) BURNS: I just — the last sentence in the observation that they generally do so using free text, I’m not sure what that’s referring to, in what instance are they using free text?
MARGRET A.: In capturing medication history.
TERRI (ph) BURNS: Right. From the payers and PBMs?
MARGRET A.: I believe this was Steve’s comment that he added, but I think he was saying that in general, when these applications take in medication history, they either get it in the form of free text or in NDCs.
SIMON COHN (ph): Yes, I guess I mention one more thing. I wonder if that whole sentence can be safely removed. Is that — I guess Steve isn’t here to defend his comments here.
STAN HUFF (ph) (?): Yes, I guess I would ask — maybe we could just ask what do you think truth is, Terri (ph)?
TERRI (ph) BURNS: Well, I know when they get the medication history from the payers or PBMs, it’s definitely at the NDC level because that is the drug that was dispensed. I wonder if he was referring to maybe when they consider a prescribed drug as medication history, you know, in applications.
That may be free text. That may be the drug name because that’s what they prescribed. But I guess I was trying to understand where that came from and what the relevance was. If this is in relevance to medication history from a payer/PBM to the prescriber, and I don’t know that there’s — well, I do know there are others doing it outside of RxHub that say, I believe, they also set it at an NDC level because it’s based on the drug that was dispensed and paid for by the PBM or payer.
JEFF BLAIR (ph): Could I interrupt for a second. Simon, there’s about 25 minutes left in the call.
SIMON COHN (ph): Right.
JEFF BLAIR (ph): Maybe we could consider, since we went through these things on Wednesday, and this is another time when we’re going through it on the wordsmithing part, if in order to try to complete going up through 11, could we concentrate on the recommendations for these next set of observations, and if somebody has some wordsmithing on the observations, they can send that by email to Margret?
JUDY WARREN (ph) (?): Yes, no problem (ph).
STAN HUFF (ph) (?): I think we’re doing OK. I mean, I think it’s — I think these are important discussions, probably as important as the recommendation.
SIMON COHN (ph): Yes.
TERRI (ph) BURNS: Actually — and this is Terri (ph) again. We did — we thought we had sent some stuff that just didn’t get to Margret. So Shelley Wooley (ph) resent it, and I actually had wordsmithed this section.
So Margret, if you’re willing to…
MARGRET A.: Yes, I’ll take a look at that and I think in recalling Steve’s suggestion, he put this in at several different places, and I think, I’m quite sure that he was referring to e-prescribing applications in general so that it would refer to…
STAN HUFF (ph) (?): Yes.
MARGRET A.: …if the physician was trying to capture medication history from the patient even.
TERRI (ph) BURNS: Yes. But that’s…
STAN HUFF (ph) (?): Yes. I think I would feel comfortable striking this sentence in the context that it now exists.
SIMON COHN (ph): Yes, I’m not sure that I see a value added to have it here, given the nature of the observation and recommendation. Judy, do you have a comment?
JUDY WARREN (ph): I’ll go with whatever people decide.
SIMON COHN (ph): OK.
JUDY WARREN (ph): I don’t feel one way or the other about it.
SIMON COHN (ph): Yes. I mean, Margret, if you look at this again and feel there’s some major issue we can discuss it again on Monday, but I’m not sure that this particular sentence adds a lot to the conversation.
MARGRET A.: I think it’s covered in terminology recommendations.
SIMON COHN (ph): That was what I thought also, so does anybody have any issues with the action items to address some of Jeff’s concerns?
I think they look pretty good.
JEFF BLAIR (ph) (?): Yes.
SIMON COHN (ph): OK.
SHELLEY WOOLEY (ph): I think I would add the word — this is Shelley Wooley (ph). I think I would add the word SCRIPT after RxHub uses one based on NCPDP SCRIPT.
MARGRET A.: Thanks.
TERRI (ph) BURNS: And that’s in the language that we sent.
SIMON COHN (ph): Fine. I think that’s — that certainly falls in the level of wordsmithing that we’re happy to get comments from others about. Anything else?
MARIA FRIEDMAN (ph) (?): If we’re going to strike that sentence, just a note to Margret we need to spell out National Drug Code down below for first mentioned.
MARGRET A.: Oh, yes.
SIMON COHN (ph): OK. Good. OK. So we’re OK to go to Observation 8?
JEFF BLAIR (ph) (?): Yes.
SIMON COHN (ph): OK.
MARGRET A.: Clinical Drug Terminology. Today’s e-prescribing systems support narrative text entry of a clinical drug and/or selection of a clinical drug code from one of several proprietary terminology systems.
A standard terminology, and there’s a footnote, terminology includes codes classification and vocabulary, for clinical drugs facilitates automated drug utilization review and decision support for patient safety. It is also necessary for interoperability among different e-prescribing systems.
However, it is recognized that not every item ordered by a prescription will always be included in a terminology, for example, compounded drugs, devices, and supplies. This means that the ability to enter text in an e-prescribing system must be preserved.
The National Drug Code is used by dispensers to identify packaged drugs. However, NDC is not appropriate for use by prescribers in describing the clinical drug. To address this need, the NLM has produced a clinical drug terminology, RxNorm, which there’s a footnote describing that.
RxNorm provides links from clinical drugs to their active ingredients, drug components, and most related brand names. Fully comprehensive RxNorm terminology for all marketed drug products, including generics, repackaged products, and over-the-counter medications, will not be available until structured product labels, and that’s defined as well, become available to the NLM from the FDA for all those items.
When this is available, it is the intent of the NLM to update the repository of drug information on a daily basis as the DailyMed.
Additionally, until the full set of brand names is included in RxNorm, some dispense as written prescriptions cannot be accommodated through e-prescribing. NCVHS observes that the FDA is looking to the NDF-RT to provide drug classifications for use in the SPL.
Further, the MMA directed HHS to request the United States Pharmacopeia to develop model guidelines for drug categories and classes that the prescription drug program sponsors participating in Medicare Part D can use in structuring their formularies.
The NCVHS documented deficiencies in the NDC that must be overcome to support many clinical applications, including e-prescribing, in its Report to the Secretary on Uniform Standards for Patient Medical Record Information, dated July 6, 2000.
NCVHS recommended adoption of the RxNorm in the core set of clinical data terminologies in its Letter to the Secretary on Recommendations for PMRI Terminology Standards, dated November 5, 2003.
Recommended Action 8.1: In the 2006 pilot tests, HHS should include RxNorm terminology in the NCPDP SCRIPT Standard for new prescriptions, renewals, and changes. RxNorm is being included in the 2006 pilot tests to determine how well the RxNorm clinical drug, strength, and dosage information can be translated into an NDC that represents the prescribers’ intent. This translation will require the participation of intermediary drug knowledge base vendors until the RxNorm is fully mapped.
8.2: HHS should accelerate the promulgation of FDA’s Drug Listing rule and hence the ability to support the correlation of NDC with RxNorm, for example, for passing daily updates of the SPL to NLM for inclusion in the DailyMed.
8.3: HHS should ensure that if the Medicare Part D Model Guidelines and NDF-RT differ, an accurate mapping exists so they both can be used successfully.
SIMON COHN (ph): OK. This has gone through significant improvements, I think, over the while. I think my only thing is minor wordsmithing on the first line where you use the term narrative. I presume you mean free text entry. Isn’t that what you mean there?
MARGRET A.: Free text entry.
SIMON COHN (ph): Yes. Since you got rid of it above we can use free text.
MARGRET A.: Yes.
SIMON COHN (ph): OK. Other comments from people. I mean, does this represent, I think, the views?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Stan?
STAN HUFF (ph): Yes.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Yes.
SIMON COHN (ph): OK. Any final comments on this one before we move on to the next item? I think we’ve talked everyone out on this one. Margret, good work.
MARGRET A.: All right. Structured and Codified SIG: Structured and codified patient instructions for medication use, commonly called the SIG, will enhance patient safety, although it is also recognized that narrative text capability must be preserved for special circumstances. NCPDP, HL7, and others are working on addressing structured SIG components and plan to seek broad industry participation.
Recommended 9.1: HHS should support NCPDP, HL7, and others, especially including the prescriber community, in addressing in their standards SIG components. This should include preserving the ability to incorporate free text when necessary, for example, for complex dosing instructions.
9.2: HHS should include in the 2006 pilot tests the structured and codified SIGs as developed through the standards development organization efforts.
SIMON COHN (ph): Comments? I think it looks pretty good. Jeff?
JEFF BLAIR (ph): Yes?
SIMON COHN (ph): Are we OK?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Stan?
STAN HUFF (ph): I like it. Yes. The only thing is narrative again. I — in the pattern (ph) I would put free text there.
SIMON COHN (ph): Free text, yes.
MARGRET A.: Got you.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): That’s fine.
SIMON COHN (ph): Other comments? OK. Let’s move on to 10 then.
MARGRET A.: Dispenser Identifier: The NCPDP Provider Identifier Number has been in use for a number of years and is widely accepted as the dispenser/pharmacy identifier. Its database contains information to support various claims processing functions, and needs to continue to be available for this purpose.
The NCPDP database can accommodate the National Provider Identifier as a reference field. The HIPAA requires the NPI, when it becomes available, to be used in the NCPDP Telecom Standard for claims processing. The National Provider System (NPS) enumerates pharmacy organizations, subparts of organizations at a particular address, and pharmacists.
10.1: HHS should ensure that the NPI, when it becomes available, is incorporated as the primary identifier for dispensers in the NCPDP SCRIPT Standard.
10.2: HHS should accelerate the enumeration of all dispensers to support transition to the NPI for e-prescribing.
10.3: HHS should permit the industry to use the NCPDP Provider Identifier Number in the event that the NPS cannot enumerate dispensers in time for Part D implementation.
10.4: HHS should evaluate how mass enumeration of dispensers for the NPI can occur using the NCPDP Provider Identifier Number database.
10.5: HHS, when requiring the NPI as the primary identifier for dispensers, should protect the ability to maintain linkages to the NCPDP Provider Identifier Number database for current claims processing purposes.
SIMON COHN (ph): OK. I think that looks pretty good. Other comments? Jeff?
JEFF BLAIR (ph): I’m fine.
SIMON COHN (ph): Stan?
STAN HUFF (ph): Yes. I’m fine.
SIMON COHN (ph): Judy?
JUDY WARREN (ph): Me, too.
SIMON COHN (ph): OK. Other comments on this one? OK. Let’s look at 11.
MARGRET A.: OK, 11. Prescriber Identifier: There is no single identifier for prescribers. The DEA Number is widely used as a proxy. Although testimony is expected to be heard from the DEA between now and March, others indicated that the DEA prefers the number to be reserved for use only on prescriptions for controlled substances.
NCPDP created HCIdea for the purpose of enumerating prescribers to eliminate usage of the DEA on prescription claims when transmitted between dispensers and payers/PBMs. It is not currently made available directly to prescribers.
The HCIdea database supports all of a prescriber’s DEA numbers, practice locations, and the National Provider Identifier, — I’m getting an echo all of a sudden…
SIMON COHN (ph): That’s fine.
MARGRET A.: …when it becomes available. The NPI is the HIPAA standard for identifying all providers, including prescribers, on all HIPAA transactions. The NPI database could accommodate a bulk load from HCIdea to include missing elements, if efficient and valid to do so.
It is further noted that the DEA is anticipated to produce an electronic signature standard to ensure the protection of messages containing prescriptions for controlled substances. Electronic signatures will also be addressed by NCVHS in subsequent recommendations.
11.1: HHS should ensure that the NPI, when it becomes available, is incorporated as the primary identifier for prescribers in the NCPDP SCRIPT Standard. It should be noted that the NPI must be at the individual prescriber level because a prescription cannot be written at a group level.
HHS should accelerate the enumeration of all prescribers to support transition to the NPI for e-prescribing.
11.3: HHS should permit the industry to use the NCPDP HCIdea in the event that the NPS cannot enumerate prescribers in time for Part D implementation.
11.4: HHS should accelerate NCPDP’s work in identifying solutions that deal with all elements of the prescriber location, and include those solutions in the 2006 pilot tests.
11.5: HHS should evaluate how mass enumeration of prescribers for the NPI can occur using the NCPCP HCIdea database.
11.6: HHS, when requiring the NPI as the primary identifier for prescribers, should protect the ability to maintain linkages to the NCPDP HCIdea database for e-prescribing routing functions.
SIMON COHN (ph): OK. You know, I think this is all good. I’m just looking at 11.4 where — I’m just not — I guess I’m looking at this one and I’m just wondering — I think that we basically need to identify solutions.
I’m just not sure if HHS should accelerate NCPDP’s work in identifying. It should be like HHS should work with the industry to identify solutions that deal with all elements of the — with all issues related to the prescriber locations.
MARIA FRIEDMAN (ph): This is Maria, and I think that’s a good point, to broaden it to the industry.
JUDY WARREN (ph): I like that, too, because HHS can’t accelerate.
STAN HUFF (ph): I agree with that. I think it’s better to have it broad.
JEFF BLAIR (ph): This is Jeff. I concur.
SIMON COHN (ph): OK. Any other changes, suggestions, recommendations on this?
MARGRET A.: Simon, could I just read that back real quick?
SIMON COHN (ph): Sure.
MARGRET A.: HHS should work with the industry to accelerate identifying solutions that deal with all elements of the prescriber location and include those solutions in the 2006 pilot tests.
SIMON COHN (ph): I don’t think it’s accelerate, should work.
MARGRET A.: Should work with the industry — oh, should work with the industry to identify?
SIMON COHN (ph): Yes. Yes, exactly. I think it’s — I think it’s identify both the issues and possible solutions.
MARGRET A.: To identify issues and solutions, possible.
SIMON COHN (ph): Yes because I think there’s the issue of — it’s an issue piece as well as a solution piece.
MARGRET A.: OK.
SIMON COHN (ph): Is that OK with everyone?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): Stan?
STAN HUFF (ph): Yes.
SIMON COHN (ph): OK. Judy?
JUDY WARREN (ph): Yes.
SIMON COHN (ph): And me, yes. OK. Anything else to 11 actions or recommendations on 11? Well, you know, I think we’ve gone all full circle here.
Shall we take a couple of minutes and go back to the very beginning of the letter and start reading through the first couple of pages knowing that we have, I think, it’s two and a half pages before we’ve gone into everything else? Or would people prefer to declare victory now and just do wordsmithing in the background on these first couple of pages?
JEFF BLAIR (ph): Yes, does anybody really have an issue on those first…
STAN HUFF (ph) (?): I have one comment. It’s, I think it’s a fairly slightly comment. So in the first paragraph under Current Prescribing Environment…
SIMON COHN (ph): OK.
STAN HUFF (ph) (?): I think we just need to add a word, probably at the start of the second sentence, that says, “Typically they give a handwritten,” because I mean, we’ve heard testimony that not everybody’s doing, you know — I just want one weasel word in there to indicate that, yes, this is the common way it happens with the handwritten prescription.
But I think myself and others reading it would say, “Well, yes, but that’s not universally true.” There is, as we described below, there’s a small but measurable proportion of the population that’s using automated methods.
SIMON COHN (ph): Should we say most?
STAN HUFF (ph) (?): Yes. Most or…
SIMON COHN (ph): I think most is probably the right term there unless somebody else has a better word. Many?
JEFF BROWN: This is Jeff Brown. I looked at that as well. I thought maybe “today, under traditional prescribing,” prescribers, blah, blah, blah.
STAN HUFF (ph) (?): Yes. And that would be acceptable to me, too.
MARIA FRIEDMAN (ph) (?): The (ph) initial comment was that typically, they give — that handles it, too.
JEFF BLAIR (ph): I like typically.
JUDY WARREN (ph): I like typically better, too.
MARIA FRIEDMAN (ph): It’s shorter.
STAN HUFF (ph): I still like it, so that’s OK.
SIMON COHN (ph): So we like typically versus most?
JEFF BLAIR (ph): Yes.
SIMON COHN (ph): OK. And that’s fine. I don’t think I have an objection. Does anybody else have any — I mean, obviously the first paragraph is just our typical introductions. We talk about current prescribing environments. Does anybody have any issues with that section?
And then current e-prescribing capabilities as we’ve described them, which is very much taken from the eHealth Initiative framework?
MARGRET A.: And I need to remove Appendix A and then reference, somehow reference in there both the eHI (ph) report and RAND (ph) report.
MARIA FRIEDMAN (ph) (?): You could do it as a footnote…
MARGRET A.: Yes.
MARIA FRIEDMAN (ph) (?): …there, Margret, and just say in the footnote, a comprehensive description of the e-prescribing process is provided in the report available at, and give the Web site. And then do you have Doug Bell’s (ph) paper?
MARGRET A.: Yes.
MARIA FRIEDMAN (ph) (?): And then you just reference and then just say also a framework for assessing was provided by Bell (ph) and colleagues, blah, blah, blah.
MARGRET A.: Right.
SIMON COHN (ph): Yes. In turn (ph), there’s already a footnote here that includes the notes, it just notes it at the page level.
MARGRET A.: Right.
STAN HUFF (ph): So one comment on this section. I wondered — I mean, this is all true information. What I wondered is — because we don’t reference, you know, these classes of basic reference information, standalone integrated, are never referenced again.
So we’re just using that as a framework for saying the other things that we want to use? Or…
JEFF BLAIR (ph): That’s just background education so that folks that are not, that may be reading this for the first time have a feeling for the environment that the standards will be relating to.
SIMON COHN (ph): Yes, I think this is — Stan, the point of this is meant to set up the recommendations so people understand that things are still early on, that people are trying to move forward but haven’t gotten there yet.
JUDY WARREN (ph): It’s hard to tee all this up so succinctly when there’s so much going on.
SIMON COHN (ph): I don’t know. I think we’ve heard a lot of what’s going on. I think it actually is pretty good, a pretty good statement of reality.
JUDY WARREN (ph): No, it’s not a criticism. I think this is good. I am proud that we were able to synthesize all that and tee it up so well.
SIMON COHN (ph): OK. So at this point what I hear is that we are comfortable with the document knowing that we need to still see sort of the outcomes of our commentary on recommendations 12 through — is it 13 through 18? I’m trying to think of what number that is.
JUDY WARREN (ph) (?): It’s 12.
SIMON COHN (ph): Twelve through 18 just to make sure that it really represents what we thought, as well as there’s going to be some wordsmithing, correct?
MARGRET A.: Yes.
SIMON COHN (ph): Now, let me just ask in the remaining four minutes. Right now we are scheduled for a one-hour conference call on the 30th, which is Monday, from seven a.m. California time until eight. Do we need to add another half an hour or even an hour to make sure that we go through the recommendations 12 through 18 a second time?
MARGRET A.: Simon, my notes from Marietta (ph) said it was two hours.
SIMON COHN (ph): Oh, is it? OK. Good. I just…
MARIA FRIEDMAN (ph): That was so that the two hours, just so we have the time in case we need it.
SIMON COHN (ph): It sounds like it — I mean, as I’m looking at this one, obviously we need to, we’ll obviously — hopefully by the end of the weekend see a revised version. But we just need to validate that we got it right with those additional recommendations, which I had thought were going to be simple but turned out to be a little more complex by the time we got through them.
So is everybody comfortable with that?
MARIETTA (ph): Simon, this is Marietta (ph). So the conference call on Monday is not going to be at 10 o’clock a.m. Eastern time?
SIMON COHN (ph): No, it will be. It will just go for two hours.
MARIETTA (ph): OK. It’s going to start at 10 a.m. Eastern time, right?
SIMON COHN (ph): Yes.
MARIETTA (ph): OK.
SIMON COHN (ph): I mean, I don’t think — just physically I can’t start any sooner than that.
MARIETTA (ph): That’s fine.
SIMON COHN (ph): Life’s going to be bad enough as it is.
MARIA FRIEDMAN (ph) (?): Just fly (ph) to Washington, Simon. That’s a break.
SIMON COHN (ph): Not for the next day but thank you for commenting.
MARGRET A.: Simon?
SIMON COHN (ph): Yes?
MARGRET A.: Could I give people my email address so they have it?
SIMON COHN (ph): Please.
MARGRET A.: It’s MARGRETCPR@AOL.COM, and Margret is spelled MARGRET, CPR as in cardiopulmonary resuscitation.
SIMON COHN (ph): What you may feel like at this point. So Margret, my understanding is that you’ll make the remaining modifications based on our input. This goes to an editor and then, what, on Sunday night we receive a new copy? Is that the…
MARGRET A.: Yes. Yes, yes.
MARIA FRIEDMAN (ph): Margret, this is Maria. I’m going to get off the call and go work on Appendix, what is it, C now?
MARGRET A.: Yes.
MARIA FRIEDMAN (ph): Should I send that to you for the editor to look at, too, or should I just send it on to Marjorie (ph)?
MARGRET A.: I suspect you could send it on to Marjorie (ph) because she won’t know how to spell anybody’s names. I mean, she won’t know whether the names are spelled correctly or not.
MARIA FRIEDMAN (ph): OK. I’ll just make it like I always do.
SIMON COHN (ph): But you need to send a copy to Margret though, just because that will have some input on one of those sections where we talk about how many testifiers.
MARGRET A.: Right.
MARIA FRIEDMAN (ph): Right. Yes, I’ll do that.
SIMON COHN (ph): OK.
JEFF BLAIR (ph): And Maria, do you give up (ph) the cleaned up version of the version 10 of the work plan?
MARIA FRIEDMAN (ph): Yes. And I forwarded it back to Marietta (ph) for posting, also.
JEFF BLAIR (ph): Good.
SIMON COHN (ph): OK.
MARGRET A.: And you got the working document from me.
MARIA FRIEDMAN (ph): Right. And I did that as well.
MARGRET A.: Good.
SIMON COHN (ph): OK. So you have…
STAN HUFF (ph): And I — the version that’s sent out I would like to see a version that has the edits marked.
JEFF BLAIR (ph): Oh, that would — yes. We could get it…
STAN HUFF (ph): The edit tracking on that so that I can see the difference between what we saw today and what we’re asserting is now good.
JEFF BLAIR (ph): Good thinking.
STAN HUFF (ph): If that’s possible. If that’s not too much work.
MARGRET A.: Are you asking, Stan, for me to clean this up and then send it to the editor and use the only per (ph) edits, or are you asking me to recall all of the changes I made here today?
STAN HUFF (ph): Yes. I would like to see from the document that we started with today that was, you know, the document clean today with no edits, and then to see the edits reflected with edit tracking on…
MARGRET A.: OK.
STAN HUFF (ph): …that were made today.
MARGRET A.: I have been accepting changes when it sounded like everybody was fine with something, and then did not accept them, you know, until I…
STAN HUFF (ph): You should be able to do it just by doing the comparison, then, between — I mean, what you can do is make the final document…
MARGRET A.: It will be…
STAN HUFF (ph): …and then do a comparison between it and the version we started with this morning.
MARGRET A.: OK. You’re…
STAN HUFF (ph): And that should show all of the changes.
MARGRET A.: OK. It will — all of them.
SIMON COHN (ph): OK. But what you also want to see is all the edits on top of that. Now are you sure you want to see every wordsmithing — I guess we do need to see every wordsmithing edit.
MARIA FRIEDMAN (ph) (?): The changes…
STAN HUFF (ph): It’s — unfortunately I think it can change meaning inadvertently.
SIMON COHN (ph): Yes, I think we do. OK. So that will be the expectation for Sunday night, obviously getting you all ready for Monday.
Now obviously, once again, I want to thank everyone, staff, obviously the subcommittee for hanging in there, all of our experts. We’ve really appreciated your input as we’ve gone along. I guess the bad news is that we’re all going to get even more friendly as we continue on knowing this is not the last hearing that we’ve done.
So I really want to thank everyone. I’m actually a little embarrassed because I was actually being very proud that I would have gotten everybody out absolutely on time, but it is one minute late. So my apologies to everyone.
But on the other hand, we’ve made it five hours and it’s like an airplane, we almost landed on time.
UNKNOWN MALE #43: You know, this might be a world’s record, Simon.
SIMON COHN (ph): The five hours and almost landing on time?
UNKNOWN MALE #43: No, for the length of a conference call. Certainly for NCVHS I believe it is.
SIMON COHN (ph): Yes, well…
MARIA FRIEDMAN (ph): Objectives (ph). I mean everybody was engaged and had to stay engaged. It wasn’t one of those ones that you could sleep through.
SIMON COHN (ph): Well, actually I guess I kept calling on everybody, so that…
JEFF BLAIR (ph): And Simon, the airlines consider that, you know, as long as you’re within 15 minutes it’s considered on time, so declare victory.
SIMON COHN (ph): Well, sounds good. Listen, thank you, everyone, very much.
JUDY WARREN (ph) (?): Thank you, Simon.
SIMON COHN (ph): Obviously have a great weekend.
UNKNOWN FEMALE #26: Thank you.
UNKNOWN MALE #43 (?): I’m so excited to see you all again next week.
SIMON COHN (ph): That’s right. OK. Thanks a lot. OK. Bye-bye.
UNKNOWN MALE #43 (?): See you.
JUDY WARREN (ph) (?): Bye.
END