[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
Subcommittee on Standards and Security
September 2, 2004
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
P R O C E E D I N G S [8:15 a.m.]
DR. COHN: Good morning everyone, 8:00 is certainly early in Washington, D.C. I’m going to call this meeting to order, this is obviously a morning breakout session and hopefully we’ll be done in time that we can take a stretch and get some coffee and all of this before the main session starts at 10:00.
This is the Subcommittee on Standards And Security of the NCVHS, I’m Simon Cohn, chair of the subcommittee and national director for health information policy. I obviously want to welcome all of you, I want to congratulate you all on I think what has been a signal achievement though we aren’t quite there yet, but I was reviewing the letter and it didn’t seem like we had that many changes which I thought was reassuring. I obviously also want to just acknowledge Jeff in particular who without his work plan and his drive on all of this stuff, I mean we would not be here, we would not have had this letter done, so Jeff I really want to thank you and just acknowledge you.
Now as I understand it we are actually not on the internet today which means we are being recorded but people can’t call in and ask us questions so it’s probably okay. However as having said that of course this is an open session, we don’t have many people this early in the morning.
DR. HUFF: Only the really faithful fans —
DR. COHN: That’s right, I woke up this morning and I’ll tell you, I had some issues myself.
Anyway, what we’re going to do this morning is obviously go around and do introduction as we normally do, obviously if there are issues coming before us today for which you need to recuse yourself around please state in the introductions. Then we’re really going to try to handle two things, one is to go through the letter and look at edits, I think some of them we’ve got right, some of them need to be, this is obviously our job to sort of fix this up for the full committee and get this thing passed today. And then we need to start, I mean believe it or not we need to take a deep breath and we need to reflect on both the upcoming hearing for October as well as, and maybe this is the final act in relationship to the letter, is to look at all those next step items and see where the priorities are. So I think if we can do that I think we will have really done a good morning’s work and then we can do other work starting at 10:00.
Well, with that Stan do you want to lead off the introductions?
DR. HUFF: I’m Stan Huff from Intermountain Health Care and the University of Utah in Salt Lake City, member of the subcommittee and member of the committee. And if we talk about HL7 I would need to recuse myself, actually LOINC too but it doesn’t come up so much here.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, vice chair of the subcommittee.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.
MS. AMATAYAKUL: Margaret Amatayakul, independent consultant.
MR. LOCALIO: Russ Localio, I’m a member of the committee.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, member of the committee.
MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the subcommittee.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, I would also need to recuse myself if questions come up about HL7 and I’m a member of the subcommittee.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MR. KASPER(?): Andrew Kasper, FDC Reports.
MR. ROTHERMICH: Phil Rothermich, Express Scripts.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, committee staff.
MS. ADLER: Jackie Adler, NCHS and staff to the committee.
DR. COHN: Okay, and welcome everyone. I always obviously want to thank Margaret A. for her diligence in terms of getting us to this point as well as Maria, there you are, for keeping us on track as we move forward.
Now obviously this is open session, we are not on the internet but this still is open session as we’ve done historically. I really think that the main work right now is to work through the letter, make sure, look at the changes, make further modifications —
DR. HUFF: How many more times are you going to make us read this?
DR. COHN: I was saying the same thing to myself this morning. I think the answer is until we get it right, but we’re pretty close —
PARTICIPANT: You do know that we’re at 38 revisions.
DR. COHN: I actually stopped counting, actually the thing that bothered me was the fact that we were on our tenth work plan, but we all have our issues that bother us. Margaret?
MS. AMATAYAKUL: I have a question. How do you want to present this for this afternoon, do you want me to clean it up as we go, if we accept things, or do you want me to leave it in redline for them —
DR. COHN: It needs to be left in redline because I think everybody’s accepted everything, what we need to do is go through and show them the changes to the initial letter and so redline has to be the way it is.
MS. AMATAYAKUL: And do you need printed copies of that for everybody?
DR. COHN: Yes.
MS. AMATAYAKUL: Will do, okay.
DR. COHN: I think it’s actually unclear about whether it will be this afternoon or this morning, that I think be a negotiated item with John, and as I say that I haven’t really looked at the agenda to see, I know we have some time in the morning for various reports —
MS. GREENBERG: I think it’s not until —
DR. COHN: I think that if this letter doesn’t get handled until 2:00 p.m., which is where the agenda is right now and John’s already announced a 2:30 adjournment, I think I would be concerned. That isn’t something we need to fix right this second since John isn’t here.
MS. GREENBERG: We have one set of speakers at 11:00 but other then that —
DR. COHN: And then we have a speaker at 1:00.
MS. GREENBERG: No, that unfortunately the NIH roadmap was postponed —
DR. COHN: Oh, okay, well maybe there actually is time this afternoon.
MS. GREENBERG: So then you’ll be right after lunch I guess.
DR. COHN: Well, under those circumstances we may be okay, but we’ll figure this all out. Anyway, but yet, I think we need to leave it redlined, there aren’t that many redlines here, I think everybody needs to clearly see the areas that we were in contention yesterday, and obviously we need to go through them ourselves at this point, as you come in you’re seeing additional changes also.
So Margaret, do you want to lead us through the changes that have been proposed for the subcommittee to accept or further modify.
MS. AMATAYAKUL: In the first sentence of the letter identifying NCVHS has been called upon by MMA to develop recommendations for uniform standards to enable electronic prescribing we added in ambulatory care.
MR. BLAIR: Fine.
DR. COHN: Steve has his hand up.
DR. STEINDEL: Yeah, I just have a question, I don’t mind the change or anything, but can prescribing be done outside of ambulatory care? Then it’s a drug order and it’s a different type of environment, I mean I have no problem with adding the word, I was just asking from an informational point of view.
MR. BLAIR: You’re probably correct.
DR. COHN: I think it’s, I think when you start talking about the world of e-prescribing, at least to my view, I think I’ve thought about it as not something that is necessarily separate from CPOE in a hospital and so I think this clarification of the world, I mean it may not be 100 percent necessary but given that people started asking it from the first sentence on and it does I think create for everybody the sphere that we’re talking about —
DR. STEINDEL: I totally agree with that and like I said I don’t have an objection to it, I was just asking as an informational question.
DR. COHN: And I guess Jeff I should ask you because you had issues with this wording yesterday, I think it actually looks okay.
MR. BLAIR: It’s fine.
DR. COHN: Okay, super.
DR. WARREN: I was just going to say that I think it’s fine to clarify it but again, it’s beginning to split hairs I think and make it difficult, and I was just responding from a standards perspective, from a standards perspective there’s no difference.
DR. COHN: Okay, so you’re saying that —
DR. WARREN: I’m fine with it.
DR. COHN: You’re fine, okay, good, that’s what I was hoping you were going to say.
MS. AMATAYAKUL: The next area that we changed went all the way to the standards evaluation process, so unless anybody has anything prior to that. In the guiding principles for selecting standards section we had in making its recommendations NCVHS utilized the guiding principles and requirements identified in the MMA, which we listed, we then added a statement that says these elements also align with the dimensions of care identified by the Institute of Medicine that care be safe, effective, efficient, timely, patient centered, and equitable, and that’s attributed to the Institute of Medicine Crossing the Quality Chasm.
MR. BLAIR: How did that, that’s something that I wasn’t aware of, how did that get submitted?
MS. AMATAYAKUL: Dr. Carr, Justine added that.
MR. BLAIR: Well, I think it’s, I am not going to objective to it in the sense that there’s no harm done but I don’t know that that was part of our guiding principles so, whatever the rest of the committee decides to do.
DR. COHN: Well actually we have a couple of options here because I don’t think there’s anything wrong with the sentence, we do have an option about whether it’s actually in the body of the text or as a footnote.
DR. STEINDEL: I kind of feel a little bit like Jeff, not part of our guiding principles but it is important and a footnote would be, just put a note and put the whole text of that as a footnote with the Institute.
DR. COHN: Yeah, do others, in sort of looking, Mike’s nodding his head yes —
MR. REYNOLDS: Putting in a footnote says we were aware of it but we were not driven by it.
MS. GREENBERG: My sense was that Justine was making this as an observation rather then a suggestion that it should actually be put into the letter, but I think as a footnote it’s fine.
DR. COHN: I think the only question then is what we footnote it too here.
MR. BLAIR: We could footnote it to the phrase guiding principles.
DR. STEINDEL: For the first sentence of the paragraph.
MS. GREENBERG: Just right there at the colon I think.
MS. AMATAYAKUL: I’ll clean it up. The second minor edit was to spell out ANSI, in addition NCVHS believes the standards should be vendor neutral and technology independent, preferably be developed by standards development organizations accredited by the American National Standards Institute and have suitable indications of market acceptance.
The next change was in Observation 3, prescription messages, with respect to fill status notification, and we reworded the last sentence, the fill status notification is not used today. Testimony revealed that there may be business case, clinical utility, and individual privacy rights implications, and in the recommended action 3.2, HHS should include the fill status notification function of the NCPDP SCRIPT standard in the 2006 pilot test. These tests should assess business case, clinical utility, and individual privacy issues. Maybe I should say privacy rights issues.
MR. BLAIR: One piece on that, I’m generally satisfied with that, certainly I’d like to see all of that happen, I’m a little bit sensitive that we don’t wind up putting recommendations forward that HHS may not be able to totally achieve within their timeframes, so if Maria is here I’d like to ask her opinion as to whether we should add an if possible, or if there’s something there where that could be closer to maybe reality or achievability, something where we could make it more accurate or something like that. Maria, are you here?
MS. FRIEDMAN: I’m here. On one hand I mean these are recommendations, and so to the extent that we can address them all, they are recommendations. Whether they’re totally doable or not, probably not, in the timeframes that we have.
DR. COHN: But let’s go back, I think that this isn’t right at this point so let’s see if we can fix this. Maria, did you have your hand up just in general? And then Marjorie?
MS. FRIEDMAN: I’m concerned about privacy rights, I would just make it privacy, take rights out in both places.
MR. BLAIR: The word rights, just say privacy issues or privacy considerations.
MS. GREENBERG: Well, I just have a problem with that sentence —
DR. COHN: I’m having trouble with both sentences so let’s see if we can fix these things.
MS. GREENBERG: I’m fine with the sentence of fill status notification is not used today, I think that’s clear. You’d have to say something like testimony revealed that this component of the standard or something, it doesn’t make sense the way it is.
DR. COHN: Okay, let me try it and others can chime in here. I said testimony revealed that there were questions regarding business value, clinical utility, and there were also questions about possible privacy implications.
MS. GREENBERG: For this part of the standard.
DR. COHN: Well, yes, in relationship to that, I mean somehow we need to relate to that, but is that sort of what we’re talking about here?
DR. STEINDEL: I would be happy with that type of wordsmith —
MR. BLAIR: Yeah, it makes it a complete sentence.
DR. COHN: So there were questions about business value and clinical utility —
MS. GREENBERG: Of this standard as well as —
DR. FITZMAURICE: Associated with fill status —
MS. GREENBERG: As well as individual privacy implications —
DR. COHN: As well as possible privacy implications —
MS. GREENBERG: Issues?
DR. COHN: Possible privacy concerns?
MR. REYNOLDS: Considerations.
MS. GREENBERG: Any of the above.
MR. BLAIR: Concerns or issues.
DR. HUFF: Don’t you need something on the end that says like with use of this transaction or something like that.
MS. GREENBERG: I think you’ve got have something in there that ties this to the fill status, for this feature or something.
DR. COHN: Still not quite —
MS. FRIEDMAN: Instead of having all that hanging at the end it needs to be moved up, there were questions, it would be used in the fill status notification concerning business value and clinical utility as well as possible privacy issues or something, you don’t want concerns twice in that sentence.
DR. COHN: Wells, let’s see, obviously we try to stay away from wordsmithing but this is sort of now or never wordsmithing, so let’s get this right. So basically the fill status notification is not used today. Testimony revealed that there were questions about the use of the fill status, no —
MS. GREENBERG: Maybe about the business value and clinical utility of the fill status notification as well as possible related privacy concerns, I’m okay with that.
DR. COHN: Okay, so let’s read it over and see if we like it.
MS. AMATAYAKUL: The fill status notification is not used today. Testimony revealed that there were questions about the business value and clinical utility of the fill status notification as well as possible privacy concerns.
DR. COHN: Okay, now should that be the last two sentences of this paragraph or should this be a separate, those last two sentences, should that be separated from the rest of that paragraph —
MS. GREENBERG: No, I think you’re ticking off all the different functions, I think it’s okay.
DR. COHN: Okay, are we okay with that? I see everybody nodding their heads, okay, let’s take a look at the recommendation there.
MS. AMATAYAKUL: These tests should assess business case, clinical utility, and individual privacy concerns.
DR. COHN: That’s still not right, should assess business value and clinical utility? What do we do, I mean privacy concerns is sort of an odd one, how do we assess privacy concerns?
MS. GREENBERG: These tests should assess business case, clinical utility, I thought we were talking about patient acceptance or something.
DR. COHN: I think that’s later on, and so basically these pilots should assess the business value and clinical utility and identify any privacy concerns —
MR. BLAIR: I don’t think we want to identify, but if you did evaluate and then you had issues, because people may not raise concerns or not but we want to evaluate the privacy issues.
MS. GREENBERG: — privacy issues, explore —
MR. ROTHERMICH: Just a comment, Simon, Phil Rothermich, I think if you’re going to have privacy issues you’re going to have to deal with those before the pilot because that may implicate whether you can include it in the pilot, so I don’t know that the privacy issue is a piece for the pilots, I think that’s something that needs to get resolved before you pursue it.
MS. GREENBERG: Well, unless you include it in some kind of patient acceptance —
MR. BLAIR: And in a sense if we put it here, Phil, I think, or at least I’m assuming, folks from CMS could verify this, that if we put it here that as they plan what will be in the pilot tests they will be taking a look at how do they measure each of these things or identify these things. So I think it will be achieved as you properly indicated.
DR. COHN: Still not right though. Let’s see, these tests should assess the business value and clinical utility, we’re okay on there —
MR. BLAIR: You want to break into a separate sentence and then just have another additional sentence with respect —
DR. COHN: I don’t think it matters but let’s see, we just haven’t figured out what we need to say about these, I’m not sure what the right answer here is but we don’t have it yet, so I’m looking to others, Harry?
MR. REYNOLDS: Yeah, I want to make, the issue of privacy is not just related to this, I mean we get to a later on medication history we’ve got exactly the same, because I can tell you, if we’re telling them that there are privacy concerns on the fill status, you’ve got huge privacy concerns because medication history trumps fill status philosophically so I want to make sure that as we’re going through here, if we’re going to say something about privacy in these recommendations, which we should because we obviously care about the privacy, but putting it here, because if each of these is looked as an individual piece and not really looked at, whatever we come up with, whatever standards we come up with or they adopt privacy should be overlaid on them, period, is my feeling, not necessarily just beating one or another kind of death, because I think it’s really, the privacy issue pervades throughout e-prescribing, not just fill status, which is the only place we’ve mentioned it so far. And then we go into medication history, then we go into some other things, so I’m not —
DR. COHN: Well, let’s as we go through figure out where and how and whether it’s in the pilot objectives or somewhere else, whether it’s in the introductory text to the observations and recommendations. Margaret has a comment, Steve has a comment, I have some —
MS. AMATAYAKUL: Yesterday we talked a little bit about potentially moving Observation 13, which is the pilot test, to be this third item under general. And I wonder if that isn’t appropriate and that we include the privacy up there. I didn’t make the move but we talked about it a little bit yesterday.
MS. GREENBERG: During the meeting?
MR. BLAIR: Yeah, we did. My thoughts on that, I’d prefer to leave it where it is, not because it’s not general, I think it is correct, that it is a general topic, whoever, I think that some of the things we talk about when we start to get to the pilot test won’t be really understood or appreciated until the reader has read through a lot of the other issues.
DR. COHN: Let’s fix this one and then figure out, I mean I think we need to look through the observations and recommendations and then figure out where privacy, where additional comments go. Steve?
DR. STEINDEL: Yeah, we discussed this yesterday a little bit in the committee meeting and we are going to have focused hearings on the whole question of privacy and e-prescribing and we’re assuming that letters addressing the privacy concerns of e-prescribing will come out of that and influence both the pilot studies and the program. Because of that subsequent work, which appears as future work to be done in this letter, and is spelled out fairly clearly, I think what we should do at this point is identify in the observations that we’ve observed some privacy implications but in the recommendation for this letter we don’t say anything and remain mute and allow the privacy letter to address those specific fill status concerns. The observation puts the Privacy Subcommittee on notice that they need to look at this.
MS. GREENBERG: I have a variant on that. Well, two things, I’m sorry to go back but I think the reason that you had this problem here is because it seemed to be kind of out of place with the fill status notification. I think if you just said the fill status notification function, because you’ve referred to the function of each of these others above, each function has varying degrees, this function, that function, so I’d say the fill status notification function is not used today, I think then it would seem to be part of it.
Then I would suggest that what you do here is say that the pilot, these tests should assess business value and clinical utility, and then say separate hearings are planned to address privacy issues and concerns. So don’t pin it on the pilot tests but I think if you’re going to note it in the observation you have to say something down here in the recommendations so you could just say that hearings are planned —
DR. COHN: Well, let me ask, because I was actually going, I don’t know that that’s the place to put that particular comment, but leave it there for the moment and let’s discuss it, my own sense was that for right there we need something like as well as further evaluate privacy issues and possible mitigating strategies, which would be something reasonable to do in a pilot, mitigating strategies, possible mitigating strategies, whatever. And that would be what I think we need to stick there but I would ask others for whether that’s an appropriate, but then the question is is where we start saying privacy issues. Judy?
DR. WARREN: Yes, I was going to follow-up on what Marjorie said except instead of having a separate hearing sentence up there in observation I would make that a footnote in the bottom, because if it’s up there in the observation and it calls attention to it and you want to have to address it down in recommendations, and I don’t think we want to get into privacy in these recommendations for fill status. All we want to do is test that particular message, but we’ve put it in a footnote that that will be later, and then at the end of the letter when we do talk about privacy you kind of get a background of where it’s coming from. I’m just concerned that in the discussion that went on yesterday this was the first recommendation where privacy came up and people were jumping on it on the first one, and then that didn’t happen in later ones, and so for it just to happen for this one function to me is undue influence on this function and we don’t want to draw to it.
MR. BLAIR: I agree.
DR. COHN: Well, it’s hard to take back all the discussion Judy.
DR. WARREN: But I think we, what they were concerned with is that we weren’t talking about the privacy implications —
DR. COHN: Literally, this is what Harry’s talking about. Okay, well I guess the question is, let’s stop for a second and figure out how we’re going to, I mean I guess the question I’m having is is there someplace early on where we need to make some comment that doesn’t overwhelm the rest of the document, and I don’t know that a footnote or at the end is exactly where we bring it up the first time. Steve?
DR. STEINDEL: Simon, I don’t have a problem with discussing the privacy implications of fill status notification in the observations, and maybe even making a note like we did here about the recommendations, because I think the privacy implications that were pointed out to us with regard to the fill status notification are different then the privacy implications of a lot of other parts of e-prescribing which are very, very similar to what we see in general with HIPAA. So I think there’s some separate things that they need to look at here.
DR. COHN: Okay, I mean Harry, I feel like even though you haven’t raised your hand you have a comment I’m sure.
MR. REYNOLDS: And I’m fine with that, but I have equally the same issue when we get to medication history, which is dramatically more of an impact and there’s nothing in the letter focusing on privacy on that piece. So all I’m saying is we either do it generally because when this is all pieced together, and some may be done in pieces, when it’s all pieced together there’s a privacy influence that has to be considered. So I’m find if we want to note it but then I want to note it in the other places that probably have more of a direct focus on that person then the fill status. The fill status is minimal, if I’m going to tell the doctor every drug that I got from another doctor versus arguing whether they told me whether I filled it or not, that’s a huge difference in my opinion.
DR. STEINDEL: Harry, where I see the difference between the two is depending on how they use the fill status notification, if they actually use it in the sense that the patient picked up the drug, this is providing information on the way the patient is handling their medical care that goes beyond what we’re providing today with respect to HIPAA and has direct privacy implications.
Now when we’re talking about transmitting medical history between —
MR. REYNOLDS: Medical history.
DR. STEINDEL: — medication history between care providers or between the person, the payer, the PBM, etc., who may be housing the medication history or the pharmacy, the dispenser that’s housing the medication history back to the care provider, that’s still within the present domain of HIPAA privacy, that is for the purpose of medical care. And I agree with you, there are different types of implications but it’s still under the basic rubric of HIPAA privacy.
MS. GREENBERG: So is fill status —
MR. REYNOLDS: The point to me is that when I tell that the doctor that the person didn’t pick up, when I download the medication history and the prescription that he or she wrote is not in there because the person didn’t pick it up I told them the fill status. I didn’t tell them the fill status at the moment but I told them the fill status three days letter, so I’m saying they really interject.
DR. COHN: Maria, do you have a solution here?
MS. FRIEDMAN: I agree with Harry that we probably need to tee up this issue up front somewhere, and I’ve been looking for a place to put it, and there’s really no god place to put it but one possibility is under observations and recommended actions and then add a separate, go through what we’ve done and blah, blah, blah, and then just say the NCVHS knows that there may be overarching privacy issues involved with e-prescribing, these will be addressed in other hearings or something like that.
MS. GREENBERG: Well, you’ve got general standards compatibility, and of course one of the standards of HIPAA is privacy, so you could just make it a second observation with a recommended action that hearings be held.
DR. COHN: I don’t think that’s on the level of the same observation but I do think it is a —
MS. GREENBERG: It could be under the guiding principles.
MS. FRIEDMAN: Well, it wasn’t one of our driving principles, it’s the same issue we had with Justine’s issue, while it’s related it wasn’t among the core set and I think given the level of concern in the discussion we heard yesterday I think it deserves a sentence or two somewhere —
MS. GREENBERG: How about types of standards and important related issues?
DR. WARREN: Right, because it looks like it would fill, if we put it as the last paragraph under that so right above this section.
DR. COHN: Isn’t there where it is? You’re not saying, I mean it looks like it’s about right where it is right there —
DR. WARREN: Put it right above observations and recommended actions.
DR. STEINDEL: I see where Judy’s going and I think that makes sense.
MS. GREENBERG: It would be before that last sentence, because it says, the last one, work flow, it says outside the scope of standards but are important related issues, so I’d say you’d put it above that because this isn’t outside of the scope.
I’m going to have to go to the Quality Workgroup but I have confidence in all of you. If you actually want to run anything by me you can send Susan down to get me okay?
DR. WARREN: Does that mean that we take it out of the recommendation and leave the recommendation the way we originally had it?
MR. BLAIR: — redundancy on this because apparently we want to call special attention to this because it is a new type of privacy issue that we haven’t encountered before, it’s dealing directly with the patient not within the institution, and then in addition it sounds as if we want to indicate an overall concern about privacy which will be addressed in additional hearings.
DR. COHN: I don’t know where we want to look at, whether we want to finish up three or whether we want to go back up to where we’ve done and Margaret is moving back and forth here. Why don’t we go back up to where, I mean the overarching is more important that we get this right now both in placement and in terminology.
Now the question is, it is says the NCVHS notes that there may be overarching privacy issues involved in e-prescribing which will be addressed in subsequent testimony and recommendations, now is that what we want to say or do we want to say that there may be particular privacy issues? Or unique privacy issues?
MR. BLAIR: Why don’t we say that there are privacy issues uniquely related to e-prescribing that we would be exploring, or especially related to e-prescribing.
DR. COHN: Which will be addressed in subsequent testimony and recommendations —
MS. FRIEDMAN: Subsequent hearings?
DR. COHN: Subsequent hearings and recommendations. Now are we comfortable with this sentence? I’m actually sort of looking at Russ for a second just to see if this —
MR. LOCALIO: I agree that it needs to come up here, I agree that by putting it with just the fill status as Harry said —
DR. COHN: It’s too small, yeah.
MR. LOCALIO: There probably needs to be repeated however at the end when we’re talking about pilot testing because this is a part of pilot testing, patient participation.
DR. COHN: Okay, well let’s make sure we have this wording in this sense right, and Richard I’m actually, I know you’re waking up this morning but since you’re on the Privacy Committee also I want you to take a look at this one and see if this, since you’re part of the team as am I and Harry that’s going to be holding hearings in this area, this is early in the discussion, right before we go to observations and recommended actions. Let Richard look at it for just a second first —
DR. HARDING: That would be in blue there? To clarify, that seems reasonable.
DR. STEINDEL: When we put in and recommendations we’re presuming that the hearings will result in recommendations. Now I haven’t seen a Privacy hearing that hasn’t resulted in recommendations but I would just say hearings.
MR. LOCALIO: One suggestion, it’s not that there may be, there are privacy issues, we know that, Harry’s already articulated —
DR. STEINDEL: I think Russ is right.
DR. COHN: Well, I guess the question is we know, well, let me wordsmith here for a second, are there issues or concerns?
MR. REYNOLDS: Or considerations?
DR. COHN: Or considerations, because I’ve heard things, I don’t know whether they’re issues or concerns at this point.
MR. REYNOLDS: There is a HIPAA privacy law and there needs to be consideration as to whether this new process for e-prescribing brings new issues to the table, not that they are there, that needs to be evaluated against what’s already there to decide if it does or doesn’t fit. So I’m not ready as a committee to say there are absolute issues, there are things that need to be considered and balanced directly against what the current law is and if there are issues then fine, we need to find those in the hearings.
DR. STEINDEL: And I think that’s why I was leaning towards dropping out the words and recommendations because you could go through the hearings and we could hear gee, everything fits under the rubric of HIPAA privacy.
MR. REYNOLDS: I think Simon I am comfortable, I’ve said a lot so I’m just letting you know I’m comfortable —
DR. COHN: Is it considerations, is that the right word? Margaret continues to wordsmith as we talk so we just need to make sure that we’re, is it considerations, considerations. Now, is it addressed in subsequent hearings or needs to be investigated, I mean it isn’t what needs to be investigated, which will be explored —
MR. BLAIR: Explored or investigated, I think either word would be fine.
MS. FRIEDMAN: I like explore better, more active —
DR. WARREN: I like investigated better —
DR. COHN: Okay, which will be investigated, okay, should we say, the NCVHS notes that there are privacy considerations uniquely related to e-prescribing which need to be investigated in subsequent hearings. This is still not right —
MR. LOCALIO: — NCVHS will —
DR. COHN: Which NCVHS will —
MR. BLAIR: One other piece, would you feel okay instead of subsequent hearings if we wind up saying that they will be investigated in the hearings that will support, that will be prior to our recommendations March 2005, it sort of I think reflects our priorities that we’ll make sure we’re going to be having those hearings of March of 2005.
DR. COHN: Steve’s not talking but he’s making all these facial things, so let’s hear his comment.
DR. STEINDEL: Well, first of all I think we should just say which will be investigated instead of using NCVHS twice in that sentence right next to each other.
DR. COHN: Let’s say which we will investigate.
MS. AMATAYAKUL: We haven’t used we before —
MS. FRIEDMAN: Which will be investigated at subsequent hearings.
DR. STEINDEL: And while I agree with Jeff that we want the results of this before we do our March but basically we’ve somewhat turfed this to the Privacy Subcommittee and —
DR. COHN: We have a quorum of the Privacy Committee here and this is based on the conversations we had from 3:00 to 4:30 yesterday, I think there was an agreement that we would —
DR. HARDING: Yeah, there are four of the five of us here.
DR. STEINDEL: If they want to commit themselves to results before March I think that’s up to them.
DR. COHN: How about this and that’s why I actually have Richard at the table with us, the NCVHS noticed that there are privacy considerations uniquely related to e-prescribing which will be investigated in subsequent hearings and reflected in our March recommendations, March 2005 recommendations.
MR. REYNOLDS: I think that’s very solid.
DR. COHN: Okay, I just want to make sure that everybody is sort of, fix the privacy, all of us in the privacy side our nodding our heads —
So now let’s go down and look at what we have here, now we actually had, the observation was, we had it right and then somehow it changed. Let me read to you what we have right now and it’s got a problem. We have testimony revealed that there were questions about the business value and utility of fill status notification, in addition there are privacy concerns raised, and it used to be one sentence and the privacy concerns directly related to the fill status notification, now it sounds like there’s a general statement in relationship to the entire paragraph, and I don’t know what, I’m just not sure, we had something there before, what did we have there before —
MR. REYNOLDS: I think we should return it to the sentence, business case, clinical utility, and you changed business value —
DR. COHN: Questions about business value and clinical utility —
MR. REYNOLDS: Clinical utility and privacy, period.
DR. COHN: It’s still not right.
DR. WARREN: Take out the word the in front of business, then I think it reads better.
DR. COHN: I mean we still don’t have this right though, as well as, no it isn’t privacy implications, or is that, I mean are we okay? This is the problem of ongoing wordsmithing is we may like the previous version but we don’t seem to be holding it. Testimony revealed that there were questions about business value, okay, we used to have this relating specifically to fill status notification and now we’ve sort of lost that —
MR. BLAIR: This function, do you want to refer to this function because the sentence before is fill status notification isn’t it?
DR. COHN: Let’s say it explicitly so that people don’t think of this function as the whole NCPDP SCRIPT. Okay, this is actually looking better, so hold for just a second Margaret, let’s read this and see if we’ve gotten close here. Testimony revealed that there were questions about the business value and clinical utility of the fill status notification function as well as, maybe it’s as well as possible, it’s either as well as privacy concerns, or is it possible privacy issues, what do we want to say there?
DR. STEINDEL: I like possible privacy issues.
MR. REYNOLDS: I do too.
MR. BLAIR: Potential instead of possible.
DR. COHN: No, I think possible actually may be okay there. Margaret, do you want to just read it over again before changing it any further here?
MS. AMATAYAKUL: Testimony revealed that there questions about the business value and clinical utility of the fill status notification function as well as possible privacy issues.
DR. COHN: Are we okay?
MR. BLAIR: Sold.
DR. COHN: Okay, now in recommendation 3.2 just to marry with that, and it really should be these pilots rather then these tests, these pilot tests, maybe that’s okay. These pilot tests should also assess the business value and clinical utility as well as further evaluate privacy issues and possible mitigating strategies, so I think that begins to marry closer but it’s sort of like we need a little bit, the pilot test should also assess the business value and clinical utility of something.
MR. BLAIR: Well, if you didn’t have an and between business values and clinical utility and you had a comma there then maybe you can wind up having the and after that before the privacy piece and it would flow better.
DR. COHN: Actually no, it’s just that we don’t know what it relates to, well actually —
DR. STEINDEL: It’s in the sentence before.
DR. COHN: I apologize, this gets down into English and I’m —
MS. AMATAYAKUL: HHS should include the fill status notification function of the NCPDP SCRIPT standard in the 2006 pilot tests. These pilot tests should also assess the business value and clinical utility of the fill status notification function as well as evaluate privacy issues and possible mitigation strategies.
DR. STEINDEL: That’s good, I’m fine but I think the second fill status notification is redundant.
MR. BLAIR: It may be but you know, people will understand what it says.
DR. COHN: Okay, anybody have comments? Harry?
MR. REYNOLDS: Once you complete this I want to talk about the words pilot tests, the reason is, they can stay here but Gene left a question yesterday that I think affects any time we use pilot tests.
DR. COHN: Gene did?
MR. REYNOLDS: Gene Lengerich, who was, he pulled out the legislation and the legislation says a pilot test, so as we go through here we continually say pilot tests so he just mentioned, since he’s not going to be here today, he mentioned that that at least ought to be discussed by us as to whether or not, and I defer to everybody else —
MS. FRIEDMAN: Our lawyers tell us that that doesn’t preclude us from doing more then one.
DR. COHN: Well, do we want to put pilot test and then in parentheses (s)?
MR. BLAIR: That’ll do it.
MS. AMATAYAKUL: Throughout the whole letter?
DR. COHN: I think probably.
DR. STEINDEL: I think we should just defer to what Maria just said.
MR. REYNOLDS: And that’s what I was hoping would happen, I hope.
MS. FRIEDMAN: I say pilot tests is fine.
MR. REYNOLDS: But since it was brought up by a member of the committee who couldn’t be here I wanted to make sure that we didn’t keep going with this and then somebody else bring it up at the full session.
MS. FRIEDMAN: We’ve had a lot of discussions about pilot, do you have one giant pilot that tests everything in the world and then comes up with nothing because it’s too big, or do you break it up and a lot of it will depend on the participating PDPs.
MR. REYNOLDS: That’s great, I just wanted to make sure we didn’t get caught on that one.
DR. COHN: Okay, so let’s just take a final look at that sentence here before we move on and then hopefully we’ll be able to move to the next issue.
Now my one question on Action 3.2 and let’s just read it, HHS should include the fill status notification function of the NCPDP SCRIPT standard in the 2006 pilot tests. These pilot tests should also assess the business value and clinical utility of the fill status notification function as well as evaluate privacy issues and possible mitigation strategies. I guess the one question I would have is is the word also the right word we want to have there or we should say these pilot tests should assess the business value and clinical utility, is that really what we want, yes —
MS. AMATAYAKUL: I added also because the standard itself is not fully used and ready so you’re testing the functionality of the standard as well as these other issues.
DR. COHN: Yeah, I guess the word also just doesn’t seem to relate to anything that we have said anywhere.
DR. STEINDEL: Margaret, I think that’s a subtlety that will be lost on people reading the letter.
DR. COHN: Okay are we comfortable now we got rid of the also? Everybody okay? Good to go? Let’s continue on.
MS. AMATAYAKUL: In Observation 6 relating to eligibility and benefits messages I took out the lengthy reference to the version and put those in footnotes and spelled out ASC as Accredited Standards Committee. But you should observe that in Recommendation Action 6.1 I left the full version in because it was important to make sure that we had the version as opposed to some other version.
DR. COHN: Fine.
DR. STEINDEL: I object, I liked to see Simon fumbling over reading it yesterday.
MS. AMATAYAKUL: I did the same in Observation 7, prior authorization messages, and then I added two sentences to help address the issue that was raised yesterday about how ready this was, it is estimated that two percent of prescriptions require prior authorization and that there is a disproportionately higher rate for Medicaid payers. This provides a natural body of experience from which to draw data for study of economic and quality of care impacts.
DR. COHN: Yeah, Steve?
DR. STEINDEL: Can we put a temporal it is estimated that two percent of prescriptions now require?
MR. BLAIR: Good.
DR. COHN: And we had testimony that all said that?
MS. AMATAYAKUL: Yes.
DR. COHN: Okay, are we comfortable with that? I see heads nodding, okay.
MS. AMATAYAKUL: In Recommended Action 7.2 HHS should support standards development organizations and other industry participants in developing and testing prior authorization scenarios in the 2006 pilot tests. This would help determine the proper flow of prior authorization information throughout the entire communication process, including NCPDP SCRIPT Telecom and SCRIPT standards, NCPDP Telecom and SCRIPT standards and the ASC X12N 278 standard.
DR. COHN: I guess I have a little question here and this may be more wordsmithing, I don’t know that we test scenarios, I think we’re developing prior authorization scenarios to be tested in the 2006 pilots, or is that, or maybe it’s to be used, these really aren’t tested, they’re used, right? I mean help me with, used in the 2006 pilot tests —
MS. FRIEDMAN: How about evaluated?
DR. COHN: Well the problem is that we aren’t evaluating the scenarios, we’re using the scenarios to evaluate everything else, I mean they’re sort of the —
MR. BLAIR: Simon? I acknowledge that that language might be more precise but I feel as if people do understand what this is communicating —
DR. COHN: Well, Jeff, the reason I’m bringing it up is that there were questions yesterday about scenario —
MR. BLAIR: Oh, there were questions about it?
DR. COHN: Yes, that’s why we’re looking at this area —
MR. BLAIR: Alright then, what I say is not true.
DR. COHN: And people had issues around what the check scenarios were and what we’re talking about here. Steve and then Judy, and I’m not sure I have the right answer here but that’s why we’re wordsmithing this piece.
DR. STEINDEL: Simon, why don’t we say in developing prior authorization scenarios for the 2006 pilot tests?
DR. COHN: That sounds fine. Judy?
DR. WARREN: One of the concerns I had, and this was one of the points that Vickie brought up yesterday, is she did not understand how developing scenarios would help us and so we added to test in response to her request to show that, so that’s how the to test got up there, because I agree with you, you really don’t test scenarios, but I just wanted bring that back, that was something that Vickie had asked to be added.
DR. COHN: And maybe rather then using this maybe its use of the scenarios would help determine —
DR. STEINDEL: Or just say developing prior authorization scenarios for evaluation in the —
DR. FITZMAURICE: Would it help to replace scenarios with functions? Do test functions?
DR. STEINDEL: No, these are actually, I think these are more scenarios because we’re not sure of —
DR. COHN: What exactly goes on.
DR. STEINDEL: What exactly goes on.
MR. BLAIR: So maybe its, if you wind up saying the developing the scenarios to help us test the appropriate functions.
DR. WARREN: That may be better and I think Vickie would understand that one, that approach better.
DR. COHN: I’m looking up there to see what we’re getting.
DR. STEINDEL: To help design the 2006 —
DR. COHN: To help design, okay, now let’s see if, the next sentence doesn’t hang together any longer, it probably never did but it’s becoming increasingly clear so let’s take a look. I think Phil has a comment, he’s come to the table —
MR. ROTHERMICH: I don’t know what the answer is but just an observation, the scenarios are going to come out of the benefit decisions that HHS makes with respect to Medicare so what they test are going to be related to drugs that they decide to put on prior auth and so I’m not sure that referencing, scenarios to me sounds like something in a vacuum and that’s not really the way it will work.
DR. COHN: Well how would you use the term if you were doing this with things that weren’t Part D?
MR. ROTHERMICH: I guess what I’m thinking is is what you’re suggesting here is that they test the use of e-prescribing to automate prior authorization I think.
DR. COHN: Steve, Maria, Judy.
DR. STEINDEL: Phil, I think in this case we actually are talking about scenarios because you’re talking about one specific aspect of prior authorization which is dependent on the drug that we’re asking for prior authorization for where we will have a flow sheet and a set of steps. We also heard things about how the prior authorization process works and we need to develop scenarios for that, does it go from the prescriber, if it goes from the prescriber to the PBM does it now flow into the dispenser so they know prior authorization has been received, if it goes from the prescriber without prior authorization to the dispenser and the dispenser has to get prior authorization how does that flow, so I think there’s also work flow scenarios that are involved in this that need to be tested.
MR. ROTHERMICH: I didn’t appreciate that from this.
MR. REYNOLDS: Yeah, I agree with that.
DR. COHN: Yeah, and the reality of how this is all going to work is is that obviously PDP plans are going to have a fair amount of flexibility in how they actually choose to do that sort of thing, I mean it’s one thing to have a formulary, it’s a whole other thing to decide that certain things will be on prior authorization and how they’ll invoke it and all of that so it’s not going to look a whole lot, I mean it will look different then now but it won’t be CMS telling everybody how it’s going to be. So once again we’re back to the industry determining how best to do prior authorization.
I think Maria wanted to comment and then Judy wanted to comment.
MS. FRIEDMAN: I just wanted to piggyback on what you said that pilot tests really are focused on Part D, but in a broader context as you pointed out that different PDPs depending on where they are and how they’re structured and where their catchment area is for lack of a better term, there are going to be different ways that people are going to address these kinds of issues.
DR. COHN: Okay, Judy and then let’s see if we can come to a conclusion on this one.
DR. WARREN: Well I was wondering if the term scenario is what’s bothering us and I think most of us agree to this because in a standards development process most of the organizations start developing their standards by first creating a scenario of real world workflow and activity and then you begin to deconstruct that so that you can abstract it into a standard. So is that what we’re getting hung up on is the word?
DR. COHN: Well, do we have another word?
DR. HUFF: I think it would benefit from having workflow scenario there.
DR. WARREN: That may be what could clarify it.
MR. BLAIR: That’s good.
DR. WARREN: I’m just saying that we’re beginning to mix —
MR. BLAIR: Spoken like a true standards expert.
DR. COHN: Is that what we’re talking about here?
MR. REYNOLDS: Yeah, because I can think of three or four workflow scenarios, you’re going to have one standard but you’re going to have multiple workflow scenarios that you’re going to have to do to really understand if it isn’t, how CMS wants to do it in one standard.
DR. COHN: Okay, are we comfortable with that at this point? Let’s take a look at the next sentence, we have HHS should support standards development organizations and other industry participants in developing prior authorization workflow scenarios to contribute to the design of the 2006 pilot tests. Use of the scenarios would help determine the proper flow of prior authorization information through the entire communication process. I’m actually wondering whether we need that second sentence at all, it looks to me, I don’t understand it, I mean I sort of remember why we put it there —
MS. FRIEDMAN: Workflow covers all that.
DR. COHN: So are we okay, should we just get rid of all of that? Hey, that made life easier. Are we happy now? Okay, let’s go on.
MS. AMATAYAKUL: In Observation 9, clinical drug terminology, I added a bit of information about the DOD prescription information and what I have up here in yellow on the screen I actually changed from the version you have in front of you on paper, I’ll read the paragraph. The NDC is used by dispensers to identify package 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, Rx-Norm. Rx-Norm provides links from clinical drugs to their active ingredients, drug components, and most related brand names. Preliminary analysis of the prescriptions written by the Department of Defense found that within the first one thousand most common prescriptions written the NLM matched 974 to Rx-Norm concepts. And in a footnote I have the information about the remaining 26 prescribed items that did not match the Rx-Norm concepts were primarily medical supplies which Rx-Norm does not include, and drug delivery devices, for example steroid taping dose packs and oral contraceptives, which Rx-Norm is just starting to include.
While fairly comprehensive Rx-Norm terminology for all marketed drug products including generics, repackaged products, and over the counter medications will not be available under structured product labels for all those items become available to the NLM from the FDA the Rx-Norm contains sufficient concepts to be included in the 2006 pilot tests. When the SPLs become available it is the intent of the NLM to update the repository of drug information on a daily basis as in DailyMed. Additional until the full set of brand names is included in the Rx-Norm some dispensed as written prescriptions cannot be accommodated through e-prescribing.
MR. REYNOLDS: Margaret, help me with the word concepts rather then functionality, rather then capability —
MS. AMATAYAKUL: That’s a UMLS term, it’s actually called an Rx-Norm concept.
MR. REYNOLDS: No, I understand, but if somebody else reads it, a concept to me doesn’t say you necessarily map something, it’s a word but somebody else reading it, I want to make sure we have —
DR. HUFF: It’s the difference between lay use and expert use —
MR. REYNOLDS: That’s my point.
MR. BLAIR: In a sense it’s a technical term within the field of medical informatics because it’s winding up distinguishing between a term and the meaning of the term, and in the medical informatics community that distinction is made by saying if you get down to the concept, which is the meaning of the word, that it can be semantically specific. So I’m not saying that we don’t have a problem that we need to fix here but maybe we need to have footnote by the word concept where we’re winding up indicating the definition of the word concept within the medical informatics community to explain what I just said, maybe that would help?
DR. COHN: Well, there’s already a footnote there, I guess we can just expand it.
DR. HUFF: I would ask you what would be most, see I understand this fine the way it is because I’m used to using it in its more specific use but if anybody else is confused I’m happy to say something else there.
DR. COHN: Well, I think something in the, well, I think if it’s the right term that’s fine, it’s footnoted —
DR. COHN: You could say Rx-Norm code —
DR. COHN: It’s just a question of we have a footnote, we just need to say what it is if it’s not understandable and I can appreciate that it’s a, I mean if it were a colloquial we could put parentheses around it or dashes but we obviously it’s not a colloquial —
DR. WARREN: It’s a term of art, I understand the need to be technically precise here but also as more of a lay person then most of the people here, I agree with Harry, I think it’s confusing.
DR. HUFF: The other way you could fix it is just to put concept to Rx-Norm concept identifiers, or to concept Rx-Norm codes —
MR. BLAIR: Could I suggest that it would probably take a full sentence and maybe two to clarify what the word concept means and so I think that if it’s done with a footnote right on the word concept that they’ll be room for Margaret to put that sentence or two describing what the word concept means.
DR. COHN: I think that’s what Margaret is doing at this point and I would actually ask Stan maybe to assist with a, or actually Vivian I guess, to assist Margaret with coming up with an English word understanding since we’re using this term to, Vivian you can help on that offline? Because I think we’re beginning to run, I mean we can’t wordsmith this particular definition. Steve, you’re looking at me funny —
DR. STEINDEL: No I was just going to say why can’t we just use Rx-Norm codes? It’s not precise, I totally agree, it’s not precise, but we have questions from the lay people and my sense in the statement that we’re making we have described that we looked at one thousand of the most common prescriptions written and we said we matched it to 974 items in the Rx-Norm index, so instead of using the precise term why don’t we just say Rx-Norm codes —
DR. COHN: That might be a much simpler solution and might save us a lot of work.
MR. BLAIR: Could I argue the other way? And that is one of the pieces that I think is missing in this letter for people that don’t understand the real value of Rx-Norm, if we have the footnote it does give us the opportunity to explain why, what those Rx-Norm codes do that is unique, that it’s not just another code.
DR. COHN: Jeff, I actually am concerned, I mean we’re getting way out of proportion on the Rx-Norm piece here, I mean this is not, I mean we’ve already written things about Rx-Norm, this is one objective, one observation, one thing —
DR. HUFF: I think making it into codes would make it simpler —
DR. COHN: In the interest of time at this point —
DR. STEINDEL: And if we want to expand on it what we should just do is reference the PMRI terminology letter.
DR. COHN: So I think what we’re doing is change codes, Jeff, I don’t mean to overrule you on this one but I just think that this one, we’ve already got a footnote on here, if we don’t watch out the footnote will be longer then the whole text of the document.
MR. REYNOLDS: And it’s sufficient to me because what it then says to me is that you can go ahead and use this, that’s what I’m looking for, this says —
DR. COHN: Okay, I’d like to have us finish this one off —
MS. FRIEDMAN: If you’re going to put codes there, you need to change concepts to codes in the next —
DR. HUFF: That next revision too.
DR. COHN: Okay, so are we okay? Good to go? Okay, let’s keep going on then.
MS. AMATAYAKUL: 9.2, HHS should accelerate the promulgation of FDA’s drug listing rule and hence the ability to support the correlation of NDC with Rx-Norm, for example for passing daily updates of the SPL to NLM for inclusion in the DailyMed. Timely rulemaking is critical to sustain the daily use of Rx-Norm beyond the 2006 pilot tests.
DR. COHN: Good to go.
MS. AMATAYAKUL: Okay, under Observation 10, structured and codified SIG, Recommendation Action 10.1, we enhanced the example. HHS should support NCPDP, HL7, and others especially including the prescriber community in addressing SIG components in their standards. This should include preserving the ability to incorporate free text when necessary, for example for complex dosing instructions and to address special cultural sensitivities, language, and literacy requirements.
DR. COHN: Okay, are we okay to go on that one?
MR. REYNOLDS: Instead of when necessary, does whenever necessary? And the reason I say that is that doesn’t put a restriction on.
DR. COHN: Okay, Steve?
DR. STEINDEL: Phil, you’re probably the only one in the room who might have any familiarity in the nitty gritty of the NCPDP SCRIPT standard and I’m not sure if you do because I have about that much as well, Phil indicated very little. I’m not sure if maybe there’s another place in the NCPDP SCRIPT standard where free text information could also be transmitted. So this is fine, I’m just pointing out that it may not necessarily be needed as part of the SIG, and that’s just a comment, I don’t think it requires any change.
DR. WARREN: I think this came out of a huge discussion yesterday about giving directions to the patient on how to do this, it is part of the SIG.
DR. STEINDEL: My comment is just strictly that the same type of patient information instructions and other types of information from a technical point of view may also be able to be transmitted in another part of the message, but I have no problem leaving it like this.
DR. COHN: But this in no way impacts —
DR. STEINDEL: No.
DR. COHN: Harry, did you have a comment?
MR. REYNOLDS: I think it’s good like it is.
DR. COHN: I think we’re sort of, I mean I think this is fine.
MS. AMATAYAKUL: Okay, Observation 11 under dispenser identifier, and I think this is also true for 12, prescriber identifier, the question came up with regard to Recommended Action 11.1, HHS should ensure that the NPI when it becomes available is incorporated as the primary identifier for dispensers in the NCPDP SCRIPT standard. And the question was do you want to say and other e-prescribing standards, I didn’t change it because it didn’t sound like there was strong consensus on that.
MR. BLAIR: I think Stan raised a point —
DR. HUFF: I just raised it, and I don’t —
DR. COHN: I raised it last week —
MR. BLAIR: My opinion on that was that we recognize that harmonization needs to occur with other standards but we’re directing the tests with respect to, the pilot tests with respect to NCPDP SCRIPT and our recommendations with respect to NCPDP SCRIPT, so my inclination would be that we don’t add that.
DR. COHN: Well, this is not a pilot test issue though, Jeff. Actually I guess it is sort of but it’s really just a statement of what we’re going to use. And I’m fine however this is, I’ve raised it before.
MS. FRIEDMAN: Just to remind everybody again that it’s in the HIPAA standard for retail pharmacy in 270/271.
DR. COHN: You mean it’s already in there.
DR. HUFF: Yeah, it’s already in there and to the extent that we could I would like to send a message to HL7 that they ought to use it in their messages. But again, I think that’s true whether we say it here or not so I don’t care whether we say it here or not.
DR. COHN: Steve, you obviously had some issues with expanding this, was this untoward and uncertain consequences if we expanded this one out?
DR. STEINDEL: Well I kind of agree with Jeff because the NPI is already required to be used in certain areas that we’ve stated specifically are part of the foundational standards and we’ve said that the e-prescribing needs to be harmonized or coordinated is the word we’re using, coordinated. So by that implication if things other then NCPDP SCRIPT choose to use an identifier other then NPI, in the coordination efforts they’re going to be forced to coordinate to NPI. And I don’t think it needs to be spelled out here.
DR. COHN: Well the question is, I know we’ve done a lot of spelling out of everything else, I guess the question is is, I just don’t think if there’s anything, we could leave it as it is, we can say and other applicable e-prescribing standards and other e-prescribing standards —
DR. STEINDEL: Simon I think this is one of these things that’s probably not worth spending any more time on, if people are somewhat indifferent then let’s just add it.
DR. COHN: Opinions, comments? Down side?
DR. STEINDEL: It doesn’t hurt.
DR. COHN: Let’s see how it looks in other, do you want to read this and see if we’re —
MS. AMATAYAKUL: HHS should ensure that the NPI, when it becomes available is incorporated incorporated as the primary identifier for dispensers in the NCPDP SCRIPT standard and other applicable e-prescribing standards.
MR. BLAIR: Maybe if they’re applicable or not, could we say just as Stan had said —
DR. COHN: And other e-prescribing standards? And it’s maybe in the NCPDP SCRIPT and other e-prescribing standards. Is that okay? Margaret, are you okay with that terminology? Okay, why don’t we just replicate that in 12.1 also.
Now we’re up to our favorite area which is 13 and our charge has come in since I know he had issues about 13 also, let’s see if we got at this one, it was like a lot of changes and I’m not sure that we’ve got it quite right here quite frankly.
MS. AMATAYAKUL: Observation 13, pilot test objectives. We added a couple sentences at the end. NCVHS has observed that there were many impediments to full adoption in the implementation of the HIPAA transaction code set standards. With the requirements for pilot testing in e-prescribing HHS has the opportunity to address these issues. As previously noted while the foundation standards being recommended here are suitable for early industry adoption there are several areas in the foundation standards that do not support all the MMA requirements. We added in addition there are a number of stakeholder issues, including those related to patients, which must be identified, studied, and addressed. It must also be recognized that the success of the pilots will require much work by vendors to incorporate these standards into their pilot test application.
And then in 13.3, HHS should identify and widely publicize specific goals, objectives, timelines, and metrics to guide the design and assessment of the 2006 pilot tests. The information gained from the pilot tests should facilitate industry adoption, prescriber usability, system functionality, and patient safety. The metrics should address economic quality of care, patient safety, and patient outcome factors.
And then in 13.4, HHS should develop and widely disseminate information concerning the economic and quality of care benefits of e-prescribing, provide comprehensive education on implementation strategies, probably should say describe how e-prescribing fits into HIPAA privacy, and address other elements that contribute to successful and widespread adoption.
DR. COHN: John, why don’t you start out and then we’ll jump in from there.
DR. LUMPKIN: That last sentence in the introductory paragraph, much work by vendors to incorporate the standards into their applications before the pilot tests can begin, because it really was an issue of time more so then work. So incorporate the standards into the pilot tests, into their applications, so delete pilot tests, then before the pilot tests can begin.
DR. COHN: Let’s take a look at the sentence, are we okay with that? Steve? Before we got to the sentence before —
DR. STEINDEL: I would say for use in the pilot tests.
MR. BLAIR: There you go, in order to be ready for the pilot tests.
DR. STEINDEL: I mean the implication here is that they’re going to introduce these into their applications and these are the actual applications that may be used for everything.
MR. BLAIR: Or even to say so that they can be tested in the pilots.
DR. STEINDEL: Yeah, these may be special applications that are designed for the pilot tests.
DR. LUMPKIN: Right.
DR. COHN: Okay, so they can be tested in the pilot tests.
MR. BLAIR: — the word test after pilot if you wind up moving the word test up front by saying so they could be tested in the pilot.
DR. COHN: How about so they can be pilot tested?
MR. LOCALIO: The statute calls it a pilot project if you want to use that.
DR. COHN: I think we’re okay with pilot test. Now let’s take a look at the sentence above it which, gosh, I’m having a little trouble with. I think I sort of understand what you’re trying to say but it sure doesn’t come out to me. In addition there are a number of stakeholder issues including those relating to patients, which must be identified, studied, and addressed. Now for the life of me what are we trying to say there?
MS. FRIEDMAN: That was that whole discussion yesterday about related to —
DR. COHN: I thought we had a patient discussion, I didn’t know we were having a stakeholder discussion, which oh by the way also included the patients. Am I mistaken here? Isn’t that what the conversation was, or was it wider and I just was missing it a little bit? Don’t start knocking things out here —
DR. LUMPKIN: Then the way to do that would be in addition there are a number of —
DR. COHN: Patient specific issues —
DR. LUMPKIN: Patient specific issues, yes, which must be identified, studied, and addressed.
DR. HUFF: Didn’t it have to do with patient, we hadn’t said anything about patient acceptance, wasn’t it that we need to say more about whether these processes and things were putting in place would be acceptable to patients and the impact on their perceptions.
DR. COHN: So why don’t we specify those things rather then, I mean it sounds to me like we don’t know what in the heck we’re talking about since we’ve got to identify what the issues even are, so let’s begin to specify them. So basically there are a number of patient specific issues which must be studied and addressed including patient satisfaction —
DR. HUFF: Patient convenience, acceptance, satisfaction —
DR. LUMPKIN: Patient acceptance, convenience, and satisfaction.
DR. COHN: Do we have anything else that we want to, this is actually good rather then us not knowing what they are we can actually even describe them now.
MR. BLAIR: Should we say e.g. these things instead of including these things? These are for example, so that it’s not —
DR. COHN: Well, we have for example, patient acceptance, convenience, and satisfaction, this is looking better. Should we read this paragraph again and sort of see where we are with this?
MS. AMATAYAKUL: NCVHS has observed that there were many impediments to full adoption and implementation of the HIPAA transaction and code sets standards. With the requirements for pilot testing and e-prescribing HHS has the opportunity to address these issues. As previously noted while the foundation standards being recommended here are suitable for early industry adoption there are several areas in the foundation standards that do not support all the MMA requirements. In addition there are a number of patient specific issues which must be studied and addressed, for example patient acceptance, convenience, and satisfaction. It must also be recognized that the success of the pilots will require much work by vendors to incorporate the standards into their applications to they can be pilot tested.
DR. COHN: Okay, I guess the question I would have is I think I can do patient acceptance and satisfaction, I’m not sure how you measure patient convenience, I think satisfaction and acceptance might cover the convenience issue. Maria?
MS. FRIEDMAN: I just wanted to deal with that second sentence, the foundation standards really are the ones with which there is already widespread industry experience, so I think that wording is confusing in that second sentence.
MS. AMATAYAKUL: Do you want to say incorporate new standards or —
MS. FRIEDMAN: Aren’t we talking about functionality?
DR. LUMPKIN: The second sentence in blue or the second sentence of the paragraph?
MS. FRIEDMAN: The second sentence in blue. The vendors, we’re not changing, the foundation standards pretty much are what the industry is using today —
DR. COHN: So it’s new functionality or new standards —
MR. BLAIR: New standards functions —
MS. FRIEDMAN: I just want to make it clear to people who haven’t been in these discussions —
DR. LUMPKIN: Standards and functionality.
MR. REYNOLDS: Because the difference is you’re bringing in the patient and the prescriber, the standards that are going right now a lot of them are between dispensers and PBMs and others, there’s not as much of that being done actually in the doctor’s office and there’s not as much impact on the patient as we are going to here. So I think that’s what we’re calling out the patient related and this may be a time to add both patient and prescriber because both of those things where you’re talking about acceptance and satisfaction, both of those groups, if both of those groups buy into this we got a winner, because we know the rest of the industry has already bought into the rest of it, moving this stuff back and forth and so on.
MS. FREIDMAN: Those are the remaining market segments —
MR. REYNOLDS: So if we can really focus on how we touch there —
DR. COHN: Are we comfortable, Steve?
DR. STEINDEL: The second sentence if we’re modifying it in that way should say new standards and functionality.
DR. COHN: This actually is looking pretty good, do you want to read it, go ahead.
DR. HUFF: Well, this is even above there so if you go back up, it sounds like in the second sentence there, it says with the requirements of the pilot testing HHS has the opportunity to address these issues, I mean this is really picky so you can just blow this off if you want, but it sounds like we’re going to correct the HIPAA code set problems by these tests, and so the way I would suggest is say address any similar issues that might arise with e-prescribing standards.
MR. BLAIR: Good.
DR. HUFF: So that sentence would read now, I’d say with the requirements for pilot testing HHS has the opportunity to address any similar issues that might arise with the e-prescribing standards, or with the e-prescribing implementation or something like that.
DR. COHN: Now which similar issues are we talking about?
DR. HUFF: The impediments to full adoption and implementation of the HIPAA transaction and code sets. Like I said you can blow if off if you want.
DR. COHN: I guess I’m having trouble, I see the word impediments, I’m not sure, does impediments equal issues here?
DR. HUFF: Well, we could say issues, then we could say impediments, any similar impediments that might arise, that would make it more —
DR. COHN: Is everybody okay with that? I just want to conceptually make sure that we’re okay, are we okay with that one? Okay, so do you want to read this over and then we’ll move down to the recommendations?
MS. AMATAYAKUL: HHS has observed that there were many impediments to full adoption and implement of HIPAA transactions and code set standards. With the requirements for pilot testing in e-prescribing HHS has the opportunity to address any similar impediments that might arise with e-prescribing standards implementation. As previously noted while the foundation standards being recommended here are suitable for early industry adoption there’s several areas in the foundation standards that do not support all the MMA requirements. In addition there are a number of patient and prescriber specific issues which must be studied and addressed, for example acceptance and satisfaction. It must also be recognized that the success of the pilots will require much work by vendors to incorporate new standards and functionality into their applications so they can be pilot tested.
DR. COHN: I think it sounds good. Okay, now let’s go down to the recommendations area. Now 13.3 has certainly had a lot of changes hasn’t it, what are we trying to, do you want to read over what we have there and then we’ll figure out what we’re trying to say?
MS. AMATAYAKUL: Actually there was a recommendation that we pull out timelines and make that separate but I wasn’t sure so I didn’t do that.
HHS should identify and widely publicize specific goals, objectives, timelines, and metrics, to guide the design and assessment of the 2006 pilot tests. The information gained from the pilot tests should facilitate industry adoption, prescriber usability, system functionality and patient safety. The metrics should address economic quality of care, patient safety, and patient outcome factors. I don’t know if we need that last sentence —
DR. COHN: Well, let’s figure out what we don’t need there because it’s certainly a mess, well, I don’t mean to say, I’m not sure what it’s saying even anymore so let’s, what do we need to do to this one to clean it up.
MS. FRIEDMAN: There was some discussion about metrics were meant and that’s what that last sentence was trying to flesh out a little bit.
DR. COHN: And of course it looks like we almost have a new sentence in between it looks like. Okay, so we basically identify and widely publicize, now I guess I’m a little confused here, I think we wanted the HHS at one point to identify goals, objectives, and metrics to guide the design and assessment of the 2006 pilot tests, right? Which is like what you would do with any pilot test, that’s not very rocket science here, I think that’s what one does. And then we were sort of, we wanted those learnings to facilitate industry adoption, I don’t know, prescriber usability isn’t quite parallel there but system function, boy. Okay, and I guess I’m sort of struggling a little bit here because I mean there, I think as I remember from our conversation we obviously wanted CMS to do some study design, then what we were also talking about yesterday was the idea that we wanted them to widely publicize the timeline as well as sort of the things that needed to be tested, is that right? Isn’t that what we were sort of like so functionality and standards and at that point I think so that the vendors would be able to know about it in a timely fashion. Wasn’t that what we were talking about?
MR. REYNOLDS: Yes.
DR. COHN: Now, we’ve all obviously, earlier we sort of referenced the fact that they’ll be much vendor work that needs to go on, I know you’ve tried to set this all into one recommendation so I’m just trying to think, I mean do we want to have a separate recommendation which is —
MR. BLAIR: Break it into two, it will be easier to digest.
DR. COHN: The timelines for the pilot —
DR. LUMPKIN: I think that works okay the way it is, I might, I think the problem is the second sentence —
DR. COHN: I mean there’s something wrong there, John.
DR. LUMPKIN: And the way to maybe reconstruct that is HHS should identify and widely publicize specific goals, objectives, timelines and metrics, that’s fine, to guide the design and assessment of the 2006 pilot tests, and I think that deals with the issue of timelines.
Then the next sentence should be those metrics should, that might be a separate recommendation just on metrics, what the metrics should include, pull that out as a separate one.
Then the sentence that doesn’t work is the one about the information gained from the pilot tests should facilitate industry adoption, that’s fine, but prescriber usability and system functionality and patient safety doesn’t work because those are different things.
DR. COHN: So it isn’t the metrics, so basically, now we have, let’s see what we have there.
DR. LUMPKIN: That second sentence really belongs up with the first one about the pilot tests, and that’s the one that needs to be fixed. The information gained from the pilot tests should facilitate widespread adoption, or industry adoption, period.
DR. COHN: Do we need to say anything more then that?
DR. LUMPKIN: No.
DR. COHN: Maria?
MS. FRIEDMAN: We’ve heard over and over that the critical adopter piece has to be physician, so if we say industry adoption to a certain extent the industry has already adopted part of it, I’d like to get in the physician, the prescriber.
DR. LUMPKIN: How about facilitate wide adoption?
MR. BLAIR: Well, I think the point that Maria is making is that the lagging element of adoption right now is the prescriber and the patient community, for the most part the PBMs, the payers, and the pharmacists have indicated that they’re willing to adopt it and in a sense are heavily influencing the nature of the networks and the designs and solutions, and the pilot tests are to try to bring in the prescribers and patient acceptance. So I think it’s an important point we don’t want to leave out.
DR. COHN: Margaret, do you want to help us with the —
MS. AMATAYAKUL: The information gained from the pilot tests should facilitate widespread prescriber adoption and patient acceptance.
DR. COHN: Certainly addresses the prescriber and patient comments we made in the early observation.
MR. BLAIR: We may not need the word widespread anymore there, it would just focus on those two stakeholder groups.
DR. LUMPKIN: But I think that there are some current physician adopters, rudimentary ones, so I think widespread may be fine.
DR. COHN: Why don’t we look at 13.3 again and see where we are.
MS. AMATAYAKUL: HHS should identify and widely publicize specific goals, objectives, timelines and metrics to guide the design and assessment of the 2006 pilot tests. The information gained from the pilot tests should facilitate widespread prescriber adoption and patient acceptance.
DR. COHN: I mean I’m sort of in agreement though, the feeling the information gained from —
DR. HUFF: I was thinking maybe you could put something in there that said and address prescriber usability and patient safety issues or something like that, so you address that with the information.
DR. FITZMAURICE: On that first sentence, since the purpose is to make the industry aware of this do we want to say at the end to guide the design and assessment of the 2006 pilot tests and improve industry awareness? I mean the point made to us was that the industry has to know about this and has to start designing their products to make these tests, so it kind of hits it head on.
DR. COHN: Should identify and widely publicize, and increase industry awareness?
DR. FITZMAURICE: You might want to increase industry awareness up in front of and metrics.
MS. FRIEDMAN: I think we have kind of a non-sequitor now, I think that sentence about the information gained from the pilots really goes down into 13.4, 13.3 addresses publicizing the pilots and then 13.4 talks about what the pilots should do.
MS. AMATAYAKUL: I’m lost.
MS. FRIEDMAN: My suggestion, Margaret, is to take the second sentence information gained from the pilots and move that to 13.4.
DR. STEINDEL: At the end of 13.4.
MS. FRIEDMAN: Then instead of the information, this should facilitate prescriber usability —
MS. AMATAYAKUL: Maria, I can’t hear you.
MS. FRIEDMAN: I’m sorry, in the second sentence take out the information gained from the pilot and say this should facilitate prescriber usability and patient acceptance, something like that.
DR. STEINDEL: What’s this?
MS. FRIEDMAN: This is the metrics.
DR. COHN: No, no —
MR. BLAIR: I don’t think it’s the information gained from this —
DR. COHN: Facilitate isn’t the right word.
MS. FRIEDMAN: Will be used to promote? I don’t know.
DR. LUMPKIN: What did we have before Stan messed with it?
MS. AMATAYAKUL: We had facilitate industry adoption and prescriber usability —
DR. LUMPKIN: Yeah, should facilitate prescriber adoption and patient acceptance, I think it was widespread.
DR. COHN: Should we take a look at 13.3 and 13.4 here again?
MS. AMATAYAKUL: Okay, 13.3 is HHS should identify and widely publicize specific goals, objectives, timelines, and metrics to guide the design and assessment and increase industry awareness of the 2006 pilot tests. 13.4, HHS should utilize metrics that address economic, quality of care, patient safety, and patient outcome factors. The information gained should facilitate widespread prescriber adoption and patient satisfaction.
DR. COHN: HHS should utilize metrics that address economic quality of care, we have patient safety and patient outcomes, of course it’s the first time we’ve mentioned patient outcome in all of this but are we talking about patient and provider satisfaction, isn’t there something in there about that?
MS. FRIEDMAN: Compliance.
DR. COHN: Compliance?
MS. FRIEDMAN: There was discussion yesterday about compliance with —
DR. COHN: I know what compliance means, you means compliance of taking medicine, when CMS says compliance I tend to think of something else. Kevin, did you have a comment here?
KEVIN: Outcomes to me often means actually clinical outcomes, sort of impact on the patients, the actual, where satisfaction is more —
DR. COHN: Well I tend to think of patient outcomes almost as quality of care, those are very close together, so I think quality of care is probably the better umbrella there, outcomes usually take a long to figure. So let’s see what we have here.
MS. AMATAYAKUL: HHS should utilize metrics that address economic, quality of care, patient safety, and patient satisfaction factors. The information gained from the pilot tests should facilitate widespread prescriber adoption and patient acceptance.
MR. BLAIR: Yes.
DR. COHN: Let’s ask the question, 13.4, do we have the, are those all of the metrics or are those some of the metrics, are those —
DR. LUMPKIN: It doesn’t say only.
DR. COHN: Should include, okay, I think that’s better. Now second sentence, I’m a little concerned, this seems to be a little bit of a, let me think, the information gained from the pilot tests should facilitate widespread provider adoption and patient acceptance. Maybe I’m sort of missing something here, I’m just not sure —
DR. FITZMAURICE: Do you want to delete that sentence?
DR. COHN: I don’t know, it just seems like, maybe it’s the wrong verb, Harry?
MR. REYNOLDS: What about validate instead of facilitate?
DR. COHN: Well, we aren’t validating widespread prescriber adoption —
DR. HUFF: No, I think you could say something like tests should be used to promote or encourage —
DR. FITZMAURICE: Well presuming we know the outcome is going to be positive.
MR. REYNOLDS: Where I was going with the thought, we’re down to the level of the prescriber and the patient again and we’ve got to run tests, a test has got to show ways that it’s going to be able to be delivered to them that they’re going to accept it, so I’m talking about that philosophy, the word might not be right.
DR. LUMPKIN: But doesn’t 13.5 do that?
MR. BLAIR: What does 13.5 say?
MS. AMATAYAKUL: HHS should develop and widely disseminate information concerning the economic and quality of care benefits of e-prescribing, provide comprehensive education on implementation strategies, describe how e-prescribing fits into HIPAA privacy, and address other elements that contribute to successful and widespread adoption.
MR. BLAIR: But it doesn’t include the pointing out that the adoption needs to be among the prescribers and acceptance by the patients.
MS. AMATAYAKUL: We could say widespread —
DR. COHN: I think we could just leave widespread, I don’t know that for that sentence we need to talk about prescriber and patient. I guess the question is is that we could say learnings from the pilot tests should be used but I’m not sure what they should be used for.
DR. LUMPKIN: Why do you need it?
DR. COHN: Should we get rid of it? So maybe we should get rid of it? Okay, gone. Okay, are we comfortable? HHS should include metrics that address economic, quality of care, patient safety, and patient satisfaction factors. Now the question is is this a separate action item at this point or is it really part of the one above?
MR. BLAIR: You just removed a sentence, did we have agreement by everybody to do that?
DR. COHN: No, we were going to read it over but we were just going to —
MR. BLAIR: My only thought is that I feel fine removing that sentence as long as we don’t lose that one focus and if it’s somewhere else then I’ll be fine.
DR. COHN: So what is the focus?
MR. BLAIR: The focus is that we need to make sure the pilot tests have a focus on prescriber adoption and patient acceptance.
DR. COHN: Okay, well we have HHS should include metrics that address economic, quality of care, patient safety, and patient and provider satisfaction —
Margaret I think we are running out of time, I guess the one question I would have here, and you can review it, do you want to read 13.3, 13.4, and 13.5? The question is is 13.4 a separate issue or is it really the second sentence of 13.3.
MS. AMATAYAKUL: HHS should identify and widely publicize specific goals, objectives, timelines, and metrics to guide the design and assessment and increase industry awareness of the 2006 pilot tests. 13.4, HHS should utilize metrics that address economic, quality of care, patient safety, and patient and prescriber satisfaction factors. I think it could go together because we’ve got the metrics in three. And then the last one is HHS should develop and widely disseminate information concerning the economic and quality of care benefits of e-prescribing, provide comprehensive education and implementation strategies, describe how e-prescribing fits into HIPAA privacy, and address other elements that contribute to successful and widespread prescriber adoption and patient satisfaction.
DR. COHN: Okay? Jeff, I see you nodding your head, that’s probably a good sign. And I think that’s actually the last change we have isn’t it?
MS. AMATAYAKUL: The only other addition is a footnote to identify the reference to the commercial bias in the conference agreement.
DR. STEINDEL: And then the addition of the last sentence in the last paragraph.
MS. AMATAYAKUL: And then the last paragraph, very last paragraph, NCVHS wishes to thank you for the opportunity to make these recommendations. NCVHS notes its availability to review and comment on plans for the 2006 pilot tests.
DR. COHN: John you might want to wordsmith that last sentence but we’ll defer to you on that one.
DR. FITZMAURICE: Would you rather make it an offer rather then a note?
DR. COHN: Yes.
DR. STEINDEL: I think we decided on offer yesterday.
MS. AMATAYAKUL: NCVHS offers to review and comment on plans for the 2006 pilot tests.
DR. COHN: I think we spelled their name right so I think we’re okay. Okay, now group I apologize, we’re obviously running late. I think we need to get this letter obviously to bed, we’ll let Margaret, I mean we need to obviously look at the letter again when we get together to talk, about all of this. We obviously have not had a chance really to talk about the October hearings, which we will obviously just have to arrange a conference call to probably deal with over an hours time. Okay?
MR. REYNOLDS: And one recommendation, if you and Jeff have a chance to talk before that and you can put it in some kind of priority order it might —
DR. COHN: That wouldn’t be bad.
MR. REYNOLDS: That wouldn’t be a bad idea.
DR. COHN: Okay, and if we could figure out a way to handle it by email into further conversations of October that would even be better. Okay, sounds good.
Okay, this meeting is adjourned.
[Whereupon at 10:05 a.m. the meeting was adjourned.]