[This Transcript is Unedited]


Subcommittee on Standards and Security

August 25, 2004

Conference Call

Subject: To discuss recommendation letter to the HHS Secretary on initial e-Prescribing standards.

12:00 p.m. EST

JILL HELM (ph):  Hello.  This is Jill Helm (ph), from All Scripts (ph).

PHIL ROBINIC (ph):  Hi, Phil Robinic (ph), with Express Scripts (ph).

ROY BUSSEL (ph):  Roy Bussel (ph), with NACDS (ph).

CAROLYN ZIGMAN-LUKE (ph):  Carolyn Zigman-Luke (ph) and Kelly Vogel (ph), from AHIP (ph).

JERI SWANSON (ph):  Jeri Swanson (ph), Signa Pharmacy Management (ph).

LESHAN DORSEY (ph):  Leshan Dorsey (ph), American Academy of Ophthalmology.

MICHAEL ZAPOLO (ph):  Michael Zapolo (ph), with Blue Cross Blue Shield Association.

SHELLEY WOLLEY (ph):  Shelly Wolley (ph), Rx-Hub (ph).

JUDY WARREN (ph):  Judy Warren (ph), The Committee (ph).

MARK GORDON (ph):  Mark Gordon (ph), ACP (ph).

ANDER SKILBERG (ph):  Ander Skilberg (ph), American Medical Association.

EMILY KAMB (ph):  Emily Kamb (ph), American Society of Cataract and Refractive Surgery.

NANCY TRENTY (ph):  Nancy Trenty (ph), American Psychiatric Association.

JENNIFER COVICH (ph):  Jennifer Covich (ph), eHealth Initiative (ph).

LIVIA KNALLS (ph):  Livia Knalls (ph), National Library of Medicine Staff Subcommittee (ph).


PAUL SPIDALL (ph):  Paul Spidall (ph), Medical Group Management Association.

MARK BRUCKEL (ph):  Mark Bruckel (ph), Academy of Managed Care Pharmacy.

MARGARET LYDIA (ph):  Margaret Lydia (ph) …


JENNIFER MCGEEAN (ph):  Jennifer McGeean (ph), Federation of American Hospitals.

ANWARDE MORPSHIRE (ph):  Anwarde Morpshire (ph), Scripts (ph).

STAN HUFF (ph):  This is Stan Huff (ph).  I just entered.

SIMON COHN (ph):  OK, good.  I guess I would ask just the roll of the subcommittee members for a moment, Stan.  I hear (ph) this is Simon Cohn (ph) Stan, I hear that you re there.  Judy Warren (ph), you re there.

JUDY WARREN (ph):  Yes.

SIMON COHN (ph):  Other subcommittee members?

JEFF BLAIR (ph):  Jeff Blair (ph).

SIMON COHN (ph):  Jeff, OK.

MARIA (ph) (?):  Maria (ph) and Karen (ph).

SIMON COHN (ph):  OK.  You re not subcommittee.  We re going to ask for staff next.  My understanding is that Harry Reynolds (ph) will be calling in, in a couple of minutes.  He s running a little late because of a presentation he needs to make.  Now, staff and have I heard Maria (ph) and Karen (ph)?

MARIA (ph) (?):  Yes.

VIVIAN ALD (ph):  And Vivian Ald (ph).

MARJORIE GREENBERG (ph):  And Marjorie Greenberg (ph).

SIMON COHN (ph):  OK, good.



SUSIE BEBING (ph):  This is Susie Bebing (ph).

RUSS MARTIN (ph):  Russ Martin (ph) just joined.

SIMON COHN (ph):  OK (ph).

JUDY WARREN (ph):  Simon, this is Judy (ph).  Earlier I had told that I d have to leave after two hours.  My meeting got canceled, so I ll be on the line for the whole meeting.

SIMON COHN (ph):  OK, good.

MARJORIE GREENBERG (ph):  Actually, Simon, this is Marjorie (ph).  I have to go to another call at two.  But I think Donna Pickett (ph) will call in then.

SIMON COHN (ph):  OK, great.  Now, Maria (ph), help me is this one is this being recorded?

MARIA (ph):  I believe it is.

UNIDENTIFIED PARTICIPANT:  Yes.  Is Marietta (ph) on the line?  Go check with her, but I m almost sure I m positive that it is, so just a second.

SIMON COHN (ph):  Hope we don t spend the three hours just getting ourselves organized for an open conference call.

UNIDENTIFIED PARTICIPANT:  Yes.  It is being recorded, and she s calling in.

SIMON COHN (ph):  OK.  Well, in that case, why don t we just do the usual introduction to a to a session, and then we ll begin to move into the agenda items.  Obviously, this is an open conference call for the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics.  I m Simon Cohn, Chairman of the Subcommittee and the National Director for Health Information Policy for Kaiser Permanente.  I obviously want to welcome both subcommittee members and staff, as well as others here, listening in.

Obviously, the purpose today is to deliberate in open session and review a current draft document related to recommendations that we re going to be bringing forward, hopefully to the full National Committee next week.  These draft recommendations and observations are, I believe, on the Internet site at this point.  So anyone who is listening in is certainly welcome to go onto the Internet, and look at them.

Be aware that, of course, this is an early draft.  It will go through modification, literally, during the conference call.  And there will be subsequently further versions produced.  There is likely also to be another conference call looking at a further refined version that will be at the same time and, I think, same phone numbers on Friday of this week.

Obviously, I want to, as usual, thank Jeff Blair (ph), who reminded me you (ph) spent five hours working on this on Sunday, as well as Margaret A. (ph) for her work putting this together, and Maria (ph) for helping us move forward on all of this.

Now, before we move into actual discussion of the document, I guess I would like the subcommittee members, if there s anything that you need to recuse (ph) yourself about in relationship to this document, would you please introduce yourself, and state your recusals at this point?

JEFF BLAIR (ph):  This is Jeff Blair (ph).  I m Vice Chair of the Subcommittee.  And I don t think that there s anything in this topic letter at this point that I need to recuse myself on.

HARRY REYNOLDS (ph):  This is Harry Reynolds.  I have no reason to recuse myself.

SIMON COHN (ph):  And welcome, Harry (ph).

STAN HUFF (ph):  This is Stan Huff (ph), a member of the committee, with Inter Mountain Healthcare (ph) and University of Utah in Salt Lake City.  And I would need to recuse myself any votes about HL7 (ph).

JUDY WARREN (ph):  This is Judy Warren (ph), University of Kansas School of Nursing.  I would also need to recuse myself on any votes about HL7 (ph).

SIMON COHN (ph):  OK.  And, of course, this is Simon Cohn.  And as I think I ve mentioned frequently, I am a member of the CPT (ph) Editorial Panel.  So if anything comes up in relationship to CPT (ph) which I doubt, but you just never know I will obviously be recusing myself from those discussions.  Now, before we jump in here, I …


SIMON COHN (ph):  Yes?

STEVE STEINDELL (ph):  Steve Steindell (ph), Staff to the Subcommittee.

SIMON COHN (ph):  OK, thank you for introducing yourself (ph).

STEVE STEINDELL (ph):  And Simon, I can t find the PDF document on the Web.

UNIDENTIFIED PARTICIPANT:  Right.  I couldn t find it either right now.  We sent it as soon as we got it, this morning.  But is Marietta (ph), are you on the line now?

MARIETTA (ph):  Yes, I m on the line.  And I did call Jack (ph) about an hour ago, when I noticed that it had not been posted, and asked him to please post it as soon as possible.

STEVE STEINDELL (ph):  OK, thank you.

UNIDENTIFIED PARTICIPANT:  Is there any possibility, Steve (ph), that if you have access to your e-mail that you could get …

STEVE STEINDELL (ph):  No, I have the document.  I was just checking for outside people.


SIMON COHN (ph):  Yes.  Well, in that case, I do want to apologize to those listening in that you re flying a little blind.  But we ll obviously be reading through the recommendations as we go.  Now …

MARJORIE GREENBERG (ph):  Simon, are you going to have everyone else introduce themselves?

SIMON COHN (ph):  I thought we already had.


STEVE STEINDELL (ph) (?):  There s probably about 20 other folks on the call that are, you know, folks that had testified to us during these last few weeks.

SIMON COHN (ph):  Yes.  Marjorie (ph), do you believe that these people were not recorded?

MARJORIE GREENBERG (ph):  You mean when they called in, their names got recorded.

STEVE STEINDELL (ph) (?):  Yes.  And they introduced themselves, just before 10.

MARJORIE GREENBERG (ph):  OK, (ph) fine.


STEVE STEINDELL (ph) (?):  … before noon.

SIMON COHN (ph):  Yes.


SIMON COHN (ph):  OK …

UNIDENTIFIED PARTICIPANT:  They (ph) are all in support.

SIMON COHN (ph):  OK (ph).  Let me just talk about process for just a minute.  Because this is obviously a little more difficult than many sessions we ve had.  This is both going to be a relatively long session so we would ask for everyone s forbearance on that however, this is also an open session.  And there s no way I know obviously listening to (ph) you know, being the one leading the conference to know who needs to say what, when.  So I would ask for people to leave a little bit of silence after they have made a comment.

I would ask first if subcommittee members could address any of the recommendations.  I will try, on a regular basis, to ask if there s anyone else in attendance who has any comments about any of these items, just to give those who are not members of the subcommittee and not staff the opportunity to make comments about the recommendations, or observations.

So once again, we ll try to run it very much like we do face to face.  But you just have to realize we are a little handicapped, since, you know I mean, I do have eyes in the back of my head, but I don t have any way of knowing what issues are going to be particularly of concern to those listening in.  Now Jeff, would you like to make any comments, as we (ph) (INAUDIBLE)?

JEFF BLAIR (ph):  The only comments that I wanted to make was for especially for those folks who are listening in that Margaret tried faithfully to capture everyone s input and include it in.  We re moving very quickly …


JEFF BLAIR (ph):  I m sorry Margaret.  Did I say Marjorie (ph)?  Yes, Margaret Almajealkin (ph), who is our consultant.  What we did was we deliberately posted when you are able to get to the Internet we deliberately posted this document with the track (ph) changes showing.  And you do have the option of accepting the changes.  But this way, you can see where the track (ph) changes are.

UNIDENTIFIED PARTICIPANT:  Actually, Jeff, I think we my understanding we re posting it without the track (ph) changes.  It went to all the members.  Is that correct …

JEFF BLAIR (ph):  Well …


JEFF BLAIR (ph):  … Marietta (ph) called me this morning and asked me which way to do it.  And I thought it would be helpful for only attendees to see where the changes are.  But if it s not posted that way, then …

MARIETTA (ph):  I did send it that way.  I sent it with the track (ph) changes.

UNIDENTIFIED PARTICIPANT:  Yes, Jeff, it s supposed to be posted as a PDF document, so they couldn t change it if it …

MARIETTA (ph) (?):  Yes.


MARIETTA (ph) (?):  That is the case.

JEFF BLAIR (ph):  Right.  Right.  So in short, we hope that we re helpful to everyone listening.  And let me turn it back to Simon, because we re limited on time; I think that the three hours will go quickly.

SIMON COHN (ph):  Yes.  Now I m going to suggest for everyone that we at least, initially focus on the observations and recommendations, knowing that that s, at this moment, the thing that we need most to get right.  Plus I think we ve all been sort of looking at the first part of the document for awhile.

Now, I am going to suggest that the main point of this particular conference call is to not deal with exquisite wordsmithing.  And by that, I mean, if a sentence doesn t sound right to you, I think we are in a situation where Margaret A. (ph) would love to receive an e-mail from you about ways of saying something better.  I think the bigger issue is to make sure that we re in agreement with what we re saying, and recognizing, as (ph) I said, we can continue to do wordsmithing between now and Friday.  Is everyone in agreement with that sort of level of work?








SIMON COHN (ph):  Now, however, obviously, if the if the wordsmithing if the wording is so bad that it misses the point, that comment does need to be made.  And then we ll need to figure out, either on the phone or somebody sending something to Margaret how to fix it.  OK?  Now with that, Margaret, do you want to begin to lead us through the observations and recommendations in the current version?

MARGARET ALMAJEALKIN (ph):  Sure.  Simon, should I read the little process to the observations and recommended actions section?

SIMON COHN (ph):  Yes, I think …


SIMON COHN (ph):  … that that is a very useful thing.

MARGARET ALMAJEALKIN (ph):  OK.  The NCVHS observed 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 D.

Each of the following recommended actions is processed (ph) by an observation concerning the purpose and extent of industry experience of the standard or issue the recommended action is addressing.  The observations and recommended actions are listed first with general observations and recommended actions, then message formats, terminologies, identifiers and important related issues.

The recommended actions are sequenced to first identify the foundation set of e-prescribing standards.  These are standards that provide basic functionality and are used today.  Then the remaining recommended actions address the enhancements, developments and pilot testing necessary to meet the MMA requirements that many of the foundation set standards do not meet.

JEFF BLAIR (ph):  Margaret, this is Jeff.  In the second paragraph, the second sentence when you read it, you articulate it in a way that it makes sense.  However, when somebody reads it cold, like my assistant read it to me, we struggled quite a bit on that second sentence.  So I think I would just leave it to you to look at the second sentence in the second paragraph, that also appeared to be redundant.  But I d just leave it to you to look at …


JEFF BLAIR (ph):  … to make that more readable.

MARJORIE GREENBERG (ph):  This is Marjorie (ph).  I ve actually got some suggestions on both the first and the second sentence, which I had some problem with.  And I ll send that to Margaret.

SIMON COHN (ph):  Great, OK.  So that s a that s a great example of how we will deal with wordsmithing.  Thank you both (ph).  OK.  Other comments on this one?  Are people generally in agreement with at least the direction, if not the exact wording here?


SIMON COHN (ph):  OK.  Why don t we go to observation one?

MARGARET ALMAJEALKIN (ph):  Observation one:  general standards compatibility.  MMA (ph) requires that e-prescribing standards should be compatible with HCFA standards and general health and general health information technology standards.

JEFF BLAIR (ph) (?):  Margaret, can (ph) I just suggest that for the folks that are listening in if you have a mute on your phone, so we don t hear the background noise, then that would help keep the line quiet, so we could hear Margaret better.

MARGARET ALMAJEALKIN (ph):  Thanks.  Many testifiers indicated to NCVHS that the e-prescribing standards must be compatible with all HCFA standards, CHI standards, and the clinical data terminologies recommended by NCVHS in November 2003.  The recommended action 1.1 (ph) HHS should ensure that standards adopted for e-prescribing should not only be appropriate for Medicare Part B but should ensure that the standards can be implemented by prescribers, dispensers and public- and private-sector payers.

UNIDENTIFIED PARTICIPANT:  Excellent.  I know that I ve puzzled over that a long time.  And you found a way to say the same thing in shorter words.

SIMON COHN (ph):  Yes.  Margaret, I don t think I have a great suggestion for wordsmithing here.  But I found, as I looked at this one, that I agree with both the observation and I agree with the action.  But they didn t seem to follow one another, as best I could tell here.  I mean, I think that the if indeed what we re talking about is that MMA should be compatible with HCFA standards, CHI standards and NCVHS recommendations, I think we re totally in agreement with that.  But I think that that s different from saying that whatever is recommended as an MMA standard should be generally applicable with the industry for all (ph) e-prescribing.  It seems to me to be a slightly different topic.

MARGARET ALMAJEALKIN (ph):  OK.  Maybe I can add something to the observation about the fact that MMA is directed to Medicare Part B, but also indicates that whatever standards must be compatible with HCFA and general health information technologies, and bring that Medicare …

STAN HUFF (ph):  Definite (ph) go beyond that this is Stan I mean, I m with Simon.  It seems to me that we have two distinct things.  And we maybe even need another you know, after reading the observation, I would have said the recommendation that follows from that observation would have been, you know, HHS should ensure that e-prescribing standards are consistent with HCFA standards, CHI standards and the clinical data terminologies recommended by NCVHS.

And then I would have thought there would have been a second observation that would have said, there s, you know testifiers noted that Medicare Part B prescribing, as dictated in MMA, was important, but that whatever was suggested for e-prescribing standards should work for the whole system, not just for Medicare Part B.  And then the and then that observation would have been followed by the recommendation 1.1 that we have here now.

MARGARET ALMAJEALKIN (ph):  Stan, that s actually how we had it initially.  And then I think we backed off.  So let me go back and retrieve what we had originally and replace it.

SIMON COHN (ph):  OK.  Other comments on this observation one?  I guess I should ask those who are listening in so kindly:  Do any of you have any major issues so far?  OK.  Well, Margaret, I think you ve captured that, or at least captured the comments.


SIMON COHN (ph):  OK.  Should we move on to observation two, then?

MARGARET ALMAJEALKIN (ph):  Observation two:  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.

Currently, the NCPDP SCRIPT standard uses Free Text (ph), which is unable to support automated decision-making for many of the elements required by the patient safety portions of MMA.  The standard, however, can support the use of coded elements to enable decision-making functions as they mature.  The new prescription function is mostly widely used.

The renewal function has good industry acceptance and represents an easy transition, and provides the most immediately apparent return on investment.  The NCPDP SCRIPT standard cancellation and change function have minimal current usage.  The business case for fill status notification from the dispenser to the provider has not yet been made.

NCPDP will continue to provide guidance on use of the SCRIPT standard for the fill status notification function, and expects to test enhancements that support other requirements of MMA in pilot tests to be conducted by CMS starting in January 2006.

Recommended action 2.1 (ph):  HHS should recognize as a foundation standard the NCPDP SCRIPT standard version 4 (ph) release 3 (ph), its present code sets, and various mailbox functions for communication of prescription information between all prescribers and community I m sorry and dispensers, that should be and dispensers, for new prescription, prescription renewals, cancellations and changes.

MARJORIE GREENBERG (ph) (?):  Could you could you read that again, that last between all prescribers …

MARGARET ALMAJEALKIN (ph):  And dispensers for new prescriptions, prescription renewals, cancellations and changes.

MARJORIE GREENBERG (ph) (?):  OK (ph). So then the community and is deleted?

MARGARET ALMAJEALKIN (ph):  Yes.  I realize I had not gotten that first part of that phrase deleted.


MARGARET ALMAJEALKIN (ph):  Recommended action 2.2 (ph):  HHS should include in pilot tests to be conducted, starting in January 2006, further guidance on the NCPDP SCRIPT standard for fill status notification, with adoption of the fill status notification function to be determined from those results.

HARRY REYNOLDS (ph):  Simon, this is Harry (ph).

SIMON COHN (ph):  Yes, hi, Harry (ph).

HARRY REYNOLDS (ph):  If in the last sentence of the observation, the fact I know that the law says that they can start them in January of 2006.  But this continuing to state that would we have a different opinion if they wanted to start them earlier?

SIMON COHN (ph):  Now are you talking in terms of the …

HARRY REYNOLDS (ph):  Pilots.

SIMON COHN (ph):  OK.  I think this is …


SIMON COHN (ph):  … to the fill status (ph) notification.  Is that what you re referring to?  Were (ph) you referring to is that the issue you were referring to?  Or are you referring to you re reading this as something related, that we need to test the whole thing and pilot?

HARRY REYNOLDS (ph):  Oh, no, no, no.  I was no, that s fine, never mind.

SIMON COHN (ph):  Yes.  Well, no actually, Harry (ph), I want to want to follow on with your comment.  I get a little confused by the last three sentences of the observations.  And I m and I m trying to think of the case we re making.  I mean, we observe common usages of the new prescription and refill.  We make a comment here about a couple of other functions having minimal current usage.  And I m not sure I agree with the term minimal there.

And then we basically talk about a business case for something else not having been made.  And then we talk about NCPDP will continue to provide guidance on the use of SCRIPT standard, or (ph) the fill status notification function, and expects to test enhancements that support other I guess I m really sort of confused about all three of those sentences.

First of all, I m not sure that they re I mean I don t know, Margaret, I guess I m just sort of looking at this with a fresh eye.  But I m wondering if we need any of those three sentences …

MARGARET ALMAJEALKIN (ph):  Perhaps I can help a little bit.  First of all, the cancellation and change function …

SIMON COHN (ph):  Yes?

MARGARET ALMAJEALKIN (ph):  … several testifiers indicated that even though those functions were available, they didn t use them.  That s why the minimal current use.

SIMON COHN (ph):  Right.  And so I think I guess I would tend to think if they don t have widespread usage, and was the reason I mean, was it minimal usage, or was it not widespread?  I mean or can you make that conclusion based on the testimony?

MARGARET ALMAJEALKIN (ph):  I would suggest minimal was more appropriate than not widespread.


MARGARET ALMAJEALKIN (ph):  Because it sounded like it sounded like a number of the vendors didn t even have them in their systems (ph).

STAN HUFF (ph):  I this is Stan you know, I the take-home message I got from that part of the testimony, I think, was that this was an area that people weren t (ph) taking advantage of that they could have taken advantage of.  In other words, this is a place that could really save time and money.  And it was used as a justification for why we needed to educate and train people.  Because function existed that people weren t taking advantage of.  I don t remember saying that it was minimal.  It was that it was underutilized might even be a better …

PHIL ROBINIC (ph):  Simon, this is Phil Robinic (ph).  Can I jump in?

SIMON COHN (ph):  Yes.

PHIL ROBINIC (ph):  I think I guess I m focused on the fill status notification.  And I would agree that it is minimally used.  And I would agree that the business case hasn t really been made.  Because from the pharmacy perspective and I don t know if we ve got a, you know, retail pharmacy on the phone but, you know, it s another it s another step in their process that from their perspective, from the pharmacy s perspective doesn t necessarily provide value.  And, you know, telling the physician that the drug has been filled is one piece of information doesn t necessarily tell the doctor that the patient went home and took the medication as directed.  So there s still a question to be asked.

And so I would agree that maybe the business case hasn t been made.  And I m just I guess, I was curious on their (ph) action item 2.2 what the further guidance would be and, I guess, wanted to be sure that when you re saying you re going to pilot it, part of piloting is, you know, figuring out if it s something that should necessarily be required.  Because it s a part of the process that doesn t exist today.  And so you re adding steps work steps for pharmacy.  And so I think one thing to test is whether the value is worth the additional effort in this fulfillment process.

SIMON COHN (ph):  OK.  You know, I apologize who is it?  Who just spoke?

PHIL ROBINIC (ph):  Phil Robinic (ph), with Express (ph) …

SIMON COHN (ph):  Oh, OK, good.  The voice was very familiar.  But obviously it was hard to catch.  OK.  So obviously, we ve just now talked about the change in cancellation function; now we ve moved over to the fill status notification.

We ve sort of got couple of issues going on here at the same time.  I think that the let me ask the subcommittee their views on this one.  I actually, first of all, support the recommendation 2.1 about our description of foundation standards.  And I thought that the NCPDP SCRIPT foundation standard included the functions that we describe as new prescription, prescription renewals, cancellations and changes.

And so I guess I find it hard, in an observation text, to describe a couple of the functions that we re suggesting as foundation standards to be described as minimal usage.  It seems to undercut that piece.  And I guess I like what Stan what sort of saying about this more.

Now, I think the other piece, which is I think what we re trying to say here is that there is a piece that is that we think that one of these functions which is the fill status notification specifically needs to be tested in a pilot.  And I don t know about further guidance, but that s …

UNIDENTIFIED PARTICIPANT:  … NCVHS call (ph).  That s why I didn t answer your …

SIMON COHN (ph):  Hello?  Would you please put your phone on mute if you re having sidebar conversations?  But anyway, the pilot test should be on that fill status notification.  And it isn t so much further guidance, but it should be piloted for and I think what we heard in the last discussion was sort of this issue of for, you know, does it work (ph), value, and all the other things that one would want a pilot about.  So Margaret, is that I don t know if others feel like I do on this one.

And as I look at all of this stuff, the last sentence about where it says in the observations where it says NCPDP will continue to provide guidance on use of the SCRIPT standard and expects to test enhancements I thought HHS was going to test enhancements.

JEFF BLAIR (ph) (?):  Simon, can you hear me?

SIMON COHN (ph):  Maybe I m confused there.  So you re having (ph) a little bit of confusion on this one, but general agreement on direction.

MARGARET ALMAJEALKIN (ph):  I think I ve got the point, Simon.

SIMON COHN (ph):  Yes.  Jeff, please, comment.  Jeff?

MARJORIE GREENBERG (ph) (?):  Hello?

SIMON COHN (ph):  Did Jeff put himself on mute?

JEFF BLAIR (ph):  No.  Can you hear me now?

SIMON COHN (ph):  Yes, I can we can hear you now.

JEFF BLAIR (ph):  Oh, I m so sorry.  One of the things that I think is a little difficult to work with and I m not sure that I have an exact way of dealing with this but I think that it becomes difficult for us to make a sharp distinction between the portions of NCPDP SCRIPT which are foundation standards meaning that they are in current use and the ones which are not in widespread use, or underutilized.  Because the reality is that when we go into the pilot test, the foundation standard would also need to be used in the in the pilot test to support a lot of other things that need to be pilot tested.

So it I think that a little ambiguity there may allow the fact that when we talk about the pilot test, NCPDP SCRIPT overall, I think, needs to be included, even though we may be testing other functions of SCRIPT, or the terminologies, or the identifiers.

SIMON COHN (ph):  Well, Jeff, I think I agree with what you just said.  But I don t think that s what this observation or recommended actions does.  I don t actually think that there is ambiguity here.  And I don t even think we intend to I think our position all along has been that there s a foundation, and then there s additional functions that or terminologies, or codes, or whatever that may need to be tested in a pilot.  And I think that s said (ph) elsewhere …


SIMON COHN (ph):  … as well as here what I think should be said here and I think it s once again, I don t I m not being too harsh on this one but I think the wording is wrong, and I just think we need to take a hard look at the last three sentences of the observation.  And I think Margaret, are you OK with where I m going on that one?

MARGARET ALMAJEALKIN (ph):  Yes.  In fact, perhaps we should just say the NCPDP SCRIPT standard cancellation and change functions are currently underutilized.  The business case or fill status notification from the dispenser to the provider has not yet been made, and just drop the rest of it.

SIMON COHN (ph):  I think that that actually would certainly meet my needs, and then some wordsmithing on 2.2 …


SIMON COHN (ph):  … where we just identify, really, who s doing the pilots, and who s I mean, I don t know what we re going to get out of the pilots.  But I don t know the term further guidance is how I would describe what HHS is going to give us after the pilots.

JEFF BLAIR (ph):  Simon …

SIMON COHN (ph):  Yes?

JEFF BLAIR (ph):  … can you clarify for me I thought that the law had referred to this as demonstration projects.  And, is pilots the right word?

SIMON COHN (ph):  I don t know.  I would defer I don t have the legislation in front of me.  But whatever terminologies in the law we ought to be using in here.  I m just using your terminology, or the terminology that s currently in the letter.

UNIDENTIFIED PARTICIPANT:  The (ph) law requires HHS to have a pilot.

SIMON COHN (ph):  Does it?  OK.  So actually, the word is pilot, then.



SIMON COHN (ph):  Yes?

MARJORIE GREENBERG (ph):  This is Marjorie (ph) if I could just interject here for a minute the letter is now posted on the NCVHS Web site.  Actually, where I find it is under NCVHS Reports and Recommendations.  It does at least on my system, it does not appear to be where the call-in (ph) information is.  But …

RUSS MARTIN (ph):  Simon, this is Russ Martin (ph).  May I just interject one thing?  Point of (ph) for people to access it their cache on their Web site browser may not be able to see the new version.  They may need to click on refresh.  Typically, on a Windows machine, it could be using the F5 while they re holding down their control key may make the link pop up on the actual conference call page.

MARJORIE GREENBERG (ph):  OK, I tried that.  But in any event, you can find it at NCVHS Reports and Recommendations, if you click there.  It s posted as a bathleter (ph).


MARJORIE GREENBERG (ph):  It will only be there, I believe, until this call is over.  But …

SIMON COHN (ph):  Yes.  And then we start working on the next version.


SIMON COHN (ph):  OK.  Thank you …

HARRY REYNOLDS (ph):  … Harry (ph).  In 2.2 recommendation 2.2, the second paragraph second line, where it says 2006 further guidance wouldn t evaluation be a better word than guidance there?

SIMON COHN (ph):  That s right.  OK.  For further evaluation Harry (ph), thank you.  OK.

MARIA (ph):  This is Maria (ph).  Evaluation might not be such a good word, because it has such specific meaning in our world.  Can (ph) we find another one?

SIMON COHN (ph):  Piloting?   Of course (ph), we got two pilots in the same sentence.

Margaret, I guess you re going to have to work on the right word there.

MARGARET ALMAJEALKIN (ph):  Oh, good (ph).  I ll get it (ph).

SIMON COHN (ph):  OK.  So are we OK with I mean, we ve made (ph), obviously, a number of comments.  Margaret, I m hearing that you re sort of capturing, I think, the essence of what we re talking about here.  And people generally OK with observation two, at least until we see it next?

MICHAEL ZAPOLO (ph):  Just a suggestion that came to my mind:  Instead of guidance, you might want to put testing should include further testing on that standard.


MICHAEL ZAPOLO (ph):  Doesn t (ph) have the same connotation as evaluation.   And it (ph) seems to work.


MARJORIE GREENBERG (ph) (?):  Thank you, Michael (ph).

SIMON COHN (ph):  OK.  Should we go on to observation three?

LYNN GILBERTSON (ph):  This is Lynn Gilbertson (ph), from …

SIMON COHN (ph):  Oh, say (ph), Lynn (ph).

LYNN GILBERTSON (ph):  … NCPDP.  Hi.  A couple of comments in the third line, in observation two that starts, Currently, the NCPDP SCRIPT standard uses Free Text (ph) I would suggest that move down.  Because the whole discussion is on the different transactions.  And that sentence kind of just sticks out.  And what I m trying to understand is what are we trying to say with that statement.

MARGARET ALMAJEALKIN (ph):  I think that was Steve s (ph) suggestion; maybe he could respond to that.

STEVE STEINDELL (ph) (?):  I can see that it gives us an (ph) emphasis towards coded information, as opposed to Free Text (ph).


LYNN GILBERTSON (ph):  Are we …

STEVE STEINDELL (ph) (?):  … works (ph), but we (ph) tend to move to coded information.

LYNN GILBERTSON (ph):  Are we just talking about a sig here, and should say sig?  Because we have DUR (ph) codes.  We have drug codes, we have dosage and form codes.  So I m not quite sure what we would like worked on, besides sig.

STEVE STEINDELL (ph) (?):  The …

UNIDENTIFIED PARTICIPANT:  Steve (ph) contributed that one.  Maybe if Steve (ph) could make a comment on it.  I know that when he did, I thought it was a good comment to add you know, to start off with that as a as a base observation.

SIMON COHN (ph):  Well, the question is whether this is the right place for it.  And I think Lynn s (ph) sort of …


SIMON COHN (ph):  … commenting about whether this is either in the right observation or the right place in the observation.  Stan, were you going to comment?

STAN HUFF (ph):  Yes.


STAN HUFF (ph):  I think the point and we probably do want to say this differently the codes are allowed there.  But you don t specify a code.  And so anybody can use basically one of three or four codes there; I don t know exactly how many, for instance, for the drug.

And so, what you what you want to set the stage for is that we specify a particular code, and that that s a part of the implementation of this, then, that really needs probably to be investigated as part of the pilots is how well it works to have a single code there, and for that single code to work there, as opposed to allowing the multiple codes that are currently allowed.  Now that s the thought that, you know, I think we re trying to communicate.  But I m not sure this says that as well as it might.

SIMON COHN (ph):  And this really doesn t result in an action.

SIMON COHN (ph) (?):  Right.

LYNN GILBERTSON (ph):  Right.  Right.

SIMON COHN (ph):  Well, you know, first of all, then I (ph) actually sort of (ph) I had made a note here, but didn t want to get to that level where I agree that I thought that this sentence, even though it looked very interesting, and I fundamentally agree with it seemed oddly placed in this, since it (ph) it seems out of out of context.  And so, at the very least, we need to move it down probably to the end.


SIMON COHN (ph):  And maybe I m just going to say (ph) and maybe this results in an action, which is that the that we you know, that we recognize, I mean, somehow, that the foundation standard may have to be will need to piloted with additional functionality such as this sort of coded elements.


SIMON COHN (ph):  Margaret, you were going to give a great comment at this point.  You were going to solve our problem here.

MARGARET ALMAJEALKIN (ph):  Well, actually, now I have two.  I was going to suggest that this may be more appropriately put in observation eight, under clinical drug terminology, and reword it a little bit.  But now you ve just brought up the notion of whether the foundation standard needs to be piloted.

SIMON COHN (ph):  Well, it isn t the foundation standard needing to be piloted; it s that you use the foundation standard as the vehicle to pilot other functionalities.

MARGARET ALMAJEALKIN (ph):  Which we have later on in the …

SIMON COHN (ph):  Well, if we have that, then let s think about moving this out of two, then.

JEFF BLAIR (ph) (?):  Simon, I asked for this to be put in there.

SIMON COHN (ph):  Well …

JEFF BLAIR (ph) (?):  And it can be reworded and changed.  But the point that I want to make, right here, under observation two, is that there are aspects of the foundation standards that don t fully meet the requirements of MMA.  And those parts of the foundation standards need to be tested.


JEFF BLAIR (ph) (?):  I like wording that you suggested, which expresses that thought.  And I have no problem about moving it to the end of the paragraph.  But I do want the thought maintained under observation two.

HARRY CASARI (ph):  Simon, Harry Casari (ph) I agree.

LYNN GILBERTSON (ph):  I think it would be helpful to know what kinds of things because I m not sure what actions to take on that, and I m not sure HHS would know what to do with those.

JEFF BLAIR (ph) (?):  Well, Lynn (ph), I don t think there s any actions that you particularly need to take, meaning NCPDP.  Because the foundation standards do support coded drugs.  They support a coded sig.  But right now, the standard is being used with those fields (ph), sometimes sent as Free Text (ph).  And the Free Text (ph) part if it s sent as Free Text (ph), then it s very difficult to feed into the decision support systems that are required by the patient safety side of MMA.

MARIA (ph):  This is Maria (ph).  And I think some of this might be addressed by more fully fleshing out the paragraph at the top of page five.  Because (ph) I don t think we really teed up very well or very fully, perhaps what we mean by the foundation standards, and how this all works:  what s piloted, what s not, and all of that.  So maybe that could be put up there.

UNIDENTIFIED PARTICIPANT:  Yes, I think that s also a good idea, Maria (ph).


UNIDENTIFIED PARTICIPANT:  I mean, that s another place where it can be put.  I just want to make sure that early in the letter, that thought is expressed.

JEFF BLAIR (ph):  This is Jeff.  Can you hear me?  Simon?

SIMON COHN (ph):  Yes.

JEFF BLAIR (ph):  Oh, OK.  My opinion is that I tended to feel comfortable with where it is now.  And the reason that I did is because when it wasn t there, I m afraid that a lot of folks will assume that these things are in coded form.  And it says right up front that most of it is in textural form.  It s sort of like a basic description of the content of the message.  So I felt it was in the right place.  And I felt it eliminated a lot of wrong assumptions.  And it set a good foundation for the rest of the description.

SIMON COHN (ph):  Well …

LYNN GILBERTSON (ph):  Well, I would ask that if you re going to use the term Free Text (ph), you define what fields (ph) you re talking about then.  Because there s only a couple of Free Text (ph) type fields (ph).  So I just don t think it s very clear.

SIMON COHN (ph):  Yes.  And Lynn (ph), I think we re all sort of agreeing that it s not the second sentence of this observation.  And Jeff, I think I think what I m hearing from everybody is that we ought to have something sort of like this at the end of this observation.  And I m also hearing from Maria (ph) that we need to flesh out this concept of foundation standard a little more, I guess, in our sort of introductory comment, so people know what that means.

And we probably need to make a very explicit point that by foundation standard, we mean that this is something that has had adequate industry experience and doesn t need piloting.  And we need to say that relatively explicitly not doing that.  But I guess I would defer to Margaret.  And Margaret, I think you re sort of hearing the flavor here.  Is do you need …


SIMON COHN (ph):  … more guidance from us on this one?


SIMON COHN (ph):  Jeff and I would ask your forbearance of letting her sort of figure out where an observation to and (ph) exactly how they might come out, in terms of being worded.

JEFF BLAIR (ph):  Certainly.

SIMON COHN (ph):  Is that OK?

MARIA (ph):  This is Maria (ph) …

SIMON COHN (ph):  Because (ph) I think we re all in agreement that it will not necessarily disappear from observation two.  Just (ph) needs to find its right place in the paragraph.

MARIA (ph):  I just want to make this is Maria (ph) I just want to make a comment that I think, again, teeing up some of these concepts in the observations is important.  And they don t necessarily, in my mind, have to have recommendations.  Some of this is just providing context.  And again, providing the right context has to do with not only (ph) the right words, but the right place.

SIMON COHN (ph):  Well, yes.  But I think those context things (ph) probably ought to be before we move into the observations, if at all possible.


SIMON COHN (ph):  Agreed?  Hello?


SIMON COHN (ph):  You re there.  I think we just lost Maria (ph).

MARIA (ph):  No, I m here.


MARIA (ph):  I mean, there are a number of ways to do that.  That was just my take on this.  And thank you for clarifying how this works, Simon.

SIMON COHN (ph):  Well, I mean, I was (ph) wanting to make sure that you agreed, rather than just making a statement there.  Margaret, are you I guess I m asking at this point I mean, are you getting sort of the sense of what we need to do with this?

MARGARET ALMAJEALKIN (ph):  I think so, yes, Simon, thank you.

SIMON COHN (ph):  OK.  Do others have comments at this point?  Or are we I think what we ve decided on this one is that there s going to be modifications to the observations.  There s going to be some things moved around, some things taken out.  We ve come up with changes to action 2.2 that recognize that HHS is doing the pilot and will be testing or whatever words we want to use the fill status notification.

I guess the one thing I was just trying to think of and then we are going to figure out somewhere to put in sort of further statements around foundation standards and the fact that they are we are describing them that way because we believe that they don t need pilot testing and can and obviously don t need all of that, but also serve as the vehicle for testing of additional functionalities that really do begin to meet all of the MMA additional requirements.  Does that sound everybody in agreement generally, as I was (ph) describing this (ph)?

JEFF BLAIR (ph):  Yes, Simon.

SIMON COHN (ph):  OK, good, OK.

JEFF BLAIR (ph):  This is Jeff.

HARRY REYNOLDS (ph) (?):  (INAUDIBLE) this is Harry (ph) …

UNIDENTIFIED PARTICIPANT:  I have a I have a question about what you just said.

SIMON COHN (ph):  Well, please.

UNIDENTIFIED PARTICIPANT:  If you are we are we agreeing to the structure of the foundation standard or the content, or both, when you say it doesn t need to be piloted?

SIMON COHN (ph):  Well, I will refer you to action item 2.1.  It says, HHS should recognize as a foundation standard the NCPDP SCRIPT standard version 4 (ph) release 3 (ph), its present code sets, and on and on and on.  So I think we are talking at this point, presently, about accepting all the above.

HARRY REYNOLDS (ph) (?):  Except (ph) ones that we call out and say need more work.

SIMON COHN (ph):  Well, I think what we re saying on that is that we re still accepting the current version.  But we think that there needs to be future enhancements to meet MMA needs.


SIMON COHN (ph):  I think that s where we re (ph) …

HARRY REYNOLDS (ph) (?):  Correct.

SIMON COHN (ph):  … are you agreeing?

UNIDENTIFIED PARTICIPANT:  Simon, that s my interpretation.

SIMON COHN (ph):  OK.  And if we re not saying that, we need to make sure in the next version it says that.  Harry (ph), you OK?

HARRY REYNOLDS (ph):  Yes.  I think I understand it now.

LYNN GILBERTSON (ph):  Hey (ph), this is Lynn Gilbertson (ph).  One more on recommended action 2.1?


LYNN GILBERTSON (ph):  Just curious why version 4 (ph) release 3 (ph) is specifically stated, and then also why it calls out the various mailbox functions for the first time, and if that s really important.

MARGARET ALMAJEALKIN (ph):  I can respond to that, Simon.  I understood, Lynn (ph), that the current version of the standard was version 4 (ph) release 3 (ph).  But if that s not correct, if you could update that for me, I d appreciate it.

LYNN GILBERTSON (ph):  Well, I m just curious why you want to name any particular version release.  Because I thought we had discussed that we didn t want to tie into a particular version.  Because by the time this might you know, 2006 rolls around, you know I thought we were going to say something about something and above.

MARGARET ALMAJEALKIN (ph):  We have that later on.  But would it be appropriate, Simon, to suggest that HHS should recognize that the foundation standard the most current version of the NCPDP SCRIPT?

SIMON COHN (ph):  I would ask others for their comment on that one.  I could we could either say that, or we could be silent about the version and release.

JEFF BLAIR (ph):  This is Jeff.  I feel comfortable with Margaret s suggestion that we wind up indicating that it would be the most current version.

UNIDENTIFIED PARTICIPANT:  I m actually a little bit more comfortable saying, you know, version 4 (ph) release 3 (ph), or later releases.

RUSS MARTIN (ph):  That was the gist …


RUSS MARTIN (ph):  This is Russ Martin (ph), from Pfizer (ph) that was the gist of the conversation.  I understood from last hearing that you were looking to make sure that there wasn t a lock down of the (ph) particular version, but you wanted to have some starting point.  And if you just say the latest version, I m not sure what that means in terms of where we are in the piloting you know there are versions that are undergoing revisions constantly.  And out in the field, there are a number of versions in play.  So if you always say the latest version, you re not giving (ph) I m not sure what we re piloting versus what we re going to be recommending at the end.

KAREN TRUDELL (ph):  This is Karen Trudell (ph).  I think from an implementation perspective, it s six of one, half a dozen of the other.  I think we would wind up in the same place, no matter what.  But CMS could work with either one.

RUSS MARTIN (ph):  Either one means what?

KAREN TRUDELL (ph):  Either one of those recommendations:  either the most current version, or version whatever and later.

MARGARET ALMAJEALKIN (ph):  Simon, may I ask Lynn (ph) a question, please?

SIMON COHN (ph):  Sure.

MARGARET ALMAJEALKIN (ph):  Lynn (ph), we are talking about potentially using the term later release.   Is there an anticipation that the version would go from 4 (ph) to 5 (ph)?  And should we say versions and releases?

LYNN GILBERTSON (ph):  Yes to your statement.  I hate for you to get into a wordsmithing, or to have somebody point one way or the other.  So if you wanted to say latest version/release, you could you know, that would probably cover it.  I would think most people would take it at its face value, and not cite, Well, you said the word versions, and this is a release.  It s just how much of the letter of the law do you think someone s going to come back.

SIMON COHN (ph):  OK.  Let me ask everyone actually, at least subcommittee members given that we have a recommendation later on talking about how to handle versions and releases, and how HHS ought to handle that, do we is it necessary here to mention specifically the version and release?

JEFF BLAIR (ph):  Could we leave this to Margaret after we …

SIMON COHN (ph):  After we ve gone through it (ph)?

JEFF BLAIR (ph):  … get down further?

SIMON COHN (ph):  I think that may be the best way to do it.  Jeff, thank you for getting us out of what could be another hour s conversation.

LYNN GILBERTSON (ph):  OK.  Then the other one was the comment about the mailbox functions (ph).

SIMON COHN (ph):  Oh, I m sorry.  Yes, Margaret, can you can you describe why mailbox functions …

MARGARET ALMAJEALKIN (ph):  Yes.  We included what are essentially mailbox functions, also added to the 272-72 (ph), those acknowledgments of receipt (ph) simply because when HCFA was released and they did not clearly and explicitly state that those were included, they were excluded from consideration and implementations.  And work-arounds were created instead of those standards they used, because they thought they couldn t use them.  So I was just trying to avoid that issue by including the mailbox functions, and not having to elaborate upon them (ph).

SIMON COHN (ph):  OK.  Margaret, maybe I need to understand this one.  As I m (ph) reading this one, it sounds like we have various mailbox functions for communication of prescription information between all prescribers, dispensers, da-ta-da-ta-da (ph).  Do you mean various mailbox functions, and it s really NCPDP standard for communication of prescribing information?

MARGARET ALMAJEALKIN (ph):  Yes, the latter.

SIMON COHN (ph):  The latter, OK.  So this is just another piece of functionality, in addition or another piece of description in relation (ph) to present code sets.


SIMON COHN (ph):  That does require some wordsmithing, then.  I guess, Lynn (ph), I would ask you, are there other pieces, when we get down to this level of granularity, that we need to be specifying?

LYNN GILBERTSON (ph):  It s almost like you want to recommend the package, and not call out specific pieces.  It (ph) was just thinking in terms of the observation with (ph) the prescription messages.  And there was nothing mentioned about mailboxes until we got down to the recommended action.

JEFF BLAIR (ph):  This is Jeff.  I have two suggestions here:  Number one, if Lynn (ph) and Margaret could work out the details and the precision, and if this is simply divided into two sentences, which makes it easier for the inclusions of the detail to be in there or three sentences then I think that they could work it out and get the specificity in there.

LYNN GILBERTSON (ph):  OK.  And what I wanted to make sure the committee wants the mailbox functions to be cited …

JEFF BLAIR (ph):  I (ph) …

LYNN GILBERTSON (ph):  … rather than removing that term at all.

STEVE STEINDELL (ph):  Yes, Lynn (ph), this is a question that I have for you, and a question that I have for Margaret concerning the mailbox functions especially when you relate it to the X12 (ph) acknowledgment-no acknowledgment messages.  Specifically, is that what we re talking about concerning mailbox functions?  Because there s a whole slew of mailbox functions defined in SCRIPT.  That s number one.

And number two, Lynn (ph) this is (ph) one for you to answer are people who implement SCRIPT today using acknowledgment-no acknowledgment messaging?  And I think that has a lot to do with what we re recommending here.  Because if it s not in widespread current use, I don t know if we really want to want to recommend it.

MARGARET ALMAJEALKIN (ph):  Steve (ph), the intent here was various all the various mailbox functions and maybe it would be suitable to put as applicable we did that in the 270 (ph) section as well.


UNIDENTIFIED PARTICIPANT:  I think there s I think there s value well, you know, I think the intent that Margaret had is a good one.  But I think you could do this.  And there is a difference, clearly.  And they are in use (ph) at least, we asked that question in the testimony the mailbox functions are in use for people who are doing these things batch (ph) as opposed to Real Time.  And, you know, is I think we clearly I think it adds value to make it clear that we re not precluding people from continuing to use those mailbox functions.

There are a whole bunch of other things that are the response would correspond to the acknowledgment parts of the 270 (ph), 271 (ph) stuff, that are also in there, and we aren t calling out individually.  So but I mean, I think you know, I think we could say something here, and say and specifically including these parts.  Because the I think we might even say the mailbox and acknowledgment messages, to (ph) make it clear to people that we are being inclusive of the whole standard, not just the not just a new prescription and refill, and et cetera.

MARGARET ALMAJEALKIN (ph):  … may be appropriate to include reference to this information in the observation, and then it may not be needed in the recommended action.  I ll see how that works out.

SIMON COHN (ph):  OK.  Are we OK with this one?  Can we move on to three?


SIMON COHN (ph):  Yes.  I would (ph) say, otherwise we re going to spend the whole day, and we ll be done with observation four.  We re about one hour into it.  So just we just need to make sure that we re I think it s important that we make it through all of the observations and recommendations by the end of this call.  Observation three?

MARGARET ALMAJEALKIN (ph):  Harmonization of prescription method standards HL7 (ph) is commonly used to communicate medication orders within a hospital and with clinical pharmacies within an enterprise.  Harmonization of HL7 (ph) 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 (ph) and NCPDP have already begun to map their standards to support common functions.

Recommended action 3.1:  HHS should accelerate initial harmonization activities between HL7 (ph) and NCPDP and help support ongoing maintenance of HL7 (ph) NCPDP SCRIPT harmonization for electronic medications on (ph) ordering and prescribing.  Recommended action 3.2:  HHS should recognize that a (ph) standard specification for exchange of new prescriptions, renewals, cancellations, changes and fill status notification within the (ph) same enterprise is outside the scope of MMA.

Recommended action 3.3:  HHS should require that a prescriber using an HL7 (ph) message enterprise and who needs to send a prescription to a community or retail pharmacy of the patient s choice, convert or use an intermediary to convert the HL7 (ph) message to NCPDP SCRIPT or telecommunication standard for transmission to the community or (ph) retail pharmacy.

Recommended action 3.4:  HHS should recognize that there may be new messages e-prescribing (ph) that warrant an HL7 (ph) message and support demonstration projects, if applicable.

SIMON COHN (ph):  Comments, questions?

STAN HUFF (ph):  So I this is Stan I wondered, in 3.3, why telecommunication standard was inserted there.  Because I thought that was for isn t that primarily the billing standard, and not clinical?

MARGARET ALMAJEALKIN (ph):  Yes, I believe that was a suggestion that came from Karen Trudell (ph).

KAREN TRUDELL (ph) (?):  No, it didn t.

MARGARET ALMAJEALKIN (ph):  Oh, sorry.  Maria (ph)?

MARIA (ph):  No, we only specified SCRIPT.  Because SCRIPT was missing from a lot of this stuff.  We asked that it be put in.


STAN HUFF (ph):  Yes.  Adding SCRIPT makes a lot of sense.  But telecommunication standard seems to be out of place there.

MARGARET ALMAJEALKIN (ph):  Well, somebody suggested it, and I added it.  So I …

STAN HUFF (ph):  Well, it (ph) sounds like you should remove it.


STAN HUFF (ph):  OK.

SIMON COHN (ph):  Margaret, overall, I think this reads pretty well.  I guess the only question I would have and maybe it s so obvious that it s stated everywhere else is that I think we were also mean, what we re seeing is that if you re within one of these enterprises, and you send something out, it has to be it has to be converted to an NCPDP SCRIPT.  I think what we were also saying is that retail pharmacies within an enterprise also have to be capable of accepting NCPDP SCRIPT e-prescriptions.  Is that somewhere (ph) else?

JEFF BLAIR (ph) (?):  Simon, that it s a surprise to me.  I didn t know that we were saying, within an enterprise, that they needed to accept NCPDP SCRIPT if they already had a message sent to them in HL7 (ph).

SIMON COHN (ph):  Well, I guess it s I mean, maybe I should withdraw that comment.  Maybe that s not where we re going.

STAN HUFF (ph) (?):  Well, I mean, I guess we didn t I guess that was always my understanding as well.  My understanding was the same as Simon s.  In other words, if I m if I m IHC (ph), and I have pharmacies that are owned by IHC (ph), I can communicate to those pharmacies via HL7 (ph) messages.  If some other enterprise is sending prescriptions to IHC s (ph) pharmacies, that should be in (ph) SCRIPT standard as well.

JEFF BLAIR (ph) (?):  Oh.  I think that s new.  And maybe, if you all feel like that s appropriate, that that would be an additional recommendation.

STAN HUFF (ph) (?):  Well, it s we said that in different ways.  I mean, the way that we said that before was that retail pharmacies that any prescription that went outside of an enterprise should adhere to NCPDP SCRIPT standard.  That s the way we ve said it before.

JEFF BLAIR (ph) (?):  Oh …

STAN HUFF (ph) (?):  And the implication of that statement is exactly what I said.

JEFF BLAIR (ph) (?):  OK.  See, I had always interpreted that meaning that if it went to a retail or commercial pharmacy, it had to be in NCPDP SCRIPT.  So you re saying something yes I have no problem with your adding that.  But that came as a concept that was new to me.

SIMON COHN (ph) (?):  Well …

JEFF BLAIR (ph) (?):  Didn t realize that that s what you had meant.

PAUL ZAPOLO (ph) (?):  Yes.  I think it s actually an additional sentence to action 3.3.  Stan, what do you think?

MARGARET ALMAJEALKIN (ph):  Let me craft (ph) something and shoot it out to you, Paul (ph).

PAUL ZAPOLO (ph) (?):  OK.  OK.  I mean, if we re misinterpreting, or we re going over the bounds of what was intended but I think that the view was (ph) that within an enterprise, people had the option to use HL7 (ph).  But an actual retail pharmacy within that enterprise also had to be able to accept a prescription from outside, in the in the national standard format.

STAN HUFF (ph) (?):  Yes.  I mean, again, I think that s I think it s all that s (ph) understood through this whole thing.

PAUL ZAPOLO (ph) (?):  Right.

UNIDENTIFIED PARTICIPANT:  I mean, (ph) that s been my understanding as well.

PAUL ZAPOLO (ph) (?):  Yes.

STAN HUFF (ph) (?):  Yes.  And (ph) essentially, again, the goal is that a pharmacy that any prescriptions sent between enterprises would adhere to SCRIPT.

JEFF BLAIR (ph) (?):  Maybe that s a good way to say it.

SIMON COHN (ph) (?):  Margaret, it sounds like you re going to come up with some wordsmithing here.  I m not sure that that is actually the way to say it …

UNIDENTIFIED PARTICIPANT:  I don t I don t I don t think yes, I don t think we want to say it exactly that way.

SIMON COHN (ph) (?):  Yes (ph).

UNIDENTIFIED PARTICIPANT:  I think I think we re better off to just add one sentence.  I think we re close enough here if we just add one sentence that says, you know, that prescriptions from outside an enterprise would still need to be accepted in the SCRIPT standard.

SIMON COHN (ph):  Yes.



Could you (ph) move on to observation four, or do we need to talk about observation three more?

UNIDENTIFIED PARTICIPANT:  One more question on 3.4.

SIMON COHN (ph):  Sure.

UNIDENTIFIED PARTICIPANT:  Are we saying in 3.4 that, if there are new message functions, that they should be HL7 (ph), or that they should be looked at through NCPDP SCRIPT first, and if not, then use HL7 (ph)?

JEFF BLAIR (ph) (?):  Margaret, I think you need to explain that one.

MARGARET ALMAJEALKIN (ph):  I think that by saying that there may be new message functions for (ph) e-prescribing (ph) that warrant an HL7 (ph) method (ph) and that that (ph) should be supported in a demonstration project.  I don t think it s saying if (ph) they have to be in HL7 (ph); I don t think it precludes NCPDP.

UNIDENTIFIED PARTICIPANT:  But it but it but it doesn t it doesn t make the first look be at NCPDP, either.

JEFF BLAIR (ph):  My understanding this is Jeff is that it was leaving the door open, that if we had and these are just examples; I m not saying it s going to have to be this way at all but we were leaving the door open that if there was a new message to communicate either medication history or medical history, or something else and if that, you know, had either is being developed in HL7 (ph), that this didn t preclude the fact that there could be an HL7 (ph) message in the future, a new message in the future, which might be HL7 (ph).

UNIDENTIFIED PARTICIPANT:  Then what should HHS do by recognizing this?  Should it make a portion of the pilot for new HL7 (ph) messages?

JEFF BLAIR (ph):  No, we re not there yet.  It s just holding the door open.  Margaret, is my interpretation correct?

MARGARET ALMAJEALKIN (ph):  I believe that was the intent, and that the point was that if there was a new message function, that HHS responsibility would be to recognize that and (ph) support demonstration projects, as applicable.

LYNN GILBERTSON (ph):  Right.  But it sounds like NCPDP can t do that.

UNIDENTIFIED PARTICIPANT:  I agree.  That s where that s where I was coming from, Lynn (ph).

SIMON COHN (ph) (?):  Right (ph).

JEFF BLAIR (ph) (?):  Yes, and you know …

UNIDENTIFIED PARTICIPANT:  Or it sounds (ph) like people just have a choice between the two.

UNIDENTIFIED PARTICIPANT:  But it but it but it doesn t reference NCPDP.  So if we ve set a foundation standard, then I would like to have I know from a standard standpoint, you should stay with your foundations until they are proven not to serve the purpose.  And then you could go to HL7 (ph).  We don t want them going somewhere else.  That s where I m trying to go, so that we continue to use this foundation until it breaks down.  And then we ll know why it broke down.

MARGARET ALMAJEALKIN (ph):  Perhaps we could just fix (ph) this by saying HHS should recognize that there may be new messaging functions for e-prescribing (ph) that warrant either an NCPDP or HL7 (ph) standard message (ph) and support (ph) …

STEVE STEINDELL (ph):  I personally think we should just leave it out.

JEFF BLAIR (ph):  I think I agree with Steve (ph).  I don t see a need for 3.4, and I didn t when it first appeared.

STEVE STEINDELL (ph) (?):  Yes.  It was trying to hold the door open.  But maybe we don t need to say anything to hold the door open.

SIMON COHN (ph) (?):  I agree.

UNIDENTIFIED PARTICIPANT:  When we define the door, we ll decide how to open it.

JEFF BLAIR (ph) (?):  Right.



SIMON COHN (ph):  I m hearing support for deleting this from Jeff, from …

HARRY REYNOLDS (ph) (?):  Harry (ph).

SIMON COHN (ph):  What?

HARRY REYNOLDS (ph) (?):  Harry (ph).

SIMON COHN (ph):  Harry (ph) …

JUDY WARREN (ph):  Judy (ph).

SIMON COHN (ph):  … Judy (ph) …

STAN HUFF (ph):  Stan.

SIMON COHN (ph):  Stan, OK.  So let s delete it.

UNIDENTIFIED PARTICIPANT:  That covers everyone.

SIMON COHN (ph):  Yes.  OK.  This plain (ph) charter (ph) may be better.  I mean, we re up to 13, 14 pages here.  Formulary messages, observation are we OK with three, and we can move on to four?

RUSS MARTIN (ph):  This is Russ Martin (ph), from Pfizer just one comment.  The coordinators or the participants in the mapping process have been using not the word harmonization, but the word coordination.   And there were a number of reasons for that.  And I would just ask that you consider using that word instead of harmonization.


RUSS MARTIN (ph):  Thank you.

SIMON COHN (ph):  And (ph) we ll keep that in mind as we and there will be plenty of time for us to talk about that as we move forward, I think.  (INAUDIBLE) I guess I guess that actually is in 3.2.  So …

UNIDENTIFIED PARTICIPANT:  Simon, I have been very uncomfortable with the word harmonization.   So I …

SIMON COHN (ph):  You agree with …


SIMON COHN (ph):  … coordination?

UNIDENTIFIED PARTICIPANT:  I would encourage changing the word to coordination.

SIMON COHN (ph):  OK.  OK.  Margaret, you re OK with that?


SIMON COHN (ph):  OK.  Let s go to four, then.

MARGARET ALMAJEALKIN (ph):  Formulary messages formulary and benefit coverage information, including information on the availability of lower-cost therapeutically appropriate alternatives, if any, for the drug prescribed from payers (ph) pay (ph) DMs (ph) to prescribers currently is communicated with proprietary messages.

Rx-Hub (ph), a formulary information consolidator, has committed its intent to submit its proprietary formulary and benefit information file transfer protocol, which uses the NCPDP SCRIPT standard in its (ph) underlying structure to NCPDP to broaden the consensus and ensure the protections to the industry afforded by becoming an NC-accredited (ph) standard.  Convergence to an NC-accredited (ph) appears to be possible in an accelerated timeframe.  This process will afford consideration of any specific requirements affecting the implementation of Medicare s new Part B prescription drug program.

Recommended action 4.1:  HHS should support rapid adoption I m sorry rapid development of an NCPDP standard for formulary and benefit information file transfer using their (ph) XF (ph) protocol as a basis to broaden industry consensus.  4.2:  NCVHS will monitor the progress of NCPDP standardizing of formulary and benefit information file transfer protocol and provide subsequent advice to the secretary about (ph) its readiness for adoption.  4.3:  If a formulary and benefit information file transfer protocol standard is ready by January 2006, CMS should include in (ph) pilot tests to ensure that it meets any special Medicare requirements.

RUSS MARTIN (ph) (?):  I would put it after include, in that last one.


RUSS MARTIN (ph) (?):  CMS should include it in pilot tests.


SIMON COHN (ph):  Comments from the subcommittee?  I guess I should ask, first of all, if there s a representative from Rx-Hub:  Are we describing your company appropriately by describing you as a formulary information consolidator?

SHELLY WOLLEY (ph):  That s this is Shelley Wolley (ph) that is not really a correct description of the company, as it makes it look like we only do formulary.

SIMON COHN (ph):  OK.  Maybe you can send a note to Margaret Almajealkin (ph), so that we can so we can reflect this appropriately (ph).  I looked at that one, and I didn t think that that exactly applied (ph) to (ph) company.

SHELLY WOLLEY (ph):  Be happy to.



SIMON COHN (ph):  Yes?

UNIDENTIFIED PARTICIPANT:  This is (INAUDIBLE).  I would change in the second line, on recommendation 4.1 …

SIMON COHN (ph):  Yes?

UNIDENTIFIED PARTICIPANT:  … last word, I would change to expedite.   Broaden sounds like the rest of them don t understand.

SIMON COHN (ph):  Would (ph) you read the recommendation with your new wording?

MARGARET ALMAJEALKIN (ph):  HHS should support rapid development of an NCPDP standard for formulary and benefit information file transfer using their (ph) XF (ph) protocol as a basis to expedite industry consensus.

SIMON COHN (ph):  OK.  Everybody OK with that one?


RUSS MARTIN (ph) (?):  On the last sentence of the observation this process will afford consideration I m not sure I understand the meaning of it, or that that process will actually do it.  I m questioning whether we need to have that sentence in there.

KAREN TRUDELL (ph):  This is Karen (ph).  Let me explain to you where we re where we re coming from.  There was a this was intended to replace a very long sentence that essentially said Part D is (ph) a new program.  And, you know, Medicare may have requirements that are out of the ordinary.  And it didn t actually do anything but raise a red flag.  And so, what I was trying to do was make that into a positive statement:  that if there are new Part D requirements that people aren t aware of, this process will allow them to be discussed and addressed.

SIMON COHN (ph) (?):  So maybe …

RUSS MARTIN (ph) (?):  (INAUDIBLE) … process of networking with …

SIMON COHN (ph):  Yes.

RUSS MARTIN (ph) (?):  … NCPDP …

KAREN TRUDELL (ph):  If we don t want to put that in at all, I m fine to take it out.  I just wanted the sentence before it to come out.

JEFF BLAIR (ph) (?):  Yes, I agree with Karen (ph).  I never liked the long sentence that s been in there.  And I thought Karen s (ph) rewording of it was an acceptable replacement.  I mean, it basically says we re going to use the pilot process to test what we need to test.  And because we are using the pilot process, I m equally comfortable with dropping the sentence.

SIMON COHN (ph) (?):  Yes.  You know, I think actually the sentence is fine.  I don t know if I like the word afford; it seems like enable is probably a better word, only because I m not sure what afford means in this context.  I (ph) think this process will enable consideration of any specific requirements.

KAREN TRUDELL (ph) (?):  Works for me.


SIMON COHN (ph) (?):  Seems like if we say that, I think I m fine with all of that.

UNIDENTIFIED PARTICIPANT:  Is the process the process where Rx-Hub (ph) is working with NCPDP?

SIMON COHN (ph):  Say that again what?

UNIDENTIFIED PARTICIPANT:  We talk about this process.  Is the process Rx-Hub (ph) working with NCPDP is that the process that will (ph) bring (ph) this about?

KAREN TRUDELL (ph) (?):  Well, the process …

UNIDENTIFIED PARTICIPANT:  Or is it something broader?

KAREN TRUDELL (ph) (?):  The process is not so much Rx-Hub (ph) working with NCPDP, but Rx-Hub (ph) contributing its proprietary standard to NCPDP to go through the regular SGO (ph) process.

UNIDENTIFIED PARTICIPANT:  And the process would be, generally, anybody who has a standard that would be beneficial could contribute it to NCPDP.  And it s that process of contributing their portion of a standard to NCPDP that will afford consideration or that will enable consideration of special requirements.

JEFF BLAIR (ph) (?):  I interpreted that as the standards development process.

UNIDENTIFIED PARTICIPANT:  Yes.  No, I agree with you.

UNIDENTIFIED PARTICIPANT:  Well, I mean, the immediately preceding sentence says conversion to an NC-accredited (ph) standard appears to so I thought that s what the this referred to, is that convergence to an NC-accredited (ph) standard, which is the process, you know, that encourages all those things that you said, you know …


UNIDENTIFIED PARTICIPANT:  … people contributing and …

UNIDENTIFIED PARTICIPANT:  Well, I guess the other question I would ask here aren t we talking about development of NC-accredited (ph) standards of NC-accredited (ph) standard?  I don t know what convergence to means.

UNIDENTIFIED PARTICIPANT (?):  That would be better.

UNIDENTIFIED PARTICIPANT:  And at (ph) that point, this begins to become a little clearer, I think.

UNIDENTIFIED PARTICIPANT:  That does make it clearer.

PHIL ROBINIC (ph):  Simon, this is Phil Robinic (ph).  Can I jump in for a second?

SIMON COHN (ph):  Oh, please.

PHIL ROBINIC (ph):  I just want to make an observation.  You know, we talked about standards that have adequate industry experience.  And this really is one.  And I m not you know, I support the NCPDP process for, you know, making the art (ph) sub-processes sort of NC-accredited (ph) standards.  But, you know, I ve pointed out to a couple of you, when this first came up, the concern that the NCPDP process includes a lot of stakeholders that don t have anything to do with formulary messaging.  And so, there s an opportunity for this thing to get derailed a little bit.

And so, one concern I have is that (ph) people who are doing formulary messaging today are using the art (ph) sub-process, and it works.  And so, if the default in 4.3 is to not do anything in the pilot if the NCPDP process isn t finished, then you run the risk of, you know, that getting bogged down, and ending up with nothing.  And I m wondering if it could be valuable to recognize that what exists today has adequate industry experience.

And the NCPDP process is really, I think, intended as sort of an industry validation, as opposed to sort of starting from scratch.  And so you could default to using it as it exists, and use the NCPDP process for an industry validation to make it an NC-accredited (ph) standard.  But if you get to 2006, and they re still working through that process, you could include the standard as it exists today.  Because there is adequate industry experience using it.

SIMON COHN (ph):  OK.  Well, Phil, I think we ve discussed a number of your issues before in open session, so I won t rehash some of that.  I guess, however, from your comment, the one thing I would ask the subcommittee which I think had been sent seemed (ph) that I d sent as (ph) a comment to Margaret, but didn t seem to be reflected here is I was wondering whether 4.3 was necessary at all, given that I think what we are doing is monitoring the progress of this effort.

And I thought sometime next year, depending on the progress, we had a couple of options.  One would be recommending that functionality be tested in pilot; or, B, that really, whatever had been done really was of good quality, industry supported, it (ph) had adequate industry experience and should be moved into something that the secretary could actually move forward with without piloting …

PHIL ROBINIC (ph):  Simon, for my benefit, what is 4.3?  Could you just …

SIMON COHN (ph):  It s the whole discussion of pilot tests.  It says, If a formulary and benefit information transfer protocol standard is ready by January 2006, CMS should include it in pilot tests to ensure that it meets any special Medicare requirements.

PHIL ROBINIC (ph):  Thank you.  I understand your point.

SIMON COHN (ph):  And I had thought that basically we had recommended on this one, as well as one later on, that really what we were going to be doing was monitoring.  And at (ph) that point, we had depending on how it went and what the industry thought of it we might we had a couple of options on what we recommended.


SIMON COHN (ph):  So I guess I ask for the rest of the committee to help me on this one, or tell me if I m remembering inaccurately here.

JEFF BLAIR (ph) (?):  If you re suggesting, Simon, that we don t need 4.3, I would feel OK with that.

STAN HUFF (ph):  I agree with Simon.  I mean, I think the gist of it is, in fact I mean, there s the pilot test.  But actually, what we re talking about is, before the pilot test, we can we can evaluate next year progress towards this being adopted as an NC (ph) conversion, if you will, or however you want to describe it, to an NCPDP standard, and then decide what to do.  If that hasn t occurred, we can decide that it s in the best interest to go ahead without you know, to use it in spite of the fact that it s a proprietary standard.  Or we can say, you know, we think there s substantial risk to that.  And we suggest, then, that you know, that we ll just wait until their is a true NC (ph) standard for this.

JEFF BLAIR (ph) (?):  I agree with Stan.  4.2 covers that and gives us the latitude to do that.


HARRY REYNOLDS (ph) (?):  This is Harry (ph).  I d consider adding one thing to 4.2.  If I m sitting there as you think of the pilot s (ph) going to go in, in January of 06, we don t say when we would monitor, or when we would get back to the secretary.  And it might not be bad to say in there that we would we would respond to him by a certain date, which would allow inclusion into the pilot, if it appears to be ready.

JEFF BLAIR (ph):  Well, since we don t really know when that deadline is yet, I think we could determine when that deadline would be, and we could work towards that.  But I don t know that we could put a date in right now that is …

HARRY REYNOLDS (ph) (?):  But (ph) I guess my point, Jeff if you re starting pilots January of 2006 …


HARRY REYNOLDS (ph) (?):  … three to six months ahead of that, you re going to have to know whether or not this needs to be included in the pilot.


HARRY REYNOLDS (ph) (?):  That s (ph) my point.

UNIDENTIFIED PARTICIPANT:  Yes, Harry (ph), let me make sure that I m you appear to be going to a different point than where I was going to.  So let s make sure that we re all sort of in agreement with the basics here.  I was recommending that 4.3 be removed …

JEFF BLAIR (ph):  And I agree with that …


JEFF BLAIR (ph):  … I agree with that …


JEFF BLAIR (ph):  But I agree that you might want to add something to two, so that …

UNIDENTIFIED PARTICIPANT:  Well, no but the reason I was deleting it was because one option for us to recommend is that it be piloted.  Another recommendation is to say that, geez (ph), based on what we ve heard from the industry, and the work that s gone on in this development of the NC (ph) standard based on the Rx-Hub (ph) proprietary solution, that the industry feels that this actually has had adequate industry experience doesn t need piloting.


UNIDENTIFIED PARTICIPANT:  So all I m saying is I want you to be very well aware of (ph) the reason I m removing 4.3.  And it s why I would sort of reject your wording in 4.2.  Because you were specifying it as only being advisory to the secretary in relationship to pilots.  Harry (ph)?

HARRY REYNOLDS (ph) (?):  OK.  OK, I OK.

UNIDENTIFIED PARTICIPANT:  Are you OK with that one?  Margaret, did you have a comment?

MARGARET ALMAJEALKIN (ph):  Yes.  I think if we do that, we d need to be a little bit clearer at the end of 4.2.  And I suggest something like, NCVHS will monitor the progress of NCPDP standardized in a formulary benefit information file transfer protocol and provide subsequent advice to the secretary about adopting (INAUDIBLE).

SIMON COHN (ph):  We ve lost you.


SIMON COHN (ph):  About?

MARGARET ALMAJEALKIN (ph):  Adopting a formulary and benefit information file transfer protocol.  That the way it read previously suggested that they would only advise about the standards, and not the Rx-Hub (ph) form of the protocol.

BECKY JACKSON (ph):  This is Becky Jackson (ph) for Rx-Hub (ph).  Are you basically saying the ability to advise is independent of the outcome with regard to the NCPDP process?

JEFF BLAIR (ph):  No.  I think that the I ll just speak for myself; this is Jeff I feel it is very important for every effort to be made to convert the excellent Rx-Hub (ph) solutions and messages through the standards development process, which is an open consensus process, and that we get that done as quickly as possible.  Because we do need to have the other voices.

Yes, some of them may be difficult to deal with, but that s because they have other interests, including the you know, the prescriber community, for example maybe the dispenser community but they need to be heard prior to the fact that this be recognized as a national standard.  So that is what I think we re trying to achieve.

BECKY JACKSON (ph):  But are we trying to achieve the right or the ability of NCVHS to go forward with the recommendation on this issue, in the event that the NCPDP process it (ph) takes too long, or ends up getting derailed in some (ph) …

JEFF BLAIR (ph):  The wording here was we would (ph) monitor their process, we want HHS to expedite, we want everybody to move aggressively forward to make this successful, so that it can become a national standard as quickly as possible.  And we ll (ph) validate the progress before we wind up making any further recommendations.

JUDY WARREN (ph):  Margaret, this is Judy (ph).  Can you read again what you put in for 4.2?

UNIDENTIFIED PARTICIPANT:  Margaret, before you read it, can I comment?


UNIDENTIFIED PARTICIPANT:  Yes, I think we can just say advise (ph) to the secretary about adoption.  I think that captures your point.

MARGARET ALMAJEALKIN (ph):  Yes.  The word its (ph) concerns me.  Because it does suggest that the only thing you look at is whether the NCPDP standard is ready.  If it s not ready, it appears (ph) like you re not going to look at the Rx-Hub (ph) as an industry default.

UNIDENTIFIED PARTICIPANT:  Yes.  And so, if we just remove it readiness for, I think it captures it.


SIMON COHN (ph):  Well, Margaret, then, would you read what the current what the current language would look like?

MARGARET ALMAJEALKIN (ph):  NCVHS will monitor the progress of NCPDP standardizing a formulary and benefit information file transfer protocol and provide subsequent advice to the secretary about adoption.

JEFF BLAIR (ph) (?):  This is Jeff Blair (ph) at Arcsub (ph).  If we say adoption and piloting?

SIMON COHN (ph):  And/or piloting?  I think that would be fine.

UNIDENTIFIED PARTICIPANT:  I think it would be fine.  But I think it s a little redundant, but I have no problem with it.

SIMON COHN (ph):  OK.  Well, I think we all reserve the right to look at this …

STEVE STEINDELL (ph):  Simon, I d like to return to Harry s (ph) point.


STEVE STEINDELL (ph):  I think Harry (ph) made a very good point there, that we really should put a time limit on this as to when we re going to report back to the secretary.  Because that actually put the (ph) stake in the ground for the people that are involved with the process.  If they know NCVHS is looking to say to the secretary, progress has been made by such and such a date, you know, I think that gives them something to aim for as to how to manage their process.  And (ph) we could pick a date like we could report back in our March letter, or we could report back in June.  But I think we should put a date in there:  you know, by June 2005, or March 2005.

JEFF BLAIR (ph) (?):  Well, they may need more time, Steve (ph).  And I d hate to cut it short if we don t see enough progress by March or June.  And they may be struggling.  And, you know, it may be, you know …


JEFF BLAIR (ph) (?):  … August or September when we have a full committee meeting in June and another full committee meeting in September.  And …

UNIDENTIFIED PARTICIPANT:  Pick September.  Just I think it s …

JEFF BLAIR (ph) (?):  All right (ph) …

UNIDENTIFIED PARTICIPANT:  … good idea to pick a date …

JEFF BLAIR (ph) (?):  Then pick September …

UNIDENTIFIED PARTICIPANT:  So if they haven t made progress, we can report back to the secretary.  Because we re just reporting back on it about adoption.  We can report back to the secretary that the SGOs (ph) haven t reached consensus.

JEFF BLAIR (ph) (?):  OK, then pick September.

TERRY VERN (ph):  This is Terry Vern (ph).  Can I make a comment?

SIMON COHN (ph):  Please.

TERRY VERN (ph):  As the person who s probably who s going to be (INAUDIBLE) …

SIMON COHN (ph):  Yes, this is going to be your job for the next year.

TERRY VERN (ph):  Yes.  I think putting a date in there s a really good idea.  Because I think if we have a date and if we don t have a date, then we re not going to know exactly when to decide are we far enough or not.  And I think September is the latest that we should put, because if we want to pilot anything in January, the participants in the pilot need to have developed to something to pilot that.

SIMON COHN (ph):  Yes.  Well, Terry (ph), let me ask you because I m actually a little uncomfortable using I mean, (ph) my experience has always been that you don t pick the last possible date.

TERRY VERN (ph):  Right.

SIMON COHN (ph):  And so, I guess I should ask you, since we know you re this is going to be your new job for the next year.  Hopefully …

TERRY VERN (ph):  One of them.

SIMON COHN (ph):  … Rx-Hub (ph) loves you anyway.  Would June be something that would be worth striving towards?

TERRY VERN (ph):  I think that we could have a good feel in June for whether we re making process or not.  And I think we should at least report in June, and say, you know, We re far enough along to know that we can develop to something new.  Or, We re not getting anywhere.  And do we want to choose (ph) something?


KAREN TRUDELL (ph):  This is Karen (ph).  I think if you if you wait until June to say, Uh-oh, we re not going to make it, then that precludes churning (ph) to anything else.  I think that s too late, just for a pulse check.

HARRY REYNOLDS (ph) (?):  Simon, this is Harry (ph).  That was my whole point for raising the issue.  The formulary is a huge portion of the success of the MMA situation.  And if we don t if we don t know whether or not they re going to they re going to succeed, whether or not we need to make some other recommendation, that s what worries me.  Because we could have a pretty ineffective pilot without some kind of significant progress being made there.

TERRY VERN (ph):  Well and this is Terry (ph) again I don t have a problem, you know, if we have multiple checkpoints.  I m fully supportive of reporting back to the committee on how it s going at, you know, whatever you know, if you want to do it quarterly, or at each meeting.  I think that s good.  Because then you (ph) would (ph) have a better opportunity to have support for making it happen.

SIMON COHN (ph):  Well, let me let me ask the subcommittee.  Because there s many ways of going about this.  I m obviously I mean, I think I had always perceived that we would have multiple checkpoints.  When we talk about monitoring something, the history of the subcommittee is that it s on the issues list, it gets monitored.  And I guess I m wondering whether the term closely monitor is better than monitor.

However, I am wondering whether or not using a date like June is helpful, or really whether we sort of talk more about the fact that we ll be closely monitoring, and that that s really the more important concept here.

KAREN TRUDELL (ph) (?):  Simon, is the purpose of the date for when we re going to tell HHS what we think?  Or is the purpose of the date to remind us to monitor?

SIMON COHN (ph):  Well, I don t think we need a reminder to monitor.

KAREN TRUDELL (ph) (?):  Well, I don t, either.  That s the point.  I mean …

SIMON COHN (ph):  I think the and the question of the date gets to be one of I think it s more helpful to help the standards organizations focus on deadlines.

UNIDENTIFIED PARTICIPANT:  Yes.  I think the purpose of the date is to tell the standard development organizations that s when we re going to report.

KAREN TRUDELL (ph) (?):  OK.  Then …

JEFF BLAIR (ph) (?):  And I think it gives Karen (ph) an opportunity to have a checkpoint as to what that pilot s going to look like.

KAREN TRUDELL (ph) (?):  Then I would recommend that we choose the September deadline.

SIMON COHN (ph):  No, actually, I don t think September which year?

KAREN TRUDELL (ph) (?):  2005.

SIMON COHN (ph):  That s too late.  I (ph) think at that point, we need to talk about June, if we re going to pick a date.

KAREN TRUDELL (ph) (?):  OK.

SIMON COHN (ph):  And I (ph) hope you guys all don t mind.  But I just I think September is maybe the last possible date.  And my bet is it probably even is a (ph) little too late at that point.

UNIDENTIFIED PARTICIPANT:  I think Simon s right.  If they haven t started specifying what the pilot s going to be by September, the process is going to be in a heap of trouble.  And I don t think it will be in a heap of trouble.  But the advice in June would be much better for them.

SIMON COHN (ph):  Yes.  But once again, I guess I m sitting here struggling I mean and Margaret, maybe we need to let you wordsmith this one a little bit.  Because I think what we re talking about both (ph) is closely monitoring the progress you know, and we may want to say, you know, we will be providing periodic updates to you on this I m just trying to think what we say about I mean, because I think we re talking about both periodic updates, maybe even something included in the March letter.


SIMON COHN (ph):  But there s sort of a drop-dead date, from my view, probably around the June timeframe.

UNIDENTIFIED PARTICIPANT:  Yes, OK.  So maybe it s closely monitor, with a final recommendation by June.

SIMON COHN (ph):  Yes, no later than June.

KAREN TRUDELL (ph) (?):  June s pushing it.

UNIDENTIFIED PARTICIPANT:  Yes.  That only gives about nine months.

UNIDENTIFIED PARTICIPANT:  See, deadlines cut many different ways.  Deadlines can be constructive but they can also be used in a negative manner and my thinking is to put for us to try to debate about what the right date is in this letter may not be that useful.  I think the point is that we want to closely monitor it.  We realize that this is important and I think we have to work with the SDO (ph) and with Rx-Hub (ph) as we monitor these things to make sure we re doing this in a way that tries to make this successful.


HARRY REYNOLDS (ph):  Simon, this is Harry (ph).  I d like to make one more point and then I ll back completely off of this one.

UNIDENTIFIED PARTICIPANT:  Oh, come on, Harry (ph).  You re not fun.


SIMON COHN (ph):  Go ahead, Harry (ph).

HARRY REYNOLDS (ph):  We also put in this letter continuously the pilot date of January of 06.  This is a key ingredient in the pilot for January of 06.  If we don t resolve this and resolution doesn t have to be it s ready it s totally ready or totally not ready.  It s whether or not it should be included in the pilot.  We should we I feel we have the responsibility to do that otherwise how do they pilot?

SIMON COHN (ph):  OK.  Harry (ph), there s a couple of different outcomes here.  One is a pilot outcome.  Another is a recommendation to the Secretary that this has adequate industry experience and can just be brought forward as a standard without piloting.  Right?

HARRY REYNOLDS (ph) (?):  That s a fact.

SIMON COHN (ph):  OK.  So and both of them sort of had the same deadlines associated with them, right?

HARRY REYNOLDS (ph) (?):  Right.


UNIDENTIFIED PARTICIPANT:  Simon, I have a suggestion?

SIMON COHN (ph):  Sure.

UNIDENTIFIED PARTICIPANT:  NCBA Council (ph) closely monitor the progress of NCPDP (ph) standardizing a formulary and medicine information (ph) file transfer protocol and provide advice to the Secretary in time for adoption and/or readiness for pilot testing.



SIMON COHN (ph):  Great.


SIMON COHN (ph):  OK.  Amen?  Everything (INAUDIBLE)?





SIMON COHN (ph):  OK.  Let s move on.  OK.  So we move on to five now.

HARRY REYNOLDS (ph):  Simon, one quick comment.  This is Harry (ph).  I have to drop off for 30 minutes.  I ll be back on.

SIMON COHN (ph):  Oh, was that your comment?

HARRY REYNOLDS (ph):  Yes.  Yes.

SIMON COHN (ph):  OK.  Does that mean you vote yes on everything while you re gone?

UNIDENTIFIED PARTICIPANT:  Yes.  Try (ph) to push some stuff.


SIMON COHN (ph):  Yes.

TERRY VERN (ph):  This is Terry Vern (ph) again.  I just have one quick comment.  In the observation where it talks about the file transfer protocol and it says Which uses the NCPD (ph) script standard as an underlying structure, that s an incorrect statement.  This actual format does not use script as an underlying structure so we (ph) suggest that we remove that.

SIMON COHN (ph):  Well, in the interest of accuracy, I guess we will have to take your recommendation.




SIMON COHN (ph):  Thank you.  OK.  Observation five.

UNIDENTIFIED PARTICIPANT:  Eligibility and benefit messages HIPAA requires eligibility and benefits communications between retail pharmacy dispensers and payers PDM (ph) to be performed by a NCPDP (ph) telecommunication standard.  HIPAA requires eligibility and benefits communication between dentists, professionals and institutions health (ph) plans to be performed by ASAX-12-M-200-271 (ph) healthcare eligibility and (INAUDIBLE) response (INAUDIBLE) attempt.  ASAX-12-M (ph) has identified that the standard s general healthcare use has not has not had as widespread adoption primarily due to the fact that information returned in the response is not required to match the level of information in the inquiry.

Industry experience with its use for drug eligibility verification from prescriber to payer PBM (ph) appears to be limited.  ASAX-12-M (ph) has identified workgrounds (ph) for some of the for some of the gap (ph) (INAUDIBLE) between 270-271 (ph) with respect to drug listing and step (ph) therapy.  ASAX-12-M (ph) reports that version 40-50 (ph) addresses some of these workgrounds (ph) more directly and that version 50-10 (ph) is under development and can (ph) more tightly address industry need (ph) for e-prescribing (ph).  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, AJ (ph) test (ph) should recognize ASAX-12-M 270-271 (ph) health care eligibility increment (ph) response version 40-10 (ph) as foundations that s standards for conducting eligibility in benefit inquiries from prescribers to payers PDM (ph).  AJ (ph) test (ph) should also require that the level of detail returned by the payer PDM (ph) match the level of detail in this inquiry made by the prescriber.

Use of the ASAX-12-M-270-271 (ph) version 40 (ph) should support both batch (ph) and real-time transactions and include proper usage of the TA1197 and 999 acknowledgement that s applicable.  5.2 HHS (ph) should support NCPDPs (ph) efforts to create a guidance document to map the pharmacy information on the pharmacy ID card information to the appropriate fields on the ASAX-12-270-271 (ph) in further support of use in e-prescribing (ph).  5.3 HHS (ph) should support enhancements to the ASAX-12-270-271 (ph) health care eligibility (INAUDIBLE) prescribing.

These enhancements need to be included in the 2005 form.  HHS (ph) should ensure synchronization between the ASAX-12-M-270-271 (ph) health care eligibility creating (ph) response standard for use in HIPAA and e-prescribing (ph) applications as new versions are introduced.

SIMON COHN (ph):  OK.  Comments/questions.  I have a couple but I ll see if anybody has anything.

LISA MILLER (ph):  This is Lisa Miller (ph) with X-12 (ph).


LISA MILLER (ph):  And I do have a few.

SIMON COHN (ph):  OK.  Why don t we start with you and then we ll see if you and I agree by the time we re done.

LISA MILLER (ph):  Oh, that would be wonderful, thank you.  OK.  So in the observation in the main body of the text, I actually took some time this morning while I was listening to everything else and contacted the work groups specifically with an x-12 (ph) that handles the eligibility transaction and a few of their comments were as follows:  They would like the widespread adoption to mention the fact that the 8-37 transaction was implemented prior and that is part of the reasons for the lack of widespread adoption payers (ph) focused on the 837 transaction and they wanted to use the word Quality of the response.

Just some wordsmithing (ph) so when we talk about the responses not required to match the level of information, they want to get in the concept of that when it was implemented, the quality of the response was not what was anticipated by the provider community and that also diminished the widespread adoption lack of value, basically.  So they were their two comments there.  And then as we get down into the recommendations 5.1 the proper use of the TA199799 (ph) acknowledgements is applicable that we may just want to say the proper use of the X-12 (ph) functional acknowledgements as applicable and not name specific transactions.  That way it gives them the full spectrum of acknowledgments to use as applicable and does not tie us to specifically only three.

SIMON COHN (ph):  So these are EGs (ph)?

LISA MILLER (ph):  That s correct.



SIMON COHN (ph):  Is that it?  Go ahead (ph).

LISA MILLER (ph):  And one more.

SIMON COHN (ph):  (INAUDIBLE).  Please, go ahead and &


SIMON COHN (ph):  & we ll move back to one (ph).

LISA MILLER (ph):  And then the last one that we have is talking about the new versions and (ph) it (ph) actually ties (ph) in 5.1 and 5.3 that right now we re saying 40-10 (ph).  We recommend that we spell out the exact document we re speaking about which is would be 004010XO92A1 (ph) rather than just saying 40-10 (ph) and we have an issue kind of with the enhancements because if we re tying ourselves to 40-10 (ph) in 5.1, are we precluding ourselves from moving forward and, Karen Trudell (ph) may want to comment on this as well.

We have the issue of HIPAA versioning that s kind of overlapping this a little bit that, you know, if we say we have enhancements, we can t enhance 40-10 (ph) 40-10 s (ph) outdone (ph) so there s another addenda (ph) to 40-10 (ph) so our next version would either be 40-50 or 50-10 as adopted by HHS (ph).  Does that make sense, Karen (ph)?

KAREN TRUDELL (ph):  Yes.  It does and, in fact, this is the comment that I made myself, Lisa (ph).


KAREN TRUDELL (ph):  There s almost a disconnect here between the concept of synchronizing the 270-271 (ph) for HIPAA and non-HIPAA uses and the concept of the backwards compatibility and for the (ph) prescribing adopting a standard or higher because you can t do those two things at one time.

LISA MILLER (ph):  Yes.

KAREN TRUDELL (ph):  Either the 270-271 (ph) are synchronized and that means that basically they re synchronized according to the HIPAA version.  You (ph) can only change when the regulation changes or that we have a disconnect between HIPAA and non-HIPAA and the e-prescribing (ph) 270-271 (ph), you know, might be increased.  Now, from a legal perspective, I think we are this is a HIPAA transaction and I think at this (ph) point HIPAA pretty much trumps.

So I would say that maybe the recommendation needs to be something like, you know, there needs to be consideration that between HIPAA and e-prescribing (ph) that the 270-271 (ph) functionality under HIPAA needs to keep pace through the HIPAA modification process with e-prescribing (ph) requirements.

UNIDENTIFIED PARTICIPANT:  Those are good words (ph).

KAREN TRUDELL (ph):  There s one other potential issue here and I do apologize because some of this it didn t occur to me until I actually saw all the recommendations together and that is that we did not adopt the functional acknowledgement requirements under X-12 (ph) for the HIPAA transactions and I am not sure whether I can legally adopt them now without regulation.


KAREN TRUDELL (ph):  For anything.  You can t make a distinction between e-prescribing (ph) I mean, an eligibility query is an eligibility query whether it s done for e-prescribing (ph) purposes or not.  The HIPAA definition of an eligibility transaction is broad enough to cover everything.




UNIDENTIFIED PARTICIPANT:  I was going to ask you why does HIPAA trump and that distinctly defines it.  Thank you.



SIMON COHN (ph):  Well, let me make a couple of comments here and let s see what we can do to address some of the concerns including yours, Karen (ph).  Now, first of all, (INAUDIBLE) Lisa (ph) at the very comment where you &

LISA MILLER (ph) (?):  Sure.

SIMON COHN (ph):  & where you asked for some modifications to the observation section.  I think I previously and I guess, Margaret, this was not an accepted (ph) request but I have actually recommended that we remove completely the sentence that has to do with issues of adoption of the 270-271 (ph) and it s a HIPAA mandated standard.

It is actually being used more widely, as we speak, primarily because the 837 went first and I don t think that it s helpful to I mean, even comment on general healthcare usage especially since we didn t (INAUDIBLE) hear testimony about its current level of usage.  I think if Harry (ph) were on the phone, he would be speaking of greater use and, Karen (ph), I think you ve spoke greater use in the CMS (ph) transaction so I don t know what point it makes so I think that from my view, that could easily be removed as a whole sentence &

KAREN TRUDELL (ph) (?):  And then (ph) &

SIMON COHN (ph):  & without out hurting anything.

KAREN TRUDELL (ph) (?):  I concur completely.

SIMON COHN (ph):  OK.  So &

TERRY VERN (ph):  Simon?

SIMON COHN (ph):  Yes.

TERRY VERN (ph):  This is Terry Vern (ph).  Just for background, because we I believe we do have good industry (ph) experience in using this in e-prescribing (ph).  We ve done almost nine million transactions in the last since 2002 in (ph) just just the (INAUDIBLE) model for getting drug coverage eligibility in e-prescribing (ph) so &

SIMON COHN (ph):  Yes.

TERRY VERN (ph):  & I think that would be considered, you know, pretty good adoption at this point.

SIMON COHN (ph):  Well, sure.  I was just referring to general healthcare uses.

TERRY VERN (ph):  Well &

SIMON COHN (ph):  You trumped me on the next one which is this issue that apparently a sentence appears to have been removed in this version that describes it I think as far as I was concerned, I heard different things.  I heard one thing from Lisa (ph), you representing X-12 (ph) …

LISA MILLER (ph):  Yes.

SIMON COHN (ph):  & talking about limited or, actually, the need for workarounds and I heard almost in the same breath at the same hearing others who actually have been using the transaction feeling that there that it was sort of working fine.  So I don t know what the right answer here is except to I think that we need to represent both perspectives in our observations.

UNIDENTIFIED PARTICIPANT:  Well, and (ph) from an X-12 (ph) perspective, I think one of the things that has to be stated here is that although our ex-hub (ph) may be utilized in the transaction, their workarounds may not be the recommendation of the SDO (ph).

So some of the concern from the SDO (ph) side (ph) of this is that we still need to do that evaluation and come out with prescriptive guidance about how if there is a workaround that needs to be done and we need to use some of those segments as the workgroup had identified that we leave that opening there and we don t say, Well, it s been used today and because we heard that some people are using it and that they have potential workarounds or things that they ve implemented, doesn t necessarily flow that that might be the final consensus process.

TERRY VERN (ph):  Can I this is Terry (ph) and I think I need to clarify because I think Lisa (ph) and I are talking about different things.


TERRY VERN (ph):  So the way our sub (ph) uses the eligibility transaction is to determine does this patient have eligibility and what are some of the characteristics of that eligibility.  You know, what s their cardholder information?  What s their formulary ID and things like that?  We do not use it in a context of a Real Time coverage for a specific drug which I think, Lisa (ph), is what you re talking about and I ve not heard of anybody in the industry who s trying to do that or have attempted to do that because it doesn t fit the model of the e-prescribing (ph) application.

So as far as workarounds, I don t believe we ve implemented workarounds and we d be happy to take this transaction back to the SDO (ph) which (ph) we ve already done that once.  We ll do it again for review but we are not trying to ask if (ph) a specific drug is covered and I think that &

UNIDENTIFIED PARTICIPANT:  Lisa (ph), when you re saying there may be gap (ph).

LISA MILLER (ph):  No, actually, I was more concerned that the original 40-10 (ph) did not encompass necessarily the business needs of e-prescribing (ph) and the workgroup has, rightly so, said, You know, we need to reevaluate and look at this to make sure that we have met those needs and are there any changes that need to occur to the transaction, so I wasn t really looking to that specificity but more from I think we have to recognize at the time that they created and developed the 40-10 (ph) implementation guide e-prescribing (ph) wasn t really something that they were focusing on and it was that statement that are they now meeting all of those needs.

SIMON COHN (ph):  Yes.

LISA MILLER (ph):  And I think in due diligence they have to look at that.

SIMON COHN (ph):  Well, and I guess what I m hearing is the difference of opinion here and I m hearing X-12 (ph) is saying one thing and a major industry user is saying another thing about exactly the same standard and about exactly the same set of uses.  Is that correct?

UNIDENTIFIED PARTICIPANT:  I don t (INAUDIBLE) we re (ph) disagreeing.  I think it s just I think the FDO (ph) is reserving making those kinds of comments and making a definitive statement until they review this one more time and if our ex-hub (ph) is willing to bring that forward, I think collaboration and the convergence is absolutely appropriate and would be welcomed.


SIMON COHN (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  I d like to focus on the word that Lisa (ph) used which (ph) said changes.   We re talking about a HIPAA standard here.  Once we introduce the word changes we re talking about regulation.

JEFF BROWN (ph):  This is Jeff Brown (ph) for Ex-Hub (ph) attorney outside (ph) attorney.  That s absolutely right.  The implementation guide that s required under HIPAA on pages 20 and 21 have a section on HIPAA compliant use of the 270-271 (ph) transactions that (ph) and it gets very detailed about how you could ask a bunch of questions but HIPAA does not require the health plan to respond if it doesn t have the functionality.


JEFF BROWN (ph):  And I m afraid that the I think it s the second sentence of recommended action 5.1 talking about requiring a quality of response is directly in opposition to what s in that section of the implementation guide.

UNIDENTIFIED PARTICIPANT:  Yes.  And we just heard Karen (ph) saying HIPAA trumps.


KAREN TRUDELL (ph) (?):  Wait, wait.  I want to make a very important distinction here and that is the distinction between recommendations that relate to the implementation of Part D which is something that is completely within CMS purview (ph) as a health plan and something that would be considered an e-prescribing (ph) standard nationwide.  CMS as the implementer of Part D can certainly put requirements on the Part D plan to conduct transactions according to the HIPAA implementation guides and provide full responses.

UNIDENTIFIED PARTICIPANT:  And (ph) then it ll be like a trading partner agreement &

KAREN TRUDELL (ph) (?):  It would be a training partner agreement because the implementation guide provides the floor.

JEFF BROWN (ph):  Simon?  This is Jeff.  could I suggest that rather than try to get to the exact wording here, I think Karen (ph) and Karen (ph), I think probably could work with Margaret to get to the proper wording that they both heard this discussion and I think they have an idea of the intent and Karen (ph) can help the wording steer away from any violations or new regulations with HIPAA or at least minimize those.

KAREN TRUDELL (ph) (?):  Will do.

UNIDENTIFIED PARTICIPANT:  This (ph) is more or less things of our sub (ph) point of view which is that a full response to high quality response that I think is as pointed to and recommended action 5.1 is not something that our (ph) subs (ph) support today so when we say we do support X-12 (ph), 270-271 (ph) and we ve done these seven million transactions, we ve done them solely on the is this person eligible.  Yes or no?

KAREN TRUDELL (ph) (?):  Right.  And you ve done the yes or no response.

UNIDENTIFIED PARTICIPANT:  A little bit more than yes or no but not the full sweep that you could get under 270 (ph).

UNIDENTIFIED PARTICIPANT:  Well, and what the committee needs to consider is what are the requirements needed for the eligibility transaction.  Is it to function as the eligibility as defined under HIPAA and if the 270-271 (ph) as being used today meets that need?  That s one answer.  Now, do you want more features and functionality?  That s the next observation because there s work to be done for whatever that next (INAUDIBLE) needs to be.

UNIDENTIFIED PARTICIPANT:  And one other comment, most of you have not looked at the, you know, the standard s (ph) body (ph) keep moving forward and from (INAUDIBLE) next 12 perceptive just to let everybody know the next version has much stronger language and really does pump-up the quality of that response.

So you re going to see change in that front (ph) matter if you d look at the other implementation guides 40-50 (ph) and the one that they re working on 50-10 (ph) so we ve already recognized that perhaps not saying you have to give some better answers was maybe not right thing so that was that was one of the background comments from Steward Beaten (ph) who is one of the co-chairs so just to kind of give another perspective on that statement as well and Karen s (ph) absolutely right.  You guys can do whatever you want with &


UNIDENTIFIED PARTICIPANT:  & the trading partner agreement.

SIMON COHN (ph):  Let s see if we can wrap this one up and let me see if I can sort of describe where we are.  I think we ve made some changes to (ph) observation five and I think we re also recognizing that action 5.1 with (ph) some wordsmithing (ph) is probably in the purview (ph) of HHS (ph).  Now we ve also I think, made a and, really (ph), I maybe wordsmithing (ph) here but under 5.3 where we re talking about enhancements, I think really what we ve identified that we re talking about is if there needs to be piloting and testing of something related to the 270-271 (ph) that really is a question of testing new versions and not testing enhancements.  So and I think would be something that CMS may want to do.

Now, of course, there was (ph) an underlying tension under here that as far as I m concerned, I always presumed that the HIPAA 270-271 (ph) applied to e-prescribing (ph).  It never occurred to me that we were talking about different standards or different implementations or different versions that could somehow apply between a health plan and a provider for one use but then you d come up with another thing for another use so.  Karen (ph), maybe you need to help me with this one but I think underneath all of this is obviously is the tension that goes about the fact of how are we ever going to get off the dime and get to some new versions of the X-12 (ph) standards for HIPAA.

JEFF BROWN (ph):  This is Jeff Brown (ph).  Not to steal anything from Karen s (ph) analysis but the 270 (ph) ask (ph) a lot of questions and they re valuable questions in healthcare and they can be used in e-prescribing (ph).  They do allow the 270 (ph) to ask questions about co-pay and patient responsibility and some of the things that we ve talked about addressing outside the 270-271 (ph) transactions set (ph) and from our subs (ph) point-of-view if we were required to answer those questions or (ph) the PBS (ph) are required those questions to the 270-271 (ph), we re just not there technically.

UNIDENTIFIED PARTICIPANT:  And it also does not fit in the model.  We testified that s why we don t do Real Time inquires today or co-pay in coverage.

SIMON COHN (ph):  So how would your are you referencing action item 5.1 or 5.3?

UNIDENTIFIED PARTICIPANT:  I think 5.1 definitely and then 5.3 it depends on what the enhancements are.

SIMON COHN (ph):  So basically what you re questioning is about the issue of level of detail.



UNIDENTIFIED PARTICIPANT:  Could I make a recommendation that we add one more which would be a checkpoint on the evaluation of the FDO (ph) about what the use (ph) enhancements or prescriptive advice on the use of the current 40-10 (ph) version might look like and we have a checkpoint on this.

SIMON COHN (ph):  I don t know what you re talking about.

LISA MILLER (ph):  Well, if they re going to &

SIMON COHN (ph):  Who is this?  Is this Lisa (ph)?

LISA MILLER (ph):  Lisa.  Yes.


LISA MILLER (ph):  But I think it would be good to if you re using this towards the pilot test and we re looking at Rx-Hub (ph) and I think they bring up a very good point.  We re not there yet that there is a checkpoint because I think the intent was to be able to get a better quality of answer and I heard Karen (ph) talk about that that this is a trading partner agreement that she s looking at so I think there s a slight maybe a slight disconnect that I m hearing in quality of the response and what might be just humanly possible out there today.

SIMON COHN (ph):  OK.  I guess I m hearing a major disconnect.


SIMON COHN (ph):  Because I m hearing that the current version seems to work just fine for a variety of uses and then, Lisa (ph), I m hearing from you sort of over and over again that this isn t sufficient doesn t meet needs but then I m also hearing other people that they can t deliver any more so I m I guess I m a little confused.  Steve (ph), did you &

UNIDENTIFIED PARTICIPANT:  Simon?  Can I summarize what I ve heard?

SIMON COHN (ph):  Please.  Maybe you can help.

UNIDENTIFIED PARTICIPANT:  I don t know if this is going to help but this is what I ve heard so far is that from the e-prescribing (ph) point-of-view the 270-271 (ph) has widespread use for just answering the question is the patient eligible.  Yes?  No?  But I ve also heard that for e-prescribing (ph) purposes, there s a series of subsequent questions that people would like to ask about eligibility that are allowed under the 40-10 (ph) by HIPAA as optional segment that may that can be implemented by trading partner agreement.  They re approved.

They re out there.  They re just not used.  What Karen (ph) seems to be saying is that CMS under Part D acting as a payer is going to implement these parts as a trading partner agreement and it s those parts that haven t been implemented yet that should be tested in pilot.  And that s the way I m interpreting what I m hearing and I think that s consistent with what Lisa (ph) is saying concerning X-12 (ph) and also consistent with what Rx-Hub (ph) is saying.

SIMON COHN (ph):  Should (ph) we ask them if you ve said it right.

TERRY VERN (ph):  I don t this is Terry Vern (ph).  I don t understand.  CMS is (ph) a payer because &


TERRY VERN (ph):  Right.  OK.  But, again, this goes back to CMS is a payer is going to require information on the backend after the claim s been paid not during the e-prescribing (ph) process.  Right?

UNIDENTIFIED PARTICIPANT:  CMS when what implements Part D, it s going to implement Part D as the payer.  It s going to be doing it s (INAUDIBLE) intermediary but it s going to have a certain requirements before it will pay a Part D claim and that s a that and they re going to do those portions that they re allowed under the HIPAA transaction as any other payer would do in their trading partner agreement.

TERRY VERN (ph) (?):  Right.  And we ve &

UNIDENTIFIED PARTICIPANT:  It has not been tested.  It has not been used.

TERRY VERN (ph) (?):  I know we &


TERRY VERN (ph) (?):  & we talked about I believe that the things that Lisa (ph) is talking about are telling (ph) specifying maybe a particular drug is covered.  What is the co-pay for this drug?  It s very specific information that we talked about does not work in the e-prescribing (ph) model for the same reason we don t have a Real Time formulary request because the physician doesn t want to keep asking the question over and over again.  And it s virtually impossible to send an entire formulary or an entire benefit over one request response transaction so I think we re making a lot of assumptions about that what the requirements are of (ph) e-prescribing (ph) or of the payer.

UNIDENTIFIED PARTICIPANT:  Actually, Terry (ph), I keep trying not to get down to that level and specifically because I ve heard from the workgroup that they re just unsure that this just wasn t something that was on their radar at the time so I want to make sure that I m not I don t know what personally, I don t know what the requirements are and if I m hearing from inside of the FDO (ph) and I m representing them so I m bringing their voice forward which is they need to look at this and review it and they also need to give guidance on the use of the current and the work around that they need to be any (ph) or if they say, Hey, no, it works just fine.

So I think that as we re moving something forward for national adoption that that kind of evaluation is important and valuable and it needs to that voice needs to be heard.  But I don t I don t think that we re getting down to that specific level of the drug at this point and if it s not appropriate for the business process, we wouldn t have an issue with that.


SIMON COHN (ph):  Yes, Steve (ph).

STEVE STEINDELL (ph):  What I m hearing with respect to this letter &

SIMON COHN (ph):  Yes.

STEVE STEINDELL (ph):  & is we do not have a clear picture of eligibility.

SIMON COHN (ph):  Well, actually, no.  I think maybe I m hearing something else and let me suggest and there are a couple of things need to be happening here.  One is that I think I m hearing the four-based (ph) functions 270-271 (ph) seem to work just fine.  I think there s a difference of opinion or there s some certainty on the part of the groups that are actually using this that the functions are sufficient for the needs.  There s uncertainly from the standards development organization about what exactly the needs are.  Am I missing that?

KAREN TRUDELL (ph) (?):  Yes.  I was this is Karen (ph) again (ph) and I think I d go back to I agree with what Steve (ph) said is that, you know, if the requirement is yes or no the patient s covered, then I think the 270-271 (ph) is sufficient.

SIMON COHN (ph):  OK (ph).

UNIDENTIFIED PARTICIPANT:  Maybe this is why Lisa (ph) I think it was Lisa (ph) wound up suggesting that we monitor this in order to capture the additional information.

LISA MILLER (ph) (?):  Agreed.  And that if there is something that is missed in the business process that just hasn t been evaluated.  It s just some concern and, Terry (ph), we may be just fine.  It s just something that I think that we need to give the workgroup the opportunity to evaluate this and the opportunity is in October at our next meeting.

TERRY VERN (ph) (?):  OK.  Evaluate what?  That the requirements are being are being met.  The requirements of NMA (ph)?

LISA MILLER (ph) (?):  Just look at NMA (ph).  Are the requirements are there any issues with the transaction.  You know, just they need to look at it and I don t think it s I know it hasn t been on their agenda.

KAREN TRUDELL (ph):  I this is Karen (ph).  I have to say that October is way too late for me.

LISA MILLER (ph) (?):  OK.

KAREN TRUDELL (ph):  If it s going to be a foundational standard, it has to be a foundational standard in September or not all.  The second thing, I guess, I m hearing, is sort of a vague discomfort on the part of the standard s developers and a sense of fairly high level of confidence on the part of the people who have been using it and I guess what I need to ask Terry (ph) is it appears that you ve been using the 270-0271 (ph) for its extremely high level responses the yes/no.

TERRY VERN (ph):  Well, it s yes/no &

KAREN TRUDELL (ph):  But then where let me finish let me finish my question.  Is there anything in the 270-271 (ph) 40-10 (ph) implementation guide whether you ve been implementing or not that might be a problem if I tried to implement it.  That s what I need to know.

TERRY VERN (ph):  I guess my answer to you, Karen (ph), would be what questions are you asking.  I don t know.  For the questions that we re asking, it is sufficient and that s why I m trying to get a clarification on, you know, how should the transaction be used.  For and, you know, just for clarification also when we first implemented this transaction, we worked very closely with the workgroup who Tim McNeil (ph) has been part of for many years.  He s an ex-Hill (ph) member.

We worked very closely in asking them questions on how to use this transaction and then once we developed our implementation guide, we had it reviewed for HIPAA compliance and approved so I, you now, I d be happy to go back and we can work with the workgroup and, you know, we ll join whatever conversation that they re having in May or whenever to determine but I think that as a first (ph) to NMA (ph), we re going to have to be very clear on what the requirements are.  Otherwise we could get lost in what utilization of this transaction should be.

KAREN TRUDELL (ph) (?):  Well, then I would suggest that you might want to say, Here are some things that the current version does not do.

TERRY VERN (ph) (?):  But (ph) then you re assuming that we found gaps and we haven t.  That s my point.

SIMON COHN (ph):  OK.  And I think that s the point I think what we re hearing is users saying or a major user saying, Geez, we ve used this.  There have been no gaps (INAUDIBLE) organization saying, Geez, we haven t really evaluated this but we re uncomfortable because we haven t evaluated it for this &


UNIDENTIFIED PARTICIPANT:  Yes.  And the user being Rx-Hub (ph) has used it for specific in a specific area and maybe we can go forward with that and wind up indicating it to (ph) foundational standard for in the way that Rx-Hub (ph) has been using it and that indicating that the additional requirements need to be assessed and monitored and that way it can be identified as a foundational standard but in a narrow way and that we could wind up indicating whether (ph) we ll be examining the additional capabilities and CVHS (ph) will monitor that for, maybe, a broader recommendation in June.

SIMON COHN (ph):  March (ph).  March, Jeff.

JEFF BROWN (ph):  March (ph).

UNIDENTIFIED PARTICIPANT:  OK.  I would say one thing I want to reiterate that when we when X-12 (ph) looked at the requirements that were in the worksheet that they felt very strongly that 40-10 (ph) did meet the needs to move forward.  For and they had short term.  They said, you know, we can use short-term fixes and move forward so as a foundational standard, I think we can say it right now.  I don t want to give the impression that we re not comfortable using this standard moving forward in (ph) e-prescribing (ph).  That is not the statement here but I do think it warrants saying when that standard 40-10 (ph) was created, e-prescribing (ph) wasn t one of those things that the workgroup looked at.  We just have to &

SIMON COHN (ph):  OK.  So &

UNIDENTIFIED PARTICIPANT:  We just have to realize that, that s all.

SIMON COHN (ph):  OK.  But that s fine so I think what we re hearing is overall agreement that the I mean, in fact (ph), I m hearing changes to the observation because, obviously, there s a lot of tentative wording regarding X-12 (ph) and I think that I m hearing a stronger statement from X-12 (ph) as well as the industry saying this standard is a good foundational standard.  I m also hearing that there s probably a recommendation that relates to the last sentence of our observations that has to do because Medicare s Part D prescription drug program is new.

Specific requirements are not known at this time and new requirements may emerge therefore we recommend that there go be ongoing analytic efforts HHS (ph) work with X-12 (ph) in (ph) the industry on ongoing analytic efforts to identify whether or not there are new requirements that may result from the Medicare Part D prescription plan.  Is that what I m sort of hearing?  I think we re hearing about potentially unknown things but there needs to be some work to figure that out which I think is aligned with what Jeff is suggesting.

UNIDENTIFIED PARTICIPANT:  I concur and (INAUDIBLE) comfortable on even more comfortable.

SIMON COHN (ph):  Is that OK?  So, I think I m hearing Margaret, are you OK, so far?

MARGARET ALMAJEALKIN (ph):  Yes.  I don t have exact wording but I ve got it all (ph).

SIMON COHN (ph):  Yes.  I guess I m wondering, then, looking at recommendations.  The reason I m pursuing this one is because I would really like to get one done rather than having to go back and rewrite it all but I guess I m wondering on recommendation 5.1 given our discussion.  Do we need the second sentence (ph) at this point.

MARGARET ALMAJEALKIN (ph):  I don t think so.

SIMON COHN (ph):  OK.  So I guess I would suggest that we all think about removing the second sentence (ph) and then we re fine with recommendation two (ph) which is the pharmacy ID card.  Now and, basically (ph), the recommendation 5.3 is almost along the lines of that recommendation we just made which is that HHS (ph) should work with the SDOs (ph) and the industry to identify whether there are any new requirements related to eligibility and if they are identified, then there ought to be pilot testing related to those new requirements.

And I think that s what that recommendation is.  Recommendation 5.4 I guess I would only ask the question about is the concept here synchronization or is it that we re sort of saying that these are HIPAA I mean, I guess I m confused here because it never occurred to me that we would have a different 270-271 (ph) standard.  This appears to me to be covered under HIPAA.  Am I confused?


KAREN TRUDELL (ph):  No.  And, Simon, it s Karen (ph) I ll work with Margaret on some language to clarify that.


KAREN TRUDELL (ph):  Don t need to spend time on this call.

SIMON COHN (ph):  That s fine.  OK.  So are we OK with this?  Can we move on to six?  Jeffrey (ph), are you OK?

JEFF BROWN (ph):  Yes.

SIMON COHN (ph):  Judy (ph)?

JUDY WARREN (ph):  Yes.  I m OK.

SIMON COHN (ph):  OK.  Stan, you still standing?

STAN HUFF (ph):  Yes.


STAN HUFF (ph):  I m fine.

SIMON COHN (ph):  OK.  Let s move on to six, then.  We re down to about 45 minutes here.  It s regrettable but this is I guess I m reminded by Jeff you ve spent five hours on this the other day.  Observation six.

UNIDENTIFIED PARTICIPANT:  Higher (ph) authorization messages.  Under HIPAA claims eligibility and benefits information between dispensers and payers PDM (ph) are communicated using the MCPDP (ph) telecommunication standard.  The need for prior authorization for a drug is identified between the Payer PBM (ph) and dispenser through this process.  The MCPDP (ph) script standard may then be used by it s dispenser to request that the prescriber obtain a prior authorization for a drug.  However, the request for a prior authorization for a drug from the prescriber to the payer PDM (ph) is now conducted in a manual mode.

This is due in part to the complexity of the decision making involved and insuring the use of an expensive drug is medically warranted.  The ASAX-12 (ph) and 278 (ph) health care services review (ph) standards provides for prior authorization in (INAUDIBLE) response in general but provides very limited support for prior authorization of drug (ph).  6.1 HHS (ph) should support ASAX (ph) (INAUDIBLE) efforts to incorporate and then recognize the (ph) use (ph) of e-prescribing (ph) functionality for Real Time prior authorization messages for drugs in AFC (INAUDIBLE).

Healthcare services reduce standard for use between subscriber and payer PDM (ph).  6.2 HHS (ph) should facilitate standard development organizations and other industry participants in developing scenarios to ensure the proper flow of prior authorization information throughout the entire communication process including NCPAD (ph) telecommunications and script standard and (ph) the X-12 278 (ph).  6.3 CMS should evaluate the economic and quality of care impact of automating prior authorization communications in its 2006 pilot.

SIMON COHN (ph):  OK.  Comments/questions?

TERRY VERN (ph):  This is Terry Vern (ph).

SIMON COHN (ph):  Sure.

TERRY VERN (ph):  In the observation, the one piece that s missing is where the PDM (ph) repair is able to communicate prior authorization for a drug ahead of time to the prescriber.

UNIDENTIFIED PARTICIPANT:  I think that s a good point, Terry (ph).

TERRY VERN (ph):  And that s that will provided in the formulary and benefits structure the benefit file transfer because I think we ve included all the other pieces of the process here.

RUSS MARTIN (ph):  And this is Russ Martin (ph) with Pfizer.  There is another piece that s missing that the script standard does support the transmission of the prior authorization code from the prescriber to the dispenser.  It just doesn t have a mechanism for any of the other pieces.  Excuse me, that s not mentioned that s not (ph) already mentioned here.

UNIDENTIFIED PARTICIPANT:  Didn t you mean the other way around that it provides for the request from the dispenser to the provider?

RUSS MARTIN (ph):  No.  That s in there already but if the prescriber does have a prior authorization code, there is a field where they can send that back to the back to the dispenser so that exists but there s no what the point of this whole thing is that there s no mechanism for actually doing the actual request for the code for the prior authorization itself.

UNIDENTIFIED PARTICIPANT:  Right.  To the payer.  Yes.

UNIDENTIFIED PARTICIPANT:  Simon, may I comment on that?

SIMON COHN (ph):  Sure.  Please.

UNIDENTIFIED PARTICIPANT:  The sentence the need for prior authorization for a drug is identified between the payer PDM (ph) and dispenser through this process.  We re not that s not unidirectional.  It s bi-directional.  I can fix that to address Russ (ph) comment but that the intent was to have it both ways both directions.

SIMON COHN (ph) (?):  OK.

RUSS MARTIN (ph):  I was just referring to the sentence after that says the NDPD (ph) script standard may be used by a dispenser to request that the prescriber obtain prior authorization for a drug.  Well, for one thing, it shouldn t really be may then be used.  That the situation that would normally happen is the prescription would go to the dispenser.  The dispenser would see that prior authorization is required if the prescriber hadn t already recognized that and there is a capability for them to say, Hey, prescriber, you don t have the code, or You don t have a prior authorization code.

If they get that code from (ph) a manual or a fax process or whatever, they are able to send that code via script back to the dispenser and so that s the part of the communication that was left out in my mind.  I think the sentence there that you had before does I mean, to me that does say, Yes, there is a there needs to be a methodology for the communication, and it is bi-directional.

SIMON COHN (ph):  OK.  Margaret, did you need an e-mail sent from &

MARGARET ALMAJEALKIN (ph):  No.  Let me I ll just reword this.  (INAUDIBLE).

SIMON COHN (ph):  OK.  This is wordsmithing (ph) stuff, I think.

MARGARET ALMAJEALKIN (ph):  Yes.  I ve got it.

SIMON COHN (ph):  OK.  So is anybody concerned otherwise with these recommendations.  I think they &


SIMON COHN (ph):  & sound fine.

PHIL ROBINIC (ph):  I have a couple of comments.  This is Phil Robinic (ph).

SIMON COHN (ph):  Sure.

PHIL ROBINIC (ph):  I ll try and be brief.  The observation recognizes that the script standard can be used by a dispenser to request that the prescriber obtain prior auth but it doesn t acknowledge the conversation that took place at the last hearing that exists but nobody s using it and then the recommended actions go on to sort of deal with other issues.

And so there really isn t a recommendation with respect to that piece of it so while the focus seems to be on enabling the communication between the payer and the prescriber there isn t a recognition of any work that s necessary to really make use of the channel that already exists for the communication between the dispenser and the prescriber and, frankly, that s a easy piece so, you know, that s one time.

The other comment on 6.3, I think, there ought to be something about 6.3 that recognizes that it may not be feasible so when we say they (ph) should evaluate the economic and quality of payer (ph) impacts, it seems to me that ought to be somehow limited by, you know, a determination of feasibility because the other thing that we talked about was the sort of functional limitations of trying to do that so it s one thing to say you re going to evaluate economic and quality of payer (ph) impacts (ph) but there s a threshold question as to, you know, which prior OX (ph) is even possible.  I just think that ought to be reflected in the recommendation.

SIMON COHN (ph):  Thank you.

UNIDENTIFIED PARTICIPANT:  Phil, this is Jeff.  I was wondering if on your first point you re winding up saying some additional work could be done and it wouldn t be all that difficult.  Maybe if you sent an e-mail to Margaret indicating what you would suggest might be wording for a recommendation to address that.

PHIL ROBINIC (ph):  Well, I guess my thinking is if the recommendations are to (ph) you know, what s (ph) going to be adopted as a standard, then the threshold, at least, would be that, you know, you adopted a script standard as the standard for that piece of it.  Now, the problem with adoption is a problem that, you know, is sort of systemic.  I mean, if we can get if we can get everybody in the chain to use it and get (ph) physicians, you know, signed up then it solves a lot of our problems so I m not sure in the standard you actually have to address that piece but I think the real piece that s missing here it s just a recognition that we all (ph) adopt that piece because it already exists and it s available.

SIMON COHN (ph):  Well, so I think that what I m hearing is both statement of the observation that this may then be used by the dispenser to request a prescriber obtaining prior authorization drug but it is not widely used.


SIMON COHN (ph):  So I think is your observation &

UNIDENTIFIED PARTICIPANT:  Not that it s standard (INAUDIBLE) with adoption.  We have to deal with it across the board.

SIMON COHN (ph):  Yes.  But I think you re also referencing (ph) that it s a recommended action.  We are recommending that this standard piece be part of the foundational standards.


SIMON COHN (ph):  And I m just trying to think of if, indeed, that s the case then it doesn t really get piloted or tested.

UNIDENTIFIED PARTICIPANT:  Yes.  I think it s a constructive point but the foundational standards I think one of the criteria of foundational standard is that they are in use and may not necessarily need to be tested.  I do think that your suggestion was constructive.  Maybe we, you know, we d want to indicate that this should be part included in the pilot test.

SIMON COHN (ph):  I don t know.  Phil, was that where you were going or were you just saying that I mean, because I could imagine 6.3 could include both the T78 (ph) as well as (INAUDIBLE).

PHIL ROBINIC (ph):  I guess I don t have a strong opinion about the standard itself other than and, you know, the overall section six seems to mix that point that there seems to be an underlying assumption that it already is existing and in use which isn t the case and so even though there s a standard for it, I think glossing over the fact that nobody s using it is missing something whether we (INAUDIBLE) foundational standard or (ph) we include it in the pilot to see whether, you know, it s practical in actual real life.  You know, I think you could go either way on that.

SIMON COHN (ph):  Well, OK.  Subcommittee then (ph) I would propose this as that first-of-all in the observation we do note that it s not or little used or not widely used depending on how Margaret was wordsmith it (ph) and then 6.3 where we talk about automating prior authorization communications we should reference that this both includes communications between the dispenser and the prescriber regarding prior authorization as well as directly from the PDM/health (ph) to a health plan and the prescriber.


SIMON COHN (ph):  We (ph) talk about both communications as things that need to be piloted.

UNIDENTIFIED PARTICIPANT:  Right.  And my other comment was that all of 6.3 be somehow limited by the termination of feasibility.

SIMON COHN (ph):  I m going to actually I heard that comment (ph).  I didn t forget it.  I wasn t proposing that, Phil&


SIMON COHN (ph):  & but maybe somebody else &


SIMON COHN (ph):  & committee feels that that s an important distinction to make.

UNIDENTIFIED PARTICIPANT:  I think we leave it to HHS.  They re going to go ahead and craft (ph) these things as well as they can.  You know, doing something that s impractical that, you know, waste money and time but I don t think we need to put that in the language.

SIMON COHN (ph):  OK.  Is everyone comfortable with where we ve gone on recommendation six?  I guess, Judy (ph), are you comfortable?  Are you there?

JUDY WARREN (ph):  Yes.  I m here.

SIMON COHN (ph):  Stan?

STAN HUFF (ph):  Yes.

SIMON COHN (ph):  OK.  Is Harry (ph) back yet?

HARRY REYNOLDS (ph):  Yes.  I am.

SIMON COHN (ph):  Harry (ph), you missed all the fun on eligibility.  I mean (ph), we really missed you.

HARRY REYNOLDS (ph):  Well, I wanted to people grow when you kind of leave them to their own.

SIMON COHN (ph):  Harry (ph), you left at exactly the wrong time.  Jeff, and you re in favor of it?

JEFF BROWN (ph):  Yes.

SIMON COHN (ph):  OK.  So I think we ve got observation six and, Phil, thank you for your suggestions.

JEFF BROWN (ph):  This is Jeff Brown (ph).  (INAUDIBLE), I apologize.  I have one,  kind of,  wordsmithing (ph) request.

SIMON COHN (ph):  Sure.

JEFF BROWN (ph):  Observation six and that would be that we would have a similar statement as we do in observation five about HIPAAs requirements because prior authorization is covered by the HIPAA standards.

LISA MILLER (ph):  And this is Lisa (ph).  I was going to request the same thing.  I also had one other comment, then.


LISA MILLER (ph):  Which would be I noticed this is continuity in the document.  Really there were no problems with the recommendations as they were stated but in the previous document, we do list the requests and the response and by just saying the 278 (ph) healthcare services review standards we re really not saying that there s a request and a response so we may want to be a little bit more brobost (ph) there and we also mentioned 40-10 (ph) with the eligibility recommendation and we didn t mention anything along those lines so a little bit of a continuity issue that we re not going to the same depth and breadth around the 278 (ph) that we did around the 270-271 (ph).


LISA MILLER (ph):  See, that was easy.

SIMON COHN (ph):  That was easy.  Those were thank you (ph).

LISA MILLER (ph):  You re welcome.

SIMON COHN (ph):  OK.  Are we all set here?  Can we move on to seven?


SIMON COHN (ph):  I think we re seven.  Aren t we?  OK.  We are in seven.  You know, I hate to say this group, but we may wind up in the five hour conference call on Friday.  Anyway, that s not meant to scare anybody but just, I think, realizing that we are now 2.5 hours into this call.  Observation seven Margaret.

MARGARET ALMAJEALKIN (ph):  Medication (ph) history messages from payer PDM (ph) prescriber.  The exchange of medication history may incur in multiple points among prescribers between patients and prescribers between payers (ph) and prescribers (INAUDIBLE) successors (ph).  MMA (ph) indicates that medication history should be provided to prescribers and dispensers but does not explicitly identify the source or sources for (ph) actual intended use of the medication history.  Today, most e-prescribing (ph) applications do not include transmittal of medication history.

When they do transmit medication history, e-prescribing (ph) applications generally use (INAUDIBLE) or FCC (ph) codes.  Medication history from payers PDM (ph) to prescribers is currently performed in multiple proprietary formats.  Rx-Hub (ph) uses several (INAUDIBLE).  One is a based on (INAUDIBLE) PDP that is being submitted to NCPDP (ph).  It s also the standard s (ph) development process to become a MD (ph) accredited (ph) standard.  The following recommended actions address only if exchange of medication history from payers PDM (ph) to prescribers.

The (INAUDIBLE) does plan to address other medication history communication in March 2005.  7.1 HHS should support rapid development of an NCPDP (ph) standard for a medication history message for communication from a payer PDM (ph) to a prescriber using the Rx-Hub (ph) protocols of basis to broaden (INAUDIBLE).  7.2 (INAUDIBLE) will monitor the progress of NCPDP (ph) standardizing a medication history message standard from communication from a payer PDM (ph) to a prescriber and provide subsequent advice to the secretary about it s readiness for adoption.  7.3 if a standard medication history message is ready by January 2006, CMS should include it in the pilot test to be conducted starting in January 2006.

The new NCPDP (ph) medication history message standard for communication from a payer PDM (ph) to a prescriber to ensure (INAUDIBLE) special Medicare requirements.  And I think we had made a few changes in previous ones (ph) that we (INAUDIBLE).

SIMON COHN (ph):  Yes.  I think the recommendation, too (ph), should exactly mirror what we recommended in four.  Correct?

UNIDENTIFIED PARTICIPANT:  You mean, in format, there (ph), yes.

SIMON COHN (ph):  Well, format and I think we also I think we by the time we were done, we had deleted the final action also which had to do with the decisions about pilot testing as opposed to closely monitoring.

UNIDENTIFIED PARTICIPANT:  Oh, I see where you re going.


SIMON COHN (ph):  Yes.  Because I these are this is the same sort of recommendation and so the wording, I believe, should mirror that exactly in terms of the recommended actions.



SIMON COHN (ph):  OK.  Good.  That s helpful.  Now, do we have any comments about either the observations or anything like that except to say that that wording needs to mirror four also?

PHIL ROBINIC (ph):  I have one.  Simon, this is Phil Robinic (ph).

SIMON COHN (ph):  Please.

PHIL ROBINIC (ph):  And the changes that you ve already made, I think they are valuable but the statement in the observation that says today most e-prescribing (ph) applications do not include transmittal of medication history.  I m not sure if I agree with that.  I mean, many of the partners we work with use it.  I don t know what the point of it is in the observation so I m not sure if it s worth debating.

TERRY VERN (ph):  Yes (ph).  This is Terry Vern (ph).  I would agree with Phil s comment.  I don t know who testified to that or where that came from.

UNIDENTIFIED PARTICIPANT:  So that Margaret, are you able to indicate where it came from?

MARGARET ALMAJEALKIN (ph):  This wasn t a change.  I d have to go back and look at the (INAUDIBLE) testimony.  This was not a change that somebody just added (ph).

UNIDENTIFIED PARTICIPANT:  Yes.  I don t think it adds that much to the observation whether it was testified to or not.  It can be safely deleted.

UNIDENTIFIED PARTICIPANT:  Well, it s the next it s really the next couple of sentences that deal with it and so maybe, Terry (ph), if you could comment.  I think one clarification is important.  I mean, it says (INAUDIBLE) uses (ph) several formats.  I think what testified to is that they use HL7 (ph) in (ph) a couple of instances and they use SAPPDP (ph) format in other instances.  Is that right, Terry (ph)?

TERRY VERN (ph):  Yes.  And it I was going to comment on that, Phil, where it says multiples of proprietary formats we actually have one proprietary format and that is the NCPDP-like (ph) format that we re planning to take to NCPDP (ph).  In the other instances, we use two HL7 formats that are already (INAUDIBLE) credited formats.  So, yes, I think we need to reword that.  If that s if that needs to be stated, then we need to reword it.

SIMON COHN (ph):  Yes.  Terry (ph), since you re on the phone, let me ask a very specific question for you that occurred after our hearings yesterday it feels like it was yesterday.  And the question really has to do with you had been talking about multiple formats.  As I thought about it afterwards and just tell me if I m capturing this correctly or if there s some fallacy in my thinking.

What I heard was is that that you using HL7 specifically for communication between Rx-Hub (ph) and specifically hospitals in relationship to the medication histories and all of this.  And, therefore, this is really not within the scope of Part D prescribing and really what you re using for in the context is something that would really be used for e-prescribing (ph) is really this the NCDPD-like (ph) format that or the format that you re going to be submitting to NCPDP.  Am I misunderstanding that?

TERRY VERN (ph):  Yes.  Well, our intention originally was to use the HL7 (ph) format with hospitals and NCPDP (ph) with everybody else but as we start to work with some of the larger EMR vendors, they actually (INAUDIBLE) HL7 (ph) so they re asking us to speak with them in HL7 (ph) as well.

SIMON COHN (ph):  Oh, OK.  So they want that distinction.  OK.  I take that back.

UNIDENTIFIED PARTICIPANT:  But you re getting the history from the payers (ph) in the NCPDP (ph) like (ph).

TERRY VERN (ph):  Yes.  That s true.

UNIDENTIFIED PARTICIPANT:  And that s being translated to the prescribers systems in whatever thing they need.

TERRY VERN (ph):  That s true.


KAREN TRUDELL (ph):  Simon, this is Karen (ph).  in the interest of time, could I suggest that Margaret go back and look through testimony make sure that any statements that are made in observation seven are backed up by value testimony since I don t think I mean, Rx-Hub (ph) is obviously on the line but I don t think a number of the other people who testified as having live installations are necessarily here to make their own statements.

So let s go back to the testimony and, Terry (ph), if you have anything in particular that you want to correct about Rx-Hub (ph) utilization that isn t already in your written testimony perhaps you would let Margaret know about that, too.  Otherwise, we ll just go by the written testimony which is already on the record.

SIMON COHN (ph):  Margaret, are you OK?


SIMON COHN (ph):  OK.  Rest of the sub-committee OK?  It may allow us to actually allow us to get onto eight.



LYNN GILBERTSON (ph):  I have this is Lynn (ph).  I had one just one slight question.  it s something we didn t really talk about and I don t know if anybody even described it in any of their testimony but the forth line under observation says that MMA (ph) indicates that medication history should be provided to prescribers and dispensers and we have not discussed anything about dispensers getting any of this information.

UNIDENTIFIED PARTICIPANT:  Yes.  And, Lynn (ph), that s one of the reasons why we you know, the last item that s listed is we re going to have to look more into medication history.  What we tried to do was separate out what we could address in a recommendation on medication history included in this portion but the rest of those issues is going to be after September.


SIMON COHN (ph):  Yes.  And we actually, Lynn (ph), for your you might have actually heard a fair amount of comment about that but, you know, it was sort of diffused through a lot of testimony in (ph) order (ph) but are we OK with this at this point?  OK.  Let s move on to eight.

MARGARET ALMAJEALKIN (ph):  OK.  Eight Simon, I received comments from Steward Nelson (ph).  I don t know whether you received them as well.

SIMON COHN (ph):  Yes.  I think he recommended that one of the actions be removed.


SIMON COHN (ph):  So mention that as you go through.


UNIDENTIFIED PARTICIPANT:  I saw that note and I feel fine with Steward s (ph) suggestion.


SIMON COHN (ph):  Yes.

MARGARET ALMAJEALKIN (ph):  Clinical job terminology today the prescribing systems for (INAUDIBLE) clinical drug (ph) and/or a selection of a clinical drug associated with proprietary coding system.  Coding of the clinical drug (ph) is a necessary functionality for automated drug utilization (INAUDIBLE) activity.  Non-proprietary coding of the clinical drug selected by prescribers (INAUDIBLE) among different e-prescribing (ph) systems however it is recognized but not everything can be ordered using a code.  Example compounded (ph) drugs, devices (ph) and (ph) supplies (ph).

This means that the ability to enter text in an e-prescribing (ph) system must be preserved.  The NDC is used by dispensers who identify package drugs however NDC is not appropriate for use by prescribers and describing the clinical drug.  The national library of Medicine has produced a clinical drug Nomanclacher (ph).  RxNorm RxNorm provides links from clinical drugs to their active ingredients drug components as some related brand name.

Fully comprehensive RxNorm terminology for all marketed drug products including I m sorry, I m just trying to check both at one time here including generic repackage products and over-the-counter medication will not be available until structured product labels become available to the NLM (ph) from the FDA.  At such time it is the intent of the NLM (ph) to update the repository of drug information on a daily basis as the (ph) daily met (ph).  (INAUDIBLE) the structured product label provides computer readable information that is to accompany dispensed medication  (INAUDIBLE).

Some dispensed as written prescriptions cannot be accommodated through the RxNorm until the full set of brand names are included.  NCBHS (ph) serves (ph) that the FDA is looking to the NDFRT (ph) to provide drug classifications for use in the SPL (ph) and MMA (ph) has (ph) the USP (ph) with developing model guidelines for drug categories and classes that the prescription drug program sponsors can use to structure in their formulary.  The NCBHS (ph) documented deficiencies in the NDC (ph) in its report to the Secretary uniform (ph) standard to patient medical records information (ph) July 6, 2000 that must be overcome to support many clinical applications including e-prescribing (ph).

Recommended Action 8.1 HHS should adopt RxNorm for the specific purpose of e-prescribing (ph) with its actual implementation the NCDPDP (ph) script new prescription renewal and change functions with standard included in the 2006 pilot test.  The pilot test should include determining that the RxNorm clinical drug strength and dosage information can be translated into a ND (ph) stated representative (ph) prescribers intent.

This translation will require the participation of intermediary drug knowledge base centers until the RxNorm is fully met (ph).  The adoption of RxNorm is consistent with the NCDMHS (ph) November 2003 recommended (INAUDIBLE) of clinical data terminology.  8.2 HHS should accelerate the ability and I m going to read Steward s (ph) comments.  I think these are either Stewart s (ph) or Randy s (ph) or both.

SIMON COHN (ph):  Well, I thought his OK.  Go ahead.  I thought we were removing that one.


SIMON COHN (ph):  Was it 8.3 that we re removing?

MARGARET ALMAJEALKIN (ph):  I think it s 8.3.

SIMON COHN (ph):  OK.  I m sorry.  Please go ahead.




UNIDENTIFIED PARTICIPANT:  Yes.  You were saying since we have 8.3, we don t need 8.2.

MARGARET ALMAJEALKIN (ph):  Oh, got you.  Got you.  OK.  So we ll &

SIMON COHN (ph):  Good.

MARGARET ALMAJEALKIN (ph):  OK.  8.3 HHS should accelerate the FDAs current efforts to incorporate all orderable items in the NDC (ph) and to accelerate the promulgation (ph) of (INAUDIBLE) rules and (ph) enhance (ph) the ability to support FDAs correlation of NDC (ph) of RxNorm for passive (ph) daily updates of the FBL (ph) and NLM (ph) for inclusion in the daily med (ph).  Four which would be three HHS should insure that were the USPD (ph) and NDF (ph) (INAUDIBLE) and differ and (ph) accurate mapping (INAUDIBLE) both can be used for (INAUDIBLE).

SIMON COHN (ph):  OK.  Comments?

UNIDENTIFIED PARTICIPANT:  On 8.3, I have a question about all orderable items.  Are we talking about all orderable drugs or do we include things like devices like artificial hips?

SIMON COHN (ph):  I don t think you order up hips (ph).

UNIDENTIFIED PARTICIPANT:  Not under e-prescribing (ph) &

SIMON COHN (ph):  No, not under &

UNIDENTIFIED PARTICIPANT:  (INAUDIBLE) you don t.  No.  And I believe the only supplies that are included are related to insulin.


SIMON COHN (ph):  Yes.  I guess that needs to be wordsmithed (ph) better.


RANDY (ph):  I this is Randy (ph).  The orderable items does that but that includes certain supplies like dipsticks and things like that?  Urine dipsticks and &

SIMON COHN (ph) (?):  Yes.  I presumed that that was the intent was.

UNIDENTIFIED PARTICIPANT:  It sounds like, Margaret, we need to define the word items.

SIMON COHN (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  Well, I think we can help work on that but the subject the coverage of Part D is limited to what is defined as a drug under MMA (ph) and MMA (ph) includes certain items like the supplies that go with insulin so we can do that offline.

SIMON COHN (ph):  Well, and that s probably some wording that you might want to consider using to that describes what you just said.

UNIDENTIFIED PARTICIPANT:  Well, and we use NDC (ph) throughout if those are not NDC (ph) items, it needs to clearly state that they are HRIs (ph) or whatever or UPCs (ph).

UNIDENTIFIED PARTICIPANT:  Yes.  I was going to say that I mean, it seems to me I mean, the way this worded, it sounds like we want the FDA to include to make NDC (ph) codes for those other things which I m not sure that s appropriate.  I mean, we need standard codes to order those but I m not sure we need NDC (ph) codes to order those.


UNIDENTIFIED PARTICIPANT:  I mean, isn t what you can make NDC codes for restricted in some way, Randy (ph)?

RANDY (ph):  It is though the procedure could be, Stan, could be theoretically expanded through other products that we regulate.  The NDC (ph) is limited to drugs but there is if you are interested in these other products that we regulate then that would be something similar to that if you follow what I m saying.

UNIDENTIFIED PARTICIPANT:  I just think we need to be clear that if it s something has an NDC (ph), we actually say that but if it s something that has a code we don t lump it under and NDC (ph).  Because too many people think everything s got an NDC (ph).

UNIDENTIFIED PARTICIPANT:  Right.  If you are interested in the FDA supplying NDC (ph) like identifiers for other products that it regulates then you would say you should say that.

UNIDENTIFIED PARTICIPANT:  Yes.  Well, I think that would be highly desirable.


SIMON COHN (ph):  OK.  So I think, once again, that s wordsmithing (ph) to 8.3 because I think that is sort of what it says.

KAREN ETHERTS (ph):  This is Karen Etherts (ph) from Modospan (ph).  I ve got a question regarding recommendation 8.1 if we re ready for that.

SIMON COHN (ph):  Yes.

MARGARET ALMAJEALKIN (ph):  Simon, I have a I m just not clear on 8.2.  Could we stay on that for just one &

SIMON COHN (ph):  8.2 or 8.3?


MARGARET ALMAJEALKIN (ph):  (INAUDIBLE) talking about.  The new yes.

SIMON COHN (ph):  Yes.

MARGARET ALMAJEALKIN (ph):  It sounded to me like we re saying HHS (ph) should accelerate the FDAs current efforts to incorporate all FDA regulated orderable items such as insulin supplies to (ph) the FDC (ph) but then I heard that you want to reference HRI (ph) and UPC (ph).  Is that I don t I m not clear on how you want to reference HRI (ph) and UPC (ph).

UNIDENTIFIED PARTICIPANT:  No.  I would have said it differently.  I think what we said is that two things well, and I don t know how to relate exactly to those two things we want to encourage the FDA to go ahead and fix what s wrong with NDC (ph) codes.  Secondly, we would like the FDA to make standard codes for other items that it regulates.

SIMON COHN (ph):  Well, actually &

UNIDENTIFIED PARTICIPANT:  And they wouldn t be they wouldn t be NDC (ph) codes.  That s part of the they would be &

UNIDENTIFIED PARTICIPANT:  Well, Stan, I think the question is is my understanding HRI (ph) codes are actually our (ph) FDA regulated, aren t they?

UNIDENTIFIED PARTICIPANT:  Right.  This would be it would be an extension of what it would be what Stan is saying but you would be and giving an example, HRR (ph) HRI (ph) codes.

SIMON COHN (ph) (?):  We re talking about incorporating the HRI (ph) codes into NDC (ph).

UNIDENTIFIED PARTICIPANT:  Or it s more that you have NDC that s for drugs and now you want similar and equivalent type of coding for other regulated products and that an example of that is extension of the HRI (ph) to include more products like HRI (ph) is for medical supplies and you want to expand that.  It was what Stan had said, I guess.  An example is HRI (ph).

UNIDENTIFIED PARTICIPANT:  Well, who s keeping track of HRIs (ph) today?

UNIDENTIFIED PARTICIPANT:  Well, you what Stan had said is that NDC (ph) drugs and also develop similar or whatever I forget how you said it, Stan, for medical supplies and other regulated products.  HRI (ph) is handled in the say way a very similar way that NDCs (ph) are handled today.  That s not the ideal way.  That s not what you have been recommending for NDCs (ph).

SIMON COHN (ph):  You know, I m trying to think of what the right way of describing this.  Margaret, are you more confused or less confused?

MARGARET ALMAJEALKIN (ph):  Slightly less confused.

SIMON COHN (ph):  Well, that s good.  I m actually more concerned about what we might say here.

MARGARET ALMAJEALKIN (ph):  I have some wording if I could run by you.  HHS should accelerate the promulgation of FDAs drug listing rule and hence (ph) the ability to support FDAs correlation of NDC (ph) with RxNorm samples (ph) of (INAUDIBLE) for inclusion to daily (ph) met (ph).  FDA should make equivalent standard codes for orderable items such as insulin supplies that are regulated that it regulates.  Example an extension of the HRIs (ph).

SIMON COHN (ph):  Well, I thought those were HRI (ph) codes already?  Are others (ph) on the phone?

MARGARET ALMAJEALKIN (ph):  That s why I said an extension of.

SIMON COHN (ph):  Well, but I already thought they had HRI codes.

UNIDENTIFIED PARTICIPANT:  Very limited number of HRI (ph) and I don t think they really give out those codes anymore.  I mean &

SIMON COHN (ph):  Is that right?  OK.

UNIDENTIFIED PARTICIPANT:  So it would be something that you something but even before you gave the example, it said the essence is that you re saying create these other code sets for other products other regulated products orderable that you re describing as Margaret put down.

UNIDENTIFIED PARTICIPANT:  Well, then none of these are going to be in the RxNorm, right?

RUSS MARTIN (ph):  Yes (ph).  And that was my question.  This is Russ (ph).  I wasn t clear as to whether RxNorm would be used as a bridge between these codes in a similar was that it s done for the NDC (ph) or if there would be some other RxNorm like bridging code so that somebody using Medistand (ph) and somebody using First Data Bank (ph) would be able to translate that and that was one question and I m also wondering if for the purposes of this recommendation and I make that limited caveat that we recommend that if these (ph) four things covered by Part Medicare Part D.

The reason being, you know, we want to quotify (ph) the world but we also want to make sure that for this purpose at least we have the codes that are covered by Part D in a timely fashion and those should be given priority over quotifying (ph) the universe.

UNIDENTIFIED PARTICIPANT:  Yes.  As far as the first the first issue without (ph) RxNorm, the concepts for other regulated products especially device is medical supplies would be a different concept and the than RxNorm so something what you would need is something equivalent like you said for bridging.

UNIDENTIFIED PARTICIPANT:  I would suggest that, actually, we I mean, Stewart (ph) offered and I think it s actually the right place to have RxNorm, you know, essentially what we re talking about is RxNorm would have the generic names for these things and that HRI (ph) codes would be the product specific codes exactly and (INAUDIBLE) to NDC (ph) codes.

SIMON COHN (ph) (?):  Yes.

VIVIAN ALD (ph):  This is Vivian (ph).  You re talking about orderable supplies, essentially, right and if that s the case, they wouldn t Randy s (ph) correct.  They wouldn t be in RxNorm.

RANDY (ph) (?):  I know they re not in there now but Steward (ph) offered to add those if we thought that was appropriate.

VIVIAN ALD (ph):  He wasn t offering to put them in RxNorm.  He was offering to put them in another vocabulary.

RANDY (ph):  So another NLM (ph) maintained vocabulary?

VIVIAN ALD (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  If that s the case, then this is an example what that Lynn (ph) was giving (ph) before about, you know, until we know what the regulations are, we re not going we re not sure if we re going to have what s going to be required to support the communication of these within, say, NCPCP (ph) script for example or HL7 (ph) for that matter and if there are two separate codes and they are kind of exclusive to one another meaning you only use either an RxNorm code or this I m going to say FX (ph) norm because it s for supply.

Supply code then maybe as simple as just putting two vocabulary terms in what kind of code are you using here RxNorm or FX-Norm (ph) or it could be more complicate that that so that s one of the things we need to address.

UNIDENTIFIED PARTICIPANT:  Well, I think it s I mean, is it really in question.  NCPDP (ph) already supports that.  I mean, it has the qualified that says what kind of code this so that you might need to add a new one that says this a NLM (ph) supply code.  You need to add a, you know, you need to add that to the allowed set of qualifiers but the structure is I mean, can t we say now that the structure is sufficient?

UNIDENTIFIED PARTICIPANT:  My gut reaction is if all you need is a qualifier that says what follows is an RxNorm or what FX-Norm (ph) or whatever, the standard can handle that.  I m more concerned that I don t have a good grasp that this is all functionable, especially for a pilot.  I just you know, we need to put all the the As have to follow Bs have to follow Cs.

KAREN TRUDELL (ph):  And this is Karen (ph).  That was sort of the point I wanted to make about 8.1 because that was where I thought we were touching the feasibility of the code being able to describe the physician s intent of being prescribed and until we can validate that, I m just wondering if we re premature on the other recommendation.

SIMON COHN (ph):  So you re saying with 8.1, you re suggesting that the wording is more along the lines of piloting?

KAREN TRUDELL (ph):  The second sentence, I think, is great.  The pilot test should include determining that the RxNorm and the concepts translate into an NDC (ph) that represents the prescriber s intent.

SIMON COHN (ph):  Right.

KAREN TRUDELL (ph):  And we haven t illustrated that in the marketplace and so to keep saying the Rx in the first sentence (INAUDIBLE) &

SIMON COHN (ph):  We just lost you.

KAREN TRUDELL (ph):  & a little premature.  That s our intent.  That s our hope but until we prove it, I think it s premature.

SIMON COHN (ph):  So you re suggesting and I think I have sort of agreed about the idea of changing the wording in a one, it s supposed to (ph) we re adopting but should be piloted &

KAREN TRUDELL (ph):  I mean, does that second sentence there, I think, is right on.

SIMON COHN (ph):  Yes.  And you d like the sentence to (INAUDIBLE) more like piloting rather than adopt.


SIMON COHN (ph):  Yes.  Do others have opinions on that on the subcommittee?

UNIDENTIFIED PARTICIPANT:  It sounds like that s appropriate.

SIMON COHN (ph):  Yes.  I think this I mean Stan?

STAN HUFF (ph):  Yes.  I m fine.  Yes.  I think this is clearly a test.  There s no assumption that it s that it will work until we test it.

SIMON COHN (ph):  OK.  So let s Judy (ph)?

JUDY WARREN (ph):  I agree.  It needs to be tested.

SIMON COHN (ph):  Harry (ph)?

HARRY REYNOLDS (ph):  I think we lost Harry (ph) again.  OK.  So let s adopt that change.  For 8.3 so I think we we re generally fine with 8.1 with that change and sort of focus.  I think in 8.3 we re sort of you know, I hear the word agreement with the first part of the recommendation that we were wordsmithing (ph) out which is what Margaret had read as the new first sentence.  I hear we re having some significant issues grappling with how we would even describe the second recommendation and I think that maybe, for the moment, we ought to just go with that first that first sentence and leave it at that.

UNIDENTIFIED PARTICIPANT:  Well, what is it that we would not include?

SIMON COHN (ph):  This issue about incorporating all orderable items in the NDC (ph) and we re seeing we re (ph) having a conversation about what s in NDC (ph) what s not.  What s in RxNorm?  What s not?

UNIDENTIFIED PARTICIPANT:  So we just say (ph) silent on that topic.

SIMON COHN (ph):  I think we could be silent on that topic for the moment.

UNIDENTIFIED PARTICIPANT:  But you re saying to take out 8.3?

SIMON COHN (ph):  No.  Margaret, would you read that first sentence again?

MARGARET ALMAJEALKIN (ph):  HHS should accelerate the promulgation of FDAs drug listing rule and hence (ph) the ability to support FDAs correlation of NDC (ph) with RxNorm.  Example, for passing daily updates for the (INAUDIBLE).

UNIDENTIFIED PARTICIPANT:  This background noise is really is hard to hear.


SIMON COHN (ph):  (INAUDIBLE) people were able to hear that?

UNIDENTIFIED PARTICIPANT:  Well, no, because Margaret faded out.

MARGARET ALMAJEALKIN (ph):  I m sorry.  HHS should accelerate the promulgation of FDAs drug listing rule and hence (ph) the ability to support FDAs correlation of NDC (ph) with RxNorm.  For example, for passing daily updates of the FPL (ph) to NLM (ph) for inclusion in the daily med (ph).

SIMON COHN (ph):  Period.




SIMON COHN (ph):  OK.  Are we OK with that.  That gets us out of the last ten minutes of quandary that we had.

UNIDENTIFIED PARTICIPANT:  Yes.  I think that what we ought to do is put this on the list of things to consider more for March.


UNIDENTIFIED PARTICIPANT:  Yes, Tom (ph), we could talk about because I think we want to do that and I think there are things that we could do good there but we don t have to put them in this letter.

SIMON COHN (ph):  That s well said.  OK.  So at this point are we fine, then, with observation eight?



UNIDENTIFIED PARTICIPANT:  I think there s a factual it s not correctly stated up in the observation eight in the first paragraph and second to the last sentence.  However, it is recognized that not everything can be ordered using a code.  Actually everything can be ordered a code if there is a code.  So there s so the real the real thing is that some things don t have not everything has a code so.

SIMON COHN (ph):  And everything has a code.  OK.


SIMON COHN (ph):  Stan, you can send that via e-mail to Margaret.

STAN HUFF (ph):  Yes.


STAN HUFF (ph):  She can fix it.

SIMON COHN (ph):  OK.  Let me just ask everybody and Marjorie (ph), I need your help on this one also.  Do we turn into pumpkins in three minutes?  Are you even there, Marjorie (ph)?

UNIDENTIFIED PARTICIPANT:  I think she s already turned into a &

UNIDENTIFIED PARTICIPANT:  I think we already turned into a pumpkin.

UNIDENTIFIED PARTICIPANT:  Marietta (ph), are you on the line?

MARIETTA (ph):  Yes.  I m here.  Marjorie (ph) is off the line.

SIMON COHN (ph):  Yes.  Are we how long are we good to go?


SIMON COHN (ph):  What?

UNIDENTIFIED PARTICIPANT:  No, I was just going to say can we keep going for a while?

SIMON COHN (ph):  Well, that s what I was going to ask if we could go for another half an hour.

UNIDENTIFIED PARTICIPANT:  I think you can.  I m not sure.

SIMON COHN (ph):  OK.  Can you double check with us and we ll just keep going and, of course, if we stop hearing each other, we ll know that we re dead and we start off on Friday.  I &

UNIDENTIFIED PARTICIPANT:  Simon, can I ask one question go back to recommendation point three.

SIMON COHN (ph):  Let s finish off this one thought first.


SIMON COHN (ph):  OK.  I guess we will continue on hopefully for half an hour.  In case we get cut off, we re going to at least need to go for three hours on Friday and my bet is that (ph) more than likely we need to go for four.  Now is the subcommittee comfortable with that?


SIMON COHN (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  This is my suggestion here is that given the experience of today and even when we get through his section is probably going to be some folks that may have some comments on the background section or on the audible process or procedure or something else.  If the subcommittee is willing, I would be willing to go for five hours.

PHIL ROBINIC (ph):  Simon, this is Phil Robinic (ph).

SIMON COHN (ph):  Well, let s ask the subcommittee to deal with this one first.

PHIL ROBINIC (ph):  Well, I want to comment on that.


PHIL ROBINIC (ph):  Just in the interest of sort of keeping the process public, given that this is sort of scheduled time, I wonder if it may be useful to schedule a longer time on Friday and defer until then rather than just dragging (ph) on today and losing people or, I guess my question is can we start on Friday with an update as to what went on after 2 clock.

SIMON COHN (ph):  Oh, I think the later one absolutely and we re only going to go on for another half an hour at most at this point.


SIMON COHN (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  Sheryl (ph) said you can press pound, zero and ask the operator to extend the call.

SIMON COHN (ph):  OK.  Hang on.  Let me just do that, then.  And I guess if I m hearing before I do that, is everybody still there?




SIMON COHN (ph):  OK.  Are we saying five hours on Friday that we should at least hold?  Stan?

STAN HUFF (ph):  Yes.

SIMON COHN (ph):  Judy (ph)?

JUDY WARREN (ph):  Yes.  I need to do some rescheduling but I think I can make it.

SIMON COHN (ph):  Harry (ph)?  Lost Harry (ph).  Jeff, you re there.  I can do it so let me now let me see if we can get another half hour now but otherwise we ll be on five regardless we ll be on five hours on Friday.  Give me just a second here.


SIMON COHN (ph):  And we said Marietta (ph), is it zero, pound or pound, zero?

MARIETTA (ph):  Pound, zero.

SIMON COHN (ph):  OK.  That didn t seem to do anything.

UNIDENTIFIED PARTICIPANT:  Yes.  Since he signed into the conference call, I doubt that pound, zero will enable him to do that.  I think somebody else, externally, has to do that.

MARIETTA (ph) (?):  (INAUDIBLE) should be able to contact the operator but Sheryl s (ph) going to e-mail me to let me know for sure and then I ll let you know.

UNIDENTIFIED PARTICIPANT:  It would be the person who signed in as the leader.

SIMON COHN (ph):  So pound, zero.  Let me try it again.

MARIETTA (ph) (?):  OK.  I m sorry.  She said that you can talk as long as you want.  Go ahead and talk.

SIMON COHN (ph):  OK.  Great.  Well, we don t want to do that.  I think we ve already done that but we ll talk for another half an hour anyway.

MARIETTA (ph) (?):  OK.

SIMON COHN (ph):  OK.  So there was a question or a comment about 8.3?

RANDY (ph):  Yes.  This is Randy (ph).  There was I don t have Margaret s sentence but there s something there that said something about correlation of NDC (ph) with RxNorm.  Did it say FDAs correlation, Margaret?



RANDY (ph):  Yes.  Can does it have to say FDA (ph)?  Can it just say the correlation (INAUDIBLE) with RxNorm?

MARGARET ALMAJEALKIN (ph) (?):  Support doc (ph) correlation of NDC (ph) with RxNorm?

RANDY (ph) (?):  Yes.

UNIDENTIFIED PARTICIPANT:  And the point being that it s the library that s making the correlation, not you.


SIMON COHN (ph):  OK.  OK.  Well, let s are we OK, then?  Move on to nine?

VIVIAN ALD (ph):  Can I make one last comment on eight?  This is Vivian (ph).

SIMON COHN (ph):  Well, sure.

VIVIAN ALD (ph):  Just to point out, Margaret, that there s a couple of more comments that you had on the second paragraph of the observation.  If you don t find those, let me know.

MARGARET ALMAJEALKIN (ph):  Oh, the most (ph) and for all of those items?

VIVIAN ALD (ph):  Yes.

MARGARET ALMAJEALKIN (ph):  I ll include those.  Thanks.

VIVIAN ALD (ph):  OK.  Thanks.

KAREN TRUDELL (ph):  Simon, this Karen (ph).  I have come a comment about the recommended action the originally 8.4 and now 8.3 &

SIMON COHN (ph):  OK.  Please.

KAREN TRUDELL (ph):  Which says HHS (ph) should incur that where &

SIMON COHN (ph):  Ensure.

KAREN TRUDELL (ph):  & ensure that where the USPNDFRT (ph) may differ and accurate mapping (ph) exists first of all, it s not the USP (ph).  It s the Part D model of therapeutic categories and classes that happens to be &

SIMON COHN (ph):  Yes.

KAREN TRUDELL (ph):  & developed.

SIMON COHN (ph):  So you want to change the &

KAREN TRUDELL (ph):  Under (ph) contract with &

SIMON COHN (ph):  OK.  So USP (ph) is the wrong name.

KAREN TRUDELL (ph):  Exactly.  And the other thing is that I m not sure that there will be a difference between the Part D model and NDFRT (ph) because we have been looking at NDFRT (ph) and the first draft that I saw showed that it was a perfect crossover and we won t really know whether there are or are not differences for quite some time because the first public meeting is only occurring Friday.

SIMON COHN (ph):  But we all have seen draft proposals.

KAREN TRUDELL (ph):  We have but that s &

SIMON COHN (ph):  OK.  Well &

KAREN TRUDELL (ph):  It’s a drafty draft.

UNIDENTIFIED PARTICIPANT:  Karen (ph), I think the only thing I’m hearing from you in terms of a change to recommended action four is changing USP to the right now.

KAREN TRUDELL (ph):  I’m saying that instead of saying where there’s difference I’m saying if there’s a difference.


UNIDENTIFIED PARTICIPANT:  Fine.  OK.  Other comments before we move on to nine?  OK, let’s plow into nine.

UNIDENTIFIED PARTICIPANT:  Structured and codified sig.  Structured and codified instructions for medication used commonly called the sig will enhance patient safety, although it also although it is also recognized that Merideth (ph) Tech’s capability must be preserved for special circumstances.  A structured and codified sig is in keeping with the abbreviations initiative underway by the Joint Commission on Accreditation (ph) and Health Care Organizations (ph).

NCPDP, HL7 and others are working on addressing structured sig components and wish to seek broad industry participation.  If maintenance of a vocabulary is also needed in the structured sig example, describing reasons for a PRN prescription it may be necessary to elicit a vocabulary developer for support and maintenance.  9.1  (ph).  HHS should support NCPDP, HL7 and others, especially including the prescriber community, in addressing in their strict (ph) sig component.

This should include preserving the ability to incorporate free text when necessary.  Example, for special compounding of drugs.  And 9.2 (ph).  HHS should include in pilot tests to be conducted starting January 2006 structured and codified sigs as developed to the Standards Development Organization effort.

UNIDENTIFIED PARTICIPANT:  So just on recommendation 9.1, the sig you don’t do the compounding of drugs in the sig.

UNIDENTIFIED PARTICIPANT:  Can you give another …


UNIDENTIFIED PARTICIPANT:  … example, please?  Because somebody asked for an example.

UNIDENTIFIED PARTICIPANT:  Yes.  It would be for a the common use (ph) case …


UNIDENTIFIED PARTICIPANT:  … special or, you know …

UNIDENTIFIED PARTICIPANT:  Special dosing instructions.

UNIDENTIFIED PARTICIPANT:  … special dosing instructions, you know, like the things that are commonly done in free text are very complicated things where you say I want you to take this the first Monday of every month or I want you to take this, you know, every other Tuesday or, you know, Wednesday, Monday, and Fridays, but not holidays, or …



UNIDENTIFIED PARTICIPANT:  Well, if I just put, for example, for special dosing situations, that should …




UNIDENTIFIED PARTICIPANT:  For complex dosing instructions or something like that.

UNIDENTIFIED PARTICIPANT:  OK.  What do people feel about this one?

RUSS MARTIN (ph):  This is Russ Martin (ph).  The only comment I have is that I’ve been on a hospital pharmacy list serve, and I mentioned this conversation that was going on about the JAYCO (ph) standards because there was a there was a thing about structured sig going on in the list serve.  And one of the one of their responses was this the JAYCO (ph) set is very limited and they know that there are many other many other issues.  But I think that’s an example of a minimum standard.  So it’s fine to mention it, but I would suggest that we don’t, you know, stop there or there’s also the I think it’s called the ISMP, the Institute for Safe Medication Practices or something like that, that also has sets of recommendations.

SIMON COHN (ph):  Simon.  I was going to mention that also.  So I don’t see the purpose of that statistic.



UNIDENTIFIED PARTICIPANT:  Everybody comfortable with that?


UNIDENTIFIED PARTICIPANT:  I think it’s off-point.

UNIDENTIFIED PARTICIPANT:  It is off-point.  And the I mean, JAYCO’s (ph) thing is not a list of abbreviations you should use.  They only list what you should not use.  So that’s it’s not it’s not a starting point for making a structured sig.  It’s something that needs to be considered so that you don’t use the things that they tell you not to use.  But it’s not a specification …


SIMON COHN (ph):  Simon.  Another comment.  Is a PRN prescription something the secretary is going to know?


SIMON COHN (ph):  It’s in it’s in the last sentence of the comment …

UNIDENTIFIED PARTICIPANT:  Oh, OK.  It’s (ph) spell it out?

SIMON COHN (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  God, describing the reason for a PRN prescription.


UNIDENTIFIED PARTICIPANT:  I’m not sure we need this last sentence either.

UNIDENTIFIED PARTICIPANT:  Yes, I I think I’d get rid of the last sentence, too.


UNIDENTIFIED PARTICIPANT:  I think maybe the intent of the last sentence was that they sentence above, it starts NCPDP and others.   That was the comment Scott Robertson had made, that the standards developers can decide what goes in as standard, but there may still be a vocabulary behind what you fill into the fields in the standard.  And that may be outside the SDO’s (ph) level of knowledge.

RUSS MARTIN (ph):  I this is Russ (ph).  I would I would make a suggestion that you make that a little bit more generic and just say that there may be a need for vocabulary developers to be supported in this as well.  And I don’t even think the example of the reason field is the more significant one.


UNIDENTIFIED PARTICIPANT:  Yes, I actually (INAUDIBLE) should be removed.  But, Stan, do you have a comment?

STAN HUFF (ph):  Well, I’d be in favor of removing it or making it general in the way that Russ (ph) suggested.  Because I mean, the parts of the structured sig are actually known.  I mean, they’re in use.  And so the only way that you can get a level where you need a vocabulary maintainer is if you’re getting into some list of goal diagnoses, which are usually not part of the not part of the sig.  So I would either make it general or I would just eliminate it.

LYNN GILBERTSON (ph) (?):  I would vote to remove it.  I don’t think that it adds anything.

STAN HUFF (ph):  I mean, your statement, Lynn (ph), is true.  I just don’t think it belongs in this letter necessarily.

LYNN GILBERTSON (ph) (?):  OK.  Jeff?  We lost Jeff?  Judy (ph)?

JUDY WARREN (ph):  Yes, I’m here.

UNIDENTIFIED PARTICIPANT:  Do you agree with removing that whole sentence?

JUDY WARREN (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  OK.  Harry we know is not here.  Stan.

STAN HUFF (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  You’re in agreement.  Jeff, are you there again?  I guess we really lost Jeff.  I guess we have three.  So we still have a quorum, so we’ll support removal.

JEFF BROWN (ph) (?):  Oh, I’m sorry.  I had my mute on.  I agree with Stan’s last comment.

UNIDENTIFIED PARTICIPANT:  OK.  You’d vote in favor of removing the sentence.

JEFF BROWN (ph) (?):  Yes.

UNIDENTIFIED PARTICIPANT:  OK.  Any other commitments on nine?

JEFF BROWN (ph) (?):  I was trying to agree, but I muted myself.

UNIDENTIFIED PARTICIPANT:  Yes.  Well, I had a feeling that you were doing that.  OK.  OK.  So I think we’re done with nine.  I guess I would ask everybody the next two are both identifier issues.  Shall we wade into those?  Jeff, do you have any advice on that one at this point?  I saw some note here some information we received this morning.

JEFF BROWN (ph) (?):  Prompt me.  I’m not sure what you’re suggesting here.

UNIDENTIFIED PARTICIPANT:  Well, I’m just wondering whether we need whether we should go into identifiers at this point or defer them till Friday and handle other issues.

JEFF BROWN (ph) (?):  Let me see what time it is.  I would …


JEFF BROWN (ph) (?):  Yes.  I would prefer to continue to go down.


JEFF BROWN (ph) (?):  Maybe we can do one more.

UNIDENTIFIED PARTICIPANT:  … that sounds fine then.  Observation 10.  Margaret?

MARGARET ALMAJEALKIN (ph) (?):  Dispenser identifier.  The NCPDP provider identifier number has been in use for a number of years and is widely accepted as a dispenser pharmacy identifier (ph).  It’s database contains information to support various claims processing functions and to continue to be available for this purpose.

The NCPDP database can accommodate the national provider identifier, NPI, as a reference field.  The NPI will be required in the NCPDP telecom for claims processing as a HIPAA standard.  Then (ph) the national provider system enumerates pharmacies and (INAUDIBLE) chains (ph) at a particular address and pharmacists.  10.1.  HHS should adopt the NPI as the standard identifier for dispensers in e-prescribing when it becomes available.

And please note that this action was recommended last week, but additional information provided by NCPDP today (INAUDIBLE) will still have deficiencies, making the NCPDP provider identifier seemingly the preferred choice.  10.2.  HHS should accelerate the enumeration of dispensers to support transitions the (ph) NPI for e-prescribing.  And 10.3.  HHS should permit the industry to use the NCPDP provider identifier in event that the MPS (ph) could not enumerate dispenser in time for e-prescribing.

And four 10.4.  HHS should evaluate how mass enumeration of dispensers for the NPI can occur using the NCPDP provider identifier number database while protecting the ability to preserve linkages to the NCPDP provider identifier number database for current claims processing purposes.

UNIDENTIFIED PARTICIPANT:  Comments or questions.

UNIDENTIFIED PARTICIPANT:  Well, I think that the additional information that we received from NCPDP, from Lynn (ph), I think that we’re OK with that.  You know, Lynn (ph), do you feel like Margaret was able to capture your input appropriately in these recommendations?

LYNN GILBERTSON (ph)::  Yes, Margaret, maybe you need to reread the one that you modified based on that input.

MARGARET ALMAJEALKIN (ph) (?):  Yes.  I felt that 10.1 originally was HHS should adopt the NPI as the standard identifier for dispensers and e-prescribing.

LYNN GILBERTSON (ph)::  When it becomes available.

MARGARET ALMAJEALKIN (ph) (?):  Well, originally it was just e-prescribing.


MARGARET ALMAJEALKIN (ph) (?):  OK.  And then we got the note from NCPDP, and it sounded to me like maybe that was not the best choice, but added when it becomes available.   Because for the dispenser identifier, NCPDP’s recommendation was the use in the NCPDP provider ID and file fulfills the needs today for billing and for e-prescribing.  So it sounded like they were saying that it should be the NCPDP provider ID rather than the NPI.

LYNN GILBERTSON (ph)::  But I think they would have said that before.  I mean, I guess I didn’t I didn’t see anything in the information that was sent out that would that would have changed my mind from the original recommendation.

UNIDENTIFIED PARTICIPANT:  Yes, and I agree.  You know, actually the thing that we were really asking for and maybe it wasn’t necessary or at least the thing I was trying to ask for was whether or not we needed to include something in the recommendations to make sure that the mapping to the NCPDP identifiers was protected or preserved.  And, you know, if we didn’t need to include a sentence like that, I thought all of our recommendations were OK.

UNIDENTIFIED PARTICIPANT:  Right.  What the what the folks felt was that the NPI could be used for dispenser.  But the reality is that it would probably be used only as a reference to go back to the NCPDP provider ID and get the rest of the information that they knew to be usable and real.  And, I mean, there was a concern about keeping things in synch and up-to-date and all those kind of things.  But there they couldn’t really find a business function that the NPI provided that they wouldn’t get off the NCPDP provider ID for dispensers.


UNIDENTIFIED PARTICIPANT:  So it was a key to a key, and that’s all it’s going to be doing in the e-prescribing world.

UNIDENTIFIED PARTICIPANT:  Yes, but that’s an important that’s an important thing.  Because what it means is that if the NPI is the standard and then it’s cross-referenced, then it allows a free market opportunity for somebody else who either sees a business opportunity or can do it better than NC Idea (ph) to enter the marketplace.  If we adopt NC Idea (ph), then that basically excludes the possibility of others providing like service, you know, for less money or more efficiently.

UNIDENTIFIED PARTICIPANT:  No, this isn’t the HC Idea (ph).  This is only at the provider-dispenser.

UNIDENTIFIED PARTICIPANT:  The argument is still the same.

UNIDENTIFIED PARTICIPANT:  OK.  Well, maybe I’ll phrase this differently.  Lynn, do you have any problems with the way the recommendations are now worded?


UNIDENTIFIED PARTICIPANT:  OK.  I would declare victory.

UNIDENTIFIED PARTICIPANT:  OK.  And they are worded basically as we’re looking at them now.

UNIDENTIFIED PARTICIPANT:  HHS should adopt the NPI as the standard identifier for dispensers and e-prescribe e-prescribing when it becomes available.

UNIDENTIFIED PARTICIPANT:  Right.  And then the other supportive (ph) recommendations.  OK.  Any other comments on 10, then?

JERI SWANSON (ph):  (INAUDIBLE) this is Jeri Swanson (ph), from Cigna.  I have one question on 10.23, which is saying let’s move forward with the NCPDP provider ID in the event that we cannot enumerate in time for e-prescribing.  I guess my comment is what does in time mean, you know, as we look at the pilot.  I know there’s been some conversation on earlier items about what timing would be necessary.  And I’m wondering if it would be better to be more specific there.

JEFF BROWN (ph) (?):  This is Jeff.  And this is where I feel like it’s difficult for us we don’t know exactly where the deadlines are right now.  This is why we wound up saying in time for.   Because probably by March we probably will be able to pin that down more specifically.

KAREN TRUDELL (ph):  Jeff, this is Karen (ph).  I would suggest that we might want to change that to simply say in time for part D implementation.   That pretty much encompasses everything, including pilot.



LYNN GILBERTSON (ph):  This is Lynn.  I just had one question back for Karen (ph).  Under observation, the very last line.  Parts of chains at a particular address.   Is that how that is, or is it should we really say pharmacies, organizations, or whatever you call that level …

KAREN TRUDELL (ph):  I would I would say subs-parts (ph) instead of parts of chains.  Because that’s what it does.

LYNN GILBERTSON (ph):  Sub-parts of pharmacies or sub-parts of organizations or …

KAREN TRUDELL (ph):  Sub-parts of organizations.

UNIDENTIFIED PARTICIPANT:  And still add a particular address?

KAREN TRUDELL (ph):  Yes, that s correct.


UNIDENTIFIED PARTICIPANT:  OK.  So we re OK with 10.  Should we go on to 11?


UNIDENTIFIED PARTICIPANT:  Proscribe (ph) your identifier.  There is no significant identifier for prescribers.  I m sorry there s no single identifier for prescribers.  The Drug Enforcement Agency DEA number is widely used as a proxy, although testimony is expected to be (INAUDIBLE) between now and March, others indicated that the DEA prefers the numbers to be reserved for use only on prescriptions for controlled substances.  (INAUDIBLE).

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 (INAUDIBLE) in subsequent recommendations.

NCPDP (ph) created HCID (ph) of the prescribers to eliminate usage of the DEA and prescription claims when transmitted between dispensers and payers PDM (ph) (INAUDIBLE).  It is not currently available directly to prescribers.

The HCID (ph) database supports all of the prescriber s (ph) CEA (ph) numbers, practice locations and the National Provider Identifier when it becomes available in its database.  The NPI will be required in all prescriber standards as a HIPA (ph) standard.  The NPI database could accommodate a bulkload  (ph) from HCID (ph) to include missing elements if efficient (ph) and valid to do so.

Fragmented (ph) actions HHS (ph) should include a (ph) pilot test to be conducted starting January 2006, both the NPI and the HCID for (ph) prescriber identifier determining which most completely meets the needs of e-proscribing (ph), including the ability to tie the prescriber to a specific location.  And that s a change based on NCPDP s (ph) input today, but we could go back to, I think, Stan s comment that they could be similar to 10-1 (ph).

UNIDENTIFIED PARTICIPANT:  I wonder if I could ask Karen (ph) a question.  Karen (ph), will we have national producer identifier enumerations so that we could use them for prescribers in January 2006?

KAREN TRUDELL (ph) (?):  Well, as I testified at the at the hearing, we re scheduled to begin enumeration in August of 2005.  And there is the potential of doing bulkloads (ph) from other prevalidated databases, of which HCID (ph) is clearly one.  So that s a potential to be discussed.

I would be more concerned not about the timing, but about what this does in terms of having the ability to stovepipe the prescribing environment.  Essentially what NIP was supposed to do was to be one enumeration mechanism for all health care provider, not just prescribers, and for use in not just administrative transactions, but one of the reasons that we said that we would enumerate RNs and others was that we hoped that the same enumeration schema could be used throughout (ph) electronic health care.

So I think in light of observation one, where compliance with HIPA (ph) is something that was raised as kind of a guiding principle, if (ph) there s going to be a recommendation to do something else, I think that the subcommittee needs to be very clear about why it is making that deliberate decision to treat prescribers completely differently than everybody else.

UNIDENTIFIED PARTICIPANT:  And we just (ph), at the very least, anybody who is willing to participate in a pilot could be given a National Provider Identifier for that pilot, which then (ph) becomes their permanent identifier.

KAREN TRUDELL (ph) (?):  I guess I guess my point was that I m not sure I heard anything in the testimony that said that there was a lack in the functionality of the NIP that we could not work around.  I mean, and we (ph) talked about the whole idea of locations and using phone numbers as a proxy.  And I don t get I don t feel like there s been closure on that.

UNIDENTIFIED PARTICIPANT:  In other words, Karen (ph), are you saying why even mention the HCID (ph) idea (ph) if the &

KAREN TRUDELL (ph) (?):  Why would we pilot &


KAREN TRUDELL (ph) (?):  Why would we pilot them both?

UNIDENTIFIED PARTICIPANT:  Well, and that s my proposal.


UNIDENTIFIED PARTICIPANT:  So Stan, your proposal s basically a replicated of the recommendations in 10 (ph)?

STAN HUFF (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  Oh (ph), but there were quite a few testifiers who said that the HCID (ph) did need to be looked at.

STAN HUFF (ph) (?):  And that s OK.  I mean, we heard the testimony but the point I mean, I m persuaded again, it s not arguing against the value of the HCID (ph) at all.  It s the argument that I made before that if you make if it gets adopted, then it precludes other people who want to (ph) provide a similar database function from doing that.

And secondly, I think I find Karen s (ph) argument compelling that yes, it s not just e-prescribing (ph).  Looking at it from IHC s (ph) perspective, we want a single identifier for this person as the identifier in the electronic medical record, in claims that we send out, in prescriptions that we send out, et cetera.  And if we want to reference any prescribing to the information that s in the in the HCID (ph) database, that s a wonderful thing.

But I think as the standard identifier, I didn t I agree with Ken (ph) I didn t hear any arguments or, in the literature you sent, see any arguments about why this couldn t be used as the identifier in the e-prescribing message.

I saw lots of arguments about why HCID (ph) had a value and was an appropriate and (ph) necessary part of the process, but I didn t see anything that precluded NPI (ph) being and (ph) ACC (ph) as disadvantages to making HCID (ph) the identifier in this message.

JEFF BROWN (ph) (?):  Could I could I this is Jeff.  Could I chime in?  I totally agree with Stan.  I found Karen s (ph) descriptions and position very compelling.  And the only piece that I was concerned about is, you know, I see the need for mapping, and I just wanted to make sure that we didn t create a problem if these recommendations went forward without a statement that protected the ability of NCPDP (ph) and/or dispenser and/or, well, whoever is going to be doing the mapping.  So that was the thing, Lynn (ph), that I was really looking for from you is, is there anything in these recommendations on 11 where we need to make a statement about protecting the mapping?

LYNN GILBERTSON (ph):  Right.  And, you know, the intent was not to give you guys a sales pitch or anything like that.  It was really we re (ph) and if it came across that way, I do apologize, because that was not the intent.  The real concern is that if there is no control on (ph) the NPI, that the number that s given can tie back to the medical record for this prescription for this patient.  We can t tell where to send that transaction because doctors leave practices and things like that.

So you need something that says as of this date, this doc was at this location so that it can be transmitted back to that location so that somebody else in the practice can pick up that prescription instead of just saying, Sorry, we don’t know about this patient anymore, or those kind of rejections that can occur.

And if there’s no control at the NPI level of the location we seriously can’t route with it, so we’re going to have to figure out what else do we have to add to cross reference to MPIs to figure out what locations are on there and which ones really do map.  So then if we’re saying …

UNIDENTIFIED PARTICIPANT:  Maybe we’re miscommunicating because my assumption is that you would need to map from MPI to some database to do exactly what you said.  There’s no assumption in what I said that I think you can route based on the MPI alone.  There is the essential need for that other database, but that’s a very different thing than saying that the NC (ph) idea should be used as the identifier in the message.

UNIDENTIFIED PARTICIPANT:  So what we’re basically saying is that we need to look at the functionality that says, OK, MPI can be hauled around on claims and in prescribing transactions.   But we also probably need to haul around a secondary identifier so that you can figure out which one you, which specifically you really were talking about.


UNIDENTIFIED PARTICIPANT:  If you give me an MPI, I can reference an HC ID (ph) but if that guy has three locations or five locations, I don’t know which one you wanted so you’re going to have to tell me.

UNIDENTIFIED PARTICIPANT:  Well, it comes back then, either you need to clarify previous questions in the testimony, because we said is what is placed in the script field for the prescriber a unique identifier for the person or is it a unique identifier that combines the person with a location.  And we ask it about three times and the answer was that it was a unique identifier just for the person.  Now if that is different than, you know, if I’ve misunderstood that …


UNIDENTIFIED PARTICIPANT:  … the reason for asking was exactly, you know, related to this question.  The assumption is if that number in the script standard is a unique identifier for the individual, then the MPI works fine there because it assumes then that somewhere else in the message there’s information about where this prescription came from, either in the envelope or somewhere else.


UNIDENTIFIED PARTICIPANT:  And if that information is present, then the combination of that unique identifier and the location from which this prescription came is the key into the HC ID (ph) database that allows me then to do the routing.


UNIDENTIFIED PARTICIPANT:  So please clarify if I have a misunderstanding of what was testified to.

UNIDENTIFIED PARTICIPANT:  I don’t have total recall because I know we discussed location quite a bit.  I believe it was probably answered exactly as you stated.  It’s not in current use as far as in prescribing right now.  When we went back based on the discussions and the types of questions we had last Friday or last Thursday or whatever that was, that’s when I took it back and said, OK, what is it we’re really saying here, and that’s why the clarification.  So what will be brought forth is that what is really needed is the ability to have the location code with the HC ID (ph).  So that’s work that we have as well to clarify.

SIMON COHN (ph):  OK.  You know, and I do appreciate you comments, and I am reminded, obviously, that this is not something in current use, which makes it hard for everybody to remember exactly what it does and what it doesn’t do.

I guess, you know, I mean, you’ve heard from Jeff and you’ve heard from Stan.  You know, I tend to personally support I think I am persuaded also that the MPI makes sense, and I actually look at the recommendations 10-1 through 10-4 appear to be almost directly applicable to this one, with the exception being that currently we can’t make statements about what’s being used now because it sort of seems like there’s a wide variety of things being used now.

And as you’ve commented, HC ID is not something that is widely implemented in the industry.  I guess I am also, though, persuaded that one of the things that CMS or HHS needs to do in the pilot is to evaluate the issues around location and either come up, either test solutions that deal with the location or something along that line.  So maybe that’s one of the recommendations …

UNIDENTIFIED PARTICIPANT:  Excellent, Simon.  That’s a good way to handle it.

SIMON COHN (ph):  Yes.

UNIDENTIFIED PARTICIPANT:  But actually we need to be working on that beforehand because we need the standards to be ready to support whatever it is.

SIMON COHN (ph):  Exactly.  Exactly.  I don’t know if it may already be there.  Maybe the telephone, I mean, maybe the phone number and maybe God knows what, but I think it’s a conversation that needs to occur now.  Of course, the other piece I also think, and just suggest, I think I’ve said this before is that my own belief is that the work that NCPTP (ph) has done is very valuable for the industry in its own right.  And I think the comments that I made before were that I thought that there was tremendous value to the databases.

But once again, that’s different than the actual final number that gets affixed at the end of the day.  But that’s just a personal opinion based on, I think, your testimony and just a measure of thank you for all of you taking the leadership to develop that.  But once again, I still can’t wait for you, the MPIs probably to write one for both of these uses.  I guess I should ask, Judy (ph), what is your thought?  Harry, if you’re on the phone, what are your thoughts on this one?  Are you there anymore, Judy (ph)?

JUDY WARREN (ph):  Excuse me.  I muted myself like Jeff.


JUDY WARREN (ph):  I need to think more about this, but I agree we probably need to add a recommendation about a pilot.

UNIDENTIFIED PARTICIPANT (?):  About a testing …

SIMON COHN (ph):  Or efficient (ph) location.

JUDY WARREN (ph):  The location.


RUSS MARTIN (ph):  This is Russ Martin (ph). I’m sorry but I’m just I would extend that beyond just location but also context because you want to understand what their role is there beyond who they are as an individual, but what are their internal rules.  Can you identify kind of the habitat of that prescriber at the time of prescribing.

JUDY WARREN (ph):  That cleared the room, Russ (ph)?

SIMON COHN (ph):  Yes, I actually don’t think so but I guess I could be persuaded otherwise.

UNIDENTIFIED PARTICIPANT (?):  I would have to say more I mean, are you I mean, it’s you’re talking about …

RUSS MARTIN (ph):  Am I writing this prescription on behalf of my partners?  And our rules are that all of our prescriptions go to one, you know, box for processing and internal routing.  Or am I doing this as me, myself, as, you know that context needs to be captured beyond just where I am physically or which office I’m physically writing from.

SIMON COHN (ph) (?):  I think that would be a consideration in some whole new version of this standard.  But I mean that, I don’t think any of the business or transaction part of, that currently exists anticipates that sophistication.

UNIDENTIFIED PARTICIPANT:  Yes.  And nor does HC ID (ph) or the MPI express that.

RUSS MARTIN (ph):  Yes.  Exactly.  And I was equally persuaded by Karen’s (ph) comments about that in terms of identifying the prescriber using the MPI makes sense.  It’s that other, that thing we’ve been calling location which I think also includes some other things.  So it’s not I think it’s a little more it’s a little more comprehensive than just location but …

JEFF BROWN (ph) (?):  Russ (ph), this is Jeff.  I think that Simon’s suggestion for this additional recommendation was to be a proxy so that we give some latitude to make sure that if it was anything in HC ID (ph) that we needed to be able to preserve or map to, that the pilot test gave an opportunity for us to evaluate that and protect it.  Simon, did I say it correctly?

SIMON COHN (ph):  Yes.  That sounds fine.  I think there’s a friendly amendment.

RUSS MARTIN (ph):  That’s great.

SIMON COHN (ph):  So as long as it’s kept high-level and I will be ambiguous about what else we need to be tested.  So Judy (ph), you I apologize.  You were in the midst of saying yes, no or maybe.

JUDY WARREN (ph):  Well, I’m a little confused about context so I can’t really comment on that.


JUDY WARREN (ph):  But I do think we need to include location in the pilot.


JUDY WARREN (ph):  And the rest of it I’m fine with.

SIMON COHN (ph):  OK.  Harry, are you on the phone?  OK.  Well, I guess it’s what I’m hearing is and Jeff, you’re comfortable with where we’ve gone on this one, and Margaret, you understand where we went?

MARGARET ALMAJEALKIN (ph) (?):  I think so.

SIMON COHN (ph):  OK, which is basically taking the, or at least what I understand are the action recommendations in 10 and applying them as appropriate to 11.

MARGARET ALMAJEALKIN (ph) (?):  It’s done.

SIMON COHN (ph):  What?

MARGARET ALMAJEALKIN (ph) (?):  It’s done.

SIMON COHN (ph):  It’s done.  OK.

MARIA (ph):  Simon, it’s Maria (ph). I just have one quick it’s the Drug Enforcement Administration, not Agency.

MARGARET ALMAJEALKIN (ph) (?):  Oh, thanks.

SIMON COHN (ph):  Thank you.  OK.  Now I think we need to stop now.  We’ve been going three and a half hours.  Now we are going to be, as I said, as painful as it may sound, and I think we’ll all wear badges of honor or something like that after Friday.  I think the current intent is to go for a hopefully it won’t be that long but we’re going to reserve five hours on Friday to make sure we make it through all of this.  Now at this point, through observation, through recommendation 10 …

JEFF BROWN (ph) (?):  Eleven.


SIMON COHN (ph):  I’m sorry.  Eleven.  I’m sorry.  I don’t mean to understate things.  So we have 12, 13, 14 actually we don’t have that many.  We have another five to go through.  Obviously what we would do is to ask the subcommittee to send any comments about any of these other recommendations, as well as the first part of the document.

What we’ll do is to finish up at the next session going through the end, and then we’ll start back and take recommendations on the beginning.  Jeff, I would imagine at this point that we may be hopefully getting an editor to help with some of the work that’s gone on so far.  Is that correct?

JEFF BROWN (ph) (?):  Yes.  And Claudia (ph), you know, Margaret, you actually spoke directly with Claudia (ph).  My understanding is she’s going be available to help us this weekend, probably on Sunday?

MARGARET ALMAJEALKIN (ph) (?):  Yes.  That’s correct.  And what I will do is I will clean up what we’ve got so far here and send it back around not later than tomorrow night, maybe sooner.

SIMON COHN (ph):  OK.  And then that will be posted at the end of the day tomorrow, hopefully.

MARGARET ALMAJEALKIN (ph) (?):  May I ask, instead of sending everybody a red-line version, I think we’ve now got so much red that it’s all red instead of all black.  And I think it would be clearer if I cleaned it up and sent it as a clean version, if you don’t mind.


JEFF BROWN (ph) (?):  Yes.  I feel comfortable with that.  I just wanted to make sure that everyone was able to see what changes there were beginning at this meeting, but at this stage, I think they have.  That goal’s been accomplished.

SIMON COHN (ph):  OK.  Are there any final comments from those who have been very patiently listening to this whole thing?  We may want to provide a long open session.  I think we’re all sort of tired at this point, but do any of you have any comments?  I’d be happy to hear them at this point.

UNIDENTIFIED PARTICIPANT:  Congratulations on doing this.

SIMON COHN (ph):  Yes.  I’ll think very hard before I start making commitments to deliverables like this again.

UNIDENTIFIED PARTICIPANT:  Simon, what’s our intent to get this to the full committee?  What’s …

JEFF BROWN (ph) (?):  We were hoping that we could send it out on Monday.

UNIDENTIFIED PARTICIPANT:  OK.  So you said there was an editor going to be working on it on Sunday and so the presumption is that that version would go out to the full committee essentially without review?

JEFF BROWN (ph) (?):  I’m afraid that that’s the status that we’re in.  If …

SIMON COHN (ph):  You’ll get a chance to wordsmith and a chance to there.  Jeff, I guess I would ask the one question is if we could get the editor to start working now, if there’s anything that that person could do.

MARGARET ALMAJEALKIN (ph) (?):  Simon, I’ve been talking with Claudia (ph) and she is not available during the week.

SIMON COHN (ph):  Oh, OK.

MARGARET ALMAJEALKIN (ph) (?):  However, what I you know, I know her very well.  We’ve worked together in the past in many different capacities, and the intent is for me to send her stuff Saturday morning for her to get back to me Saturday night.  I look at, see if I’ve got any questions, get back and forth on Sunday …

SIMON COHN (ph):  Yes.

MARGARET ALMAJEALKIN (ph) (?):  So that by Sunday night we’re done.  And I would also comment, though, that Claudia’s (ph) editing is primarily proofreading with only minor changes and maybe putting a phrase here that belongs in.

SIMON COHN (ph):  Yes, kind editions (ph), right verbs, things like that.

MARGARET ALMAJEALKIN (ph) (?):  Right.  She’s not going to completely revise, you know, statements.

UNIDENTIFIED PARTICIPANT:  Yes.  I just wanted to understand the time frame.


UNIDENTIFIED PARTICIPANT:  I’m comfortable with it.

KAREN TRUDELL (ph):  Yes, this is Karen (ph).  I’m very worried about it, too, because even minor tweaking, as we all know, can significantly change the tone or even the substance of a recommendation.  So I really think that if we’re going to have an editor, the subcommittee needs to still look at it before it goes to full.

JEFF BROWN (ph) (?):  Karen (ph), can I indicate this?  I think that the way it could work is that and I think the way Margaret has worked with Claudia (ph) in the past is Claudia (ph) typically does her edits, which may be typos or grammar or something like that, and sends it back to Margaret to accept or not accept.  So all I can say is that while this is less than ideal, I trust and feel comfortable that Claudia’s (ph) edits, which are then accepted or rejected by Margaret, I would trust them to not change meaning or content.

UNIDENTIFIED PARTICIPANT (?):  Yes, and Karen (ph), as Simon pointed out, we get a shot at it next week.

SIMON COHN (ph):  Yes, I think what we need to say is that everybody will keep their old copies, whatever we come up with on Friday, and then we will review this to make sure it’s improvements and not changes.

UNIDENTIFIED PARTICIPANT (?):  Yes, because we present it on Wednesday and then vote on Thursday and we can make changes on Wednesday.  So if we find some editing errors, they can be corrected.

UNIDENTIFIED PARTICIPANT:  Or we can see a tracked changes version Monday.

UNIDENTIFIED PARTICIPANT (?):  Yes.  And to tell you the honest truth, this is a 13, 14-page letter, and I’m uncomfortable sending it out any later than Monday morning to the full committee.

KAREN TRUDELL (ph):  Well, I agree with that, too.


SIMON COHN (ph):  OK.  Well, I guess the outcomes of this, let me just summarize them as well as give people an option.  Then I would like to wrap up and close.  Basically we will be meeting for five hours on Friday, maybe less but certainly we will reserve five hours for discussion.  We’ll obviously start with just a quick review of where we are, especially the last couple of items for people that had to get off after the posted three-hour time.  We will hopefully go through the remainders of things on Friday.

We will, at that point, judge where we are and also reflect on, based on our sort of confidence of it, we may, at that point, elect to have a Monday morning call.  If we look at a revised, you know in case we need to in any way further modify or otherwise a revised version of the letter for Monday since we could conceivably do something early Monday morning if we need.  Now I’m not suggesting we do that.  I think we can decide that on Friday, I think, unless others feel differently.  That got everybody excited, didn’t it?

UNIDENTIFIED PARTICIPANT:  That seems appropriate.

SIMON COHN (ph):  I mean, should we schedule a Monday morning early call for an hour to give anybody the right to comment about the editing before we send it out to everybody?

JEFF BROWN (ph) (?):  Let’s see, time frame.

SIMON COHN (ph):  I wouldn’t want it to be any more than an hour.

JEFF BROWN (ph) (?):  Simon, you know, you think the only problem is that since there’s the three hour time difference, it would mean that if it’s, you know, if it started for you at eight or even seven in the morning, that’s 10 or 11 o’clock.  That means that Margaret can’t get it out to the full committee until probably noon.

But I would I would reserve how do I want to say this.  If on Friday we feel as if there’s so much stuff to be done or if there’s assent in the committee as a whole that they feel that they need to review it on Monday morning, then we can decide to do that.  And if you want to go ahead and reserve telephone time at this time, we could do that as a backup.

SIMON COHN (ph):  How does everyone else feel about that?

UNIDENTIFIED PARTICIPANT:  Let’s do it.  We can always cancel out.

SIMON COHN (ph):  OK.  I would suggest just in the interest of timeliness, again, I’m not terribly happy about it, but we could do a seven a.m. California, 10 a.m. Eastern time.  Does that that means, eight o’clock, Jeff, for you and Stan.

JEFF BROWN (ph) (?):  Yes.  That’s fine with me.

KAREN TRUDELL (ph) (?):  Yes.

JEFF BROWN (ph) (?):  I mean, I could if you wanted to get up at six, I could get up at 7.

SIMON COHN (ph):  I am getting up at six.  OK.  So seven a.m.  Marietta (ph), are you on the phone?

DEBBIE (ph):  Hi.  It’s Debbie (ph) for Marietta (ph).

SIMON COHN (ph):  OK.  Can you give us an hour call at, on the 30th in the morning.

DEBBIE (ph):  Fine.  10 to 11 eastern time.

SIMON COHN (ph):  Yes.  Actually, make it 10 to 11:30 in case we go a couple minutes over, just so we have the time.

JEFF BROWN (ph) (?):  And that may be reserved, either more likely, for, you know, some major issue rather than wordsmithing.  Whatever it is.

SIMON COHN (ph):  No, I actually don’t think it’s going to need to be reserved for if we don’t get the major issues handled on Friday, we’re not going to get them handled on Monday.

JEFF BROWN (ph) (?):  Yes.  OK.  Whatever.  It’s there.

SIMON COHN (ph):  OK.  So everyone comfortable with that?

KAREN TRUDELL (ph) (?):  Yes.


SIMON COHN (ph):  OK.  OK.  So you can publish that and put it on the site and all that stuff.



DEBBIE (ph):  Hi, this is Debbie (ph).  Just clarification.  I thought that you were going to verify if you were going to need this call on Friday.

SIMON COHN (ph):  Yes.  We do a five-hour call on Friday from 12 noon to five p.m.

DEBBIE (ph):  So in terms of putting it on the Web, you’re saying to preemptively (ph) put that on even though …

SIMON COHN (ph):  Yes.

JEFF BROWN (ph) (?):  Yes.  Put it on because we’re going to end at five o’clock on Friday.  That may be too late for you to do something.

DEBBIE (ph):  OK.

SIMON COHN (ph):  It will be too late for you to do something.  OK?

DEBBIE (ph):  OK.

SIMON COHN (ph):  Great.  OK.  Well, thanks very much.  Thank you all for your hard work and talk to you on Friday.



SIMON COHN (ph):  Thanks again.  Bye-bye.