[This Transcript is Unedited]
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
SUBCOMMITTEE ON STANDARDS
February 26, 2009
Hubert Humphrey Building
200 Independence Avenue SW
Washington, DC
Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 352-0091
Table of Contents
P R O C E E D I N G S (8:00 a.m.)
Agenda Item: Call to Order, Welcome
DR. WARREN: While we’re trying to get the magic of projectors and computers
to work, I would like to start the session. This is a breakout session of the
National Committee and Vital and Health Statistics, The Subcommittee on
Standards.
We are going to be having some testimony this morning as part of our
breakout session. This particular testimony addresses some of our
responsibility for HIPAA transactions and update of versions.
With that I would like everyone here to introduce themselves. State whether
or not you are a member of the committee and whether or not you have any
conflicts.
I will start. I’m Judith Warren, University of Kansas School of Nursing. I
am co-chair of NCVHS Standards Subcommittee, and I have no conflicts.
MR. BLAIR: Jeff Blair, director of health informatics at Lovelace Clinic
Foundation Albuquerque, New Mexico. I am the other co-chair of this
Subcommittee. If something comes up with respect to the nationwide health
information network, Lovelace Clinic Foundation has a contract as one of the
nine HIE – one of the nine states that are part of the NHIE trial
implementation.
DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for Information
Technology. The director of the Agency for Healthcare Research and Quality. I
am not a member of the committee and in fact I am not sure I would want to be a
member of a committee that would have me.
DR. FERRER: Jorge Ferrer.
MR. MCKINNEY: My name is Frank McKinney. I work at a company called MDI
Achieves. They make software for the long term care industry for facilities to
use long term care, nursing facilities and assisted living.
MR. WHITTEMORE Good morning, I am Ken Whittemore with SureScripts RxHub.
DR. OVERHAGE: Good morning, Marc Overhage with Regenstrief Institute and The
Indiana Health Information Exchange. I am a member of the committee and the
subcommittee. We too, are NHIN contractors through Indiana University but
otherwise have no potential conflicts.
DR. CARR: Justine Carr, Caritas Christi Healthcare. Member of the committee,
member of the subcommittee, and also I have to leave at 9:00 o’clock to go to
the Quality Subcommittee of which I am also a member of. I have no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield North Carolina, North
Carolina. Member of the subcommittee and no conflicts.
(Audience introductions)
DR. WARREN: Do we know anymore about the laptop?
While we’re getting set up with the slides, let me just give a brief
introduction. We have responsibility for working on standards for
e-prescribing. As part of that responsibility NCPDP has been creating standards
and updating those in order to meet some of the challenges that are happening.
So today we have a request from NCPDP to look at a new version that was
developed to handle some of the problems of e-prescribing in long-term care.
We have a panel of speakers, one to talk NCPDP’s perspective and what they
want to present to the committee and how they would like to work with us in
updating the standard. Then we will hear from Frank McMurray, actually he is
also speaking for NCPDP, and then he is going to switch hats and he is going to
talk about the use of the standard in long-term care.
Then we have Ken Whittemore, who is going to talk about how this update will
impact the use of the standard in ambulatory care. Those are the two prime
constituencies right now that are using the standard in e-prescribing.
While we have just a minute, Jeff, do you want to add any comments or
anything to this?
MR. BLAIR: Maybe the only thing I would add is that when congress, under the
MMA, identified NCVHS with the responsibility for selecting and recommending
the e-prescribing standards, the industry worked in a commendable fashion to
move quickly to provide those standards and do it in a manner where it had
broad industry support. This is kind of almost like an update to our work of
– is it three years ago now?
DR. WARREN: I think so.
MR. BLAIR: Yes, three to four years ago. So this is sort of the next
chapter.
DR. WARREN: Then, Harry, do you want to make any comments since you are a
former co-chair and you were co-chair when this work started?
MR. REYNOLDS: I’ll just echo the same thing, we as a committee have talked
for a longtime about expediting the standards process. I think NCPDP, through
their work especially as it relates to e-prescribing, and the whole industry
around that, has pretty much made that a much easier task for us because they
have gotten together, gotten everybody’s approval, and in doing so we get
industry recommendations, we get recommendations that have been fully vetted
and it allows us to select the next version which we can move forward different
than some of the other things where it’s not quite so coordinated. I commend
them for that and look forward to the continued growth of e-prescribing for
lots of reasons.
MR. BLAIR: Judy, if you ask me to do a tap dance.
DR. WARREN: No. But I think what I am going to do since we do have some time
constraints is while Ken tries to make the magic happen – we do have
copies of the slides for NCPDP. Can we go ahead and get you to start talking
off of the handouts.
Agenda Item: NCPDP Version 10.6 Request
MR. MCKINNEY: I think your preface gives the background for this discussion.
What we are basically doing today is coming with an update to progress and the
standard and an update to an earlier recommendation that NCPDP had made in
2007, recommending version 10.5 of SCRIPT for use in the Part D program. Again,
I think we have given enough background, but NCPDP we appreciate the
opportunity to provide input to the standards setting process and we do have
the opportunity to speak to the different stakeholders in the setting that use
the standards today and would be the ones responsible for implementing new
standards when they are named. So the recommendations that we are giving today
are based on discussion at NCPDP workgroups with the long-term care, retail,
mail order, constituencies all having a chance to discuss the standards, the
opportunities with new standards, and the challenges or the costs of
implementing those. That has been considered in the recommendations that we are
giving today.
We stated earlier, in December of 2007 NCPDP offered a recommendation to the
subcommittee suggesting that SCRIPT 10.5 be adopted as part of the Part D
program. However during the course of the year even though the subcommittee did
recommend that 10.5 be adopted, there has not been any steps taken toward that
end. During this time the standards body has continued to enhance SCRIPT.
Notably in the last year in some areas that support long-term care needs in
terms of providing information to partner long-term care pharmacy about
residents and their conditions and problems and allergies.
Because those additional features this year are very valuable in terms of
allowing the long term care pharmacy to have a full understanding of the
patient that they can use during the dispensing process during drug utilization
checks, we thought it was important to take the opportunity if possible to
update our recommendation so that at a point where a new standard is named for
the Part D program, that it could be this one as opposed to the one recommended
earlier.
What we will be talking about today really focuses on the differences
between the last recommended version which was also recommended to the
Secretary by your committee, and the version that was developed last year
through SCRIPT, the SCRIPT version 10.6.
Specifically, there were a few updates in the standard that we will talk
about today. Ken, later in his presentation, will discuss the standard in terms
of specific value to the retail and mail order settings. I will talk a little
bit more about how they benefit long-term care. But to outline the
improvements, one improvement was made that would support both settings and
that would be to notify a pharmacy of safety alerts that are considered during
the prescribing process.
So today in systems such as those, that are used in clinics and hospitals,
when a physician is creating a medication order, decision support features
provide information about potential conflicts with that medication with other
medications that the patient might be on; allergy conflicts, dosage conflicts.
The physician will take note of those. In some cases it might make sense to
prescribe that medication to the patient even in light of those so it is very
common in systems that a physicians rational for that acceptance of those risks
is noted in the system and that provides a way to track usage patterns but it
also captures the decision process.
However, today that information does not make it any farther than that. It
is there for use in terms of monitoring practice over time but it doesn’t
provide the pharmacy with any insights as to why that medication was prescribed
even though when it gets to the pharmacy their system will most likely flag the
same conflicts.
With this version we created a way for the physician’s acknowledgement of
potential drug conflicts and the rationale for overriding those to be
communicated to the pharmacy so that that information can be used during the
dispensing process.
That functionality is one that would benefit retail and mail order or long
term care settings. There are a few long-term care features that were added on
this version, specifically around sharing allergy and diagnosis profiles
between the facility and the pharmacy.
So in long-term care there is a very close relationship between the nursing
facility and the partner long-term care pharmacy. There are responsibilities at
the pharmacy for helping manage medications for the residents, as well as often
providing consultant pharmacist practice.
And in order to support that today there is a certain amount of information
that is provided between those parties on paper. So information about patient’s
allergies and diagnosis currently don’t get transferred electronically. They
will be transferred via telephone calls or paper, there is not sort of a
systematized way to share that information that is really required day to day
in the care in the pharmacy practice to support those patients.
What we added to Version 10.6 of SCRIPT were two new segments enabling a
person’s full allergy profile and diagnosis profile to be communicated to the
pharmacy at the time that they are admitted and at the time that either of
those change. When the pharmacist is dispensing medications for the person,
those can be brought into the drug utilization review process and provides the
opportunity to catch additional potential conflicts and to support any sort of
medication therapy practice at the consultant pharmacist who is doing it on
behalf of the facility and the patient.
The next two slides just put those features into the context of long-term
care communication process between the facility and the pharmacy. This is
fairly small so at your leisure you can read it on the slides.
The crux is that at admission time there is the opportunity to share
information with the pharmacy that will help in their care for the patient.
That is where the allergy and diagnosis checks come into play. At the bottom of
the page, it would be the process by which medication orders are created for
the resident. It is during that process that the prescribing alert potential
conflict information can be shared with the pharmacy to support dispensing.
Likewise at points at which there are transfers of care or changes in the
level of care, any additional diagnosis or allergy information that is
discovered for the patient can be shared at that time as well.
To sum up, what NCPDP would recommend to the subcommittee is that SCRIPT
version 10.6 be recommended for use under the Medicare Modernization Act for
all settings that the Act covers, including long-term care as of January
1st, 2010. And that 2010 date is simply the date that we had
previously recommended for use for the adoption of Version 10.5.
Really the industry is ready to move toward adopting 10.6 at the earliest
opportunity. However, we do believe that it is important that there is a
transition period, and place which allows for beginning of that transition to
occur as soon as possible but allowing at least a 18 month period during which
all participants currently using the current standards have an opportunity to
move up to that before Version 8.1, which is soon to be the standard, will be
allowed to be ???.
The third bullet, in the long-term care setting we further recommend that
the current exemption for long term care be lifted and that during this
transition period to 10.6, the versions that are currently in use, which are
SCRIPT 10.2 and 10.3, be allowed to continue as well until the 18 months has
transpired and everyone at that point would be using SCRIPT 10.6.
Lastly, in terms of the impact of this recommendation it is the feeling of
NCPDP and its stakeholders through discussions at NCPDP workgroups, that the
change of the recommendation from 10.5 t 10.6 does not impede the industry’s
transition to an improved standard. The work involved is materially more in the
long-term care environment than in retail so it doesn’t put an additional
burden really on the retail environment. Ken can talk more to that.
Naming SCRIPT 10.6 for use under MMA will establish a single standard as a
basis for all of these settings, which we think will provide greater simplicity
and clarity in terms of the requirements as well.
That is the end of this presentation.
DR. WARREN: Before we move to the next presentation, we are going to hold
our questions to the end but I just wanted one clarification, on your slide
that has recommendation, the first one, you wanted to recommend that the
current MMA exemption be eliminated. Can you clarify why you wanted to
eliminate it?
MR. MCKINNEY: Sure. We will talk more about that in my second presentation.
DR. WARREN: I can wait if it goes better there.
MR. MCKINNEY: We certainly can.
DR. WARREN: With that, we’ll go to the next presentation.
MR. REYNOLDS: Judy, can I ask you or Jeff a question? So the first
presentation was made on behalf of NCPDP. Now we’re going to hear from Ken,
which is always a good thing. Is this part of the industry support for this?
DR. WARREN: Yes.
MR. REYNOLDS: So usually we have areas of support from the industry on these
things.
DR. WARREN: Right.
MR. REYNOLDS: Okay. Does either set of testimony or other things that we
received represent the long-term care industry?
DR. WARREN: Yes, Frank is going to give this one. We are getting double
duty.
MR. REYNOLDS: That is good. These guys are multi-talented. I have no problem
with that. Put your different hats on and here we go. In the past when we’ve
done this – I’m just trying to understand the process – in the past
when we have done this we have usually had a significant amount of the industry
here. You can kind of look around and everybody is kind of nodding their head
or you can say what is going on. I want to make sure that as we go forward to
make a recommendation I want to make sure that we have enough to back it. So
now I understand. I wanted to make sure I listened in the way that I knew we
were getting what we wanted.
DR. WARREN: Right. When Lynn Gilbertson and I planned this panel, some of
the constraints that we have is the ability to bring everybody in to talk about
this. So we thought we would start here, see where we got today, and then if we
felt there was more need to hear it would behoove Jeff and I to figure out how
to bring more people in to provide testimony.
MR. REYNOLDS: Or what we could consider is some kind of letter of support.
When they are here we can call them up and we can talk to them. As we did this
along the way you had a lot of faces behind those. Letters of support at least
shows that for us moving this along like we are that we do have the appropriate
support. So that may be further documented. We can make a decision today, but
if we can get anything like that from a more broad spectrum, other than just —
DR. WARREN: The only decision we would make today, this is step one, what do
we need to do next? There is no intent to jump to that immediately.
MR. REYNOLDS: Fine, okay please proceed. I just wanted to make sure I
understood the process so that when I am listening that I am not expecting
something —
DR. WARREN: We’re trying a new model –
MR. REYNOLDS: I’m fine with that but we were not aware of that.
DR. WARREN: I don’t know why you could not crawl in my head and understand.
MR. WHITTEMORE: Good morning. Ken Whittemore with SureScripts RxHub. Just to
follow up, I am sure that Lynn could probably send something out to the
membership of NCPDP asking for letters of support if that would assist the
subcommittee in its deliberations.
What I am going to briefly talk about is the ambulatory side with respect to
10.5 and 10.6. Before I do that I just thought I would give a little bit of an
update to the committee. It has been a while since we appeared before you.
Since then, I am sure that you are aware, that we at SureScripts joined RxHub
and are now SureScripts RxHub. That happened on July 1 of last year and since
then we have been working very to consolidate the operations between those two
organizations.
To give a little bit up an update in terms of where things are in regards to
ambulatory prescribing as far as we are concerned. This slide shows some of the
matrix that we can share from last year. In terms of eligibility requests,
there were 100 million of those processed versus 50 million in 2007. There were
approximately 19 million requests for medication or prescription versus 8
million in 2007. Approximately 83 million prescriptions were routed in the
ambulatory environment versus 36 million in 2007. There are approximately
75,000 prescribers routing prescriptions as of December.
As the second bullet says, we are going to be issuing our national progress
on e-prescribing probably by this time next month and we will make sure that
the members of the subcommittee get copies of that.
This 75,000 statistic was current as of December. We have noticed a very
significant uptake in December, January and February, in terms of additional
physicians coming onto the network. That number is significantly higher. But
again, that is just to frame things in terms of our part of the industry.
We have been using NCPDP SCRIPT version 8.1. We began late in 2005. As you
folks know we were involved with the 2006 MMA pilots, and due to that we needed
to accelerate some of the participants and get them onto 8.1 so they could
participate in the pilot.
We completed our transition as a network and all of our network participants
completed the transition late in 2007. We now feel that there are sufficient
values offered by moving to 10.6 that we would like to do so. And we note that
SCRIPT 10.6 was approved by ANSI this past November 12th.
We would like to as an organization, begin the transition to 10.6 around the
middle of this year if possible. But we have found that many of the folks that
connect to our network are reluctant to do so until the Secretary has said
something with regard whether the standard can be used for Medicare
e-prescribing either on a voluntary or mandatory basis. This is one of the
reasons we are appearing here today and we would make the case for 10.6.
Frank already talked about some of the issues. I am just going to share a
few others. One of the most important parts of 10.6 and this is also in 10.5,
is the Structured Sig Segment. Although that is undergoing testing right now I
believe you heard from Doug Bell earlier this week, and he probably shared some
of the work he is doing pursuant to a CMS pilot to test both structured and
codified Sig and Rx norm, we would like to ahead and offer the functionality to
those participants who might want to undertake it on a voluntary basis.
I can tell you that the input that we have gotten from pharmacists, the rank
and file, and I just did a site visit in an independent pharmacy just a week
ago. This is one of the areas that the pharmacist really feel is stymieing the
process if you will, in terms of e-prescribing because they have a great deal
of difficulty interpreting sigs when they come through as they are coming
through today. So a structured sig segment would definitely benefit and there
are a lot of other benefits to the other participants.
There is now an XML version of the SCRIPTS implementation guide that NCPDP
produced. That is something that rides along with 10.6. Ten point six supports
the federal medication terminologies. And as Frank mentioned earlier, there is
an enhancement with respect to drug utilization review processing and I would
just like to flesh that out a little bit more. It is clearly a value to
pharmacists if they can receive information that tells them that the physician
has already seen this particular alert and has considered it and decided that
it was not a consequence for this particular patient because they are going to
get as Frank said, alerted from their system and in all likelihood when they
submit the claim the PBM is also going to send the same alert back to them. If
they can get the information from the physician, that gives them an additional
level of assurance that the decision that they are making with regard to that
particular alert is satisfactory.
Another item is prior authorization status which is also added. If a
physician starts down the road of handling the prior-authorization process,
this will allow them to convey that fact to the pharmacist so that the
pharmacist will know that the prior-authorization process is already begun and
that in turn, has an impact on their workflow.
As Frank has already mentioned, he is going to talk a little bit more in
detail about the long-term care changes. In addition to those there are a
couple of rather small tweaks that facilitate medication history delivery to
prescribers; 10.6 will now prescribe an order number, a source and fill number
to be added to the medication history. That allows the automation and
streamlining of the presentation of that particular information and in
particular, the de-duplication of records making it a little easier for
prescribers to make sense of those medication histories.
In addition, the actual date of where the prescription is sold or picked
will now be included with the addition of 10.6.
Those are small tweaks to the medication history process that we feel will
make a difference in terms of workflow at the physician end.
From our standpoint our recommendation is that in order to facilitate
delivering these additional values to the industry on the ambulatory side we
would urge the committee to recommend to the Secretary that NCPDP SCRIPT
version 10.6 be adopted as a Medicare Part D Standard as soon as practicable on
a voluntary basis. As I said, we would like to get moving with that this summer
but we do feel, and we have already experienced this, that there are a lot of
folks that are not interested in doing that coding and putting it into place
until again, there is some sign from the Secretary that adoption is going to
occur in the nearer term.
We further recommend that no less than 18 months elapse between the period
when organizations can start using SCRIPT 10.6 on a voluntary basis until it is
actually required for everybody to use.
In addition while I have the floor and we do feel this is closely related to
NCPDP SCRIPT, we wanted to make an additional recommendation that you folks and
the folks at CMS, look at the guidance that has been given in terms of who must
adopt the various standards. The last final rule stated that Medicare Part D
plans must adopt all of the standards. As you folks know, prescribers and
pharmacies, it is voluntary but that particular statement was made a number of
times. We have run into a practicality – a practical difficulty, I should
say, in that there are certain standards that different participants just don’t
use in the course of their business or practices. This particular global
statement, if you will, that Part D plans must support, all of the standards,
does not mesh well with the way a lot of those standards are used.
That table that I provided in addition to the slides, is basically our
evaluation of the various standards that were adopted in both the first and
second final rules and our suggestions with respect to who should be expected
to be adopting this.
The best example, and the one that has become most troublesome, has been the
issue of RXFILL or fill-status because the Part D plans are not participants in
a fill status. That message is set up to go from a pharmacy to a prescriber but
yet the final rule says that they must support that. So they have been
scrambling to try and figure out a way to do that. Most of them have not been
able to figure out a way, but we do know that there are some participants in
marketplace who are Part D plans who own pharmacies and the guidance from their
legal counsel to them has been that your pharmacies must start sending these
messages even though there is nothing that we can do with them or nothing right
now that the prescribers can do with these messages.
We would like to recommend that both the committee and CMS revisit this
particular requirement and make the requirement more specific to business and
the practice needs of the participants.
DR. OVERHAGE: Could you clarify that where you say that providers can’t do
anything with those messages? I am not following that.
MR. WHITTEMORE: Well, the infrastructure – there are not agreements,
there are no workflow agreements, business agreements, in place right now that
would provide for taking those messages and delivering them to the prescriber
applications and the prescriber applications then putting them into a form that
could be assimilated by the physician. In other words, it is kind of ahead of
the game that they would start sending these messages before everybody was on
line and ready to take them.
DR. OVERHAGE: This might be an area where we would like to get some
testimony from providers.
MR. WHITTEMORE: Don’t take me wrong, I am not questioning the value of
RXFILL in any way. But the fact that the final rule says that Part D plans must
implement all of the standards, as you can see from the table, it doesn’t make
sense in all cases.
DR. CARR: I have a question about the overrides in terms of – there are
two parts to the question – one is, what is the pharmacist accountability
for issuing a medication for which there is an alert? Then second, are you
using like first databank level one alerts or what are level of alerts? I am
trying to get at the point of when there is an alert how often is the physician
just overriding because it is a commonly expected thing or it is a real thing?
And the absence of the pharmacist knowing the reason for the alert, does that
trigger need for the pharmacist to speak with the physician or can they safely
within their license and accountability just go ahead and fill it without
knowing the reason for the alert?
MR. WHITTEMORE: I think both prescribers and pharmacists are going to be
held accountable for their decision to override these alerts. As you said, and
this is documented in the literature, but a great number of those alerts are
superfluous and probably don’t apply.
I know speaking from the pharmacy side, that when a pharmacist does override
such an alert, there system asks for the reason. So they must document in their
practice management why they overrode that particular alert.
What this particular aspect of 10.6 would provide is a way when an
e-prescriber receives an alert and they judge it not to be clinically important
in that particular case, they can make that notation and pass it on to the
pharmacist and then that make the process at the pharmacy that much easier
because they know that the physician has been apprised of that and they have
made the decision in that case it is not an issues.
The other scenario, if they don’t receive such an alert it is then up to the
pharmacist’s professional judgment as to whether that particular alert rises to
the level of where they should pick up the phone and call the prescriber and
talk to them about it.
DR. CARR: So do you have any sense of what would be the efficiency
improvement? In other words, of the number of alerts that pharmacist see and
don’t speak with the physician versus those that trigger a call to the
physician? What would be the estimated –
MR. WHITTEMORE: I could really only speculate. I know there was recently an
article that came out in terms of the number of alerts that the physicians
override – I think it was just a couple of weeks ago. Anyhow, I do know
that in the pharmacy side there is literature that says that pharmacist
override somewhere on the order of 88 percent of these and they would have to
document them when they override them. I don’t know that that rate would change
by the fact that the physicians are sending to them a note saying that they
have decided to override them.
I would assume that the 88 percent of the pharmacists have chosen to
override probably is an overlapping set, if you will, of the ones that the
physicians have chosen to override. It would be interesting to see once this
comes into play what impact that does have on the pharmacist workflow.
DR. WARREN: Just to add, Justine, I think this is one of the things that
Doug Bell is monitoring for in his research that he is doing as a follow up on
the e-prescribing pilots. But I don’t know if it will get us at a quantity but
at least he can describe situations from that.
DR. CARR: I actually think it is an important safety thing because I know
there is a gray zone where it is not so obvious and pharmacists are being put
in a position of doing the extra work or using their judgment. It is not always
so clear so I think there is a value.
DR. WARREN: Just to clarify what 10.6 is it provides a field for this?
MR. WHITTEMORE: Correct.
DR. CARR: A forcing field or just an optional field?
MR. WHITTEMORE: I can’t speak – I don’t have it in front of me so I
don’t know whether it is optional.
MR. MCKINNEY: It is optional.
DR. WARREN: So this would be a field for the physician to put down why they
have overridden the alert so that the pharmacist can see that when they get the
prescription.
DR. FITZMAURICE: Does it give a reason or it just says, I’m aware that there
is an alert? Does the physician put in that I am overriding the alert because
or is it just check, I have seen the alert?
MR. MCKINNEY: It enables both the codified reason as well as a textual
reason to be sent. It will vary by practice management system or prescribing
system, likely depending on how they implement. But it does provide for both.
Like Ken said, I think it will be interesting to see how it is used. I think
there is consensus that it is valuable information. I know that there are
differences in how prescribing systems capture this but most of them do so I
think we will see some information from across and there will be an opportunity
– probably to be said overtime.
DR. FITZMAURICE: So what you are asking is that there are some Part D plans
who don’t want to bother with the expense of using this standard because they
don’t feel that they don’t feel that they need to use it and the fax is working
just fine or the written prescription is working just fine and they should be
exempted because they don’t want to bare the expense?
MR. WHITTEMORE: No, it’s not that, it is not a workflow that they are
typically involved with. In other words, the RXFILL in particular, that is
probably the best example, is designed to go from a pharmacy to the prescriber.
There is no accommodation made in that particular part of the standard that the
Part D plans would even be involved in that communication, but yet the final
rule says Part D plans must support all of the standards. It doesn’t say you
must support all of the standards that you are normally involved with. It says
all. That is why the confusion has occurred.
MR. REYNOLDS: If you relate this to some of the other HIPAA implementations,
if you took eligibility, you could say is the person eligible, yes or no? So
there was a minimum necessary use of – the whole standard was there –
the whole dataset was there, but you had to have at least a minimum usage of
it.
I am not relating this exactly but what you are saying is or what I think I
am hearing is, that all e-prescribing transactions should use the standard but
within the standard, based on the business that you officially do is how you
actually decide which pieces you do or don’t use of the whole?
MR. WHITTEMORE: Exactly.
MR. REYNOLDS: So that’s the thing we’re going to have to figure out because
there will be certain pieces of that – if you don’t do that business then
you would not fill it. That is what I think I hear you saying – I am not
an expert at it.
MR. WHITTEMORE: No, that’s exactly –
MR. REYNOLDS: But because for example, some of the things that I am doing
with CAQH, there was a requirement to do the minimum necessary in the HIPAA
eligibility, but now as an industry we are building out that you actually have
to have a much more robust use of that to be certified at the next level.
I am trying to understand some words we could use because using all the
standards is one thing. Using all the fields and functionality in all the
standards is where I think you are trying to ask us to draw a line. I want to
understand how we would communicate that because you are using all the
standards – you just might not be using a certain field in a certain
standard because you don’t do that business and/or —
DR. WARREN: But I think the critical element is you have legal advice say
you must use all of the fields in the standard whether or not it matches your
workflow –whether or not it is even part of your business.
MR. WHITTEMORE: I think probably functionalities, rather than fields so that
we don’t confuse – That was the guidance in the final rule to the Part D
plans.
DR. WARREN: Marc, you had a question?
DR. OVERHAGE: I am still struggling a little bit because the assumption here
or the assertion is that Part D providers are not involved – there is no
value – it is not part of the workflow to notify somebody about a
dispensing event. And yet, that might be the only way that that dispensing
event might be available to the provider because clearly the pharmacy that is
dispensing it is going to notify the Part D plan. Right? Somehow, someway.
MR. WHITTEMORE: But that’s not how RXFILL works. An RXFILL transaction goes
from the pharmacy to the prescriber.
DR. OVERHAGE: Why?
MR. WHITTEMORE: That is the way it is developed.
DR. OVERHAGE: Why so narrow?
MR. WHITTEMORE: Well, if you want to expand the participants involved with
that I am sure we can take that back to NCPDP, but as things stand now it is
designed to go from the prescriber.
The other thing and I am actually kind of remiss and we are probably
focusing more on RXFILL than we needed to, but when RXFILL was created in the
early days of creating the standards, there was no such thing as medication
history. It is our feeling and that of a lot of folks in the industry, that
that information is much richer information that can be provided to the
prescriber so it obviates the need for an RXFILL in most cases.
So in view of the fact that medication history is now generally available,
and as I mentioned there were 19 million that were requested last year, you can
get the same information to the prescriber and again, richer information,
because you are not getting a ping every time that prescription is dispensed
– you are getting a full set of the medications that that physician would
want to see when they are prescribing, again obviating the need for RXFILL.
DR. OVERHAGE: As I said, I think we need more testimony on this. They don’t
play into each other.
DR. WARREN: Let me just summarize where I think we are because I think this
is going to help us plan what our next steps are. What we are hearing today –
DR. FERRER: Judy, I have a comment before you start summarizing things.
DR. WARREN: Just let me finish. What we are hearing today is the advantage
of 10.6 over 10.5. This Committee has already supported version 10.5 and
written a letter to the Secretary.
MR. BLAIR: Including fill status notification. MR. M
DR. WARREN: Right. Now what we’re being asked to do is 10.5 did not really
support long-term care. There were some very big deficits and we are going to
hear more from Frank on where those deficits are, that we are now passing
medication history. We need to be clear in what we are being asked to do as
well as are there other concerns such as Marc is bringing up?
I just want to be clear of what today’s testimony is focused on and not get
lost in some of the other areas.
DR. FERRER: Just a clarification. What percentage is still on 8.1, roughly
speaking?
MR. MCKINNEY: Ken is probably in a better position to answer that.
MR. WHITTEMORE: All of the participants that are certified on our network
are on 8.1 right now.
MR. MCKINNEY: Except for those that are using SCRIPTS for long-term care.
MR. WHITTEMORE: But that is not on our network. I am just speaking to our
network because it is not live – the long-term care implementation.
DR. WARREN: So Jorge, this is what Frank is going to testify on. Let us let
him do his presentation and then come back to your question because we don’t
have everything yet.
All right, Frank, now you have the long-term hat on.
MR. MCKINNEY: Thank you. This presentation just builds on the workflows and
information of long term care much better than it did back when it was piloted
in 2006. My company, MDI Achieve, is a provider of software and services to
eldercare primarily at skilled nursing facilities, but also assisted living. We
have got 7500 clients. We are actives in the industry and we also participated
in the 2006 MMA e-prescribing pilots where we piloted the use of 8.1 SCRIPTS
standard in our setting and found deficiencies as it relates to long-term care
processes and information required by the nursing home and the pharmacy in
medication management.
Since the pilot as we will go through further down in the presentation, over
the course of these years quarter by quarter, enhancements have been made to
SCRIPT to address those things that were found in the pilot. Even as early as
in 2007, some of the key deficiencies had already been addressed. So the
ability to communicate open ended orders would be a good example. In retail
ambulatory situation orders have to be for a specific quantity with a certain
number of refills. However in a skilled nursing setting, they are most commonly
chart orders which are stated in terms of daily administration and often with
an open end date and then supplied by the pharmacy until a discontinuation
occurs and then the meds stop being administered and the pharmacy stops
delivering.
At a point in that enhancement process, SureScripts RxHub agreed to support
an interim version, which is version 10.2, that our company and a couple of our
partners implemented. So we have got experience with that version, which does
contain some of the enhancements that version 10.6 has in it to support the
setting.
My background, I lead a long term care e-prescribing task group at NCPDP. It
is a group of today, over 130 people or so that represent around 90 different
organizations all interested in enhancing the standards for e-prescribing
long-term care. We are very active in terms of coming up with the specific
proposals that would improve functionality or add features to SCRIPT. The
process by which these get into SCRIPT is that our task group brings in folks
from the industry and folks from the retail and mail order as well, to develop
enhancements. We propose those to NCPDP, who votes on them, and the process
addresses any shortcoming and those become part of the standards.
As I said earlier, including the 2006 MMA Pilot, SCRIPT has been used in
long-term care continuously since 2006. We have adopted SCRIPT 10.2. Other
participants in the industry have adopted SCRIPT 10.3, that is only by virtue
of their previously having been to routing networks SureScripts and RxHub, that
implemented very slightly different versions. However there is industry
experience using the standards.
Just one adoption driver that I think is notable is that at this point, most
long-term care pharmacies do use systems that are capable of accepting
e-prescriptions by virtue of some of the larger participants having adopted
SCRIPT and are certified and are active today. I think we are over the hump in
terms of industry acceptance of the standard, with the key larger players
having moved forward to adopt the standard voluntarily. As I said, real world
experience has driven enhancements to a standard; experience in the pilot,
experience post-pilot and actual live nursing home settings that brought
forward needs that we have been able to address through NCPDP improvement
process over ten separate extensions descriptive and added in the past few
years. That largely was within the long-term care e-prescribing task group’s
area – bringing those things forward for the full NCPDP participants to
approve.
As a result and we believe that SCRIPT 10.6 does address all the weaknesses
that were identified in the 2006 pilots. At that time we used SCRIPT Version
8.1. We had to make several work-around adjustments just to adopt to the
differing long-term care workflows. There were certain things that could not be
address at all given that standard. So things like open-ended chart orders,
adding capability to create an open-order order, to change it or discontinue it
at a later time. Combination orders, long-term care is very common to have tape
redoses or combinations routine in TRN medications and the codified sigs, in
addition to what Ken spoke of, addresses those needs. Support from more complex
long-term care directions, are also supported by codified sig. Facility,
resident, responsible party information has been added.
PARTICIPANT: Could you repeat that one again?
MR. MCKINNEY: Sure. Facility resident and responsible party information.
Long-term care you have people in particular locations and that comes into play
in terms of the delivery process. And responsible party information comes in
play in terms of reimbursement or coverage of expenses. Census event community;
admission information change, discharge, all those drive pharmacy processes and
those can be communicated today.
Protocol via dispensing quantity; just refers to the fact that in the
long-term care setting it is much more like a hospital in-patient setting where
orders are created in terms of the administrations that are involved as opposed
as a particular quantity that would be packaged for pick-up.
Then pharmacy notification of over the counter medications dispensed by the
facility. So as we discussed, the long-term care pharmacy most frequently
provides another role in terms of managing medications for the residents at a
facility much more than in an ambulatory setting. It is critical that they
understand not only the medications that they are being asked to dispense, but
also those that may be dispensed at the facility through the stock that they
keep on hand.
In addition to meeting those gaps that were identified in 2006, the version
that we are requesting be recommended, 10.6 goes farther and adds some things
that had not been anticipated. So I think it’s fair to say that the basic needs
have been met in SCRIPT and the industry is now looking for opportunities to do
things that we did not have the chance really to consider when we piloted in
2006. So things like the allergy profile, diagnosis profile, all current
medication lists, including the facility and over the counter meds,
notification of potential drug conflicts, which we spoke of earlier today, and
notification of time-sensitive medications, stat orders and special delivery
needs.
For instance, it is possible now to communicate with an order – a
timeframe in which it is needed. So if you have a stat med, it is clear to the
pharmacy on accepting that that it is needed in a short period of time.
MR. BLAIR: Can I ask when my question does come up would you remember where
you are in your list? I can’t see the page or whatever that you are showing as
your list, the diagnosis, the allergies. My question is going to be related to
those.
MR. MCKINNEY: Okay, sure, slide number five.
So our recommendation to remove the long-term care assumption and then to
recommend 10.6.
With respect to the exemptions, going back to Judith, your earlier question,
we believe that at this point in time that SCRIPT is the accepted standard for
long-term care e-prescribing. It has been named for long-term care medication
management in the HITSP process in the medication management use case. That was
with participation of a number of long-term care participants as well as those
in ambulatory and in-patient. Also, in HL7 long-term care EHR functional
profile, which was a project that was conducted last year to develop a
functional profile for an HER system to support long-term care. It was
sponsored by HL7 in cooperation of NCPDP and it basically identifies the
capabilities of system we need to have in order to be certified as an EHR long
term care.
As has been the case in the past, in expected to be abeyance for CCHIT
certification, which is I believe preliminarily scheduled to begin this year
with a standard or a certification process ready I believe, in 2010. So that
again, had a great deal of participation from the various participants in
long-term care clinicians as well as vendors.
That is why long-term care professional provider advocacy groups are
on-record supporting elimination and naming SCRIPT to long term care.
About a year ago I was part of a panel that presented to this subcommittee
that included some clinicians and other vendors. Association of Certified
Consultant Pharmacist was here as well as some provider organizations. In terms
of providing other supporting statement, I am real confident that we could have
those from those groups that participated earlier, as well as others.
Then last, long-term care implementers are already moving to SCRIPT. Even
without the requirement to use it, it has hit a critical mass I believe, in
terms of acceptance, the larger long-term care pharmacies are either already
certified or are in the process of certifying on the standard with SureScripts
RxHub. There is other that are in the process of getting started.
However, as Ken said, I think uncertainty in this area does remain an
impediment for some to begin that implementation. We think that lifting that
exemption would remove that uncertainty and provide clear directions for those
smaller vendors that have not started the process and not comfortable that the
direction is final.
Last, with the lifting of that exemption, we expect the SCRIPTS 10.6 to be
the main standard for long-term care as well as the other settings. Again,
allowing voluntary use as soon as possible. Providing a transition period
during which the currently implemented versions which are 10.2 and 10.3, would
be allowed to continue until those participants had moved up to the new
version.
Last, because long-term care medication management requires certain messages
that are not used in other settings, we think it is critical that the full
appropriate set of SCRIPT messages be named the long-term care use.
The next slide gives an overview of those. The additional long-term care
messages would be the census. That is how a facility would communicate the
comings and goings of a resident to the pharmacy as well as changes and
condition. That is where the allergies and diagnosis are carried as well.
The re-supply message is used when a prescription is created as an open
order. This really applies most to PRN or as needed medications. It allows the
facility to notify the pharmacy when they are almost through with the supply
they have and the pharmacy needs to supply some more.
I guess those are the two unique long-term care messages. The RXFILL Fill
Status does play a different role in long-term care than it does in the other
settings and it has been accepted as a required standard message in long-term
care because of the close relationship that long term care pharmacy has with
the long-term care facility.
That is the end of these comments.
DR. WARREN: Frank, we were just looking. We don’t have that last slide. I
thought it was the same information. We got a grid.
Mr. MCKINNEY: We will make sure –
DR. WARREN: — that we get this slide and then I will send it around.
MR. MCKINNEY: It is in the same format as the grid so it should be –
either if there are common messages it will be identical to what is in that
grid.
DR. WARREN: It probably has the same information – it is just organized
differently so it is hard for us to look at.
MR. WHITTEMORE: The table was from the ambulatory side and then Frank put
this together for the long-term care side.
DR. WARREN: It would be really helpful for us to have this one as well.
MR. WHITTEMORE: I would just like to quickly amend my remarks before. When I
said 8.1 was being used for network that was on the ambulatory side and
obviously not the long-term care side.
DR. WARREN: So now, Jorge, you want to finish up your question that I
interrupted?
DR. FERRER: Bear with my simple mind here. Frank, I am just trying to
grapple with some of these concepts. Is it fair to say that the core of 10.6 is
10.5 customized to the long-term care environment? If that assumption is
correct, was your company the one that was asked to make those enhancements?
And how long did it take you for you to make those enhancements to that
particular niche – long-term care need?
MR. MCKINNEY: That is a good question. I think about the relationship
between 10.5 and 10.6 is simply that 10.6 added some features. The features are
I think, more valuable in the long-term care settings for the allergy and
diagnosis profile are the things that could be used more quickly in our
setting. But it really just represents another extension, another version of
the standard.
So really between version 8.1, which was initially piloted by our company in
2006, and 10.6, there have been a number of intervening improvements. The way
that the SCRIPTS standard is put together – when messages might be useful
across settings, they are not limited. So, for instance, my task group has put
together some enhancement requests that are really very specific to long-term
care and those are noted as such. But other enhancements that may have unique
use in long-term care or more value perhaps, but could still be used in other
settings, are available to anyone.
So the standard itself were used in all settings with certain long-term care
specific functions named as such, but in general could be used in any setting.
In terms of how long it has taken to implement, we have completed the pilot in
2006 on the original standard, 8.1, and moved up to Version 10.2 last year. I
guess it was really just a year and a half or so in the interim there.
We believe that much of the basic long-term care functionality is now
addressed. We don’t expect the same rate of additions I guess, as we have had
in the last few years.
DR. FERRER: And I appreciate it that is very clear. Is it common in the
industry of standards to kind of get the standard up well enough to be systems
integrated, then offer for free, then it a requirement. Is that a correct
assumption?
MR. MCKINNEY: I’m not sure I understand completely. Do you means in terms of
– would this be a question around –
DR. FERRER: A business model. The industry offers a tremendous amount of
back-end work just to get the standard enough to be received, if you will, by
the industry. But at one point somebody has to make some money on that
standard; is that correct?
MR. MCKINNEY: The organization that maintains the SCRIPT standard it is
sustained through membership. So there is no fee for use of the standard per
se, it is just a membership cost to participate in the standards process.
DR. FERRER: So there is no way to monetize? Often times we grapple with
those – how do you really put the value if you will, on that? In the
standards world that is kind of difficult to do.
DR. WARREN: Frank, let me clarify. If you are not a member of NCPDP you
would have to pay to use the SCRIPT standard?
MR. MCKINNEY: You need to become a member which is annual membership.
Actually the mechanics of the arrangement is that you need to be a member in
order to receive the detailed implementation documentation.
DR. WARREN: Actually that’s helpful because that is a little bit different
model than what we see in other SDOs.
MR. MCKINNEY: Is that accurate?
MR. WHITTEMORE: Yes. Any member of NCPDP is entitled to use any of the
standards and receive copies of them. I think membership is $600 a year now as
an individual membership. I think you can also purchase the standards but I
think that they price it such that it just makes sense to join.
DR. WARREN: Okay. Actually, I think that’s probably pretty critical for us
to take a look at. So I will get together with Lynn and get NCPDP to send us a
statement so that we know that it is there.
Thank you, Jorge, for picking up on that. I had failed to look at it. Harry?
MR. REYNOLDS: I have a couple of questions mainly on process. What we have
done – we felt has been exciting but now with everything happening so fast
in general, and we spent a day, Tuesday, really thinking about how standards
should be done in the future. Let me play back what I think I am hearing. This
is not directed at the two of you, it is directed at what is going on in
general. Then we have got to figure out how we help make some sense of that.
So if I were – I always like to sit on the other side of the table
– so if I was somebody that did not like what was going on with standards
right now. If I just take the presentation this morning – there is version
8.1 out there, there is version 10.2 out there, there is version 10.3 out
there, there is version 10.5 out there, and there is version 10.6 out there.
Now if I wanted to go up on the Hill or anywhere else and really have at
something I could take just this and say, wait a minute, this things is a free
for all. I did not say that I am right. Remember it is very important in
today’s world as we look at this to understand perception.
So we recommend 10.5, correct?
DR. WARREN: Uh-huh.
MR. REYNOLDS: And we recommended that the exemption be pulled off. So I am
not sure we heard back from that. But we are now about to recommend 10.6. I
like the process that is going on but at some point, if I am somebody small and
I am somebody who wants to get involved, the playing field has five or six
versions in play, plus whatever else is being considered.
I think what is going to be important as we consider this is that at some
point “upper compatible” is a word that we have tried to use and that
is one of the reasons we have been able to move this along faster. At some
point six standards in play at the same time “upper compatible”
starts to come apart. Not that it is good or bad – it just puts everybody
in a different view.
Remember if you are talking to a layman, and that is what is important, we
are supposed to represent the whole environment.
The second is, back to our meeting the other day, Judy and Jeff, which I
think will be important for us to consider as we finish our deliberations on
how standards should be created. One of the other things in the slides – CCHIT
is probably going to adopt this. So on one hand, CCHIT might adopt something,
on the other hand, there is a law out there that makes an exemption for it, and
on the other hand, there are five or six standards in place and we are going to
recommend 10.6.
You have got to take all those messages and we have got to somehow synergize
this so whether we are working with – as we are working closely with ONC.
As these things are starting to move and we all want to help move them faster,
if you just sat back as a layman and just took the words, not the message, we
have been supporting this all along, we have got to make this a little more
crisp because we were talking yesterday, Don Detmer or anybody else talking
about, communicating to the world this looks like a whole lot of things in
play, and to those of us who know it and those of you who are close to it, let
us take the person that is not part of what Jorge was just bringing up.
They say, I am going to start. My vendor says, well, I’m on 10.3 and that’s
fine, but there’s 10.6 We have got to figure a way as we move this forward and
ask for exemptions or do whatever we do, at some point that train can’t be that
long. I implement HIPAA and I do other things. I would not want six versions of
HIPAA out there right now that I was trying to chase.
I am not asking you to defend that because I think what you are doing is
good. I am asking you to make sure that we help – you help us craft the
message to the general whoever could pick this up. We try to write our letters
to everyone that could get a sense that this is a good thing. And oh, by the
way, once I start – if I go out and spend my money and go at 10.6, there
are not going to be six more out there by the time I go implement 10.6 and then
I am five behind again.
Speed is good but speed is confusing if we are not careful as to how we get
real good at communicating. I’m leveling a lot of this at us as a committee, to
make sure as to how we approach it. This is not about the testifiers and this
is not about what is going on to date, but it sure can look confusing if you
are not really staying close to it and you are not really on top of it.
MR. MCKINNEY: I think the challenge is balancing and really allowing on one
hand innovation to continue unhampered while retaining a certain amount of flow
consistent change to the norm I guess, over time in terms of regulations.
MR. WHITTEMORE: I would also suggest that there is some clarity in terms of
what the Secretary has adopted because that has come out in final rules. As
things stand now the final rule says we’re transitioning to 8.1 becomes
mandatory. Whereas if you folks move forward with recommendation 10.6, we would
expect that the Secretary would hopefully do likewise. So then at some point,
it would go from 8.1 to 10.6, without those intervening versions being a
factor.
MR. REYNOLDS: Right, but again I think the reason as I mentioned earlier, I
would like to see some letters and some other things because again, with five
of them out there – there may be people out there spending money on 10.2.
Remember I did not say I understand how everybody does things, but I want to
make sure that if we recommend something, we did not just take somebody who
just implemented 10.2 and recommend to the Secretary that the real answer is
10.6 and oh, by the way, nice try. I am not saying that is the way it is.
The exciting thing about fast right now is that it is fast. The thing we
have to be very clear on with fast is somebody needs to make sure that we are
saying it in a coordinated way and that is one of the reasons we are so close
with ONC on some of this because there are so many players now naming,
deciding, picking, choosing, recommending, and that can create a little
different scenario.
In the past, standards were way too slow. Now maybe they are real fast and
there are a lot of people who are able to say, I like that one – go.
DR. WARREN: And I think part of the challenge that NCPDP has is they were
very successful at pulling together these standards and evolving and working
with the recipients of the standards to meet needs.
You are kind of at a point you have done really well and helped us identify
some of these issues. We will be needing more from you and we will work with
you about what we need so we can help do that.
With that I have got Jeff on the list. Marc, did you have any questions
after that?
Okay, Jeff.
MR. BLAIR: Thanks for putting that tag on I think you said it was slide 5,
where you wound up indicating that the enhancements here that we are talking
about 10.6 that are beyond 8.1, are meeting additional needs like providing a
field for diagnosis, a field for allergies. All of those – I can’t
remember them all. Can you tell me which of those are text fields, which of
those require a specific code or terminology, and which code or terminology is
used in which of the fields?
MR. MCKINNEY: Sure. The allergy and diagnosis profiles are both
multi-valued, so the opportunity is to provide all known allergies and all
known diagnoses for a patient. They are codified with the additional
opportunity to provide text. Actually text is required. The codes are optional.
The terminologies and codification are identical to those used HITSP and its
definition of C-32 summary.
MR. BLAIR: Thank you, you went right to the heart of my question.
MR. MCKINNEY: It was done with an eye toward inoperability consistent with
those standards.
MR. BLAIR: Good. Is that true for all of the other fields?
MR. MCKINNEY: Yes. The medication list would be the other full profile list
that uses industry convention of using indices today with the opportunities to
use RX norm when it becomes the norm.
MR. BLAIR: Let me make sure that I understand this thing about lifting the
exemption on long-term care. My understanding was that the previous times when
we went through approving the NCPDP SCRIPT standards we did not want to burden
long-term care with a requirement for compliance before they were ready.
I am interpreting your being with us today, saying that the long term care
industry now feels like they are ready because NCPDP has now with 10.5 and 10.6
modified the SCRIPTS standard in such a manner that long-term care can comply.
So you are saying that we can now go forward and lift the exemption on them. Is
that a correct interpretation of what we are doing?
MR. MCKINNEY: Yes, it is.
MR. BLAIR: Then the other piece that I want to make sure that I understand.
In terms of – and this is not new information – this is really going
back to previous things that had been discussed and decided on, which was the
fill status notification. I am trying to recall where that was. I think that
that was one of the things where the first time three years ago we went through
this, we had indicated that that message from pharmacies back to physicians
would be approved.
Now the word that I think that you used was “support”. That the
pharmacies and the provider systems – healthcare provider being clinicians
– needed to support all of the standards including the fill status
notification. The thing in my mind is I thought that the semantic distinctions
were that it did not necessarily mean that when the clinician got that message
back that the clinician had to read it, or use it, or act upon it, and that
there was some concern within the provider community, the clinician community,
that they were nervous about receiving that message with the idea that they
could be held legally accountable either if they failed to check on that or
that they would be responsible for doing so and that was an additional
administrative workload on them.
Is that a correct statement of where we have been or if it is not, could you
bring me up to date?
MR. WHITTEMORE: Was that directed at Frank or me?
MR. BLAIR: It’s the testifier in the sky because I can’t see either one of
you.
MR. WHITTEMORE: I’m sorry.
MR. BLAIR: Whoever feels more comfortable responding to that question.
MR. WHITTEMORE: I want to apologize because I think I probably made things a
little more difficult today. I certainly wasn’t meaning to question the utility
of a RXFILL message. All we were making the case for was being clear about who
is required to use certain standards.
I guess to get to your question, we have certainly heard from some folks in
the prescriber community concerns that you have stated, that if the message
comes in and they happen to miss it and don’t take action on it and there is an
adverse patient outcome, then are they going to be held liable for that and
have a concern about that. We have also heard from a lot on the prescriber side
who would like to be aware of when patients actually pick up the medications.
Certainly there are proponents on both sides.
Again, we may as an organization, implement RXFILL. We just have not had the
dialogue I guess, necessary to resolve what the workflow issues are on both the
physician side and the pharmacy side to do that.
MR. BLAIR: But in short, the fill status notification is an issue that had
been addressed and determined previously. That is not one of the things that
you are asking us to revisit?
MR. WHITTEMORE: No, no, not at all.
DR. FITZMAURICE: A question about – this is Ken’s testimony on
functionality offered by SCRIPT. In the bullets it is supported federal medical
terminology based on HITSP. Part of HITSP recommended SNOMED. Part of HITSP
recommended federal medication terminology. And we are still kind of debating
that in a committee or subcommittee, that is trying to harmonize things where
you find some disconnect. I think that NCPDP and please correct me if I am
wrong – doesn’t care which it is. Just make a choice and we will use it. I
am talking about route of administration or a dose form. It may not be a big
deal – like how many inches are on this pen versus that pen, but choose
one and go with it. Does that pretty much sum it up?
MR. WHITTEMORE: Frank might be closer to this than I am. I think the point
is here that the standard would now allow the use of the medication terminology
depending on what the requirements were.
DR. FITZMAURICE: It’s like give you the code set and you’ll use it.
MR. MCKINNEY: I don’t think NCPDP has a preference one way or another.
DR. WARREN: Then I have a question. One of the things that impressed me when
we did the hearings on e-prescribing is how at the first hearing people came
just to do their hearings and then people started getting excited and so
everybody started coming. We started seeing collaboration taking place in the
back rows that we never had any – we did not expect that to go on.
So you have been very successful at pulling together NCPDP, HL7, working
with SNOMED, working with the terminology standards, of trying to bring all
this together and harmonizing. I noticed on the slides and I think some of this
is on there that now you have also been collaborating with HITSP. Then you also
said that you are working with CCHIT. Could you talk more about this new
collaborative activity with HITSP and CCHIT?
MR. MCKINNEY: That was probably on mine. What I was referring to there was I
believe prior to the beginning of CCHIT certification for ambulatory or
in-patient EHRs, that HL7 had produced what they call a functional profile,
which describes the capabilities that a system should have in order to call
itself an EHR. Those were done earlier.
In the course of last year and actually I think it started the year before,
there was another such effort kicked off by HL7 in collaboration with NCPDP, to
develop one of those for the long-term care setting. It was really under the
auspices I guess, of HL7 that that was developed. It was balloted at the end of
last year and passed. It is now a HL7 standard or long-term care functional
profile. That was done in preparation, it is my understanding, to provide that
as support for CCHIT when they develop certification requirements for long-term
care at EHR.
I think it is really true just your overall comment regarding the
collaboration between these various groups is that it is understood by everyone
that in order to simplify the landscape as much as possible, that even though
there are different organizations focusing on different things that there is a
continuity between the activities of those various organizations. Each of those
organizations then I think, has made it a priority to remain aware of what
other organizations are doing and to involve themselves across organizations as
much as possible so that when things are being resolved in the HITSP committee
as far as how you describe an allergy, that that is not duplicated or closely
duplicated by another group and that those standards are accepted and used
across the board. I think that has been really the common approach, at least as
far as I have seen over the last few years.
DR. WARREN: Then this goes back to our subcommittee started this new set of
hearings of really looking at standards development; adoption, implementation,
and testing. Today’s hearings are kind of following up on our e-prescribing
responsibilities and that has not been folded in yet to this set of hearings
that we are designing. You are also talking about having this part of
certification and yet this is a standard that also has to undergo regulatory
oversights.
Help me understand how when you are working with the certification group
when you are dealing with standards that do need to be endorsed by the
Secretary. How do you fold all that stuff in?
MR. MCKINNEY: Recognizing that these efforts, for instance, the efforts that
identify a long-term care EHR standard does not have the authority to identify
a version of the standard, in that case what that group did was identify the
capabilities that related to e-prescribing that applied to long-term care and
made a recommendation that – I think we worded it something to the affect
that the most recent version of SCRIPT.
DR. WARREN: So you really were taking a look at the functionality you are
requiring and not tying that to a specific version of the standard?
MR. MCKINNEY: Right.
MR. REYNOLDS: You stated that you wanted it to include the most current
version of the standard. That is fine. What I am saying if we can move the most
current version of the standard then you are still doing the same things. At
some point they are going to have to decide what that current version is that
they are picking up on.
Part of our whole effort is trying to figure out this whole thing so that
you guys are not chasing different places thinking that you are getting one
thing or another and we are not all thinking it.
DR. WARREN: Plus a lot of follow up because you have seemed to be very
successful in this particular area of collaborations. That there may be an
emerging model out there that we can transition into other kinds of standards
effort.
Just to be clear, you have really brought the industry together – by
industry I am talking about e-prescribing, long-term care, and ambulatory care,
to really collaborate around this. You brought in HL7 as you worked on the
acute care side so that all of the information can go from acute into the
pharmacies and ambulatory care. So you have wrapped that one up.
Now you are really looking at functionality of these records and so
collaborating there and then going to HITSPI, working there to make sure that
you are not duplicating any of the recommendations, and then working with the
certification side on functionality that should be there. Then kind of
referencing regulations that may occur in the future. I have that process.
In-between, especially the companies that are writing software, you are
doing testing to make sure that these standards really do work in your
products?
MR. MCKINNEY: Yes. I think the example of there being these intervening
versions of SCRIPT are really the result of that and a reflection of that.
DR. WARREN: Okay. So talk a little bit more, oh, we’re running out of time.
What we may do is contact you ore to talk about the impact that the
e-prescribing pilots had and this subsequent work of testing more of that. What
we are beginning to hear on some of the other testimony is it is the testing
cycle that is becoming incredibly important for adoption.
Okay, are there any last questions, knowing that we only have about ten
minutes left for some other work we have to do.
DR. FITZMAURICE: Back to fill status. There is a recommendation that not all
participants in Medicare e-prescribing need use all prescribing standards. It
is hard to then develop a criteria of who should use the standard and who
should not use the standard. But come in and testify the cost of our doing it
is very large. We are not in the workflow loop. We are a payor of claims –
we don’t want to be our brother’s keeper or keeper of our brother’s clinical
information. That is between the pharmacist and the physician.
Is that pretty much the argument that Part D firm would use?
MR. MCKINNEY: I’ll take a whack. I think the challenge hinges on the fact
that in general standards that apply to practitioners or pharmacists are to be
used if those functions are being used. So it is optional in that sense that
you do not have to receive a history, medication history, but if you do then a
standard must be used.
Whereas the Part D sponsors, are required to use standards that apply to
them. I think where the crux of the confusion is that Part D sponsor and its
activities as a sponsor, as a payor organization, is not involved in dispensing
medications. Whereas, they may have a network of pharmacies or own a pharmacy
that is. I think that can be sort of the confusing aspect that —
MR. WHITTEMORE: Maybe we focused too much on RXFILL. On the table you could
also look at a cancel prescription message which is designed to go from the
prescriber to the pharmacy. As the language is now in the final rule I think
the Part D plan is required to support that too. But they have no role in a
cancel message going from a prescriber to a pharmacy. That is why when you look
at the table we have identified those transactions where it doesn’t – and
it is not just for Part D sponsors – there are some transactions in here
that don’t make sense for a pharmacy or prescriber vendor to be involved with.
That is the point we were trying to make.
DR. FITZMAURICE: By supporting this then do you mean that Part D plan would
get a fill status notification or cancellation notification every time that it
is sent regardless of it just being between the pharmacy and the physician?
MR. WHITTEMORE: Frankly, we’re confused as to how a Part D plan could even
implement RXFILL. We have had calls and they have been asking us how do we meet
this requirement in the final rule and we have not been able to give them good
guidance.
DR. WARREN: So that is probably something we need to hear more detail on
about exactly what Part D is required to do.
I’m going to have to end this part of our meeting and I want to thank you.
You will be hearing from us again as we progress through standards development.
Harry is chuckling over here. Because I still think we have been pretty good
partners in developing all this and we really appreciate all that.
Moving right along, because we have about five to ten minutes before
everybody else –
DR. FITZMAURICE: Judy, are we postponing a decision on whether 10.6 is
Equis(?) compatible or not? Not whether they like it? It is okay with me, you
are the chairlady.
DR. WARREN: At this point, we don’t have time to do that. What I am
proposing as co-chair, because Jeff and I have talked about this, we are going
to be scheduling a conference call to do some of the planning. What I would
like to do is give the subcommittee a task and then we have questions to
discuss the task before we adjourn. So in your packet you will see a very rough
draft proposal of days two, three, and four, for the rest of our hearings for
this year.
MR. BLAIR: this is for the other topic that we are switching to now?
DR. WARREN: The standards initiative.
MR. BLAIR: Which is the NCVHS standards initiative, the hearing where we had
the first day of those hearings on Tuesday.
DR. WARREN: This is the one where we’re asking the question; what have been
successes in standards development? What processes did you use to be
successful? And then, what are the remaining challenges to standards
development? Then what processes or models would you propose to reduce those
barriers to be more successful and then who should be at the table and what
kind of processes are there?
What we would like the committee to do is to take a look at these two lists,
think of this morning’s presentation because I think there are some other items
that Jeff and I had not considered when we put this draft together. This draft
is very similar to the one we showed you in November.
What Jeff and I would like to do is we need to get the testifier’s invited
for our April meeting. Our April meeting will be April 28-29. You have seen
that coming through the e-mail. If you can get to Jeff or I by a week from
tomorrow, any questions, additions, recommendations, for how you would like to
see days two and three follow, knowing that day four we will probably plan
again after we hear days two and three.
MR. BLAIR: Let me add one other piece to that. Just so that it is not too
easy for you, it is always easy to say here is my list of all the other folks
we need to hear from. But we have a budget constraint, quite candidly, I know
it seems like it is difficult in this year where money flows freely, but there
is a budget constraint.
We only have in the NCVHS budget four days of hearings and we had to fight
for that. If you feel that you want to prioritize something that is not on that
list indicate as well, what item you would remove in order to make room for
alternative hearings. We
DR. WARREN: Just to add on to Jeff, there may be people we need to hear from
so make a determination do we need to hear from them person or can be illicit
written testimony and meet our needs that way.
MR. BLAIR: We are planning on sending out invitations for written testimony
to a large number of professional associations, to a large number of standard
development organizations, because as you take a look at these lists we are not
going to get to all the SDOs or all of the professional associations. So
written testimony is part of this.
DR. WARREN: Okay, so we will open the last couple of minutes for
clarification. Harry, first and then Jorge.
DR. FERRER: Why does Harry always go first?
DR. WARREN: Because he held his hand up first.
MR. REYNOLDS: I’m concerned about the list because it’s a cast of thousands.
I know that there are others. I guess what I am worried about after having the
first day, I want to be careful that we just don’t invite everybody in so that
we can say that we invited everybody in. A couple of the testimonies yesterday
did not stay on message. They did not talk about – they talked about what
they were doing and not how standards should be done in the future.
I want to make sure that if we could come up with something that would allow
– because the other thing is there is no time for discussion in those
agendas.
MR. BLAIR: Yes there is.
DR. WARREN: I have to say one of the things I did not do and I have made a
comment, is we had panels that when we were planning them that each speaker was
given so many minutes and there were minutes planned in there for questions.
Each panel had 30 minutes designed for discussion.
MR. REYNOLDS: No, I’m talking about us. So for example, out of the meeting
the other day – what I am saying is that I at some point, and I would like
it to not be too far in the future, I would hope that even a half of day of one
of these is about us sitting down and saying what are we hearing? What are we
thinking? What might we need? I would rather you not fill up the fourth one
because I would love to either discuss part of the way through the second one
or in the second and the third one, to figure what the fourth one ought to be.
Because in the end, I think the charge that you guys have taken on is that we
will help recommend how standards should be done in the future. Not everybody
that is doing them and not everybody that wants to come in and tell us they are
doing them, but enough representation to talk about how it should be done.
The minute you hear Don Detmer and you hear Bill Stead and you hear Carol
Diamond – and whether I hear five standard organizations or 500 standard
organizations, I am not sure it matters unless you have somebody in that is
doing it so differently and is not going up through the same path.
Again, the mistake you made was gave us Tuesday. Up until Tuesday you had us
going down a path. You gave us Tuesday and now you caused us to think
different. I am not apologizing for that – you did that.
That is my point.
DR. WARREN: I think it’s a good point.
MR. REYNOLDS: We have a momentum. I want to make sure that that momentum is
not there because we are afraid that we would not include people. We have to
figure out how to come up with an answer. I am asking that we really, really
look at that.
DR. WARREN: That was the strategy for asking for written and stuff like
that.
MR. BLAIR: Let me add just a little piece there. We actually had 30 minutes
at the end for discussion but we ran 30 minutes late so our discussion time was
taken up that way.
MR. REYNOLDS: I’m talking about hours, Jeff, I’m not talking about 30
minutes.
MR. BLAIR: So that is what I was about to say is that maybe what we need to
do is schedule a full hour at the end instead of just 30 minutes.
DR. WARREN: Or more.
DR. FERRER: We schedule this prior to this new world we’re going to live in
now. I think we also need to expand a little bit the concept of how is the
federal government and how are these new FACA committees going to be integrated
in this process? There wasn’t even a FACA when we did all this. To Harry’s
point, the value is that at the end of all of this to have a strategic
orientation as to how we are going to develop them incorporating the new FACAs,
NCVHS, and a whole host of learned lessons from the last 20 years on how
standards have been developed.
We need to devote time to that, because if the committee can’t make crisp,
clear – and I would recommend that the recommendations maybe not be done
in the full committee type, because standards now touch so many of us, and I’m
not so sure just putting it into standards discussion is as rich as if we
opened it to full committee
MR. BLAIR: The other piece is on the time piece, is that Judy and I had
actually scheduled to begin earlier and we were told that we couldn’t start
before 9:00 o’clock. That took another 30 minutes away from us. If there is a
possibility when we schedule these other days, if we could start at 8:00 or
8:30, then that makes it a lot easier for us to generate additional discussion
time.
DR. WARREN: We’re right at time where it’s ten till, the Full Committee
starts in ten minutes. What I would like to do is to do this. Maybe when you
give us direction on who you would like to see on day two and three, consider
what went on Tuesday. Consider that we now have the legislation and everything
else because quite honestly, since Tuesday I have not had time to really go
back and look at these and Jeff has not either.
That is why I said this is an incredibly rough draft. We did this last
November. We have been working off of the plan. We may now need to reshift some
of that. Do remember that we are on the time of the end of April for a two-day
set of hearings. We now have lots of folks that are calling and e-mailing Jeff
and I, who want to play in this. They see the importance. And I am not saying
we have to – we have to respond to them. I don’t know which way we need to
respond and that we still need to craft on how we are doing that.
I know that Leslie has a question and I will take it off-line so that we can
deal with that.
DR. FRANCIS: I just have a timing question. The timing question is we are
planning a hearing for either the last week in April or the first week in May
– the Privacy subcommittee.
DR. WARREN: That needs to occur in the Executive Committee, that’s not here.
MR. REYNOLDS: That is a Full Committee discussion.
DR. WARREN: So if anybody has wonderful thoughts the rest of the day or
after you go home or while you are on the plane, please let Jeff and I know
what they are. Trust us, we are not done and we will have lots more to do.
With that I would like to adjourn and just thank everybody for participating
and being a terrific subcommittee. Thank you.
(Whereupon, the subcommittee adjourned at 10:00 a.m.)