[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
September 1, 2004
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
TABLE OF CONTENTS
Call to Order, Welcome and Introductions, Review of Agenda – Dr. Lumpkin
Update from the Department
Privacy Letters, Marketing, Fundraising, and Privacy Advocate – Mr. Rothstein
NHII Letter – Dr. Lumpkin
Standards and Security, Letter on e-Prescribing – Dr. Cohn
P R O C E E D I N G S [ 9:06 a.m.]
DR. LUMPKIN: Well with the start of this meeting summer is officially over,
however for the Standards and Security Subcommittee they would never know that
there was a summer. What did I do on my summer vacation? And thanks to all of
you who worked so hard over the summer to bring forward the recommendation that
we have in our packet on e-prescribing.
We have a full day today, we’ve got three letters from Privacy, we have a letter
from NHII, and then we have a short letter on e-prescribing, which they just
folded last night after talking to no one, but I think it was 65, is that
number I remember correctly? People who testified at the various hearings,
very impressive, so we have a fair bit of work today. I actually was following
up on one of our reports that we issued, when did we do the report on the
MS. GREENBERG: I think it was ’99.
DR. LUMPKIN: Around ’99, and just a few short days back from a trip out to
American Samoa, Guam, and Iyap(?), which is one of the states of the, federated
states of Micronesia, a compact nation, sort of sparked by our report. It was
really a fascinating trip, I think perhaps for us one of the most fascinating
parts was to go to a place like American Samoa, population of 50,000, and to go
to the hospital, the LBJ Tropical Medicine Hospital, which was really a
fascinating institution in of itself, but to realize that they were
implementing Vista and had a number of the components in place, it really was
very impressive and had gotten a lot of support from the VA hospital in Hawaii
in setting up that system. So the activities of this committee are no unknown
even all the way across, not quite the International Dateline but certainly on
the other side of the equator in the Western Pacific, so it was really quite a
fascinating trip and sometime maybe I’ll tell you about my trip to American
Samoa and the gecko that decided to climb up my shirt on the inside, it was
truly an interesting experience.
So having done that that’s what I did on my summer vacation, it wasn’t really a
Why don’t we start off with introductions, my name is John Lumpkin, I’m senior vice
president with the Robert Wood Johnson Foundation and I am chair of the
committee. And we’ll go around, as usual we’re broadcasting on the internet,
also as we go around if you have any conflicts if you would state them at this
particular time. So why don’t we start off with Jim.
MR. SCANLON: Good morning, I’m Jim Scanlon, I’m the deputy assistant secretary for
science and data policy in ASPE at HHS and I’m the executive staff director of
DR. COHN: I’m Simon Cohn, the national director for health information policy for
Kaiser Permanente, a member of the committee.
MR. ROTHSTEIN: I’m Mark Rothstein, director of the Institute for Bioethics, Health
Policy, and Law at the University of Louisville School of Medicine, member of
DR. CARR: I’m Justine Carr from Beth Israel Deaconess Medical Center in Boston and
a member of the committee.
DR. STEUERLE: I’m Gene Steuerle, I’m a
senior fellow at The Urban Institute and also a member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality,
liaison to the national committee and staff to the Subcommittee on Standards
and Security, and wondering if John Lumpkin bought any insurance from that
gecko who crawled under his shirt.
DR. HUFF: This Stan Huff with Intermountain Health Care and the University of Utah
in Salt Lake City and I would need to recuse myself from any votes relative to
HL7, I’m a co-chair, vocabulary co-chair within HL7.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison
to the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
MR. ROTHWELL: Charlie Rothwell, National Center for Health Statistics,
representing Ed Sondik, I’m the director of the National Vital Statistics
System and also the National Survey of Family Growth.
MS. FRIEDMAN: Maria Freidman, Centers for Medicare and Medicaid Services, staff to
the Subcommittee on Standards and Security. I’m also glad John has revealed
his plan to have NCVHS go for total world domination.
MS. MCANDREW: Sue McAndrew, Office for Civil Rights, and I am liaison to the
subcommittee, and I would also like to introduce to Christina Hyde(?), from my
office, who will also be helping with the liaison duties to the Subcommittee on
MR. LOCALIO: I’m Russell Localio from the University of Pennsylvania School of
Medicine and a member of the committee.
DR. VIGILANTE: Kevin Vigilante, principle at Booz-Allen & Hamilton, and member
of the committee.
DR. LENGERICH: Gene Lengerich, member of the
committee, Penn State University.
MR. REYNOLDS: Harry Reynolds, Blue Cross and
Blue Shield of North Carolina, member of the committee.
MR. HOUSTON: John Houston, University of
Pittsburgh Medical Center, member of the committee.
DR. HARDING: Richard Harding, University of
South Carolina, member.
MS. BEREK: Judy Berek, Centers for Medicare
and Medicaid Services, liaison to the committee.
DR. WARREN: Judy Warren, University of
Kansas School of Nursing and I would need to recuse myself if we have a vote
about HL7, I’m the co-chair of the patient care technical committee.
DR. MAYS: Vickie Mays, University of
California, Los Angeles, member of the committee.
MR. HUNGATE: Bob Hungate, Physician Patient
Partnerships for Health, member of the committee.
MS. GREENBERG: I’m Marjorie Greenberg,
National Center for Health Statistics, CDC, and executive secretary to the
committee, and I did want to note that although we weren’t able to obtain
laurel wreaths in honor of the e-prescribing Olympics several members of the
NCVHS team are wearing crowns.
MS. AMATAYAKUL: Margaret Amatayakul,
consultant to the Subcommittee on Standards and Security.
MR. ALFANO(?): Bill Alfano, Blue Cross and
Blue Shield Association.
MS. VERTAIN(?): Laura Vertain with Wexler
and Walker Public Policy on behalf of IMS Health.
MS. JONES: Katherine Jones, National Center
for Health Statistics, CDC, and staff to the committee.
MS. DRISSEL(?): Danielle Drissel, Hogan and
MS. JACKSON: Debbie Jackson, National Center
for Health Statistics, CDC, committee staff.
MS. POKER: Anna Poker from Agency of
Healthcare Quality and Research, lead staff to the Quality Subcommittee and
staff to the NHII.
MS. PAISANO: Edna Paisano, Indian Health
Service, staff to the Subcommittee on Populations.
MS. HYDE: Once again Christina Hyde with the
Office for Civil Rights.
DR. KILE: Frank Kile, American Dental
MS. ZIGMAN-LUKE: Marilyn Zigman-Luke,
America’s Health Insurance Plans.
MR. MUSKO(?): Tom Musko with the Office of
Health Policy at ASPE.
MR. RODY(?): Dan Rody with the American
Health Information Management Association.
DR. CATECORD(?): Doug Catecord on behalf of
the American Medical Informatics Association.
MS. WHITE: Gracie White, NCHS.
MS. FLORAKOWSKI(?): Irene Florakowski,
American College of Surgeons.
MR. LANDRIGEN(?): Dan Landrigen, Atlantic
MR. DUBOIS: Jason Dubois, American Clinical
MS. GREENBERG: Jackie Adler —
DR. LUMPKIN: And Jackie Adler.
MS. ADLER: Jackie Adler, NCHS and a member
of the NCVHS team.
DR. LUMPKIN: Great. Just before we get
started, Richard which side of Cape Fear are you on?
DR. HARDING: I hope the correct side, we’re
just kind of waiting, we don’t know yet.
DR. LUMPKIN: Well, we’ll all be hoping that,
well, I don’t know what you hope when you have a category four storm heading —
DR. HARDING: You’ve all seen the rain but
you ought to see the wind.
DR. LUMPKIN: How close are you to the
DR. HARDING: 80 miles, so if it’s a glance
it just gets a lot of rain but if it’s like comes straight on —
MR. BLAIR: We can’t hear him —
DR. LUMPKIN: What he said was he’s 80 miles
from shore but Francine is it, Frances, didn’t we have Gaston and Hermoine
already, anyway, not all of them grow up and some of them sort of procrastinate
before they do grow up, but certainly we’ll keep our fingers crossed for your
Why don’t we start off with the update from
the department, Jim?
MR. SCANLON: Okay, thanks John. Good
morning, everyone. Since we met in June, it doesn’t seem so long ago, when we
met in June actually a number of things as you all know occurred over the
summer relating to health information technology, data policy, and other
activities and let me just spend a couple minutes updating the committee on
what those were and where we’re heading.
You’ll remember first back to May, May 6th,
the Secretary convened a summit involving over 100 leaders in the health
information technology industry and made a number of announcements, three major
announcements, and several of the NCVHS members were there. First of all the
Secretary announced on behalf of the department, and VA, and DOD that we were
adopting an additional Consolidated Health Informatics standards for use in the
federal health care enterprise. That announcement brought the total number of
CHI standards up to about 20 and they include most of the standards, clinical
data standards, that were recommended by the committee here. I won’t go
through those 15, they’re available on the website, but I think you’re familiar
with all of them including SNOMED, LOINC, Rx-Norm, Daily Med and so on.
He also announced at that meeting the
availability of SNOMED CT for downloading for free from the NOM Website and he
also announced at that meeting the appointment of our National Health
Information Technology Coordinating in HHS, Dr. David Brailer. You’ll remember
that the President signed an Executive Order on April 27th, just a
month before, creating such a position, and he was actually appointed fairly
quickly at the May 6th meeting. Now Dr. Brailer met with the full
committee I believe at our June meeting and he met again with the Executive
Subcommittee in July and he was unable to come to this meeting, I think he’s
actually moving, trying to move, but we’ll have him again at our November
Later in the summer on July 21st
HHS held —
DR. LUMPKIN: Jim, did you mention he was
like Modern Health Care number one?
MR. SCANLON: That kind of upset the
— [Laughter.] —
DR. LUMPKIN: Modern Health Care does an
annual list of the most influential people in health care and David Brailer was
listed at number one.
MR. SCANLON: He’s going to have to try to
stay in first place I think.
And at our NHII conference, again many of you
participated in that conference in July here in Washington, HHS released the
framework for strategic action as called for in that Executive Order, I think
you all have copies, this is on our HHS website as well. And it was called the
Decade of Health Information Technology Delivering Consumer Centric Information
Rich Health Care. It includes a number of goals, I won’t go over them here
this morning, and a number of strategies and specific action steps and I think
David’s office will be pursuing some of those action steps in the months
You’ll recall that the conference concluded
with a public meeting of the NHII Workgroup of the committee in which the
findings and recommendations from the various breakout sessions were presented
to the full committee and to the workgroup and I think we’ll be discussing them
later today for transmittal to the department. So actually a number of very
positive things are occurring, things seem to be moving along very well.
In terms of budgets we are pretty much
winding down now on fiscal year 2004, in fact this is the final month,
September, and the new fiscal year ’05 begins October 1st. Very few
federal agencies have budgets enacted already for fiscal year ’05 and most
likely will have a Continuing Resolution so I will describe just briefly what
the President’s budget request for ’05 includes in the area of health
information technology and data policy and again we hope this will, these will
turn into actual budgets later in the fall.
There’s about $115 million dollars in the
President’s ’05 budget relating to health information technology and data
standards and so on and this includes a couple of things that I’ve described,
they’re continuations from the ’04 budget. The ’05 budget would continue the
joint AHRQ/ASPE data standards initiative, remember this was $10 million
dollars for use, for the promotion and the development and the adoption of
standards. And that funding came in very handy in fiscal year ’04, it really
allowed us to fund a number of critical developmental projects such as Rx-Norm
and Daily Med and it allowed us to begin a number of the terminology mapping
projects that the committee had recommended, among the major and the core
terminologies as well. So that initiative at least so far is included at the
level of $10 million in the President’s ’05 budget.
Also in the President’s ’05 budget there’s
$50 million dollars in the AHRQ budget, this is a continuation of an ’04
initiative. This provides planning, demonstration, and evaluation grants for
improving patient safety through health information technology in hospitals and
ambulatory care practice organizations. I think the first year of grants
probably will be awarded, Mike you know better then I, probably this month —
DR. FITZMAURICE: Yes.
MR. SCANLON: It would have to be this month,
and again that would be continued at the level of $50 million in the
President’s ’05 budget.
A new investment in the Office of the
Secretary would be an additional $50 million dollars in the President’s ’05
budget that will be included for demonstrations really dealing with the
community and regional data exchange networks and the whole practical
interoperability. The focus here would be on data exchange networks and
interoperability so that would be a whole new grant program here in HHS.
In the ’05 budget we actually have some good
news on the population statistics side as well as the information technology
side. The President’s budget includes a $25 million dollar increase for the
National Center for Health Statistics, this was the amount determined to be
needed to transform, maintain, and stabilize the core statistical systems
there, vital statistics, health interview survey, NHANES, and so on in the
health care provider surveys and allow a little bit for methodological research
as well. This you’ll recall was the Data Council’s highest priority across the
department for data investments in the ’05 budget and the Secretary agreed, OMB
agreed, and the President forwarded that request to Congress so we await their
For the ’06 budgets, which is really not that
far away, we’re always working on the next year’s budget, we’ve already begun
to plan, very preliminary, and the Data Council is beginning to review all of
the requests for data collection investments and discussing initial thinking on
what the priorities and the strategies might be for ’06 but that’s in a very
Just a couple of other things, the Data
Council is looking at a couple of areas in the months ahead and these are
largely in the populations statistics area though e-prescribing will be one of
those areas, and our leadership in HHS asked us to look at some gaps in these
areas. The first will be at our September 8th meeting of the Data
Council, next week, we’ll be looking at some data gaps in the prescription drug
area. This is not the e-prescribing so much as the data on prescription drug
utilization and expenditures and so on, really for program and policy purposes
as well as research and statistics so we’ll have that discussion. And the
second part of that meeting will probably have Dr. Cohn briefing us on the
e-prescribing standards that the committee will probably approve later today
and tomorrow so the theme of that meeting is on both the data side and on the
standards side for e-prescribing.
Later in the month, September 20th,
we are planning to convene our HHS agencies and the Census Bureau to look at
national and state health insurance data and some related health care resources
and access data and we’ll be inviting the Census Bureau there as well. The
focus there will be to look at sort of where we are, where are the gaps, are
there opportunities for coordination and methodological work and joint
analytical work as well.
And then looking to October we’ll be looking
at how do measure income and wealth and related resources in our surveys and
major data systems and then what are the opportunities for coordination in
analytic work, methodological work, there as well. We’ll also be looking at in
just very preliminary way the use of standards, data standards, statistical
standards, and other standards in our HHS surveys.
Let me stop.
DR. LUMPKIN: Any questions? Steve.
DR. STEINDEL: Thank you, Jim. The money
that you were talking about for AHRQ, the $50 million dollars, if I recall
correctly the funding this year was for a new program and that program, the
proposals were to extend out to three years. Is this $50 million dollars a
continuation of that program or is it $50 million dollars of new money?
MR. SCANLON: No, it’s the $50 million of
that program, it’s not an additional, but there is an additional $50 million
that is new in the Office of the Secretary for the other.
DR. MAYS: I just want to ask a couple of questions
about the work at the Data Council on some of the population issues. Some of
the things that you talked about like how to measure income and wealth, pops
has discussed for quite some time, what’s the most effective way for us to make
sure that during that discussion either our past recommendations or current
activities that we have are transmitted, is that through Simon, should we send
a note, or should we resurrect things, what would you suggest?
MR. SCANLON: Well, Simon will be, Simon
attends and participates in the meetings, the income and wealth measurement
issue will be at the October meeting, we could, Simon, any way we want to
represent the views of the committee. I think we’re going to start by looking
at how do we now measure, it’s largely income at the moment in our major
surveys to some extent, some of them get a bit on wealth, I think no one’s
entirely happy with the way we measure even income so I think we’re starting
with the fairly basic approach. So I’m not sure, certainly we can talk about
this about Simon will be there, we can make any other arrangements as well.
DR. COHN: I just had a suggestion and it
just occurs to me that probably the best thing to do is for us to share the
agendas with you and then see if there’s pertinent documentation or other
respectives from the Population Subcommittee as these issues come up. I think
that Data Council as obviously received and considered all the letters, as you
know there’s nothing like just in time information.
DR. MAYS: My second question, in terms of
your planning in terms of the budget, again I guess I want to get in on that
because it seems like we tend to recommend things that have budget implications
and since I want to look ahead, again, what’s the probably the best way for us
to see if things that we’ve recommended in the past that were unable to be
funded, is there a need for us to raise them again or what?
MR. SCANLON: Well, I think you’re right, I
mean we got through a lot of trouble in the Data Council to try to have an influence
on the budget because if the resources are not there in advance then you’re
hardly going to be in a position to plan beyond that. But I think for the
recommendations for the committee, a number of them from the past are sort of
being fed into the process, for example, the NCHS budget enhancement is to some
extent comes out of committee discussions. The National Children’s Study is a
more complicated budget issue, they did by the way, they are responding to our
letter and they tell me that they’re actually addressing most of the issues
that we raised in the letter, at least at the planning stages, but there’s a
big budget issue there, that’s a very expensive study, there’s certainly no
money in the ’04 budget or the ’05 budget for that, but that’s a bigger, I
think everyone’s aware of the funding there.
But it’s hard, the only activity on the ’05
budget of course is on the Hill now and so we’re kind of locked into what may
happen there. For the ’06 budget it’s very preliminary, I don’t think, I think
in a few months it will be a little clearer, it’s just unclear now and we’re
pretty much looking at the ’05 budget as the basis for the ’06 budget. But I
can assure you that the recommendations from the committee get factored in, any
way we can get the committee more directly involved consistent with FACA we can
certainly do that.
DR. LUMPKIN: Other questions? Thank you.
MS. FRIEDMAN: Good morning. HIPAA keeps
rolling along. In Medicare compliance we’re up about 97 percent and we’re
actually conducting some additional analysis to find out what’s up with the
other three percent, we’re very pleased to see the numbers there. As far as
regs, the claims attachment reg is still scheduled for December of this year,
since that had been presented to the committee before I thought I would let you
know about that.
MPI we had issued an RFI for an enumerator,
we got the advice that we wanted and so now our contracts people are looking to
issue an RFP sometime in the near future, I don’t have a date for that yet.
Enumeration is still scheduled to begin at the end of next May.
Enforcement, I have some detail for you on
that. To date we’ve received a total of 168 complaints, of this 145 are
related to transactions and code sets violations, the remaining 23 were related
to privacy and of course we dutifully sent those over to Sue and company and
some non-HIPAA kinds of issues. For complaint status, currently 58 of the 145
complaints are open, of the 87 that have been closed 43 were deemed invalid and
44 were resolved by the parties involved in the complaint or via the completion
of a corrective action plan that was approved by CMS. Apparently there are
five open and active corrective action plans.
The kinds of complaints we’re getting have
changed a little bit, following the deadline last October most of the
complaints we got were related to transactions and code sets and now we’re
getting some on a little wide range of issues, we’ve gotten several, actually
42 regarding trading partner disputes alleging that excess fees are being
charged. And of the 42 trading partner complaints six have been closed. So
we’re working them.
And let’s see, I think I have just a couple
notes on CHI, Jim took care of a lot of what I had to say about the standards
adoption, so we are working with ONCHIT to coordinate CHI and FHA and we’re
looking at activities in phase two and they break into three major categories
and that’s implementation of the standards that have already been adopted,
maintenance and improvement of standards that have already been adopted, and
the need for new standards. Of course a critical piece of all this is mapping
and NLM is charged with mapping and maintaining of CHI standards. An example
of mapping activities for example would be SNOMED to ICD-9.
So that’s it.
DR. LUMPKIN: Okay, any questions? Mike?
DR. FITZMAURICE: Any word on when the health
plan identifier will be out?
MS. FRIEDMAN: No. I wish I knew but I
DR. LUMPKIN: Just one question on the
enumeration for the national provider ID, I don’t know if Jim mentioned to you
I had my sights set on 007, is that still possible?
MS. FRIEDMAN: Does that mean Brailer is
going to be number one?
DR. LUMPKIN: Let me think about this, no the
Secretary is not a provider so he has a shot.
Any other questions?
DR. COHN: John, I guess we could have CMS
explore the concept of vanity plates as a profit center which is I think where
we’re going with this conversation. I guess I also wanted to comment that
given Maria’s presentation it seems like the mapping issues which are NLM are
really critical to the success of all of this and we may want to have NLM come
specifically in November and update us on exactly what’s going on with all of
that. I mean I get some updates but it would be nice to hear it directly from
the people doing it.
DR. FITZMAURICE: Are there any statistics on
how many claims have been slowed down as part of the compliance process in
CMS? I think the plan was to pay electronic claims within 14 days and to slow
down the payment of the non-complaint, or non-electronic claims, to 29 or 30
MS. FRIEDMAN: I don’t have any information
on that but I can report back to the committee, I don’t know if we have that
data actually, I can check.
DR. LUMPKIN: Okay, Susan?
MS. MCANDREW: I love this part because I
really get to upstage CMS.
These numbers aren’t official yet because we
haven’t closed out the August numbers but as of last night we were, we had
received 8,096 complaints, including the 23 that were referred from CMS. We
have closed approximately 57 percent of those claims, the complaints. We have
still not issued any CMPs, civil monetary penalties. The issues continue to be
the regular suspects, uses and disclosures and safeguards are far and away the
most frequently complained about issues. Access continues to garner a number
of complaints, and then behind them are complaints about minimum necessary
standards, violations of notice, and violations of authorization standards.
The complaints continue to come in largely
from provider groups, private practices, general hospitals, pharmacies,
outpatient clinics, group health plans struggles along in fifth place as an
entity against whom most complaints are filed. I would say in terms of our
closure rate we continue to close a little more then a third of the cases for
non-jurisdictional or failure to allege a violation reasons. There are about
15 percent of the cases are closed following some sort of corrective action or
the provision of technical assistance or other forms of voluntary compliance.
The large gap in the middle is an issue we continue to work on with our regions
in terms of coding because there is a large, we made a mistake of putting an
other category, closure category in there and that button gets pushed far too
often. So we are trying to work through what is being put into that other
category so we get a better sense of the exact reason of the closure of these cases.
We have in addition made approximately 125
referrals to the Department of Justice and you probably have seen in the papers
there was the first prosecution under HIPAA by the Department of Justice, there
was a guilty plea that was entered in a case in Seattle where an employee of a
health care provider in Seattle was using, had taken patient identifiers and
had used that to obtain credit cards in the name of the patient and had charged
something in the neighborhood of $10,000 dollars worth of goods on those credit
cards and he has entered into a guilty plea with the U.S. attorney out there,
currently the plea agreement envisions a term of imprisonment from ten to I
believe 16 months, and the plea agreement is subject to the sentencing and
acceptance by the judge and that will, there will be a hearing on that I think
in the early part of November, November 2nd. So the Department of
Justice has made their first charges under HIPAA and I understand that there
may be others still to come but there is at least one identity theft has gone
down because of HIPAA.
Other then compliance I wanted to make you
all aware, we have recently put up on our website new fact sheets, consumer
oriented fact sheets about the privacy rule and about individual’s privacy
rights, and we are in addition to making them available on the website we are
interested in partnering with groups that would be interested in having printed
copies of these available for distribution at the local level, entities that
have interactions with the public, we are more then welcome, if you’d like to
hear from them and if you all have any suggestions for us as to how to get
these into a distribution stream we would be very appreciative of your efforts.
Finally I wanted to let you know that we have
based on your last set of recommendations, I wanted to let you know that we
have also a new frequently asked question that addresses disclosures to the law
enforcement community and when you, it provides a general roadmap throughout
the rule, not just the law enforcement section but the other types of
disclosures that were scattered throughout the rule about who can, when you can
make a disclosure to law enforcement, we think that that will help move that
dialogue along, there’s additional specific questions that we will be
addressing per your recommendation with the DEA.
It turns out that not only the DEA but the IG
and even DOL is interested in clarification not so much on the law enforcement
disclosures but also potential for law enforcement officials to be involved in
health oversight so that they have two hats that they can wear in terms of
accessing information and they wanted to make sure that it was also clear that
just because they have a badge doesn’t mean they necessarily have to do this
through a law enforcement type disclosure. So we are working on some
additional FAQs that will clarify those issues.
DR. LUMPKIN: One question on prosecution,
the civil monetary penalties, do you have to do a referral to the Department of
Justice to assess a CMP?
MS. MCANDREW: Yes, I mean we do, our CMP
authority has to be, DOJ does have to approve a CMP before we issue it but it’s
a different referral then the criminal referrals that we’ve been making.
DR. LUMPKIN: So when you said that there
have been no CMPs assessed then would that, would I be correct in assuming that
none of the I think 125 referrals to DOJ were all for criminal prosecution and
not for CMPs?
MS. MCANDREW: Right, they were all criminal
referrals and actually the way the law is structured we cannot impose a CMP on
any activity that’s subject to the criminal sanctions.
DR. LUMPKIN: Thank you. Other questions?
MR. LOCALIO: This is Russ Localio. Sorry to
sound like a broken record but I want to read your frequently asked question
answer number 302 dated March 3rd, 2003, this is the answer, we do
not believe that the privacy rule will hinder medical research, indeed patients
and health plan members should be more willing to authorize disclosures of
their information for research, etc. Has OCR or anybody else to the best of
your knowledge in HHS in the last year and a half assessed whether your beliefs
as of March 2003 are well founded? Or am I the only person who constantly gets
complaints about the negative impact of the privacy rules on research? Do you
know if NIH has complied any information on this?
MS. MCANDREW: As far as I know there has
been no survey or study or statistical sampling undertaken with regard to the
impact of the rule, not only in the area of research but with regard to any of
the potential disclosures, how much they are used. We do continue to get, to
have dialogues with the research community and we are aware of their concerns,
not only I think the AAMC as well as others have raised concerns about
confusion, negative reaction to the authorization process, the multiplicity of
forms, we are working these issues through with NIH and with others in terms of
what additional clarifications need to be made and whether or not it’s an
implementation issue with regard to the research or whether there is need for
changes in the way the privacy rule interacts with the research areas.
MR. HOUSTON: Regarding your statistics side,
could you reread the, you had described by type of entity who were the most
common complaint, subject of complaints, you had said first was providers —
MS. MCANDREW: It’s private practices,
general hospitals, pharmacies, outpatient facilities, and then group health
MR. HOUSTON: In that order?
MS. MCANDREW: In that order.
MR. HOUSTON: I know last time we’d all met
there was a desire to sort of get some concrete statistics and I know that some
of this is probably in response to that request, is there something that you
can provide that’s written that has sort of the detail behind this or is OCR not
able to do that?
MS. MCANDREW: We have been working with our
data management people and we are trying to develop a report that would, what
is the term, I keep seeing it, more robust data —
MR. HOUSTON: I think last time I had given
you some —
MS. MCANDREW: You had given us and we are
trying to, we’re testing now a report that would provide some of those
crosswalks between mapping issues to providers and both to geographical
patterns and right now we’ve gotten, we’ve gotten the report but it’s a little
hard to manage, it comes out a 500 page report, not what I need, so we’re
continuing, trying to boil that down to something that can be eyeballed and
made sense of.
MR. HOUSTON: Thank you very much.
DR. LUMPKIN: Vickie.
DR. MAYS: I just want to follow up on the
question that was raised by Russell because I guess I’m also one of those
people that gets barraged with these questions. I guess I’m wondering if
there’s a way to be proactive about trying to determine what to do for the
research community not NIH per se, what NIH may need as an entity versus what a
person who’s out there in the field may need might be a little bit different
and I do think that there might be some misunderstanding, I mean even here I
think when we were talking about what predominates in terms of the CFR, etc.,
those are the kinds of questions that would be I think helpful to kind of
proactively try and get information out and I’m just wondering, even as we talk
about categories, the research one doesn’t come up too often. Is there a way
in which we can make sure that we can address some of these needs? Because I
know the AAMC held testimony, etc., so that you all could get some sense of
what some of the issues were.
MS. MCANDREW: I just did want to make clear,
I mean when I mentioned NIH it really wasn’t their research issues per se but
we have, we do work with NIH as a liaison, as our liaison, to the research
community as well as with the Office of Human Subjects Protection. And we, I
understand that the Secretary’s Advisory Committee on Human Subjects Protection
is formulating a set of recommendations which I believe may largely be based on
the AAMC’s concerns and so those will be coming to the Secretary and we are
interested in working with the research community to make sure that barriers
that we did not intend to exist are taken care of.
DR. LUMPKIN: Gene?
DR. STEUERLE: Sort of along the lines of I
guess questions of Russell’s and others, and I guess Susan we even talked about
it briefly, I don’t know where responsibility in the department lies for
gathering data on the cost of these various provisions, and not just cost to
the research community, so that there’s some way of assessing sort of what’s
being done. And I think we all hear complaints and those are anecdotal and
certainly some material is hard to quantify, maybe it’s just me, I don’t get a
sense that there’s some group who’s job it is to assess the cost of these
various, I was thinking whether it was something narrow like what’s the cost of
dealing with the complaints that you have which would be a narrow subset of
issues to the possible potential cost to the research community to other cost
of compliance and I don’t know, I don’t know how to ask even the question but
is there some committee that deals with statistics, is there some data
gathering arm that’s looking at the cost side of this so that there’s some way
to assess in a slightly more scientific, and I recognize some of the data would
be qualitative but even qualitative data is often better then none at all. Or
is that something that the committee should think about?
MS. MCANDREW: Actually I may defer to Jim
because I thought at one point there was discussion about —
MR. SCANLON: There was some, these things
are very hard to do, it’s hard enough to develop benefit cost analyses for any
regulation and this area I think it’s particularly difficult. We initially
thought that we would in ASPE try to get a sense, and this was for research and
public health, this was not overall costs and benefits of a regulation, we
would try to look at what was occurring but it was really very, first of all we
were at the initial stage of the implementation of the regulation and it was
hard to tell how things would settle out.
Secondly, when we asked folks who design evaluations,
and we have plenty of them within our office as well, I don’t think anyone
really had a research design to be able to do this, other then a normal
actuarial and sort of economic analysis which is largely assumptions, I don’t
think we had any real benefit costs to rely on.
So we’d certainly, if the committee wants to look into, now the other thing is
what’s the objective of such a study, again, I think you’d have to be clear
about going in, what’s the objective of such a study anyway.
But if you have ideas or you want to pursue
how one might approach this analytically or methodologically I think we’d be
receptive. But we sort of ran up against, we could not find any real design,
evaluation design to do this, and others thought that it was just premature,
that until things had settled a bit it was hard to know what was noise and what
was a real barrier. So again, we would, any advice you have we’d be open to
DR. LUMPKIN: Okay, I’ve got Mike, Mark, and
Richard and then we’re going to have to move on. Mike?
DR. FITZMAURICE: I want to respond to
Russell’s question and then to the following conversation. AHRQ is funding a
contract with APT(?) Associates to do a purposeful investigation, not a
scientific survey, but to find out what the burden of the privacy rule is on
researchers. So it’s asking a couple handfuls of people, maybe three handfuls
of people, in different research areas what is the burden to you of the privacy
rule. It’s not meant to estimate the cost of it but to get categories of
burden and to get some idea of the magnitude. The results of the study should
be out next summer, it’s just begun this summer.
Secondly we’re also working with Academy
Health, we’ve held two workshops to inform the research community but we kept
our ears opened and listened to what they’ve said back to us. We had an expert
meeting in June, plan to have a wider expert meeting late this fall, but the
sense is that the burden of the privacy rule is also tied up with the burden of
the common rule and that what the requirement of the research is to go to the
IRB for privacy rule, they then get involved in a lot of common rule
considerations, particularly if the university gives assurances that they will
pass all the research through the IRB process.
So I’m not sure that we can separate the two
out but we’re trying to get a handle on what is the total burden of researchers
for researchers of the privacy rule and try to separate that form the common
rule if I could, and then what are some action items to try to reduce that
burden and still maintain the same kind of methods. One subtle point that
we’re concerned about is are there some methods that are so burdensome that
researchers are not going into that methodology, not developing research in
that area, because it’s too burdensome for them.
DR. LUMPKIN: Mark?
MR. ROTHSTEIN: Thank you, John. I just want
to remind the members of the committee that in June 2003 we sent a letter to
the Secretary in which we urged the Secretary to put into place some formal
mechanism for doing research on the HIPAA privacy rule to find out, not just in
terms of quantifying the benefits which, quantifying the costs which as
difficult as that is is the easier of the two, to try to get some idea of
whether the privacy rule was actually succeeding in improving the privacy of
health information and that of course might take a range of sort of qualitative
measures and we thought that maybe it would be the province of some other
agency in the department to put out RFPs and actually researchers from the
wider community. So that continues to be an interest of certainly, a personal
interest and the full committee is on record on that.
The other point that I want to make relative
to research that many people here may not know is that on August 10th
OHRP issued new guidance on research repositories that in my judgment further
widened the rift between the privacy rule and the common rule which is
acknowledged in the OHRP document and that of course runs contrary to our last
letter, or some letter that we sent, in which we urged the department to try to
harmonize the common rule with the privacy rule and therefore it was somewhat
discouraging to see this new guidance and I would hope that the department
somehow would reconsider those issues to try to relieve the burden on
DR. LUMPKIN: Now as that a final rule or an
NPRM from OHRP?
MR. ROTHSTEIN: It was a guidance.
DR. LUMPKIN: Guidance, oh —
MR. HOUSTON: Is there a way to get that
printed out while we’re still here? Is there somebody who would, I’d love to
read it and I don’t think I have seen it.
MR. ROTHSTEIN: Well it’s on their website so
it is available, could some staff, Sue, you must have a copy of that somewhere
MS. MCANDREW: It’s not ringing any bell.
MR. ROTHSTEIN: August 10th is the
issue date from OHRP.
DR. LUMPKIN: Richard?
DR. HARDING: For the sake of time I’ll pass
and talk to Susan privately.
DR. LUMPKIN: Thank you. Well, thank you for
the updates, we’re going to move on to the privacy letters, which I think, I
believe are under tab two, three, that’s correct. The first one marketing.
MR. ROTHSTEIN: Thank you, you should all have a copy in your books on the
marketing letter, this is of course is a topic that we’ve discussed on many
occasions and John for the benefit of the internet folks should I read the
letter or how do you want to proceed?
MR. BLAIR: If in fact since this was in the
briefing book, if virtually everyone on the committee has read their stuff
before they got here then maybe Mark could focus on the recommendations, is
that, do we have the flexibility to do that?
DR. LUMPKIN: Yes, I think so, that was a
good suggestion. Mark?
MR. ROTHSTEIN: Thank you, we can speed up
the process then. Let me just go to the essence of the letter and explain it,
this is a different kind of letter then we usually write because it does not
contain recommendations, it contains concerns. And the reason for that is the
following, as explained in the letter we didn’t think we had enough information
to make specific recommendations and yet we didn’t want the issue to be lost
until we had more hearings and we weren’t even sure whether we ought to have
more hearings until we got further input from the department.
So we listed those concerns and let just
review those for you, they’re on the second page of the letter, we’re concerned
that PHI is being used to target individuals for the sale of specifics products
and services without any disclosure of the commercial relationships of the
covered entity and commercial entity. Second is that we’re concerned that in
the course of some commercial activities that target individuals their PHI may
be disclosed and we’re concerned about that, such as sending out product specific
postcards to individuals saying you should switch from brand X to brand Y of
your anti-depressants. And third, we’re concerned that covered entities have
no requirements to afford individuals an opportunity to opt out of receiving
communications regarding products and services and we note that this is quite
complicated when you apply it to the full range of covered entities and we ask
the department to further explore that issue.
So these were the three areas of concern for
us but we don’t have any specific recommendations, we may hold additional
hearings on this but as you’ll see our plate is very full, especially now with
e-prescribing on top of NHII on top of our regular HIPAA stuff and we need to
focus very clearly on what we’re doing. So that’s the essence of our letter
and I’d be happy or other subcommittee committee members would be happy to
DR. LUMPKIN: Any questions on the letter?
Seeing none I think I’m willing to entertain a motion that we send the letter.
MR. BLAIR: I make a motion that the
committee approve this letter on marketing, privacy and marketing.
MR. HOUSTON: I’ll second it.
DR. LUMPKIN: Moved and seconded. Is there
any debate on that? All those in favor signify by saying aye.
DR. LUMPKIN: Any opposed say nay. Any
abstentions? Okay. The second letter.
MR. ROTHSTEIN: Our second letter deals with
the issue of fundraising another frequent topic of our concerns and our
recommendation appears on the second page, we believe the privacy rule had
adversely impacted fundraising and we are recommending that HHS allow covered
entities to use information related to the patient’s department of service for
fundraising activities without an authorization and we further urge that this
be applied broadly, that is the designation broadly, and to retain the
prohibitions on disclosure of information relating to diagnosis for treating
So in other words the broadest possible
definition of department of service so you can imagine in a hospital setting we
would be thinking of six or seven broad designations rather then the
subspecialty group. This in itself we believe would be very cost effective for
large general hospitals, at the same time would not infringe upon the privacy
rights of patients for reasons that we explain in the letter.
DR. LUMPKIN: Any questions on the second
MR. LOCALIO: This is Russ Localio. It was
several years ago when I first read the rules on fundraising and I said this is
going to be an issue and there are going to be a lot of complaints because I
always follow the money. But having said that and I’m not really opposed to
this change what I do want to say is this in some fashion raises a problem of
expectations of privacy because we’re now going to have people who have been
treated who are no longer going to have an expectation of privacy about what
department they were treated in for purposes of fundraising but the research
community faces real problems in this same area because they cannot use the
same even broad designation to try to recruit patients in many institutions,
this becomes a problem in recruitment. So you can recruit people, when this
letter goes out in some sense you’ll be able to recruit people for fundraising
using this type of information but not for research. And I think that poses
some inconsistency, so again, I’m not opposed to this, I would just like to see
the same type of consideration given to other essential activities of
DR. LUMPKIN: Other discussion on the letter?
DR. WARREN: When I read the letter I was
just wondering if you heard testimony from patient advocacy groups about this,
what their response to recruiting for fundraising this way was.
MR. ROTHSTEIN: We did solicit input from
patient advocacy groups, not in terms of witnesses at this hearing, we did get
written testimony from the Georgetown Health Privacy Institute. We also in the
past have received oral and written testimony at at least two, maybe three
prior hearings on this issue and so we are familiar with the issue.
My impression is that there have been few
complaints about fundraising and I’ll defer to Sue whether there have been any
complaints that she’s aware of in terms of fundraising. It could be that there
may be further complaints if this new policy were implemented. I think that
clearly the current policy strikes a balance between patient privacy and the
interests of non-profit organizations to support their research and clinical
activities through patients and I think the current rule strikes a balance that
is I think quite favorable in terms of the patient side of it.
I’m not sure, I mean knowing the way I tend
to look at things the members of the full committee would realize that I would
not support this letter were it not for my belief that a very slight increase
in patient privacy may be gained at a very substantial cost to the financial
viability of the institutions and therefore I am convinced that this is
DR. LUMPKIN: John.
MR. HOUSTON: Let me just add one comment, I
know it’s stated in the letter but I think it’s relevant and important. One of
the issues that we did hear of was the fact that if you were a free standing
specialty facility you would be able to do fundraising to that specific patient
population anyways and really who is disadvantaged in these cases was very
large hospitals and health systems that had a number of specialty areas and
then would be at a disadvantage in terms of trying to do fundraising to those
specific populations. So depending on who you were you might be able to do
targeted fundraising, you might not be able to do targeted fundraising, just
simply because of your organizational structure.
So in one sense we sort of saw that there
wasn’t any additional infringement on a patient’s privacy just simply because
of that and I think also having come off the marketing hearings it’s clear that
you have, here you have pharmacies and other people, individuals, who might be
sending mailings to a patient which were very descriptive of their condition
under the guise of treatment or offering treatment alternatives, whereas I
think what we heard from the fundraising people is they take great pains to
respect the privacy of individuals and they take great pride in that yet they
demonstrated statistically there was a substantial impact on profit giving.
DR. LUMPKIN: And I would be remiss to note
that we do have agreement between two lawyers which is also equally unique.
DR. MAYS: My first point actually was raised
by Russell, Russell we seem to have so much agreement today. But the second
one I want to get to is the one that was also just raised, what bothers me in
the letter is if you heard from like patient advocacy groups it might be
helpful to have a little balance to it or something because when you actually
read it, hear what’s talked about, is when you’re reporting what happened with
Johns Hopkins and then you talk about their inability to secure approximately
one half of their patient agreement it worries me then, and it’s like we can
hear from you that the patient advocacy groups and others have said that
they’re okay with this but in just reading the letter I would worry just a
little bit that that side isn’t represented.
DR. LUMPKIN: Bob?
MR. HUNGATE: A related comment, Bob Hungate,
the disclosure form that I recall signing in my dentist’s office, my doctor’s
office, and at the hospital made mention of sharing of information for
processing of claims and various assorted things. I don’t think it said
anything about fundraising and so I’m not sure about the coherence between this
recommendation and what the patient has allowed in terms of what they signed
off on so that’s an element of uncertainty in terms of the applicability of
this on the street and I don’t know how to deal with that.
MR. ROTHSTEIN: Well, I think certainly if a
change were made in the privacy rule that it may be one of the things that
would have to be added to the NPP, which would indicate that non-profit
organizations will be given X, Y, and Z, and you have an opportunity to opt out
of that information if you want, I think that’s certainly a position that I
would take but it’s not one that the subcommittee specifically addressed.
John, do you want to speak to that?
MR. HOUSTON: I agree with you, I mean I just
simply agree with Mark, I think we could probably add that to the letter —
MR. ROTHSTEIN: But I am, I think Vickie also
raises a good point and maybe we need to revisit this letter in terms of the
documentation and add some additional language. The other thing that I would
further suggest that we revisit is possibly taking out the specific statistics
that we have in there because these are industry reported numbers and frankly
I’d have no idea what that means given the fact that the contributions to all
sorts of charities have declined over the last several years and I wouldn’t
want people to draw any conclusions from our listing those in the letter.
MS. MCANDREW: If I could just respond to a
couple of things, in terms of complaints that we have had I don’t know that
we’ve actually had a formal complaint about fundraising, I do know early on
with regard to some of the complaints that we had about notice one of the most
frequent things that people reacted to was the inclusion in the notice of the
reference to fundraising, this is just isolated instances and I can’t indicate
that it’s any kind of a trend but it does also serve to go to the notice
conversation and the current requirements are that there be an expressed
reference to use of patient information for fundraising purposes in our current
notice requirements. What that reference is would only go to what the rule
currently permits used for fundraising purposes and if we made this change in
the rule that provision for notice is already there and it wouldn’t need to be
DR. LUMPKIN: Gene?
DR. STEUERLE: I view this letter as partly
information providing and I guess I would not take out the data the industry is
providing because that apparently is although anecdotal information they’re
providing on what they think are issues of concern to them. By the way, giving
to the charitable sector is not really down on average, it went down and then
it went back up a little so I wouldn’t make too much of how you compare to
I do see, this gets back to some earlier
issues sort of in conflict here, I think from a legal standpoint the issue is
what does the law require as to regulate, what is the intent of the
legislator. But from an economics standpoint the general rule is if you don’t
know the burden of proof is on the regulator and not the regulated so when you
restrict somebody from fundraising and I have actual experience about a lot of
fundraisers quite honestly, but when you restrict somebody from fundraising
without fully knowing what’s going on the burden of proof is, the general
principle of government is on the regulator and this is saying we’re having an
impact in an area, we may, we don’t know, we may be having a negative impact,
and that calls into question at least if that regulation doesn’t have to be
there, that interpretation doesn’t have to be there, whether we want to do it.
I don’t know whether this makes sense or not,
I guess I would favor putting the letter, I would favor putting in Russell’s
comment about other implications for providing this information and you’re
going to have this tension between if Congress clearly intended that you
couldn’t fundraise then yes, maybe as a legal matter, or you couldn’t provide
this information to fundraisers then maybe that’s an interpretation. But if
that’s not a clear intent and you don’t know, as I say the burden of proof is
not on the hospital community and the fundraisers to prove that they’re doing
more harm then good, it’s on the regulator to say we’re restricting you from
doing something and we have some evidence that this is worth doing. So I’m
somewhat speaking in favor of the letter with the additional information, I
would not take out information.
MR. ROTHSTEIN: Well I appreciate your
support for the letter but I would say that I disagree with your rationale, I
think as a principle of ethics and as a matter of law when you invade someone’s
privacy and disclose private information about them without their consent you
better have a pretty darn good reason and that means that the burden is on
those who would claim access to that information without the authorization or
consent of the individual. I think in this case after weighing the best
evidence that we could get that it was justified but only with all the various caveats
that we want to put there, but we’re certainly willing to concede that it’s a
close case. And for the record we have previously in a letter to the Secretary
suggested changes along these lines even before the rule went into effect, if
you’ll check back through our fundraising recommendations to the department, so
this is not that great a departure, it is sort of a revisiting of the issue and
sort of a post implementation date assessment of what we perhaps need to do to
improve the implementation of the rule.
DR. LUMPKIN: Judy, and what I was motioning
to you to is that we can’t let you two sit together again because when I look
at you and say Judy then you don’t know who —
DR. WARREN: I just wanted to support that
when I read this letter I really got a negative impact because it didn’t
mention anything about patients, it only mentioned about the ability of
institutions to fundraise. And so I came in prepared to really be kind of
negative about the letter but if you could include in the letter the piece
about the patients and that you’ve heard from the advocates then I’m very
pleased with that, so I just wanted to support your inclusion of some of that
MS. BEREK: We sat together on purpose just
to confuse you. And I’m not speaking as CMS, I’m speaking right for a second
as a patient of multiple institutions and facilities, and I get just as angry
when I get fundraising letters that are clearly based on private information as
I get drug company letters, and I have never filed a complaint but I think in
fact it is a real issue for people, for patients, and it’s something to just
think about in terms of, I mean I understand the institutions need money but I
think we really, before you vote on this since I don’t have a vote we really
ought to think about that.
DR. LUMPKIN: Okay, I think we’ve given some
guidance to the subcommittee.
MR. ROTHSTEIN: Indeed. The third letter I’m
confident will be less controversial, although I do have two minor changes to
make, this draft you see was on July 19th so I propose to change the
first sentence to the end be retired instead of will retire —
DR. LUMPKIN: Okay, can you perhaps read the
entirety since, given the character of the letter.
MR. ROTHSTEIN: Oh, sure, I’d be honored to
read this letter.
On July 30th, 2004, after more
then forth years of service to the Department of Health and Human Services,
John P. Fanning, the Department’s Privacy Advocate, retired. The National
Committee on Vital and Health Statistics (NCVHS) is writing to commend John P.
Fanning on his distinguished career. For many years the members of the NCVHS,
and particularly its Subcommittee on Privacy and Confidentiality, have relied
heavily on John Fanning’s intelligence, experience, dedication, good judgment,
and common sense. We are indebted to him for his exemplary service and wish
him well in his retirement.
The NCVHS would like to take this opportunity
to reaffirm the importance of the position of Privacy Advocate. New
developments in health information technology and its legal regulation make
clear the increasing importance of thoughtfully anticipating and addressing the
numerous issues of health privacy. We respectfully urge the Department to
begin the process of selecting a successor to Mr. Fanning.
DR. LUMPKIN: Is there any opposition to
this? All those in favor signify by saying aye.
DR. LUMPKIN: Opposed nay. That was moved by
Mark Rothstein and seconded by John Houston.
Well, I think we have, is that it?
MR. ROTHSTEIN: Yes, John, that’s it.
DR. LUMPKIN: What we’re going to do is take
a 15 minute break and then we’re going to proceed with the letter on the NHII.
DR. LUMPKIN: Okay, the next item is a letter
to the Secretary as a follow-up to the meeting of the NHII Workgroup, this
meeting was at the tail end of the Secretary’s Health Information Technology
Conference/NHII Conference that was held in July. It seems like it was just
yesterday, it seems like it was yesterday but it also seems like it was a long,
long time ago.
We have in front of you the letter, I will
just read the areas that were identified, this letter will be sent in addition
there will be two appendices attached to it, one is the reports that were given
by the various breakout sessions to the NHII workgroup, and then the second
being we received from communications from individuals subsequent to that
Some areas where additional work appeared to
be needed first was understanding from the consumer and health care industry
perspective, approaches and best practice and the issues related to the use of
master patient indexes and other methods to assure that healthcare information
can be reliably associated with the right individual. And in this we note that
the NCVHS will schedule hearings on this issue, at the Executive Subcommittee
we kind of worked out a lead subcommittee for that activity, right Simon?
DR. COHN: I think in some cases we realized
that some of these things were joint subcommittee activities.
DR. LUMPKIN: Yes, yes. The second is issues
related to patient control of their personal health information, deficiencies
in the privacy rule, and the need to balance data exchange that is essential to
health care with enhanced personal control. And we are holding hearings and
will continue to hold hearings on this area.
General policy issues elated to personal
health records and the workgroup is scheduling a hearing for this fall and
we’ll talk about the agenda for that hearing at our meeting this afternoon.
The next is general policy issues related to
developing a research agenda for the NHII, this again was discussed at the
Executive Subcommittee and we’ll talk a little bit about this more tomorrow but
the importance of looking at that as a role of the NCVHS paying attention to
the research agenda.
The next is issues related to the movement of
data between health care, population health, and personal health dimensions in
general and secondary uses of data from any dimension.
The next item was developing a comprehensive
statement on rules of the road, including but not limited to interoperability,
legal obstacles, and in general the key things that potential participants need
to know about how to participate in NHII. And the workgroup will be discussing
that this afternoon, Steve Steindel developed a straw document for us to work
off to begin that discussion.
There were two issues that were raised but we
thought that since there was some indication that this was already ongoing in
HHS we did not put on the agenda, the first is metrics for measuring progress
and the second is conformance testing.
The proposal is we would send this letter
with the attachments, which would be essentially a report from the conference
to the Secretary. Are there any questions or discussion on the letter? Mike.
DR. FITZMAURICE: A question on the first
page, first bullet, the committee recognizes that the issue of linking personal
health information is associated with that of privacy and authorization which
will also be examined as indicated next. Does that mean next in time, that is
that’s the next thing on the agenda, or is that a word that could be deleted?
DR. LUMPKIN: I think it means the next
bullet, below, yes.
DR. COHN: John, I guess as Michael brings up
this first bullet, I guess it was causing me to look hard at the sentence that
I think he was referring to. And I guess I’m wondering, it says the committee
recognizes that the issue of linking personal health information is associated
with that of privacy and authorizations which will also be examined as
indicated next, and I guess the questions I’d have for you is I’m not sure that
I necessarily saw the first sentence as being explicitly linking personal
health information though it may lead us to that conclusion, and I guess I’m
trying to figure out whether the issues are privacy and authorization are in
hearings identified next, or whether they’re part and parcel of the hearings
around master patient indexes and all of those issues.
DR. LUMPKIN: Well perhaps the clearest would
be just to say which will also be examined, period.
DR. COHN: Okay, I guess is there different
wording other then linking personal health information that we might use? I
mean we’re talking about linking between the patient and the information, is
that the linkage we’re talking about? Or are we necessarily talking about
linking all information about a person to that individual, which linkages are
we talking about here?
DR. LUMPKIN: I think in the context of this
it really is the issue of record linkage, so it’s how do you uniquely identify,
let me not use that term, how do we take an individual and assure that the
information that is being used to do clinical or other kinds of care related
decision making is actually that person’s information.
DR. COHN: Maybe this is a friendly amendment
only because I’ve tried to stay away from this particular concepts in the
bullet that has anything that I have to do with. But I’m actually wondering if
basically saying something like the committee recognizes this is an issue both
of standards as well as privacy and confidentiality or something on that level,
and both will be examined, and maybe leaving it at that.
DR. LUMPKIN: The committee recognizes that
this is an issue of standards —
MS. GREENBERG: This is what, a standards and
a privacy issue?
DR. LUMPKIN: Yes, the committee recognizes
that this is both a standards and a privacy issue and will examine both
aspects. So let me try to see if I can read that again, the committee
recognizes that this is both a standards and privacy issue and will be
examining both aspects. I hope somebody has that. Good. Any other, Bob?
MR. HUNGATE: Yes, on the second page the
third bullet relating to issues related to the moving of data, second sentence
says the information flows are essential to strength and quality assessment and
research as well as other endeavors. I would like to add the concept of
quality improvement to quality assessment in the verbiage there.
DR. LUMPKIN: Quality assessment and
MR. HUNGATE: Or improvement, assessment and
improvement is probably the right order.
DR. LUMPKIN: Okay, so that sentence will
read these information flows are essential to strength and quality assessment
and improvement and research as well as other endeavors. Okay, seeing no other
questions or comments I think we can move this one, it’s been moved by Jeff and
seconded by Simon, oh, John seconds —
DR. COHN: I think John seconded it, yes.
MR. HOUSTON: Yes, I second it.
DR. LUMPKIN: Okay. All those in favor
signify by saying aye.
DR. LUMPKIN: Opposed say nay. Any
abstentions? Okay, we’ll ship that one off.
Let’s move on to discussion of our major item
on e-prescribing. A letter was sent out before the meeting, the draft of the
letter, and I hope everyone had a chance to read it.
Before I toss it over to Simon I would just
again like to congratulate the Subcommittee on Standards and Security for doing
such a wonderful job in such a short timeframe, I know it was extremely a lot
of work and I also wanted to thank the staff members who worked with the
committee who spent their August not recreating in the Western Pacific but
actually working on getting this forward and I thought the letter was certainly
has moved us in a big step towards e-prescribing, so let me turn it over.
DR. COHN: Well John thank you, obviously I
hope that we all feel as positive about it after we’ve gone through our reading
of it but we do appreciate the nice comments.
Obviously it’s with great pleasure that I bring forward for consideration by the full
committee this first set of recommendations on standards for e-prescribing. As
you know this is a work of the Subcommittee on Standards and Security and is
really meant to be the first of two sets of recommendations planned as
requested by the Medicare Modernization Act of 2003. As I think we’ve said a
number of times there will be additional hearings later this fall and winter
with an additional set of recommendations coming forward so this is I think an
important set of recommendations but there will be more that we will be
considering in March.
Now we will soon start reading this letter and given that you’ve only had about a
day and a half with it I think we do need to read through it and sort of take
it section by section by comments. But before that I want to just thank a lot
of people, I think we want to start off by thanking Jeff Blair, our vice chair,
who has been instrumental in moving the work plan forward, developing and
moving the work plan forward, and obviously Maria Friedman who has been our
lead staff, obviously without them we would not be able to come forward today.
I also wanted to thank just a moment and just recognize all the others,
subcommittee members and then staff, obviously Harry Reynolds, Stan Huff, Judy
Warren, all of whom have spent much of their summer in Washington helping make
this all happen.
Now John indicated all the days of hearings
we’ve had, he neglected probably because he didn’t know about the additional
ten days of open conference calls we had in the last week to try to bring this
letter to a more polished version for you all to consider. Obviously we also
want to thank all of the other subcommittee members that have been assisting
us, Steve Steindel, Vivian Auld, I’m missing others, Randy Levin and others,
who I think once again without their work and assistance we once again would
not have a polished document at this point.
MS. GREENBERG: And of course Margaret.
DR. COHN: I’ll get everything but the
obvious here, obviously Margaret A, who is before us, who’s I think done a
tremendous job, Marjorie also who has sat in all meetings and all conference
calls to provide input and guidance in all of this. Have I missed anybody? Is
there anybody in the room, oh, Michael Fitzmaurice, thank you, I knew I was
going to, since I didn’t have this list, Jeff I started out with so I think
I’ve covered everybody, oh, Karen Trudel, okay Karen is not a member of the staff
but it certainly felt like it during last session —
MS. GREENBERG: She is staff.
DR. COHN: Are you staff? Okay, anyway, this
will teach me to try to name off everybody without having a list.
Anyway, it was my original plan actually to
bring some Power Points to set the stage and actually I was persuaded that that
is not something that we should do, on the other hand John Lumpkin did bring up
one issue so we will go through one Power Point as we go through the letter
just describing the process of e-prescribing, so I can’t say truly we’re not
going to do Power Points but what I want to emphasize is that it’s very
important the letter be able to stand on its own. This letter is not going to
be very effective and not going to do what it needs to do if anytime it’s being
discussed one has to start out with a couple of Power Points to describe what’s
going on and so I’d like you all as we go through the letter to keep that in
mind and so if things are not clear we need to hear from you about that.
Now we have about, I guess at this point we
have about three hours to go through the letter and I realize that’s a lot of
time, but on the other hand getting, one hour before and then two hours after
lunch, but on the other hand this is a 15 page letter so I don’t want to, I
think we probably will need the time. It has I believe I think it’s 16
observations and about 40 recommendations so it puts it sort of on the level of
an IOM report in terms of the number of recommendations so I think we will need
Before lunch what we’re going to try to do is
to go through sort of the introductory material, it basically describes things
like current prescribing and e-prescribing environments, our process leading to
the observations and recommendations and make sure that everybody is
comfortable with that. After lunch we’ll jump into the observations and
recommendations. Obviously I think what we’ve asked people to do and as you
look through this we obviously want to talk about the issues and the
recommendations, if there is wordsmithing, and we obviously know that
everyone’s good at this, we would ask unless it’s substantive that you
basically hold the wordsmithing and we’ll take it and incorporate it as
appropriate into the letter. Indeed I guess we would hope that eventually what
would happen is that the letter would be accepted with the ability to do
further wordsmithing as necessary as long as it doesn’t change the meaning of
the document, so that’s one again what we want to keep in mind. Is everybody
okay with this at this point?
Now any questions before we start with the
reading? Okay, now I think you also notice that you’ve received, and it’s
obviously smaller print so I do apologize, a slightly marked up version. I
will note where there’s been a couple of changes, once again wordsmithing
changes and the addition of a footnote as it comes up but being over 50 I find
the larger versions a little bit easier to read so I will read from that and
Margaret you can help us if we come to an area where I’m noting that there’s a
Okay, the letter starts out and I’ll just
read it section by section and then I’ll ask if there’s any comments.
Dear Secretary Thompson:
The National Committee on Vital and Health
Statistics has been called upon by the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 to develop recommendations for uniform standards
to enable electronic prescribing, otherwise known as e-prescribing.
E-prescribing should enable significant improvements in patient safety, quality
of care, and cost effectiveness. Standards for e-prescribing must not only
meet the requirements of MMA but must also be compatible with all other
standards that are becoming part of the NHII. This includes standards
developed under HIPAA and the Consolidated Health Informatics Initiative.
In order to expedite the development,
implementation, and pilot testing of e-prescribing standards by HHS NCVHS is
providing this first set of recommendations. Additional recommendations will
be sent in March 2005.
MR. LOCALIO: This is Russ Localio, when I
read the first section here I just said to myself I think I know where people
are going but it doesn’t say exactly where you’re going. The report on April
14th of 2004 talks about recommendations da, da, da, in ambulatory
care but the letter, and I kept going back and forth when I was looking at the
letter, it does not have that restriction so I would have to ask the
fundamental question is it the purpose of the e-prescribing letter and
initiative to be confined to ambulatory care prescribing and if so why and if
DR. COHN: Jeff, I see that you want to
answer that, please go forward.
MR. BLAIR: It’s a good observation and it
really was missing up front intentionally because the MMA focuses on ambulatory
care but as we go through the letter we point out that we cannot look at the
issue of e-prescribing in isolation only in the context of ambulatory care.
Some of the recommendations, or many of the recommendations, have to be
specific to MMA but they also have to be compatible with the other standards
and that is the reason that we didn’t at the beginning isolate this to
MR. LOCALIO: I gathered that because when I
read the statute I said well it’s obvious this is confined to Part D which is
ambulatory but again, I’m not sure that, given the letter is meant for more
then, the intention of the letter, the audience for the letter is more then
Secretary Thompson, do we agree on that?
DR. COHN: Yes.
MR. LOCALIO: Okay. So I don’t know how you
want to address this problem because it hit me in two seconds when I started
off, that this was a big issue, I just see the problems of prescribing
inpatient which is what I’m more familiar with as being different but the same,
and I just don’t know how to react to what you just informed me that you’re
deliberately leaving out the fact that it’s ambulatory or that that’s the
MS. GREENBERG: Well, I was just wondering if
you could just say standard, expand this one sentence here, standards for
e-prescribing must not only meet the requirement of MMA and the ambulatory care
environment but must also be compatible with all other standards and the rest
of that sentence.
DR. COHN: I’m struggling because I think, I
actually agree with you, Russ, and I actually think the best place to stick it
is actually at the end of the first sentence, to enable electronic prescribing
in ambulatory care. But I actually think we need to probably at the
subcommittee level talk about how best to insert those terms and where it
should be in the first paragraph, or how we frame it, because what we’re really
talking about is Part D, which is 99.9 percent and ambulatory, actually is
probably 99.999 and ambulatory —
MR. BLAIR: Marjorie’s suggestion I think really
was a very good one though because it —
DR. LUMPKIN: Let’s do this, rather then
trying, I think we can bookmark that as a potential solution, let the
subcommittee work on that.
DR. COHN: But Russ I want to thank you
because I think it actually is a good point, that we need to somehow, because I
really think that even though we do touch on other environments it’s really
focused on enabling ambulatory e-prescribing so we need to come up with a way
to say that up front.
DR. LUMPKIN: So we can ambulate on.
DR. COHN: Yes, we will ambulate on. Other
comments in this first section? Okay.
Current Prescribing Environment. Today
prescribers, and by that we mean physicians and others who write
prescriptions, make their drug-prescribing decisions using whatever medical,
medication, and eligibility information is known or available to them.
Typically they give a handwritten prescription to the patient or fax it to the
dispenser, in other words the patient’s pharmacy of choice. At the dispenser
tasks are somewhat more automated. Through internal and external electronic
claims, eligibility and benefits verification processes the dispensing
pharmacist may identify contraindications, lower cost alternatives, or the need
for prior authorization. At any of the steps in the process the dispenser may
need to contact the prescriber by phone for clarification or approval of
changes. Dispensers also must frequently call the prescriber to obtain
approval for refills or renewals where they are not specified on the prescription
or when they have run out. According to some estimates almost 30 percent of
the three billion prescriptions written annually require dispenser calls. This
equals 900 million prescription-related telephone calls annually.
Many reports have identified that the current
prescribing process is prone to errors. Prescribers may not have access to the
latest drug knowledge. They often do not have a complete or accurate
medication list or even medical history for their patient, and, as a result,
they can miss potential contraindications or duplicate therapies. Dispensers
often have difficulty reading handwritten prescriptions and frequently have
little or no information about the patient’s condition for which the
prescription is written. Contacting the prescriber by phone to clarify what is
ordered and to make changes often results in delays for the patient, and it is
time consuming for both the prescriber and the dispenser. There are
disconnects between the prescriber and the patient in the medication process,
with little or no feedback to the prescriber on whether a prescription was
filled of what generic substitutions were made. Each year more then eight
million Americans experience outpatient adverse drug events. Analysis shows
that e-prescribing systems can avoid more then two million adverse drug events
annually, of which 130,000 are life threatening.
Questions? Comments? Okay. Do people want
to have a quick look at the e-prescribing process at least as I think Margaret
and the rest of us envision it currently? Is this a useful quick Power Point?
Margaret, do you want to just quickly go through, and I will apologize to
everyone but this is a, and once again we just have to realize that the process
is highly variable but I think this describes often what is a normal set of
processes occurring and communications between the prescriber, dispenser,
otherwise known as the pharmacy, and payers or pharmacy benefits managers,
which obviously at the end of the day is the one paying for much of the medication
prescribed. Margaret, do you want to quickly just go through this?
MS. AMATAYAKUL: Okay, this is a work in
progress. The prescriber examines the patient and reviews the patient’s chart,
writes a prescription, gives the patient a paper copy or faxes to the dispenser
the prescription. The dispenser receives the prescriptions, hopefully, checks
the pharmacy information system for allergies, other medications the patient
may be on, and some limited formulary information from the payer perhaps if they
have the patient already registered. Calls the prescriber if the prescription
is illegible or if there are an other issues that need to be discussed with the
prescriber. Then transmits a claim to the payer, payer receives the claim,
checks formulary and benefits, and advises the dispenser if there are other
contraindications that the payer PBM may know about and the pharmacy did not,
indicates the co-pays and whether there are any prior authorization
The dispenser then calls the prescriber if
there’s a change needed, so the prescriber receives the call from the
dispenser, calls the payer PBM for prior authorization if necessary, calls the
dispenser back with prior authorization if necessary. The dispenser then may
have to reinstate the claim, at that time the claim is paid and the dispenser
receives payment and finally the prescription gets filled.
DR. COHN: Everybody got that? They’ll be a
test at the end. Any questions? And once again this is a highly variable
process but this sort of speaks of all of the communication that occur between
and obviously why it may make sense to computerize a lot of all of this.
Current E-Prescribing Capabilities, which is
the next session.
E-prescribing has the capability of
addressing many of these issues. The eHealth Initiative provided a helpful
framework to conceptualize e-prescribing systems. It describes graduated
levels of functionality, producing differing sets of benefits. Today, various
levels of e-prescribing systems are being implemented. However, the lack of
prescribing standards has forced the industry to use workarounds to accomplish
many aspects of e-prescribing. The following describes levels of e-prescribing
systems derived from the eHealth initiative framework and the extent of their
The first bullet is Basic Reference
Information. E-prescribing reference tools provide basic drug information,
dosing calculation, and formulary information. Recent estimates suggest that
about 15 percent to 17 percent of prescribers use such systems. These systems
may prevent errors by making appropriate reference information readily
available. While there are several formulary reference products on the market,
their content and format are not standardized. Some community projects have attempted
to map the various formulary products to one another.
The second bullet is Standalone Prescription
Writers. These e-prescribing applications produce a legible prescription and
include dosage information. They do not provide access to any patient specific
information or connectivity with dispensers.
The next bullet is Integrated E-Prescribing
Systems. These systems are more sophisticated in several ways. Some products
combine patient demographics, allergy, formulary, and plan information. Others
can assist in medication management. Still others may connect the prescriber
with the dispenser to transmit a prescription. To obtain patient demographics
and allergy information the products depend on either linking to a practice
management system or the re-entry of data. To receive formulary and plan
information prescribers may connect with third party information exchange
networks that integrate medication history and other eligibility information
from pharmacy benefits managers. To route e-prescriptions to dispensers
prescribers often use electronic fax, which require re-entry of the
prescription information by the dispenser. Some prescribers with electronic
data interchange capability are routing prescriptions through a switching
network. The National Council for Prescription Drug Programs, hereafter
referred to as NCPDP, has developed a standard called SCRIPT for communications
between prescriptions and dispensers. NCPDP estimates that 75 percent of
pharmacies have the capability to receive messages using the SCRIPT standard.
However, fewer then three percent of all prescriptions are written by
prescribers using an integrated e-prescribing system.
The final bullet, Electronic Health Record
Systems with E-Prescribing. Still further enhancements to quality and patient
safety can be achieved by integrating the medication order into the overall
process of medical care delivery. This level of e-prescribing requires an
electronic health record that integrates data from multiple sources, is used at
the point of care, and provides evidence based clinical decision support. EHR
systems are deployed at an estimated 14 to 28 percent of practices. It is
unknown how many of these are comprehensive EHR systems and how many utilize
standard industry protocols.
Comments, questions? Shall we move forward?
Okay, Standards Evaluation Process.
Charged with the task of recommending
standards for e-prescribing to promote patient safety and quality health care
NCVHS scheduled testimony in 2004 to learn what standards are needed to support
e-prescribing, how MMA requirements are supported or not supported by current
standards, i.e., standards gaps and limitations. Finally what related issues
exist that may affect the implementation or acceptance of e-prescribing.
After this information was gathered NCVHS
then reviewed the standards gaps and limitations with the standards
developers. This dialogue helped NCVHS determine what standards have adequate
industry acceptance and what actions are necessary to address gaps and
limitations in standards for them to be available for the MMA demonstration
projects beginning January 2006, and then we have an appendix that will be
included that describes the work plan, which I think you’ve all received
The MMA provides that pilot testing of
standards is not required where there already is adequate industry experience
with the standards. At the July 21, 2004, Health Information Technology Summit
HHS announced its intent to accelerate the implementation of e-prescribing by
proposing an initial set of well established standards for implementation by
January 2006, when the Medicare Part D benefit begins. Standards appropriate
for inclusion in this initial set are identified in the NCVHS recommendations
below as “foundation standards.”
I think I’ll stop there for a second and ask
if anybody has any questions at this point. Obviously we’re referencing part
of the MMA regulation, we’re also mentioning this concept of foundation
standards as being something the Secretary might come as an initial set. Okay.
Stakeholder Testimony. NCVHS received
testimony from all stakeholder groups identified in the MMA, i.e., standards
setting organizations, practicing physicians, hospitals, pharmacies, practicing
pharmacists, pharmacy benefit managers, state boards of pharmacy, state boards
of medicine, experts on e-prescribing, other appropriate federal agencies. In
addition, testimony was heard from e-prescribing networks, demonstration
projects, software developers, and consumer advocacy organizations, and then we
have an appendix with a list of all the testifiers. In over 11 days of
deliberations from March to September 2004 NCVHS heard from 65 testifiers and
other industry experts.
In making its recommendations NCVHS utilized
the guiding principles and requirements identified in the MMA for selecting
e-prescribing standards. And these bullets are improve patient safety, improve
quality of care, improve efficiency, including cost savings, not present an
undue administrative burden on prescribers and dispensers, be compatible with
other standards, permit electronic exchange of drug labeling and drug listing
information maintained by the FDA and the National Library of Medicine, include
quality assurance measures and systems, permit patient designation of
dispensing pharmacy, comply with HIPAA privacy regulations, and support
interactive and real time transactions.
Types of Standards and Important Related
Issues, and then we’ll sort of discuss all of these three areas, and this is
really I think an important one that everybody just needs to be aware of
because it really speaks of the scope of the recommendations.
There are three types of e-prescribing
standards that NCVHS identified and evaluated as being necessary to support
e-prescribing. They are message format standards that provide communication
protocols and data content requirements, including those to support medication
decision making, terminologies to ensure —
MR. BLAIR: Simon?
DR. COHN: Yes?
MR. BLAIR: I think there was a sentence or
two that was skipped at the bottom of the guiding principles.
DR. COHN: Oh, I’m sorry, you know you’re
right, okay let me read this and I will go back and reread that. Thank you,
this will teach me for trying to zip through this.
Terminologies to ensure data comparability
and interoperability, and identifiers for all relevant entities within the
NCVHS further observed that deployment of
e-prescribing may involve policy or workflow issues that are outside the scope
of standards but are important related issues.
Now as Jeff has commented and I apologize,
there actually is a sentence that I skipped over and let me just reference this
in related to guiding principles for selecting standards and then we’ll discuss
this whole page.
It says in addition NCVHS believes the
standards should be vendor neutral and technology independent, preferably be
developed by ANSI accredited standards development organizations, and have
suitable indications of market acceptance.
So I just want to stop there and Jeff I do
apologize for missing what you’re right is a key sentence. Well, we’re moving
Our next section and this is the remaining
part of the document that’s observations and recommended actions, Jeff before I
jump into this one I actually had meant at the every beginning to offer you an
opportunity to make any comments. Do you want to make any comments as we move
into observations and recommended actions, other then I need to read slower —
MR. BLAIR: There’s only one brief comment
and the one comment that I kind of would share with the full committee as we
start to go through this is that the Subcommittee on Standards has come up with
recommendations and brought it to the full committee many, many times and what
we’ve listened to the industry in the past. And as much as we’ve tried to be
close and sensitive to the industry the e-prescribing recommendations I think
are remarkable in the degree of, I think maybe the word is almost
collaboration, we worked so closely because we were limited on time with the
testifiers and we reviewed so closely back with the developers of the standards
and terminology developers in crafting these recommendations that I think it
would be very fair to say that these recommendations very closely reflect the
advice and guidance of the e-prescribing industry.
DR. COHN: And I think I want to second
Jeff’s comments, I mean this was I think an extraordinarily open process by all
accounts even down to our ten hours of conference calls over the last week
which were all once again posted conference calls. So I think that once again
I think the industry certainly, at least from my perspective, felt that they
were heard and hopefully we’ve moved this process forward.
Anyway, with your permission shall we move
into our observations and recommended actions at this point? Okay.
NCVHS observes the that the U.S. healthcare
system has made considerable progress in developing pragmatic solutions for
e-prescribing. These solutions provide an excellent foundation to build upon.
The status of each e-prescribing standard evaluated is described in detail in
the working document in Appendix C, which is how many pages is it? 65 pages,
we didn’t send that out, and once again this is more of a reference document
that will be included with the letter, it’s an appendix.
DR. LUMPKIN: There are many trees that are
very glad that you didn’t send that out.
DR. COHN: Yes, exactly, this is sort of the
fact base upon which we used to help validate a number of the recommendations.
Following is a list of observations and
associated recommended actions. The observations describe the purpose and
extent of industry experience regarding a standard or issue. The recommended
actions under each observation recognize first any foundation standards, then
the actions to address additions, development, and pilot testing necessary to
meet the MMA requirements. While foundation standards do not in themselves
need to be pilot tested they do need to be tested with the expanded
functionality required by MMA. The observations and recommended actions are
grouped as follows: general overarching items, message format standards,
terminologies, identifiers, and important related issues.
Observation 1, actually Observation 1 and 2
are these, are things that we describe as general overarching items.
Observation 1 is general standards compatibility. Many testifiers emphasized
to NCVHS how important it is that e-prescribing standards be compatible with
all HIPAA standards, CHI standards, and clinical data terminologies recommended
by NCVHS in November 2003. This is to avoid dual standards for Medicare Part D
and all others. The testifiers’ observations are consistent with the MMA
requirements that e-prescribing standards should be compatible with HIPAA
standards and “general health information technology standards.”
Recommended Action 1.1: HHS should ensure
that e-prescribing standards are not only appropriate for Medicare Part D but
also for all types of prescribers, dispensers, and public and private sector
Recommended Action 1.2: HHS should ensure
that e-prescribing standards are compatible with those adopted as HIPAA and CHI
standards and with those recommended in November 2003 by NCVHS for clinical
Only 15 more to go.
MS. BEREK: I’m going to make one general
comment, I’m not from the part of CMS that actually does this piece so that I
read this letter last night cold without any general knowledge, this letter
does an incredibly good job of explaining the issues, the problems, and then
coming up with recommendations and I think that’s why we’re so quiet, that you
really have done an incredible job of making it possible for those people who
do not do this every day to understand where you’re going. So the silence I
think is a real compliment to the people who wrote the letter.
DR. COHN: Well, let’s wait until we’re done
with the rest of the 15 recommendations —
And Jeff and Margaret you obviously need to
be lauded for incredible work.
Okay, so we’re into Observation 2, which is
general standards versioning. There are lessons learned from HIPAA regarding
both the value of standards and the need for flexibility to respond to industry
requirements and technology changes. There are a number of approaches that
could be considered to provide the industry greater flexibility and ability to
advance while maintaining standardization of messages and data. For example
the CHI has set a precedence for this through adopting a version of its
clinical information standards as a baseline from which new versions may be
adopted by the industry when ready although this process is different from the
process required for standards adopted under HIPAA.
Recommended Action 2.1: HHS should work with
the industry in its rulemaking process to determine how best to afford
flexibility in keeping standards in pace with the industry, including standards
for HIPAA and e-prescribing. For example HHS might consider recognizing new
versions of standards, without a separate regulation, if they are backward
Okay, the next set are leading to message
Observation 3 is Prescription Messages,
actually let me, I think we have one minor wordsmithing change in Observation 3
as I remember so let me, okay, these are just very minor grammatical fixes.
Prescription Messages: The NCPDP SCRIPT standard provides for the exchange of
new prescriptions, changes, renewals, cancellations, and fill status
notifications. Each function has varying degrees of industry experience. The
NCPDP SCRIPT new prescription function is most widely used. The renewal
function has good industry acceptance, represents an easy transition, and
provides the most immediately apparent return on investment. The NCPDP SCRIPT
standards cancellation and change functions are currently underutilized. The
business case for fill status notification from the dispenser to the provider
has not yet been made.
The NCPDP SCRIPT standard allows for both
free text in certain fields and choices of codes. It is critical to standardize
on common, interoperable terminologies to provide automated decision support
required by portions of the MMA that relate to patient safety and cost
benefits. These items are specifically addressed in later recommendations.
Recommendation Action 3.1: HHS should
recognize as a foundation standard the most current version of NCPDP SCRIPT for
new prescriptions, prescription renewals, cancellations, and changes between
prescribers and dispensers, and the world all has been removed. The NCPDP
SCRIPT standard would include its present code sets and various mailbox and
acknowledgement functions as applicable.
Recommended Action 3.2: HHS should include
the fill status notification function of the NCPDP SCRIPT standard in the 2006
DR. MAYS: Observation three you say the
business case for fill status notification for the dispenser da, da, da, can I
just ask are you advocating they do it or I’m just trying to understand why,
that sentence just seemed to be there, do you advocate that, do you need it?
DR. COHN: Would somebody like, Stan —
DR. HUFF: The reason I think the sentence is
there is that potentially fill status has an important medical benefit, that is
the prescriber could know whether this thing would fill and so it could give
the provider significant information about compliance. On the other hand we
heard testimony from patients who said we actually don’t want our physician to
know whether we received that or not and so this is an issue that we actually
listed as one that we said we need more experience, then we actually need to
talk to more people and we need to do experiments about that and that’s why we
left this one in question.
DR. MAYS: Now I understand it but it just
seemed kind of —
DR. COHN: I think Harry has a comment too on
MR. REYNOLDS: It also comes into play when
we talk about downloading medication history because whether you do or don’t
have the fill status when the person goes to the doctor the next time if the
medication history is pulled down you also have the fill status again. So the
whole thing around that process is why we left it that it needs to be piloted
to truly understand exactly how this all works together.
DR. MAYS: Can you say that? Because
otherwise it just hangs.
DR. COHN: Well, what should we say? Because
the second piece which is Harry’s comment is actually the reference to the
business case which is this issue of well, do people even really need it which
seemed to be the question from the industry given that people would have an
opportunity potentially if they were getting the medication history to pull
down the next time they were seen. I don’t think we actually specifically
addressed, we heard what Stan was referencing but I think we didn’t want to
address it necessarily in the body of this particular recommendation.
MS. GREENBERG: I’m thinking it’s more, the
problem I think is more one of parallelism which talks about one of the part
standard is widely used, another part has good industry acceptance, a third is
under utilized, and then you’re trying to say why the fill status I guess isn’t
used at all, or maybe isn’t, so maybe just a kind of, I think this is kind of
shorthand so people in the standards area understand well you’ve got make a
business case before a standard is actually adopted and what have you, so maybe
just a little expansion of that last sentence.
DR. COHN: Well maybe we need to say
something, I’m just sort of thinking, Margaret may have a suggestion here but
we’re almost sort of saying that the fill status notification function is not
used and its business case is in question or is uncertain. Would that help, be
a little more parallel?
DR. MAYS: Well, it’s kind of a little
different, it’s interesting once you explained it it was a little different and
it’s not just about the business case but it’s more that, you’re almost saying
the business case needs to be made as if it’s a definite as opposed to we just
need to have the business case made because it seems like it’s fine but we just
need to have a case made for it. But it seemed like what was said today was
that you’re not sure whether to do this or not, that’s a little different.
DR. LUMPKIN: It’s not just the business
case, it’s the use case.
MR. BLAIR: Maybe this in combination with
clarifying the sentence that Vickie has properly pointed out could be confusing
to people, forgive my lack of a photographic memory but on the recommendations
do we then recommend an action that the fill status be included in the pilot
tests so that we could evaluate this? I thought we did but I’m not sure —
DR. LUMPKIN: Yes, 3.2.
MR. BLAIR: So if those are the two parts of
the ways to address Vickie’s thought, but I’m not sure, Vickie, does that still
leave an open question?
DR. LUMPKIN: I would suggest maybe we could
have language something along the line the fill status notification function is
not used today and its use case is not clear.
DR. ROBINS: Because the comment that was
made over here is that the patient may not want the physician to know so what
do you do if you are able, you do the pilot and you’re able to make the
business case, which is that it makes sense from a cost perspective or an
efficiency perspective to the dispensers and the prescribers but then the
patients don’t really want it, so then what do you do? I mean is there a
privacy issue here too?
MS. GREENBERG: Well, yeah, and I guess
Stan’s point was not one that I would have incorporated into business case, it
was more the issue of whether it’s redundant or whether people would use it or
whatever. Being part of treatment and payment, I mean I would think that the
provision of the information is already allowed under HIPAA but you could say
here when you’re talking about the need for pilot tests, you could say to
evaluate the use case or something like that, and patient acceptance if you
thought that needed to be included in the pilot, I don’t know if you —
DR. COHN: That’s actually not a bad
MS. BEREK: If I understood what Stan said is
that we’re really trying to balance patient privacy and patient quality of care
and so I think maybe that’s what needs to go in this sentence is that we need
to look at the privacy and quality tension and the balance and I don’t know,
I’m not a good wordsmither, but I think those are the two tensions really
because if the quality of care works then the business case is there because it
will give you better quality of care which will thus save money, but you need
to, I mean I tell my doctors whether I take my drugs or not, I find it hard to
believe people don’t want them to know but I think it’s worth looking at.
DR. COHN: Well, actually I won’t comment —
DR. CARR: I was going to say just something
to the effect of clinical utility and value added, something, to be explored,
but I think, I don’t know if it’s for us to decide the issue about whether the
physician is allowed to know if the patient took the medication but I would
vote that they are, speaking as one. I mean there are other ways physicians
can measure and find out if a patient has taken their medicine so it’s not
outside the realm of information that a physician already knows.
DR. LUMPKIN: And filling a prescription and
taking the medicines aren’t the same thing.
DR. MAYS: I think Judith’s point is
important because it gets back to what Harry just said and I think that, the
notion of thinking about privacy and the patient and quality of care are the
two issues here because I agree with what was said at first about you can make
a business case but we’ve just left out this very important comment about the
DR. COHN: I think for the record let me make
a couple of comments, I don’t think I ever heard, this was nothing something we
held specific testimony on in relationship to this particular issue, in fact if
it is going to be brought up it will be brought up at the Privacy and
Confidentiality hearings in relationship to all of this stuff. I think we
heard allusions to this particular issue. I find myself, I think there’s a
term here, I’m not sure the term is privacy, but I don’t know what the right
term is just because this is so intimately involved with treatment and care of
the patient, I guess I’m having trouble, it just doesn’t seem like it’s the
right term here just because we usually speak of privacy as inappropriate access
to information. But as I say that I’m just trying to think of where we go with
this thing, we may be handling it appropriately by the way Margaret has
wordsmithed it up here but we should look at it. Judy?
DR. WARREN: Well I’m wondering the issue,
and I’m speaking purely from a standards perspective, we have several different
parts of the SCRIPT standard and so as we took a look at each one of these
messages that were part of the SCRIPT standard we were trying to figure out
which ones were foundational and that we could recommend and which ones needed
further testing. And so when we looked at fill status what the industry told
is very few people use this currently, however the standard’s out there and so
we felt that it should be evaluated within the pilots. We really didn’t talk I
think about the ethical problems of privacy and I’m wondering if that should be
in some place else but not with this recommendation. And then as soon as I say
that then I struggle with the whole notion of privacy but somewhere we’re
mixing apples and oranges in this and I’d like for us to try to clean it up a
DR. STEINDEL: What we heard during testimony
as I recall it was there was discussion of the use of the fill status
notification and the implications of it. The fill status notification can serve
one of two purposes and is designed in that way, one is when the actual
dispenser fills the prescription, i.e., the drug is sitting on the shelf
waiting for someone to come in and get it. And there was a general feeling from
the providers that that message really did not do any good. What they really
wanted to know was when the patient came in to pick up the drug and the fill
status notification is not really being used for that. And then several people
brought up the implication that sometimes patients do not pick up drugs for a
lot of privacy related reasons, some of which may have to do with affordability
of the drug, some of it may have to do with their willingness to take the drug,
they just accepted the prescription from the physician because they wanted to
leave the office but really had no plans to take it, and we never explored that
in any depth. And I think this is all related to the issue that the fill
status notification is not clear and it needs to be explored in pilot if we
want to use it and what are the implications of it.
MR. BLAIR: I want to plagiarize in open
public session and steal some of John’s words and Steve’s words. John you
wound up pointing out, Steve you said the implications of the use of fill
status and then I’d steal John’s words is unclear. If we say that in the
observation piece then in the recommendation piece we indicate how this needs
to be pilot tested to resolve the unclear issues related to the standard.
MR. ROTHSTEIN: I just wanted to make a
general observation and I’ll leave to Simon and his folks where to put this,
and that is the issue that we’re talking about now, and that is patient control
of this information, is one that we’re going to be seeing in a much greater
light when we get to NHII. And it’s an overall theme of how much control the
patient should have over the patient’s own health information as we go to a
more electronic system, and we may want to flag it somewhere in the letter, I
mean I’ll leave up to you the specifics of that, but I think that it’s an issue
we’re going to see repeatedly.
And Simon I would say that this is precisely
defined as privacy, this really is the right of an individual to control
certain information, whereas what we often call privacy is really
confidentiality, the provisions that restrict the redisclosure of information
without authorization or consent. But we’ve been dealing mostly in HIPAA and
elsewhere with confidentiality issues and security issues, etc., but now we’re
going to have to focus on the real privacy issues, the core issues of control,
and that may be even more complicated then the stuff that we’ve been dealing
DR. COHN: Well, maybe I should ask Mark just
sort of odd question, does it make sense for us to say in the observations here
that testimony regarding the fill status notification revealed that there may
be confidentiality issues that, privacy, I’m sorry privacy, privacy issues,
real concern about possible privacy issues that will be explored with the
Subcommittee on Privacy and Confidentiality in later hearings?
MR. ROTHSTEIN: That would be fine, we have
plans to do that.
MR. HOUSTON: I notice on page 13 though you
do speak of the fact under next steps that there are issues related to privacy
and security with respect to e-prescribing, so you do have that place there
already because I would argue that it’s not just the fill status, the whole
concept of using e-prescribing does raise privacy implications and so I think
this is a global issue that you may want to leave more global.
MS. GREENBERG: After this discussion I’m
thinking that maybe the best thing to say here is that the fill status note,
you had it before, the fill status notification function is not used today and
further testimony and testing are needed before recommendations can be made.
Because that just, you’re not making, that’s what is obviously needed, that’s
what I’m hearing, rather then getting into the issues of use case, value,
privacy, I mean you’re not ready to make a recommendation on this other then
you know, it sounds like you even need more testimony on it.
MR. BLAIR: Would that then remove the
recommendation to include it in the pilot test?
DR. LUMPKIN: I hear Marjorie’s comments but
I’m not sure that I completely agree with them, I think that we’ve heard
testimony, and part of this thing is that let’s test it and find out how real
people feel about this sort of thing and I think so taking it out of the
recommendation that this should be part of the testing —
MS. GREENBERG: I didn’t actually recommend
that it be taken out of the recommendation.
DR. CARR: I have a question, on the Power
Point that we saw we saw mapped out very nicely the process, that this is a
process, but underneath this is there a data repository, so that if I go to CVS
and CVS can talk to my doctor but can my doctor see, have access to all the
pharmacies I’ve gone to? I mean I guess it’s a more global issue, we’re fixing
a process but where does this data reside and who has access to it?
DR. LUMPKIN: Well, that’s probably more in
relationship to the architecture of the NHII as a whole and some discussions
about how that sits, I don’t think that anyone, at least what I’ve seen here,
nor would we propose a central drug repository, that would have such a negative
response I think to many sectors of the American public if we were to create
such a repository, rather we’re talking about how we have interactions.
The other piece, and I want to sort of toss
this one to Mark, not to respond today, but it really gets to the issue of
granularity of the patient’s control of their own health information. My guess
is is that if you were to ask most patients they probably believe their
pharmacist and their doctors talk, and so that there are very few people who
would be surprised if their doctor knew, or if their doctor didn’t know that
they didn’t fill their prescriptions. That may be a confusing statement but I
think that most people believe that occurs.
So we really have to at some point begin to
tease out can you really get to the point, what’s the burden on the system of
trying to have every single potential information transaction be under the
patient’s control as opposed to classes of transactions, in other words I want
my doctor who prescribes my medications only to know about that, as opposed to
I want my doctor to know about the fact that they wrote a prescription but not
whether or not I’ve filled it. That’s a much higher level of granularity
control and I think at some point we’re going to need to make some recommendations
in relationship to that although not in this particular document.
MR. BLAIR: The privacy aspects of this are
unclear but they’re not the only aspects of its usage that are unclear, so it
would be my suggestion that as we go through the modification of the sentence
that’s in the observation piece, the observation piece were worded to
communicate the status and any issues or problems related to the particular
standard, and I think we have to separate out the status and the problems,
which are in the observation section, from what our recommendations are below
so what I’ve been hearing so far is attempts to clarify the sentence that’s in
the observation section and I don’t think I’ve heard so far that anybody has
opposed the recommendation to address those. And if that’s the case then if we
go back to the observation section if we acknowledge that there are a number of
issues, including privacy, which are unclear then it gives us the opening to
address them then in the recommendation which says that they need to be tested
and we might add in the recommendation that we also need to get additional
testimony but that’s kind of a recommendation back to ourselves.
MS. GREENBERG: Steve added a very
interesting feature here and what it made me think was that at least I’m still
thinking in a paper environment and we’re talking an electronic environment and
it sounds like this fill status notification has nothing to do with whether the
patient filled the prescription. The prescription is sent electronically to the
pharmacy, the patient, unless they say to the prescriber don’t send it, it’s a
fait complete, it’s sent, the dispenser then goes through whatever he or she
has to go through to get authorizations, whatever, but assuming that everything
is okay he fills it, and that’s what the fill status notification is. The
patient has not been involved at all at that point, I mean other then getting,
but they haven’t taken any action. Am I correct? So this is —
DR. HUFF: That’s one way it could be done,
but I mean it’s a matter of how the system is programmed, in other words the
pharmacy obviously, it’s sitting there, and they in fact will re-shelve that
prescription if it’s not picked up in a certain point of time. And so they
could trigger the fill status to be sent at the time that it actually leaves
when the patient picks it up if they wanted to program their system that way.
And just to throw one other thing in there,
one of the other issues that was referred to in the testimony was in fact
providers may not want to get the information because it then increases their
liability for non-compliant patients.
MR. BLAIR: That’s not in the letter.
DR. CARR: Well just that right now it seems
like a uni-directional system, the prescription is written, it goes to the pharmacy,
the drug is dispensed, it goes to the patient, we don’t have a system that’s
bi-directional, that sends that information back to the physician and in the
absence of a repository I’m trying to figure out how that communication would
be happening anyway unless a physician inquired.
DR. LUMPKIN: Well, it would be an
end/end(?), so if it sends back a notification to the physician’s electronic
health record then it would complete a field and when you called out the
prescription right next to it would be a marker that would say filled or not
filled, I mean there are any number of ways that you can do that without a
DR. CARR: But is that what we’re
envisioning, a bi-directional system that —
DR. LUMPKIN: If in fact, and I think that’s
what this whole description is is that most of this thing is uni-directional,
this one particular field is bi-directional and is not used.
MR. REYNOLDS: I think if you step back from
the process so the full committee can follow, we are recommending when you go
through this whole set of recommendations an entire process, and to play off of
Justine’s comment a minute ago, it is very bi-directional, this is step one,
this is only the first thing we’ve hit that’s starting to get, when you talk
about medication history which is another one of our recommendations and the
reason I brought the point up earlier was not the business case, it was based
on the privacy, it’s based on the quality of care, if a physician is treating a
person under ultimate e-prescribing which is this letter, they will be able to
download from a PBM or from the Medicare PBM, all of the prescriptions that the
person has taken, so there’s no single pharmacy involved anymore, it’s coming
down with everything that they get. So we’re talking about one situation where
somebody might not want a doctor to know, we’re going to be talking to you
about a recommendation in a little bit that says oh by the way it doesn’t
matter what pharmacy you went to, it doesn’t matter what doctor you went to,
your physician that you are standing in front of right now on their desktop or
wherever they are will get a picture of your medication history. When they
order a drug it will put against there for contraindications, you will make
sure that they are not prescribing, if we use this example, you can be myopic
and say no, but on the other hand then the doctor gives a prescription to
someone, didn’t know they were taking something else, and we have all these
issues that we hear.
So as you listen to the letter and as we take
each point we are painting for you a picture of an entire new process. We
showed you the chart on the current, you haven’t seen the chart, you’re seeing
it an indication at a time on what e-prescribing is. So all of this data, and
we talk at times, because it does improve patient safety, it does improve
quality, but it does also make more information available then is currently
available which brings all these other things into play. So I ask you as you
listen to these each one of these is a piece but it is a piece of a full
painting that we’ve done for you and that’s what’s going to be, as we discuss
this that’s what’s going to be key in relation to our answers to you. Because
a single answer looks like it’s out of balance but it’s not when you look at
the overall thing but it does raise these issues.
DR. VIGILANTE: I was just going to suggest a
process issue, I think and seconding what Jeff said and what Harry is saying,
perhaps either we have a more austere sentence that says less, or a more robust
sentence that includes sort of all the spectrum of possible objections, I think
perhaps we delegate that or come back to it, and focus on the recommendation
which I think is sort of the bottom line for this particular segment and just
move on perhaps.
MR. HUNGATE: I think I’m probably saying
kind of the same thing that Kevin is saying, it seems to me that in the
observations we’re making a distinction between those things that are ready for
foundation and those that are not and that it ought to be pretty small there in
what’s said. But we haven’t done very much to say what the pilot test should
cover and so the recommendation it seems to me needs to be a little more
complex while the observation can be quite straightforward, which we got it
mixed up a little bit the way it is I think, but I’m comfortable with leaving
the rest of that to the subcommittee.
DR. LUMPKIN: I’m trying to understand your
comment, I’m still going to try to understand it, your recommendation is that
there be some fiddling with the last sentence under the observation and that
the recommendation 3.2 needs to be enhanced a bit.
MR. HUNGATE: Enhanced, to cover the
complexity of our discussion.
DR. LUMPKIN: So something to the effect that
HHS should include the fill status notification function in NCPDP SCRIPT
standard in the 2006 pilot test, these tests should review issues related to
privacy, utility and so forth, and business case —
DR. COHN: That actually probably is a good
way, is that —
DR. LUMPKIN: Can we move on?
DR. CARR: I’d like to see Simon’s other
Power Points actually now, but I think to Harry’s point we probably need to
know the big picture where we’re going because we’re starting with this and
we’re heading to the electronic health record and each of these issues as we go
through them, we need to where we’re going with them and whether we’re at tier
one just making things legible, tier two, checking against other medicines,
tier three, checking against best practice or whatever it is, because we’re
getting there incrementally and we’re touching on one issue that actually is
the topic of an entire other committee.
DR. LUMPKIN: Okay, I think that if you look
back on page three and you look at the discussions of the various e-prescribing
capabilities I think those kind of give the big picture of what the potential
is for the system.
DR. COHN: And we’re talking about levels
three and above, and I guess I would also comment that I think Justine you’ve
described a uni-directional system but at least in my experience the current
environment is not uni-directional, I get calls from pharmacies all the time,
XYZ, there’s a contraindication, geez, did you know that XYZ isn’t taking this
medicine so before you up the dose you need to be aware they didn’t get it
filled last time so you ought to stay at the same dose, I mean all of this
happens, it just happens verbally now. So I don’t think we should of say that
geez, I mean if there’s lack of information it’s not intentional and that lack
of information actually harms people currently, probably all the adverse drug
events and all of this, so I think the intent here is to provide a safer better
way of doing this and so I think that was the logic underneath all of this.
DR. CARR: But what Harry said is we are
going to have a kind of local repository at whatever it is, I mean it’s not the
whole electronic health record but according to this you will be able to
download all the medications by all the doctors from all the pharmacies, right?
MR. BLAIR: In some cases.
DR. COHN: Why don’t we hold that until we
get to it because that’s really an issue of if you’re an insurer and the person
is insured and there’s, there are obviously ways now to get that information
down to the provider, just in the same way if you work in a health care system
you might have an understanding of what other people in your groups have
MR. BLAIR: Could I suggest one thing that I
think may help a little bit?
DR. LUMPKIN: Jeff, what I’m going to suggest
is I think, unless we have something specific on this particular
recommendation, which I think we’re done with, we’re scheduled to break for
lunch, and we’re actually ten minutes late. Let’s do that and then maybe we
can start off the next portion of the discussion with a little bit more
framing. Vickie, did you have something —
DR. MAYS: Yes, it was a suggestion, I was
going to suggest that maybe it would be helpful to put graphics in that
describe the process and that just for the sake of transparency, because I
think some people are thinking as some of us were in this uni-directional mode
that you say up front somewhere that it’s characterized as being more
bi-directional so that, I think people need to get it, this is for more then
just the Secretary so maybe the graphic and a second, I mean you have so much
appendix so I don’t think putting in a couple of graphics would kill this and
just maybe kind of characterizing this as bi-directional.
DR. LUMPKIN: Well actually if you go back to
the graphic that you had, that’s a bi-directional graphic there, I mean there’s
back and forth, it’s an interactive environment, the question is is that
there’s actually, and Simon raised the point that you get calls, but then the
assumption is is that if you write a prescription and you give it to the
patient and you don’t get a call it was fine and the patient took it, that’s
not a reasonable assumption and that’s really the difference of the new
environment versus the old environment is that you have the potential to not
make the assumption but to actually have the loop completed that when you wrote
a prescription the patient filled it and that there wasn’t a drug/drug
interaction because there was no fill back, so I think it’s an issue not of it
being bi-directional or not bi-directional, but the question of what is the
potentiality to enhance quality of care in a new system.
DR. MAYS: I’m just saying make that a little
clearer I think.
DR. VIGILANTE: I mean I call now sometimes
to find out if a prescription has been filled because there’s sometimes for a
variety of reasons I think it’s important to know whether, because I have
reason to believe that perhaps its not and it helps me in the treatment, I’ll
pick up the phone and say did this patient fill this prescription. So it is
bi-directional now but it’s a lot more work, it’s very inefficient, but the
information is accessible to me if I want it and this just automates the
DR. LUMPKIN: John, last point.
MR. HOUSTON: Can I just suggest a framework
for getting through this letter? Because I think it might be helpful based
upon some comments I know that Harry made, that maybe we should try to read
through the letter because it sounds like there are some common themes as I
recollect that may become clear or maybe we want, it sounds like it almost
becomes a global issue in some ways, read through the letter and then say okay,
if people have comments mark up so we can go back by section and discuss it, or
discuss global issues, because again —
DR. COHN: Do you think this is going to come
MR. HOUSTON: Oh, I think it’s going to come
up again, just simply based on what Harry said, I don’t remember specifically
when I read through it, but then again, I notice in the next steps there is a
lot of coverage of the fact that there are some global issues that simply will
need to be evaluated, I’m just thinking this might be a little quicker if we
went through the letter in its entirely and then went back by section and said
does anybody have a comment on 3.1 or whatever.
DR. LUMPKIN: I think it may be perhaps more
useful of our time and productivity if people took some time during lunch to
read ahead. Some of us, because we sent it out ahead of time hopefully most
people have had an opportunity at least to skim through it and I would
encourage that people do that and that we still try to work through it
methodologically because if we read through there’s so much detail that it
won’t be productive to read through and then come back.
MS. GREENBERG: Just in case Margaret is
going to work on this flow chart or graphic during lunch or whatever I just
wanted to mention the first thing that really struck me when you put it up and
it was partly because it then came down, but when you had the prescriber, the
dispenser, and the payer but where was the patient. So obviously the patient
then gets imbedded in many of the subgroups but I would suggest, and I saw
probably that’s the only way to do it, it probably doesn’t make sense to have
the patient as a fourth bar up there although you could think about. But at
least I would do something with wherever the patient comes up to highlight it
so it’s clear that this isn’t just something going on between a prescriber, a
dispenser, and a payer, but there is a patient involved.
DR. STEINDEL: I would just like to point out
there are multiple diagrams for the e-prescribing process and it is extremely
complex and very varied and I think we should leave the diagrams out of this
because to put them in would delay the letter greatly or would give the letter
less impact because of industry comment on the areas that we missed.
DR. LUMPKIN: And with that we’re going to
take a lunch break. We’ll be back at 1:00.
[Whereupon at 12:15 p.m. the meeting was
adjourned, to reconvene at 1:10 p.m., the same afternoon, September 1, 2004.]
A F T E R N
O O N S E S S I O
N [1:10 p.m.]
DR. LUMPKIN: Okay, we’re going to get back
in the saddle, starting off with Observation 4 —
DR. COHN: [Off microphone.]
DR. LUMPKIN: We’re going to let the
subcommittee look at the wording for Observation 3 before it gets brought back.
DR. COHN: I guess I would ask for committee
members to at least take a look at the wording that’s being proposed for
Observation 3 and Action 3.2, we don’t need to discuss it right now but if it’s
not adequate to, if it doesn’t meet your needs the subcommittee does need to
hear about it. And that’s it up there as has been wordsmithed.
DR. LUMPKIN: Well, let me read the two
sentences then. It would say as the last line in Observation 3 the fill status
notification function is not used today, testimony revealed that there may be
business case, clinical utility and individual privacy right implications. And
then Recommendation 3.2 is changed to read HHS should include the fill status
notification function of the NCPDP SCRIPT standard in the 2006 pilot test.
These tests should assess business case, clinical utility, and individual
DR. COHN: Okay? Good. Okay, let’s move on
to Observation 4, for Observation 4 I would point out the new 8 pt version of
the document that you received that now has a footnote on it and we’ll
recognize that as we read through all of this.
Observation 4 is Coordination of Prescription
Message Standards: HL7 is commonly used to communicate medication orders within
a hospital and with clinical pharmacies within an enterprise. Coordination of
HL7 with NCPDP SCRIPT would result in functions being more seamless across
healthcare environments. This would remove a barrier to adoption of electronic
medication ordering and prescribing. HL7 and NCPDP have already begun to map
their standards that support common functions.
Recommended Action 4.1: HHS should
financially support the acceleration of coordination activities between HL7
and NCPDP for electronic medication ordering and prescribing. HHS should also
support ongoing maintenance of the HL7 and NCPDP SCRIPT coordination.
Recommendation Action 4.2: HHS should
recognize the exchange of new prescriptions, renewals, cancellations, changes,
and fill status notification within the same enterprise as outside the scope of
MMA e-prescribing standard specifications. Now there’s a footnote within the
same enterprise where it says NCVHS recognizes that properly defining
“enterprise” may be complex. NCVHS encourages the Secretary to clarify the definition
Recommendation Action 4.3: HHS should require
that any prescriber that uses an HL7 message within an enterprise convert it to
NCPDP SCRIPT if the message is being transmitted to a dispenser outside of the
enterprise. HHS also should require that any retail pharmacy within an
enterprise be able to receive prescription transmittals via NCPDP SCRIPT from
outside the enterprise.
Comments, questions? Compared to the last
one that sounds easy.
DR. LUMPKIN: Well, the committee was very
enterprising in coming up with that.
DR. COHN: Okay, Observation 5, Formulary
Messages: Formulary and benefit coverage information, including information on
the availability of lower cost, therapeutically appropriate alternative drugs
(if any), from payer/PBMs to prescribers currently is communicated with
proprietary messages. RxHub, which is a national electronic formulary and
pharmacy benefits information exchange, has communicated its intent to submit
its proprietary formulary and benefits information file transfer protocol to
NCPDP to establish industry consensus and ensure the protections for the
industry afforded by becoming an ANSI accredited standard. Development of an
ANSI accredited standard appears to be possible in an accelerated timeframe.
This process will accommodate any specific requirements affecting the
implementation of Medicare’s new Part D prescription drug program.
Recommended Action 5.1: HHS should actively
participate in and support the rapid development of an NCPDP standard for
formulary and benefit information file transfer using the RxHub protocol as a
Recommended Action 5.2, and I would point out
that that’s been wordsmithed slightly, now it says NCVHS will closely monitor
the progress of NCPDPs developing a standard for a formulary and benefit
information file transfer protocol and provide advice to the Secretary in time
for adoption as a foundation standard and/or readiness for the 2006 pilot
tests. And the rationale here was depending on how that all goes and the
industry perspectives on this, if it happens quickly enough and the industry is
confident enough about it it actually could be recommended as one of the
foundation standards, otherwise it might be recommended as something to be
MR. SCANLON: Simon, this as I recall would
support any plans’ formulary?
DR. COHN: Well, by the time, yes, I believe
the intent, I can’t speak for the current standard whether it supports everyone
but maybe this is supposed to go through a standards process to have it
validated and become part of that process so theoretically any PBM which would
choose to use it should be able to use it, I think I sort of answered that, I
think the answer should be hopefully yes.
Six, eligibility and benefits messages. Eligibility
inquiry and responses are HIPAA transactions, and standards have been adopted
for their use in retail pharmacy and other sectors. The HIPAA standard for
eligibility communications between retail pharmacy dispensers and payers/PBMs
is the NCPDP Telecommunication Standard Implementation Guide, Version 5,
Release 1. While the HIPAA standard for eligibility and benefits
communications between dentists, professionals, institutions, and health plans
is the ASC X12N 270/271 Health Care Eligibility Benefit Inquiry and Response
Version 004010X092A1 (ASC X12N 270/271), which we will otherwise refer to ASC
X12N 270/271 transaction for short. There is good industry experience in using
the ASC X12N 270/271 standard for general drug benefit functions. ASC X12 has
identified workarounds for some of the gaps in ASC X12N 270/271 standard with
respect to drug listings and step therapy. ASC X12 reports that version 4050
addresses some of these workarounds more directly and that version 5010 is
under development and can more tightly address industry needs for
e-prescribing. Because Medicare’s Part D prescription drug program is new
specific requirements are not known at this time and new requirements may
Recommended Action 6.1: HHS should recommend
the ASC X12N 270/271 Health Care Eligibility Inquiry and Response Standard
Version 004010X092A1 as a foundation standard for conducting eligibility
inquiries from prescribers to payers/PBMs.
MR. BLAIR: Simon, you said HHS should
DR. COHN: Should recognize, I’m sorry, as a
foundation standard, so we’re saying the 270/271 should be a foundation
standard for these eligibility inquiries.
DR. LUMPKIN: Is that version A1 or A2?
DR. COHN: Thank you, John.
Okay, Recommended Action 6.2: HHS should
support NCPDP’s efforts to create a guidance document to map the pharmacy
information on the Medicare Part D Pharmacy ID Card to the appropriate fields
on the ASC X12N 270/271 in further support of its use in e-prescribing.
Recommended Action 6.3: HHS should work with
ASC X12 to determine if there are any requirements under MMA with respect to
how situational data elements are used in the ASC X12N 270/271, especially
concerning the quality of information needed for real-time drug benefits. Use
of these situational data elements could be addressed in trading partner
agreements, and there’s a slight wordsmithing here. Specifications of use of
situational data elements, as well as proper usage of the functional
acknowledgements, should be included in the 2006 pilot tests. The word these
has been removed in directly relating now to what we’re talking about.
Recommended Action 6.4: HHS should ensure
that the functionality of the ASC X12N 270/171, as adopted under HIPAA, keeps
pace with requirements for e-prescribing and that new versions of the standard
be pilot tested.
Okay, Observation 7, prior authorization
messages. Under HIPAA claims, eligibility, and benefits information between
dispensers and payers/PBMs are communicated using the NCPDP Telecommunication
Standard Implementation Guide, Version 5 Release 1. The need for prior
authorization for a drug is identified between the payer/PBM and the dispenser
through this process. The formulary and benefit file transfer protocol
developed by NCPDP provides information from the payer/PBM to the prescriber
about the need to obtain prior authorization of a drug. The NCPDP SCRIPT
standard may be used between the dispenser and prescriber to communicate the
prior authorization approval for a drug. However, the request for a prior
authorization for a drug from the prescriber to the payer/PBM is now conducted
in a manual mode. This is due, in part, to the complexity of the decision
making involved in ensuring that the use of a drug considers cost, patient
safety, special handling or administration procedures, and other
The ASC X12N 278 Health Care Services Review
Standard, and I will not mention the version here, is a HIPAA standard that
provides for prior authorization inquiry and response in general. It provides
very limited support for prior authorization of drugs and is not widely used.
Recommended Action 7.1: HHS should support
ASC X12 in their efforts to incorporate functionality for real-time prior
authorization messages for drugs in the 278 Health Care Services Review
Standard for use between the prescriber and payer/PBM.
Recommended Action 7.2: HHS should support
standards development organizations and other industry participants in
developing scenarios to ensure the proper flow of prior authorization
information throughout the entire communications process, and this includes
obviously the Telecommunications and SCRIPT standards as well as the 278
Recommended Action 7.3: HHS should evaluate
the economic and quality of care impacts of automating prior authorization
communications between dispensers and prescribers and between payers and
prescribers in its 2006 pilot tests.
Recommended Action 7.4: HHS should ensure
that the functionality of the 278, as adopted under HIPAA, keeps pace with
requirements for e-prescribing and that new versions to the standard be pilot
DR. MAYS: Recommended action 7.2, I had
questioned, I brought this up, what this issue of scenarios are, I don’t
understand that particular recommendation where it’s, you develop scenarios to
ensure the proper flow of prior authorization information, what do you mean
there and how can a scenario actually accomplish that?
DR. HUFF: With prior authorization the
problem is I think we didn’t even understand the information flow, and what I
mean by that is that you can imagine that the provider was aware of the need
for prior authorization and then they might query the benefit person and ask
them what are the actual needs, I mean does a patient have to be over a certain
age, do they have to have had this lab test done before you can do this, can
you do that, and they respond back and say these are the requirements for prior
authorization, the clinician would then fill those out and send them back, but
it wasn’t clear how that would work. And so part of what we wanted to get to
here is that in fact we need to discuss and examine those issues of
understanding whether it’s a single exchange, or maybe the other way it would
work is that drugs that need prior authorization they would download the
information about what information was needed for a particular drug as part of
the benefits, as part of the formulary loading process, and so the knowledge
and logic of what needed to be accomplished to get the drug would be known at
the time of prescribing.
Anyway, the fact that we didn’t understand
all of the issues of how that might work is what we’re trying to allude to here
and that developing the scenario is to say it might be one or two different
ways that it could work but we really need to say how the information would
flow before you could design the transaction that would support that flow, and
the content of the messages.
DR. COHN: Vickie, I agree with sort of what
Stan was saying here, I’m just sort of wondering if we, if this is a
wordsmithing issue here because I think we’re talking about developing
scenarios but it’s more then just developing scenarios, it’s sort of like, I’m
not sure whether it’s developing and testing scenarios in the pilot, which I
think is what we sort of meant here, but maybe we need to add that sort of a
concept, would that be helpful?
DR. MAYS: It would be a lot clearer because
I was like well how can a scenario, now I understand what you’re trying to do,
I think if you added a little more clarity, there’s nothing above that kind of
tells you that you don’t have that kind of information so then when it gets
down to here, how is the scenario that powerful.
DR. COHN: I think we have some wordsmithing
up there, I’m not sure that I’m completely satisfied with it —
DR. MAYS: See, even in a parallel process
that part just kind of comes, to me again kind of out of the blue, I mean I
understand what you need to do in terms of the last two sentences, the last two
parts of that, last two sentences, last two lines, I’m sorry, I’m getting tired
here, the last two lines, the first two, it just needs a little more
information but I think you all can do, we don’t need to wordsmith here.
DR. COHN: Okay, but I think you’re pointing
out something the subcommittee needs to work on and we’ll bring back but I
think it’s a good point that it somehow doesn’t quite, I think we have all the
ideas but it somehow isn’t well expressed.
Okay, anything else related to 7.2? We’ll
see Margaret beginning to work on this, I’m sorry, Russ, excuse me.
MR. LOCALIO: This is Russ Localio. You may
want to defer my question to the end but when I see a pilot test of the
economic and quality of care impacts of anything I view that as very different
from a pilot test of what I would call the implementation of standards in some
type of an electronic system. Now at some point I think we have to discuss
what are going to be the recommendations, or what should be the recommendations
of the committee, on pilot testing, what is going to be pilot tested, and are
the pilot tests that need to be done going to be possible, feasible, in
calendar year 2006. This is one of them that I really question whether it’s
going to be feasible but we can defer that until the end if you want.
DR. COHN: Well, why don’t we talk a little
bit about it at least now and then we can potentially talk about it more when
we talk about the pilot objectives, which I think is what you’re also
reflecting on —
MR. LOCALIO: This is one of them/
DR. COHN: I guess from our view and I’m just
sort of reflecting I think some of the testimony we heard, and once again this
is not well said here, obviously we thought it was perfect when we walked in
but of course as we look at this up on the screen we’re seeing things, but it’s
basically, I think for this particularly piece unlike many others I think we’re
talking about the pilot test both evaluating the ability of the standard to
support the business process, and I’m using the wrong words, in other words it
being able to work, but I think we were also very specifically wanting to sort
of make sure that knowing how complex and how delicate the balance is around
prior authorization within the industry that we wanted to make sure that we
understand if changing how prior authorization occurred whether it was going to
have unanticipated economic consequences or unanticipated patient care
outcomes, so we thought that was part of the criteria for this very
MR. LOCALIO: I think I agree with you except
I submit that a pilot test for what you just said, that concept, I’m not sure
that that can be done by the end of 2006 if we start it in the next five
minutes, if we started right now I’m not sure that it could be completed by the
end of 2006 unless I’m greatly mistaken as to what you’re talking about here.
Or do I have a different concept of what we anticipate out of pilot testing of
the economic and quality of care impacts of something such as automated prior
DR. COHN: Well, I don’t know because I don’t
know what your concepts are.
MR. LOCALIO: I work on a lot of studies that
take three to five years to do, that’s once you get the funding, that are
easier to do then this. And yet I know from reading the statute says here,
during the one year period that begins on January 1, 2006, the Secretary shall
conduct a pilot project to test for the efficient implementation of the
requirements described in paragraph two, and that’s basically everything in the
Act. So maybe we should defer this until the end but I get the feeling that we
can’t possibly, what we’re recommending can’t possibly be done.
DR. COHN: Steve?
DR. STEINDEL: This is a very complex issue
both from an industry point of view and as you point out from a study point of
view. We are somewhat aided in this in that there’s a natural experiment going
on that we really haven’t gathered data that we don’t mention in this, and
there’s a significant difference in the rate of prior authorization that goes
on in the Medicaid system versus both the Medicare and the private sector
systems. So we do have something that we could look at to derive some
inferences on the economics and quality of care issues from a natural
experiment point of view that can help jump start the pilot. So I think there
are ways to derive useful information in a year, I don’t think we’ll get a
definitive answer, but I think we will get some useful information.
MR. LOCALIO: Let me suggest then that we
defer this until the end and when we talk about what is going to be pilot
tested we may want to ask do we really want to recommend that A, B, C, D, E,
and F be pilot tested or how do we want to distinguish the things that we think
can be done and those we ought to know that they can’t be done.
DR. COHN: Okay, well we can rediscuss it
towards the end when certainly when we hit the pilot test objectives and beyond
as seems appropriate, I think that’s fine.
Any other comments about all of this? Okay.
Observation 8 is medication history messages
from payer/PBM to prescriber. The exchange of medication history may occur at
multiple points, among prescribers, between patients and prescribers, between
payers and prescribers, and between prescribers and dispensers. MMA indicates
that medication history should be provided to prescribers and dispensers but
does not explicitly identify the source or actual intended use of the
Medication history from payers/PBMs to
prescribers is currently communicated primarily with proprietary messages.
RxHub has communicated its intent to submit its proprietary medication history
message to NCPDP to establish industry consensus and ensure the protection of
the industry afforded by becoming an ANSI accredited standard. Development an
ANSI accredited standard for medication history messages between payers/PBMs
and prescribers appears to be possible in an accelerated timeframe.
The following recommended actions address
only exchange of medication history from payers/PBMs to prescribers. NCVHS
plans to address other medication history communications in its March 2005
Recommended Action 8.1: HHS should actively
participate in and support rapid development of an NCPDP standard for a
medication history message for communication from a payer/PBM to a prescriber
using the RxHub protocol as a basis.
And recommended Action 8.2, which has once
again I think been wordsmithed a bit, and I will pull out my little version
here, it says NCVHS will closely monitor the progress of NCPDP’s developing a
standard medication history message for communication from a payer/PBM to a
prescriber and provide advice to the Secretary in time for adoption and/or
readiness for the 2006 pilot tests. I mean basically this very much mirrors
the recommendations I think in Action 4, and so we’re talking about in time for
adoption as a foundation standard and/or readiness for the 2006 pilot test. My
apologies for referencing back but our intent was to make this parallel to the
recommendations actually in Action 5.2.
Comments or questions?
The next item is Observation 9 which is
clinical drug terminology, this may in many ways be the most complex topic that
we discuss and I will apologize, I think we made every attempt to make it as
understandable as possible but when were talking in the world of terminologies
there’s always some complexity.
This is clinical drug terminology. Today’s
e-prescribing systems support free text entry of a clinical drug and/or
selection of a clinical drug code from one of several proprietary terminology
systems. A standard terminology for clinical drugs facilitates automated drug
utilization review and decision support for patient safety. It is also
necessary for interoperability among different e-prescribing systems. However,
it is recognized that not every item ordered by a prescription will always be
included in a terminology, e.g., compounded drugs, devices, and supplies. This
means that the ability to enter text in an e-prescribing system must be
The National Drug Code, otherwise known as
NDC, is used by dispensers to identify packaged drugs. However, NDC is not
appropriate for use by prescribers in describing the clinical drug. To address
this need the NLM has produced a clinical drug terminology, Rx-Norm. Rx-Norm
provides links from clinical drugs to their active ingredients, drug
components, and most related brand names. Fully comprehensive Rx-Norm
terminology for all marketed drug products, including generics, repackaged
drugs, and over the counter medications will not be available until structured
product labels, otherwise described as SPL, for all those items become
available to the NLM from the FDA. When the SPLs become available it is the
intent of the NLM to update the repository of drug information on a daily
basis, and that’s called as the DailyMed. Additionally until the full set of
brand names is included in Rx-Norm some “dispense as written” prescriptions
cannot be accommodated through e-prescribing.
NCVHS further observes that the FDA is
looking to the VA’s National Drug File-Reference Terminology, otherwise
described as NDF-RT, to prescribe drug classifications for use in the SPL. In
addition the MMA directed HHS to request the United States Pharmacopoeia to
develop model guidelines for drug categories and classes that the prescription
drug program sponsors participating in Medicare Part D can use in structuring
NCVHS documented deficiencies in the NDC that
must be overcome to support many clinical applications, including
e-prescribing, in its Report to the Secretary on Uniform Standards for Patient
Medical Record Information, dated July 6, 2000. NCVHS recommended adoption of
the Rx-Norm in the core set of clinical data terminologies in its Letter to the
Secretary on Recommendations for Patient Medical Record Information Terminology
Standards, dated November 5, 2003.
Recommended Action 9.1: HHS should include in
the 2006 pilot tests the Rx-Norm terminology in the NCPDP SCRIPT standard for
new prescriptions, renewals, and changes. Rx-Norm is being included in the
2006 pilot tests to determine how well the Rx-Norm clinical drug, strength, and
dosage information can be translated from the prescriber’s system into an NDC
at the dispenser’s system that represents the prescriber’s intent. This
translation will require the participation of intermediary drug knowledge base
vendors until the Rx-Norm is fully mapped.
Recommended Action 9.2: HHS should accelerate
the promulgation of FDA’s Drug Listing rule and hence the ability to support
the correlation of NDC with Rx-Norm, e.g., for passing daily updates of the SPL
to NLM for inclusion in the DailyMed.
Recommended Action 9.3: HHS should ensure
that, if the Medicare Part D Model Guidelines and NDF-RT differ, an accurate
mapping exists so they both can be used successfully.
Enough acronyms for everybody? Russ.
MR. LOCALIO: This is Russ Localio, I’m sorry
but again I have a problem with this section, let me just kind of recite a few
concerns. There’s the sentence, the FDA is looking to the Department of
Veterans Affairs, what happens if the VA cannot deliver a complete version of
NDF-RT in time? Then I ask well, what happens if the participation of the
intermediary drug knowledge based vendors is not as forthcoming as one would
hope under Recommended Action 9.1? And these are my concerns, it seems to me
that for this to work it has to rely on the VA, the FDA, private enterprise,
and this is at the beginning of the pilot test on January of 2006. Can the
recommendations, let me ask this, are the recommendations forceful enough or
are they sober enough to get the point across that we don’t have too much time
to go here, or am I just desperately worried about this?
DR. COHN: Why don’t we address, I’m going to
let Jeff comment, I think Stan, I know we have Randy Levin from the FDA here, I
think really what you’re asking is is how much of all of this stuff is good to
MR. LOCALIO: Correct.
DR. COHN: Just to bring it down to the
MR. LOCALIO: If you look on the NLM website
as I did yesterday and you look at some of these pointers here, they don’t
point to anything real, they point to descriptions of what there is or what
might be but this is September of 2004 and we don’t have that much time to go.
DR. COHN: Okay, Jeff, Stan, and then we’ll
let Randy —
MR. BLAIR: Russell, you are not alone. The
subcommittee shares your concerns very much so and the recommendations that are
there we developed in part by trying to see how we could be constructive in
these recommendations to address those concerns. Now that I’ve said that, so
you know you’re not alone and that we share these concerns and that we try to
develop recommendations that would address them, if you or anyone else has a
way to either be more emphatic but still constructive I think that many of us
would be very receptive to any constructive suggestions to make this stronger.
MR. LOCALIO: I’m not very good at being
politically correct because of my background, but suppose there was, I mean I
don’t get down to Washington except to come to these meetings, but suppose
there was a statement that said something like this, for this to work we’re
going to have to have the daily cooperation among disparate agencies, such as
A, B, C, and D, and that is a prerequisite for pilot testing to begin on
January of 2006 —
MR. BLAIR: Maybe if you focus in on that 9.2
because that’s where we tried to get at this concern and if that, if 9.2 is not
sufficient what could we do to strengthen it, but strengthen it in a
DR. COHN: And why don’t we let some of these
other, we have other people talking and I think some people want to reflect on
I think what the status of things are, so Stan, I think you’re next.
DR. HUFF: I agree with strengthening the
statements in any what that would be appropriate. One thing that I would point
out is that the paragraph in the observation about NDF-RT is in fact
observational, that is there is no recommendation here about NDF-RT and that
was partly because of the fact that there’s NDF-RT and then there’s this drug
classification that was asked, that USP was asked to provide and that all needs
to evolve and so we didn’t take any action relative to NDF-RT because that’s
obviously much less understood and defined then some of the others.
In terms of Rx-Norm there was testimony that for
instance Rx-Norm took the thousand most prescribed drugs in the VA and found
that of those top thousand 26 were missing out of Rx-Norm and that most of the
things that were missing were names of devices or supplies. So we had a
reasonable comfort that Rx-Norm is fairly complete in terms of content so the
real part that’s missing and most in question is the mapping between Rx-Norm
and the fillable drugs at the NDC level.
The other thing that was testified to, I mean
they were all in the same room at least where we had the drug knowledge based
vendors, MediSpan and FirstDataBank and those other guys, who have really been
supplying most of the content for that, and they said we plan to or we’re
already working on doing that. But again, I’ll second what Jeff said, that
anything we can say here to strengthen and underscore that that needs to be
done would really be I think helpful.
DR. COHN: Which one to go first, Vivian or
Randy? Vivian, do you want to maybe talk about Rx-Norm for just a second and
then let Randy Levin from the VA talk about his perspective, and I think once
again we can sort of reach a conclusion after we heard all of this.
MS. AULD: I am Vivian Auld from the National
Library of Medicine. Picking up on what Stan just said the drug knowledge
bases, many of those already exist in the Unified Medical Language System,
which is where Rx-Norm resides, so a lot of that mapping has already been done
up front, it’s just a question of how useful that is to the industry and so
that’s what we really need to test. But we’ve been doing this not just on our
own but in conjunction with the developers so we feel that it’s pretty good up
front. I’m not sure what else, I’m going to hand it off to Randy.
MR. LEVIN: I think some of the testing for
the Rx-Norm was test how that model concept would work in the SCRIPT so that
can be done at this point. As far as the NDF-RT classification, we have looked
at the classification from the VA and we’ve looked, and we’re comparing it to
what the USP has been proposing and we’re going to be meeting with the USP to
try to see how those two things would match. But we’ve already had a
classification system being developed at the VA that we’ve looked at.
MS. BEREK: The Secretary and the CMS
administrator have both been very public and very aggressive about saying
they’re going to make this happen on time and so I think if it is humanly
possible it will happen on time and I will say in the last few years I have
watched things that we all said we can’t possibly get done on time get done on
time. And so I think if you want to talk about a way of making it stronger
maybe in the opening paragraphs you want to talk about the Secretary’s public
commitment to making this move at almost inhuman speed and how that is
necessary in order to get this done, I mean that’s, but I think we really,
maybe you want to end with it, but I think there is no question that he has the
commitment to make this happen when it is supposed to happen because nobody
wants to go back to Congress and say we’re terribly sorry we can’t do the drug
benefit when you want it to be done. There isn’t anybody who’s going to say
that and so whatever has to happen for that benefit to go into effect is going
to happen. And I think that we sort of have to reflect, think about that as
we’re doing this, you may, Russ, look at this and say it can’t possibly happen,
well it will. It may not be in great shape when it happens but it will happen.
MR. LOCALIO: That’s what I’m afraid of.
DR. COHN: Okay, let Steve and then I have a
comment and then I’ll let Jeff talk.
DR. STEINDEL: I’d like to somewhat react to
what Judith just said but it’s in part to what Russ’s concerns, etc. I think
we’re really addressing two concerns in this area, the first involves the pilot
study. And the pilot study, what we’ve heard is that the pieces do exist for
the pilot to work, as Stan pointed out for prescribed drugs Rx-Norm covers a
large portion of them, we did hear not in public testimony but informally that
the private drug database vendors have been mapping to NDC from Rx-Norm to see
if that works, which is not that big of a problem for them because they already
map their own clinical drugs to NDCs. So we are aware that that system can
work, now much how much of that system will be available publicly for pilots,
it’s all in pieces and can be brought together as Judith said for the pilot
studies, those will happen.
I think the other important part of this that
is only somewhat emphasized but addresses some of Russ’s concerns is we also have
to think about a system that evolves this on a daily basis once we start
putting Part D into regular use. And there’s parts of that that we are very
uncertain about and I don’t think we can just make them happen, in part because
they involve a lot of regulatory changes. And somehow, which is what we’re
getting at in 9.2, is we have to create an atmosphere within FDA to look at and
promote those regulatory changes in an expeditious fashion so that
e-prescribing can be maintained beyond the pilot studies. And I don’t know if
this adequately expresses that or not.
DR. COHN: Well, I think I was going to
comment and maybe I should let others also comment but I’m, I mean Russ,
obviously I do hear your concern and I know the context of it which is feeling
that there are may some vapor(?) wear(?) out there, if I can say this nicely.
I think the good news is that this is being proposed for a pilot as opposed to
being something that will be mandated on X date. I think most of us, and I
think I agree with Steve, that many of the pieces actually have been
sufficiently developed at this point, that they actually are ripe for a pilot,
this is not something where we’re saying we’ll get started on it and develop
it, you can start now and maybe by 2006 you’ll have something to pilot, there’s
actually things that are being published by the NLM on a twice yearly basis,
three times a year, four times a year, whatever, basis in relationship of
updating this and so there actually is something there.
Now I agree also with Steve that obviously
one of our big concerns is this issue about the FDA’s connection to the VA,
which right now is being handled through the proprietary knowledge base vendors
and their relationship with the NLM but obviously we’d like to see the FDA move
faster on this. But I don’t know that we can say much more then what we have
in 9.2 already in relationship to that, I mean I think we’re pretty forward
about it. I think this actually reflects what we ought to be saying, I guess I
wouldn’t argue if we wanted to use more emphatic verbs but I don’t know that
for a letter like this that emphatic verbs in the middle of otherwise, I mean
all of these recommendations are important so I don’t know what else to say
Jeff, you had a comment, and then we’ll
decide what to do about this.
MR. BLAIR: The only area, I guess I’m
resonating back to Russ’s concerns and this statement is not in disagreement
with what anyone else has said, I agree with everybody’s position on this, this
is a specific exposure that I think might be the greatest exposure for the
pilot tests, is will the information from the structured product labeling be
far enough along to feed to Rx-Norm to support the pilot tests. And I again, I
say this as a concern, if there’s something in this letter that we could do to
create a higher priority to get that done and that’s constructive, on the other
hand if we say it inappropriately where we’re not constructive then I would
leave it out. But I want to raise that as what I perceive to be the greatest
exposure to impeding the ability for Rx-Norm to be appropriately or fully
tested in the pilot test is the information from the structured product
DR. COHN: Steve, last comment and then let’s
wrap up on this one and see if we think that 9.2 represents our feelings.
DR. STEINDEL: I’d like to comment on being a
little bit more emphatic because we have a sentence in the observations, NCVHS
documented deficiencies in the NDC that must be overcome to support many
clinical applications, including e-prescribing, in its report to the Secretary
on Uniform Standards for PMRI dated July 6, 2000. Randy, when’s the NPRM
coming out? Don’t answer. I think that that’s the point, we’ve got to say
something very emphatic, the world has changed and there needs to be, things
that need to go through regulation if we want to meet the deadlines that are
being put on us by the Secretary there needs to be a realization that the world
is changing and there needs to be some more rapid responses especially in the area
where we need regulation.
DR. LUMPKIN: But this is a letter to the
DR. STEINDEL: Right, that’s why I think we
need to put a little bit more emphatic language in 9.2.
DR. LUMPKIN: And the language that’s up
there would be for 9.2, HHS should accelerate the promulgation of FDA’s drug
listing rule and hence stability to support the correlation of NDC with
Rx-Norm, e.g., for passing daily updates to the SPL to NLM for the inclusion in
DailyMed. This rulemaking is critical to sustain the daily use of Rx-Norm
beyond the 2006 pilot tests.
DR. STEINDEL: And John I thank you for
pointing me to the screen because I hadn’t looked at it, that would be perfect.
DR. COHN: So Russ, I don’t know that this
has fully satisfied your —
MR. BLAIR: It does have the word critical in
MR. LOCALIO: Yeah, it’s critical.
DR. COHN: I don’t know that we’ve completely
satisfied your desires but at least we’ve aired them —
DR. LUMPKIN: We got a thumbs up.
DR. COHN: That’s good. Okay, shall we move
on to the next item —
DR. FITZMAURICE: Could I make a one word
suggestion, could we say the timely, right there, that’s it.
DR. LUMPKIN: The timely rulemaking —
DR. FITZMAURICE: Yes, because with 2006
people will say oh we’ve got two years to do it —
DR. COHN: So timely rulemaking is critical,
okay. People comfortable with that? Okay, good.
DR. LUMPKIN: Please, come to the microphone
and identify yourself.
DR. COHN: I should comment this is one of
our experts —
MR. ROTHERMICH: Phil Rothermich with Express
Scripts. I just wanted to comment because none of the vendors are here, and a
couple places here we talk about including things in the pilots and we ought to
keep in mind that the software vendors that are doing electronic prescribing
will need some lead time to change their systems to accommodate some of these
things and so that ought to be anticipated. It’s really not reflected here.
DR. LUMPKIN: Is that a general statement
about the pilots that ought to be someplace in the document?
DR. COHN: I guess what I’m hearing is is
that HHS should provide guidance as soon as possible about the nature of the
pilots, or the functionality expected to be piloted —
MR. ROTHERMICH: Yeah, my concern is you talk
about the structured and codified SIG and you talk about clinical drug
terminology, to the extent these systems today are using what’s out there now
they’re going to have to change the way their systems work and presumably when
you’re piloting electronic prescribing the pilots will involve some of these
existing software vendors because that’s what’s out there today.
DR. COHN: Okay, well let’s hold that thought
for 13 because I think that may be the place to put it where it says pilot test
objectives, and we’ll see if it fits in there which is more along the lines of,
and I think this is more as a general statement, that HHS needs to quickly
determine the functionality that needs to be tested and let the industry know.
DR. STEUERLE: It seems to me this last
question raises the issue of whether there is being developed now appropriate
timelines to make sure that things are implemented on time and those timelines
including the types of steps and developments that have to take place both
within the private industry as well as the public sector, continual statements,
things need to be done quickly and timely, doesn’t really give us a sense
unless somebody I presume is developing timelines on how these things are going
to take place. So does Express Scripts need a month, do they need two weeks,
somebody should be sitting back and developing a timeline so I hope somewhere
in here that this development of time, instead of constant sentences about
being timely and accelerating I hope it’s related to somebody developing a
timeline. You don’t really need to respond —
DR. LUMPKIN: Well, I’m not sure it’s
necessarily our responsibility to put the timeline, I think what our charge is
DR. STEUERLE: But there needs to be a
DR. LUMPKIN: What our charge is is to say
what is it that needs to be done and in fact the Secretary is accelerating the
timeframe that was put into MMA and because of that acceleration then obviously
things need to be done quicker, and the same person who’s accelerating is the
one who wants to see it done. But let’s hold that thought for 13.
DR. COHN: I think some of these things can
be added as additional actions because I in some ways agree with you, in many
ways agree with you and let’s see if we can come up with something there.
DR. LUMPKIN: I mean just to follow up,
because the issue is is that it’s probably not going to be good utility for
there to be a timeline if only a certain number of people know about the
timeline, so if we’re going to make a recommendation it ought to be a public
DR. COHN: I made a little note here and
we’ll try it out when we get to 13. Okay? Can we go to 10? Are we good to
Observation 10, structured and codified SID,
I want to thank Mike Fitzmaurice for his help with the derivation of SIG.
Patient instructions for taking medications are placed at the end of a
prescription. These are called the signatura, commonly abbreviated
SIG. Structured and codified SIGs will enhance patient safety, although it is
also recognized that free text capability must be preserved for special circumstances.
NCPDP, HL7, and others are working on addressing structured SIG components and
plan to seek broad industry participation.
Recommended Action 10.1: HHS should support
NCPDP and others, especially including the prescriber community, in addressing
SIG components in their standards. This should include preserving the ability
to incorporate free text when necessary, e.g., for complex dosing instructions.
Recommended Action 10.2: HHS should include
in the 2006 pilot tests the structured and codified SIGs as developed through
standards development organization efforts.
DR. HARDING: So off label SIGs could be
handled in the text, so if you were writing a SIG and it was an off label
indication that would be incorporated in the text? It would be free text?
DR. COHN: Well, I think that’s to be
determined by the standards development organization —
DR. HUFF: The only time the indication,
because the SIG is just a part of this and so if you, yeah, the indication
would normally only be there as part of a PRN thing and what we actually said
is that, I think we say down below that that’s a thing, the part we’re really
trying to standardize in the SIG is the frequency that the codes that are used
to indicate whether you’re taking it the route that you’re taking it by and
have those be consistent with the JACHO, with JACHO’s prohibited list of things
that are ambiguous and all that sort of stuff. So normally you’re not, the
indications wouldn’t come in here and whether it’s on label or off label
doesn’t really apply to this particular —
DR. LUMPKIN: Well, it seems to me that there
are a couple of parts and this may be where it comes in. I’ve got a patient,
I’m dealing with a particular ethnic or other group where communication is
important, I may need to communicate in Spanish. How do I electronically fill
out a prescription that gives the information that the patient needs to know
how to take it that then shows up when they go to the pharmacist? I’ve already
communicated with the patient, I shouldn’t be relying upon the pharmacist to
try to reinterpret something in a language that the pharmacist may not be able
to speak. And it seems to me that that plain text section under SIG would be
the area where that would occur. Is that correct?
DR. HUFF: Yeah, that’s true.
DR. LUMPKIN: And that would also apply to
whether it’s even off label, it may be under experimental protocol that you’ve
got a special way you want the patient to take it, you don’t want to encode
that, you want to —
DR. COHN: Yeah, but of course there’s a lot
that you can encode, QID, BID, TID, QOD, QHS, I mean on and on and this is
probably and 80/20, 90/10, and I think this is really an area for, rather then
us trying to micromanage this one this is something where it looks like the
standards organizations are beginning to work on it and that they need to
decide it themselves how best to work in this area.
DR. LUMPKIN: Well my question and concern,
and this is one that’s probably significant for us as a committee, I’m not
necessarily over confident given the usual composition of the standard
development organization community of their sensitivity to issues that
particularly affect cultural minorities, ethnic minorities, within this
country, and I think we may need to have some sort of statement that as we
think about this automated process we’re kind of taking people out of it and
there are many instances where if you take people out the chances of
misinterpretation when you have a standardized structured language increases
particularly for those for who English isn’t their first language, or for who
the culture of this country is not their first culture.
DR. COHN: John, maybe I’m thinking about
this a little differently but I’m thinking of sort of making it so there would
be sort of drop down lists with choices of things that then get sent, maybe
codified but they’re basically QID, TID, whatever, whatever, and then that
information gets sent over to the pharmacy, and I guess I would presume that
there might be some choice of what language gets printed out on based on who’s
receiving the medication. How are you thinking of this? You may be thinking
of it a different way.
DR. LUMPKIN: Well, I’m thinking let’s look
at choice of language, okay, Spanish, but is it going to be Puerto Rican Spanish,
is it going to be Mexican Spanish, is it going to be Costa Rican Spanish, so
there are really a number of issues where right now the big struggle is how do
we communicate. I think for special complex dosing instructions and where
cross cultural communication —
DR. VIGILANTE: But isn’t this communication
with the pharmacist? This is with the pharmacist right —
DR. LUMPKIN: Well, let’s go back to our
process which is right now I write a prescription and I give instructions to
the patient verbally. But what becomes written, which is that, now I’ve
developed an ability to communicate with this patient either because I’ve used
an interpreter or whatever, so I want to explicitly have something that goes
with that prescription and then shows up with that medication. So when the
patient gets it they will understand in a way that they can understand, which
is not just language but also is cultural context, Vickie help me out here, I
hope that’s why you’re raising your hand.
DR. MAYS: Yeah, I think what John’s trying
to say is let’s not miss an opportunity but I think we’re backing into it as
opposed to maybe being clear. Say for instance that in your office you have
communicated to a patient a particular way you want them to take this drug,
maybe because of diet issues, it may be because of any number of things. And
you in your office have the capacity because you have an interpreter or because
you yourself have gone to medical school in a place in which you’re taught
language. So you then do a set of instructions. What it seems that John is
saying is that okay, once this is sent how does that same set of instructions,
or is it a standardized set of instructions —
DR. VIGILANTE: I mean something like that
you happen to know whether it’s cultural or just patient specific, this patient
happens to like yogurt and you want them to take these non-steroidals with the
yogurt, something like that —
DR. LUMPKIN: Right, you’ve got a patient who
has a developmental disability and you know he takes yogurt at the same time
every day and the instruction is, not the standard one, take it with your
MR. BLAIR: Can we accommodate this by simply
adding an additional sentence to the recommendation indicating that HHS should
encourage the standard development organizations when they develop the SIG
standards to consider language and cultural requirements?
DR. LUMPKIN: That works, that works as a
DR. MAYS: I guess I’m concerned because I
don’t think people are, again, it’s one of these things when we have the
discussion it’s like wow, but when you read what you say, once you walk out the
room I don’t know they’re going to understand that. Maybe you should say
something about this a little bit earlier so that by the time it gets to the recommendation
they understand because I don’t think anybody is going to go out of their way
to make it, to understand what you mean in terms of the broadness because as
soon as you say cultural they’re really thinking racial ethnic minorities, when
it really is language, I mean there’s a variety of things this includes. So it
may require some little discussion before because this is an opportunity, it’s
an opportunity to not have populations come back two years from now complaining
DR. VIGILANTE: Isn’t it more just about
providing directions in a patient specific manner? In however that’s
appropriate, whether it’s language or other behavioral —
DR. LUMPKIN: I think that in the Observation
10 there should be some point that the SIG component may be the only place in
this electronic media to convey specific patient instructions in a way that
cannot be encoded.
DR. WARREN: John as a member of the
subcommittee I need to ask a question because I’m getting very confused. We’ve
said in here that we need to maintain the free text ability in this message to
convey whatever unique directions you want to give, so how is what you’re
asking for different then the ability to write out in free text what you want
the patient to see?
DR. LUMPKIN: I actually was not suggesting
that we change that statement as much as to enhance it so that there’s an
understanding that it’s not just because you have —
DR. WARREN: So more then just complex dosing
things but comments that would consider culture, etc.
DR. LUMPKIN: And language.
DR. WARREN: If we add it that way then I’m
okay with it, so up there on the e.g. for special or complex dosing or cultural
sensitivity or instructions, those kinds of issues. The standard itself I
think is pretty good, it allows for all that, it’s just letting people know
what goes into what box.
DR. COHN: So are we getting there? So we
read 10.1 as it’s been —
DR. WARREN: I think it’s more language
understanding or something like that, not requirements.
DR. MAYS: Unless it’s literacy requirements,
language and literacy requirements.
DR. WARREN: And then change it to
DR. LUMPKIN: It’s really for special complex
dosing, special or complex communication challenges which may result due to
language or cultural issues.
DR. MAYS: I think you want literacy —
MR. REYNOLDS: Isn’t it even more basic then
that? Isn’t it any necessary communication between the prescriber and the
patient? Why make a list? It’s really anything that the prescriber wants to
be able to say to the patient.
DR. WARREN: But I think it needs to be a
list for exactly what Vickie was pointing out, sometimes we forget to include
the cultural pieces and right now, I mean there’s lots of research literature
out there that says that we miss it because we don’t consider that and so it’s
just one more way to give an example.
DR. LUMPKIN: Right, I think it’s kind of a
blend of saying any other communication that’s essential to be there and then
especially address those areas, but I think we’re close enough that we can move
DR. COHN: Okay, and certainly for this one
if Vickie and John would sort of look at this during the next break and make
sure we have it right that would be helpful.
Okay, now I’m going to read over Observation
11 and 12 together because they’re basically both different types of
identifiers, one’s dispenser identifier and one’s prescriber identifiers —
DR. LUMPKIN: And one knows we love
DR. COHN: We love identifiers, and I mean I
think you’ll find there’s a certain similarity of the action items and
discussion, so I’ll read through 11 and 12 and then we’ll move from there onto
the pilot discussions and all of that.
Okay, dispenser identifier. The NCPDP
Provider Identifier Number has been in use for a number of years and is widely accepted
as the dispenser identifier, otherwise known as the pharmacy identifier. Its
database contains information to support various claims processing functions
and it needs to continue to be available for this purpose. The NCPDP database
can accommodate the National Provider Identifier, the NPI, as a reference
field. HIPAA requires the NPI, when it becomes available, to be used in the
NCPDP Telecommunication Standard for claims processing. The National Provider
System, the NPS, enumerates pharmacy organizations, subparts of organizations
at a particular address, and pharmacists.
Recommended Action 11.1: HHS should ensure
that the NPI when it becomes available is incorporated as the primary
identifier for dispensers in the NCPDP SCRIPT standard.
Recommended Action 11.2: HHS should
accelerate the enumeration of all dispensers to support transition to the NPI
Recommended Action 11.3: HHS should permit
the industry to use the NCPDP Provider Identifier Number in the event that the
NPS cannot enumerate dispensers in time for Medicare Part D implementation.
Recommended Action 11.4: HHS should evaluate
how mass enumeration of dispensers for the NPI can occur using the NCPDP
Provider Identifier Number database.
Recommended Action 11.5: HHS, when requiring
the NPI as the primary identifier for dispensers, should protect the ability to
maintain linkages to the NCPDP Provider Identifier Number database for current
claims processing purposes.
Now Observation 12 is the prescriber
identifier. There is no single identifier for prescribers. The DEA Number is
widely used as a proxy. Although testimony is expected to be heard from the
DEA between now and March 2005 others indicated that the DEA prefers the number
to be reserved for use only on prescriptions for controlled substances. NCPDP
created HCIdea for the purpose of enumerating prescribers in order to eliminate
usage of the DEA on prescription claims when transmitted between dispensers and
payers/PBMs. It is not currently made available directly to prescribers. The
HCIdea database supports all of a prescriber’s DEA numbers, practice locations,
and the NPI when it becomes available. The NPI is the HIPAA standard for
identifying all providers, including prescribers, on all HIPAA transactions. The
NPI database could accommodate a bulk load from HCIdea to include missing
elements, if efficient and valid to do so.
It is further noted that the DEA is
anticipated to produce an electronic signature standard to ensure the
protection of messages containing prescriptions for controlled substances.
Electronic signatures will also be addressed by NCVHS in subsequent
Recommended Action 12.1: HHS should ensure
that the NPI, when it becomes available, is incorporated as the primary
identifier for prescribes in the NCPDP SCRIPT standard. It should be noted
that the NPI must be at the individual prescriber level because a prescription
cannot be written at a group level.
Recommended Action 12.2: HHS should
accelerate the enumeration of all prescribers to support transition to the NPI
Recommended Action 12.3: HHS should permit
the industry to use the NCPDP HCIdea in the event that the NPS cannot enumerate
prescribers in time for Medicare Part D implementation.
Recommended Action 12.4: HHS should work with
the industry to identify issues and possible solutions that deal with all
elements of the prescriber location and include those solutions in the 2006
Recommended Action 12.5: HHS should evaluate
how mass enumeration of prescribers for the NPI can occur using the NCPDP
Recommendation Action 12.6: HHS, when
requiring the NPI as the primary identifier for prescribers, should protect the
ability to maintain linkages to the NCPDP HCIdea database for e-prescribing
DR. LUMPKIN: Has anybody identified any
comments on this section?
DR. COHN: Anybody located any problems?
DR. HUFF: The only thing that occurred to me
on rereading this is whether, certainly what we said was true, that we want
this used in NCPDP SCRIPT and I wondered if our intent was to focus it only on
that or if really we meant that we wanted to use the NPI in any of the messages
where users or dispensers were identified. So that we would just add in there
in NCPDP SCRIPT and other e-prescribing messages or something like that, that’s
DR. COHN: I think maybe we’ll defer that
back to the subcommittee, I think we actually discussed that once, or at least
maybe we sent emails off about it and I think it was the opinion of the
subcommittee that we not go there but we can certainly review it. Do others
have a strong feeling depending on what we come back with on this one?
MR. BLAIR: I think we’d need to really
discuss it and think about it, I’m not saying no, I’m just saying we need to
discuss and think about it and I don’t know if —
DR. HUFF: [Off microphone.]
DR. LUMPKIN: Okay, we’ll have the
subcommittee think about it tomorrow morning.
DR. COHN: Okay, so bring back either the
same thing or some changes to it. Steve.
DR. STEINDEL: John in light of the
conversation we had this morning do you want us to add a recommendation 12.7
that you get 007?
DR. LUMPKIN: Yeah, that works.
MS. BEREK: I was looking for the vanity
MR. BLAIR: I want to know if we have to have
a recommendation to protect ourselves against weapons of mass enumeration.
DR. COHN: I think we’ve been going at this
Okay, shall we move into Observation 13,
pilot test objectives.
NCVHS has observed that there were many impediments
to full adoption and implementation of the HIPAA transactions and code sets
standards. With the requirements for pilot testing in e-prescribing HHS has
the opportunity to address these issues. As previously noted, while the
foundation standards being recommended here are suitable for early industry
adoption there are several areas in the foundation standards that do not
support all the MMA requirements.
Recommended Action 13.1: HHS should support
the efforts of standards development organizations to incorporate in the
foundation standards as many as possible of the additional functions required
for MMA as identified in these recommendations.
Recommended Action 13.2: HHS should include
foundation standards with as many as possible of the additional functions
required for MMA in the 2006 pilot tests.
Recommended Action 13.3: HHS should identify
specific goals, objectives, and metrics to guide the design and assessment of
the 2006 pilot tests so that the resulting information from the pilots facilitates
industry adoption and prescriber usability. The metrics should include
economic and quality of care factors.
Recommended Action 13.4: HHS should develop
and widely promulgate information concerning the economic and quality of care
benefits of e-prescribing, provide comprehensive education on implementation
strategies, and address other elements that contribute to successful and
And probably there’s a 13.5 based on our
previous conversation that HHS should develop and publicize a timeline for the
pilot projects and expectations of the industry for the 2006 pilots, which
needs to be wordsmithed but I think that’s sort of what we’re trying to say.
Should develop and publicize a timeline for the pilots as well as expectations
for the industry or of the industry, I mean this isn’t quite right but we’re
sort of trying to I think reflect on a view that there needed to be a timeline
that was publicized and that both related to what it was going to go on as well
as expectations of the private sector.
DR. LUMPKIN: I was wondering if there should
be an additional sentence also added, a sentence or two, to the observation
along the lines of commencement of, beginning a pilot requires some prior
actions by the vendor community and that a 2006 start up requires some earlier
development of the standards, something like that.
DR. COHN: Let’s see what we’ve got up here.
MS. AMATAYAKUL: Just a note.
DR. COHN: Success for the 2006 pilots will
require much pre-work by the industry, something on that level. Okay, other
DR. LUMPKIN: Well, go this way so we’ll
start off with Bob.
MR. HUNGATE: In Recommendation 13.4
promulgating information, I’m wondering about privacy, confidentiality
protection aspects and the communication that goes out relating to that, I
think they’ll be sensitivities, I wonder if they shouldn’t be addressed as part
of this, it’s partly a question is this the right place to raise that
question. It’s really 13.4, if I said 3 I meant 4, comprehensive education I
think should respect the need to communicate to individuals how their
information is protected as well.
DR. MAYS: Can I piggyback on his because I
have almost the same, so if you’re going to consider this I was going to ask
the same thing there, we’ve been worried in these pilot objectives about the
prescriber, and we’ve been worried about the industry, but what about the
actual patient in terms of their concerns about this process in terms of
privacy and confidentiality or any barriers that may come from their perception
or attitudes? Is this the place to also consider as a part of the objective to
learn if there are barriers that they have?
DR. STEINDEL: Simon I think we do state at
the end of the letter that we’re going to be addressing privacy concerning e-prescribing
after this letter, it’s obviously a very complex issue and I think just adding
a couple of words here and a couple of words there does not do it justice and
it needs a separate letter. The question is do we need to point out before the
very last paragraph, like someplace in the introduction or something like that,
just a one sentence statement more or less to the effect of we understand
privacy in the e-prescribing arena is complex and we’ll be addressing it at a
later date, something like that.
DR. LUMPKIN: But I think the issue is not
being raised, I mean privacy is a whole separate discussion but patients might
want to know that there’s a change coming on and how that impacts them.
MS. BEREK: This is slightly unrelated
because you’re talking about timeline, I just want to remind us all that in
fact the timeline begins when we send this letter, and the longer we take to
send this letter the longer it takes to kick off the timeline. Just an
obnoxious remark from CMS that can’t issue any regulations on this until this
letter goes, so I just think we need to just remember that and finish our
DR. LUMPKIN: Is tomorrow soon enough?
MS. BEREK: Yes, tomorrow would be just
fine. Karen told me I could give you until tomorrow, I was going to say today
but she’s doing the work, she said tomorrow is okay.
DR. LUMPKIN: Well it’s good to see that
Karen is in a good mood because usually she’s not that lenient. Jeff.
MR. BLAIR: I rise in support of the
honorable lady from California, Vickie Mays, who has I think raised a point
that I think is not covered in the letter, I do fully agree with Steve’s
observation that we will be hitting privacy as a subject and there’s so many
aspects to that and covers so many things that that’s why we deferred to
afterwards, so I’m not talking about the privacy piece. But Vickie questioned
in my mind, at least what I’ve heard, was we’ve not said anything about
measuring the reaction of consumers in the pilot test, so when we get down to
the pilot test issues, those questions, I think that that would be an
appropriate place for us to include that point that Vickie has made.
MS. GREENBERG: I don’t know if this is so
much the pilot test, I was going to say on the widely promulgated information
concerning the benefits, I mean I think, I don’t know whom that was directed
to, whether it was primarily directed to the industry, but I think that we
should specifically say information for the health industry and consumers, that
we should mention consumers there.
MR. BLAIR: And maybe we’re blurring it when
we say consumers versus patients, so maybe when we get down to the pilot test
piece we could see what words we put in.
DR. FITZMAURICE: Could I suggest just a word
change, instead of promulgate might we say disseminate, to make it
distinguished from passing a regulation? Under there where it says, on 13.4,
HHS should widely, should develop and widely promulgate information, kind of
promulgate regulations and disseminate information.
DR. COHN: Well, I guess I’m trying to keep
up with all the comments coming north, south, east, and west, and I’m sort of
looking at what Margaret’s doing and I’m somehow feeling that we’re now, we’re
going to sort of look at each other tomorrow and have not gotten this right at all,
so I guess I want us all to sort of look and sort of think about where the
various comments ought to be and I mean once again which recommendations are we
talking about here and all of that, and maybe Judy has a comment to help us
with this one.
DR. WARREN: I was noticing where Margaret
put patient response and this whole action is about disseminating information,
and in listening to everybody talk, I mean we’ve not made any recommendations
that patient response be part of the pilot and maybe that’s a really strong one
and it should be its own recommended action, that when the pilot is designed
and developed that it should include paying attention to how patients respond
DR. COHN: Is that one of the metrics that’s
just the next sentence there?
DR. WARREN: Oh, I wish you hadn’t asked me
DR. COHN: Well, it says metrics should
include economic and quality of care factors, as well as patient satisfaction.
DR. LUMPKIN: The metrics should include
economic and quality of care factors —
DR. COHN: As well as patient satisfaction —
DR. WARREN: That would be a good place, I’d
go with that.
DR. LUMPKIN: Satisfaction is not the right
DR. COHN: Well, okay, then help us with that
DR. WARREN: Patient acceptance.
MR. BLAIR: Patient reactions.
DR. LUMPKIN: How about just patient factors?
MS. GREENBERG: No, that could mean —
DR. WARREN: Factors is too vague I think.
MR. BLAIR: Patient reactions —
MR. HUNGATE: I think reactions is pretty
MR. LOCALIO: Don’t you want patient participation?
I mean you have to have everybody participating in the pilot study or nothing
is going to be pilot studied, and that’s one of the key elements, they have to
go along with it. If everybody wants a piece of paper when they go out of the
physician’s office this won’t work, if everybody demands a prescription piece
of paper. So pilot testing as in any study, any study, you’ve got to have the
patient’s participation and you can’t study them. Think of it as a clinical
trial, this is just a very big kind of messy clinical trial and the patients
have to consent and participate.
DR. COHN: So is that part of the metrics, is
that what you’re describing? That patient participation is one of the metrics?
DR. LUMPKIN: Yeah, but they could
participate and not be happy about it, which would not be a good outcome.
MR. LOCALIO: Actually satisfaction is in
addition to participation, once they participate if they’re satisfied then you
still have a problem.
DR. LUMPKIN: Harry and then Vickie.
MR. REYNOLDS: I’d like to see us consider
adding to 13.5 and I won’t wordsmith right now but somewhere in there a clear
definition of the functionality to be tested in the pilot, a lot of the
discussions that have gone on previously, if the codified SIG is not ready you could
still pilot, if Rx-Norm, because there’s still functionality, significant
interoperability and other things you can test, so it just, so if vendors have
to get ready for the pilot, others have to get ready for the pilot, the
quicker, that when that timeline is set it also clearly has to identify the
functionality and the functionality may come in stages. If the Secretary could
look at it and say I’m starting these pilots now, six months from now that we
will also include the codified SIG, da, da, da, da, da, da, it gives you a
possible way to, because people can’t develop anything without knowing what
that functionality is that they’re having to do if all the long term stuff
isn’t necessarily ready.
DR. STEINDEL: Harry, why doesn’t 13.2
address that? We’re leaving it open but we’re saying just put as many pieces
as you can when they’re ready, we can’t list the pieces now.
MR. REYNOLDS: I’m not trying to list them
but when we talk about a timeframe —
DR. STEINDEL: Yeah, but we already say in
13.2 that we can do this in pieces.
MR. REYNOLDS: I don’t think it’s too clear
but I’ll defer.
DR. MAYS: I guess I’m a little concerned
with trying to kind of just throw the “patient” whatever factor, whatever, in
13.4, partially because if you go back to your kind of lead in in Observation
13 it really does seem like it’s only the patient in relationship to the
industry standards, something like that, so I think it just requires another
sentence, either another sentence up above that says something about the patients
and then I guess it can be in 13.4, or both, which is a sentence and then maybe
a separate recommended action.
DR. STEUERLE: I mean I don’t think we can
wordsmith it now but if we’re going to put in some of this information about
patients I am concerned that we be clear, that we really want an informed
patient reaction, if for instance all we do is ask patients how they feel about
some additional information being floated around without them having any idea
that perhaps they’re getting better health care, or if this is a pilot that as
a result of the pilot it’s done on a broader scale it may improve national
health or something, you’re not getting a full consumer reaction, the only
patient reaction I’m getting is to the paperwork and all we’re inviting are the
negative comments, and it seems to me if we’re suggesting this has to be part
of the pilot there has to be an accompanying information process, I mean I
don’t know whether it’s a survey or whatever it else, but it has to give them
more information just in that they were participating in this process and this
additional paperwork is passing around because then we only invite the negative
reactions and we don’t get there action to the consumer advantages on the other
DR. CARR: I think Vickie’s point and the
points that have been made are very good because in fact the patient
participation in this is going to change, they’re going to have to arrive at
their doctor’s office with their pharmacy number, knowing what pharmacy they’re
going to, what the phone number is, when they’re available, and so on. And so
in fact there may be some element of patient education and just sort of as I
read through this I couldn’t, the whole wonderful document that you guys have
done, it made me think of the dimensions of care that we are offering the
patient and the system is care that is safe, effective, efficient, patient
centered, timely, equitable, and what am I missing, anyway, each of those
dimensions and so I think it really is important to bring the patient centered
element into it as well and they will have a change in their behavior but their
benefits will be that we have more closely approximated the IOM ideal patient
DR. LUMPKIN: Okay, I think what we need to
do with 13 is really to look at the issue of, because I think that the issue of
the patient needs to be injected into the observation, into 13.3 under metrics,
and then 13.4 in informing, in those three areas.
MR. HOUSTON: I was just talking to Richard
about this, I guess there is a classic patient safety issue here that still
needs to be considered and the question is is I sort of heard that there’s all
these reasons why it’s to the benefit of the patient but I think it’s part of
what’s trying to be established here is that there are those benefits to the
patient as well as others and so should we say something about pilot test
objectives to ensure that it is safe and effective and does it merit IRB, I
would think an IRB of some sort needs to be involved in this type of activity.
DR. LUMPKIN: See I told you guys you
shouldn’t be talking —
MR. HOUSTON: If they would have put Judith
between me and Richard this would never have happened, and then you would’ve
never had that problem earlier.
DR. LUMPKIN: I don’t know if you need an IRB
if it’s mandated by Congress, that wasn’t a serious comment. Okay.
DR. COHN: I think we’re about done with this
one, I guess I would ask those of you who have all commented, I mean what
happened was that there were a bunch of rapid fire comments and I would I guess
have you all look at these, especially the ones as Margaret, I mean Margaret’s
been fiddling with it, once again at the next break you might want to go up and
make sure that your meanings at least are up there so we can consider them
tomorrow morning, because I heard a lot of things, some of which Margaret got,
some of which Margaret didn’t, so I would just ask you to take a look and sort
of see how closely it aligns with your views, I don’t think I have much
objection with almost, with what everyone was saying, but it’s really a
question of how we get it up there in a way that won’t take us an hour
DR. LUMPKIN: I agree, and I know we need to
move on because as Jeff pointed out we have 20 minutes and a few more things to
go. But I actually want to just sort of ask a question back on the
identifiers, and it’s sort of prompted by something that Justine said that sort
of made me pause, if I go to my doctor and they ask me who my prescriber is,
who my dispenser is, I’m going to say Walgreen’s at 95th and
Western. But as I was trying to look back at our description of the NPI it’s
going to be Pharmacist Smith or Jones or whatever, how do we handle that?
MR. BLAIR: That’s why there’s the pilot test
with the mapping.
DR. COHN: Margaret, I believe actually it
gets it at that level also.
DR. LUMPKIN: So the pharmacy?
MR. BLAIR: And it has to map to that NCPDP
MS. AMATAYAKUL: The NPI maps to the NCPDP
database that contains much more information about location.
DR. LUMPKIN: And I have a sister-in-law
who’s a pharmacist who works at two or three different locations, which if I’m
going, and it may be that there’s no need for that, well, how does my doc know
where to send my prescription?
MR. ROTHERMICH: The NPI is used on the NCPDP
transactions but the prescribing systems, the actual software systems, can
still show Walgreen’s at 95th and Western, so the patient won’t need
to know any numbers or anything about that, they’ll still be able to use sort
of their common parlance, but the systems behind that support this will be more
DR. LUMPKIN: And the doc will be able to
pick that off of a scroll down list or something like that —
MR. ROTHERMICH: Right, and then the system
behind the scenes will have an NPI associated to that pharmacy.
DR. LUMPKIN: Great. Next?
DR. COHN: I think we’re okay. I think Karen
wanted a further comment —
MS. TRUDEL: I just wanted to clarify one
other issue and that’s that while the NPI can enumerate the pharmacist when we
say the dispenser ID we really mean that Walgreen’s address.
DR. LUMPKIN: So the Walgreen’s at 95th
and Western would also have an NPI.
MS. TRUDEL: An NPI, right.
DR. COHN: I think the answer is yes.
DR. LUMPKIN: Okay, 14.
DR. COHN: Okay, Observation 14 is support
for standards collaboration. A significant level of collaboration is occurring
among SDOs and with vendors who have proprietary solutions as there is growing
momentum for e-prescribing and other components of the NHII. It is important
to support the open, consensus based, actually there’s a change here, what is
it, it is important to support the open consensus based and voluntary nature of
standards development organizations while accelerating the process of standards
development and coordination.
Recommended Action 14.1: HHS should
financially support standards coordination activities to ensure a seamless
e-prescribing process across provider domains, e.g., physician office,
hospital, long term care, dispensers, and payers/PBMs.
Recommended Action 14.2: HHS should encourage
standards development organizations to adopt a change management process that
permits versions to maintain interoperability.
Observation 15, policies to remove barriers.
Testimony identified widespread industry concerns relating to safe harbor,
preservation of provider/patient choice, and freedom from commercial bias in
messages received through e-prescribing applications.
Recommended Action 15.1: HHS should ensure
that regulations define the parameters of safe harbor, ensure preservation of
provider/patient choice, and require that e-prescribing messages received
through e-prescribing applications be free from commercial bias.
Okay? Any comments on that one?
Observation 16, and I think this is another
where I’ll have you look at the small print, and this is conformance testing
and certification. Testimony identified the need for testing conformance to
standards and certification of e-prescribing systems, i.e., standards
conformance, functionality, and interoperability. While conformance testing
and certification are two distinct but interrelated concepts it should be
recognized that some parts of the industry use the term “certification” in the
limited sense of passing a conformance test.
Recommended Action 16.1: HHS should support
SDOs in their development of conformance tests for the e-prescribing standards
and their implementation guides.
Recommended Action 16.2: HHS should require
that e-prescribing system vendors validate the conformance of their
Recommended Action 16.3: The HHS Office of
the National Coordinator for Health Information Technology should investigate
how e-prescribing applications might best be certified.
DR. MAYS: Can you just tell me what you want
in terms of support, HHS should support standards development organizations,
what does that mean? What do you want them to do?
DR. COHN: You mean in terms of their
development of conformance tests?
DR. MAYS: 16.1, yeah.
DR. COHN: Well, I think it might include up
to and including funding work that they have to do. Jeff, did you have a
MR. BLAIR: Yeah, Vickie your perceptive, you
picked up, we used different words here, we said financially support and we
didn’t use that in other standards activities, and the reason that we did that
is that for the most part the standard development organizations are self
sustaining, but the coordination between standards organizations, am I on the
wrong question? What is the phrase, never mind.
DR. STEINDEL: Vickie, this was actually, came
up when we used the word support versus financial support in a lot of these, if
you notice this is one where you picked it up. This is more of a direction to
HHS that when HHS is working with the SDOs, like for instance when I go to HL7
and I’m wearing my HHS/CDC hat and we’re talking about standards, that I should
look at those meetings and bring up the question of conformance testing and
certification and to try to include that as part of the standards and if
necessary go back to HHS and maybe ask for more support in this area, perhaps
financial. But we deliberately worded it broadly so it covers both of those
but this is somewhat of a requirement that’s more on the HHS people that are
working with the SDO processes.
MR. REYNOLDS: I think one other opportunity
that’s available with the SDOs is most of them are volunteers and if you want
to accelerate something HHS could offer them some financial aid where
consultants or others could be assigned to them to produce these things faster
then they would be done through a normal voluntary organization, especially
since these are key in making sure that people do it right rather then somewhat
the interpretation free for all that was going on with some of the HIPAA stuff,
so that’s what this meant. Because with the volunteers you can only do it at a
certain speed, you put money in you can actually bring bodies of people to the
table to go ahead and do it and do it much quicker and in a much more
DR. LUMPKIN: Okay, next steps.
DR. COHN: Should we read the next steps
here? Other comments?
DR. LUMPKIN: Wait, Richard has been talking
to John again.
DR. HARDING: Just a minor thing but back on
15.1 the last phrase of the recommendation 15.1, be free from commercial bias.
Now I’d like to think that’s possible but it just seems like it’s a negative
statement, free from commercial, could it be something else like be evidence
based or something that is different because I think it’s impossible to say
that we could have something free from commercial bias.
DR. COHN: This is actually referencing both
the conference report on the MMA legislation as well as I believe a letter we
received from Senator Grassley in the process of our deliberations, and I think
there was some, this is a reminder to us that there was a requirement at least
from the conference report that it be free from commercial bias. Now how you
do it I agree with you —
DR. HARDING: Could you put quotes around it?
MR. HOUSTON: Could we put a footnote that
references the conference report or something so that at least if somebody says
what are they talking about commercial bias is indicated that it’s simply they
can go and understand why we used that particular phase.
DR. COHN: Sure. Is that okay?
DR. LUMPKIN: Next steps?
DR. COHN: Okay, next steps. There are
several other message format, terminology, and identifier standards and
important related issues that were identified by NCVHS but that are not
addressed in this initial set of recommendations. NCVHS plans to receive
testimony on as many of these topics as possible between now and March 2005 and
make further recommendations in March 2005. The topics include: electronic
signature for use in e-prescribing, issues related to privacy and security with
respect to e-prescribing, and I want to thank Mark Rothstein for taking the
lead on that. A directory that would identify prescribers, nursing facilities,
and pharmacies that are able to accept e-prescribing transactions, codification
of allergens, drug interactions, and other adverse reactions to drugs,
incorporation of indications for drug therapy into e-prescribing messages, a
standard for units of measure, methods for patient identification for
e-prescribing, use of the National Health Plan ID for e-prescribing, formulary
identifier, exchange of medication history among all participants in the
e-prescribing process, exchange of medical history within the e-prescribing
process, how best to ensure the interoperability among e-prescribing standards,
standard codes for orderable items, such as insulin supplies, exchange of drug
labeling and drug listing.
And then finally NCVHS wishes to thank you
for the opportunity to make these recommendations, Sincerely John Lumpkin.
And the floor is open.
DR. KIMMEL: This is Dr. Zebediah Kimmel from
Dr. Brailer’s Office. We’d like to request that NCVHS consider adding the
topic of clinical decision support explicitly to this list of next steps and
we’re particularly interested in your input on the topic of advanced clinical
decision support functionalities which have to heretofore been extensively
addressed perhaps in discussions such as these.
DR. COHN: I think that’s a friendly
amendment, Jeff has time on his hands.
MR. BLAIR: In concurrence.
DR. COHN: Thank you.
DR. MAYS: Would this be the place to also
put something back in about the patients in terms of, since you’re going to get
testimony would you want to do it here or do you want to just leave that to the
DR. COHN: I’m sorry, help me with this one.
DR. MAYS: Well, what I’m asking is here is
whether or not, for example you’re talking about getting testimony, is there,
we talked about for example learning more about patient’s acceptability and
what kind of patient education you may need to do in the pilot, as part of
pilot objectives, this is testimony, would it at all facilitate there being any
kind of testimony to understand what kind of patient education to do, what kind
of patient factors to look at?
MR. BLAIR: I feel as if we’re not going to
be able to learn as much about asking patients about their reactions when
e-prescribing systems are not in use that much today, especially the ones that
we’re talking about, but I do think we could learn a lot if we make sure that
patients are included, or the reactions of patients are included in the pilot
test so if you feel strongly about requesting testimony I think we could do so
but I feel like we’re going to get more information on including the patients
in the pilot tests.
DR. WARREN: Just as kind of an aside, we’ve
been getting a lot of information in our testimony about patient responses,
either from advocacy groups or examples from physicians, and we already have on
example that I thought was incredibly good about e-prescribing, that one
pediatrician was using e-prescribing and the mothers absolutely adored it
because they had to spend less time in the pharmacy waiting for the drugs to be
filled. So here they are with sick children, they go in, the drugs are ready
when they get there. Unfortunately the pharmacy lost income because now the
mother was no longer buying toys for the children while they were waiting for
the drugs to be filled. So I think we’re getting some of these things as we’re
getting other testimony.
DR. COHN: I think there’s also decreased
child satisfaction —
DR. STEINDEL: John, what came to mind with
all these comments, in the closing remarks, we’re making recommendations for
the pilot and we’re saying that we’re going to hold further hearings on the
pilots. Do you think we might want to add a comment that NCVHS would like to
review the pilot? The instructions, what they’re going to do?
DR. LUMPKIN: I think that we would be happy
to assist the Secretary by reviewing —
DR. COHN: And that’s in the final sentence
MR. BLAIR: Could we describe that as an
offer rather then a request, that we are available to do that?
DR. LUMPKIN: Yes. And I’m just concerned
that I’m going to get a Dear John letter back from the Secretary.
DR. COHN: Well, I guess we should talk about
sort of next steps on this letter, certainly as you can imagine I don’t intend
to reread this tomorrow, I think I had my day of reading pages for everyone, so
let’s talk a little bit about getting from here to the next version to
consideration tomorrow in a serious fashion.
DR. LUMPKIN: Before we do that I have a note
on here, something about section 7.3 that we wanted to, did we adequately cover
that? And I don’t remember what it was but someone had raised a point and we
wanted to —
MR. LOCALIO: Especially if we’re going to
offer to review the pilot test, that would be certainly the opportunity to
raise some of these issues about the potential success of some of these
proposed pilots, or their feasibility.
DR. COHN: So you’re basically okay with 7.3
at this point assuming that we’re able to review what they’re planning on
doing, okay, great.
DR. LUMPKIN: I think methodology, the
approach tomorrow, there have been a number of recommendations, I think what we
should is just walk through those changes tomorrow.
DR. COHN: Okay, and so what we’ll do is get
a redlined version with just changes that occurred out of our conversation
today, or actually let me think about it, things that I guess we agreed to
today we probably don’t need to show, it’s only the things that we’re putting
in after the end here —
DR. LUMPKIN: Right, the things that the
committee has —
DR. COHN: Deferred, okay, is everybody okay
DR. LUMPKIN: We’re going to get a copy
tomorrow, sometime before lunch I assume —
MS. GREENBERG: Will it highlight everything
that we’ve added to this version?
DR. COHN: Obviously what we have are a
couple of different versions in front of us, we have a version that was sent
out, a version that we walked in today that had had some changes made, then
there were also some changes that we sort of said oh yes, so I guess what we
ought to do is look through all the changes that we sort of suggested during
our conversation as well as additional things that the subcommittee, so
basically anything from sort of this version on will be reviewed as we go
forward, and I guess we will be reviewing it initially at the 8:00 a.m.
Standards and Security Subcommittee meeting and yet any changes beyond that
will be available to people shortly after the full meeting occurs at 10:00 for
them to review and I guess we’ll consider it in the afternoon.
MR. BLAIR: One last observation, I want to
especially recognize the patience and the leadership that Simon has provided,
that have gotten us through especially these last few months and especially
these last few weeks because I think a lot of us really questioned whether this
was possible and I think Simon has really provided the leadership, thank you.
DR. LUMPKIN: And Marjorie said there wasn’t patients on this.
Before we break we need to take a count for dinner tonight.
[Whereupon at 3:05 p.m. the meeting was adjourned.]